Unassociated Document
As
filed with the Securities and Exchange Commission on July 29,
2009
Registration
No. 333-153278
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
AMENDMENT
NO. 4
TO
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
GENTA
INCORPORATED
(Exact
name of registrant as specified in its charter)
Delaware
|
2836
|
33-0326866
|
(State
or other jurisdiction of
|
(Primary
Standard Industrial
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Classification
Code Number)
|
Identification
Number)
|
200
Connell Drive
Berkeley
Heights, New Jersey 07922
(908)
286-9800
(Address,
including zip code, and telephone number, including area code, of registrant’s
principal executive offices)
Raymond P. Warrell, Jr.,
M.D.
Chairman
and Chief Executive Officer
Genta
Incorporated
200
Connell Drive
Berkeley
Heights, New Jersey 07922
(Name,
address, including zip code, and telephone number, including area code, of agent
for service)
Copies to:
Emilio
Ragosa, Esq.
Morgan,
Lewis & Bockius LLP
502
Carnegie Center
Princeton,
New Jersey 08540
tel:
(609) 919-6600
fax:
(609) 919-6701
Approximate date of commencement of
proposed sale to the public: As soon as practicable after the effective
date of this Registration Statement.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, check
the following box. £
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. £
If this
form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. £
If this
form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. £
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer £
|
Accelerated filer £
|
Non-accelerated filer R
(Do not check if a smaller reporting company)
|
Smaller reporting company £
|
CALCULATION
OF REGISTRATION FEE
|
|
Title
of Each Class of Securities
to
Be Registered
|
|
Amount
to be
Registered
|
|
|
Proposed
Maximum
Offering
Price Per
Security
|
|
|
Proposed
Maximum
Aggregate
Offering
Price
|
|
|
Amount
of
Registration
Fee(2)
|
|
Units(1),
each unit consisting of
|
|
|
7,000 |
|
|
$ |
1,000 |
(1) |
|
$ |
7,000,000.00 |
|
|
$ |
390.60 |
|
(i) 70%
Convertible Notes, and
|
|
|
4,900 |
|
|
|
|
(1) |
|
$ |
4,900,000.00 |
|
|
|
|
(1) |
(ii) 30%
Shares of Common Stock (par value $0.001 per
share)
|
|
|
2,100 |
|
|
|
|
(1) |
|
$ |
2,100,000.00 |
|
|
|
|
(1) |
Shares
of Common Stock (par value $0.001 per share) underlying the Convertible
Notes
|
|
|
49,000,000 |
|
|
$ |
0.10 |
(6) |
|
$ |
4,900,000.00 |
|
|
|
|
(3) |
Convertible
Notes issuable as payment of interest on the Convertible
Notes
|
|
|
832 |
|
|
$ |
1,000 |
|
|
$ |
832,308.00 |
|
|
|
— |
|
Shares
of Common Stock underlying the Convertible Notes issuable as payment of
interest on the Convertible Notes
|
|
|
8,323,080 |
|
|
$ |
0.10 |
(6) |
|
$ |
832,308.00 |
|
|
|
|
(3) |
Warrants
to purchase Common Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
of Common Stock underlying the Warrants
|
|
|
12,250,000 |
|
|
$ |
0.10 |
(6) |
|
$ |
1,225,000.00 |
|
|
|
|
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
390.60 |
(5) |
(1)
|
Each
Unit will be issued in $1,000 denominations and will consist of 70% (or
$700) convertible notes and 30% (or $300) shares of common
stock.
|
(2)
|
Estimated
solely for the purpose of calculating the amount of the registration in
accordance with Rule 457(o) under the Securities Act of 1933, as amended,
based on the average of the high and low sale prices of the Registrant’s
common stock on March 2, 2009, as reported by the Over-the-Counter
bulletin board. In accordance with Rule 416 under the Securities Act of
1933, in order to prevent dilution, a presently indeterminable number of
shares of common stock are registered hereunder which may be issued in the
event of a stock split, stock dividend or similar transaction. No
additional registration fee has been paid for these shares of common
stock.
|
(3)
|
Pursuant
to Rule 457(i), no separate registration fee is required for Shares of
Common Stock underlying the Convertible Notes because we are registering
those securities in the same registration statement as the Convertible
Notes.
|
(4)
|
Pursuant
to Rule 457(g), no separate registration fee is required for the Shares of
Common Stock underlying the Warrants because we are registering those
securities in the same registration statement as the
Warrants.
|
(5)
|
A
registration fee of $905.00 was previously paid by the registrant in
connection with the initial filing of this Registration Statement on Form
S-1 (File No. 333-153278), which was filed by the Company on August 29,
2008.
|
(6)
|
Estimated
solely for purposes of calculating the proposed maximum aggregate offering
price.
|
The registrant hereby amends this
registration statement on such date or dates as may be necessary to delay its
effective date until the registrant shall file a further amendment which
specifically states that this registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933 or until the
registration statement shall become effective on such date as the
Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the Registration Statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and we are not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted.
PROSPECTUS
Subject
to completion, dated July 29, 2009
GENTA
INCORPORATED
Up
to $7.0 million of an aggregate principal amount of Units consisting of 70% (or
$4.9 million) Convertible Notes and 30% (or $2.1 million) Common
Stock
Up to 49,000,000 shares of Common
Stock underlying the Convertible Notes
$832,308
Convertible Notes issuable as payment of interest on the Convertible
Notes
8,323,080
shares of Common Stock underlying the Convertible Notes issuable
as
payment
of interest on the Convertible Notes
Warrants
to purchase 12,250,000 shares of Common Stock
12,250,000
shares of Common Stock underlying the Warrants
We are
offering units consisting of an aggregate principal amount of $4.9 million
convertible notes and $2.1 million common stock, 49,000,000 shares of common
stock underlying the convertible notes, $832,308 convertible notes convertible
into 8,323,080 shares of common stock issuable as payment of interest on the
convertible notes, warrants to purchase 12,250,000 shares of our common stock
underlying the principal amount of the convertible notes and 12,250,000 shares
of common stock underlying the warrants collectively referred to as the
securities. All costs associated with this registration will be borne by
us. On June 26, 2009, we effected a 1-for-50 reverse stock
split. As a result, the share numbers and stock price numbers found
herein are all reflected on a post-split basis.
On
July 28, 2009, the closing price of our common stock was $0.38 per share. Our
common stock is quoted on the OTC Bulletin Board under the symbol
“GETA.”
Brokers
or dealers effecting transactions in these shares should confirm that the shares
are registered under the applicable state law or that an exemption from
registration is available.
These
securities are speculative and involve a high degree of risk.
Please refer
to “Risk Factors” beginning on page 12.
|
|
Price
to Public
|
|
|
Placement
Agent
Discounts
and
Commissions
|
|
|
Proceeds
to Genta,
before
expenses
|
|
Per
Unit
|
|
$ |
1,000.00 |
|
|
$ |
60.00 |
|
|
$ |
930.00 |
|
Total
|
|
$ |
7,000,000.00 |
|
|
$ |
420,000.00 |
|
|
$ |
6,580,000.00 |
|
We
have retained Rodman & Renshaw, LLC as placement agent to use its reasonable
best efforts to solicit offers to purchase our securities in this offering in
one or more closings. We have agreed to indemnify the placement agent against
some liabilities, including liabilities under the Securities Act of 1933, as
amended, or the Securities Act, and to contribute to payments that the placement
agent may be required to make in respect thereof. For more information related
to our arrangement with Rodman & Renshaw, LLC, including the fees payable to
Rodman for their placement agent services in connection with this offering,
please see “Plan of Distribution” on page 109.
The securities offered herein will only be offered to investors
who qualify as institutional Accredited Investors as defined in Regulation D
under the Securities Act of 1933.
None of
the proceeds from the sale of securities will be placed in escrow, trust or any
similar account, and all of the subscription monies will be immediately
available for our use. There is no minimum amount of securities that must be
sold.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities, or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
We expect
to deliver the securities to purchasers pursuant to this prospectus on or about
[___].
The
date of this prospectus is July 29, 2009.
Rodman
& Renshaw, LLC
TABLE
OF CONTENTS
|
|
Page
|
|
PROSPECTUS
SUMMARY
|
|
|
1 |
|
RISK
FACTORS
|
|
|
12 |
|
FORWARD-LOOKING
STATEMENTS
|
|
|
29 |
|
USE
OF PROCEEDS
|
|
|
30 |
|
DIVIDEND
POLICY
|
|
|
30 |
|
CAPITALIZATION
|
|
|
31 |
|
DILUTION
|
|
|
33 |
|
DESCRIPTION
OF BUSINESS
|
|
|
34 |
|
LEGAL
PROCEEDINGS
|
|
|
45 |
|
PRICE
RANGE OF COMMON STOCK
|
|
|
46 |
|
SELECTED
FINANCIAL INFORMATION
|
|
|
47 |
|
SUPPLEMENTARY
FINANCIAL INFORMATION
|
|
|
48 |
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
|
|
49 |
|
CHANGE
IN INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
|
|
64 |
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
|
64 |
|
MANAGEMENT
|
|
|
65 |
|
EXECUTIVE
COMPENSATION
|
|
|
67 |
|
SECURITY
OWNERSHIP OF MANAGEMENT
|
|
|
81 |
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
|
|
|
82 |
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
|
|
|
83 |
|
DESCRIPTION
OF SECURITIES
|
|
|
84 |
|
PLAN
OF DISTRIBUTION
|
|
|
109 |
|
LEGAL
MATTERS
|
|
|
110 |
|
EXPERTS
|
|
|
110 |
|
HOW
TO GET MORE INFORMATION
|
|
|
111 |
|
INDEX
TO FINANCIAL STATEMENTS
|
|
|
F-1 |
|
PART
II
|
|
II-1
|
|
You
should rely only on the information contained in this prospectus. We have not
authorized anyone to provide you with information different from the information
contained in this prospectus. We are offering to sell the securities, and
seeking offers to buy the securities, only in jurisdictions where offers and
sales are permitted. The information contained in this prospectus is accurate
only as of the date of this prospectus, regardless of when this prospectus is
delivered or when any sale of our common stock occurs.
FOR CALIFORNIA
RESIDENTS: WITH RESPECT TO SALES OF THE SECURITIES BEING
OFFERED HEREBY TO CALIFORNIA RESIDENTS, SUCH SECURITIES MAY BE SOLD ONLY TO: (1)
INSTITUTIONAL "ACCREDITED INVESTORS" WITHIN THE MEANING OF REGULATION D UNDER
THE SECURITIES ACT OF 1933 (THE “SECURITIES ACT’), (2)
“QUALIFIED INSTITUTIONAL BUYERS” WITHIN THE MEANING OF RULE 144A UNDER THE
SECURITIES ACT, (3) BANKS, SAVINGS AND LOAN ASSOCIATIONS, TRUST COMPANIES,
INSURANCE COMPANIES, INVESTMENT COMPANIES REGISTERED UNDER THE INVESTMENT
COMPANY ACT OF 1940, PENSION OR PROFIT-SHARING TRUSTS, CORPORATIONS OR ENTITIES
WHICH, TOGETHER WITH THE CORPORATIONS OR OTHER AFFILIATES WHICH ARE UNDER COMMON
CONTROL, HAVE A NET WORTH ON A CONSOLIDATED BASIS ACCORDING TO THEIR MOST RECENT
REGULARLY PREPARED FINANCIAL STATEMENTS OF NOT LESS THAN $14,000,000 AND
SUBSIDIARIES OF THE FOREGOING OR (4) ANY PERSON (OTHER THAN A PERSON FORMED FOR
THE SOLE PURPOSE OF PURCHASING THE SECURITIES BEING OFFERED HEREBY) WHO
PURCHASES AT LEAST ONE MILLION DOLLARS AGGREGATE AMOUNT OF THE SECURITIES
OFFERED HEREBY. EACH CALIFORNIA RESIDENT PURCHASING THE SECURITIES
OFFERED HEREBY WILL BE DEEMED TO REPRESENT BY SUCH PURCHASE THAT IT COMES WITHIN
ONE OF THE AFOREMENTIONED CATEGORIES, THAT IT WILL NOT SELL OR OTHERWISE
TRANSFER SUCH SECURITIES TO A CALIFORNIA RESIDENT UNLESS THE TRANSFEREE COMES
WITHIN ONE OF THE AFOREMENTIONED CATEGORIES AND THAT IT WILL ADVISE THE
TRANSFEREE OF THIS CONDITION WHICH TRANSFEREE, BY BECOMING SUCH WILL BE DEEMED
TO BE BOUND BY THE SAME RESTRICTIONS ON RESALE.
FOR INVESTORS OUTSIDE THE UNITED
STATES: Neither we nor the placement agent has done anything that would
permit this offering or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other than in the United
States. You are required to inform yourselves about, and to observe any
restrictions relating to, this offering and the distribution of this
prospectus.
PROSPECTUS
SUMMARY
This summary does not contain all of
the information you should consider before buying our securities. You
should read the entire prospectus carefully, especially the “Risk Factors”
section and our consolidated financial statements and the related notes appearing at
the end of this prospectus, before deciding to invest in our
securities.
Introduction
Unless
otherwise stated, all references to “us,” “our,” “we,” “Genta,” the “Company”
and similar designations refer to Genta Incorporated and its
subsidiaries.
This offering relates to the sale of
units consisting of our common stock and convertible notes convertible
into 49,000,000 shares of our common stock, 49,000,000 shares of common stock
underlying the convertible notes, convertible notes issuable as payment of
interest on the convertible securities convertible into up to 8,323,080 shares
of our common stock, up to 8,323,080 shares of common stock underlying any
convertible notes issued as payment of interest on the convertible securities,
12,250,000 warrants to purchase shares of our common stock underlying the
principal amount of the convertible notes and 12,250,000 shares of common stock
issuable upon exercise of the warrants.
Overview
We are a
biopharmaceutical company engaged in pharmaceutical, or drug, research and
development. We are dedicated to the identification, development and
commercialization of novel drugs for the treatment of cancer and related
diseases. Our research portfolio consists of two major programs: “DNA/RNA
Medicines” (which includes our lead oncology drug, Genasense®); and “Small
Molecules” (which includes our marketed product, Ganite®, and the
investigational compounds tesetaxel and G4544).
The
DNA/RNA Medicines program includes drugs that are based on using modifications
of either DNA or RNA as drugs that can be used to treat disease. These
technologies include antisense, decoys, and small interfering or micro RNAs. Our
lead drug from this program is an investigational antisense compound known as
Genasense®, an oblimersen sodium injection. Genasense® is designed to block the
production of a protein known as Bcl-2. Current science suggests that Bcl-2 is a
fundamental, although not the sole, cause of the inherent resistance of cancer
cells to anticancer treatments, such as chemotherapy, radiation, and monoclonal
antibodies. While Genasense® has displayed some anticancer activity when used by
itself, we are developing the drug primarily as a means of amplifying the
cytotoxic effects of other anticancer treatments.
Genasense®
The Company’s principal goal has
been to secure regulatory approval for the marketing of Genasense®. Genasense®
has been studied in combination with a wide variety of anticancer drugs in a
number of different cancer indications. We have reported results from randomized
trials of Genasense® in a number of diseases. Under our own sponsorship or in
collaboration with others, we are currently conducting additional clinical
trials. We are especially interested in the development, regulatory approval,
and commercialization of Genasense® in at least three diseases: melanoma;
chronic lymphocytic leukemia, referred to herein as CLL; and non-Hodgkin’s
lymphoma, referred to herein as NHL.
Genasense®
has been submitted for regulatory approval in the U.S. on two occasions and to
the European Union (EU) once. These applications proposed the use of Genasense®
plus chemotherapy for patients with advanced melanoma (U.S. and EU) and relapsed
or refractory chronic lymphocytic leukemia (CLL) (U.S.-only). None of these
applications resulted in regulatory approval for marketing. Nonetheless, we
believe that Genasense® can ultimately be approved and commercialized and we
have undertaken a number of initiatives in this regard that are described
below.
Melanoma
The
Company’s major current initiative is a randomized controlled trial that tests
whether the addition of Genasense to standard chemotherapy can improve outcomes
for patients with advanced melanoma. In 2004, the Company withdrew
its New Drug Application (NDA) for Genasense® in melanoma after an advisory
committee to the Food and Drug Administration (FDA) failed to recommend
approval. A negative decision was also received for a similar application in
melanoma from the European Medicines Agency (EMEA) in 2007. Data from the Phase
3 trial that comprised the basis for these applications were published in 2006.
These results showed that treatment with Genasense® plus dacarbazine compared
with dacarbazine alone in patients with advanced melanoma was associated with a
statistically significant increase in overall response, complete response,
durable response, and progression-free survival (PFS). However, the primary
endpoint of overall survival approached but did not quite reach statistical
significance (P=0.077). Subsequently, our analysis of this trial showed that
there was a significant treatment interaction effect related to levels of a
blood enzyme known as LDH. When this effect was analyzed by treatment arm,
survival was shown to be significantly superior for patients with a non-elevated
LDH who received Genasense® (P=0.018; n=508). Moreover, this benefit was
particularly noteworthy for patients whose baseline LDH did not exceed 80% of
the upper limit of normal for this lab value. LDH had also been previously
described by others as the single most important prognostic factor in advanced
melanoma.
Based on
these data, in August 2007 we initiated a new Phase 3 trial of Genasense® plus
chemotherapy in advanced melanoma. This trial, known as AGENDA, is a randomized,
double-blind, placebo-controlled study in which patients are randomly assigned
to receive Genasense® plus dacarbazine or dacarbazine alone. The study uses LDH
as a biomarker to identify patients who are most likely to respond to
Genasense®, based on data obtained from our preceding trial in melanoma. The
co-primary endpoints of AGENDA are progression-free survival (PFS) and overall
survival.
AGENDA
is designed to expand evidence for the safety and efficacy of Genasense® when
combined with dacarbazine for patients who have not previously been treated with
chemotherapy. The study prospectively targets patients who have low-normal
levels of LDH. In March 2009, we completed accrual of 315 patients into AGENDA.
In May 2009, an analysis by an independent Data Monitoring Committee for both
safety and futility indicated that the study passed an evaluation for futility
and safety. Accordingly, the Committee recommended that the study
should continue to completion. We expect results on the primary assessment of
PFS in the fourth quarter of 2009. If those data are positive, we currently
expect to submit regulatory applications based upon confirmation that the
addition of Genasense® to chemotherapy results in a statistically significant
improvement in PFS. Approval by FDA and EMEA will allow Genasense® to be
commercialized by us, alone or with a partner, in the U.S. and EU. Genasense® in
melanoma has been designated an Orphan Drug in Australia and the U.S, , and the
drug has received Fast Track designation in the U.S.
We
are conducting other trials of Genasense® in melanoma, including a Phase 2 trial
of Genasense® plus chemotherapy consisting of Abraxane® (paclitaxel
protein-bound particles for injectable suspension) (albumin bound) plus
temozolomide (Temodar®). We also expect to examine different dosing regimens
that will improve the dosing convenience and commercial acceptance of
Genasense®, including its administration by brief 1-hour IV
infusions.
CLL
As
noted above, our NDA for the use of Genasense® plus chemotherapy in patients
with relapsed or refractory in CLL was not approved. In CLL, we conducted a
randomized Phase 3 trial in 241 patients with relapsed or refractory disease who
were treated with fludarabine and cyclophosphamide, commonly known as Flu/Cy,
with or without Genasense®. The trial achieved its primary endpoint: a
statistically significant increase (17% vs. 7%; P=0.025) in the proportion of
patients who achieved a complete response, or CR, defined as a complete or
nodular partial response. Patients who achieved this level of response also
experienced disappearance of predefined disease symptoms. A key secondary
endpoint, duration of CR, was also significantly longer for patients treated
with Genasense® (median > 36 months in the Genasense® group, versus 22 months
in the chemotherapy-only group).
Several
secondary endpoints were not improved by the addition of Genasense®. The
percentage of patients who experienced serious adverse events was increased in
the Genasense® arm; however, the percentages of patients who discontinued
treatment due to adverse events were equal in the treatment arms. The incidence
of certain serious adverse reactions, including but not limited to nausea, fever
and catheter-related complications, was increased in patients treated with
Genasense®.
We
submitted our NDA to the FDA in December 2005 in which we sought accelerated
approval for the use of Genasense® in combination with Flu/Cy for the treatment
of patients with relapsed or refractory CLL who had previously received
fludarabine. In December 2006, we received a “non-approvable” notice for that
application from FDA. In April 2007, we filed an appeal of the non-approvable
notice using FDA’s Formal Dispute Resolution process. In March 2008, we received
a formal notice from FDA that indicated additional confirmatory evidence would
be required to support approval of Genasense® in CLL, either from a new clinical
trial or from collection of additional information regarding the progression of
disease in patients from the completed trial.
In
June 2008, we announced results from 5 years of follow-up on patients who had
been accrued to our completed Phase 3 trial. These data showed that
patients treated with Genasense® plus chemotherapy who achieved either a
complete response (CR) or a partial response (PR) also achieved a statistically
significant increase in survival compared with patients treated with
chemotherapy alone (median = 56 months vs. 38 months,
respectively). After 5 years of follow-up, 22 of 49 (45%) responders
in the Genasense® group were alive compared with 13 of 54 (24%) responders in
the chemotherapy-only group (hazard ratio = 0.6; P = 0.038). Moreover, with 5
years of follow-up, 12 of 20 patients (60%) in the Genasense® group who achieved
CR were alive, 5 of these patients remained in continuous CR without relapse,
and 2 additional patients had relapsed but had not required additional therapy.
By contrast, only 3 of 8 CR patients in the chemotherapy-only group were alive,
all 3 had relapsed, and all 3 had required additional anti-leukemic
treatment.
These
data were again submitted to FDA in the second quarter of 2008, and the
application was again denied in December 2008. Genta re-appealed the denial, and
in March 2009, CDER decided that available data were still insufficient to
support approval of Genasense® in CLL, and the Agency recommended conducting
another clinical trial. We have made no decision whether to conduct this
study.
As with
melanoma, we believe the clinical activity in CLL should be explored with
additional clinical research. We plan to explore combinations of Genasense® with
other drugs that are used for the treatment of CLL, and to examine more
convenient dosing regimens.
NHL
Several
trials have shown definite evidence of clinical activity for Genasense® in
patients with NHL. We would like to conduct additional clinical studies in
patients with NHL to test whether Genasense® can be approved in this indication.
Previously, we reported that randomized trials of Genasense® in patients with
myeloma, AML, hormone-refractory prostate cancer, commonly known as HRPC, small
cell lung cancer and non small cell lung cancer were not sufficiently positive
to warrant further investigation on the dose-schedules that were examined or
with the chemotherapy that was employed in these trials. Data from these trials
have been presented at various scientific meetings. However, we believe that
alternate dosing schedules, in particular the use of brief high-dose IV
infusions, provide an opportunity to re-examine the drug’s activity in some of
these indications.
Tesetaxel
In
March 2008, we obtained an exclusive worldwide license for tesetaxel from
Daiichi Sankyo Company Ltd. Tesetaxel is a novel taxane compound that is taken
by mouth. Tesetaxel has completed Phase 2 trials in a number of cancer types,
and the drug has shown definite evidence of antitumor activity in gastric cancer
and breast cancer. Tesetaxel also appears to be associated with a lower
incidence of peripheral nerve damage, a common side effect of taxanes that
limits the maximum amount of these drugs that can be given to patients. At the
time we obtained the license, tesetaxel was on “clinical hold” by FDA due to the
occurrence of several fatalities in the setting of severe neutropenia. In the
second quarter of 2008, we filed a response to the FDA requesting a lift of the
clinical hold, which was granted in June 2008. In January 2009, we announced
initiation of a new clinical trial with tesetaxel to examine the clinical
pharmacology of the drug over a narrow dosing range around the established Phase
2 dose.
We
have also submitted applications to FDA for designation of tesetaxel as an
Orphan Drug for treatment of patients with advanced gastric cancer and for
patients with advanced melanoma. Both of these designations were
granted. Our initial priority for clinical testing of tesetaxel includes the
evaluation of safety and efficacy in patients with advanced gastric cancer.
Maintenance of the license from Daiichi Sankyo requires certain payments that
include amortization of licensing fees and milestones. If such
payments are not made, Daiichi Sankyo may elect to terminate the license;
however, a portion of the licensing fees are due even in the event of
termination.
Oral
Gallium-Containing Compounds (G4544)
Our
third pipeline product is G4544, which is a novel oral formulation of a
gallium-containing compound that we developed in collaboration with Emisphere
Technologies, Inc. We completed a single-dose Phase 1 study of an initial
formulation of this new drug known as “G4544(a)”, the results of which were
presented in the second quarter of 2008. We are currently contemplating a second
study using a modified formulation, known as “G4544(b)”, in order to test
whether this formulation will prove more clinically
acceptable.
If we
are able to identify a clinically and commercially acceptable formulation of
G4544 or another oral gallium-containing compound, we currently intend to pursue
a 505(b)(2) strategy to establish bioequivalence to our marketed product,
Ganite®, for its initial regulatory approval. We believe a drug of this type may
also be broadly useful for treatment of other diseases associated with
accelerated bone loss, such as bone metastases, Paget’s disease and
osteoporosis. In addition, new uses of gallium-containing compounds have been
identified for treatment of certain infectious diseases. While we have no
current plans to begin clinical development in the area of infectious disease,
we intend to support research conducted by certain academic institutions by
providing clinical supplies of our gallium-containing drugs.
Ganite®
We are
currently marketing Ganite® in the U.S., which is an intravenous formulation of
gallium, for treatment of cancer-related hypercalcemia that is resistant to
hydration. We have announced our intention to seek a buyer for Ganite®, but we
have not yet found an acceptable transaction.
About
Us
Genta was
incorporated in Delaware on February 4, 1988. Our principal executive offices
are located at 200 Connell Drive, Berkeley Heights, New Jersey 07922. Our
telephone number is (908) 286-9800. The address of our website is www.Genta.com.
Information on our website is not part of this prospectus. Our website address
is included in this prospectus as an inactive technical reference
only.
SUMMARY
OF THE OFFERING
The
securities
|
We
are offering:
|
|
|
|
• up
to $7.0 million in aggregate principal amount of units consisting of (i)
70% unsecured subordinated convertible notes (the “August 2009 Notes”) and
(ii) 30% common stock, par value $0.001 (the “August 2009 Shares”) (the
“Units”);
|
|
|
|
• 49,000,000
shares of common stock issuable upon conversion of or otherwise in respect
of the August 2009 Notes;
|
|
|
|
• $832,308
in aggregate principal amount of August 2009 Notes issuable as payment of
interest on the August 2009 Notes;
|
|
|
|
• 8,323,080
shares of common stock underlying the August 2009 Notes issuable as
payment of interest on the August 2009 Notes;
|
|
|
|
• warrants
to purchase 12,250,000 shares of common stock underlying the principal
amount of the August 2009 Notes; and
|
|
|
|
• 12,250,000
shares of common stock issuable upon exercise of
warrants.
|
|
|
The
offering
|
Commencing
upon the effectiveness of the registration statement of which this
prospectus forms a part, we will offer and sell Units in the aggregate
principal amount of $7.0 million consisting of August 2009 Notes and
August 2009 Shares. Each purchaser of Units will also receive a 2-year
warrant to purchase a number of shares of our common stock equal to 25% of
the number of shares of our common stock underlying the August 2009 Notes
purchased by such purchaser having the terms outlined in this prospectus.
The offer and sale of the $7.0 million in Units is expected to occur in a
single closing as soon as practical following the effectiveness of the
registration statement.
|
|
|
Use
of proceeds
|
The
proceeds will be used to advance our product candidates through clinical
trials and clinical development, and general corporate purposes, including
working capital needs and potential acquisition or licenses to
intellectual property. See “Use of Proceeds.”
|
|
|
Fees
and expenses
|
We
estimate that the total fees and expenses of this offering will be
approximately $605,000.
|
|
|
Material
US federal income tax consequences
|
For
a discussion of material U.S. federal income tax considerations relating
to the purchase, ownership and disposition of the Units, shares of common
stock into which the August 2009 Notes are convertible, August 2009
Shares, additional August 2009 Notes issuable as payment of interest on
the August 2009 Notes, warrants and shares of common stock into which the
warrants are exercisable, see “Material U.S. federal income tax
consequences.”
|
|
|
Trading
|
Our
common stock is traded on the OTC Bulletin Board under the symbol “GETA.”
We do not intend to list the Units, August Notes or warrants on any
national securities exchange or automated quotation
system.
|
|
|
Placement
agent
|
Rodman
& Renshaw, LLC will act a placement agent for the placement for the
securities being offered pursuant to this prospectus.
|
|
|
Risk
Factors
|
You
should read the “Risk Factors” section of this prospectus for a discussion
of factors to consider carefully before deciding to invest in our Units
and
warrants.
|
The
number of shares of our common stock that will be outstanding prior to this
offering is 20,282,234 shares of common stock outstanding as of March 31, 2009
and 99,770,572 shares of common stock outstanding as of June 30, 2009 adjusted
for the 1:50 reverse stock split that was implemented on July 13, 2009. This
amount excludes:
•
|
37,573
shares and 34,261 shares of
common stock issuable upon the exercise of stock options outstanding or
the vesting of restricted stock units under our 1998 Stock Incentive Plan
as of March 31, 2009 and June 30, 2009, respectively, at a weighted
average exercise price of $1,266.50 per share and $1,293.06 per share,
respectively, of which, options to purchase 26,820 shares and 25,890
shares, respectively, were
exercisable;
|
•
|
2,045
shares of common stock issuable upon exercise of stock options outstanding
under our 1998 Non-Employee Directors Stock Incentive Plan as of both
March 31, 2009 and June 30, 2009 at a weighted average exercise price of
$1,130.47 per share, of which, options to purchase 2,045 shares were
exercisable;
|
•
|
3,070
shares of common stock available for future grant under our 1998
Non-Employee Directors Stock Incentive Plan as of both March 31, 2009 and
June 30, 2009;
|
•
|
800,000
shares of common stock issuable upon exercise of warrants outstanding as
of both March 31, 2009 and June 30, 2009 at an exercise price of $1.00 per
share;
|
•
|
23,629
shares and 109,319 shares of common stock issuable upon the conversion of
our Series A Convertible Preferred Stock as of March 31, 2009 and June 30,
2009, respectively;
|
•
|
21,306,902
shares and 28,294,633 shares of common stock issuable upon the conversion
of our 15% Senior Secured Convertible Notes due 2010 as of March 31, 2009
and June 30, 2009,
respectively;
|
•
|
59,500,000 shares
of common stock issuable upon the conversion of our 8% Senior Secured
Convertible Notes due 2012 as of June 30,
2009;
|
•
|
18,445,000
shares of common stock issuable upon exercise of warrants outstanding as
of June 30, 2009 at an exercise price of $0.50 per
share;
|
•
|
59,500,000
shares of common stock issuable upon the conversion of our 8% Senior
Secured Convertible Notes due April 2, 2012 issued pursuant to the
Purchase Option (as defined in the Securities Purchase Agreement, dated
April 2, 2009, by and between the Company and the investors set forth
therein); and
|
•
|
83,190,764
shares of common stock issuable upon the conversion of our 8% Senior
Secured Convertible Notes due April 2, 2012 issued pursuant to the
Purchase Right (as defined in the Consent Agreement, dated April 2, 2009,
by and between the Company and the holders set forth
therein).
|
The
share numbers above do not include the 49,000,000 shares of common stock
issuable upon conversion of the notes we issued in the July 2009 financing or
the 12,250,000 shares of common stock issuable upon exercise of the warrants
issued in the July 2009 financing.
Unless
otherwise indicated, all information in this prospectus assumes there is no
over-allotment option, no conversion of convertible notes or preferred stock and
no exercise of stock options or warrants after June 30,
2009.
SUMMARY
OF THE TERMS OF THE AUGUST 2009 NOTES
Issuer
|
Genta
Incorporated.
|
|
|
Notes
|
Up
to $4.9 million aggregate principal amount of 8% Unsecured Subordinated
Convertible Notes due 2011, which we refer to herein as the August 2009
Notes.
|
|
|
Maturity
|
The
notes will mature on August [__], 2011, unless earlier
converted.
|
|
|
Interest
payment dates
|
We
will pay 8.00% interest per annum on the principal amount of the August
2009 Notes, payable semi-annually in arrears on January 1 and July 1 of
each year, starting on January 1, 2010, to holders of record at the close
of business on the preceding December 1 and June 1, respectively. Accrued
but unpaid interest shall also be paid in the event of any conversion and
at maturity of the August 2009 Notes. Interest will accrue on the August
2009 Notes from and including their original issue date, or from and
including the record date with respect to the previous interest payment
date, to, but excluding, the current record date, conversion date or
maturity date, as applicable. Interest will accrue on the basis of a
360-day year consisting of twelve 30-day months.
|
|
|
|
Interest
on the August 2009 Notes will be paid in cash or in additional August 2009
Notes, having a face value equal to the accrued but unpaid
interest.
|
Ranking
|
The
August 2009 Notes will be:
|
|
|
|
• unsecured;
|
|
|
|
• subordinated
to the 2008 Notes and April 2009 Notes to the extent of the security for
such notes, and senior in time and right of payment to certain other
indebtedness of the Company; and
|
|
|
|
• pari passu in time and
right of payment to the July 2009 Notes.
|
|
|
Collateral
|
The
August 2009 Notes are unsecured.
|
|
|
|
For
more details, see “Description of notes—Security.”
|
|
|
Conversion
rights
|
Subject
to the limitations set forth below and under “Provisional limitation on
the right to convert notes” and “Permanent limitation on the right to
convert notes”, the August 2009 Notes will be convertible at any time into
shares of our common stock, based on an initial conversion rate, subject
to adjustment, of 10,000 shares per $1,000 in principal amount of the
August 2009 Notes (which represents an initial conversion price of $0.10
per share).
|
|
|
Mandatory
conversion
|
Subject
to the limitations set forth below and under “Provisional limitation on
the right to convert notes” and “Permanent limitation on the right to
convert notes”, at any time or from time to time, we may elect to cause
the conversion, in whole or in part, of the August 2009 Notes by providing
five (5) days written notice of the date on which such conversion is to
occur, which we refer to as a mandatory conversion date. Any such
conversion shall be made pro-rata among all holders of August 2009
Notes.
|
|
|
|
We
will only be permitted to cause the conversion on a mandatory conversion
date if, on the proposed mandatory conversion date (i) the Daily VWAP is
equal to or greater than $0.50 (as appropriately adjusted for stock
splits, stock dividends, reorganizations, recapitalizations, stock
combinations and the like) for each of the ten (10) consecutive prior
trading days ending on the trading day immediately prior to such date, and
(ii) the Equity Conditions (as set forth in “Description of notes –
Conversion rights – Mandatory conversion”) are satisfied and (iii) the
common stock issuable upon the mandatory conversion shall have been
immediately tradable, in each case, on each trading day during the period
beginning on the first day of such ten (10) day period and ending on the
date of the delivery of such shares of common stock pursuant to the
mandatory conversion.
|
|
|
|
See
“Description of notes—Conversion rights—Mandatory
conversion.”
|
|
|
Provisional
limitation on right to
convert
notes
|
Each
August 2009 Note may only be converted by a holder (or beneficial holder)
or by us in any mandatory conversion on any day to the extent that,
together with all prior conversions under such note following the original
issue date of such note, the total amount of such note that has been
converted since the original issue date does not exceed the product of (A)
10% of the original principal amount of such note, and (B) the number of
weeks since the date two weeks from the original issue date of the August
2009 Notes.
|
|
|
|
See
“Description of notes—Conversion rights—Provisional limitation on right to
convert notes.”
|
|
|
Permanent
limitation on right to convert notes
|
We
cannot effect a conversion of the August 2009 Notes, whether voluntary or
mandatory, and the holder (or beneficial holder) may not request a
conversion of such August 2009 Notes, if such conversion would result in
the beneficial holder and the beneficial holder’s affiliates owning more
than 9.999% of our outstanding common stock after
conversion.
|
|
See
“Description of notes—Conversion rights—Permanent limitation on right to
convert notes.”
|
|
|
Sinking
fund
|
None.
|
|
|
Events
of default
|
If
an event of default on the August 2009 Notes has occurred and is
continuing, (i) the principal amount of the August 2009 Notes plus any
accrued and unpaid interest may become immediately due and payable and
(ii) any holder may, in his sole discretion,or the trustee may on the
holder’s behalf, (a) demand redemption of his August 2009 Notes at a price
equal to the greater of the face amount of the note and the underlying
value of the common stock issuable upon conversion of such note, (b)
demand that the principal amount outstanding of his August 2009 Notes,
plus all accrued and unpaid interest be converted into shares of common
stock or (c) exercise any rights to which he is entitled under the
law.
|
|
|
|
See
“Description of notes—Events of default.”
|
|
|
DTC
eligibility
|
The
August 2009 Notes will be issued in registered form without interest
coupons, in denominations of integral multiples of $1,000 principal
amount, in the form of global securities and will be represented by one or
more global certificates, deposited with, or on behalf of, DTC and
registered in the name of a DTC or a nominee of DTC. Beneficial interests
in the global securities will be shown on, and transfers will be effected
only through, records maintained by DTC and its direct and indirect
participants. Except in limited circumstances, holders may not exchange
interests in their August 2009 Notes for certificated
securities.
|
|
|
|
See
“Description of notes—Form, denomination and registration of
notes.”
|
|
|
Listing
and trading
|
The
August 2009 Notes are a new issue of securities, and there is currently no
established trading market for the August 2009 Notes. An active or liquid
market may not develop for the August 2009 Notes or, if developed, be
maintained. We have not applied, and do not intend to apply, for the
listing of the August 2009 Notes on any securities exchange. Our common
stock is listed on the OTC Bulletin Board under the symbol
“GETA.”
|
SUMMARY
OF THE TERMS OF THE WARRANTS
Issuer
|
Genta
Incorporated.
|
|
|
Warrants
|
Warrants
to purchase an aggregate of up to 12,250,000 shares of our common stock
underlying the principal amount of the August 2009
Notes.
|
|
|
Term
|
The
warrants are exercisable during the period commencing on the date six
months from the date of their issuance and ending on the date that is two
years from the date of their issuance.
|
|
|
Exercise
Price
|
The
exercise price of the warrants is $1.00 per share of common
stock.
|
|
|
Adjustments
|
The
exercise price and number and type of securities or other property
issuable upon exercise of the warrants will be subject to adjustment for
stock splits, stock dividends, recapitalizations, reclassifications and
other events effecting the shares of our common stock. For more details,
see “Description of the warrants.”
|
|
|
Permanent
limitation on right to exercise or convert warrants
|
The
warrants cannot be exercised if such exercise would result in the holder
(and the holder’s affiliates and any other person or entity acting as a
group together with such holder or any of such holder’s affiliates) owning
more than 4.999% of our outstanding common stock after such
exercise.
|
|
|
Listing
and trading
|
The
warrants are a new issue of securities, and there is currently no
established trading market for the warrants. An active or liquid market is
not expected to develop for the warrants or, if developed, be maintained.
We have not applied, and do not intend to apply, for the listing of the
warrants on any securities exchange. Our common stock is listed on the OTC
Bulletin Board under the symbol
“GETA.”
|
SELECTED
FINANCIAL INFORMATION
The
following table summarizes our selected financial information. You should read
the selected financial information together with our consolidated financial
statements and the related notes appearing at the end of this prospectus, and
the “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” section and other financial information included in this
prospectus.
The as
adjusted balance sheet data below gives effect to the sale of our convertible
notes, common stock and warrants to purchase shares of our common stock in this
offering, at an assumed public offering price for the shares of common stock to
be issued as part of the Units offered hereby of $0.10 per share, after
deducting placement agent discounts and commissions and estimated offering
expenses.
|
|
Three
months
ended
March 31,
(unaudited)
|
|
|
Year ended
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
Consolidated
Statements of Operations Data |
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands
except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales — net
|
|
$ |
62 |
|
|
$ |
363 |
|
|
$ |
580 |
|
|
$ |
708 |
|
Total
revenues
|
|
|
62 |
|
|
|
363 |
|
|
|
580 |
|
|
|
708 |
|
Costs
of goods sold
|
|
|
- |
|
|
|
102 |
|
|
|
90 |
|
|
|
108 |
|
Operating
expenses
|
|
|
4,470 |
|
|
|
33,410 |
|
|
|
26,116 |
|
|
|
59,764 |
|
Amortization
of deferred financing costs
|
|
|
(6,287 |
) |
|
|
(11,229 |
) |
|
|
— |
|
|
|
— |
|
Fair
value — conversion feature liability
|
|
|
- |
|
|
|
(460,000 |
) |
|
|
— |
|
|
|
— |
|
Fair
value — warrant liability
|
|
|
- |
|
|
|
(2,000 |
) |
|
|
— |
|
|
|
— |
|
All
other (expense)/income -net
|
|
|
(372 |
) |
|
|
(1,435 |
) |
|
|
836 |
|
|
|
1,454 |
|
Loss
before income taxes
|
|
|
(11,067 |
) |
|
|
(507,813 |
) |
|
|
(24,790 |
) |
|
|
(57,710 |
) |
Income
tax benefit
|
|
|
- |
|
|
|
1,975 |
|
|
|
1,470 |
|
|
|
929 |
|
Net
loss
|
|
$ |
(11,067 |
) |
|
$ |
(505,838 |
) |
|
$ |
(23,320 |
) |
|
$ |
(56,781 |
) |
Net
loss per basic and diluted common share *
|
|
$ |
(0.61 |
) |
|
$ |
(455.09 |
) |
|
$ |
(39.36 |
) |
|
$ |
(125.88 |
) |
Common
shares used in computing net loss per basic and diluted share
*
|
|
|
17,999 |
|
|
|
1,112 |
|
|
|
592 |
|
|
|
451 |
|
*
|
all figures have been
retroactively adjusted to reflect a 1-for-50 reverse
stock split effected in June
2009
|
|
|
March 31, 2009
as adjusted for April 2009
financing, July 7, 2009 financing
and this finacing (unaudited)
|
|
|
March 31, 2009 as
adjusted for April
2009 financing and
July 7, 2009
financing
(unaudited)
|
|
|
March 31, 2009
as adjusted for
the April 2009
financing
(unaudited)
|
|
|
March 31, 2009
(unaudited, as reported)
|
|
|
December 31, 2008
|
|
Balance
Sheet Data |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in
thousands except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
15,043 |
|
|
$ |
8,648 |
|
|
$ |
6,148 |
|
|
$ |
598 |
|
|
$ |
4,908 |
|
Working capital
(deficiency)
|
|
|
4,935 |
|
|
|
(1,460 |
) |
|
|
(3,960 |
) |
|
|
(9,510 |
) |
|
|
(5,220 |
) |
Total
assets
|
|
|
21,582 |
|
|
|
15,187 |
|
|
|
12,687 |
|
|
|
7,137 |
|
|
|
12,693 |
|
Total
stockholders’equity/(deficit)
|
|
|
464 |
|
|
|
(1,636 |
) |
|
|
(4,635 |
) |
|
|
(10,585 |
) |
|
|
(4,864 |
) |
RISK
FACTORS
You should carefully consider the
following risks and all of the other information set forth in this
prospectus before deciding to invest in our securities. The risks described
below are not the only ones facing us. Additional risks not presently known
to us or that we currently deem immaterial may also impair our business
operations.
If any of the following risks
actually occurs, our business, financial condition or results of operations
would likely suffer. In such case, the market price of our common stock
would likely decline due to the occurrence of any of these risks, and you may lose
all or part of your investment.
Risks
Related to Our Business
Our
business will suffer if we fail to obtain timely funding.
Our
operations to date have required significant cash expenditures. Our future
capital requirements will depend on the results of our research and development
activities, preclinical studies and clinical trials, competitive and
technological advances, and regulatory activities of the FDA and other
regulatory authorities. In order to commercialize our products, seek new product
candidates and continue our research and development programs, we will need to
raise additional funds.
On
June 9, 2008, we placed $20 million of senior secured convertible notes, or the
2008 Notes, with certain institutional and accredited investors. The 2008 Notes
bear interest at an annual rate of 15% payable at quarterly intervals in other
senior secured convertible promissory notes to the holder, and are presently
convertible into shares of Genta common stock at a conversion rate of 10,000
shares of common stock for every $1,000.00 of principal. Certain members of our
senior management participated in this offering. The 2008 Notes are secured by a
first lien on all of our assets.
On
April 2, 2009, we entered into a securities purchase agreement with certain
accredited institutional investors to place up to $12 million of senior secured
convertible notes, or the April 2009 Notes, and corresponding warrants to
purchase common stock. We closed on approximately $6 million of such notes and
warrants on April 2, 2009. The April 2009 Notes bear interest at an annual rate
of 8% payable semi-annually in other senior secured convertible promissory notes
to the holder, and will be convertible into shares of our common stock at a
conversion rate of 10,000 shares of common stock for every $1,000.00 of
principal amount outstanding.
On
July 7, 2009, we entered into a securities purchase agreement with certain
accredited institutional investors to place up to $10 million in aggregate
principal amount of units consisting of (i) 70% unsecured subordinated
convertible notes, or the July 2009 Notes, and (ii) 30% common stock, or the
July 2009 financing. In connection with the sale of the units, we
also issued to the investors two-year warrants to purchase common stock in an
amount equal to 25% of the number of shares of common stock issuable upon
conversion of the July 2009 Notes purchased by each investor. We
closed on approximately $3 million of such July 2009 Notes, common stock and
warrants on July 7, 2009.
We will
need to obtain more funding in the future through collaborations or other
arrangements with research institutions and corporate partners or public and
private offerings of our securities, including debt or equity financing. We may
not be able to obtain adequate funds for our operations from these sources when
needed or on acceptable terms. Future collaborations or similar arrangements may
require us to license valuable intellectual property to, or to share substantial
economic benefits with, our collaborators. If we raise additional capital by
issuing additional equity or securities convertible into equity, our
stockholders may experience dilution and our share price may decline. Any debt
financing may result in restrictions on our spending.
If we are
unable to raise additional funds, we will need to do one or more of the
following:
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delay,
scale back or eliminate some or all of our research and product
development programs;
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license
third parties to develop and commercialize products or technologies that
we would otherwise seek to develop and commercialize
ourselves;
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attempt
to sell our company;
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Presently,
with no further financing, management projects that we will run out of funds in
August 2009. We currently do not have any additional financing in place. If we
are unable to raise additional financing, we could be required to reduce our
spending plans, reduce our workforce, license to others products or technologies
we would otherwise seek to commercialize ourselves and sell certain assets.
There can be no assurance that we can obtain financing, if at all, on terms
acceptable to us.
We
may be unsuccessful in our efforts to obtain approval from the FDA or EMEA and
commercialize Genasense® or our
other pharmaceutical products.
The
commercialization of our pharmaceutical products involves a number of
significant challenges. In particular, our ability to commercialize products,
such as Ganite® and
Genasense®,
depends, in large part, on the success of our clinical development programs, our
efforts to obtain regulatory approvals and our sales and marketing efforts
directed at physicians, patients and third-party payors. A number of factors
could affect these efforts, including:
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our
ability to demonstrate clinically that our products are useful and safe in
particular indications;
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delays
or refusals by regulatory authorities in granting marketing
approvals;
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our
limited financial resources and sales and marketing experience relative to
our competitors;
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actual
and perceived differences between our products and those of our
competitors;
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the
availability and level of reimbursement for our products by third-party
payors;
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incidents
of adverse reactions to our
products;
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side
effects or misuse of our products and the unfavorable publicity that could
result; and
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the
occurrence of manufacturing, supply or distribution
disruptions.
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We
cannot assure you that Genasense® will
receive FDA or EMEA approval. For example, the NDA for Genasense® in
melanoma was withdrawn in 2004 after an advisory committee to the FDA failed to
recommend approval. A negative decision was also received for a similar
application in melanoma from the EMEA in 2007. Our NDA for Genasense® plus
chemotherapy in patients with relapsed or refractory CLL was also
unsuccessful.
Our
financial condition and results of operations have been and will continue to be
significantly affected by FDA and EMEA action with respect to Genasense®. Any
adverse outcomes with respect to FDA and/or EMEA approvals could negatively
impact our ability to obtain additional funding or identify potential
partners.
Ultimately,
our efforts may not prove to be as effective as those of our competitors. In the
U.S. and elsewhere, our products will face significant competition. The
principal conditions on which our product development efforts are focused and
some of the other disorders for which we are conducting additional studies, are
currently treated with several drugs, many of which have been available for a
number of years or are available in inexpensive generic forms. Thus, even if we
obtain regulatory approvals, we will need to demonstrate to physicians, patients
and third-party payors that the cost of our products is reasonable and
appropriate in light of their safety and efficacy, the price of competing
products and the relative health care benefits to the patient. If we are unable
to demonstrate that the costs of our products are reasonable and appropriate in
light of these factors, we will likely be unsuccessful in commercializing our
products.
Recurring
losses and negative cash flows from operations raise substantial doubt about our
ability to continue as a going concern and we may
not be able to continue as a going concern.
Our
recurring losses from operations and negative cash flows from operations raise
substantial doubt about our ability to continue as a going concern and as a
result, our independent registered public accounting firm included an
explanatory paragraph in its report on our consolidated financial statement for
the year ended December 31, 2008 with respect to this uncertainty. Substantial
doubt about our ability to continue as a going concern may create negative
reactions to the price of the common shares of our stock and we may have a more
difficult time obtaining financing.
We have
prepared our financial statements on a going concern basis, which contemplates
the realization of assets and the satisfaction of liabilities and commitments in
the normal course of business. The financial statements do not include any
adjustments relating to the recoverability and classification of recorded asset
amounts or amounts of liabilities that might be necessary should we be unable to
continue in existence.
We
have relied on and continue to rely on our contractual collaborative
arrangements with research institutions and corporate partners for development
and commercialization of our products. Our business could suffer if we are not
able to enter into suitable arrangements, maintain existing relationships, or if
our collaborative arrangements are not successful in developing and
commercializing products.
We have
entered into collaborative relationships relating to the conduct of clinical
research and other research activities in order to augment our internal research
capabilities and to obtain access to specialized knowledge and expertise. Our
business strategy depends in part on our continued ability to develop and
maintain relationships with leading academic and research institutions and with
independent researchers. The competition for these relationships is intense, and
we can give no assurances that we will be able to develop and maintain these
relationships on acceptable terms.
We also
seek strategic alliances with corporate partners, primarily pharmaceutical and
biotechnology companies, to help us develop and commercialize drugs. Various
problems can arise in strategic alliances. A partner responsible for conducting
clinical trials and obtaining regulatory approval may fail to develop a
marketable drug. A partner may decide to pursue an alternative strategy or focus
its efforts on alliances or other arrangements with third parties. A partner
that has been granted marketing rights for a certain drug within a geographic
area may fail to market the drug successfully. Consequently, strategic alliances
that we may enter into may not be scientifically or commercially
successful.
We cannot
control the resources that any collaborator may devote to our products. Any of
our present or future collaborators may not perform their obligations as
expected. These collaborators may breach or terminate their agreements with us,
for instance upon changes in control or management of the collaborator, or they
may otherwise fail to conduct their collaborative activities successfully and in
a timely manner.
In
addition, our collaborators may elect not to develop products arising out of our
collaborative arrangements or to devote sufficient resources to the development,
regulatory approval, manufacture, marketing or sale of these products. If any of
these events occur, we may not be able to develop or commercialize our
products.
An
important part of our strategy involves conducting multiple product development
programs. We may pursue opportunities in fields that conflict with those of our
collaborators. In addition, disagreements with our collaborators could develop
over rights to our intellectual property. The resolution of such conflicts and
disagreements may require us to relinquish rights to our intellectual property
that we believe we are entitled to. In addition, any disagreement or conflict
with our collaborators could reduce our ability to obtain future collaboration
agreements and negatively impact our relationship with existing collaborators.
Such a conflict or disagreement could also lead to delays in collaborative
research, development, regulatory approval or commercialization of various
products or could require or result in litigation or arbitration, which would be
time consuming and expensive, divert the attention of our management and could
have a significant negative impact on our business, financial condition and
results of operations.
We
anticipate that we will incur additional losses and we may never be
profitable.
We have
never been profitable. We have incurred substantial annual operating losses
associated with ongoing research and development activities, preclinical
testing, clinical trials, regulatory submissions and manufacturing activities.
From the period since our inception to March 31, 2009, we have incurred a
cumulative net deficit of $955.2 million. We may never achieve revenue
sufficient for us to attain profitability. Achieving profitability is unlikely
unless Genasense® receives
approval from the FDA or EMEA for commercial sale in one or more
indications.
Our
business depends heavily on a small number of products.
We
currently market and sell one product, Ganite® and the
principal patent covering its use for the approved indication expired in April
2005. If Genasense® is not
approved, if approval is significantly delayed, or if in the event of approval
the product is commercially unsuccessful, then we do not expect significant
sales of other products to offset this loss of potential
revenue.
To
diversify our product line in the long term, it will be important for us to
identify suitable technologies and products for acquisition or licensing and
development. If we are unable to identify suitable technologies and products, or
if we are unable to acquire or license products we identify, we may be unable to
diversify our product line and to generate long-term growth.
We may be unable
to obtain or enforce patents, other proprietary rights and licenses to protect
our business; we could become involved in litigation relating to our patents or
licenses that could cause us to incur additional costs and delay or prevent our
introduction of new drugs to market.
Our
success will depend to a large extent on our ability to:
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obtain
U.S. and foreign patent or other proprietary protection for our
technologies, products and
processes;
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preserve
trade secrets; and
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operate
without infringing the patent and other proprietary rights of third
parties.
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Legal
standards relating to the validity of patents covering pharmaceutical and
biotechnological inventions and the scope of claims made under these types of
patents are still developing, and they involve complex legal and factual
questions. As a result, our ability to obtain and enforce patents that protect
our drugs is highly uncertain. If we are unable to obtain and enforce patents
and licenses to protect our drugs, our business, results of operations and
financial condition could be adversely affected.
We hold
numerous U.S., foreign and international patents covering various aspects of our
technology, which include novel compositions of matter, methods of large-scale
synthesis and methods of controlling gene expression and methods of treating
disease. In the future, however, we may not be successful in obtaining
additional patents despite pending or future applications. Moreover, our current
and future patents may not be sufficient to protect us against competitors who
use similar technology. Additionally, our patents, the patents of our business
partners and the patents for which we have obtained licensing rights may be
challenged, narrowed, invalidated or circumvented. Furthermore, rights granted
under our patents may not be broad enough to cover commercially valuable drugs
or processes, and therefore, may not provide us with sufficient competitive
advantage with respect thereto.
The
pharmaceutical and biotechnology industries have been greatly affected by
time-consuming and expensive litigation regarding patents and other intellectual
property rights. We may be required to commence, or may be made a party to,
litigation relating to the scope and validity of our intellectual property
rights or the intellectual property rights of others. Such litigation could
result in adverse decisions regarding the patentability of our inventions and
products, the enforceability, validity or scope of protection offered by our
patents or our infringement of patents held by others. Such decisions could make
us liable for substantial money damages, or could bar us from the manufacture,
sale or use of certain products. Moreover, an adverse decision may also compel
us to seek a license from a third party. The costs of any license may be
prohibitive and we may not be able to enter into any required licensing
arrangement on terms acceptable to us.
The cost
to us of any litigation or proceeding relating to patent or license rights, even
if resolved in our favor, could be substantial. Some of our competitors may be
able to sustain the costs of complex patent or licensing litigation more
effectively than we can because of their substantially greater resources.
Uncertainties resulting from the initiation and continuation of any patent or
related litigation could have a material adverse effect on our ability to
compete in the marketplace.
We also
may be required to participate in interference proceedings declared by the U.S.
Patent and Trademark Office in opposition or similar proceedings before foreign
patent offices and in International Trade Commission proceedings aimed at
preventing the importation of drugs that would compete unfairly with our drugs.
These types of proceedings could cause us to incur considerable
costs.
The
principal patent covering the use of Ganite® for its
approved indication, including Hatch-Waxman extensions, expired in April
2005.
Genta’s
patent portfolio includes approximately 65 granted patents and 66 pending
applications in the U.S. and foreign countries. We endeavor to seek appropriate
U.S. and foreign patent protection on our oligonucleotide
technology.
We have
licensed ten U.S. patents relating to Genasense® and its
backbone chemistry that expire between 2008 and 2015. Corresponding patent
applications have been filed in three foreign countries. We also own five U.S.
patent applications relating to methods of using Genasense® expected
to expire in 2020 and 2026, with approximately 50 corresponding foreign patent
applications and granted patents.
Most
of our products are in an early stage of development, and we may never receive
regulatory approval for these products.
Most of
our resources have been dedicated to the research and development of potential
antisense pharmaceutical products such as Genasense®, based
upon oligonucleotide technology. While we have demonstrated the activity of
antisense oligonucleotide technology in model systems in vitro and in animals,
Genasense® is our
only antisense product to have been tested in humans. Several of our other
technologies that serve as a possible basis for pharmaceutical products are only
in preclinical testing. Results obtained in preclinical studies or early
clinical investigations are not necessarily indicative of results that will be
obtained in extended human clinical trials. Our products may prove to have
undesirable and unintended side effects or other characteristics that may
prevent our obtaining FDA or foreign regulatory approval for any indication. In
addition, it is possible that research and discoveries by others will render our
oligonucleotide technology obsolete or noncompetitive.
We
will not be able to commercialize our product candidates if our preclinical
studies do not produce successful results or if our clinical trials do not
demonstrate safety and efficacy in humans.
Our
success will depend on the success of our currently ongoing clinical trials and
subsequent clinical trials that have not yet begun. It may take several years to
complete the clinical trials of a product, and a failure of one or more of our
clinical trials can occur at any stage of testing. We believe that the
development of each of our product candidates involves significant risks at each
stage of testing. If clinical trial difficulties and failures arise, our product
candidates may never be approved for sale or become commercially viable. We do
not believe that any of our product candidates have alternative uses if our
current development activities are unsuccessful.
There are
a number of difficulties and risks associated with clinical trials. These
difficulties and risks may result in the failure to receive regulatory approval
to sell our product candidates or the inability to commercialize any of our
product candidates. The possibility exists that:
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we
may discover that a product candidate does not exhibit the expected
therapeutic results in humans, may cause harmful side effects or have
other unexpected characteristics that may delay or preclude regulatory
approval or limit commercial use if
approved;
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the
results from early clinical trials may not be statistically significant or
predictive of results that will be obtained from expanded, advanced
clinical trials;
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institutional
review boards or regulators, including the FDA, may hold, suspend or
terminate our clinical research or the clinical trials of our product
candidates for various reasons, including noncompliance with regulatory
requirements or if, in their opinion, the participating subjects are being
exposed to unacceptable health
risks;
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subjects
may drop out of our clinical
trials;
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our
preclinical studies or clinical trials may produce negative, inconsistent
or inconclusive results, and we may decide, or regulators may require us,
to conduct additional preclinical studies or clinical trials;
and
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the
cost of our clinical trials may be greater than we currently
anticipate.
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Between
2004 and 2007, we reported that randomized trials of Genasense® in patients with
myeloma, acute myeloid leukemia, (AML), hormone-refractory prostate cancer,
small cell lung cancer and non small cell lung cancer were not sufficiently
positive to warrant further investigation on the dose-schedules that were
examined or with the chemotherapy that was employed in these trials. Data from
these trials have been presented at various scientific meetings.
We cannot
assure you that our ongoing preclinical studies and clinical trials will produce
successful results in order to support regulatory approval of Genasense® in any
territory or for any indication. Failure to obtain approval, or a substantial
delay in approval of Genasense® for
these or any other indications would have a material adverse effect on our
results of operations and financial condition.
Clinical
trials are costly and time consuming and are subject to delays; our business
would suffer if the development process relating to our products were subject to
meaningful delays.
Clinical
trials are very costly and time-consuming. The length of time required to
complete a clinical study depends upon many factors, including but not limited
to the size of the patient population, the ability of patients to get to the
site of the clinical study, the criteria for determining which patients are
eligible to join the study and other issues. Delays in patient enrollment and
other unforeseen developments could delay completion of a clinical study and
increase its costs, which could also delay any eventual commercial sale of the
drug that is the subject of the clinical trial.
Our
commencement and rate of completion of clinical trials also may be delayed by
many other factors, including the following:
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inability
to obtain sufficient quantities of materials for use in clinical
trials;
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inability
to adequately monitor patient progress after
treatment;
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unforeseen
safety issues;
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the
failure of the products to perform well during clinical trials;
and
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government
or regulatory delays.
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If
we fail to obtain the necessary regulatory approvals, we cannot market and sell
our products in the United States.
The FDA
imposes substantial pre-market approval requirements on the introduction of
pharmaceutical products. These requirements involve lengthy and detailed
preclinical and clinical testing and other costly and time-consuming procedures.
Satisfaction of these requirements typically takes several years or more
depending upon the type, complexity and novelty of the product. We cannot apply
for FDA approval to market any of our products under development until
preclinical and clinical trials on the product are successfully completed.
Several factors could prevent successful completion or cause significant delays
of these trials, including an inability to enroll the required number of
patients or failure to demonstrate adequately that the product is safe and
effective for use in humans. If safety concerns develop, the FDA could stop our
trials before completion. We may not market or sell any product for which we
have not obtained regulatory approval.
We cannot
assure you that the FDA will ever approve the use of our products that are under
development. If the patient populations for which our products are approved are
not sufficiently broad, or if approval is accompanied by unanticipated labeling
restrictions, the commercial success of our products could be limited and our
business, results of operations and financial condition could consequently be
materially adversely affected.
If
the third party manufacturers upon which we rely fail to produce our products in
the volumes that we require on a timely basis, or to comply with stringent
regulations applicable to pharmaceutical drug manufacturers, we may face delays
in the commercialization of, or be unable to meet demand for, our products and
may lose potential revenues.
We do not
manufacture any of our products or product candidates and we do not plan to
develop any capacity to do so. We have contracted with third-party manufacturers
to manufacture Ganite® and
Genasense®. The
manufacture of pharmaceutical products requires significant expertise and
capital investment, including the development of advanced manufacturing
techniques and process controls. Manufacturers of pharmaceutical products often
encounter difficulties in production, especially in scaling up initial
production. These problems include difficulties with production costs and
yields, quality control and assurance and shortages of qualified personnel, as
well as compliance with strictly enforced federal, state and foreign
regulations. Our third-party manufacturers may not perform as agreed or may
terminate their agreements with us.
In
addition to product approval, any facility in which Genasense® is
manufactured or tested for its ability to meet required specifications must be
approved by the FDA and/or the EMEA before it can manufacture Genasense®. Failure
of the facility to be approved could delay the approval of Genasense®.
We do not
currently have alternate manufacturing plans in place. The number of third-party
manufacturers with the expertise, required regulatory approvals and facilities
to manufacture bulk drug substance on a commercial scale is limited, and it
would take a significant amount of time to arrange for alternative
manufacturers. If we need to change to other commercial manufacturers, the FDA
and comparable foreign regulators must approve these manufacturers’ facilities
and processes prior to our use, which would require new testing and compliance
inspections, and the new manufacturers would have to be educated in or
independently develop the processes necessary for the production of our
products.
Any of
these factors could cause us to delay or suspend clinical trials, regulatory
submissions, required approvals or commercialization of our products or product
candidates, entail higher costs and result in our being unable to effectively
commercialize our products. Furthermore, if our third-party manufacturers fail
to deliver the required commercial quantities of bulk drug substance or finished
product on a timely basis and at commercially reasonable prices, and we were
unable to promptly find one or more replacement manufacturers capable of
production at a substantially equivalent cost, in substantially equivalent
volume and on a timely basis, we would likely be unable to meet demand for our
products and we would lose potential revenues.
Even
if we obtain regulatory approval, we will be subject to ongoing regulation, and
any failure by us or our manufacturers to comply with such regulation could
suspend or eliminate our ability to sell our products.
Ganite®,
Genasense®
(if it obtains regulatory approval), and any other product we may develop
will be subject to ongoing regulatory oversight, primarily by the FDA. Failure
to comply with post-marketing requirements, such as maintenance by us or by the
manufacturers of our products of current Good Manufacturing Practices as
required by the FDA, or safety surveillance of such products or lack of
compliance with other regulations could result in suspension or limitation of
approvals or other enforcement actions. Current Good Manufacturing Practices are
FDA regulations that define the minimum standards that must be met by companies
that manufacture pharmaceuticals and apply to all drugs for human use, including
those to be used in clinical trials, as well as those produced for general sale
after approval of an application by the FDA. These regulations define
requirements for personnel, buildings and facilities, equipment, control of raw
materials and packaging components, production and process controls, packaging
and label controls, handling and distribution, laboratory controls and
recordkeeping. Furthermore, the terms of any product candidate approval,
including the labeling content and advertising restrictions, may be so
restrictive that they could adversely affect the marketability of our product
candidates. Any such failure to comply or the application of such restrictions
could limit our ability to market our product candidates and may have a material
adverse effect on our business, results of operations and financial condition.
Such failures or restrictions may also prompt regulatory recalls of one or more
of our products, which could have material and adverse effects on our
business.
The
raw materials for our products are produced by a limited number of suppliers,
and our business could suffer if we cannot obtain needed quantities at
acceptable prices and qualities.
The
raw materials that we require to manufacture our drugs, particularly
oligonucleotides and taxanes, are available from only a few suppliers. If these
suppliers cease to provide us with the necessary raw materials or fail to
provide us with an adequate supply of materials at an acceptable price and
quality, we could be materially adversely affected.
If
third-party payors do not provide coverage and reimbursement for use of our
products, we may not be able to successfully commercialize our
products.
Our
ability to commercialize drugs successfully will depend in part on the extent to
which various third-party payors are willing to reimburse patients for the costs
of our drugs and related treatments. These third-party payors include government
authorities, private health insurers and other organizations, such as health
maintenance organizations. Third-party payors often challenge the prices charged
for medical products and services. Accordingly, if less costly drugs are
available, third-party payors may not authorize or may limit reimbursement for
our drugs, even if they are safer or more effective than the alternatives. In
addition, the federal government and private insurers have changed and continue
to consider ways to change the manner in which health care products and services
are provided and paid for in the United States. In particular, these third-party
payors are increasingly attempting to contain health care costs by limiting both
coverage and the level of reimbursement for new therapeutic products. In the
future, it is possible that the government may institute price controls and
further limits on Medicare and Medicaid spending. These controls and limits
could affect the payments we collect from sales of our products.
Internationally, medical reimbursement systems vary significantly, with some
countries requiring application for, and approval of, government or third-party
reimbursement. In addition, some medical centers in foreign countries have fixed
budgets, regardless of levels of patient care. Even if we succeed in bringing
therapeutic products to market, uncertainties regarding future health care
policy, legislation and regulation, as well as private market practices, could
affect our ability to sell our products in quantities, or at prices, that will
enable us to achieve profitability.
Our
business exposes us to potential product liability that may have a negative
effect on our financial performance and our business generally.
The
administration of drugs to humans, whether in clinical trials or commercially,
exposes us to potential product and professional liability risks, which are
inherent in the testing, production, marketing and sale of human therapeutic
products. Product liability claims can be expensive to defend and may result in
large judgments or settlements against us, which could have a negative effect on
our financial performance and materially and adversely affect our business. We
maintain product liability insurance (subject to various deductibles), but our
insurance coverage may not be sufficient to cover claims. Furthermore, we cannot
be certain that we will always be able to maintain or increase our insurance
coverage at an affordable price. Even if a product liability claim is not
successful, the adverse publicity and time and expense of defending such a claim
may interfere with or adversely affect our business and financial
performance.
We
may incur a variety of costs to engage in future acquisitions of companies,
products or technologies, and the anticipated benefits of those acquisitions may
never be realized.
As a part
of our business strategy, we may make acquisitions of, or significant
investments in, complementary companies, products or technologies, although no
significant acquisition or investments are currently pending. Any future
acquisitions would be accompanied by risks such as:
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difficulties
in assimilating the operations and personnel of acquired
companies;
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diversion
of our management’s attention from ongoing business
concerns;
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our
potential inability to maximize our financial and strategic position
through the successful incorporation of acquired technology and rights to
our products and services;
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additional
expense associated with amortization of acquired
assets;
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maintenance
of uniform standards, controls, procedures and policies;
and
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impairment
of existing relationships with employees, suppliers and customers as a
result of the integration of new management
personnel.
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We cannot
guarantee that we will be able to successfully integrate any business, products,
technologies or personnel that we might acquire in the future, and our failure
to do so could harm our business.
We
face substantial competition from other companies and research institutions that
are developing similar products, and we may not be able to compete
successfully.
In many
cases, our products under development will be competing with existing therapies
for market share. In addition, a number of companies are pursuing the
development of antisense technology and controlled-release formulation
technology and the development of pharmaceuticals utilizing such technologies.
We compete with fully integrated pharmaceutical companies that have more
substantial experience, financial and other resources and superior expertise in
research and development, manufacturing, testing, obtaining regulatory
approvals, marketing and distribution. Smaller companies may also prove to be
significant competitors, particularly through their collaborative arrangements
with large pharmaceutical companies or academic institutions. Furthermore,
academic institutions, governmental agencies and other public and private
research organizations have conducted and will continue to conduct research,
seek patent protection and establish arrangements for commercializing products.
Such products may compete directly with any products that may be offered by
us.
Our
competition will be determined in part by the potential indications for which
our products are developed and ultimately approved by regulatory authorities.
For certain of our potential products, an important factor in competition may be
the timing of market introduction of our or our competitors’ products.
Accordingly, the relative speed with which we can develop products, complete the
clinical trials and approval processes and supply commercial quantities of the
products to the market are expected to be important competitive factors. We
expect that competition among products approved for sale will be based, among
other things, on product efficacy, safety, reliability, availability, price,
patent position and sales, marketing and distribution capabilities. The
development by others of new treatment methods could render our products under
development non-competitive or obsolete.
Our
competitive position also depends upon our ability to attract and retain
qualified personnel, obtain patent protection or otherwise develop proprietary
products or processes and secure sufficient capital resources for the
often-substantial period between technological conception and commercial sales.
We cannot assure you that we will be successful in this regard.
We
are dependent on our key executives and scientists, and the loss of key
personnel or the failure to attract additional qualified personnel could harm
our business.
Our
business is highly dependent on our key executives and scientific staff. The
loss of key personnel or the failure to recruit necessary additional or
replacement personnel will likely impede the achievement of our development
objectives. There is intense competition for qualified personnel in the
pharmaceutical and biotechnology industries, and there can be no assurances that
we will be able to attract and retain the qualified personnel necessary for the
development of our business.
Risks
Related to Outstanding Litigation
The
outcome of and costs relating to pending litigation are uncertain.
In
November 2008, a complaint against us and our transfer agent, BNY Mellon
Shareholder Services, was filed in the Supreme Court of the State of New York by
an individual stockholder. The complaint alleges that we and our transfer agent
caused or contributed to losses suffered by the stockholder. We deny the
allegations of the complaint and intend to vigorously defend this
lawsuit.
In
September 2008, several of our stockholders, on behalf of themselves and
all others similarly situated, filed a class action complaint against us, our
Board of Directors, and certain of our executive officers in Superior Court of
New Jersey, captioned Collins v. Warrell, Docket No. L-3046-08. The complaint
alleged that in issuing convertible notes in June 2008, our Board of Directors,
and certain officers breached their fiduciary duties, and we aided and abetted
the breach of fiduciary duty. We filed a motion to dismiss on
December 29, 2008. On March 20, 2009, our motion to dismiss was
granted, and on April 30, 2009, the plaintiffs filed a notice of appeal with the
Appellate Division. On May 13, 2009, the plaintiffs filed a motion for
relief from judgment based on a claim of new evidence, which was denied on June
12, 2009. The plaintiffs also asked the Appellate Division for a temporary
remand to permit the Superior Court judge to resolve the issues of the new
evidence plaintiffs sought to raise. By order dated June 25, 2009, and
filed on July 6, 2009, the Appellate Division granted the motion for temporary
remand, and directed the issues on remand to be resolved in 30 days. A
hearing on the plaintiff's motion is scheduled for Friday, July 31,
2009.
Risks
Related to Our Common Stock
Provisions
in our restated certificate of incorporation and bylaws and Delaware law may
discourage a takeover and prevent our stockholders from receiving a premium for
their shares.
Provisions
in our restated certificate of incorporation and bylaws may discourage third
parties from seeking to obtain control of us and, therefore, could prevent our
stockholders from receiving a premium for their shares. Our restated certificate
of incorporation gives our Board of Directors the power to issue shares of
preferred stock without approval of the holders of common stock. Any preferred
stock that is issued in the future could have voting rights, including voting
rights that could be superior to that of our common stock. The affirmative vote
of 66 2/3% of our voting stock is required to approve certain transactions and
to take certain stockholder actions, including the amendment of certain
provisions of our certificate of incorporation. Our bylaws contain provisions
that regulate how stockholders may present proposals or nominate directors for
election at annual meetings of stockholders.
In
addition, we are subject to Section 203 of the Delaware General Corporation Law,
which contains restrictions on stockholder action to acquire control of
us.
In
September 2005, our Board of Directors approved a Stockholder Rights Plan and
declared a dividend of one preferred stock purchase right, which we refer to as
a Right, for each share of our common stock held of record as of the close of
business on September 27, 2005. In addition, Rights shall be issued in respect
of all shares of common stock issued after such date. The Rights contain
provisions to protect stockholders in the event of an unsolicited attempt to
acquire us, including an accumulation of shares in the open market, a partial or
two-tier tender offer that does not treat all stockholders equally and other
activities that the Board believes are not in the best interests of
stockholders. The Rights may discourage a takeover and prevent our stockholders
from receiving a premium for their shares.
We
have not paid, and do not expect to pay in the future, cash dividends on our
common stock.
We have
never paid cash dividends on our common stock and do not anticipate paying any
such dividends in the foreseeable future. We currently intend to retain our
earnings, if any, for the development of our business.
Our
stock price is volatile.
The
market price of our common stock, like that of the common stock of many other
biopharmaceutical companies, has been and likely will continue to be highly
volatile. Factors that could have a significant impact on the future price of
our common stock include but are not limited to:
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the
results of preclinical studies and clinical trials by us or our
competitors;
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announcements
of technological innovations or new therapeutic products by us or our
competitors;
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developments
in patent or other proprietary rights by us or our competitors, including
litigation;
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fluctuations
in our operating results; and
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market
conditions for biopharmaceutical stocks in
general.
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At
March 31, 2009, our outstanding convertible notes were convertible into 106
million shares of common stock. On April 2, 2009 we sold additional notes and
warrants, convertible into 78 million shares of common stock. On July 7, 2009,
we sold approximately $3 million of notes, common stock and
warrants. Future sales of shares of our common stock by existing
stockholders, holders of preferred stock who might convert such preferred stock
into common stock, holders of convertible notes who might convert such
convertible notes into common stock and option and warrant holders who may
exercise their options and warrants to purchase common stock also could
adversely affect the market price of our common stock. Moreover, the perception
that sales of substantial amounts of our common stock might occur could
adversely affect the market price of our common stock.
As
our convertible noteholders convert their notes into shares of our common stock,
our stockholders will be diluted.
On
June 9, 2008, we placed $20 million of senior secured convertible notes, or the
2008 Notes, with certain institutional and accredited investors. The 2008 Notes
bear interest at an annual rate of 15% payable at quarterly intervals in other
senior secured convertible promissory notes to the holder, and are presently
convertible, after adjusting for the April 2009 note offering and the 1:50
reverse stock split, into shares of our common stock at a conversion rate of
10,000 shares of common stock for every $1,000.00 of principal. Certain members
of our senior management participated in this offering. The 2008 Notes are
secured by a first lien on all of our assets. At June 30, 2009, our
outstanding 2008 Notes were convertible into approximately 28.3 million shares
of our common stock.
On
April 2, 2009, we entered into a securities purchase agreement with certain
accredited institutional investors to place up to $12 million of senior secured
convertible notes, or the April 2009 Notes, and corresponding warrants to
purchase common stock. We closed on approximately $6 million of such notes and
warrants on April 2, 2009. The April 2009 Notes bear interest at an annual rate
of 8% payable semi-annually in other senior secured convertible promissory notes
to the holder, and will be convertible into shares of our common stock at a
conversion rate of 10,000 shares of common stock for every $1,000.00 of
principal amount outstanding, adjusting for the 1:50 reverse stock
split. The April 2009 Notes are secured by a first lien on all of our
assets. At June 30, 2009, our outstanding April 2009 Notes were
convertible into approximately 59.5 million shares of our common
stock.
On
July 7, 2009, we entered into a securities purchase agreement with certain
accredited institutional investors to place up to $10 million in aggregate
principal amount of units consisting of (i) 70% unsecured subordinated
convertible notes, or the July 2009 Notes, and (ii) 30% common
stock. In connection with the sale of the units, we also issued to
the investors two-year warrants to purchase common stock in an amount equal to
25% of the number of shares of common stock issuable upon conversion of the July
2009 Notes purchased by each investor. We closed on approximately $3
million of such July 2009 Notes, common stock and warrants on July 7,
2009.
The
conversion of some or all of our notes dilute the ownership interests of
existing stockholders. Any sales in the public market of the common stock
issuable upon conversion of the notes could adversely affect prevailing market
prices of our common stock. In addition, the existence of the notes may
encourage short selling by market participants because the conversion of the
notes could depress the price of our common stock.
If
holders of our notes elect to convert their notes and sell material amounts of
our common stock in the market, such sales could cause the price of our common
stock to decline, and such downward pressure on the price of our common stock
may encourage short selling of our common stock by holders of our notes or
others.
If there
is significant downward pressure on the price of our common stock, it may
encourage holders of notes or others to sell shares by means of short sales to
the extent permitted under the U.S. securities laws. Short sales
involve the sale by a holder of notes, usually with a future delivery date, of
common stock the seller does not own. Covered short sales are sales
made in an amount not greater than the number of shares subject to the short
seller’s right to acquire common stock, such as upon conversion of
notes. A holder of notes may close out any covered short position by
converting its notes or purchasing shares in the open market. In
determining the source of shares to close out the covered short position, a
holder of notes will likely consider, among other things, the price of common
stock available for purchase in the open market as compared to the conversion
price of the notes. The existence of a significant number of short
sales generally causes the price of common stock to decline, in part because it
indicates that a number of market participants are taking a position that will
be profitable only if the price of the common stock declines.
Our
common stock is considered a "penny stock" and does not qualify for exemption
from the “penny stock” restrictions, which may make it more difficult for you to
sell your shares.
Our
common stock is classified as a “penny stock” by the SEC and is subject to rules
adopted by the SEC regulating broker-dealer practices in connection with
transactions in “penny stocks.” The SEC has adopted regulations which define a
“penny stock” to be any equity security that has a market price of less than
$5.00 per share, or with an exercise price of less than $5.00 per share, subject
to certain exceptions. For any transaction involving a penny stock, unless
exempt, these rules require delivery, prior to any transaction in a penny stock,
of a disclosure schedule relating to the penny stock market. Disclosure is also
required to be made about current quotations for the securities and commissions
payable to both the broker-dealer and the registered representative. Finally,
broker-dealers must send monthly statements to purchasers of penny stocks
disclosing recent price information for the penny stock held in the account and
information on the limited market in penny stocks. As a result of our shares of
common stock being subject to the rules on penny stocks, the liquidity of our
common stock may be adversely affected.
Risks
Related to this Offering
We have a significant amount of debt.
Our substantial indebtedness could adversely affect our business,
financial condition and results of operations and our ability to meet our payment
obligations under the notes and our other debt.
We
have a significant amount of debt. As of March 31, 2009, we had a face amount of
debt outstanding of $10.7 million, consisting solely of 2008 Notes.
As adjusted to give effect to the $6.0 million face value of our April 2009
Notes, our July 7, 2009 financing of $2.1 million in convertible notes and this
offering of $4.9 million of convertible notes, the face value of our outstanding
debt on March 31, 2009 would be approximately $23.7 million. As of June 30,
2009, we had a face amount of debt outstanding of $8.8 million, consisting of
the face value of April 2009 Notes of $6.0 million and the face value of 2008
Notes of $2.8 million. As adjusted to give effect to the July 7, 2009 financing
of $2.1 million in convertible notes and this offering of $4.9 million of
convertible notes, we would have had approximately $15.8 million of outstanding
debt.
Our
aggregate level of debt could have significant consequences on our future
operations, including:
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making
it more difficult for us to meet our payment and other obligations under
our outstanding debt, including the August 2009
Notes;
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resulting
in an event of default if we fail to comply with the restrictive covenants
contained in our debt agreements, which could result in all of our debt
becoming due and payable and, in the case of an event of default under our
secured debt, could permit the lenders to foreclose on our assets securing
such debt;
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limiting
our flexibility in planning for, or reacting to, and increasing our
vulnerability to, changes in our business, the industry in which we
operate and the general economy;
and
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placing
us at a competitive disadvantage compared to our competitors that have
less debt or are less leveraged.
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Any of
the above-listed factors could have an adverse effect on our business, financial
condition and results of operations and our ability to meet our payment
obligations under the notes and our other debt.
Our substantial amount of secured
debt may prevent us from obtaining additional financing in the future or make the
terms of securing such additional financing more onerous to
us.
The
2008 Notes and April 2009 Notes are secured by a first priority lien on our
assets and the July 2009 Notes and August 2009 Notes are unsecured. While the
terms or availability of additional capital is always uncertain, should we need
to obtain additional financing in the future, because of the existing liens on
our assets, it may be even more difficult for us to do so. Potential future
lenders may be unwilling to provide financing on an unsecured basis and may not
agree to share the collateral with our existing secured debt. Alternatively, if
we are able to raise additional financing in the future, the terms of any such
financing may be onerous to us. This potential inability to obtain borrowings or
our obtaining borrowings on unfavorable terms could negatively impact our
operations and impair our ability to maintain sufficient working
capital.
The market value of the notes and
warrants may be exposed
to substantial volatility.
A
number of factors, including factors specific to us and our business, financial
condition and liquidity, the price of our common stock, economic and financial
market conditions, interest rates, unavailability of capital and financing
sources, volatility levels and other factors could lead to a decline in the
value of the August 2009 Notes, August 2009 Shares and warrants and a lack of
liquidity in the market, if any, for the August 2009 Notes and August 2009
Shares. As has recently been evident in the current turmoil in the global
financial markets, the present economic slowdown and the uncertainty over its
breadth, depth and duration, the entire convertible note market can experience
sudden and sharp price swings and changes in liquidity, which can be exacerbated
by large or sustained sales by major investors in the convertible notes, a
default by a high-profile issuer, regulatory changes, or simply a change in the
market’s psychology regarding convertible notes. Moreover, if one or more of the
rating agencies rates the August 2009 Notes and assigns a rating that is below
the expectations of investors, or lowers its or their rating(s) of the August
2009 Notes, the price of the notes would likely decline.
Declines in the market price of our
common stock may depress the trading price of the August 2009 Notes and
warrants.
The
market price of our common stock has experienced, and may continue to
experience, significant volatility. From January 1, 2007 through May 7, 2008,
the trading price of our common stock on the NASDAQ Global Market ranged from a
low of $0.15 per share to a high of $3.36 per share. From May 7, 2008 through
July 14, 2009, the trading price of our common stock on the OTC Bulletin Board
has ranged from a low of $0.13 per share to a high of $37.45 per share. Because
the August 2009 Notes are convertible into, and the warrants are exercisable
for, shares of our common stock, declines in the price of our common stock may
depress the trading price of the August 2009 Notes and warrants. The risk of
depressed prices of our common stock also applies to holders who receive shares
of common stock upon conversion of their August 2009 Notes or exercise of their
warrants.
Numerous
factors, including many over which we have no control, may have a significant
impact on the market price of our common stock, including, among other
things:
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our
operating and financial performance and
prospects;
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our
ability to repay our debt;
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quarterly
variations in operating results;
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investor
perceptions of us and the industry and markets in which we
operate;
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changes
in earnings estimates or buy/sell recommendations by analysts;
and
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general
financial, domestic, international, economic and other market
conditions.
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In
addition, the stock market in recent months has experienced extreme price and
trading volume fluctuations that often have been unrelated or disproportionate
to the operating performance of individual companies. These broad market
fluctuations may adversely affect the price of our common stock, regardless of
our operating performance. In addition, sales of substantial amounts of our
common stock in the public market, or the perception that those sales may occur,
could cause the market price of our common stock to decline. Furthermore,
stockholders may initiate securities class action lawsuits if the market price
of our stock drops significantly, which may cause us to incur substantial costs
and could divert the time and attention of our management.
These
factors, among others, could significantly depress the trading price of the
August 2009 Notes and warrants and the price of our common stock issued upon
conversion of the August 2009 Notes and exercise of the
warrants.
The conversion rate of the August
2009 Notes may not be adjusted for certain dilutive events that may
occur.
As
described more fully herein, we will adjust the conversion rate of the August
2009 Notes for certain events, including, among others:
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the
issuance of stock dividends on our common
stock;
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the
issuance of certain rights or
warrants;
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certain
subdivisions and combinations of our capital
stock;
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the
distribution of capital stock, indebtedness, cash or other assets;
and
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certain
tender or exchange offers.
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We
will not adjust the conversion rate for other events, such as an issuance of
common stock for cash at a price above the current conversion price or in
connection with an acquisition, that may adversely affect the trading price of
the notes or our common stock. If we engage in any of these types of
transactions, the value of the common stock into which your notes may be
convertible may be diluted. An event that adversely affects the value of the
notes, but does not result in an adjustment to the conversion rate, may
occur.
We may not be able to provide you
with all of the shares of our common stock that you would otherwise be entitled
to receive upon a conversion of the August 2009 Notes, upon payment of interest
in shares of our common stock or upon exercise of the warrants because the August
2009 Notes and warrants contain a cap on the shares we may issue to any
holder.
You
will not be entitled to convert the August 2009 Notes or exercise the warrants
to the extent (and only to the extent) that such conversion or exercise would
cause you (including your affiliates) to become, directly or indirectly, a
“beneficial owner” (as defined within the meaning of Section 13(d) of the
Exchange Act and the rules and regulations promulgated thereunder) of more than
4.999% of the shares of our common stock outstanding at such time (in the case
of the warrants) and more than 9.999% of the shares of our common
stock outstanding at such time (in the case of the August 2009
Notes). This limitation also applies to our ability to pay interest
in shares of our common stock. We refer to this limitation as the “issuance
cap.”
We may not have the ability to pay
principal or interest on the August 2009 Notes when due.
The
August 2009 Notes mature on August [ ], 2011 and bear interest payable
semi-annually at a rate of 8.00% per annum. Absent additional financing, we will
likely not have sufficient funds to pay the principal upon maturity or upon any
acceleration thereof. In addition, we may not have sufficient funds to pay
interest on the August 2009 Notes. If we fail to pay principal or interest on
the August 2009 Notes when due, we will be in default under the indenture
governing the August 2009 Notes.
We are subject only to limited
covenants in the indenture for the August 2009 Notes, and these limited covenants may not
protect your investment.
The
indenture for the August 2009 Notes does not:
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require
us to maintain any financial ratios or specific levels of net worth,
revenues, income, cash flows or liquidity and, accordingly, does not
protect holders of the notes in the event that we experience significant
adverse changes in our financial condition or results of
operations;
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restrict
our ability to repurchase our securities;
or
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restrict
our ability to make investments or to pay dividends or make other payments
in respect of our common stock or other
securities.
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Furthermore,
the indenture governing the August 2009 Notes will not restrict our ability to
incur additional indebtedness, including additional secured indebtedness, or our
ability to designate any secured indebtedness as senior to, or pari-passu with,
the August 2009 Notes. We could engage in many types of transactions, such as
incurring additional indebtedness or engaging in acquisitions, refinancings or
recapitalizations, which could substantially affect our capital structure and
the value of the August 2009 Notes and warrants and our common stock. For these
reasons, you should not consider the covenants in the indenture as a significant
factor in evaluating whether to invest in the August 2009 Notes and
warrants.
If an active and liquid trading
market for the August 2009 Notes and warrants does not develop, the market price
of the August 2009 Notes and warrants may decline and you may be unable to sell your August 2009 Notes
and warrants.
The
August 2009 Notes and warrants are a new issue of securities for which there is
currently no public market. We do not intend to list the August 2009 Notes and
warrants on any national securities exchange. An active trading market is not
expected to develop for the August 2009 Notes and warrants. Even if a trading
market for the August 2009 Notes and warrants develops, the market may not be
liquid. If an active trading market does not develop, you may be unable to
resell your August 2009 Notes and warrants or may only be able to sell them at a
substantial discount.
Future issuances of common stock and
hedging activities may depress the trading price of our common stock and the
August 2009 Notes and warrants.
Any
issuance of equity securities by us after this offering, including the issuance
of shares upon conversion of the August 2009 Notes and warrants, could dilute
the interests of our existing stockholders, including holders who have received
shares upon conversion of their August 2009 Notes or exercise of the warrants,
and could substantially decrease the trading price of our common stock and the
August 2009 Notes and warrants. We may issue equity securities in the future for
a number of reasons, including to finance our operations and business strategy,
for acquisitions, to adjust our ratio of debt to equity, to satisfy our
obligations upon the exercise of outstanding warrants or options, in order to
satisfy obligations under debt that remains outstanding, or for other reasons.
In addition, the price of our common stock could also be affected by possible
sales of our common stock by investors who view our convertible notes as a more
attractive means of equity participation in our company and by hedging or
arbitrage trading activity that we expect to develop involving our common stock.
This hedging or arbitrage could, in turn, affect the trading price of the notes
and any common stock that holders receive upon conversion of the
notes.
Provisions in the indenture for the
August 2009 Notes, our charter documents and Delaware law could discourage an
acquisition of us by a third party, even if the acquisition would be favorable to
you.
The
indenture for the August 2009 Notes prohibits us from engaging in certain
mergers or acquisitions unless, among other things, the surviving entity assumes
our obligations under the August 2009 Notes. These and other provisions,
including the provisions of our charter documents and Delaware law described
under “Description of capital stock” could prevent or deter a third party from
acquiring us even where the acquisition could be beneficial to you. In addition,
in September 2005, the Board of Directors adopted a stockholder rights plan and
declared a dividend of one preferred stock purchase right, or right, for each
outstanding share of our common stock, payable to holders of record as of the
close of business on September 27, 2005. In addition, rights shall be issued in
respect of all shares of common stock issued after such date, including the
shares issued hereunder, pursuant to the plan. Generally, the rights become
exercisable upon the earlier of the close of business on the tenth business day
following the first public announcement that any person or group has become a
beneficial owner of 15% or more of our common stock and the close of business on
the tenth business day after the date of the commencement of a tender or
exchange offer by any person which would, if consummated, result in such person
becoming a beneficial owner of 15% or more of the our common
stock.
An adverse rating of the August
2009 Notes may cause their trading price to fall.
We do
not intend to seek a rating of the August 2009 Notes. However, if a rating
agency rates the August 2009 Notes, it may assign a rating that is lower than
investors’ expectations. Ratings agencies also may lower ratings on the August
2009 Notes in the future. If rating agencies assign a lower-than-expected rating
to the August 2009 Notes or to our credit ratings in general or reduce, or
indicate that they may reduce, their ratings in the future, the trading price of
the August 2009 Notes could significantly decline, the liquidity of any market
for the August 2009 Notes could be adversely impacted, our cost of financing
could increase and our access to the capital markets could be limited. A rating
is based upon information furnished by us or obtained by the rating agency from
its own sources and is subject to revision, suspension or withdrawal by the
rating agency at any time. Rating agencies may review the ratings assigned to
the August 2009 Notes due to developments that are beyond our control. We cannot
assure you that any ratings on the August 2009 Notes will not be downgraded in
the near future.
You may have to pay US taxes if we
adjust the conversion rate in certain circumstances, even if you do not
receive any cash.
We
will adjust the conversion rate of the August 2009 Notes for stock splits and
combinations, stock dividends, cash dividends and certain other events that
affect our capital structure. If we adjust the conversion rate, you may be
treated as having received a constructive distribution from us, resulting in
taxable income to you for US federal income tax purposes, even though you would
not receive any cash in connection with the conversion rate adjustment and even
though you might not exercise your conversion right.
As a holder of August 2009 Notes or
warrants, you will not be entitled to any rights with respect to our common stock, but
you will be subject to all changes made with respect to our common
stock.
If you
hold August 2009 Notes or warrants, you will not be entitled to any rights with
respect to our common stock (including, without limitation, voting rights and
rights to receive any dividends or other distributions on our common stock), but
you will be subject to all changes affecting our common stock. You will have the
rights with respect to our common stock only when we deliver shares of common
stock to you upon conversion of your August 2009 Notes or exercise of your
warrants. For example, in the event that an amendment is proposed to our
Certificate of Incorporation or code of regulations requiring stockholder
approval and the record date for determining the stockholders of record entitled
to vote on the amendment occurs prior to the date you are deemed to have
received common stock upon conversion, you will not be entitled to vote on the
amendment, although you will nevertheless be subject to any changes in the
powers, preferences or special rights of our common stock.
Recent actions taken by the SEC to
address abusive short selling may not effectively prevent security holders
from engaging in short sales, which could further contribute to downward
pressure on the trading price of our common stock. At the same time, these
actions may also make it more difficult and/or expensive to hedge positions in
convertible securities.
The
SEC recently adopted various rules and rule amendments to address potentially
manipulative short selling activities, including adopting new anti-fraud rule,
Rule 10b-21 under the Exchange Act to address naked short selling, amending Rule
203 of Regulation SHO to eliminate an exception for certain options market
makers, and adopting new Rule 204T of Regulation SHO, which generally mandates
that a sales transaction for common stock be closed out on the fourth day
following the trade’s date. In particular, Rule 10b-21 specifically provides
that it is a manipulative or deceptive device or contrivance for any seller of
equity securities of a public company to deceive its brokers about its intention
or ability to deliver the relevant securities in time for settlement and to fail
to deliver shares by the close of business on the trade’s settlement date. As a
result of the SEC’s focus on closing out failures to deliver securities in
connection with sales transactions, a holder of August 2009 Notes may find it
more difficult and/or expensive to hedge its investment. However, the full
effects of the recent SEC actions, if any, are not clear, including whether such
actions will deter short selling and the effect these rule changes will have on
the market for convertible securities generally and on the market for the August
2009 Notes.
Our use of the
offering proceeds may not yield a favorable return on your investment.
We
currently anticipate that the net proceeds from this offering will be used
primarily for clinical development, research and development activities,
commercialization expenses and for general corporate purposes. In addition, we
may also use such proceeds to acquire equipment, potential licenses and
acquisitions of complementary products, technologies or businesses. If we only
raise three million dollars, our fees and expenses will comprise approximately
12% of the aggregate offering proceeds. There is a substantial likelihood that
we would need to raise additional funds within the next two months. If we only
raise five million dollars, our fees and expenses will comprise approximately
10% of the aggregate offering proceeds. We would need to raise additional funds
before the end of 2009.
Pending
the application of the net proceeds, we intend to invest the net proceeds in
investment-grade, interest-bearing securities. Our management has broad
discretion over how these proceeds are used and could spend the proceeds in ways
with which you may not agree. Pending the use of the proceeds in this offering,
we will invest them. However, the proceeds may not be invested in a manner that
yields a favorable or any return.
As a new
investor, you will incur substantial dilution as a result of this offering and
future equity issuances, and as a result, our stock price could decline.
The
offering price will be substantially higher than the net tangible book value per
share of our outstanding common stock. As a result, based on our capitalization
as of March 31, 2009 adjusted for our April 2009 Notes and our July 7, 2009
financing, investors purchasing common stock in this offering will incur
immediate dilution of $(0.29) per share, based on the assumed offering price of
$0.10 per share. We believe that following this offering, our current cash, cash
equivalents and short-term investments, together with the anticipated proceeds
from this offering, will be sufficient to fund our operations through the third
quarter of 2009; however, our projected revenue may decrease or our expenses may
increase and that would lead to our cash resources being consumed earlier than
currently anticipated. In addition to this offering, subject to market
conditions and other factors, we likely will pursue raising additional funds in
the future, as we continue to build our business. In future years, we will
likely need to raise significant additional funding to finance our operations
and to fund clinical trials, regulatory submissions and the development,
manufacture and marketing of other products under development and new product
opportunities. Accordingly, we may conduct substantial future offerings of
equity or debt securities. The exercise of outstanding options and warrants and
future equity issuances, including future public offerings or future private
placements of equity securities and any additional shares issued in connection
with acquisitions, will also result in dilution to investors. In addition, the
market price of our common stock could fall as a result of resales of any of
these shares of common stock due to an increased number of shares available for
sale in the market.
FORWARD-LOOKING
STATEMENTS
This
prospectus contains certain forward-looking statements regarding management’s
plans and objectives for future operations including plans and objectives
relating to our planned marketing efforts and future economic performance. The
forward-looking statements and associated risks set forth in this prospectus
include or relate to, among other things, (a) our projected sales and
profitability, (b) our growth strategies, (c) anticipated trends in our
industry, (d) our ability to obtain and retain sufficient capital for future
operations, and (e) our anticipated needs for working capital. These statements
may be found under “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and “Business”, as well as in this prospectus
generally. Actual events or results may differ materially from those discussed
in forward-looking statements as a result of various factors, including, without
limitation, the risks outlined under “Risk Factors” and matters described in
this prospectus generally. In light of these risks and uncertainties, there can
be no assurance that the forward-looking statements contained in this prospectus
will in fact occur.
The
forward-looking statements herein are based on current expectations that involve
a number of risks and uncertainties. Such forward-looking statements are based
on assumptions that there will be no material adverse competitive or
technological change in conditions in our business, that demand for our products
and services will significantly increase, that our President will remain
employed as such, that our forecasts accurately anticipate market demand, and
that there will be no material adverse change in our operations or business or
in governmental regulations affecting us or our manufacturers and/or suppliers.
The foregoing assumptions are based on judgments with respect to, among other
things, future economic, competitive and market conditions, and future business
decisions, all of which are difficult or impossible to predict accurately and
many of which are beyond our control. Accordingly, although we believe that the
assumptions underlying the forward-looking statements are reasonable, any such
assumption could prove to be inaccurate and therefore there can be no assurance
that the results contemplated in forward-looking statements will be realized. In
addition, as disclosed elsewhere in the “Risk Factors” section of this
prospectus, there are a number of other risks inherent in our business and
operations which could cause our operating results to vary markedly and
adversely from prior results or the results contemplated by the forward-looking
statements. Growth in absolute and relative amounts of cost of goods sold and
selling, general and administrative expenses or the occurrence of extraordinary
events could cause actual results to vary materially from the results
contemplated by the forward-looking statements. Management decisions, including
budgeting, are subjective in many respects and periodic revisions must be made
to reflect actual conditions and business developments, the impact of which may
cause us to alter marketing, capital investment and other expenditures, which
may also materially adversely affect our results of operations. In light of
significant uncertainties inherent in the forward-looking information included
in this prospectus, the inclusion of such information should not be regarded as
a representation by us or any other person that our objectives or plans will be
achieved.
Some
of the information in this prospectus contains forward-looking statements that
involve substantial risks and uncertainties. Any statement in this prospectus
and in the documents incorporated by reference into this prospectus that is not
a statement of an historical fact constitutes a “forward-looking statement”.
Further, when we use the words “may”, “expect”, “anticipate”, “plan”, “believe”,
“seek”, “estimate”, “internal” and similar words, we intend to identify
statements and expressions that may be forward-looking statements. We believe it
is important to communicate certain of our expectations to our investors.
Forward-looking statements are not guarantees of future performance. They
involve risks, uncertainties and assumptions that could cause our future results
to differ materially from those expressed in any forward-looking statements.
Many factors are beyond our ability to control or predict. You are accordingly
cautioned not to place undue reliance on such forward-looking statements.
Important factors that may cause our actual results to differ from such
forward-looking statements include, but are not limited to, the risk factors
discussed above. Before you invest in our common stock, you should be aware that
the occurrence of any of the events described under “Risk Factors” or elsewhere
in this prospectus could have a material adverse effect on our business,
financial condition and results of operation. In such a case, the trading price
of our common stock could decline and you could lose all or part of your
investment.
USE
OF PROCEEDS
We
estimate that the net proceeds to us from our sale of up to $7.0 million of
an aggregate principal amount of units, consisting of convertible notes in an
aggregate principal amount of $4.9 million, common stock in an aggregate
principal amount of $2.1 million and warrants to purchase 12,250,000 shares of
our common stock in this offering will be approximately $6.3 million, assuming a
public offering price of our common stock of $0.10 per share and after deducting
estimated placement agent discounts and commissions and offering expenses
payable by us. Each $0.10 increase or decrease in the assumed public offering
price of our common stock sold as part of the Units offered hereby would
increase or decrease, respectively, the net proceeds to us by approximately $1.3
million, assuming the aggregate principal amount of convertible notes and
warrants to purchase shares of our common stock offered by us, as set forth
above, remains the same and after deducting placement agent discounts and
commissions and estimated offering expenses.
Investors
will be relying on the judgment of our management, who will have broad
discretion regarding the application of the proceeds of this offering. The
amounts and timing of our actual expenditures will depend upon numerous factors,
including the amount of cash generated by our operations, our cash needs and the
amount of competition we face. We may find it necessary or advisable to use
portions of the proceeds from this offering for other purposes.
We intend
to use our net proceeds of this offering approximately as follows:
|
•
|
65%
to advance our lead product candidate Genasense® through clinical trials,
especially for the long-term follow-up of patients entered into our Phase
3 trial of Genasense® in melanoma, known as
AGENDA;
|
|
•
|
15%
of the proceeds will be reserved to further advance clinical development
of our next two clinical-stage pipeline products, tesetaxel and G4544. The
clinical development plans for these products are described elsewhere in
this document. However, there is no expectation that these funds will be
sufficient to fully fund all expenses that we expect to incur in this
effort, and additional funds will be required for this purpose;
and
|
|
•
|
20%
of the proceeds will be spent for general corporate purposes, including
working capital needs, payment of accrued liabilities and potential
acquisitions or licenses to intellectual property as may be needed to
defend or expand our product portfolio as described
below.
|
Our
potential use of net proceeds for acquisitions may include the acquisition or
licensing of marketed anti-cancer products or rights to potential new products
or product candidates. Although we periodically evaluate acquisition and
in-licensing opportunities, we currently have no commitments or agreements with
respect to any specific acquisition or license.
Pending
the uses described above, we intend to invest the net proceeds of this offering
in short- to medium-term investment grade, interest-bearing
securities.
DIVIDEND
POLICY
We have
never declared or paid any cash dividends on our common stock. We currently
intend to retain our future earnings, if any, to finance the expansion of our
business and do not expect to pay any cash dividends in the foreseeable future.
Payment of future cash dividends, if any, will be at the discretion of our board
of directors after taking into account various factors, including our financial
condition, operating results, current and anticipated cash needs and plans for
expansion and restrictions imposed by lenders, if any.
CAPITALIZATION
The
following table describes our capitalization as of March 31, 2009:
|
•
|
on
an actual basis; and
|
|
•
|
on
an as adjusted basis to give effect to our sale of convertible notes in an
aggregate principal amount of $4.9 million, sale of shares of common stock
for an aggregate principal amount of $2.1
million.
|
You
should read this capitalization table together with our consolidated financial
statements and the related notes appearing at the end of this prospectus and the
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations” section and other financial information included in this
prospectus.
(000)
|
|
As
of March 31, 2009
|
|
|
|
Actual
(unaudited)
|
|
|
As
adjusted
for
April 2009
financing
(unaudited)
|
|
|
As
adjusted
for
April
2009
financing
and
July 7,
2009
financing
(unaudited)
|
|
|
As
adjusted for April 2009
financing,
July 7, 2009
financing
and this
financing
(unaudited)
|
|
Convertible
notes due June 7, 2010, as of March 31, 2009 actual $10,654 outstanding
net of debt discount of ($5,991), as of March 31, 2009 adjusted for April
2009 financing, $16,604 outstanding net of debt discount of ($11,941),
adjusted for April 2009 financing and July 7, 2009 financing $18,704
outstanding net of debt discount of ($14,041) and as of March
31, 2009 adjusted for April 2009 financing, July 7, 2009 financing and
this financing $23,604 net of debt discount of
($14,041)
|
|
$ |
4,663 |
|
|
$ |
4,663 |
(1) |
|
$ |
4,663 |
(2) |
|
$ |
9,563 |
(3) |
Common
stock, $.001 par value; 6,000,000 shares authorized, 20,282 shares issued
and outstanding at March 31, 2009 and 20,282 shares issued and outstanding
as of March 31, 2009 adjusted for the April 2009 financing, and 29,272
shares issued and outstanding as of March 31, 2009 adjusted for the April
2009 financing and the July 7, 2009 financing and 50,272 shares issued and
outstanding as of March 31, 2009 adjusted for the April 2009 financing,
July 7, 2009 financing and this financing
|
|
|
20 |
|
|
|
20 |
|
|
|
29 |
|
|
|
50 |
|
Preferred
stock, 5,000 authorized: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
A convertible preferred stock, $.001 par value; 8 shares issued and
outstanding, liquidation value of $385 at December 31, 2008 (actual and as
adjusted)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
G participating cumulative preferred stock, $.001 par value; 0 shares
issued and outstanding at March 31, 2009 (actual and as
adjusted)
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
— |
|
Additional
paid-in capital
|
|
|
944,588 |
|
|
|
950,538 |
|
|
|
953,528 |
|
|
|
955,607 |
|
Accumulated
deficit
|
|
|
(955,193 |
) |
|
|
(955,193 |
) |
|
|
(955,193 |
) |
|
|
(955,193 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders’(deficit)/equity
|
|
|
(10,585 |
) |
|
|
(4,635 |
) |
|
|
(1,636 |
) |
|
|
464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
capitalization
|
|
$ |
(5,922 |
) |
|
$ |
28 |
|
|
$ |
3,027 |
|
|
$ |
10,027 |
|
|
(1)
|
At
the time the April 2009 Notes were issued, the Company recorded a debt
discount (beneficial conversion) relating to the conversion feature and
warrants in the amount of $6.0 million. The aggregate intrinsic value of
the difference between the market price of the Company’s share of stock on
April 2, 2009 and the effective conversion price of the notes was in
excess of the face value of the $6.0 million notes, and thus, a full debt
discount was recorded in an amount equal to the face value of the
debt.
|
|
(2)
|
At
the time the July 2009 Notes were issued, the Company recorded a debt
discount (beneficial conversion) relating to the conversion feature and
warrants in the amount of $2.1 million. The aggregate intrinsic value of
the difference between the market price of the Company’s share of stock on
July 7, 2009 and the effective conversion price of the notes was in excess
of the face value of the $2.1 million notes, and thus, a full debt
discount was recorded in an amount equal to the face value of the
debt.
|
|
(3)
|
This
amount has been adjusted using the face value of the convertible notes in
this offering of $4.9 million
|
The
number of shares of our common stock that will be outstanding prior to this
offering is 20,282,234 shares and 99,770,572 shares of common stock
outstanding as of March 31, 2009 and June 30, 2009,
respectively, adjusted for the 1:50 reverse stock split that was
implemented on June 26, 2009. This amount excludes:
•
|
37,573
shares and 34,261 shares of common stock issuable upon exercise of stock
options outstanding or the vesting of restricted stock units under our
1998 Stock Incentive Plan as of March 31, 2009 and June 30, 2009,
respectively, at a weighted average exercise price of $1,266.50 per share
and $1,293.06 per share, respectively, of which, options to purchase
26,820 shares and 25,890 shares respectively, were
exercisable;
|
•
|
2,045
shares of common stock issuable upon exercise of stock options outstanding
under our 1998 Non-Employee Directors Stock Incentive Plan as of both
March 31, 2009 and June 30, 2009 at a weighted average exercise price of
$1,130.47 per share, of which, options to purchase 2,045 shares were
exercisable;
|
•
|
3,070
shares of common stock available for future grant under our 1998
Non-Employee Directors Stock Incentive Plan as of both March 31, 2009 and
June 30, 2009;
|
•
|
800,000
shares of common stock issuable upon exercise of warrants outstanding as
of March 31, 2009 and June 30, 2009 at an exercise price of $1.00 per
share;
|
•
|
23,629
shares and 109,319 shares of common stock issuable upon the conversion of
our Series A Convertible Preferred Stock as of March 31, 2009 and June 30,
2009, respectively;
|
•
|
21,306,902
shares and 28,294,633 shares of common stock issuable upon the conversion
of our 15% Senior Secured Convertible Notes due 2010 as of March 31, 2009
and June 30, 2009,
respectively;
|
•
|
59,500,000
shares of common stock issuable upon the conversion of our 8% Senior
Secured Convertible Notes due 2012 as of June 30,
2009;
|
•
|
18,445,000
shares of common stock issuable upon exercise of warrants outstanding as
of June 30, 2009 at an exercise price of $0.50 per
share;
|
•
|
59,500,000
shares of common stock issuable upon the conversion of our 8% Senior
Secured Convertible Notes due April 2, 2012 issued pursuant to the
Purchase Option (as defined in the Securities Purchase Agreement, dated
April 2, 2009, by and between the Company and the investors set forth
therein); and
|
•
|
83,190,764
shares of common stock issuable upon the conversion of our 8% Senior
Secured Convertible Notes due April 2, 2012 issued pursuant to the
Purchase Right (as defined in the Consent Agreement, dated April 2, 2009,
by and between the Company and the holders set forth
therein).
|
The
share numbers above do not include the 49,000,000 shares of common stock
issuable upon conversion of the notes we issued in the July 2009 financing or
the 12,250,000 shares of common stock issuable upon exercise of the warrants
issued in the July 2009 financing.
Unless
otherwise indicated, all information in this prospectus assumes there is no
over-allotment option, no conversion of convertible notes or preferred stock and
no exercise of stock options or warrants after June 30,
2009.
DILUTION
Our
net tangible book value as of March 31, 2009 was approximately $(21.9) million,
or $(1.08) per share of common stock. Net tangible book value per share is
determined by dividing our total tangible assets less total liabilities by the
actual number of outstanding shares of our common stock. After giving effect to
our April 2009 financing and our July 7, 2009 financing our adjusted net
tangible book value as of March 31, 2009 was approximately $(13.8) million, or
$(0.65) per share. After giving effect to our issuance of convertible notes in
an aggregate principal amount of $4.9 million, 21,000,000 shares of our common
stock at an estimated sales price of the common stock sold as part of the Units
offered hereby of $0.10 per share, 8,323,080 shares issuable as payment for
interest on the convertible notes and warrants to purchase 12,250,000 shares of
our common stock in this offering at a conversion price of $1.00 per share, and
after deducting estimated placement agent discounts and commissions and offering
expenses payable by us, our net tangible book value as of March 31, 2009 would
have been $(8.0) million or $(0.19) per share of common stock. This represents
an immediate increase in pro forma net tangible book value of $0.46 per share to
our existing stockholders and an immediate dilution of $(0.29) per share to new
investors in this offering. The following table illustrates this per share
dilution:
Assumed
public offering price per share of our common stock
|
|
|
|
|
$ |
0.10 |
|
Net
tangible book value per share as of March 31, 2009 adjusted for our April
2009 financing and our July 7, 2009 financing
|
|
$ |
(0.65 |
) |
|
|
|
|
Increase
per share attributable to new investors
|
|
|
0.46 |
|
|
|
|
|
Pro
forma net tangible book value per share after this
offering
|
|
|
|
|
|
|
(0.19 |
) |
Dilution
per share to new investors
|
|
|
|
|
|
$ |
(0.29 |
) |
Dilution
per share to new investors is determined by subtracting pro forma net tangible
book value per share after this offering from the assumed price per share paid
by a new investor. If any shares are issued in connection with the conversion of
notes or warrants, you will experience further dilution.
DESCRIPTION
OF BUSINESS
Overview
We are a
biopharmaceutical company engaged in pharmaceutical (drug) research and
development. We are dedicated to the identification, development and
commercialization of novel drugs for the treatment of cancer and related
diseases. Our research portfolio consists of two major programs: “DNA/RNA
Medicines” (which includes our lead oncology drug, Genasense®); and “Small
Molecules” (which includes our marketed product, Ganite®, and the
investigational compounds tesetaxel and G4544).
The
DNA/RNA Medicines program includes drugs that are based on using modifications
of either DNA or RNA as drugs that can be used to treat disease. These
technologies include antisense, decoys, and small interfering or micro RNAs. Our
lead drug from this program is an investigational antisense compound known as
Genasense® (oblimersen sodium injection). Genasense® is designed to disrupt a
specific mRNA, which then block the production of a protein known as Bcl-2.
Current science suggests that Bcl-2 is a fundamental (although not sole) cause
of the inherent resistance of cancer cells to anticancer treatments, such as
chemotherapy, radiation, and monoclonal antibodies. While Genasense® has
displayed some anticancer activity when used alone, we are developing the drug
primarily as a means of amplifying the cytotoxic effects of other anticancer
treatments.
Genasense®
The
Company’s principal goal has been to secure regulatory approval for the
marketing of Genasense®. Genasense® has been studied in combination with a wide
variety of anticancer drugs in a number of different cancer indications. We have
reported results from randomized trials of Genasense® in a number of diseases.
Under our own sponsorship or in collaboration with others, we are currently
conducting additional clinical trials. We are especially interested in the
development, regulatory approval, and commercialization of Genasense® in at
least three diseases: melanoma; chronic lymphocytic leukemia (CLL); and
non-Hodgkin’s lymphoma (NHL).
Genasense®
has been submitted for regulatory approval in the U.S. on two occasions and to
the European Union (EU) once. These applications proposed the use of Genasense®
plus chemotherapy for patients with advanced melanoma (U.S. and EU) and relapsed
or refractory chronic lymphocytic leukemia (CLL) (U.S.-only). None of these
applications resulted in regulatory approval for marketing. Nonetheless, we
believe that Genasense® can ultimately be approved and commercialized and we
have undertaken a number of initiatives in this regard that are described
below.
Melanoma
The
Company’s major current initiative is a randomized controlled trial that tests
whether the addition of Genasense to standard chemotherapy can improve outcomes
for patients with advanced melanoma. In 2004, the Company withdrew
its New Drug Application (NDA) for Genasense® in melanoma after an advisory
committee to the Food and Drug Administration (FDA) failed to recommend
approval. A negative decision was also received for a similar application in
melanoma from the European Medicines Agency (EMEA) in 2007. Data from the Phase
3 trial that comprised the basis for these applications were published in 2006.
These results showed that treatment with Genasense® plus dacarbazine compared
with dacarbazine alone in patients with advanced melanoma was associated with a
statistically significant increase in overall response, complete response,
durable response, and progression-free survival (PFS). However, the primary
endpoint of overall survival approached but did not quite reach statistical
significance (P=0.077). Subsequently, our analysis of this trial showed that
there was a significant treatment interaction effect related to levels of a
blood enzyme known as LDH. When this effect was analyzed by treatment arm,
survival was shown to be significantly superior for patients with a non-elevated
LDH who received Genasense® (P=0.018; n=508). Moreover, this benefit was
particularly noteworthy for patients whose baseline LDH did not exceed 80% of
the upper limit of normal for this lab value. LDH had also been previously
described by others as the single most important prognostic factor in advanced
melanoma.
Based on
these data, in August 2007 we initiated a new Phase 3 trial of Genasense® plus
chemotherapy in advanced melanoma. This trial, known as AGENDA, is a randomized,
double-blind, placebo-controlled study in which patients are randomly assigned
to receive Genasense® plus dacarbazine or dacarbazine alone. The study uses LDH
as a biomarker to identify patients who are most likely to respond to
Genasense®, based on data obtained from our preceding trial in melanoma. The
co-primary endpoints of AGENDA are progression-free survival (PFS) and overall
survival.
AGENDA
is designed to expand evidence for the safety and efficacy of Genasense® when
combined with dacarbazine for patients who have not previously been treated with
chemotherapy. The study prospectively targets patients who have low-normal
levels of LDH. In March 2009, 2e have completed accrual of 315 patients into
AGENDA. In May 2009, an analysis by an independent Data Monitoring Committee for
both safety and futility indicated that the study passed an evaluation for
futility and safety. Accordingly, the Committee recommended that the study
should continue to completion. We expect results on the primary assessment of
PFS in the fourth quarter of 2009. If those data are positive, we currently
expect to submit regulatory applications based upon confirmation that the
addition of Genasense® to chemotherapy results in a statistically significant
improvement in PFS. Approval by FDA and EMEA will allow Genasense® to be
commercialized by us in the U.S. and EU. Genasense® in melanoma has been
designated an Orphan Drug in Australia and the U.S., and the drug has received
Fast Track designation in the U.S.
We are
conducting other trials of Genasense ® in melanoma including a Phase 2 trial of
Genasense® plus chemotherapy consisting of Abraxane® (paclitaxel protein-bound
particles for injectable suspension) (albumin bound) plus temozolomide
(Temodar®). We also expect to examine different dosing regimens that will
improve the dosing convenience and commercial acceptance of Genasense®,
including its administration by brief 1- hour IV infusions.
CLL
As
noted above, our NDA for the use of Genasense® plus chemotherapy in patients
with relapsed or refractory CLL was not approved. We conducted a randomized
Phase 3 trial in 241 patients with relapsed or refractory CLL who were treated
with fludarabine and cyclophosphamide (Flu/Cy) with or without Genasense®. The
trial achieved its primary endpoint: a statistically significant increase (17%
vs. 7%; P=0.025) in the proportion of patients who achieved a complete response
(CR), defined as a complete or nodular partial response. Patients who achieved
this level of response also experienced disappearance of predefined disease
symptoms. A key secondary endpoint, duration of CR, was also significantly
longer for patients treated with Genasense® (median exceeding 36+ months in the
Genasense® group, versus 22 months in the chemotherapy-only
group).
Several
secondary endpoints were not improved by the addition of Genasense®. The
percentage of patients who experienced serious adverse events was increased in
the Genasense® arm; however, the percentages of patients who discontinued
treatment due to adverse events were equal in the treatment arms. The incidence
of certain serious adverse reactions, including but not limited to nausea, fever
and catheter-related complications, was increased in patients treated with
Genasense®.
We
submitted our NDA to the FDA in December 2005 in which we sought accelerated
approval for the use of Genasense® in combination with Flu/Cy for the treatment
of patients with relapsed or refractory CLL who had previously received
fludarabine. In December 2006, we received a “non-approvable” notice for that
application from FDA. In April 2007, we filed an appeal of the non-approvable
notice using FDA’s Formal Dispute Resolution process. In March 2008, we received
a formal notice from FDA that indicated additional confirmatory evidence would
be required to support approval of Genasense® in CLL, either from a new clinical
trial or from collection of additional information regarding the progression of
disease in patients from the completed trial.
In
June 2008, we announced results from 5 years of follow-up on patients who had
been accrued to our completed Phase 3 trial. These data showed that patients
treated with Genasense® plus chemotherapy who achieved either a complete
response (CR) or a partial response (PR) also achieved a statistically
significant increase in survival with chemotherapy alone (median = 56 months vs.
38 months, respectively). After 5 years of follow-up, 22 of 49 (45%)
responders in the Genasense® group were alive compared with 13 of 54 (24%)
responders in the chemotherapy-only group (hazard ratio = 0.6; P = 0.038).
Moreover, with 5 years of follow-up, 12 of 20 patients (60%) in the Genasense®
group who achieved CR were alive, 5 of these patients remained in continuous CR
without relapse, and 2 additional patients had relapsed but had not required
additional therapy. By contrast, only 3 of 8 CR patients in the
chemotherapy-only group were alive, all 3 had relapsed, and all 3 had required
additional anti-leukemic treatment.
These
data were again submitted to FDA in the second quarter of 2008, and the
application was again denied in December 2008. Genta re-appealed the denial, and
in March 2009, CDER decided that available data were still insufficient to
support approval of Genasense® in CLL, and the Agency recommended conducting
another clinical trial. We have made no decision whether to conduct this
study.
As
with melanoma, we believe the clinical activity in CLL should be explored with
additional clinical research. We plan to explore combinations of Genasense® with
other drugs that are used for the treatment of CLL, and to examine more
convenient dosing regimens.
NHL
Several
trials have shown definite evidence of clinical activity for Genasense® in
patients with non-Hodgkin’s lymphoma (NHL). We would like to conduct additional
clinical studies in patients with NHL to test whether Genasense® can be approved
in this indication. Previously, we reported that randomized trials of Genasense®
in patients with myeloma, acute myeloid leukemia, (AML), hormone-refractory
prostate cancer (HRPC), small cell lung cancer and non small cell lung cancer
were not sufficiently positive to warrant further investigation on the
dose-schedules that were examined or with the chemotherapy that was employed in
these trials. Data from these trials have been presented at various scientific
meetings. However, we believe that alternate dosing schedules, in particular the
use of brief high-dose IV infusions, provide an opportunity to re-examine the
drug’s activity in some of these indications.
Tesetaxel
In
March 2008, we obtained an exclusive worldwide license for tesetaxel from
Daiichi Sankyo Company Ltd. Tesetaxel is a novel taxane compound that is taken
by mouth. Tesetaxel has completed Phase 2 trials in a number of cancer types,
and the drug has shown definite evidence of antitumor activity in gastric cancer
and breast cancer. Tesetaxel also appears to be associated with a lower
incidence of peripheral nerve damage, a common side effect of taxanes that
limits the maximum amount of these drugs that can be given to patients. At the
time we obtained the license, tesetaxel was on “clinical hold” by FDA due to the
occurrence of several fatalities in the setting of severe neutropenia. In the
second quarter of 2008, we filed a response to the FDA requesting a lift of the
clinical hold, which was granted in June 2008. In January 2009, we announced
initiation of a new clinical trial with tesetaxel to examine the clinical
pharmacology of the drug over a narrow dosing range around the established Phase
2 dose.
We
have also submitted applications to FDA for designation of tesetaxel as an
Orphan Drug for treatment of patients with advanced gastric cancer and for
patients with advanced melanoma. Both of these designations were
granted. Our initial priority for clinical testing of tesetaxel includes the
evaluation of safety and efficacy in patients with advanced gastric cancer.
Other disease priorities for clinical research include advanced melanoma and
bladder cancer, among other disorders. Maintenance of the license from Daiichi
Sankyo requires certain payments that include amortization of licensing fees and
milestones. If such payments are not made, Daiichi Sankyo may elect
to terminate the license; however, a portion of the licensing fees are due even
in the event of termination.
Oral
Gallium-Containing Compounds (G4544)
Our
third pipeline product is G4544, which is a novel oral formulation of a
gallium-containing compound that we developed in collaboration with Emisphere
Technologies, Inc. We completed a single-dose Phase 1 study of an initial
formulation of this new drug known as “G4544(a)”, the results of
which were presented at a scientific meeting in the second quarter of 2008. We
are currently contemplating a second study using a modified formulation, known
as “G4544(b)”, in order to test whether this formulation will prove more
clinically acceptable.
If we
are able to identify a clinically and commercially acceptable formulation of
G4544 or another oral gallium-containing compound, we currently intend to pursue
a 505(b)(2) strategy to establish bioequivalence to our marketed product,
Ganite®, for its initial regulatory approval of G4544. We believe a
drug of this type may also be broadly useful for treatment of other diseases
associated with accelerated bone loss, such as bone metastases, Paget’s disease
and osteoporosis. In addition, new uses of gallium-containing compounds have
been identified for treatment of certain infectious diseases. While we have no
current plans to begin clinical development in the area of infectious disease,
we intend to support research conducted by certain academic institutions by
providing clinical supplies of our gallium-containing drugs.
Ganite®
We are
currently marketing Ganite® in the U.S., which is an intravenous formulation of
gallium, for treatment of cancer-related hypercalcemia that is resistant to
hydration. We have announced our intention to seek a buyer for
Ganite®, but we have not yet found an acceptable transaction.
Summary
of Business and Research and Development Programs
Our goal
is to establish Genta as a biopharmaceutical leader and preferred partner in the
oncology market and eventually, as direct marketers of our products in the
United States. Our key strategies in this regard are:
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Build
on our core competitive strength of oncology development expertise to
establish a leadership position in providing biopharmaceutical products
for the treatment of cancer.
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Expand
our pipeline of products in two therapeutic categories, DNA/RNA Medicines
and Small Molecules, through internal development, licensing and
acquisitions.
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Establish
our lead antisense compound, Genasense®, as the preferred chemosensitizing
drug for use in combination with other cancer therapies in a variety of
human cancer types; and
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Establish
a sales and marketing presence in the U.S. oncology
market.
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Research
and Development Programs
DNA/RNA
Medicines
A number
of technologies have been developed using modifications of DNA or RNA. These
agents have been used as scientific tools for laboratory use to identify gene
function, as diagnostic probes to evaluate diseases, and — more recently — as
potential drugs to treat human diseases. Collectively, these technologies
include methods known as antisense, RNA interference, micro-RNA, decoys and gene
therapy. Founded in 1988, Genta was one of the first companies established to
exploit these new technologies for use as potential drugs and we remain broadly
committed to research and development of these compounds with a specific focus
on cancer medicine, commonly known as oncology. Our most advanced drugs in our
DNA/RNA Medicines program involve the use of antisense technology.
Antisense
Technology
Most
cellular functions, including whether cells live or die, are carried out by
proteins. The genetic code for a protein is contained in DNA, which is made up
of bases known as nucleotides that are arranged in a specific sequence. The
specificity of the sequence accounts for the production of a specific protein.
In order for DNA to produce a protein, an intermediate step is required. In this
step, DNA is transcribed into messenger RNA, or mRNA. The sequence of mRNA that
encodes a protein is oriented in only one direction, which is known as the
“sense” orientation.
Antisense
drugs are short sequences of chemically modified DNA bases that are called
oligonucleotides, or oligos. The oligos are engineered in a sequence that is
exactly opposite (hence “anti”) to the “sense” coding orientation of mRNA.
Because antisense drugs bind only short regions of the mRNA (rather than the
whole message itself), they contain far fewer nucleotides than the whole gene.
Moreover, since they are engineered to bind only to the matching sequence on a
specific mRNA, antisense drugs have both high selectivity and specificity, which
can be used to attack production of a single, disease-causing protein.
Genasense® is an antisense oligo that is designed to block the production of
Bcl-2.
We have
devoted significant resources towards the development of antisense oligos that
contain a phosphorothioate backbone, which is the nucleotide chain comprised of
ribose and phosphate groups. However, we also have patents and technologies
covering later generation technologies that involve mixed backbone structures,
as well as sterically fixed chemical bonds, that may further enhance the
molecule’s ability to bind to the intended target. Moreover, we have developed
certain formulations that can be used to more efficiently increase the uptake of
oligos into cells. Some of these advanced technologies may be incorporated into
future products from our DNA/RNA Medicines program.
Genasense® as a
Regulator of Apoptosis (“Programmed Cell Death”)
The
programmed death of cells, also known as apoptosis, is necessary to accommodate
the billions of new cells that are produced daily and also to eliminate aged or
damaged cells. However, abnormal regulation of the apoptotic process can result
in disease.
Cancer is
commonly associated with the over- or under-production of many types of
proteins. These proteins may be directly cancer-causing (i.e., “oncogenic”) or
they may contribute to the malignant nature of cancer (for instance, by
increasing the longevity of cancer cells or making them more likely to spread
throughout the body). The ability to selectively halt the production of certain
proteins may make the treatment of certain diseases more effective. Apoptosis is
regulated by a large number of proteins, particularly members of the Bcl-2
protein family. In an effort to make existing cancer therapy more effective, we
are developing Genasense® to target and block the production of Bcl-2, a protein
that is central to the process of apoptosis.
Bcl-2
as an Inhibitor of Programmed Cell Death
Normally,
when a cancer cell is exposed to treatment, such as with chemotherapy, radiation
or immunotherapy, a “death signal” is sent to an organelle within the cell
called the mitochondrion. The mitochondrion then releases a factor known as
cytochrome C that activates a series of enzymes called caspases. These enzymes
cause widespread fragmentation of cellular proteins and DNA, which ultimately
causes cell death.
Bcl-2 is
normally found in the mitochondrial membrane where it regulates the release of
cytochrome C. High levels of Bcl-2 are associated with most types of human
cancer, including major hematologic cancers such as lymphomas, myeloma, and
leukemia, and solid tumors such as melanoma and cancers of the lung, colon,
breast and prostate. In these diseases, Bcl-2 inhibits the release of cytochrome
C that would ordinarily be triggered by cancer therapy. Thus, Bcl-2 appears to
be a major contributor to both inherent and acquired resistance to cancer
treatments. Overcoming resistance to chemotherapy poses a major challenge for
cancer treatment.
In cancer
cells, Bcl-2 inhibits the process of programmed cell death, thereby allowing
cells to survive for much longer than normal cells. Genasense® has been
developed as a chemosensitizing drug to block production of Bcl-2, thereby
dramatically increasing the sensitivity of cancer cells to standard cancer
treatment.
Genasense®
Genasense®
has been designed to block the production of Bcl-2. Current science suggests
that Bcl-2 is a fundamental — although not sole — cause of the inherent
resistance of cancer cells to most types of existing anticancer treatments, such
as chemotherapy, radiation or monoclonal antibodies. Blocking Bcl-2, therefore,
may enable cancer treatments to be more effective. While Genasense® has
displayed some anticancer activity when used by itself, we believe the drug can
be optimally used as a means of amplifying the effectiveness of other cancer
therapies, most of which function by triggering apoptosis, which, as noted, is
relatively blocked in cancer cells due to over-production of Bcl-2.
Overview of Preclinical and Clinical
studies of Genasense®
Preclinical
Studies
A number
of preclinical studies in cell lines and in animals have shown enhancement of
tumor cell killing when Bcl-2 antisense was used in combination with standard
cancer therapies, including anti-metabolites, alkylating agents,
corticosteroids, other cytotoxic chemotherapy, radiation and monoclonal
antibodies. Several studies have demonstrated enhanced antitumor activity and
durable tumor regression in animals engrafted with human cancers that were
treated with Bcl-2 antisense followed by antitumor agents that induce programmed
cell death. These studies include human lymphoma, melanoma, breast cancer and
prostate cancers, which were treated with Genasense® in combination with
cyclophosphamide, dacarbazine, docetaxel and paclitaxel,
respectively.
Clinical
Studies
Genasense®
has been in clinical trials since 1995. We currently have efficacy and safety
data on over 2,000 patients in Phase 1, Phase 2 and Phase 3 clinical trials that
have been conducted in the U.S., Europe, South America and Australia. These
studies have included patients with a wide variety of tumor types, including
advanced melanoma, several types of acute and chronic leukemia, NHL, multiple
myeloma and cancers of the prostate, colon, lung, breast and other tumor types.
Since 2001, Genta and its collaborators have jointly initiated approximately
twenty clinical trials. Results of these clinical trials suggest that Genasense®
can be administered to cancer patients with acceptable side-effects and that
such treatment may reduce the level of Bcl-2 protein in cancer cells. The
results of most of these trials have been publicly presented at scientific
meetings and/or published in peer-reviewed scientific journals.
Based on
work accomplished to date, we have focused on three indications for Genasense®:
melanoma; CLL; and non-Hodgkin’s lymphoma. In addition, we have sought to
develop treatment methods for Genasense® that do not involve the use of
continuous IV infusions.
In the
first quarter of 2007, we completed a trial using a concentrated solution of
Genasense® administered by bolus subcutaneous injection. This trial showed that
a total dose of 225 mg could be administered as a single subcutaneous injection,
which is approximately equivalent to the daily dose used in the Phase 3 trial of
Genasense® in CLL. The limiting reaction in this study was a localized and
reversible skin rash. In 2007, we began a new Phase 1 trial of Genasense®
administered as an IV infusion over 2 hours. This trial showed that the
maximally tolerable dose was 900 mg, and we have now advanced that study into a
trial at that dose administered twice per week. We have also continued to
escalate the single dose of Genasense® up to a total of 1200 mg over 2 hours.
The pharmacokinetic and pharmacodynamic data from these trials may be useful for
determining whether the prior requirement for treatment by continuous IV
infusion can ultimately be eliminated by these more convenient dosing
regimens.
For
additional background information on the drug application process and clinical
trials, see “Government Regulation.”
Ganite®
Ganite®
as a Treatment for Cancer-Related Hypercalcemia
In
October 2003, we began marketing Ganite® for the treatment of cancer-related
hypercalcemia. Ganite® is our first drug to receive marketing approval. The
principal patent covering the use of Ganite® for its approved indication,
including potential extensions under Hatch-Waxman provisions in the U.S.,
expired in April 2005.
Hypercalcemia
is a life-threatening condition caused by excessive buildup of calcium in the
bloodstream, which may occur in up to 20% of cancer patients. Gallium nitrate
was originally studied by the NCI as a new type of cancer chemotherapy. More
than 1,000 patients were treated in Phase 1 and Phase 2 trials, and the drug
showed promising antitumor activity against NHL, bladder cancer and other
diseases. In the course of these studies, gallium nitrate was also shown to
strongly inhibit bone resorption. Gallium nitrate underwent additional clinical
testing and was approved by the FDA in 1991 as a treatment for cancer-related
hypercalcemia. Lower doses of Ganite® were also tested in patients with less
severe bone loss, including bone metastases, a cancer that has spread to bone,
Paget’s disease, an affliction of older patients that causes pain and
disability, and osteoporosis.
Side
effects of Ganite® include nausea, diarrhea and kidney damage. (A complete
listing of Ganite®’s side effects is contained in the product’s Package Insert
that has been reviewed and approved by the FDA.)
In May
2004, we eliminated our sales force and significantly reduced our marketing
support for Ganite®. Since then, we have continued only minimal marketing
support of the product. On March 2, 2006, we announced publication of a
randomized, double blind, Phase 2 trial that showed Ganite® was highly effective
when compared with Aredia® (pamidronate disodium; Novartis, Inc.) in
hospitalized patients with cancer-related hypercalcemia.
Ganite® as a
Treatment for Non-Hodgkin’s Lymphoma and Other Cancer Types
Based on
previously published data, Ganite® showed clear anticancer activity in patients
with certain types of cancer, particularly NHL. Due to patent expirations
previously described, we do not plan further clinical trials for Ganite® as an
anticancer drug.
Other
Pipeline Products and Technology Platforms
Oral
Gallium-Containing Compounds
We have
sought to develop novel formulations of gallium-containing compounds that can be
taken orally and that will have extended patent protection. Such formulations
might be useful for diseases in which long-term low-dose therapy is deemed
desirable, such as bone metastases, Paget’s disease and osteoporosis. In March
2006, Genta and Emisphere Technologies, Inc. announced that the two companies
had entered into an exclusive worldwide licensing agreement to develop an oral
formulation of a gallium-containing compound. A number of candidate formulations
have been developed in this collaboration. In August 2007, we announced
submission of an Investigational New Drug Application, or IND, to the
Endocrinologic and Metabolic Drugs Division of the FDA for a new drug known as
G4544. G4544 is a new tablet formulation that enables oral absorption of the
active ingredient contained in Ganite®. Results of the initial clinical trial
were presented at a scientific meeting in the second quarter of 2008. In January
2009, we announced that two new patents related to the Company’s franchise in
gallium-containing products have issued in the United States. Applications
similar to these patents are pending worldwide, and several additional
applications that address other compositions and uses have been filed in the
U.S. and other territories. These patents and filings provide for claims of
compositions and uses of gallium compounds that can be taken by mouth over
extended periods for treatment of skeletal diseases as well as other
indications. Progress in the clinical development of G4544 program was delayed
in 2008 due to financial constraints, but we currently expect to continue our
program when our financial condition improves.
Antisense
and RNAi Research and Discovery
We have
had several other oligonucleotide-based discovery programs and collaborations
devoted to the identification of both antisense- and RNAi-based inhibitors of
oncology gene targets. However, spending on these research programs was sharply
reduced due to financial constraints. We have no current agents that we consider
“lead compounds” that would justify advancement into late-stage preclinical
testing.
We intend
to continue to evaluate novel nucleic acid chemistries, through sponsored
research and collaborative agreements, depending upon the availability of
resources.
Patents
and Proprietary Technology
It is our
policy to protect our technology by filing patent applications with respect to
technologies important to our business development. To maintain our competitive
position, we also rely upon trade secrets, unpatented know-how, continuing
technological innovation, licensing opportunities and certain regulatory
approvals (such as orphan drug designations).
We own or
have licensed several patents and applications to numerous aspects of
oligonucleotide technology, including novel compositions of matter, methods of
large-scale synthesis, methods of controlling gene expression and methods of
treating disease. our patent portfolio includes approximately 65 granted patents
and 66 pending applications in the U.S. and foreign countries. We endeavor to
seek appropriate U.S. and foreign patent protection on our oligonucleotide
technology.
We have
licensed ten U.S. patents relating to the composition of Genasense® and its
backbone chemistry that expire between 2008 and 2015. The U.S. composition
patents for Genasense may be eligible for extension under Waxman-Hatch
provisions. Corresponding patent applications have been filed in three foreign
countries. We also own five U.S. patent applications relating to methods of
using Genasense® expected to expire in 2020 and 2026, with approximately 50
corresponding foreign patent applications and granted patents.
Included
among our intellectual property rights are certain rights licensed from the NIH
covering phosphorothioate oligonucleotides. We also acquired from the University
of Pennsylvania exclusive rights to antisense oligonucleotides directed against
the Bcl-2 mRNA, as well as methods of their use for the treatment of cancer. The
claims of the University of Pennsylvania patents cover our proprietary antisense
oligonucleotide molecules, which target the Bcl-2 mRNA, including Genasense® and
methods employing them. Other related U.S. and corresponding foreign patent
applications are still pending.
Tesetaxel,
its potential uses, composition, and methods of manufacturing are covered under
a variety of patents licensed exclusively from Daiichi Sankyo, Inc. We believe
that composition-of-matter claims on tesetaxel extend to at least 2020 in the
U.S. and Europe and to 2022 in Japan. A number of other patents have been filed
worldwide for this compound.
The
principal patent covering the use of Ganite® for its approved indication,
including extensions expired in April 2005.
The
patent positions of biopharmaceutical and biotechnology firms, including Genta,
can be uncertain and can involve complex legal and factual questions.
Consequently, even though we are currently pursuing our patent applications with
the United States and foreign patent offices, we do not know whether any of our
applications will result in the issuance of any patents, or if any issued
patents will provide significant proprietary protection, or even if successful
that these patents will not be circumvented or invalidated. Even if issued,
patents may be circumvented or challenged and invalidated in the courts. Because
some applications in the United States are kept in secrecy until an actual
patent is issued, we cannot be certain that others have not filed patent
applications directed at inventions covered by our pending patent applications,
or that we were the first to file patent applications for such inventions. Thus,
we may become involved in interference proceedings declared by the U.S. Patent
and Trademark Office (or comparable foreign office or process) in connection
with one or more of our patents or patent applications to determine priority of
invention, which could result in substantial costs to us, as well as an adverse
decision as to priority of invention of the patent or patent application
involved.
Competitors
or potential competitors may have filed applications for, or have received
patents and may obtain additional patents and proprietary rights relating to,
compounds or processes competitive with those of ours. Accordingly, there can be
no assurances that our patent applications will result in issued patents or
that, if issued, the patents will afford protection against competitors with
similar technology. We cannot provide assurance that any patents issued to us
will not be infringed or circumvented by others, nor can there be any assurance
that we will obtain necessary patents or technologies or the rights to use such
technologies.
In
addition, there may be patents which are unknown to us and which may block our
ability to make, use or sell our product. We may be forced to defend ourselves
against charges of infringement or we may need to obtain expensive licenses to
continue our business. See the above Risk Factor entitled “We may be unable to
obtain or enforce patents, other proprietary rights and licenses to protect our
business; we could become involved in litigation relating to our patents or
licenses that could cause us to incur additional costs and delay or prevent our
introduction of new drugs to market”.
We also
rely upon unpatented trade secrets. No assurances can be given as to whether
third parties will independently develop substantially equivalent proprietary
information and techniques, or gain access to our trade secrets, or disclose
such technologies to the public, or that we can meaningfully maintain and
protect unpatented trade secrets.
We
require our employees, consultants, outside scientific collaborators, sponsored
researchers and other advisors to execute confidentiality agreements with us.
These agreements generally provide that all confidential information developed
or made known to an individual during the course of the individual’s
relationship with us shall be kept confidential and shall not be disclosed to
third parties except in specific circumstances. In the case of employees, the
agreement generally provides that all inventions conceived by the individual
shall be assigned to us, and made our exclusive property. There can be no
assurance, however, that these agreements will provide meaningful protection to
our trade secrets, or guarantee adequate remedies in the event of unauthorized
use or disclosure of confidential proprietary information or in the event of an
employee’s refusal to assign any patents to us in spite of his/her contractual
obligation.
Research
and Development
In
addition to our current focus in the areas described above, we continually
evaluate our programs in light of the latest market information and conditions,
the availability of third party funding, technological advances, financial
liquidity and other factors. As a result of such evaluations, we change our
product development plans from time to time and anticipate that we will continue
to do so. We recorded research and development expenses of $20.0 million, $13.5
million and $28.1 million during the years ended December 31, 2008, 2007 and
2006, respectively.
Sales
and Marketing
Currently
we do not have a sales force. Personnel who had been hired into our sales teams
were terminated following workforce reductions that took place in 2004 and 2006,
owing to adverse regulatory decisions. W. Lloyd Sanders, who is presently Senior
Vice President and Chief Operating Officer, was hired in January 2006 to run our
sales and marketing programs.
At the
present time, we do not contemplate rebuilding a sales and marketing
infrastructure in the United States absent favorable regulatory actions on
Genasense®. For international product sales, we may distribute our products
through collaborations with third parties.
Manufacturing
and Raw Materials
Our
ability to conduct clinical trials on a timely basis, to obtain regulatory
approvals and to commercialize our products will depend in part upon our ability
to manufacture our products, either directly or through third parties, at a
competitive cost and in accordance with applicable FDA and other regulatory
requirements, including current Good Manufacturing Practice
regulations.
We
currently rely on third parties to manufacture our products. We have a
manufacturing and supply agreement with Avecia Biotechnology, Inc., or Avecia, a
leading multinational manufacturer of pharmaceutical products, to supply
quantities of Genasense®. This agreement renews automatically at the end of each
year, unless either party gives one-year notice. We are not obligated to
purchase further drug substance from Avecia prior to approval of Genasense®. We
believe this agreement is sufficient for our production needs with respect to
Genasense®.
For
Ganite® we have a manufacturing and supply agreement with Johnson Matthey Inc.
that renews automatically at the end of each year, unless either party gives
one-year notice. Under the agreement, we will purchase a minimum of 80% of our
requirements for quantities of Ganite®; however, there are no minimum purchase
requirements.
For
tesetaxel, we are currently evaluating new suppliers of both bulk drug substance
and finished goods with the intent of completely replacing the supply chain that
was previously used to manufacture this compound. Until the new
supply chain is established, we will continue to use investigational supplies of
the compound that was manufactured and is currently in inventory at Daiichi
Sankyo Company, Ltd.
The raw
materials that we require to manufacture our drugs are available only from a few
suppliers. Under the terms of our manufacturing and supply agreement, Avecia is
responsible for procuring the raw materials needed to manufacture Genasense®. We
believe that we have adequately addressed our needs for suppliers of raw
materials to manufacture Genasense® and Ganite® and to meet future customer
demand.
Human
Resources
As of
March 31, 2009, we had 21 employees, 7 of whom hold doctoral degrees. As of that
date, there were 14 employees engaged in research, development and other
technical activities and 7 in administration. None of our employees are
represented by a union. Most of our management and professional employees have
had prior experience and positions with pharmaceutical and biotechnology
companies. We believe we maintain satisfactory relations with our employees and
have not experienced interruptions of operations due to employee relations
issues.
Government
Regulation
Regulation
by governmental authorities in the United States and foreign countries is a
significant factor in our ongoing research and product development activities
and in the manufacture and marketing of our proposed products. All of our
therapeutic products will require regulatory approval by governmental agencies
prior to commercialization. In particular, human therapeutic products are
subject to rigorous preclinical and clinical testing and pre-market approval
procedures by the FDA and similar authorities in foreign countries. Various
federal, and in some cases, state statutes and regulations, also govern or
affect the development, testing, manufacturing, safety, labeling, storage,
recordkeeping and marketing of such products. The lengthy process of seeking
these approvals, and the subsequent compliance with applicable federal and, in
some cases, state statutes and regulations, require substantial expenditures.
Any failure by us, our collaborators or our licensees to obtain, or any delay in
obtaining, regulatory approvals could adversely affect the marketing of our
products and our ability to receive products or royalty revenue.
The
activities required before a new pharmaceutical agent may be marketed in the
United States begin with preclinical testing. Preclinical tests include
laboratory evaluation of product chemistry and animal studies to assess the
potential safety and efficacy of the product and its formulations. The results
of these studies must be submitted to the FDA as part of an IND. An IND becomes
effective within 30 days of filing with the FDA unless the FDA imposes a
clinical hold on the IND. In addition, the FDA may, at any time, impose a
clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold,
clinical trials cannot commence or recommence, as the case may be, without prior
FDA authorization, and then only under terms authorized by the FDA.
Clinical
trials are generally categorized into four phases.
Phase 1
trials are initial safety trials on a new medicine in which investigators
attempt to establish the dose range tolerated by a small group of patients using
single or multiple doses, and to determine the pattern of drug distribution and
metabolism.
Phase 2
trials are clinical trials to evaluate efficacy and safety in patients afflicted
with a specific disease. Typically, Phase 2 trials in oncology comprise 14 to 50
patients. Objectives may focus on dose-response, type of patient, frequency of
dosing or any of a number of other issues involved in safety and
efficacy.
In the
case of products for life-threatening diseases, the initial human testing is
generally done in patients rather than in healthy volunteers. Since these
patients are already afflicted with the target disease, it is possible that such
studies may provide results traditionally obtained in Phase 2
trials.
Phase 3
trials are usually multi-center, comparative studies that involve larger
populations. These trials are generally intended to be pivotal in importance for
the approval of a new drug. In oncology, Phase 3 trials typically involve 100 to
1,000 patients for whom the medicine is eventually intended. Trials are also
conducted in special groups of patients or under special conditions dictated by
the nature of the particular medicine and/or disease. Phase 3 trials often
provide much of the information needed for the package insert and labeling of
the medicine. A trial is fully enrolled when it has a sufficient number of
patients to provide enough data for the statistical proof of efficacy and safety
required by the FDA and others. After a sufficient period of follow-up has
elapsed to satisfactorily evaluate safety and efficacy, the trials’ results can
then be analyzed. Those results are then commonly reported at a scientific
meeting, in a medical journal and to the public.
Depending
upon the nature of the trial results, a company may then elect to discuss the
results with regulatory authorities such as the FDA. If the company believes the
data may warrant consideration for marketing approval of the drug, the results
of the preclinical and clinical testing, together with chemistry, manufacturing
and control information, are then submitted to the FDA for a pharmaceutical
product in the form of an NDA. In responding to an NDA, biologics license
application or premarket approval application, the FDA may grant marketing
approval, request additional information or deny the application if it
determines that the application does not satisfy its regulatory approval
criteria. There can be no assurance that the approvals that are being sought or
may be sought by us in the future will be granted on a timely basis, if at all,
or, if granted, will cover all the clinical indications for which we are seeking
approval or will not contain significant limitations in the form of warnings,
precautions or contraindications with respect to conditions of use. Phase 3b
trials are conducted after submission of a NDA, but before the product’s
approval for market launch. Phase 3b trials may supplement or complete earlier
trials, or they may seek different kinds of information, such as quality of life
or marketing. Phase 3b is the period between submission for approval and receipt
of marketing authorization.
After a
medicine is marketed, Phase 4 trials provide additional details about the
product’s safety and efficacy.
In
circumstances where a company intends to develop and introduce a novel
formulation of an active drug ingredient already approved by the FDA, clinical
and preclinical testing requirements may not be as extensive. Limited additional
data about the safety and/or effectiveness of the proposed new drug formulation,
along with chemistry and manufacturing information and public information about
the active ingredient, may be satisfactory for product approval. Consequently,
the new product formulation may receive marketing approval more rapidly than a
traditional full new drug application; although no assurance can be given that a
product will be granted such treatment by the FDA.
Under
European Union regulatory systems, we may submit requests for marketing
authorizations either under a centralized or decentralized procedure. The
centralized procedure provides for the grant of a single marketing authorization
that is valid for all European Union member states. The decentralized procedure
provides for mutual recognition of national approval decisions. Under this
procedure, the holder of a national marketing authorization from a European
state may submit an application to the remaining member states. Within 90 days
of receiving the applications and assessment report, each member state must
decide whether to recognize approval.
We and
our third-party manufacturers are also subject to various foreign, federal,
state and local laws and regulations relating to health and safety, laboratory
and manufacturing practices, the experimental use of animals and the use,
manufacture, storage, handling and disposal of hazardous or potentially
hazardous substances, including radioactive compounds and infectious disease
agents, used in connection with our research and development work and
manufacturing processes. We currently incur costs to comply with laws and
regulations and these costs may become more significant.
Competition
In many
cases, our products under development will be competing with existing therapies
for market share. In addition, a number of companies are pursuing the
development of antisense technology and controlled-release formulation
technology and the development of pharmaceuticals utilizing such technologies.
We compete with fully integrated pharmaceutical companies that have
substantially more experience, financial and other resources and superior
expertise in research and development, manufacturing, testing, obtaining
regulatory approvals, marketing and distribution. Smaller companies may also
prove to be significant competitors, particularly through their collaborative
arrangements with large pharmaceutical companies or academic institutions.
Furthermore, academic institutions, governmental agencies and other public and
private research organizations have conducted and will continue to conduct
research, seek patent protection and establish arrangements for commercializing
products. Such products may compete directly with any products that may be
offered by us.
Our
competition will be determined in part by the potential indications for which
our products are developed and ultimately approved by regulatory authorities.
For certain of our potential products, an important factor in competition may be
the timing of market introduction of our or our competitors’ products.
Accordingly, the relative speed with which we can develop products, complete the
clinical trials and approval processes and supply commercial quantities of the
products to the market are expected to be important competitive factors. We
expect that competition among products approved for sale will be based, among
other things, on product efficacy, safety, reliability, availability, price,
patent position and sales, marketing and distribution capabilities. The
development by others of new treatment methods could render our products under
development non-competitive or obsolete.
Our
competitive position also depends upon our ability to attract and retain
qualified personnel, obtain patent protection, or otherwise develop proprietary
products or processes and secure sufficient capital resources for the
often-substantial period between technological conception and commercial
sales.
Available
Information
Our
reports that have been filed with the Securities and Exchange Commission, or
SEC, are available on our website free of charge, including our annual reports
on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, Forms
3, 4 and 5 filed on behalf of directors and executive officers and any
amendments to such reports filed pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, as amended, or the Exchange Act. Copies of our
Annual Report on Form 10-K may also be obtained without charge electronically or
by paper by contacting the Company at (908) 286-9800.
In
addition, we make available on our website (i) the charters for the committees
of the Board of Directors, including the Audit Committee, Compensation Committee
and Nominating and Corporate Governance Committee, (ii) the Company’s Code of
Business Conduct (the Code of Conduct) governing its directors, officers. Within
the time period required by the SEC, we will post on our website any
modifications to the Code of Business Conduct and Ethics, as required by the
Sarbanes-Oxley Act of 2002.
The
public may also read and copy the materials we file with the SEC at its Public
Reference Room at 100 F Street, N.E., Washington, DC 20549. The public may
obtain information on the operation of the Public Reference Room by calling the
SEC at 1-800-SEC-0330. The SEC also maintains a web site at http://www.sec.gov
that contains reports, proxy and information statements and other information
regarding companies that file electronically with the SEC.
LEGAL
PROCEEDINGS
In
September 2008, several shareholders of our Company, on behalf of themselves and
all others similarly situated, filed a class action complaint against our
Company, our Board of Directors, and certain of our executive officers in
Superior Court of New Jersey, captioned Collins v. Warrell, Docket No.
L-3046-08. The complaint alleged that in issuing convertible notes, our Board of
Directors, and certain officers breached their fiduciary duties, and our Company
aided and abetted the breach of fiduciary duty. On March 20, 2009, the Superior
Court of New Jersey granted the motion of our Company to dismiss the class
action complaint and dismissed the complaint with prejudice. The
plaintiffs have filed a notice of appeal to the Appellate Division of
the Superior Court from the order dismissing this case. On May 13,
2009, the plaintiffs filed a motion for relief from judgment based on a claim of
new evidence, which was denied on June 12, 2009. The plaintiffs also asked
the Appellate Division for a temporary remand to permit the Superior Court judge
to resolve the issues of the new evidence plaintiffs sought to raise. By
order dated June 25, 2009, and filed on July 6, 2009, the Appellate Division
granted the motion for temporary remand, and directed the issues on remand to be
resolved in 30 days. A hearing on the plaintiff's motion is scheduled for
Friday, July 31, 2009.
In
November 2008, a complaint against our Company and its transfer agent, BNY
Mellon Shareholder Services, was filed in the Supreme Court of the State of New
York by an individual stockholder. The complaint alleges that our Company and
our transfer agent caused or contributed to losses suffered by the stockholder.
Our Company denies the allegations of this complaint and intends to vigorously
defend this lawsuit.
PRICE
RANGE OF COMMON STOCK
Our
common stock was traded on the NASDAQ Global Market under the symbol “GNTA”
until May 7, 2008. The following table sets forth the high and low prices per
share of our common stock, as reported on the NASDAQ Global Market, for the
periods indicated.
2007
|
|
High*
|
|
|
Low*
|
|
First
Quarter
|
|
$ |
168.00 |
|
|
$ |
93.00 |
|
Second
Quarter
|
|
$ |
123.00 |
|
|
$ |
84.00 |
|
Third
Quarter
|
|
$ |
90.00 |
|
|
$ |
40.00 |
|
Fourth
Quarter
|
|
$ |
65.50 |
|
|
$ |
26.00 |
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
First
Quarter
|
|
$ |
43.50 |
|
|
$ |
18.50 |
|
Second
Quarter (through May 7, 2008)
|
|
$ |
22.50 |
|
|
$ |
7.50 |
|
*
|
all figures have been
retroactively adjusted to reflect a 1-for-50 reverse stock split effected
in June 2009.
|
Our
common stock began trading on the OTC Bulletin Board under the symbol “GNTA.OB”
on May 7, 2008. As a result of a reverse stock split effected on June 26, 2009,
our symbol was changed to “GETA.” The following table sets forth the high and
low prices per share of our common stock, as reported on the OTC Bulletin Board,
for the periods indicated.
2008
|
|
High*
|
|
|
Low*
|
|
Second
Quarter (from May 7, 2008)
|
|
$ |
20.50 |
|
|
$ |
5.00 |
|
Third
Quarter
|
|
$ |
37.50 |
|
|
$ |
12.50 |
|
Fourth
Quarter
|
|
$ |
20.00 |
|
|
$ |
0.135 |
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
First
Quarter
|
|
$ |
15.50 |
|
|
$ |
0.145 |
|
Second
Quarter
|
|
$ |
1.06 |
|
|
$ |
0.27 |
|
Third
Quarter (through July 10, 2009)
|
|
$ |
0.46 |
|
|
$ |
0.35 |
|
*
|
all
figures have been retroactively adjusted to reflect a 1-for-50 reverse
stock split effected in June
2009.
|
The
closing price of our common stock on the OTC Bulletin Board on July 15, 2009 was
$0.42 per share. There were 120 holders of record of our common stock as of July
15, 2009. We estimate that there are approximately 19,250 beneficial
owners of our common stock.
SELECTED
FINANCIAL INFORMATION
The
following tables summarize our selected financial information. You should read
the selected financial information together with our consolidated financial
statements and the related notes appearing at the end of this prospectus, and
the “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” section and other financial information included in this
prospectus.
|
|
Three
Months
ended
March 31,
2009
|
|
|
Year
Ended December 31,
(in thousands except per share
amounts)
|
|
|
|
(Unaudited)
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
Consolidated Statements of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
fees & royalties
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
5,241 |
|
|
$ |
3,022 |
|
Development
funding
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
20,988 |
|
|
|
12,105 |
|
Product
sales — net
|
|
|
62 |
|
|
|
363 |
|
|
|
580 |
|
|
|
708 |
|
|
|
356 |
|
|
|
(512 |
) |
Total
revenues
|
|
|
62 |
|
|
|
363 |
|
|
|
580 |
|
|
|
708 |
|
|
|
26,585 |
|
|
|
14,615 |
|
Costs
of goods sold
|
|
|
— |
|
|
|
102 |
|
|
|
90 |
|
|
|
108 |
|
|
|
52 |
|
|
|
170 |
|
Provision
for excess inventory
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,350 |
|
Total
cost of goods sold
|
|
|
— |
|
|
|
102 |
|
|
|
90 |
|
|
|
108 |
|
|
|
52 |
|
|
|
1,520 |
|
Operating
expenses — gross
|
|
|
4,470 |
|
|
|
33,410 |
|
|
|
26,116 |
|
|
|
59,764 |
|
|
|
37,006 |
|
|
|
101,324 |
|
sanofi-aventis
reimbursement
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,090 |
) |
|
|
(43,292 |
) |
Operating
expenses — net
|
|
|
4,470 |
|
|
|
33,410 |
|
|
|
26,116 |
|
|
|
59,764 |
|
|
|
30,916 |
|
|
|
58,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain
on forgiveness of debt
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,297 |
|
|
|
11,495 |
|
Amortization
of deferred financing costs and debt discount
|
|
|
(6,287 |
) |
|
|
(11,229 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Fair
value — conversion feature liability
|
|
|
— |
|
|
|
(460,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Fair
value — warrant liability
|
|
|
— |
|
|
|
(2,000 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
All
other (expense)/income-net
|
|
|
(372 |
) |
|
|
(1,435 |
) |
|
|
836 |
|
|
|
1,454 |
|
|
|
502 |
|
|
|
(147 |
) |
Loss
before income taxes
|
|
|
(11,067 |
) |
|
|
(507,813 |
) |
|
|
(24,790 |
) |
|
|
(57,710 |
) |
|
|
(2,584 |
) |
|
|
(33,589 |
) |
Income
tax benefit
|
|
|
— |
|
|
|
1,975 |
|
|
|
1,470 |
|
|
|
929 |
|
|
|
381 |
|
|
|
904 |
|
Net
loss
|
|
$ |
(11,067 |
) |
|
$ |
(505,838 |
) |
|
$ |
(23,320 |
) |
|
$ |
(56,781 |
) |
|
$ |
(2,203 |
) |
|
$ |
(32,685 |
) |
Net
loss per basic and diluted common share *
|
|
$ |
(0.61 |
) |
|
$ |
(455.09 |
) |
|
$ |
(39.36 |
) |
|
$ |
(125.88 |
) |
|
$ |
(6.42 |
) |
|
$ |
(122.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used in computing net loss per basic and diluted common
share*
|
|
|
17,999 |
|
|
|
1,112 |
|
|
|
592 |
|
|
|
451 |
|
|
|
343 |
|
|
|
266 |
|
*
|
all
figures have been retroactively adjusted to reflect a 1-for-50 reverse
stock split effected in June
2009.
|
|
|
At March
31,
|
|
|
At
December 31,
(in
thousands)
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
Balance
Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities
|
|
$ |
598 |
|
|
$ |
4,908 |
|
|
$ |
7,813 |
|
|
$ |
29,496 |
|
|
$ |
21,282 |
|
|
$ |
42,247 |
|
Working
capital (deficit)
|
|
|
(9,510 |
) |
|
|
(5,220 |
) |
|
|
877 |
|
|
|
12,682 |
|
|
|
11,703 |
|
|
|
(4,269 |
) |
Total
assets
|
|
|
7,137 |
|
|
|
12,693 |
|
|
|
29,293 |
|
|
|
51,778 |
|
|
|
27,386 |
|
|
|
50,532 |
|
Total
stockholders’ equity (deficit)
|
|
|
(10,585 |
) |
|
|
(4,864 |
) |
|
|
2,931 |
|
|
|
14,642 |
|
|
|
15,697 |
|
|
|
1,752 |
|
SUPPLEMENTARY
FINANCIAL INFORMATION
The
following table presents our condensed operating results for each of the eight
(8) fiscal quarters through the period ended March 31, 2009. The information for
each of these quarters is unaudited. In the opinion of management, all necessary
adjustments, which consist only of normal and recurring accruals, have been
included to fairly present the unaudited quarterly results. This data should be
read together with our consolidated financial statements and the notes thereto,
the Report of Independent Registered Public Accounting Firm and Management’s
Discussions and Analysis of Financial Condition and Results of
Operations.
|
|
|
|
|
Three
Months Ended (unaudited) (in thousands except per share
amounts)
|
|
|
|
|
|
|
Mar
31 2009
(1)
|
|
|
Dec
31
2008
(1)
|
|
|
Sep
30
2008
(1)
|
|
|
June
30
2008
(1)
|
|
|
Mar
31
2008
|
|
|
Dec
31
2007
|
|
|
Sep
30
2007
|
|
|
June
30
2007
|
|
Total
revenues
|
|
$ |
62 |
|
|
$ |
— |
|
|
$ |
115 |
|
|
$ |
131 |
|
|
$ |
117 |
|
|
$ |
266 |
|
|
$ |
115 |
|
|
$ |
105 |
|
Net
income/(loss)
|
|
$ |
(11,067 |
) |
|
$ |
29,569 |
|
|
$ |
212,613 |
|
|
$ |
(738,364 |
) |
|
$ |
(9,657 |
) |
|
$ |
(1,748 |
) |
|
$ |
(7,732 |
) |
|
$ |
(8,235 |
) |
Net
income/(loss) per basic common share: *
|
|
$ |
(0.61 |
) |
|
$ |
12.90 |
|
|
$ |
289.22 |
|
|
$ |
(1,004.58 |
) |
|
$ |
(14.29 |
) |
|
$ |
(2.85 |
) |
|
$ |
(12.63 |
) |
|
$ |
(13.45 |
) |
Net
income/(loss) per diluted common share: *
|
|
$ |
(0.61 |
) |
|
$ |
1.08 |
|
|
$ |
5.12 |
|
|
$ |
(1,004.58 |
) |
|
$ |
(14.29 |
) |
|
$ |
(2.85 |
) |
|
$ |
(12.63 |
) |
|
$ |
(13.45 |
) |
Shares
used in computing basic per common share amounts: *
|
|
|
17,999 |
|
|
|
2,292 |
|
|
|
735 |
|
|
|
735 |
|
|
|
676 |
|
|
|
612 |
|
|
|
612 |
|
|
|
612 |
|
Shares
used in computing diluted per common share amounts: *
|
|
|
17,999 |
|
|
|
27,401 |
|
|
|
41,524 |
|
|
|
735 |
|
|
|
676 |
|
|
|
612 |
|
|
|
612 |
|
|
|
612 |
|
*
|
all
figures have been retroactively adjusted to reflect a 1-for-50 reverse
stock split effected in June 2009.
|
|
|
(1)
|
The
financial results for the three-month periods ended June 30, 2008,
September 30, 2008, December 31, 2008 and March 31, 2009 have been
impacted by the accounting for the convertible notes and warrants issued
in June 2008 (see note 12 to the Consolidated Financial Statements for the
year ended December 31,
2008).
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS
Overview
Genta
Incorporated is a biopharmaceutical company engaged in pharmaceutical research
and development. We are dedicated to the identification, development and
commercialization of novel drugs for the treatment of cancer and related
diseases. Our drug portfolio consists of products derived in two Programs:
DNA/RNA Medicines (which includes our lead oncology drug, Genasense®); and
Small Molecules (which includes our marketed product, Ganite®, and the
investigational compounds tesetaxel and G4544). We have had recurring annual
operating losses since inception and we expect to incur substantial operating
losses due to continued requirements for ongoing and planned research and
development activities, pre-clinical and clinical testing, manufacturing
activities, regulatory activities and the eventual establishment of a sales and
marketing organization.
On
June 26, 2009, at a Special Meeting of Stockholders, our stockholders authorized
its Board of Directors to effect a reverse stock split at any ratio up to
1-for-100. Our Board of Directors approved a reverse stock split in a ratio of
1-for-50 and all share amounts and per-share amounts have been retroactively
adjusted for the reverse stock split.
From our
inception to March 31, 2009, we have incurred a cumulative net deficit of $955.2
million. Our recurring losses from operations and our negative cash flow from
operations raise substantial doubt about our ability to continue as a going
concern. Our consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty. We expect that such
losses will continue at least until our lead product, Genasense®, is
approved by one or more regulatory authorities for commercial sale in one or
more indications. Achievement of profitability is currently dependent on the
timing of Genasense®
regulatory approvals. We have experienced significant quarterly fluctuations in
operating results and we expect that these fluctuations in revenues, expenses
and losses will continue.
Irrespective
of whether regulatory applications, such as a New Drug Application (NDA) or
Marketing Authorization Application (MAA), for Genasense® are
approved, we anticipate that we will require additional cash in order to
maximize the commercial opportunity and continue its clinical development
opportunities. Alternatives available to us to sustain our operations include
collaborative agreements, equity financing, debt and other financing
arrangements with potential corporate partners and other sources. However, there
can be no assurance that any such collaborative agreements or other sources of
funds will be available on favorable terms, if at all. We will need substantial
additional funds before we can expect to realize significant product
revenue.
We had
$0.6 million of cash and cash equivalents on hand at March 31,
2009. Cash used in operating activities during the first three months
of 2009 was $4.3 million.
On
June 9, 2008, we placed $20 million of senior secured convertible notes with
certain institutional and accredited investors. On April 2, 2009, we entered
into a securities purchase agreement with certain accredited institutional
investors to place up to $12 million of senior secured convertible notes, or the
April 2009 Notes, and corresponding warrants to purchase common stock. We closed
on approximately $6 million of such notes and warrants on April 2, 2009. On July
7, 2009, we entered into a securities purchase agreement with certain accredited
institutional investors to place up to $10 million in aggregate principal amount
of units consisting of (i) 70% unsecured subordinated convertible notes, or the
July 2009 Notes, and (ii) 30% common stock. In connection with the
sale of the units, we also issued to the investors two-year warrants to purchase
common stock in an amount equal to 25% of the number of shares of common stock
issuable upon conversion of the July 2009 Notes purchased by each
investor. We closed on approximately $3 million of such July 2009
Notes, common stock and warrants on July 7, 2009.
Presently,
with no further financing, we project that we will run out of funds in August
2009. The terms of the April 2009 Notes enable those noteholders, at their
option, to purchase additional notes with similar terms. We currently do not
have any additional financing in place. If we are unable to raise additional
funds, we could be required to reduce our spending plans, reduce our workforce,
license to others products or technologies we would otherwise seek to
commercialize ourselves, or sell certain assets. There can be no assurance that
we can obtain financing, if at all, on terms acceptable to
us.
Our lead
drug, Genasense® has been
studied in combination with a wide variety of anticancer drugs in a number of
different cancer indications. We have reported results from randomized trials of
Genasense® in a
number of diseases. Under our own sponsorship or in collaboration with the U.S.
National Cancer Institute (NCI), we are currently conducting additional clinical
trials. We are especially interested in the development, regulatory approval,
and commercialization of Genasense® in at
least three diseases: melanoma; chronic lymphocytic leukemia (CLL); and
non-Hodgkin’s lymphoma (NHL).
Genasense® has been
submitted for regulatory approval in the U.S. on two occasions and to the
European Union (EU) once. These applications proposed the use of Genasense® plus
chemotherapy for patients with advanced melanoma (U.S. and EU) and relapsed or
refractory chronic lymphocytic leukemia (CLL) (U.S.-only). None of these
applications resulted in regulatory approval for marketing. Nonetheless, we
believe that Genasense® can
ultimately be approved and commercialized and we have undertaken a number of
initiatives in this regard that are described below.
The
initial NDA for Genasense® in
melanoma was withdrawn in 2004 after an advisory committee to the Food and Drug
Administration (FDA) failed to recommend approval. A negative decision was also
received for a similar application in melanoma from the European Medicines
Agency (EMEA) in 2007. Data from the Phase 3 trial that comprised the primary
basis for these applications were published in a peer-reviewed journal in 2006.
These results showed that treatment with Genasense® plus
dacarbazine compared with dacarbazine alone in patients with advanced melanoma
was associated with a statistically significant increase in overall response,
complete response, durable response, and progression-free survival (PFS).
However, the primary endpoint of overall survival approached but did not quite
reach statistical significance (P=0.077). Subsequently, our analysis of this
trial showed that there was a significant treatment interaction effect related
to levels of a blood enzyme known as LDH. When this effect was analyzed by
treatment arm, survival was shown to be significantly superior for patients with
a non-elevated LDH who received Genasense®
(P=0.018; n=508). Moreover, this benefit was particularly noteworthy for
patients whose baseline LDH did not exceed 80% of the upper limit of normal for
this lab value. LDH had also been previously described by others as the single
most important prognostic factor in advanced melanoma.
Based on
these data, in August 2007 we initiated a new Phase 3 trial of Genasense® plus
chemotherapy in advanced melanoma. This trial, known as AGENDA, is a randomized,
double-blind, placebo-controlled study in which patients are randomly assigned
to receive Genasense® plus
dacarbazine or dacarbazine alone. The study uses LDH as a biomarker to identify
patients who are most likely to respond to Genasense®, based
on data obtained from our preceding trial in melanoma. The co-primary endpoints
of AGENDA are progression-free survival (PFS) and overall survival.
AGENDA is
designed to expand evidence for the safety and efficacy of Genasense® when
combined with dacarbazine for patients who have not previously been treated with
chemotherapy. The study prospectively targets patients who have low-normal
levels of LDH. We have completed accrual of patient enrollment into AGENDA with
315 patients from the U.S., Canada, Western Europe, and Australia. In May 2009,
a final analysis by an independent Data Monitoring Committee for both safety and
futility informed us that the study passed its final futility
analysis for progression-free survival (PFS). If the trial progresses
to completion, we expect to release results on the final assessment of PFS in
the fourth quarter of 2009. If those data are positive, we currently expect our
regulatory submissions will be based upon confirmation that the addition of
Genasense®
to chemotherapy results in a statistically significant and clinically
meaningful improvement in PFS. Approval by FDA and EMEA will allow
Genasense® to be
commercialized by us in the U.S. and in the European Union. Genasense® in
melanoma has been designated an Orphan Drug in Australia and the United States,
and the drug has received Fast Track designation in the United
States.
Given our
belief in the activity of Genasense® in
melanoma, we have initiated additional clinical studies in this disease. One
such study is a Phase 2 trial of Genasense® plus a
chemotherapy regimen consisting of Abraxane®
(paclitaxel protein-bound particles for injectable suspension) (albumin bound)
plus temozolomide (Temodar®). We
also expect to examine different dosing regimens that will improve the dosing
convenience and commercial acceptance of Genasense®,
including its administration by brief (1-2 hour) IV infusions.
Our
initial NDA for the use of Genasense® plus
chemotherapy in patients with relapsed or refractory CLL was not approved. We
conducted a randomized Phase 3 trial in 241 patients with relapsed or refractory
CLL who were treated with fludarabine and cyclophosphamide (Flu/Cy) with or
without Genasense®. The
trial achieved its primary endpoint: a statistically significant increase (17%
vs. 7%; P=0.025) in the proportion of patients who achieved a complete response
(CR), defined as a complete or nodular partial response. Patients who achieved
this level of response also experienced disappearance of predefined disease
symptoms. A key secondary endpoint, duration of CR, was also significantly
longer for patients treated with Genasense® (median
exceeding 36+ months in the Genasense® group,
versus 22 months in the chemotherapy-only group).
Several
secondary endpoints were not improved by the addition of Genasense®. The
percentage of patients who experienced serious adverse events was increased in
the Genasense® arm;
however, the percentages of patients who discontinued treatment due to adverse
events were equal in the treatment arms. The incidence of certain serious
adverse reactions, including but not limited to nausea, fever and
catheter-related complications, was increased in patients treated with
Genasense®.
We
submitted our NDA to the FDA in December 2005 in which we sought accelerated
approval for the use of Genasense® in
combination with Flu/Cy for the treatment of patients with relapsed or
refractory CLL who had previously received fludarabine. In December 2006, we
received a “non-approvable” notice for that application from FDA. However, since
we believed that our application had met the regulatory requirements for
approval, in April 2007, we filed an appeal of the non-approvable notice using
FDA’s Formal Dispute Resolution process. In March 2008, we received a formal
notice from FDA that indicated additional confirmatory evidence would be
required to support approval of Genasense® in CLL.
In that communication, FDA recommended one option was to collect additional
information regarding the clinical course and progression of disease in patients
from the completed trial.
Subsequently,
we obtained information regarding long-term survival on patients who had been
accrued to our completed Phase 3 trial. In June 2008, we announced results from
5 years of follow-up These data showed that patients treated with Genasense® plus
chemotherapy who achieved either a complete response (CR) or a partial response
(PR) had also achieved a statistically significant increase in
survival.
Previous
analyses had shown a significant survival benefit accrued to patients in the
Genasense® group
who attained CR. Extended follow-up showed that all major responses (CR+PR)
achieved with Genasense® were
associated with significantly increased survival compared with all major
responses achieved with chemotherapy alone (median = 56 months vs. 38 months,
respectively). After 5 years of follow-up, 22 of 49 (45%) responders
in the Genasense® group
were alive compared with 13 of 54 (24%) responders in the chemotherapy-only
group (hazard ratio = 0.6; P = 0.038). Moreover, with 5 years of follow-up, 12
of 20 patients (60%) in the Genasense® group
who achieved CR were alive, 5 of these patients remained in continuous CR
without relapse, and 2 additional patients had relapsed but had not required
additional therapy. By contrast, only 3 of 8 CR patients in the
chemotherapy-only group were alive, all 3 had relapsed, and all 3 had required
additional anti-leukemic treatment.
These
data were again submitted to FDA in the second quarter of 2008, and the
application was again denied in December 2008. Genta re-appealed the denial, and
in March 2009, CDER decided that available data were still not adequate to
support approval of Genasense® in
chronic lymphocytic leukemia, and the Agency recommended conducting a
confirmatory clinical trial. We have not yet made a decision whether to conduct
this study.
Lastly,
several trials have shown definite evidence of clinical activity for
Genasense® in
patients with non-Hodgkin’s lymphoma (NHL). We would like to conduct additional
clinical studies in patients with NHL to test whether Genasense® can be
approved in this indication. Previously, we reported that randomized trials of
Genasense® in
patients with myeloma, acute myeloid leukemia, (AML), hormone-refractory
prostate cancer (HRPC), small cell lung cancer and non small cell lung cancer
were not sufficiently positive to warrant further investigation on the
dose-schedules that were examined or with the chemotherapy that was employed in
these trials. Data from these trials have been presented at various scientific
meetings. However, we believe that alternate dosing schedules, in particular the
use of brief high-dose infusions, offer the opportunity to re-examine the drug’s
activity in some of these indications, in particular multiple
myeloma.
In March
2008, we obtained from Daiichi Sankyo Company Ltd. an exclusive worldwide
license for tesetaxel, a novel taxane compound that is taken by mouth. Tesetaxel
has completed Phase 2 trials in a number of cancer types, and the drug has shown
definite evidence of antitumor activity in gastric cancer and breast cancer.
Tesetaxel also appears to be associated with a lower incidence of peripheral
nerve damage, a common side effect of taxanes that limits the maximum amount of
these drugs that can be given to patients. At the time we obtained the license,
tesetaxel was on “clinical hold” by FDA due to the occurrence of several
fatalities in the setting of severe neutropenia. In the second quarter of 2008,
we filed a response to the FDA requesting a lift of the clinical hold, which was
granted in June 2008. In January 2009, we announced initiation of a new clinical
trial with tesetaxel to examine the clinical pharmacology of the drug over a
narrow dosing range around the established Phase 2 dose.
We have
also submitted applications to FDA for designation of tesetaxel as an Orphan
Drug for treatment of patients with advanced gastric cancer and for patients
with advanced melanoma. Both of these designations have been granted.
We have submitted a proposed protocol to FDA for Special Protocol Assessment
(SPA). A SPA is intended to secure agreement on the design, size, and endpoints
of clinical trials that are intended to form the primary basis of an efficacy
claim in a NDA. We also expect to seek Scientific Advice from the EMEA for this
study to support a Marketing Authorization Application (MAA). The protocol
proposes to examine the safety and efficacy of tesetaxel in patients with
advanced gastric cancer whose disease has progressed after receiving first-line
chemotherapy. Maintenance of the license from Daiichi Sankyo requires certain
payments that include amortization of licensing fees and
milestones. If such payments are not made, Daiichi Sankyo may elect
to terminate the license; however, a portion of the licensing fees may still be
due even in the event of termination. We are currently in discussions with
Daiichi Sankyo regarding the timing of these payments.
Our third
pipeline product is G4544, which is a novel oral formulation of a
gallium-containing compound that we developed in collaboration with Emisphere
Technologies, Inc. We completed a single-dose Phase 1 study of an initial
formulation of this new drug known as “G4544(a)” and the results were presented
at a scientific meeting in the second quarter of 2008. We are planning another
study using a modified formulation, known as “G4544(b)”. The FDA has indicated
that a limited, animal toxicology study in a single species will be required
prior to initiation of multi-dose studies of G4544(b). Progress in the clinical
development of G4544 program was delayed in 2008 and through the first quarter
of 2009 due to financial constraints.
We
currently intend to pursue a 505(b)(2) strategy to establish bioequivalence to
our marketed product, Ganite®, for the
initial regulatory approval of G4544. However, we believe this drug
may also be useful for treatment of other diseases associated with accelerated
bone loss, such as bone metastases, Paget’s disease and osteoporosis. In
addition, new uses of gallium-containing compounds have been identified for
treatment of certain infectious diseases. While we have no current plans to
begin clinical development in the area of infectious disease, we intend to
support research conducted by certain academic institutions by providing
clinical supplies of our gallium-containing drugs.
Lastly,
we have announced our intention to seek a buyer for Ganite®, our
sole marketed product. Our financial constraints have prevented us
from investing in adequate commercial support for Ganite®, and the
intellectual property that provided us with an exclusive position in the United
States has expired.
Results
of Operations for the Three Months Ended March 31, 2009 and March 31,
2008
($
thousands)
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Product
sales – net
|
|
$ |
62 |
|
|
$ |
117 |
|
Cost
of goods sold
|
|
|
- |
|
|
|
25 |
|
Gross
margin
|
|
|
62 |
|
|
|
92 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
2,298 |
|
|
|
6,438 |
|
Selling,
general and administrative
|
|
|
2,172 |
|
|
|
3,638 |
|
Reduction
in liability for settlement of litigation
|
|
|
- |
|
|
|
(260 |
) |
Total
operating expenses
|
|
|
4,470 |
|
|
|
9,816 |
|
|
|
|
|
|
|
|
|
|
Other
(expense)/income:
|
|
|
|
|
|
|
|
|
Other
(expense)/income, net
|
|
|
(372 |
) |
|
|
67 |
|
Amortization
of deferred financing costs and debt discount
|
|
|
(6,287 |
) |
|
|
- |
|
Total
other income/(expense), net
|
|
|
(6,659 |
) |
|
|
67 |
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(11,067 |
) |
|
$ |
(9,657 |
) |
Product
sales-net
Product
sales-net were $62,000 for the three months ended March 31, 2009, compared with
$117,000 for the three months ended March 31, 2008. Unit sales of Ganite® declined
18%, while reported product sales include the negative impact of anticipated
returns of Ganite® due to
expired dating of product. Product sales-net include sales through the
“named-patient” program managed for us by IDIS Limited (a privately owned
company based in the United Kingdom), whereby IDIS distributes Ganite® and
Genasense® on a
‘‘named patient’’ basis. ‘‘Named patient’’ distribution refers to the
distribution or sale of a product to a specific healthcare professional for the
treatment of an individual patient. Product sales-net in 2009 include
named-patient program sales of $8,000 of Genasense® and
$5,000 of Ganite®, while
2008 results include sales of Ganite® of
$10,000.
Cost of goods
sold
During
the three months ended March 31, 2009, sales of Ganite® were
from product that had been previously accounted for as excess
inventory.
Research and development
expenses
Research
and development expenses were $2.3 million for the three months ended March 31,
2009, compared with $6.4 million for the three months ended March 31, 2008. In
March 2008, we entered into a worldwide license agreement for tesetaxel, a
taxane compound taken by mouth. Pursuant to this agreement, we recognized $2.5
million for license payments. Expenses in 2009 also declined primarily due to
lower payroll costs, resulting from lower headcount as we reduced our workforce
in April 2008 and May 2008 to conserve cash.
Research
and development expenses incurred on the Genasense® project
during the three months ended March 31, 2009 were approximately $2.1 million,
representing 90% of research and development expenses.
Due to
the significant risks and uncertainties inherent in the clinical development and
regulatory approval processes, the nature, timing and costs of the efforts
necessary to complete projects in development are subject to wide variability.
Results from clinical trials may not be favorable. Data from clinical trials are
subject to varying interpretation and may be deemed insufficient by the
regulatory bodies that review applications for marketing approvals. As such,
clinical development and regulatory programs are subject to risks and changes
that may significantly impact cost projections and timelines.
Selling, general and
administrative expenses
Selling,
general and administrative expenses were $2.2 million for the three months ended
March 31, 2009, compared with $3.6 million for the three months ended March 31,
2008. This decrease was primarily due to lower payroll costs of $0.6 million,
resulting from the two reductions in workforce and lower office rent of $0.5
million, resulting from our termination of a lease for one floor of office space
in May 2008.
Reduction in liability for
settlement of litigation
In the
fourth quarter of 2006, we recorded an expense that provided for the issuance of
2.0 million shares of Genta common stock, for a settlement in principle of class
action litigation and continued to mark this liability to market until June 27,
2008. At March 31, 2008, the revised value of the common stock portion of the
litigation settlement resulted in a reduction in the provision of $0.3
million.
Gain on maturity of
marketable securities
Interest and other income,
net
Interest
expense
The total
of the above referenced accounts resulted in expense, net of $(0.4) million for
the first three months of 2009 and income, net of $0.1 million for the
prior-year period. This increase in expense was primarily due to interest
incurred on the convertible notes, as well as lower interest income, resulting
from lower investment balances.
Amortization of deferred
financing costs and debt discount
On
June 9, 2008, we issued $20 million of our senior secured convertible notes,
issued our private placement agent a warrant to purchase 800,000 shares of our
common stock at an exercise price of $1.00 per share and incurred a financing
fee of $1.2 million. The deferred financing costs, including the financing fee
and the issuance of the warrant, are being amortized over the two-year term of
the convertible notes. At the time the notes were issued, we recorded a debt
discount (beneficial conversion) relating to the conversion feature in the
amount of $20.0 million. We are amortizing the resultant debt discount over the
term of the notes through their maturity date. The amortization of deferred
financing costs and debt discount was $6.3 million for the three months ended
March 31, 2009.
Net loss
Genta
recorded a net loss of $11.1 million, or net loss per basic and diluted share of
$0.61 for the three months ended March 31, 2009 and incurred a net loss of $9.7
million, or $14.29 per basic and diluted share, for the three months ended March
31, 2008.
The
higher net loss for the first quarter of 2009 was due to the amortization of
financing costs and debt discount resulting from the June 2008 convertible note
offering, partially offset by lower operational expenses, primarily attributable
to reduced headcount and payroll expenses.
Liquidity
and Capital Resources
At March
31, 2009, we had cash and cash equivalents totaling $0.6 million, compared with
$4.9 million at December 31, 2008, reflecting the funds used in operating our
company.
On
June 9, 2008, we placed $20 million of senior secured convertible notes, or the
2008 Notes, with certain institutional and accredited investors. The notes bear
interest at an annual rate of 15% payable at quarterly intervals in other senior
secured convertible promissory notes to the holder, and originally were
convertible into shares of Genta common stock at a conversion rate of 2,000
shares of common stock for every $1,000.00 of principal. As a result of issuing
convertible notes on April 2, 2009, (see below), these notes are presently
convertible into shares of our common stock at a conversion rate of 10,000
shares of common stock for every $1,000.00 of principal. Certain members of our
senior management participated in this offering. Pursuant to a general security
agreement, entered into concurrently with the notes, the notes are secured by a
first lien on all of our assets. In addition, the notes prohibit any additional
financing without the approval of holders of more than two-thirds of the
principal amount of the notes.
Upon the
occurrence of an event of default, holders of the notes have the right to
require us to prepay all, or a portion, of their notes as calculated as the
greater of (a) 150% of the aggregate principal amount of the note plus accrued
interest or (b) the aggregate principal amount of the note plus accrued interest
divided by the conversion price; multiplied by a weighted average price of our
common stock.
On
April 2, 2009, we entered into a securities purchase agreement with certain
accredited institutional investors to place up to $12 million of senior secured
convertible notes, or the April 2009 Notes, and corresponding warrants to
purchase common stock. We closed on approximately $6 million of such notes and
warrants on April 2, 2009. The April 2009 Notes bear interest at an annual rate
of 8% payable semi-annually in other senior secured convertible promissory notes
to the holder, and are convertible into shares of the our common stock at a
conversion rate of 10,000 shares of common stock for every $1,000.00 of
principal amount outstanding. The April 2009 Notes and warrants are convertible
into approximately 77,940,000 shares of our common stock.
On
July 7, 2009, we entered into a securities purchase agreement with certain
accredited institutional investors to place up to $10 million in aggregate
principal amount of units consisting of (i) 70% unsecured subordinated
convertible notes, or the July 2009 Notes, and (ii) 30% common
stock. In connection with the sale of the units, we also issued to
the investors two-year warrants to purchase common stock in an amount equal to
25% of the number of shares of common stock issuable upon conversion of the July
2009 Notes purchased by each investor. We closed on approximately $3
million of such July 2009 Notes, common stock and warrants on July 7,
2009. The July 2009 Notes bear interest at an annual rate of 8%
payable semi-annually in cash or other unsecured subordinated convertible
promissory notes to the holder, and are convertible into shares of the our
common stock at a conversion rate of 10,000 shares of common stock for every
$1,000.00 of principal amount outstanding. The July 2009 Notes and warrants are
convertible into approximately 61,250,000 shares of our common
stock.
Irrespective
of whether an NDA or MAA for Genasense® is
approved, we will require additional cash in order to maximize this commercial
opportunity and to continue its clinical development opportunities. We have had
discussions with other companies regarding partnerships for the further
development and global commercialization of Genasense®.
Additional alternatives available to us to sustain our operations include
financing arrangements with potential corporate partners, debt financing,
asset-based loans, royalty-based financing, equity financing, profits from
named-patient sales, and other potential sources of financing. However, there
can be no assurance that any such collaborative agreements or other sources of
funding will be available to us on favorable terms, if at all.
During
the first three months of 2009, cash used in operating activities was $4.3
million compared with $6.2 million for the same period in 2008, reflecting the
reduced size of our company.
Presently,
with no further financing, we project that we will run out of funds in August
2009. The term of the April 2009 Notes enable those noteholders, at their
option, to purchase additional notes with similar terms. We do not have any
additional financing in place. If we are unable to raise additional financing,
we could be required to reduce our spending plans, reduce our workforce, license
to others products or technologies we would otherwise seek to commercialize
ourselves and sell certain assets. There can be no assurance that we can obtain
financing, if at all, on terms acceptable to us.
We
anticipate seeking additional product development opportunities through
potential acquisitions or investments. Such acquisitions or investments may
consume cash reserves or require additional cash or equity. Our working capital
and additional funding requirements will depend upon numerous factors,
including: (i) the progress of our research and development programs; (ii) the
timing and results of pre-clinical testing and clinical trials; (iii) the level
of resources that we devote to sales and marketing capabilities; (iv)
technological advances; (v) the activities of competitors; (vi) our ability to
establish and maintain collaborative arrangements with others to fund certain
research and development efforts, to conduct clinical trials, to obtain
regulatory approvals and, if such approvals are obtained, to manufacture and
market products and (vii) legal costs and the outcome of outstanding legal
proceedings.
Recent
Accounting Pronouncements
In April
2009, the Financial Accounting Standards Board (FASB) issued FASB Staff Position
SFAS 141(R)-1, Accounting for
Assets Acquired and Liabilities Assumed in a Business Combination That Arise
from Contingencies, to amend and clarify the initial recognition and
measurement, subsequent measurement and accounting, and related disclosures
arising from contingencies in a business combination under SFAS 141(R). Under
the new guidance, assets acquired and liabilities assumed in a business
combination that arise from contingencies should be recognized at fair value on
the acquisition date if fair value can be determined during the measurement
period. If fair value can not be determined, companies should typically account
for the acquired contingencies using existing guidance. The implementation of
this standard did not have a material effect on our consolidated financial
statements.
In May
2008, the FASB issued FSP APB 14-1, Accounting for Convertible Debt That
May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement), which is effective for the Company January 1, 2009. The FSP
includes guidance that convertible debt instruments that may be settled in cash
upon conversion should be separated between its liability and equity components,
with each component being accounted for in a manner that will reflect the
entity’s nonconvertible debt borrowing rate when interest costs are recognized
in subsequent periods. This guidance does not apply to us since our existing
convertible debt instruments are settled only in stock upon conversion, and as a
result does not have an impact on our unaudited consolidated financial
statements.
In April
2008, the FASB issued FASB Staff Position 142-3, “Determination of the Useful Life of
Intangible Assets” (“FSP 142-3”), which amends the factors that should be
considered in developing renewal or extension assumptions used to determine the
useful life of a recognized intangible asset under SFAS No. 142, “Goodwill and Other Intangible
Assets” (“SFAS No. 142”). The objective of FSP 142-3 is to
improve the consistency between the useful life of a recognized intangible asset
under SFAS No. 142 and the period of expected cash flows used to measure the
fair value of the asset under SFAS No. 141(R), “Business Combinations” and
other principles of generally accepted accounting principles. FSP
142-3 applies to all intangible assets, whether acquired in a business
combination or otherwise, and shall be effective for financial statements issued
for fiscal years beginning after December 15, 2008, and interim periods within
those fiscal years and applied prospectively to intangible assets acquired after
the effective date. The implementation of this standard did not have a material
effect on our consolidated financial statements.
In June
2008, the FASB ratified EITF 07-5, “Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own Stock”. EITF 07-5
addresses how an entity should evaluate whether an instrument or embedded
feature is indexed to its own stock, accounting for situations where the
currency of the linked instrument differs from the host instrument and
accounting for market-based employee stock options. EITF 07-5 is effective for
fiscal years beginning after December 15, 2008 and early adoption is not
permitted. The implementation of this standard did not have a material effect on
our consolidated financial statements.
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles”. The statement is intended to improve financial
reporting by identifying a consistent hierarchy for selecting accounting
principles to be used in preparing financial statements that are prepared in
conformance with generally accepted accounting principles. The statement is
effective 60 days following the Securities and Exchange Commission’s (SEC)
approval of the Public Company Accounting Oversight Board amendments to AU
Section 411, “The Meaning of
Present Fairly in Conformity with GAAP”, and is not expected to have any
impact on our financial statements.
In March
2008, the FASB issued SFAS 161, “Disclosures about Derivative
Instruments and Hedging Activities, an amendment of FASB SFAS
133” (“SFAS 161”), which requires enhanced disclosures for derivative and
hedging activities. SFAS 161 became effective for financial statements issued
for fiscal years and interim periods beginning after November 15, 2008. The
implementation of this standard did not have a material effect on our
consolidated financial statements.
In
December 2007, the FASB issued SFAS 160, “Noncontrolling Interests in
Consolidated Financial Statements — an amendment of ARB No. 51” (“SFAS
160”). SFAS 160 establishes new accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. Specifically, this statement requires the recognition of a
noncontrolling interest (minority interest) as equity in the consolidated
financial statements and separate from the parent’s equity. The amount of net
income attributable to the noncontrolling interest will be included in
consolidated net income on the face of the income statement. SFAS 160 clarifies
that changes in a parent’s ownership interest in a subsidiary that do not result
in deconsolidation are equity transactions if the parent retains its controlling
financial interest. In addition, this statement requires that a parent recognize
a gain or loss in net income when a subsidiary is deconsolidated. SFAS 160 also
includes expanded disclosure requirements regarding the interests of the parent
and its noncontrolling interest. SFAS 160 is effective for fiscal years, and
interim periods within those fiscal years, beginning on or after December 15,
2008. The implementation of this standard did not have a material effect on our
consolidated financial statements.
In
September 2006, the FASB issued SFAS 157, “Fair Value Measurements”.
SFAS 157 defines fair value, establishes a framework for measuring fair
value in accordance with accounting principles generally accepted in the United
States of America and expands disclosures about fair value measurements. SFAS
157 applies under other accounting pronouncements that require or permit fair
value measurements. The Company was required to adopt SFAS 157 beginning
January 1, 2008. In February 2008, the FASB released FASB Staff Position 157-2
– Effective Date of FASB
Statement No. 157, which delayed the effective date of SFAS No. 157 for
all non-financial assets and liabilities, except those that are recognized or
disclosed at fair value in the financial statements on a recurring basis (at
least annually). In October 2008, the FASB released FASB Staff Position 157-3 –
Determining the Fair Value of
a Financial Asset When the Market for That Asset Is Not Active. In April 2009, the FASB
released FASB Staff Position 157-4 Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly. The adoption
of SFAS No. 157 for the our financial assets and liabilities did not have a
material impact on our consolidated financial statements and the adoption of
SFAS No. 157 for the our non-financial assets and liabilities, effective January
1, 2009, did not have a material effect on our consolidated financial
statements.
Critical
Accounting Policies and Estimates
Our
significant accounting policies are more fully described in Note 2 to our
consolidated financial statements. In preparing our financial statements in
accordance with accounting principles generally accepted in the United States of
America, management is required to make estimates and assumptions that, among
other things, affect the reported amounts of assets and liabilities and reported
amounts of revenues and expenses. These estimates are most significant in
connection with our critical accounting policies, namely those of our accounting
policies that are most important to the portrayal of our financial condition and
results and require management’s most difficult, subjective or complex
judgments. These judgments often result from the need to make estimates about
the effects of matters that are inherently uncertain. Actual results may differ
from those estimates under different assumptions or conditions. We believe that
the following represents our critical accounting policies:
|
·
|
Going concern. Our
recurring losses from operations and negative cash flows from operations
raise substantial doubt about our ability to continue as a going concern
and as a result, our independent registered public accounting firm
included an explanatory paragraph in its report on our consolidated
financial statement for the year ended December 31, 2008 with respect to
this uncertainty. We have prepared our financial statements on a going
concern basis, which contemplates the realization of assets and the
satisfaction of liabilities and commitments in the normal course of
business. The financial statements do not include any adjustments relating
to the recoverability and classification of recorded asset amounts or
amounts of liabilities that might be necessary should we be unable to
continue in existence.
|
|
·
|
Revenue recognition. We
recognize revenue from product sales when title to product and associated
risk of loss has passed to the customer and we are reasonably assured of
collecting payment for the sale. All revenue from product sales are
recorded net of applicable allowances for returns, rebates and other
applicable discounts and allowances. We allow return of our product for up
to twelve months after product
expiration.
|
|
·
|
Research and development
costs. All such costs are expensed as incurred, including raw
material costs required to manufacture drugs for clinical
trials.
|
|
·
|
Estimate of fair value of
convertible notes and warrant. We use a Black-Scholes model to
estimate the fair value of our convertible notes and
warrant.
|
Results
of Operations for the Years Ended December 31, 2008, 2007 and 2006
|
|
Summary
Operating Results
|
|
|
|
For
the years ended December 31,
|
|
($
thousands)
|
|
|
|
|
|
|
|
|
|
|
$
Change
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
’08 vs. ‘07
|
|
|
’07 vs. ‘06
|
|
Product
sales - net
|
|
$ |
363 |
|
|
$ |
580 |
|
|
$ |
708 |
|
|
$ |
(217 |
) |
|
$ |
(128 |
) |
Cost
of goods sold
|
|
|
102 |
|
|
|
90 |
|
|
|
108 |
|
|
|
12 |
|
|
|
(18 |
) |
Gross
margin
|
|
|
261 |
|
|
|
490 |
|
|
|
600 |
|
|
|
(229 |
) |
|
|
(110 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
19,991 |
|
|
|
13,491 |
|
|
|
28,064 |
|
|
|
6,500 |
|
|
|
(14,573 |
) |
Selling,
general and administrative
|
|
|
10,452 |
|
|
|
16,865 |
|
|
|
25,152 |
|
|
|
(6,413 |
) |
|
|
(8,287 |
) |
Settlement
of office lease obligation
|
|
|
3,307 |
|
|
|
- |
|
|
|
- |
|
|
|
3,307 |
|
|
|
- |
|
Provision
for settlement of litigation
|
|
|
(340 |
) |
|
|
(4,240 |
) |
|
|
5,280 |
|
|
|
3,900 |
|
|
|
(9,520 |
) |
Write-off
of prepaid royalty
|
|
|
- |
|
|
|
- |
|
|
|
1,268 |
|
|
|
- |
|
|
|
(1,268 |
) |
Total
operating expenses
|
|
|
33,410 |
|
|
|
26,116 |
|
|
|
59,764 |
|
|
|
7,294 |
|
|
|
(33,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
(expense)/ income, net
|
|
|
(1,435 |
) |
|
|
836 |
|
|
|
1,454 |
|
|
|
(2,271 |
) |
|
|
(618 |
) |
Amortization
of deferred financing costs and
debt discount
|
|
|
(11,229 |
) |
|
|
- |
|
|
|
- |
|
|
|
(11,229 |
) |
|
|
- |
|
Fair
value – conversion feature liability
|
|
|
(460,000 |
) |
|
|
- |
|
|
|
- |
|
|
|
(460,000 |
) |
|
|
- |
|
Fair
value – warrant liability
|
|
|
(2,000 |
) |
|
|
- |
|
|
|
- |
|
|
|
(2,000 |
) |
|
|
- |
|
Loss
before income taxes
|
|
|
(507,813 |
) |
|
|
(24,790 |
) |
|
|
(57,710 |
) |
|
|
(483,023 |
) |
|
|
32,920 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax benefit
|
|
|
1,975 |
|
|
|
1,470 |
|
|
|
929 |
|
|
|
505 |
|
|
|
541 |
|
Net
loss
|
|
$ |
(505,838 |
) |
|
$ |
(23,320 |
) |
|
$ |
(56,781 |
) |
|
$ |
(482,518 |
) |
|
$ |
33,461 |
|
Product sales -
net
Product
sales - net were $0.4 million in 2008 compared with $0.6 million in
2007. Product sales-net in 2008 included $25,000 of sales of Ganite® and in
2007 included $60,000 in sales of Genasense® through
the “named-patient” program managed for us by IDIS Limited (a privately owned
company based in the United Kingdom), whereby IDIS distributes Ganite® and
Genasense® on a
“named patient” basis. “Named patient” distribution refers to the distribution
or sale of a product to a specific healthcare professional for the treatment of
an individual patient. Unit sales of Ganite®
increased 2.7% in 2008, but reported product sales - net in 2008 include the
negative impact of returns of Ganite® due to
expired dating of product. Product sales-net in 2007 and 2006 included
favorable adjustments to a reserve for returns of Ganite® of $0.1
million and $0.3 million, respectively.
Cost of goods
sold
Cost of
goods sold increased in 2008 compared to the prior year due to higher unit sales
of Ganite®
and higher unit costs. Lower cost of goods sold in 2007 than
in 2006 is primarily the result of lower unit sales of Ganite®.
Research and development
expenses
Research
and development expenses were $20.0 million in 2008, compared with $13.5 million
in 2007. This increase was primarily due to the recognition of $2.5 million in
March 2008 for license payments on tesetaxel, $1.0 million in accrued milestone
payments related to tesetaxel, and higher expenses from the AGENDA clinical
trial. In addition, during the fourth quarter of 2007, we revised our estimate
of certain accrued expenses in the amount of $4.7 million, since such amount was
no longer deemed probable. These factors were partially offset by lower
compensation expense resulting from our workforce reductions in April 2008 and
May 2008.
Research
and development expenses incurred on the Genasense® project
in 2008 were approximately $15.0 million, representing 75% of research and
development expenses, (including the $2.5 million for license payments and $1.0
million in milestone payments related to tesetaxel).
Research
and development expenses were $13.5 million in 2007 compared with $28.1 million
in 2006. The prior year included higher manufacturing and other expenses
incurred in preparation for the possible commercial launch of Genasense® and
expenses related to regulatory review. The decline in expenses in 2007 reflects
the comparison to this higher level of expenses in 2006, as well as the impact
of a staff reduction in December 2006. Also, in 2007, we revised our estimate of
certain accrued expenses in the amount of $4.7 million, since such amount was no
longer deemed probable. Research and development expenses incurred on the
Genasense® project
in 2007 were approximately $10.3 million, representing 76% of research and
development expenses.
Due to
the significant risks and uncertainties inherent in the clinical development and
regulatory approval processes, the nature, timing and costs of the efforts
necessary to complete projects in development are subject to wide variability.
Results from clinical trials may not be favorable. Data from clinical trials are
subject to varying interpretation and may be deemed insufficient by the
regulatory bodies that review applications for marketing approvals. As such,
clinical development and regulatory programs are subject to risks and changes
that may significantly impact cost projections and timelines.
Selling, general and
administrative expenses
Selling,
general and administrative expenses were $10.5 million in 2008, compared with
$16.9 million in 2007. The decrease is primarily due to our efforts at lowering
administrative expenses, lower office rent of $1.1 million and lower
compensation expense resulting from our workforce reductions in April 2008 and
May 2008.
Selling,
general and administrative expenses were $16.9 million in 2007, compared with
$25.2 million in 2006. The prior year included a buildup of sales and marketing
expenses incurred in preparation for a possible commercial launch of
Genasense®. The
decline in expenses in 2007 reflects the comparison to this higher level of
expenses in 2006, as well as the impact of our December 2006 staff reduction. In
addition, depreciation expense declined by $0.8 million and share-based
compensation declined by $1.1 million.
Settlement of office lease
obligation
In May
2008, we entered into an amendment of our lease for office space with The
Connell Company, (Connell) whereby the lease for one floor of our office space
in Berkeley Heights, New Jersey was terminated. Connell received a termination
payment of $1.3 million, comprised solely of our security deposits and we agreed
to pay Connell $2.0 million upon the earlier of July 1, 2009 or our receipt of
at least $5.0 million in upfront cash from a business development deal. In
January 2009, we entered into another amendment of our agreement with Connell
whereby our future payment of $2.0 million is now payable on January 1, 2011. We
accrued for the $2.0 million and it is included on our Consolidated Balance
Sheets. We will pay 6.0% interest in arrears to Connell from July 1, 2009
through the new payment date. The initial interest payment of approximately
$30,000 will be payable as of October 1, 2009.
Provision for settlement of
litigation
In
2006, we recorded an expense of $5.3 million that provided for the issuance of
40,000 shares of our common stock, for a settlement in principle of class action
litigation. At December 31, 2007, the revised estimated value of the common
shares portion of the litigation settlement was $1.0 million, resulting in a
reduction in the liability for the settlement of litigation of $4.2 million. On
June 27, 2008, the date that the settlement was finalized, the revised value of
the 40,000 shares was $0.7 million, resulting in a reduction in the liability
for the settlement of litigation of $0.3 million. See Note 6 to our Consolidated
Financial Statements for the year ended December 31, 2008 for a further
discussion of this provision.
Write-off of prepaid
royalty
In
December 2000, we recorded $1.3 million as the fair value for our commitment to
issue 27,056 shares (not adjusted for 1-for-50 reverse stock split) of common
stock to a major university as consideration for an amendment to a license
agreement initially executed on August 1991 related to antisense technology
licensed from the university. The amendment provided for a reduction in the
royalty percentage rate to be paid to the university based on the volume of
sales of our products containing the antisense technology licensed from such
university. These shares were issued in 2001. In December 2006, we received a
non-approvable notice from the FDA for our NDA for the use of Genasense® plus
chemotherapy in patients with CLL. As a result, we accounted for the impairment
of these prepaid royalties and recorded a write-off of this asset, (see Note 8
to our Financial Statements).
Gain on maturity of
marketable securities
Interest income and
other income,
net
Interest
expense
The total
of the above referenced accounts resulted in expense, net of $(1.4) million in
2008 and income, net of $0.8 million in 2007. This decline was primarily due to
interest incurred on the convertible notes, as well as lower interest income,
resulting from lower investment balances. Other income, net of $0.8 million in
2007 declined from $1.5 million in 2006, primarily due to lower interest income,
resulting from lower investment balances, along with higher interest
expense.
Amortization of deferred
financing costs and debt discount
On
June 9, 2008, we issued $20 million of our senior secured convertible notes,
issued our private placement agent a warrant to purchase 800,000 shares of our
common stock at an exercise price of $1.00 per share and incurred a financing
fee of $1.2 million. The deferred financing costs, including the financing fee
and the value of the warrant, are being amortized over the two-year term of the
convertible notes, resulting in amortization of $11.2 million in
2008.
Fair value – conversion
feature liability
On the
date that we issued the convertible notes, there were an insufficient number of
authorized shares of common stock in order to permit conversion of all of the
notes. In accordance with EITF 00-19, “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock” (EITF
00-19), when there are insufficient authorized shares to allow for settlement of
convertible financial instruments, the conversion obligation for the notes
should be classified as a liability and measured at fair value on the balance
sheet.
On
June 9, 2008, based upon a Black-Scholes valuation model that included a closing
price of our common stock of $10.00 per share, we calculated a fair value of the
conversion feature of $380.0 million and expensed $360.0 million, the amount
that exceeded the proceeds of the $20.0 million from the initial closing. On
October 6, 2008, the date on which our stockholders approved an amendment to
Genta’s Restated Certificate of Incorporation, as amended, to increase the total
number of authorized shares of capital stock available for issuance, we
re-measured the conversion feature liability and credited it to Stockholders’
equity, resulting in total expense for the year ended December 31, 2008 of
$460.0 million.
Fair value – warrant
liability
The
warrant was also treated as a liability and was initially recorded at a fair
value of $7.6 million based upon a Black-Scholes valuation model that included a
closing price of our common stock of $10.00 per share. On October 6, 2008, we
re-measured the warrant liability and credited it to Stockholders’ equity,
resulting in total expense for the year ended December 31, 2008 of $2.0
million.
Income tax
benefit
New
Jersey has legislation permitting certain corporations located in the state to
sell state tax loss carryforwards and state research and development credits. We
sold portions of our New Jersey net operating losses research and development
credits and received approximate payments of $2.0 million in 2008, $1.5 million
in 2007 and $0.9 million in 2006 that are recognized as income tax
benefit.
If still
available under New Jersey law, we will attempt to sell our remaining tax losses
in 2009. We can not be assured that the New Jersey program will continue next
year, nor can we estimate what percentage of our saleable tax benefits New
Jersey will permit us to sell, how much money will be received in connection
with the sale, if we will be able to find a buyer for our tax benefits or if
such funds will be available in a timely manner.
Net loss
Genta
incurred a net loss of $505.8 million, or $455.09 per share, for 2008, $23.3
million, or $39.36 per share, for 2007 and $56.8 million, or $125.88 per share,
for 2006.
The
larger net loss in 2008 compared to 2007 is primarily due to the fair value
charge of the conversion feature liability of $460.0 million, the amortization
of deferred financing costs and debt discount of $11.2 million, the expenses
resulting from the reduction in our office space of $3.3 million, the fair value
charge of the warrant liability of $2.0 million, the recognition of $2.5 million
in March 2008 for license payments on tesetaxel, $1.0 million in accrued
milestone payments related to tesetaxel and higher expenses resulting from the
AGENDA clinical trial, slightly offset by lower compensation expense resulting
from the two reductions in workforce, as well as lower administrative
expenses.
The lower
net loss in 2007 compared to 2006 is primarily due to a comparison with a prior
year that reflected a buildup of sales, marketing and manufacturing expenses
incurred in anticipation of a possible commercial launch of Genasense®. In
addition, the lower loss in 2007 reflects our staff reduction in December 2006,
lower share-based compensation expense, lower depreciation expense and includes
a benefit of $4.2 million due to a reduction in the provision for settlement of
litigation.
Critical
Accounting Policies
Our
significant accounting policies are more fully described in Note 1 to our
consolidated financial statements. In preparing our financial statements in
accordance with accounting principles generally accepted in the United States of
America, management is required to make estimates and assumptions that, among
other things, affect the reported amounts of assets and liabilities and reported
amounts of revenues and expenses. These estimates are most significant in
connection with our critical accounting policies, namely those of our accounting
policies that are most important to the portrayal of our financial condition and
results and require management’s most difficult, subjective or complex
judgments. These judgments often result from the need to make estimates about
the effects of matters that are inherently uncertain. Actual results may differ
from those estimates under different assumptions or conditions. We believe that
the following represents our critical accounting policies:
|
·
|
Going concern. Our
recurring losses from operations and negative cash flows from operations
raise substantial doubt about our ability to continue as a going concern
and as a result, our independent registered public accounting firms
included an explanatory paragraph in their reports on our consolidated
financial statements for the years ended December 31, 2008 and December
31, 2007 with respect to this uncertainty. We have prepared our financial
statements on a going concern basis, which contemplates the realization of
assets and the satisfaction of liabilities and commitments in the normal
course of business. The financial statements do not include any
adjustments relating to the recoverability and classification of recorded
asset amounts or amounts of liabilities that might be necessary should we
be unable to continue in existence.
|
|
·
|
Revenue recognition. We
recognize revenue from product sales when title to product and associated
risk of loss has passed to the customer and we are reasonably assured of
collecting payment for the sale. All revenue from product sales are
recorded net of applicable allowances for returns, rebates and other
applicable discounts and allowances. We allow return of our product for up
to twelve months after product
expiration.
|
|
·
|
Research and development
costs. All such costs are expensed as incurred, including raw
material costs required to manufacture drugs for clinical
trials.
|
|
·
|
Estimate of fair value of
convertible notes and warrant. We use a Black-Scholes model to
estimate the fair value of our convertible notes and
warrant.
|
Liquidity
and Capital Resources
At
December 31, 2008, we had cash, cash equivalents and marketable securities
totaling $4.9 million, compared with $7.8 million at December 31, 2007,
reflecting the net proceeds from the placement of $20 million of notes on June
9, 2008 offset by funds used in operating our company. During 2008, cash used in
operating activities was $25.7 million compared with $31.7 million in 2007,
reflecting our efforts to lower our spending.
On
June 9, 2008, we issued 2-year senior convertible promissory notes bearing
interest at an annual rate of 15%, payable at quarterly intervals in stock or
cash at our option and the notes are convertible into shares of Genta common
stock at a conversion rate of 10,000 shares of common stock for every $1,000.00
of principal. Holders of the notes have the right, but not the obligation, for
the following 12 months following the initial closing date to purchase in whole,
or in part, up to an additional $20 million of the notes. We have the right to
force conversion of the notes in whole, or in part, if the closing bid price of
our common stock exceeds $0.50 for a period of 20 consecutive trading days.
Certain members of our senior management participated in this offering. The
notes are secured by a first lien on all of our assets. In addition, the notes
prohibit any additional financing without the approval of holders of more than
two-thirds of the principal amount of the notes.
The notes
included certain events of default, including a requirement that we obtain
stockholder approval within a specified period of time to amend our certificate
of incorporation to authorize additional shares of common stock. On October 6,
2008, at the Annual Meeting of Stockholders, our stockholders approved an
amendment to Genta’s Restated Certificate of Incorporation, as amended, to
increase the total number of authorized shares of capital stock available for
issuance from 255,000,000, consisting of 250,000,000 shares of Common Stock and
5,000,000 shares of Preferred Stock, to 6,005,000,000, consisting of
6,000,000,000 shares of Common Stock and 5,000,000 shares of Preferred
Stock.
In
accordance with the terms of the notes, we elected to pay interest due on the
notes on December 9, 2008 in shares of our common stock to all noteholders where
the issuance of the shares would not cause the noteholder to beneficially own
more than 4.999% of our outstanding common stock. Accordingly, on December 9,
2008, we issued 80,000 shares and $0.1 million to satisfy our interest
payment.
Through
December 31, 2008, our noteholders have voluntarily converted approximately $4.5
million of our convertible notes, resulting in us issuing 8.9 million shares of
common stock. From January 1, 2009 through February 4, 2009, holders
of convertible notes have voluntarily converted approximately $4.6 million of
their notes, resulting in an issuance of 9.2 million shares of common
stock.
Upon the
occurrence of an event of default, holders of the notes have the right to
require us to prepay all, or a portion, of their notes as calculated as the
greater of (a) 150% of the aggregate principal amount of the note plus accrued
interest or (b) the aggregate principal amount of the note plus accrued interest
divided by the conversion price; multiplied by a weighted average price of our
common stock. Pursuant to a general security agreement, entered into
concurrently with the notes, the notes are secured by a first lien on all of our
assets.
In
February 2008, the Company sold 0.1 million shares of the Company’s common stock
at a price of $25.00 per share, raising approximately $3.1 million, before
estimated fees and expenses.
Effective
May 7, 2008, we moved the trading of our common stock from The NASDAQ Capital
Markets to the Over-the-Counter Bulletin Board (OTCBB) maintained by FINRA
(formerly, the NASD). This action was taken pursuant to receipt of notification
from the NASDAQ Listing Qualifications Panel that we had failed to demonstrate
our ability to sustain compliance with the $2.5 million minimum stockholders’
equity requirement for continued listing on The NASDAQ Capital Markets. On July
10, 2008, we received notification from The NASDAQ Capital Market that The
NASDAQ Capital Market had determined to remove our common stock from listing on
such exchange. The delisting was effective at the opening of the
trading session on July 21, 2008.
In
March 2007, we sold 0.1 million shares of our common stock at a price of $108.00
per share, raising net proceeds of $10.2 million.
During
2007, the Company issued notes payable to finance premiums for its corporate
insurance policies of $1.1 million at interest rates running from 5.2% to 5.9%.
Payments were scheduled for seven or ten equal monthly installments for the
notes initiated in 2007. The remaining balance on the notes payable was $0.5
million at December 31, 2007, which was then fully paid off during
2008.
Presently,
with no further financing, we project that we will run out of funds in August
2009. We currently do not have any additional financing in place. If we are
unable to raise additional financing, we could be required to reduce our
spending plans, reduce our workforce, license to others products or technologies
we would otherwise seek to commercialize ourselves and sell certain assets.
There can be no assurance that we can obtain financing, if at all, on terms
acceptable to us.
Irrespective
of whether an NDA or MAA for Genasense® are
approved, we will require additional cash in order to maximize this commercial
opportunity and continue its clinical development opportunities. We have had
discussions with other companies regarding partnerships for the further
development and global commercialization of Genasense®.
Additional alternatives available to us to sustain our operations include
financing arrangements with potential corporate partners, debt financing,
asset-based loans, royalty-based financing, equity financing and other sources.
However, there can be no assurance that any such collaborative agreements or
other sources of funding will be available on favorable terms, if at
all.
We
anticipate seeking additional product development opportunities through
potential acquisitions or investments. Such acquisitions or investments may
consume cash reserves or require additional cash or equity. Our working capital
and additional funding requirements will depend upon numerous factors,
including: (i) the progress of our research and development programs; (ii) the
timing and results of pre-clinical testing and clinical trials; (iii) the level
of resources that we devote to sales and marketing capabilities; (iv)
technological advances; (v) the activities of competitors; (vi) our ability to
establish and maintain collaborative arrangements with others to fund certain
research and development efforts, to conduct clinical trials, to obtain
regulatory approvals and, if such approvals are obtained, to manufacture and
market products and (vii) legal costs and the outcome of outstanding legal
proceedings.
Contractual
Obligations
Future
contractual obligations at December 31, 2008 are as follows ($
thousands):
|
|
Total
|
|
|
Less
than
1 year
|
|
|
1 - 3 years
|
|
|
3 - 5 years
|
|
|
More
than
5 years
|
|
Uncertain
tax positions*
|
|
$ |
841 |
|
|
$ |
841 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
0 |
|
Operating
lease obligations
|
|
|
2,859 |
|
|
|
706 |
|
|
|
2,153 |
|
|
|
0 |
|
|
|
0 |
|
Maturity
of convertible notes
|
|
|
15,540 |
|
|
|
0 |
|
|
|
15,540 |
|
|
|
0 |
|
|
|
0 |
|
License
obligations to Daiichi Sankyo
|
|
|
2,125 |
|
|
|
2,125 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
Total
|
|
$ |
21,365 |
|
|
$ |
3,672 |
|
|
$ |
17,693 |
|
|
$ |
0 |
|
|
$ |
0 |
|
* see
Note 13 to the Consolidated Financial Statements
Virtually
all of the operating lease obligations result from our lease of approximately
25,000 square feet of office space in Berkeley Heights, New Jersey. Our lease on
this space terminates in 2010. In May 2008, we entered into an amendment of our
lease agreement with The Connell Company, (Connell) whereby the lease for one
floor of our office space was terminated. We agreed to pay Connell a payment of
$2.0 million upon the earlier of July 1, 2009 or our receipt of at least $5.0
million in upfront cash from a business development deal. In February 2009, we
entered into another amendment of our agreement with Connell whereby our future
payment of $2.0 million is now payable on January 1, 2011. We will pay 6.0%
interest in arrears to Connell from July 1, 2009 through the new payment date.
The initial interest payment of approximately $30,000 will be payable as of
October 1, 2009.
On
June 9, 2008, we issued senior convertible promissory notes maturing on June 9,
2010, (see Note 12 to the Consolidated Financial Statements). Holders of the
notes have the right, but not the obligation, to convert their notes, or a
portion of their notes, in to shares of Genta common stock at a present
conversion rate of 10,000 shares of common stock for every $1,000 of principal.
The amount in the table above, $15.5 million, is the face value of convertible
notes outstanding at December 31, 2008. This amount would be due on June 9, 2010
assuming no voluntary conversions by noteholders prior to the maturity
date. As of February 4, 2009, the amount is $10.9
million.
On March
7, 2008, we entered into a license agreement with Daiichi Sankyo Company,
Limited, a Japanese corporation based in Tokyo, Japan, whereby we obtained the
exclusive license for tesetaxel. Pursuant to the agreement, as of December 31,
2008, we owe Daiichi Sankyo two installments of $562,000 and an earned milestone
payment of $1.0 million. The agreement also provides for additional payments by
us upon achievement of certain clinical and regulatory milestones and royalties
on net product sales. The agreement provides provisions whereby failure to make
timely payments to Daiichi Sankyo may provide grounds for termination of the
agreement.
Not
included in the above table are any Genasense® bulk
drug purchase obligations to Avecia per the terms of the Manufacturing and
Supply Agreement entered into between Avecia and Genta in May 2008. The
agreement calls for Genta to purchase a percentage of its global Genasense® bulk
drug requirements from Avecia during the term of the agreement. Due to the
uncertainties regarding the timing of any Genasense® approval
and sales/volume projections, specific obligation amounts cannot be estimated at
this time. Due to past purchases of Genasense® bulk
drug substance, the Company has access to sufficient drug for its current needs.
In addition, not included in the above table are potential milestone payments to
be made to Emisphere and other suppliers of services, since such payments are
contingent on the occurrence of certain events.
CHANGE
IN INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
On
July 16, 2008, following an extensive review and request-for-proposal process,
our Audit Committee determined not to renew our engagement of Deloitte &
Touche LLP as our independent registered public accounting firm and dismissed
them as our auditors. On July 16, 2008, the Audit Committee recommended and
approved the appointment of Amper Politziner & Mattia, LLP as our
auditors for the fiscal year ending December 31, 2008, commencing immediately on
such date.
No
accountant’s report issued by Deloitte & Touche LLP on the financial
statements for either of the two (2) fiscal years ended December 31, 2007 and
December 31, 2006 contained an adverse opinion or a disclaimer of opinion, or
was qualified or modified as to uncertainty, audit scope or accounting
principles, except that Deloitte & Touche LLP’s report on our consolidated
financial statements as of and for the year ended December 31, 2007 contained an
explanatory paragraph expressing substantial doubt as to our ability to continue
as a going concern as a result of recurring losses and negative cash flows from
operations.
During
each of the fiscal years ended December 31, 2007 and December 31, 2006 and the
subsequent interim period from January 1, 2008 through our notice to Deloitte
& Touche LLP of its non-renewal on July 16, 2008: (i) there were no
disagreements with Deloitte & Touche LLP on any matter of accounting
principles or practices, financial statement disclosure, or auditing scope of
procedure, which disagreement, if not resolved to the satisfaction of Deloitte
& Touche LLP, would have caused it to make reference to the subject matter
of the disagreement in connection with its reports; and (ii) there were no
“reportable events” (as defined in Item 304(a)(1)(v) of Regulation S-K). In
addition, Deloitte & Touche LLP’s reports on our financial statements for
the past two years did not contain an adverse opinion or a disclaimer of
opinion, nor were such reports qualified or modified as to uncertainty, audit
scope or accounting principles. Deloitte & Touche LLP’s reports on our
financial statements did include an explanatory paragraph relating to our
ability to continue as a going concern and our adoption of Statement of
Financial Accounting Standards No. 123 (Revised 2004), Share-Based Payment,
effective January 1, 2006, and Financial Accounting Standards Board
Interpretation No. 48, Accounting for Uncertainty in Income Taxes — an
Interpretation of FASB Statement no. 109, effective January 1,
2007.
During
our fiscal years ended December 31, 2006 and December 31, 2007 and the
subsequent interim period from January 1, 2008 through the engagement of Amper
Politziner & Mattia, LLP on July 16, 2008, we did not consult with Amper
Politziner & Mattia, LLP regarding the application of accounting principles
to a specified transaction, either completed or proposed; the type of audit
opinion that might be rendered on our consolidated financial statements, or any
matter that was either the subject of disagreement, as that term is defined in
Item 304(a)(1)(iv) of Regulation S-K; or a reportable event, as that term is
defined in Item 304(a)(1)(v) of Regulation
S-K.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our
carrying values of cash, marketable securities, accounts payable, accrued
expenses and debt are a reasonable approximation of their fair value. If our
stock price were to increase, the Black Scholes model will calculate a higher
estimate of the fair value of our convertible notes and warrant. If our stock
price were to decrease, the Black Sholes model will calculate lower values. The
estimated fair values of financial instruments have been determined by us using
available market information and appropriate valuation methodologies (See Note 1
to our Consolidated Financial Statements for the Year Ended December 31, 2008,
2007 and 2006). We have not entered into and do not expect to enter into,
financial instruments for trading or hedging purposes. We do not currently
anticipate entering into interest rate swaps and/or similar
instruments.
Our
primary market risk exposure with regard to financial instruments is to changes
in interest rates, which would impact interest income earned on such
instruments. We have no material currency exchange or interest rate risk
exposure as of December 31, 2008. Therefore, there will be no ongoing exposure
to a potential material adverse effect on our business, financial condition or
results of operation for sensitivity to changes in interest rates or to changes
in currency exchange rates.
MANAGEMENT
Our
Directors and executive officers, their age, positions, the dates of their
initial election or appointment as Directors or executive officers, and the
expiration of the terms are as follows:
Name
|
|
Age
|
|
Position With The
Company
|
Raymond
P. Warrell, Jr., M.D.
|
|
59
|
|
Chairman
and Chief Executive Officer
|
Gary
Siegel
|
|
51
|
|
Vice
President, Finance
|
Loretta
M. Itri, M.D., F.A.C.P.
|
|
59
|
|
President
Pharmaceutical Development and Chief Medical
Officer
|
W.
Lloyd Sanders
|
|
48
|
|
Sr.
Vice President and Chief Operating Officer
|
Martin
J. Driscoll
|
|
50
|
|
Director
|
Christopher
P. Parios
|
|
68
|
|
Director
|
Daniel
D. Von Hoff, M.D.
|
|
61
|
|
Director
|
Douglass
G. Watson
|
|
64
|
|
Director
|
All
directors hold office until the annual meeting next following their election
and/or until their successors are elected and qualified. Officers are elected
annually by the Board of Directors (the “Board”) and serve at the discretion of
the Board. Information with respect to the business expenses and affiliation of
our directors and executive officers is set forth below:
Raymond P.
Warrell, Jr., M.D., 59, has been our Chief Executive Officer and a member
of our Board since December 1999 and our Chairman since January 2001. From
December 1999 to May 2003, he was also our President. From 1978 to 1999, Dr.
Warrell was associated with the Memorial Sloan-Kettering Cancer Center in New
York, where he held tenured positions as Member, Attending Physician, and
Associate Physician-in-Chief, and with the Joan and Sanford Weill Medical
College of Cornell University, where he was Professor of Medicine. Dr. Warrell
also has more than 20 years of development and consulting experience in
pharmaceuticals and biotechnology products. He was a co-founder and chairman of
the scientific advisory board of PolaRx Biopharmaceuticals, Inc., which
developed Trisenox®, a drug for the treatment of acute promyelocytic leukemia,
which is now marketed by Cephalon, Inc. Dr. Warrell holds or has filed numerous
patents and patent applications for biomedical therapeutic or diagnostic agents.
He has published more than 100 peer-reviewed papers and more than 240 book
chapters and abstracts, most of which are focused upon drug development in
tumor-related diseases. Dr. Warrell is a member of the American Society of
Clinical Investigation, the American Society of Hematology, the American
Association for Cancer Research and the American Society of Clinical Oncology.
Among many awards, he has received the U.S. Public Health Service Award for
Exceptional Achievement in Orphan Drug Development from the FDA. He obtained a
B.S. in Chemistry from Emory University, a M.D. from the Medical College of
Georgia, and a M.B.A. from Columbia University Graduate School of Business. Dr.
Warrell is married to Dr. Loretta M. Itri, President, Pharmaceutical Development
and Chief Medical Officer of Genta.
Gary
Siegel, 51, joined Genta in May 2003 as Director, Financial Services, was
appointed Senior Director, Financial Services in April 2004 and was appointed
Vice President, Finance in September 2007. During his tenure at Genta, Mr.
Siegel has been accountable for the day-to-day accounting and financial
operations of the Company including public and management reporting, treasury
operations, planning, financial controls and compliance. Mr. Siegel became an
executive officer of the Company and assumed the role of interim Principal
Accounting Officer, interim Principal Financial Officer and interim Corporate
Secretary, effective February 29, 2008. Prior to joining Genta, he worked for
two years at Geller & Company, a private consulting firm, where he led the
management reporting for a multi-billion dollar client. His twenty-two years of
experience in the pharmaceutical industry include leadership roles at
Warner-Lambert Company and Pfizer Inc., where he held positions of progressively
increasing levels of responsibility including Director, Corporate Finance and
Director, Financial Planning & Reporting.
Loretta M. Itri,
M.D., F.A.C.P., 59, has been our President, Pharmaceutical Development
and Chief Medical Officer since May 2003, prior to which she was Executive Vice
President, Pharmaceutical Research and Development and Chief Medical Officer.
Dr. Itri joined Genta in March 2001. Previously, Dr. Itri was Senior Vice
President, Worldwide Clinical Affairs, and Chief Medical Officer at Ortho
Biotech Inc., a Johnson & Johnson company. As the senior clinical leader at
Ortho Biotech and previously at J&J’s R.W. Johnson Pharmaceutical Research
Institute (PRI), she led the clinical teams responsible for NDA approvals for
Procrit® (epoetin alpha), that company’s largest single product. She had similar
leadership responsibilities for the approvals of Leustatin®, Renova®, Topamax®,
Levaquin®, and Ultram®. Prior to joining J&J, Dr. Itri was associated with
Hoffmann-La Roche, most recently as Assistant Vice President and Senior Director
of Clinical Investigations, where she was responsible for all phases of clinical
development programs in immunology, infectious diseases, antivirals, AIDS,
hematology and oncology. Under her leadership in the areas of recombinant
proteins, cytotoxic drugs and differentiation agents, the first successful
Product License Application (PLA) for any interferon product (Roferon-A®;
interferon alfa) was compiled. Dr. Itri is married to Dr. Warrell, our Chief
Executive Officer and Chairman.
W. Lloyd
Sanders, 48, assumed the position of Senior Vice President and Chief
Operating Officer in March 2008. He had been our Senior Vice President,
Commercial Operations since October 2006. Mr. Sanders joined Genta in January
2006 as Vice President, Sales and Marketing. He has twenty years of experience
in the pharmaceutical industry. Prior to joining Genta, Mr. Sanders was
associated with Sanofi-Synthelabo, and subsequently Sanofi-Aventis. From October
2004 through January 2006 he was Vice-President, Oncology Sales for the combined
companies. In that role, he had key product sales responsibility for Eloxatin®
(oxaliplatin), Taxotere® (docetaxel), Anzemet® (dolasetron mesylate), and
ELITEK® (rasburicase). He led the successful restructuring, integration,
deployment, strategic development, and tactical execution of the merged
companies’ sales forces. He was responsible for national account GPO contracting
strategy and negotiations, and he shared responsibility for oncology sales
training and sales operations. From October 2002 through October 2004, Mr.
Sanders was Area Vice President, Oncology Sales. He led the 110-member team that
achieved record sales for an oncology product launch with Eloxatin®. From 1987
until 2002, he held positions of progressively increasing levels of
responsibility at Pharmacia, Inc. (now Pfizer), most recently as Oncology Sales
Director, West/East. Mr. Sanders holds a Bachelor of Business Administration
from Memphis State University.
Martin J.
Driscoll, 50, has been a member of our Board since September 2005. Mr.
Driscoll brings more than twenty-seven years of executive experience in
pharmaceutical Marketing & Sales, Business Development and Commercial
Operations to the Genta Board. In March 2008, Mr. Driscoll became Chief
Executive Officer of Javelin Pharmaceuticals, Inc. (AMEX:JAV) of Cambridge,
Massachusetts where he had also served as a director since 2006. Javelin is a
specialty pharmaceutical company that applies innovative proprietary
technologies to develop new drugs and improved formulations of existing drugs
that target current and underserved medical need in the pain management market.
Mr. Driscoll joined Javelin from Pear Tree Pharmaceuticals, Inc., a
development-stage company focused on women’s prescription healthcare products.
Mr. Driscoll was CEO of Pear Tree Pharmaceuticals from September 2007 until
March 2008. From August 2005 until September 2007, Mr. Driscoll was President of
MKD Consulting Inc., a pharmaceutical management and commercialization
consulting firm, and a Partner at TgaS Consulting, a pharmaceutical commercial
operations benchmarking firm. From July 2003 until August 2005, Mr. Driscoll was
Senior Vice President of Marketing and Sales at Reliant Pharmaceuticals, a
privately held company that markets a portfolio of branded pharmaceutical
products, where he was a member of the Management Committee and an Executive
Officer of the Company. From 1983 to 1990, Mr. Driscoll held positions of
increasing responsibility at Schering Plough Corporation, including most
recently as Vice President of Marketing and Sales for Schering’s Primary Care
Division. He previously served as Vice President, Marketing and Sales, for the
Schering Diabetes Unit, and also for Key Pharmaceuticals, the largest Schering
U.S. Business Unit. His experience includes management of franchises that
encompass oncologic, cardiovascular, anti-infective, metabolic, CNS, pulmonary
and dermatologic products. At both Reliant and Schering, Mr. Driscoll had
extensive experience in the negotiation, implementation and management of
collaborations with other companies. Prior to joining Reliant, from 2000 to 2002
Mr. Driscoll was Vice President, Commercial Operations and Business Development
at ViroPharma Inc., where he built the first commercial Sales and Marketing
operation, and was the ViroPharma Chair for the ViroPharma/Aventis Joint
Steering Committee for their Phase 3 antiviral product
collaboration.
Christopher P.
Parios, 68, has been a member of our Board since September 2005. Mr.
Parios has more than thirty-seven years of pharmaceutical industry experience,
including product development, marketing and promotion, strategy and tactic
development, and managing pharmaco-economic and reimbursement issues. He has
worked with many of the major companies in the pharmaceutical industry including
Hoffmann-LaRoche, Ortho-McNeil, Pfizer, Novartis, Schering Plough, Janssen,
Ortho Biotech, and Bristol-Myers Squibb. For the period 1997 to May of 2008, Mr.
Parios was Executive Director of The Dominion Group, an independent healthcare
consulting firm that specializes in market research, strategic planning, and
competitive intelligence monitoring. In this role, he was responsible for the
full range of market research, consulting, and business planning activities to
facilitate informed business decisions for clients regarding product
development, acquisitions, product positioning, and promotion. Mr. Parios
continues to consult with the Dominion Group on a part-time basis. Previously,
Mr. Parios was President and Chief Operating Officer of the Ferguson
Communication Group, as well as Vice Chairman of the parent company,
CommonHealth USA, a leading full-service communications resource for the
healthcare industry. Mr. Parios was a partner in Pracon, Inc., a health-care
marketing consulting firm from 1982 to 1991, and helped engineer the sale of
that firm to Reed-Elsevier in 1989. Over a twenty-year period, Mr. Parios held
progressively senior positions at Hoffmann-LaRoche, Inc., most recently as
Director of New Product Planning and Regulatory Affairs Management. This group
established the project management system for drug development at Roche and
coordinated developmental activities for such products as Versed®, Rocephin®,
Roferon®, Accutane®, Rimadyl®, and Tegison®. Mr. Parios was also a member of the
corporate team responsible for domestic and international product and technology
licensing activities.
Daniel D. Von
Hoff, M.D., F.A.C.P., 61, has been a member of our Board since January
2000. Since November 2002, he has been Physician in Chief and Director of
Translational Research at Translational Genomics Research Institute’s (Tgen) in
Phoenix, Arizona. He is also Chief Scientific Officer for US Oncology since
January 2003 and he is also the Chief Scientific Officer, Scottsdale Clinical
Research Institute since November 2005. Dr. Von Hoff’s major interest is in the
development of new anticancer agents, both in the clinic and in the laboratory.
He and his colleagues were involved in the beginning of the development of many
of the agents now used routinely, including: mitoxantrone, fludarabine,
paclitaxel, docetaxel, gemcitabine, CPT-11, and others. At present, he and his
colleagues are concentrating on the development of molecularly targeted
therapies. Dr. Von Hoff’s laboratory interests and contributions have been in
the area of in vitro drug sensitivity testing to individualize treatment for the
patient. He and his laboratory are now concentrating on discovery of new targets
in pancreatic cancer. Dr. Von Hoff has published more than 531 papers, 129 book
chapters, and more than 891 abstracts. Dr. Von Hoff was appointed to President
Bush’s National Cancer Advisory Board for June 2004 — March 2010. Dr. Von Hoff
is the past President of the American Association for Cancer Research, a Fellow
of the American College of Physicians, and a member and past board member of the
American Society of Clinical Oncology. He is a founder of ILEX™ Oncology, Inc.
(acquired by Genzyme). He is founder and the Editor Emeritus of Investigational New
Drugs — The
Journal of New Anticancer Agents; and, Editor-in-Chief of Molecular Cancer
Therapeutics.
Douglas G.
Watson, 64, has been a member of our Board since April 2002 and was
appointed Vice Chairman of our Board and Lead Director in March 2005. From 1999
through the present, Mr. Watson is the founder and has served as Chief Executive
Officer of Pittencrieff Glen Associates, a leadership and management-consulting
firm. Prior to taking early retirement in 1999, Mr. Watson spent 33 years with
Geigy/Ciba-Geigy/Novartis, during which time he held a variety of positions in
the United Kingdom, Switzerland and the United States. From 1986 to 1996, he was
President of Ciba U.S. Pharmaceuticals Division, and in 1996 he was appointed
President & Chief Executive Officer of Ciba-Geigy Corporation. During this
ten-year period, Mr. Watson was an active member of the Pharmaceutical Research
& Manufacturers Association board in Washington, DC. Mr. Watson became
President & Chief Executive Officer of Novartis Corporation in 1997 when the
merger of Ciba-Geigy & Sandoz was approved by the Federal Trade Commission.
Mr. Watson is currently Chairman of the Board of OraSure Technologies Inc., and
Chairman of the Board of Javelin Pharmaceuticals Inc. He also serves on the
boards of Dendreon Corporation and BioMimetic Therapeutics Inc.
EXECUTIVE
COMPENSATION
Compensation
Discussion and Analysis
Overview
of Compensation Program
The
Compensation Committee, also referred to herein as the Committee, of the Board
of Directors has responsibility for overseeing our compensation and benefit
policies, evaluating senior executive performance, and determining compensation
for our senior executives, including our executive officers. The Committee
ensures that the total compensation paid to executive officers is fair,
reasonable and competitive.
The
individuals who serve as our Chairman of the Board and Chief Executive Officer
(CEO), and the Chief Financial Officer (CFO), as well as the other individuals
included in the Summary Compensation Table below, are referred to as the
“executive officers”.
Compensation
Philosophy and Objectives
Our
compensation philosophy is based on our belief that our compensation programs
should: be aligned with stockholder’s interests and business objectives; reward
performance; and be externally competitive and internally equitable. We seek to
achieve three objectives, which serve as guidelines in making compensation
decisions:
|
•
|
Providing
a total compensation package which is competitive and therefore, enables
us to attract and retain, high-caliber executive
personnel;
|
|
•
|
Integrating
compensation programs with our short-term and long-term strategic plan and
business objectives; and
|
|
•
|
Encouraging
achievement of business objectives and enhancement of stockholder value by
providing executive management long-term incentive through equity
ownership.
|
Role
of Executive Officers in the Compensation Decisions
The
Committee makes all compensation decisions regarding the compensation of our
executive officers. The CEO reviews the performance of our executive officers
and except for the President, Pharmaceutical Development & Chief Medical
Officer (President), who is the spouse of the CEO, the CEO makes recommendations
to the Committee based on these reviews, including salary adjustments, variable
cash awards and equity awards. The Committee can exercise its discretion in
modifying any recommended adjustments or awards to executives. With respect to
the President, the Committee in its sole discretion determines the amount of any
adjustments or awards.
Establishing
Executive Compensation
Compensation
levels for our executive officers are determined through comparisons with other
companies in the biotechnology and pharmaceutical industries, including
companies with which we compete for personnel. To determine external
competitiveness practices relevant to the executive officers, we review data
from two industry surveys of executive compensation: Radford Biotechnology
Compensation Survey and Organization Resources Counselors (collectively,
External Market Data). In addition, in 2007 the Committee retained Towers
Perrin, a leading compensation consultant with expertise in biopharmaceutical
industry compensation practices, to assist in its analysis of executive
compensation. Towers Perrin provided a third-party perspective based on their
extensive knowledge of the industry and they advised the Committee of
developments in the design of compensation programs and provided benchmarks
against which we compare our total compensation packages. Towers Perrin
conducted a peer group analysis in order to weigh the competitiveness of the
Company’s overall compensation arrangements in relation to comparable
biopharmaceutical companies. The peer companies were: Allos Therapeutics, Ariad
Pharmaceuticals, Avalon Pharmaceuticals, Cell Genesys, Cell Therapeutics,
Favrille, Hana Biosciences, Introgen Therapeutics, NeoPharm, Pharmacyclics,
Poniard Pharmaceuticals, Spectrum Pharmaceuticals, Telik and Vion
Pharmaceuticals. These companies were selected for the peer group because, like
Genta, they were oncology focused, public pharmaceutical companies with products
in mid to late-stage development.
In
2008, the Committee retained Aon Radford Consulting (a nationally recognized
compensation consulting firm with specific expertise in dealing with the equity
issues of biopharmaceutical companies) to conduct a review of market trends
related to equity compensation in consideration of the fact that the Company’s
1998 Plan would be expiring in May 2008. The peer group companies
used for that analysis were: Access Pharmaceuticals, Inc., AMDL, Inc., Celsion
Corp., Idera Pharmaceuticals, Inc., Infinity Pharmaceuticals, Inc., Opexa
Therapeutics, Inc., Oscient Pharmaceuticals Corp., Poniard Pharmaceuticals,
Inc., SEQUENOM, Inc. and Targeted Genetics Corp. These companies were selected
because, like Genta, they were oncology focused, public pharmaceutical companies
with products in mid to late-stage development.
It is the
Committee’s objective to target total annual compensation of each executive
officer at a level between the 50th and 75th percentiles for comparable
positions. However, in determining the compensation for each executive officer,
the Committee also considers a number of other factors including: an evaluation
of the responsibilities required for each respective position, individual
experience levels and individual performance and contributions toward
achievement of our business objectives. There is no pre-established policy or
target for the allocation between either cash and non-cash or short-term and
long-term incentive compensation. Instead, the Committee determines the mix of
compensation for each executive officer based on its review of the competitive
data and its analysis of that individual’s performance and contribution to our
performance. In addition, in light of our stage of development, considerable
emphasis is placed on equity-based compensation in an effort to preserve cash to
finance our research and development efforts.
Other Factors
Considered in Establishing 2008 Compensation for Executive Officers
Our
potential products are in various stages of research and development and limited
revenues have as yet been generated from product sales. As a result, the use of
traditional performance standards, such as corporate profitability, is not
believed to be appropriate in the evaluation of the performance of us or our
individual executives. The compensation of our executive officers is based, in
substantial part, on industry compensation practices, trends noted (in the
External Market Data, peer group analysis and by Towers Perrin), as well as the
extent to which business and the individual executive officers’ objectives are
achieved. Such objectives are established and modified as necessary to reflect
changes in market conditions and other factors. Individual performance is
measured by reviewing whether these objectives have been achieved.
Among
the significant business objectives achieved during 2008 were the following: 75%
enrollment of the Phase 3 AGENDA trial of Genasense® in patients with advanced
melanoma; the licensing of the drug, tesetaxel from Daiichi Sankyo, obtaining
from the FDA a lifting of the clinical hold on tesetaxel, Orphan Drug
designation by the FDA for tesetaxel as treatment for advanced melanoma and
preparations for the resumption of clinical trials for tesetaxel; the sale of
122,000 shares of our common stock, raising net proceeds of $2.9 million and the
sales of $20 million of senior convertible notes, raising net proceeds of $18.7
million. These milestones enabled continued progress towards the
commercialization and development of Genasense® and tesetaxel, and were
considered carefully in evaluating executive performance and making
determinations regarding executive compensation. However, three significant
factors warranted very substantial weight in evaluating our business performance
and in making executive compensation decisions. These factors were: 1) our
receipt of a complete response letter from the FDA regarding our amended New
Drug Application (NDA) for the use of Genasense® plus chemotherapy in patients
with chronic lymphocytic leukemia (CLL) determining that FDA cannot approve the
NDA in its present form and suggested the need for an additional clinical study;
2) our inability to close a licensing or partnership deal for Genasense®,
tesetaxel, Ganite® or G4544 before the close of the fiscal year ; and 3) our
inability to raise additional operating capital before the close of the fiscal
year.
The
Committee reviewed peer analysis data, the compensation history of each
executive officer including their annual salary, cash incentive bonus and stock
option awards. Due to our failure to meet critical business and financial
objectives (as described above), Dr. Warrell recommended that, for the second
year in a row, there not be any annual salary increases and that no incentive
bonuses be paid to any employee, including executive officers and the Committee
approved Dr. Warrell’s recommendation. No year-end stock option grants were made
at the end of 2008 because we do not have a stock incentive plan. Due to our
depressed stock price and the two-year freeze on annual salaries (Dr. Warrell’s
salary was decreased by 15% by the Committee effective January 1, 2008), the
equity-based long-term incentive compensation and total compensation level
(annual salary, incentive bonus and equity based compensation) for each of the
executive officers was below the median (50th percentile). The Committee also
considered Drs. Warrell and Itri’s voluntary deferral of the cash portion of
their salaries for the period from April 19, 2008 through August 17, 2008 in
order to conserve cash. The deferred amounts, totaling approximately $381,000
have been accrued as a liability and have not been paid.
Elements
of Executive Compensation
Our
compensation package for executive officers generally consists of annual cash
compensation, which includes both fixed (annual salary) and variable (cash
incentive bonus program) elements; long-term compensation in the form of stock
options and other perquisites. The main components are annual salary, cash
incentive bonus and stock options, all of which are common elements of executive
compensation pay in general and throughout the biotechnology and pharmaceutical
industry.
Annual
Salary
We pay an
annual salary to our employees and the executive officers as consideration for
fulfillment of certain roles and responsibilities. Changes in annual salaries
for executive officers, if any, are generally effective at the beginning of each
year. As noted above, there were no annual salary increases for 2009 or
2008.
Increases
to annual salary reflect a reward and recognition for successfully fulfilling
the position’s role and responsibilities, the incremental value of the
experience, knowledge, expertise and skills the individual acquires and develops
during employment with us and adjustments as appropriate based on external
competitiveness and internal equity. In consideration of our cash resources,
there were no salary increases for 2009 or 2008 and Dr. Warrell’s base salary
was decreased by the Committee by 15% effective January 1, 2008. In order to
further conserve our cash resources, Drs. Warrell and Itri deferred the cash
portions of their salaries from April 19, 2008 through August 17, 2008, and
again agreed to defer a portion of their salaries effective January 5,
2009.
Cash
Incentive Bonus Program
The
target cash incentive bonus program award for the CEO (forty percent of annual
salary) and the President (thirty percent of annual salary) is based on the
terms of their employment agreements. The Committee determines the annual target
for the other executive officers each year based on external competitiveness and
internal equity. Based on the External Market Data, the target amounts for
executive officers who were Senior Vice Presidents and Vice Presidents were
established at thirty percent and twenty-five percent of annual salary,
respectively. As noted above, there were no cash bonuses paid to any of the
executive officers for 2008.
Typically,
we award cash incentive bonuses to employees, including the executive officers,
as a reward and recognition for contributing to our achievement of specific
annual business objectives established by the Committee at the beginning of the
year. All employees are eligible for a form of cash incentive bonus, although
payment of a cash incentive bonus is made at an individual level each year
contingent upon our overall performance. However, as described above, our
business performance was insufficient in 2008 to warrant the payment of cash
incentive bonuses to our employees, including executive
officers.
Equity-Based
Compensation
We
grant equity-based compensation to employees, including executive officers, to
attract, motivate, engage and retain highly qualified and highly sought-after
employees. We grant equity awards on a broad basis to encourage all employees to
work with a long-term view. Stock options are inherently performance-based
because they deliver value to the option holder only if the value of our stock
increases. Thus, stock options are a potential reward for long-term value
creation and serve as an incentive for employees who remain with us to
contribute to the overall long-term success of the business. We also award RSUs
because we believe RSUs are an appropriate vehicle due to our ongoing concerns
over the dilutive effect of option grants on our outstanding shares, our desire
to have a more direct correlation between the FAS 123(R) compensation expense we
must take for financial accounting purposes and the actual value delivered to
our executive officers and other employees and the fact that the incentive
effects of RSUs are less subject to market volatility than stock
options. Because equity compensation is a significant component of
our compensation package, the Committee adopted our 2009 Stock Incentive Plan
subject to stockholder approval, to replace the Company’s 1998 Stock Incentive
Plan and 1998 Non-Employee-Directors Stock Option Plan.
April
2008 Restricted Stock Unit Grants
On April
18, 2008, following careful analysis which included: 1) a review of market
trends, including consultation with Aon Radford Consulting (a nationally
recognized compensation consulting firm with specific expertise in dealing with
the equity issues of biopharmaceutical companies); 2) consideration of the fact
that the 1998 Plan would be expiring in May 2008; and 3) the determination that
the commitment and motivation of our workforce would be vital to ongoing efforts
to commercialize Genasense® and achieve other corporate objectives, management
recommended to the Committee that Restricted Stock Units, or RSUs, be issued to
certain executive officers and all employees under the 1998 Plan. The Committee
reviewed management’s recommendation and approved the April 2008 RSU
grants.
Two of
the five executive officers received grants under the program. Mr. Sanders and
Mr. Siegel received RSU grants of 1,300 and 800 shares, valued on their grant
dates at $26,650 and $16,400, respectively. Pursuant to there terms, the RSUs
vested 50% on January 15, 2009 and 50% on June 30, 2009. At December 31, 2008,
the value of the RSU grants to Messrs. Sanders and Siegel were $176 and $108,
respectively.
2007
Stock Incentive Plan and September 2007 Stock Option Grants
In
September, 2007, the Board approved a 2007 Stock Incentive Plan, or 2007 Plan,
conditioned upon the receipt of stockholder approval by September 17,
2008. However, due to the marked changes in the general economic
environment combined with the deterioration of the price of Genta common stock,
the Board elected not to submit the 2007 Plan to stockholders for approval and
on September 18, 2008, the 2007 Plan expired. As a consequence, Genta
currently has no forward-looking equity incentive plan at this
time.
Acquisition
Bonus Plan
In
order to retain our executive officers and other employees prior to stockholder
approval of the 2007 Plan, the Committee concurrently approved an Acquisition
Bonus Plan. Under the program, participants were eligible to
receive a portion of the proceeds realized from a change in control
that occurred prior to the earlier of (i) December 31, 2008 or (ii) the approval
by our stockholders of the 2007 Plan. On September 27, 2007, our executive
officers and employees were granted a number of units in the Acquisition Bonus
Plan that corresponded to the number of contingent stock options granted to them
under the 2007 Plan. As noted, however, the 2007 plan was never submitted for
stockholder approval, and as a consequence the Acquisition Bonus Plan expired
December 31, 2008.
Equity
Award Exchange Offer
On
July 9, 2009, our Board approved an Equity Award Exchange Offer Program to
non-employee Directors whereby each non-employee Director was given the
opportunity to exchange their outstanding stock options to purchase shares of
Genta common stock for new replacement restricted stock units ("New RSUs")
provided the 2009 Stock Incentive Plan is approved by our stockholders. Our
outstanding options have exercise prices that are significantly higher than the
current market price of our common stock. For this reason, the Board
believes that these options have little or no current value as an incentive to
retain and motivate non-employee Directors, and are unlikely to be exercised in
the foreseeable future. By making the offer to exchange outstanding options for
New RSUs, our Board intends to provide our non-employee Directors with the
benefit of receiving equity awards that over time may have a greater potential
to increase in value, and thereby create better incentives for our non-employee
Directors to remain with us and contribute to the attainment of our business and
financial objectives and the creation of value for all of our
stockholders.
Determining
The Timing And Exercise Price Of Equity-Based Compensation
There
is no established practice of timing equity grants in advance of the release of
favorable financial results or adjusting the award date in connection with the
release of unfavorable financial developments affecting our business. Stock
option grants to Section 16 officers are made only at duly convened meetings of
the Compensation Committee. Performance awards for existing executive officers
and employees are typically made in connection with the annual review process
which occurs in January each year. Options or RSUs relating to these performance
awards are then usually granted in the January meeting of the Committee. Equity
awards for newly hired executives are typically made at the next scheduled
Committee meeting following the executive’s hire date. It is our intent that all
stock option grants have an exercise price per share equal to the closing
selling price per share on the grant date.
Retirement
Benefits
All
employees are eligible to participate in the Genta Incorporated Savings &
Retirement Plan (Savings Plan), a tax-qualified retirement savings plan, which
allows contributions to the Savings Plan on a before-tax basis in an amount up
to the lesser of 50% of the employee’s annual salary or a limit prescribed by
the Internal Revenue Service. All contributions to the Savings Plan
are fully vested upon contribution. We provide retirement benefits to our
employees because we believe retirement benefits are an integral part of
employee benefit programs within the biotechnology and pharmaceutical
industry.
Perquisites
None
of our executive officers other than our Chief Executive Officer and President,
Pharmaceutical Development and Chief Medical Officer have perquisites in excess
of $10,000 in annual value. Our Chief Executive Officer and President,
Pharmaceutical Development and Chief Medical Officer have employment agreements
that provide for the perquisites discussed under the heading “Employment
Agreements”.
Severance
Benefits
We have
adopted a severance pay program for nearly all of our employees, including
executive officers, except for Drs. Itri and Warrell, who are eligible for
severance benefits under the terms of their employment agreements as described
below. The severance pay program is intended to preserve employee morale and
productivity and encourage retention in the face of the disruptive impact of an
actual or rumored workforce reduction or a change in control of our company. In
addition, for executives, the program is intended to align executive and
stockholder interests by enabling executives to consider corporate transactions
that are in the best interests of the stockholders and other of our constituents
without undue concern over whether the transactions may jeopardize the
executive’s own employment.
These
arrangements, like other elements of executive compensation, are structured with
regard to practices at comparable companies for similarly-situated officers and
in a manner we believe is likely to attract and retain high quality executive
talent.
Although
there are some differences in the benefit levels depending on the employee’s job
level, the basic elements are comparable for all employees, except for Drs. Itri
and Warrell as noted above, and for Messrs. Sanders and Siegel, as noted
below:
|
•
|
Double
trigger. Unlike “single trigger” plans that pay out immediately upon a
change in control, Genta’s severance pay program requires a “double
trigger” — a change in control followed by an involuntary loss of
employment within one year thereafter. This is consistent with the purpose
of the program, which is to provide employees with financial protection
upon loss of employment.
|
|
•
|
Covered
terminations. Employees may be eligible for payments, if there is either a
workforce reduction or if within one year of a change in control, their
employment is terminated without cause by the
Company.
|
|
•
|
Severance
payment. Subject to signing a release, eligible terminated employees may
receive severance.
|
|
•
|
Benefit
continuation. Subject to signing a release, basic health and dental
insurance may be continued following termination of
employment.
|
|
•
|
Accelerated
vesting of equity awards. Upon a change in control, any unvested equity
awards become vested.
|
Certain
Severance Arrangements
In the
event of their termination as a result of a reduction in force or change in
control, Mr. Sanders and Mr. Siegel are eligible for up to 24 weeks of severance
equal to $131,538 and $96,923, respectively, paid in portions on a bi-weekly
basis and not as a lump sum. Mr. Sanders and Mr. Siegel are also eligible to
continue their health/dental benefits at the Company’s expense for up to four
months, with an estimated value of $7,116 each. Drs. Itri’s and Warrell’s
eligibility for severance payments are described under the heading “Employment
Agreements”.
Deductibility
of Executive Compensation
Section 162(m) of the Internal Revenue
Code disallows a tax deduction to publicly held companies for compensation paid
to certain of their executive officers, to the extent that compensation exceeds
$1.0 million per covered officer in any year. The limitation applies only to
compensation that is not considered to be performance-based. The stock options
granted to our executive officers have been structured with the objective of
qualifying those awards as performance-based compensation. Non-performance-based
compensation paid to our executive officers for 2008 did not exceed the $1.0
million limit per covered officer. The RSUs awarded as a component of equity
compensation will not qualify as performance-based compensation. However, we
believe that in establishing the cash and equity incentive compensation programs
for our executive officers, the potential deductibility of the compensation
payable under those programs should be only one of a number of relevant factors
taken into consideration, and not the sole governing factor. For that reason, we
may deem it appropriate to provide one or more executive officers with the
opportunity to earn incentive compensation, whether through cash bonus programs
tied to our financial performance or through RSUs tied to the executive
officer’s continued service, which may, together with base salary, exceed in the
aggregate the amount deductible by reason of Section 162(m) or other provisions
of the Internal Revenue Code. We believe it is important to maintain cash and
equity incentive compensation at the levels needed to attract and retain the
executive officers essential to our success, even if all or part of that
compensation may not be deductible by reason of the Section 162(m)
limitation.
2009
Objectives and Executive Compensation Guidelines
Our
business objectives for 2009 include: completing enrollment of the phase 3
AGENDA trial of Genasense® in patients with advanced melanoma; public release of
information regarding final analysis of progression-free survival (PFS) from the
advanced melanoma trial; initiating and completing enrollment of the Phase I
trial of our oral taxane, tesetaxel; and ongoing financing and business
development activities that will further the development and commercialization
of our products. At present, the 2009 compensation guidelines will be generally
comparable to the 2008 guidelines with respect to the following: components of
compensation; anticipated salary adjustments; cash incentive bonus targets and
equity-based compensation. The Committee will make adjustments if necessary
based on their assessment of a variety of factors including: industry trends;
competitive market data; business objectives and corporate
performance.
Summary
Compensation Table
The
following table sets forth certain information regarding compensation earned by
or paid to our Chief Executive Officer, and other executive officers
(collectively, the ‘‘named executive officers’’) during the years ended December
31, 2008, 2007 and 2006, respectively.
Name
and
Principal
Position
|
|
Year
|
|
Salary
($)
|
|
|
Bonus
($)
|
|
|
Stock
Awards
($)(1)
|
|
|
Option
Awards
($)(1)
|
|
|
Non-Equity
Incentive
Plan
Compensation
($)(2)
|
|
|
Nonqualified
Deferred
Compensation
earnings ($)(3)
|
|
|
All
Other
Compensation
($)
|
|
|
Total
($)
|
|
Raymond
P. Warrell, Jr. M.D.
|
|
2008
|
|
|
409,662 |
|
|
|
— |
|
|
|
— |
|
|
|
446,667 |
|
|
|
— |
|
|
|
— |
|
|
|
31,060 |
(4) |
|
|
887,389 |
|
Chairman
and Chief Executive
|
|
2007
|
|
|
480,000 |
|
|
|
— |
|
|
|
— |
|
|
|
1,139,940 |
|
|
|
— |
|
|
|
— |
|
|
|
41,096 |
(4) |
|
|
1,661,036 |
|
Officer
|
|
2006
|
|
|
460,000 |
|
|
|
— |
|
|
|
— |
|
|
|
2,743,824 |
|
|
|
50,000 |
|
|
|
— |
|
|
|
40,462 |
(4) |
|
|
3,294,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Richard
J. Moran (5)
|
|
2008
|
|
|
61,538 |
|
|
|
— |
|
|
|
— |
|
|
|
28,400 |
|
|
|
— |
|
|
|
— |
|
|
|
3,077 |
(6) |
|
|
93,015 |
|
Senior
Vice President,
|
|
2007
|
|
|
320,000 |
|
|
|
— |
|
|
|
10,463 |
|
|
|
29,100 |
|
|
|
— |
|
|
|
— |
|
|
|
17,261 |
(6) |
|
|
376,824 |
|
Chief
Financial Officer and Corporate Secretary
|
|
2006
|
|
|
304,500 |
|
|
|
— |
|
|
|
— |
|
|
|
35,900 |
|
|
|
100,000 |
|
|
|
— |
|
|
|
11,000 |
(6) |
|
|
451,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gary
Siegel
|
|
2008
|
|
|
210,000 |
|
|
|
— |
|
|
|
12,551 |
|
|
|
17,278 |
|
|
|
— |
|
|
|
— |
|
|
|
11,518 |
(7) |
|
|
251,347 |
|
Vice
President, Finance
|
|
2007
|
|
|
196,846 |
|
|
|
— |
|
|
|
— |
|
|
|
32,007 |
|
|
|
— |
|
|
|
— |
|
|
|
11,250 |
(7) |
|
|
240,103 |
|
|
|
2006
|
|
|
183,750 |
|
|
|
— |
|
|
|
— |
|
|
|
46,778 |
|
|
|
66,500 |
|
|
|
— |
|
|
|
11,000 |
(7) |
|
|
308,028 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loretta
M. Itri, M.D.
|
|
2008
|
|
|
467,500 |
|
|
|
— |
|
|
|
— |
|
|
|
78,221 |
|
|
|
— |
|
|
|
— |
|
|
|
20,061 |
(8) |
|
|
565,782 |
|
President,
Pharmaceutical
|
|
2007
|
|
|
467,500 |
|
|
|
— |
|
|
|
— |
|
|
|
459,201 |
|
|
|
— |
|
|
|
— |
|
|
|
21,836 |
(8) |
|
|
948,537 |
|
Development
and
Chief
Medical Officer
|
|
2006
|
|
|
445,200 |
|
|
|
— |
|
|
|
— |
|
|
|
979,852 |
|
|
|
— |
|
|
|
— |
|
|
|
19,848 |
(8) |
|
|
1,444,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
W.
Lloyd Sanders
|
|
2008
|
|
|
285,000 |
|
|
|
— |
|
|
|
20,396 |
|
|
|
39,100 |
|
|
|
— |
|
|
|
— |
|
|
|
5,642 |
(9) |
|
|
350,138 |
|
Senior
Vice President and
|
|
2007
|
|
|
285,000 |
|
|
|
— |
|
|
|
— |
|
|
|
39,100 |
|
|
|
— |
|
|
|
— |
|
|
|
40,405 |
(9) |
|
|
364,505 |
|
Chief
Operating Officer
|
|
2006
|
|
|
245,000 |
|
|
|
— |
|
|
|
— |
|
|
|
36,250 |
|
|
|
78,000 |
|
|
|
— |
|
|
|
33,579 |
(9) |
|
|
392,829 |
|
(1)
|
The
amounts reflect the dollar amount recognized for financial statement
reporting purposes for the years ended December 31, 2008, 2007 and 2006,
respectively, in accordance with FAS 123(R). These figures include amounts
from awards granted in 2003, 2004, 2005, 2006 and 2007. Assumptions used
in the calculations of these amounts for the years ended December 31,
2006, 2007 and 2008, respectively, are in Note 14 of the Company’s Annual
Report on Form 10-K for the year ended December 31,
2008.
|
(2)
|
As
described above, no payments were made for 2007 or 2008 performance under
our cash incentive bonus program.
|
|
|
(3)
|
Drs.
Warrell and Itri deferred a portion of their salaries from April 19, 2008
through August 17, 2008.
|
|
|
(4)
|
All
other compensation for 2008 includes $6,000 for auto allowance, $4,068 for
long-term disability (including $1,139 for income tax gross-up), $9,492
for life insurance (including $2,657 for income tax gross-up) and $11,500
Company match to the 401(k) Plan. All other compensation for 2007 includes
$6,000 for auto allowance, $13,419 for long-term disability (including
$4,641 for income tax gross-up), $10,427 for life insurance, (including
$3,592 for income tax gross-up) and $11,250 Company match to the 401(k)
Plan. All other compensation for 2006 includes $6,000 for auto allowance,
$13,003 for long-term disability (including 4,506 for income tax
gross-up), $10,459 for life insurance (including $3,624 for income tax
gross-up) and $11,000 Company match to the 401(k) Plan.
|
|
|
(5)
|
Mr.
Moran retired from Genta effective February 29,
2008
|
|
|
(6)
|
All
other compensation for 2008 includes $3,077 Company match to the 401(k)
Plan. All other compensation for 2007 includes $6,011 for life insurance
(including $2,011 for income tax gross-up) and $11,250 Company match to
the 401(k) Plan. All other compensation for 2006 includes $11,000 Company
match to 401(k) Plan.
|
|
|
(7)
|
All
other compensation for 2008 includes $1,018 for life insurance, (including
$313 for income tax gross-up) and $10,500 Company match to the 401(k)
Plan. All other compensation for 2007 includes $11,250 Company match to
the 401(k) Plan. All other compensation for 2006 includes $11,000 Company
match to the 401(k) Plan.
|
|
|
(8)
|
All
other compensation for 2008 includes $6,605 for long-term disability
(including $1,998 for income tax gross-up), $1,956 for life insurance
(including $703 for income tax gross-up) and $11,500 Company match to the
401(k) Plan. All other compensation for 2007 includes $6,770 for long-term
disability (including $2,161 for income tax gross-up), $3,816 for life
insurance (including $1,315 for income tax gross-up) and $11,250 Company
match to the 401(k) Plan. All other compensation for 2006 includes $7,028
for long-term disability, (including $2,421 for income tax gross-up),
$1,820 for life insurance, (including $627 for income tax gross-up) and
$11,000 Company match to the 401(k) Plan.
|
|
|
(9)
|
All
other compensation for 2008 includes $4,326 for long-term disability
(including $1,064 for income tax gross-up) and $1,316 Company match to the
401(k) Plan. All other compensation for 2007 includes $4,497 for long-term
disability (including $1,235 for income tax gross-up), $24,658 relocation
reimbursement (including $6,106 for income tax gross-up) and $11,250
Company match to the 401(k) Plan. All other compensation for 2006 includes
$4,370 for long-term disability, (including $1,108 for income tax
gross-up), $19,459 relocation reimbursement (including $4,914 for income
tax gross-up) and $9,750 Company match to the 401(k)
Plan.
|
Grants
of Plan-Based Awards
The
following table provides summary information concerning each grant of an award
made to a named executive officer in 2008 under a compensation plan (adjusted
for the 1-for-50 reverse stock split that became effective on July 13,
2009).
|
|
|
|
|
Estimated Future Payouts
Under Non-Equity Incentive
|
|
|
Estimated Future Payouts
Under Equity Incentive
Plan Awards (2)
|
|
|
All
Other
Stock
Awards:
Number
of Shares
of Stock
or
|
|
|
All Other
Option
Awards:
Number of
Securities
Underlying
|
|
|
Exercise
Price of
Option
|
|
|
Grant Date
Fair Value
of Stock
and Option
|
|
|
|
|
|
|
Plan Awards (1)
|
|
|
Threshold
|
|
|
Target
|
|
|
Maximum
|
|
|
Units
|
|
|
Options
|
|
|
Awards
|
|
|
Awards
|
|
Name
|
|
Grant
Date
|
|
|
Thrshold
($)
|
|
|
Target
($)
|
|
|
Maximum
($)
|
|
|
(#
Shares)
|
|
|
(#
Shares)
|
|
|
(#
Shares)
|
|
|
(#)(3)
|
|
|
(#)
|
|
|
($/sh)
|
|
|
($)
|
|
Dr.
Warrell
|
|
|
(4 |
) |
|
|
— |
|
|
|
3,840 |
|
|
|
5,760 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Mr.
Moran (3)
|
|
|
(4 |
) |
|
|
— |
|
|
|
1,920 |
|
|
|
2,560 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Mr.
Siegel
|
|
4/11/2008
|
|
|
|
0 |
|
|
|
1,050 |
|
|
|
1,470 |
|
|
|
0 |
|
|
|
400 |
|
|
|
600 |
|
|
|
800 |
|
|
|
— |
|
|
|
— |
|
|
|
16,400 |
|
Dr.
Itri
|
|
|
(4 |
) |
|
|
— |
|
|
|
2,805 |
|
|
|
4,675 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Mr.
Sanders
|
|
4/11/2008
|
|
|
|
0 |
|
|
|
1,710 |
|
|
|
2,280 |
|
|
|
0 |
|
|
|
600 |
|
|
|
800 |
|
|
|
1,300 |
|
|
|
— |
|
|
|
— |
|
|
|
26,650 |
|
(1)
|
Reflects
the range of payouts targeted for 2008 performance under the Genta Cash
Incentive Bonus Program, which would ordinarily be paid in
January 2009; however, no payments were earned based on 2008
performance.
|
(2)
|
Reflects
restricted stock units awarded in April 2008, which vested 50% on January
15, 2009 and 50% on June 30, 2009.
|
(3)
|
Mr.
Moran retired from Genta effective February 29,
2008.
|
(4)
|
There
were no grants of plan-based awards during
2008.
|
Equity
Award Exchange Offer
On
July 9, 2009 our Board approved an Equity Award Exchange Offer Program to
non-employee Directors whereby each non-employee Director was given the
opportunity to exchange their outstanding stock options to purchase shares of
Genta common stock for New RSUs.
Our
outstanding options have exercise prices that are significantly higher than the
current market price of our common stock. For this reason, our Board
believes that these options have little or no current value as an incentive to
retain and motivate non-employee Directors, and are unlikely to be exercised in
the foreseeable future. By making the offer to exchange outstanding options for
New RSUs, the Board intended to provide our non-employee Directors with the
benefit of receiving equity awards that over time may have a greater potential
to increase in value, and thereby create better incentives for our non-employee
Directors to remain with us and contribute to the attainment of our business and
financial objectives and the creation of value for all of our stockholders. The
Equity Award Exchange Offer expired on July 14, 2009.
As each of our non-employee
Directors submitted their eligible awards for cancellation, they were granted a
New RSU award on July 16, 2009 covering 695,658 shares. Each RSU will entitle a
non-employee Director to receive one share of Genta common stock following
vesting. The New RSUs were granted under the 2009 Plan. The 2009 Plan was
adopted by the Board on July 9, 2009, subject to approval by the Company's
stockholders. Upon such stockholder approval of the 2009 Plan, the eligible
options will be cancelled. If the stockholders do not approve the 2009 Plan,
then the eligible options will remain in full force and effect and the existing
stock options will remain exercisable in accordance with their
terms.
Grants
of Plan-Based Awards
The following table lists all
outstanding Equity Awards as of December 31, 2008, adjusted for the 1-for-50
reverse stock split that became effective on July 13,
2009.
|
|
Option
Awards
|
|
|
Stock
Awards
|
|
Name
|
|
Number
Of
Securities
Underlying
Unexercised
Options
Exercisable
(#)
|
|
|
Number
Of
Securities
Underlying
Unexercised
Options
Unexercisable
(#(1))
|
|
|
Option
Exercise
Price
($)
|
|
|
Option
Expiration
Date
|
|
|
Number
of
Shares
or
Units
of
Stock
That
Have
Not
Vested
(#)
|
|
|
Market
Value
of
Shares
or
Units
of
Stock
That
Have
not
Vested
($)
|
|
Dr.
Warrell
|
|
|
10,585 |
|
|
|
— |
|
|
|
800.50 |
|
|
10/27/09
|
|
|
|
— |
|
|
|
— |
|
|
|
|
2,646 |
|
|
|
— |
|
|
|
800.50 |
|
|
02/14/10
|
|
|
|
— |
|
|
|
— |
|
|
|
|
1,000 |
|
|
|
— |
|
|
|
2,390.50 |
|
|
01/01/11
|
|
|
|
— |
|
|
|
— |
|
|
|
|
1,000 |
|
|
|
— |
|
|
|
4,110.00 |
|
|
01/25/12
|
|
|
|
— |
|
|
|
— |
|
|
|
|
1,000 |
|
|
|
— |
|
|
|
2,358.50 |
|
|
01/28/13
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
3,333 |
|
|
|
2,964.00 |
|
|
05/16/13
|
|
|
|
— |
|
|
|
— |
|
|
|
|
250 |
|
|
|
— |
|
|
|
3,096.00 |
|
|
01/04/14
|
|
|
|
— |
|
|
|
— |
|
|
|
|
500 |
|
|
|
— |
|
|
|
486.00 |
|
|
01/28/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
2,646 |
|
|
|
— |
|
|
|
800.50 |
|
|
10/28/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
563 |
|
|
|
188 |
|
|
|
615.00 |
|
|
01/23/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
1,667 |
|
|
|
1,666 |
|
|
|
648.00 |
|
|
03/31/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
167 |
|
|
|
166 |
|
|
|
137.00 |
|
|
01/12/07
|
|
|
|
— |
|
|
|
— |
|
Mr.
Siegel
|
|
|
46 |
|
|
|
— |
|
|
|
3,015.00 |
|
|
05/22/13
|
|
|
|
— |
|
|
|
— |
|
|
|
|
23 |
|
|
|
— |
|
|
|
3,096.00 |
|
|
01/04/14
|
|
|
|
— |
|
|
|
— |
|
|
|
|
33 |
|
|
|
— |
|
|
|
750.00 |
|
|
06/30/14
|
|
|
|
— |
|
|
|
— |
|
|
|
|
33 |
|
|
|
— |
|
|
|
486.00 |
|
|
01/07/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
93 |
|
|
|
12 |
|
|
|
282.00 |
|
|
04/04/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
25 |
|
|
|
8 |
|
|
|
270.00 |
|
|
04/15/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
02 |
|
|
|
8 |
|
|
|
555.00 |
|
|
09/19/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
25 |
|
|
|
8 |
|
|
|
615.00 |
|
|
01/23/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
8 |
|
|
|
16 |
|
|
|
231.00 |
|
|
12/01/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
20 |
|
|
|
20 |
|
|
|
137.00 |
|
|
01/12/17
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
800 |
(2) |
|
|
108 |
(3) |
Dr.
Itri
|
|
|
1,000 |
|
|
|
— |
|
|
|
1,719.00 |
|
|
03/28/11
|
|
|
|
— |
|
|
|
— |
|
|
|
|
133 |
|
|
|
— |
|
|
|
4,110.00 |
|
|
01/25/12
|
|
|
|
— |
|
|
|
— |
|
|
|
|
100 |
|
|
|
— |
|
|
|
2,358.50 |
|
|
01/28/13
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
1,000 |
|
|
|
3,585.00 |
|
|
08/05/13
|
|
|
|
— |
|
|
|
— |
|
|
|
|
166 |
|
|
|
— |
|
|
|
3,096.00 |
|
|
01/05/14
|
|
|
|
— |
|
|
|
— |
|
|
|
|
100 |
|
|
|
— |
|
|
|
486.00 |
|
|
01/07/15
|
|
|
|
— |
|
|
|
— |
|
|
|
|
125 |
|
|
|
41 |
|
|
|
615.00 |
|
|
01/23/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
407 |
|
|
|
1,259 |
|
|
|
477.00 |
|
|
07/27/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
83 |
|
|
|
83 |
|
|
|
137.00 |
|
|
01/12/17
|
|
|
|
— |
|
|
|
— |
|
Mr.
Sanders
|
|
|
250 |
|
|
|
83 |
|
|
|
543.00 |
|
|
01/16/16
|
|
|
|
— |
|
|
|
— |
|
|
|
|
50 |
|
|
|
50 |
|
|
|
137.00 |
|
|
01/12/17
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,300 |
(2) |
|
|
176 |
(3) |
(1)
|
Each
option will vest in full on an accelerated basis upon certain changes in
control as described in more detail under the heading “Termination of
Employment and Change in Control Agreements”
herein.
|
(2)
|
Reflects
restricted stock units awarded in April 2008, which vested 50% on January
15, 2009 and 50% on June 30,
2009.
|
(3)
|
Based
on the $0.13 closing price of our common stock on December 31,
2008.
|
Option
Exercises and Stock Vesting in Last Year
None
of our named executive officers exercised options and no stock awards held by
our named executive officers vested in the year ended December 31,
2008.
Nonqualified
Deferred Compensation
The
following table shows the deferred compensation activity for each named
executive officer during the 2008 fiscal year.
Name
|
|
Executive
Contributions
in
Last FY
($)
|
|
Registrant
Contributions
in
Last FY
($)
|
|
Aggregate
Earnings
in
Last
FY
($)
|
|
Aggregate
Withdrawals/
Distributions
($)
|
|
Aggregate
Balance
at
Last
FYE
($)
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
Dr.
Warrell
|
|
|
178,104 |
|
|
|
|
|
|
|
|
178,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
Itri
|
|
|
203,010 |
|
|
|
|
|
|
|
|
203,010 |
|
Employment
Agreement with Raymond P. Warrell, Jr., M.D.
Pursuant
to an employment agreement dated as of January 1, 2006, by and between Genta and
Dr. Warrell, that was subsequently amended and restated as of November 30, 2007,
and later amended as of December 31, 2008, hereinafter referred to as the
Warrell employment agreement, Dr. Warrell continues to serve as our Chairman and
Chief Executive Officer. The Warrell employment agreement has an initial term of
three years ending on December 31, 2010 and provides for automatic extensions
for additional one-year periods. Under the Warrell employment agreement, Dr.
Warrell’s $480,000 annual base salary was reduced by 15% effective January 1,
2008; and he now receives a base salary of $408,000 per annum with annual
percentage increases equal to at least the Consumer Price Index for the calendar
year preceding the year of the increase. At the end of each calendar year, Dr.
Warrell is eligible for a cash incentive bonus ranging from 0% to 60% of his
annual base salary, subject to the achievement of agreed-upon goals and
objectives.
Dr.
Warrell is entitled to receive annual stock option awards for the purchase of up
to 225,000 shares of common stock, depending upon the achievement of agreed-upon
goals and objectives. Such options will become fully exercisable upon a “Trigger
Event” (i.e. the sale of Genasense® or our change in control). If a Trigger
Event occurs during the term of the Warrell employment agreement or within 12
months thereafter, Dr. Warrell will be entitled to receive the stock option
grants that he would have been entitled to receive in respect of the calendar
year in which the Trigger Event occurs (assuming attainment of “target” levels
of performance on all goals and objectives for the year), and such option will
be fully vested and exercisable upon grant.
We may
also, from time to time, grant Dr. Warrell additional cash, stock options,
equity and/or other long-term incentive awards in the sole discretion of our
Board. Dr. Warrell continues to be entitled to any and all medical insurance,
dental insurance, life insurance, disability insurance and other benefit plans,
which are generally available to our senior executives. He is also entitled to
receive supplemental life insurance and supplemental disability insurance, as
well as premium payments for medical malpractice insurance up to a maximum of
$25,000 annually. The aggregate amount of the benefits Dr. Warrell may receive
are subject to parachute payment limitations under Section 280G of the Internal
Revenue Code.
In the
event Dr. Warrell’s employment is terminated, he will be eligible for certain
benefits whose value has been estimated herein, but only to the extent that the
benefit is not otherwise provided to employees on a non-discriminatory basis. In
the event Dr. Warrell’s employment is terminated, he will be entitled to receive
his accrued but unpaid base salary through his termination date, his accrued but
unpaid expenses, a lump sum payment of his accrued vacation days (unless he is
terminated by us for cause or he terminates his employment without good reason
(both defined in the Warrell employment agreement)), his accrued but unpaid cash
incentive bonus, a lump sum payment of his pro-rated cash incentive bonus for
the year of his termination, valued up to $163,200, (unless he is terminated by
us for cause or he terminates his employment without good reason), and any other
benefits due him in accordance with applicable plans, programs or agreements. In
addition to the benefits listed in the preceding sentence, in the event we
terminate Dr. Warrell’s employment without cause or Dr. Warrell terminates his
employment for good reason and he executes a release, Dr. Warrell will be
entitled to receive the base salary he would have received during the
twelve-month period following the date of termination, valued at $408,000, for a
total potential payment of $571,200. If we terminate Dr. Warrell’s employment in
anticipation of our change in control or, if either party terminates his
employment upon a change in control or within thirteen months following a change
in control, Dr. Warrell will instead receive a lump sum payment equal to two
times his annual base salary, valued at $816,000 and two times his target bonus
for the calendar year of termination, valued at $326,400, for a total potential
payment of $1,142,000. Dr. Warrell will also receive immediate vesting of all
stock options that vest solely as a result of his continued employment. Finally,
if either party gives notice that they do not wish to extend the Warrell
employment agreement, Dr. Warrell will be entitled to receive his accrued, but
unpaid, base salary through his termination date; his accrued, but unpaid,
expenses; a lump sum payment of his accrued vacation days; his accrued but
unpaid cash incentive bonus; a lump sum payment of his pro-rated cash incentive
bonus for the year of his termination, valued up to $163,200; and any other
benefits due him in accordance with applicable plans, programs or agreements. If
Dr. Warrell gives notice that he does not wish to extend his employment
agreement, he will also receive immediate vesting of all stock options that
would have vested during the 90 days following his termination date, if such
stock options vest solely as a result of his continued employment. If we give
notice that we do not wish to extend Dr. Warrell’s employment agreement, he will
receive immediate vesting of all stock options that vest solely as a result of
his continued employment.
Employment
Agreement with Loretta M. Itri, M.D.
Pursuant
to an employment agreement dated as of March 28, 2006, by and between Genta and
Dr. Itri, signed on July 27, 2006, and amended as of December 31, 2008, Dr. Itri
continues to serve as our President, Pharmaceutical Development and Chief
Medical Officer. The employment agreement had an initial term of three years,
beginning March 28, 2006 and continuing through March 27, 2009 and provides for
automatic extensions for additional one-year periods. The agreement provided for
a base annual salary in 2006 of $445,200, which may be reviewed annually for
discretionary increases in a manner similar to our other senior executives and
an annual cash incentive bonus ranging from 0% to 50% of her annual base salary
to be paid if mutually agreed-upon goals and objectives are achieved for the
year. Dr. Itri was also granted an incentive stock option to purchase 1,666
shares of our Common Stock at an exercise price of $477.00 per share, of which
666 shares become exercisable upon the first FDA approval of Genasense®, 666
shares become exercisable upon approval by the EMEA in Europe of Genasense® in
any first indication and 333 shares become exercisable over a period of
approximately 32 months from the grant date by means of (i) an initial amount of
37 shares to be exercisable and vest on the Date of Grant, (ii) an additional
amount of 286 shares in 31 equal monthly increments of 9 shares each, commencing
on August 1, 2006 and continuing on the first day of each of the next successive
30 calendar months, and (iii) a final amount of 9 shares on March 1, 2009. We
may also, from time to time, grant Dr. Itri additional stock options consistent
with the stock option guidelines applicable to our other senior executives. Dr.
Itri is entitled to any and all medical insurance, dental insurance, life
insurance, disability insurance and other benefit plans, which are generally
available to our senior executives. She is also entitled to receive supplemental
life insurance and supplemental disability insurance. The aggregate amount of
the benefits Dr. Itri may receive are subject to parachute payment limitations
under Section 280G of the Internal Revenue Code.
In the
event Dr. Itri’s employment is terminated, she will be eligible for certain
benefits whose value has been estimated herein, but only to the extent that the
benefit is not otherwise provided to employees on a non-discriminatory basis. In
the event Dr. Itri’s employment is terminated, she will be entitled to receive
her accrued, but unpaid, base salary through her termination date; her accrued,
but unpaid, expenses; her accrued vacation days; any earned but unpaid cash
incentive bonus; and any other benefits due her in accordance with applicable
plans, programs or agreements. In addition to the benefits listed in the
preceding sentence, in the event we terminate Dr. Itri’s employment without good
reason (as defined in the employment agreement), due to a change of control, or
Dr. Itri terminates her employment for good reason (as defined in the employment
agreement), and she executes a release, Dr. Itri will be entitled to receive a
lump sum payment equal to her current annualized base salary, valued at $467,500
plus a pro-rated cash incentive bonus for the calendar year of termination,
valued up to $140,250, for a total potential payment of $607,750, and each of
her outstanding stock options will immediately vest to the extent vesting
depends solely on her continued employment. Finally, if either party gives
notice that the employment agreement will not be extended, Dr. Itri will be
entitled to receive her accrued, but unpaid, base salary through her termination
date; her accrued, but unpaid, expenses; her accrued vacation days; any earned,
but unpaid, cash incentive bonus; a pro-rated cash incentive bonus for the year
of her termination, valued up to $140,250, for a total potential payment of
$607,750; and any other benefits due her in accordance with applicable plans,
programs, or agreements. If we give notice that we do not wish to extend Dr.
Itri’s employment agreement, she will also receive immediate vesting of all
stock options that would have vested during the 90 days following her
termination date, if such stock options would have vested solely as a result of
her continued employment.
Compensation
of Directors
Our
non-employee directors receive $15,000 per year for their services. Non-employee
directors receive an additional $1,500 for each Board meeting and $1,000 for
each committee meeting attended in person and $750 for each Board or committee
meeting attended telephonically. The Lead Director and each non-employee
Chairperson of a Committee of the Board receive annual cash compensation of
$5,000. Non-employee Directors receive $2,500 per day for Board or committee
activities outside of normal activities. Due to the Company’s inability to raise
capital and in order to conserve cash, only a small portion of the amounts
earned by each Director was paid during 2008.
Currently,
under our Non-Employee Directors’ 1998 Stock Option Plan, each non-employee
Director receives an option to purchase 80 shares of our common stock upon his
or her initial election to the Board. In addition, on the date of each annual
stockholders’ meeting, each individual who is to continue to serve as a
non-employee Board member is granted an option to purchase 67 shares of our
common stock. The Lead Director and each non-employee Chairperson of a committee
of the Board receive an option to purchase 17 shares of our common stock
coinciding with their annual election to the Board. Each such option will have
an exercise price per share equal to the fair market value per share of the
common stock on the grant date and will have a maximum term of 10
years.
On
June 25, 2009, our Board approved, subject to stockholder approval at the 2009
Annual Meeting of Stockholders, the 2009 Stock Incentive Plan (the “2009 Plan”),
pursuant to which 83,478,929 shares of our common stock will be authorized for
issuance. If the 2009 Plan is approved, on the date of the Annual Meeting, each
individual who (i) is to continue in service as a non-employee Board member
following such date and (ii) tendered for cancellation his or her outstanding
equity awards pursuant to our Equity Award Exchange Offer will be automatically
granted a restricted stock unit (“RSU”) covering 695,658
shares.
Each
individual who is first elected or appointed as a non-employee Board member at
any time after the 2009 Annual Meeting of Stockholders shall automatically be
granted on the date of such election or appointment, an award in the form of
fully vested shares of common stock and/or options with a value equal to the
Applicable Annual Amount. Our Compensation Committee will have the
sole discretion to determine the amount and type of award for each year. The
Applicable Annual Amount will be determined by the Compensation Committee on or
before the date of the grant, but in no event will such amount exceed
$100,000.00
On the
date of each annual stockholders meeting, beginning with the 2010 Annual
Meeting, each individual who is at that time serving as, and is to continue to
serve as, a non-employee Board member will automatically be granted an award
(the “Annual Award”) in the form of fully vested shares of common stock and/or
options with a value not to exceed $100,000.00. Our Compensation Committee will
have the sole discretion to determine the amount and type of award for each
year. The Applicable Annual Amount will be determined by the
Compensation Committee on or before the date of the grant, but in no event will
such amount exceed $100,000.00.
The
following table sets forth certain information regarding compensation earned by
the following non-employee directors of the Company during the year ended
December 31, 2008:
Name
|
|
Fees paid ($)
(1)
|
|
|
Stock
Awards
($)
|
|
|
Option
awards
($) (2)
|
|
|
Non-Equity
Incentive Plan
Compensation ($)
|
|
|
Change in Pension
Value and Nonqualified
Deferred Compensation
($)
|
|
|
All Other
Compensation
($)
|
|
|
Total
($)
|
|
Martin
J. Driscoll
|
|
$ |
38,000 |
|
|
|
- |
|
|
$ |
6,753 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
44,753 |
|
Christopher
P. Parios
|
|
$ |
36,750 |
|
|
|
- |
|
|
$ |
4,267 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
41,017 |
|
Daniel
D. Von Hoff, M.D.
|
|
$ |
27,000 |
|
|
|
- |
|
|
$ |
733 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
27,733 |
|
Douglas
G. Watson
|
|
$ |
43,250 |
|
|
|
- |
|
|
$ |
1,100 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
44,350 |
|
|
(1)
|
Reflects
the dollar amount earned by the non-employee Director during 2008. Due to
the Company’s inability to raise capital and in order to conserve cash,
only a small portion of the amounts earned by each Director was paid
during 2008. The amount of fees paid to each Director during 2008 was:
Martin J. Driscoll: $2,250; Christopher P. Parios: $3,750; Daniel D. Von
Hoff, M.D.: $3,000; Douglas G. Watson:
$3,750
|
|
(2)
|
Represents
the compensation cost recognized for financial statement purposes for the
year ended December 31, 2008, in accordance with Statement of Financial
Accounting Standards No. 123(R) (FAS 123(R)) with respect to the option
awards made to the non-employee Directors, including awards which may have
been made in earlier years. For information regarding assumptions
underlying the FAS 123(R) valuation of our equity awards, see Note 15 of
the Consolidated Financial Statements in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2008. As of December 31, 2008,
each Director had the following number of options outstanding, (adjusted
for the Company’s 1-for-50 reverse stock split that became effective on
July 13, 2009): Martin J. Driscoll: 363; Christopher P. Parios: 280;
Daniel D. Von Hoff: 756; Douglas G. Watson:
647.
|
Committees
of the Board of Directors and Director Independence
The Board
currently consists of five directors. They are Raymond P. Warrell, Jr., M.D.,
Martin J. Driscoll, Christopher P. Parios, Daniel D. Von Hoff, M.D., and Douglas
G. Watson. The Board has determined that, except for Dr. Warrell, all of the
members of the Board are “independent directors”. Dr. Warrell is not considered
independent, as he is an executive officer of the Company.
Compensation
Committee
The
Compensation Committee currently consists of Martin J. Driscoll, Christopher P.
Parios and Douglas G. Watson. Mr. Watson serves as Chairman of this Committee.
Each member of the Compensation Committee is independent.
Nominating
and Corporate Governance Committee
The
Nominating and Corporate Governance Committee currently consists of Martin J.
Driscoll and Daniel D. Von Hoff, M.D. Mr. Driscoll serves as Chairman of this
Committee. Each member of the Nominating and Corporate Governance Committee is
independent.
Audit
Committee
The Audit
Committee was established in accordance with Section 3(a)(58)(A) of the
Securities Exchange Act of 1934, as amended. The Audit Committee currently
consists of Martin J. Driscoll, Christopher P. Parios and Douglas G. Watson. Mr.
Driscoll serves as Chairman of this Committee. Each member of the Audit
Committee is independent.
Compensation
Committee Interlocks and Insider Participation
None of
the members of our Compensation Committee, Mr. Watson, Mr. Driscoll and Mr.
Parios, was at any time during our year ended December 31, 2008, or formerly our
officer or employee. None of our executive officers have served as a director or
member of the Board of Directors or the Compensation Committee (or other
committee serving an equivalent function) of any other entity while an executive
officer of that other entity served as a director of or member of our Board of
Directors or our Compensation Committee.
SECURITY
OWNERSHIP OF MANAGEMENT
The
following table sets forth, as of July 17, 2009, certain information with
respect to the beneficial ownership of our common stock (the only voting class
outstanding), (i) by each Director, (ii) by each of the named executive officers
and (iii) by all officers and Directors as a group.
|
|
Amount and Nature of Beneficial
Ownership
|
|
Name and Address (1)
|
|
Number of Shares (2)
|
|
|
Percent of Class
|
|
Raymond
P. Warrell, Jr., M.D.
|
|
|
6,765,517 |
(3) |
|
|
4.999 |
% |
Loretta
M. Itri, M.D.
|
|
|
6,765,517 |
(4) |
|
|
4.999 |
% |
Richard
J. Moran
|
|
|
434 |
(5) |
|
|
* |
|
Gary
Siegel
|
|
|
761 |
(6) |
|
|
* |
|
W.
Lloyd Sanders
|
|
|
1,110 |
(7) |
|
|
* |
|
Martin
J. Driscoll
|
|
|
408 |
(8) |
|
|
* |
|
Christopher
P. Parios
|
|
|
278 |
(9) |
|
|
* |
|
Daniel
D. Von Hoff, M.D.
|
|
|
749 |
(9) |
|
|
* |
|
Douglas
G. Watson
|
|
|
838 |
(10) |
|
|
* |
|
All
Directors and Executive Officers as a group
|
|
|
6,772,211 |
(11) |
|
|
5.0 |
% |
*
|
Less
than one percent (1%).
|
(1)
|
The
address of each named holder is in care of Genta Incorporated, 200 Connell
Drive, Berkeley Heights, NJ 07922.
|
(2)
|
Beneficial
ownership is determined in accordance with the rules of the SEC and
generally includes voting or investment power with respect to securities.
Shares of common stock subject to options exercisable within 60 days of
July 17, 2009 or issuable on conversion of Senior Secured Convertible
Promissory Notes due June 9, 2010 are deemed outstanding for computing the
percentage of the person holding such securities but are not deemed
outstanding for computing the percentage of any other person. Except as
indicated by footnote, and subject to community property laws where
applicable, the person named in the table has sole voting and investment
power with respect to all shares of common stock shown as beneficially
owned by them.
|
(3)
|
Consists
of 2,077,759 shares of common stock held in Dr. Warrell’s IRA, 8,115
shares of common stock held in a joint account with Dr. Warrell’s wife,
Dr. Itri and 22,021 shares of common stock issuable upon exercise of
currently exercisable stock options. Also includes 1,543,398 shares of
common stock issuable upon the conversion of Senior Secured Convertible
Promissory Notes due June 9, 2010. Dr. Warrell indirectly owns 3,114,224
shares held in Dr. Itri’s IRA, of which Dr. Warrell is the
beneficiary.
|
(4)
|
Consists
of 8,115 shares of common stock held in a joint account with Dr. Warrell,
3,114,224 shares held in Dr. Itri’s IRA, and 2,113 shares of common stock
issuable upon exercise of currently exercisable stock options. Also
includes 1,563,306 shares of common stock issuable upon the conversion of
Senior Secured Convertible Promissory Notes due June 9, 2010. Dr. Itri
indirectly owns 2,077,759 shares of common stock held in Dr. Warrell’s
IRA, of which Dr. Itri is the
beneficiary.
|
(5)
|
Consists
of 433 shares of common stock and 1 share of common stock owned by Mr.
Moran’s wife. Mr. Moran retired from the Company in February
2008.
|
(6)
|
Consists
of 503 shares of common stock and 258 shares of common stock issuable upon
the exercise of currently exercisable stock
options.
|
(7)
|
Consists
of 919 shares of common stock and 191 shares of common stock issuable upon
exercise of currently exercisable stock
options.
|
(8)
|
Consists
of 50 shares of common stock and 358 shares of common stock issuable upon
the exercise of currently exercisable stock
options.
|
(9)
|
Consists
of shares of common stock issuable upon the exercise of currently
exercisable stock options.
|
(10)
|
Consists
of 200 shares of shares of common stock and 638 shares of common stock
issuable upon the exercise of currently exercisable stock
options.
|
(11)
|
Consists
of 5,202,205 shares of common stock and 26,608 shares of common stock
issuable upon the exercise of currently exercisable stock options. Also
includes 1,543,398 shares of common stock issuable upon the conversion of
Senior Secured Convertible Promissory Notes due June 9,
2010.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
The
following table sets forth, as of July 17, 2009, certain information with
respect to the beneficial ownership of our common stock by persons known by us
to be beneficial owners of more than 5% of our common stock. The
information in this table is based solely on statements in filings with the SEC
or other reliable information.
|
|
Amount and Nature of Beneficial
Ownership
|
|
Name and Address
|
|
Number of Shares
|
|
|
Percent of Class
|
|
Tang
Capital Partners Ltd(1)
4401
Eastgate Mall
San
Diego, CA 92121
|
|
|
11,697,025 |
(1) |
|
|
9.999 |
% |
(1)
|
Tang
Capital Partners is the beneficial owner of 11,697,025 shares of Common
Stock, comprised of 2,847,183 shares of Common Stock, $79,939.84 face
amount of the Issuer’s 15% Senior Secured Convertible Promissory Notes due
June 2010 (the “June 2010 Notes”), $1,850,000.00 face amount of the
Issuer’s 8% Senior Secured Convertible Promissory Notes due April 2012
(the “April 2012 Notes”), and $664,000.00 Face Amount of the Issuer’s 8%
Unsecured Subordinated Convertible Promissory Note due July 2011 (the
“July 2011 Notes”). Additionally, Tang Capital Partners is the beneficial
owner of a warrant to purchase 4,625,000 shares of the Issuer’s Common
Stock at an exercise price of $0.50 per share (the “April 2009 Warrant”)
and a warrant to purchase 1,660,000 shares of the Issuer’s Common Stock at
an exercise price of $1.00 per share (the “July 2009 Warrant”). Tang
Capital Partners also has the right, pursuant to a Securities Purchase
Agreement dated April 2, 2009, to purchase an additional $1,850,000.00
face amount of the April 2012 Notes. Tang Capital Partners also
has the right, pursuant to a Consent Agreement dated April 2, 2009, and
amended on May 22, 2009 and July 7, 2009, to purchase $2,832,951.79 Face
Amount of the April 2012 Notes. Pursuant to a Securities
Purchase Agreement dated July 7, 2009, Tang Capital Partners is obligated,
subject to certain conditions, to purchase $2,383,757.69 Units (the
“Units”) from the Issuer on August 6, 2009. Such Units will
consist of 70% July 2011 Notes, 30% of the Issuer’s Common Stock, and an
additional July 2009 Warrant to purchase a number of shares equal to 25%
of the shares underlying the July 2011 Notes purchased in such
closing. The Common Stock of such units will be priced at 25%
of the VWAP for the five trading days immediately preceding such closing,
subject to a minimum price per share of $0.10. The April 2012 Notes can
only be converted to the extent that, after such conversion, the Reporting
Persons would beneficially own no more than 4.999% of the Issuer’s Common
Stock. The July 2011 Notes can only be converted to the extent
that, after such conversion, the Reporting Persons would beneficially own
no more than 9.999% of the Issuer’s Common Stock. The April
2009 Warrants are not exercisable until October 2, 2009, and after such
date, are only exercisable to the extent that, after such exercise, the
Reporting Persons would beneficially own no more than 4.999% of the
Issuer’s Common Stock. The July 2009 Warrants are not
exercisable until January 7, 2010, and after such date, are only
exercisable to the extent that, after such exercise, the Reporting Persons
would beneficially own no more than 4.999% of the Issuer’s Common
Stock.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Dr.
Daniel Von Hoff, one of our directors, holds the position of Physician in Chief
and Director of Translational Research at the Translational Genomics Research
Institute, or Tgen, which provides preclinical testing services under direction
of and by contract to us. During 2008, Tgen performed services for which it was
compensated by us in the amount of approximately $36,419. We believe that the
payment of these services was on terms no less favorable than would have
otherwise been provided by an ‘‘unrelated’’ party. In the Board’s opinion, Dr.
Von Hoff’s relationship with Tgen will not interfere with Dr. Von Hoff’s
exercise of independent judgment in carrying out his responsibilities as our
Director.
We have
set forth certain policies and procedures with respect to the review and
approval of related-party transactions. Specifically, pursuant to our Audit
Committee Charter, the Audit Committee is required to review and approve any
related-party transactions. In connection with such review and approval, the
Audit Committee may retain special legal, accounting or other advisors and may
request any of our officers or employees or our outside counsel or independent
auditors to meet with any members of, or advisors to, the Audit Committee as
well as perform any other activities consistent with the Audit Committee
Charter, our by-laws, and governing law, as the Audit Committee or the Board
deems necessary or appropriate.
On June
5, 2008, we entered into a securities purchase agreement with certain
institutional and accredited investors to place up to $40 million of senior
secured convertible notes with such investors. On June 9, 2008, we placed $20
million of such notes in an initial closing. Each of Dr. Raymond Warrell, our
Chief Executive Officer and Chairman, and Dr. Loretta Itri, our President,
Pharmaceutical Development and Chief Medical Officer, participated in the
initial closing by purchasing $1,950,000 and $300,000, respectively, of such
notes. The remaining Board members independently discussed Dr. Warrell and Dr.
Itri’s participation in the transaction and resolved that such participation
will not interfere with Dr. Warrell or Dr. Itri’s exercise of independent
judgment in carrying out their responsibilities in their respective positions.
In connection with the June 2008 convertible note financing and in accordance
with the Audit Committee Charter, the Audit Committee reviewed and approved the
June 2008 convertible note financing with Dr. Warrell and Dr. Itri. Pursuant to
the terms of the 2008 Notes, Dr. Warrell and Dr. Itri also have the right to
participate in this offering. If Dr. Warrell and/or Dr. Itri decide to
participate in this offering, the Audit Committee will need to approve their
participation.
DESCRIPTION
OF NOTES
We
will issue the August 2009 Notes under an indenture, between us and U.S. Bank
National Association, as trustee, to be dated as of the date of the initial
issuance of the August 2009 Notes. We refer to the indenture as the “indenture.”
The following summary of the terms of the August 2009 Notes and the indenture
does not purport to be complete and is subject, and qualified in its entirety by
reference, to the detailed provisions of the August 2009 Notes and the
indenture. We will provide copies of the indenture to you upon request. The
indenture also will be available for inspection at the office of the trustee.
The August 2009 Notes and the indenture and not this description, define your
legal rights as a holder of the August 2009 Notes. For a discussion of certain
tax consequences to a holder that purchases notes, see “Material US federal
income tax consequences.”
For
purposes of this summary, the terms “Genta”, “we”, “us” and “our” refer only to
Genta Incorporated, unless we specify otherwise.
GENERAL
The
August 2009 Notes we are offering:
|
•
|
are
limited to up to $4.9 million aggregate principal
amount;
|
|
•
|
are
in exchange for $4.9 million cash
consideration;
|
|
•
|
bear
interest at a rate of 8.00% per annum, payable semi-annually in arrears on
January 1 and July 1 of each year, beginning on January 1, 2010, to
holders of record at the close of business on the preceding December 1 and
June 1, respectively, and upon conversion or at
maturity;
|
|
•
|
will
be issued in denominations of integral multiples of $1,000 principal
amount;
|
|
•
|
subordinated
to the 2008 Notes and April 2009 Notes to the extent of the security for
such notes, and senior in time and right of payment to all other
indebtedness of the Company;
and
|
|
•
|
pari passu in time and
right of payment as the August 2009
Notes.
|
|
•
|
are
convertible at any time into shares of our common stock based on an
initial conversion rate of 10,000 shares per $1,000 principal amount of
notes under the conditions and subject to such adjustments described under
“—Conversion rights,” and subject to the limitations described under
“—Conversion rights—Provisional limitation on right to convert notes” and
“—Conversion rights—Permanent limitation on right to convert
notes;”
|
|
•
|
are
subject to mandatory conversion by us, as described under “—Mandatory
conversion,” on any mandatory conversion date;
and
|
|
•
|
mature
on August [___], 2011, unless previously
converted.
|
All
cash payments on the August 2009 Notes will be made in US
dollars.
We
will issue the August 2009 Notes in denominations of integral multiples of
$1,000 principal amount, without coupons. We will issue the August 2009 Notes as
global securities in book-entry form. We will make payments in respect of August
2009 Notes by wire transfer of immediately available funds to DTC or its nominee
as registered owner of the global securities through the paying
agent.
You
may convert August 2009 Notes at the office of the conversion agent, present
August 2009 Notes for registration of transfer at the office of the registrar
for the August 2009 Notes and present August 2009 Notes for payment at maturity
at the office of the paying agent. We have appointed the trustee as the initial
conversion agent, registrar and paying agent for the August 2009
Notes.
We
will not provide a sinking fund for the August 2009 Notes. The indenture does
not contain any financial covenants and will not limit our ability to incur
additional indebtedness, including secured indebtedness. In addition, the
indenture does not provide any protection to holders of August 2009 Notes in the
event of a highly leveraged transaction. In the event of a change of
control (as defined in the indenture), the trustee or any holder of
outstanding August 2009 Notes may require the Company to prepay, effective
immediately prior to the consummation of the change of control, all of such
holder’s then outstanding August 2009 Notes at a price equal to the greater of
the face amount of the August 2009 Notes and the underlying value of the common
stock. In the event more than one holder of the August 2009 Notes
request prepayment upon a change of control and we can prepay some, but not all
of the August 2009 Notes up for prepayment, will prepay to each holder of August
2009 Notes electing to have its August 2009 Notes prepaid at that time an amount
equal to such holder’s pro-rata amount of all outstanding August 2009 Notes
being prepaid.
If any
payment date with respect to the August 2009 Notes falls on a day that is not a
business day, we will make the payment on the next business day. The payment
made on the next business day will be treated as though it had been made on the
original payment date, and no interest will accrue on the payment for the
additional period of time.
INTEREST
PAYMENTS
We
will pay interest on the August 2009 Notes at a rate of 8.00% per annum, payable
semi-annually in arrears on January 1 and July 1 of each year, beginning on
January 1, 2010. We will pay interest that is due on an interest payment date to
holders of record at the close of business on the preceding December 1 and June
1, respectively. Interest will accrue on the August 2009 Notes from
and including their date of initial issuance or from and including the last date
in respect of which interest has been paid, as the case may be, to, but
excluding, the maturity date, as the case may be. We will pay interest on the
August 2009 Notes on the basis of a 360-day year consisting of twelve 30-day
months. Interest will be paid in cash or in additional August 2009 Notes having
a face amount equal to the accrued interest.
In
addition, our ability to pay interest in August 2009 Notes is subject to the
limitations set forth below and under “Provisional limitation on the right to
convert notes” and “Permanent limitation on the right to convert
notes.”
If
August 2009 Notes are converted after a record date but prior to the
corresponding interest payment date, upon conversion we will pay the holder of
such note the interest accrued from the record date through the date of
conversion and on the interest payment date will pay the interest accrued as of
the record date to the record holder of the note as of the record
date.
If we
force conversion of a July 2009 Note, we will pay accrued and unpaid interest,
if any, to the holder that surrenders the July 2009 Note for conversion.
However, if we force conversion of a July 2009 Note after a record date but
prior to the corresponding interest payment date, upon conversion we will pay
the holder of such note the interest accrued from the record date through the
date of conversion and on the interest payment date will pay the interest
accrued as of the record date to the record holder of the note as of the record
date.
CONVERSION
RIGHTS
Holders
of August 2009 Notes may convert their August 2009 Notes in integral multiples
of $1,000 principal amount into shares of our common stock, based on an initial
conversion rate of 10,000 shares of our common stock per $1,000 principal amount
of August 2009 Notes, subject to adjustment as described below. We will not
issue fractional shares of common stock upon conversion of the August 2009 Notes
and instead will pay a cash adjustment for fractional shares based on the Daily
VWAP of our common stock for the five (5) consecutive trading days immediately
before the conversion date. Except as described above, we will not make any
payment or other adjustment on conversion with respect to any accrued interest
on the August 2009 Notes, and we will not adjust the conversion rate to account
for accrued and unpaid interest.
The
right to convert the August 2009 Notes will terminate at the close of business
on the final maturity date of the August 2009 Notes.
Mandatory
conversion
Subject
to the limitations on conversion described below, we may elect to cause the
mandatory conversion (a “Mandatory Conversion”) of all
or any portion of the principal and accrued and unpaid interest then outstanding
under the August 2009 Notes by providing five (5) days written notice thereof
the mandatory conversion date (each such date, a “Mandatory Conversion Date”).
Any such notice shall state the date for such mandatory conversion and the
principal amount of the August 2009 Notes to be converted on such date. Subject
to the limitations on conversions described below, all conversions shall be made
pro-rata among all noteholders.
We
will only be permitted to cause a Mandatory Conversion on a Mandatory Conversion
Date if, on the proposed Mandatory Conversion Date, (i) the Daily VWAP is equal
to or greater than $0.50 per share (as appropriately adjusted for stock splits,
stock dividends, reorganizations, recapitalizations, stock combinations and the
like) for each of the ten (10) consecutive prior trading days ending on the
trading day immediately prior to such date, and (ii) the Equity Conditions (as
set forth below) are satisfied and (iii) the common stock issuable upon the
mandatory conversion shall have been immediately tradable, in each case, on each
trading day during the period beginning on the first day of such ten (10) day
period and ending on the date of the delivery of such shares of common stock
pursuant to the mandatory conversion.
As
used above, the term Equity Conditions means that on each trading day during the
period in question, (i) that we have duly honored all conversions and
redemptions scheduled to occur or occurring by virtue of one or more conversion
notice of the holder, if any, (ii) all liquidated damages and other amounts
owing to the holder in respect of the August 2009 Notes have been paid; (iii)
our common stock is trading on a trading market and all of the shares issuable
in connection with this financing are eligible for trading on a trading market
(and we believe, in good faith, that trading of the common stock on a trading
market will continue uninterrupted for the foreseeable future), (iv) there is a
sufficient number of authorized but unissued and otherwise unreserved shares of
common stock for the issuance of all of the shares then issuable in connection
with this financing (disregarding any limitations on issuance or conversion
contained in such documents), (v) there is then existing no event of default or
event which, with the passage of time or the giving of notice, would constitute
an event of default, (vi) the issuance of the shares in question to the holder
would not violate the limitations set forth in the August 2009 Notes, and (vii)
no public announcement of a pending or proposed change of control has
occurred.
Under
the August 2009 Notes, the Daily VWAP means, for any date, (i) the daily volume
weighted average price of our common stock for such date on the principal
trading market for our common stock as reported by Bloomberg Financial L.P.
(based on a trading day from 9:30 a.m. Eastern Time to 4:02 p.m. Eastern Time);
(ii) if our common stock is not then listed or quoted on a trading market and if
prices for the common stock are then reported in the “Pink Sheets” published by
the Pink Sheets, LLC (or a similar organization or agency succeeding to its
functions of reporting prices), the most recent bid price per share of our
common stock so reported; or (iii) in all other cases, the fair market value of
a share of common stock as determined by an independent appraiser selected in
good faith by the holder and reasonably acceptable to us.
Provisional
limitation on right to convert August 2009 Notes
The
August 2009 Notes may only be converted by a holder (or beneficial holder) or by
us in any mandatory conversion on any day to the extent that, together with all
prior conversions under such note, the total amount of such note that has been
converted does not exceed the product of (A) 10% of the original principal
amount of August 2009 Notes held by such holder (or beneficial holder) on the
original issue date, and (B) the number of weeks since the date that is two
weeks from the original issue date of the August 2009 Notes.
Permanent
limitation on right to convert August 2009 Notes
Notwithstanding
the right of holders to convert their August 2009 Notes at any time, no holder
(or beneficial holder) of August 2009 Notes will be entitled to receive shares
of our common stock upon conversion, including any mandatory conversion, or as
payment of interest in shares of our common stock to the extent (but only to the
extent) that such receipt would cause such holder to become, directly or
indirectly, a “beneficial owner” of more than 9.999% of the shares of our common
stock outstanding at such time. For purposes of the foregoing, “beneficial
ownership” shall be deemed to mean “beneficial ownership” within the meaning of
Section 13(d) under the Securities Exchange Act of 1934, as amended, and the
rules and regulations promulgated thereunder. We refer to this limitation as the
“issuance cap.” Any purported delivery of shares of our common stock upon
conversion of August 2009 Notes or payment of interest in shares of our common
stock shall be void and have no effect to the extent (but only to the extent)
that such delivery would result in the holder (or beneficial holder) becoming
the beneficial owner of more than 9.999% of the shares of the our common stock
outstanding at such time.
Conversion
procedures
To
convert interests in the August 2009 Notes, the holder must comply with DTC’s
then applicable conversion program procedures.
As
soon as practicable, but in no event more than two business days after the
conversion date of a July 2009 Note, we will deliver, through the conversion
agent, a certificate for, or to the extent permissible, in book entry form
through DTC, the number of full shares of common stock into which the note is
converted, together with a cash payment, or shares of common stock, representing
the accrued but unpaid interest on the note being converted and a cash payment
for fractional shares.
For a
discussion of certain tax consequences to a holder that converts August 2009
Notes, see “Material US federal income tax consequences—Consequences to US
Holders—Conversion of the August 2009 Notes” and “—Consequences to non-US
holders—Conversion of the August 2009 Notes.”
Change in the conversion right upon
certain reclassifications, business combinations and asset
sales
Except
as provided in the indenture and as described below, if we reclassify or change
our common stock, whether by reclassification, exchange, substitution or
otherwise (other than as provided below), in each case pursuant to which our
common stock would be converted into or exchanged for, or would constitute
solely the right to receive, cash, securities or other property, then, at the
effective time of the transaction, the right to convert a note into common stock
will be changed into a right to convert it into the kind and amount of cash,
securities or other property (the “reference property”), which a holder of such
note would have received (assuming, if applicable, that the holder would have
made the applicable election referred to in the immediately following paragraph)
if the holder had converted the note immediately before the transaction. A
change in the conversion right such as this could substantially lessen or
eliminate the value of the conversion right. If a transaction described above
occurs and holders of our common stock have the opportunity to elect the form of
consideration to receive in that transaction, then we will make adequate
provision to give holders of the August 2009 Notes, treated as a single class, a
reasonable opportunity to elect the form of such consideration for purposes of
determining the composition of the “reference property” described above. Once
the election is made, it will apply to all holders of our August 2009 Notes
after the effective time of the transaction.
If we
are party to a consolidation, merger or other business combination, or a sale,
transfer disposition or exclusive license of more than fifty percent of our
intellectual property or assets or we close on a purchase, tender or exchange
offer made to holders of more than fifty percent (50%) of the outstanding shares
of common stock in which more than fifty percent (50%) of the outstanding shares
of common stock were tendered and accepted, then as a part of such transaction,
each holder of August 2009 Notes shall have the right to demand prepayment at a
price equal to the greater of (x) the face amount of such holder’s August 2009
Notes and (y) the value of the common stock underlying such holder’s August 2009
Notes.
We will
agree in the indenture not to become a party to such a transaction unless its
terms are consistent with these provisions.
Adjustments
to the conversion rate
Subject
to the terms of the indenture, we will adjust the conversion rate
for:
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stock
splits or combinations of the outstanding shares of our common
stock;
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dividends
or distributions on our common stock payable in shares of our common stock
to all or substantially all holders of our common
stock;
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dividends
or distributions on our common stock payable in other than shares of our
common stock to all or substantially all holders of our common
stock;
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reclassifications,
exchanges or substitutions to our common stock whereby our common stock is
changed to the same or different number of shares or other securities of
any class or classes of stock or other property, other than by way of a
stock split, combination of shares or stock dividends or a reorganization,
merger, consolidation, or sale of
assets;
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distributions
to all or substantially all holders of our common stock of certain rights
or warrants to purchase or subscribe for shares of our common stock, or
securities convertible into or exchangeable or exercisable for shares of
our common stock, at a price per share that is less than the applicable
conversion price then in effect, or if after any such issuance, the price
per share is amended or adjusted and such price as amended or adjusted is
less than the applicable conversion
price;
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in
the event of a reorganization, merger, consolidation or sale of assets;
and
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issuances
or sales by us of additional shares of common stock at a price per share
less than the conversion price then in effect or without
consideration.
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Subject
to the provisions of the indenture, if we:
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distribute
shares of common stock in accordance with the second bullet point above,
then we will generally decrease the conversion price then in effect
immediately prior to such event by multiplying the applicable conversion
price then in effect by a fraction the numerator of which shall be the
total number of shares of common stock issued and outstanding immediately
prior to the time of such issuance or the close of business on such record
date and the denominator of which shall be the total number of shares of
common stock issued and outstanding immediately prior to the time of such
issuance or the close of business on such record date plus the number of
shares of common stock issuable in payment of such dividend or
distribution.
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make
distributions or issue dividends in other than shares of common stock in
accordance with the third bullet point above, then, we will make an
appropriate revision to the applicable conversion price and provision will
be made so that upon conversion of the August 2009 Notes, the holders will
receive (in addition to the number of shares of common stock they are
entitled to upon conversion) the number of securities or other property
that they would have received had the August 2009 Notes been converted
into common stock on the date of such event and had thereafter, during the
period from the date of such event to and including the conversion date,
retained such securities and any distributions or assets, applying all
adjustments called for during such period pursuant to the terms of the
July 2009 Note with respect to the rights of the holders of the August
2009 Notes; however, if a record date has been fixed and the dividend is
not fully paid or such distribution is not fully made on the date fixed
for such payment or distribution, then the conversion price will be
adjusted as provided in this bullet point as of the time of actual payment
of such dividends or
distributions.
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make
distributions in accordance with the fifth or seventh bullet point above,
the applicable conversion price upon each such issuance or distribution
shall be reduced to a price equal to the consideration per share paid for
such additional shares of common stock; however, the amount of
consideration received for such additional shares of common stock shall
not include the value of any additional securities or other rights
received in connection with such issuance or distribution of additional
shares of common stock.
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On
conversion, the holders of August 2009 Notes will receive, in addition to
additional August 2009 Notes, the rights under our stockholder rights plan or
any future stockholder rights plan that we may establish, unless the rights have
separated from our common stock at the time of conversion, in which case the
conversion rate will be adjusted at the time of separation as if we had
distributed to all holders of our common stock shares of our capital stock,
evidences of indebtedness, other assets or certain rights or warrants as
described in the fifth bullet point under “—Adjustments to the conversion rate”
above, subject to readjustment in the event of the expiration, termination or
redemption of such rights.
In the
event of:
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a
taxable distribution to holders of common stock which results in an
adjustment to the conversion rate;
or
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an
increase in the conversion rate at our
discretion
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the
holders of the August 2009 Notes may, in certain circumstances, be deemed to
have received a distribution subject to US federal income tax as a dividend.
This generally would occur, for example, if we adjust the conversion rate to
compensate holders for cash dividends on our common stock and could also occur
if we make other distributions of cash or property to our stockholders. See
“Material US federal income tax consequences—Consequences to US holders” and
“—Consequences to non-US holders.”
RANKING
The
August 2009 Notes will be unsecured and subordinated to the 2008 Notes and April
2009 Notes to the extent of the security for such notes, and senior in time and
right of payment to all other indebtedness of the Company and pari passu in time and right
of payment to the July 2009 Notes.
The
indenture does not limit the amount of additional indebtedness, including
secured indebtedness, which we can create, incur, assume or guarantee, nor does
the indenture limit the amount of indebtedness or other liabilities that our
subsidiaries can create, incur, assume or guarantee.
For a
description of our existing indebtedness, see “Description of other
indebtedness.”
SECURITY
The
August 2009 Notes will be unsecured.
CONSOLIDATION,
MERGER AND SALE OF ASSETS
The
indenture prohibits us from consolidating with or merging with or into, or
selling, transferring, leasing, conveying or otherwise disposing of all or
substantially all of our property or assets to, another person (including
pursuant to a statutory arrangement), whether in a single transaction or series
of related transactions, unless, among other things:
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such
person expressly assumes all of our obligations under the August 2009
Notes and the indenture, and
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no
default or event of default exists immediately after giving effect to the
transaction or series of
transactions.
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When
the successor assumes all of our obligations under the indenture, our
obligations under the indenture will terminate.
There is
no precise, established definition of the phrase “all or substantially all”
under applicable law. Accordingly, there may be uncertainty as to whether the
provisions above would apply to a sale, transfer, lease, conveyance or other
disposition of less than all of our property or assets.
Pursuant
to the terms of the indenture, in the event of a change of control, the trustee
may require the Company to prepay, effective immediately prior to the
consummation of the change of control, all of such holder’s then outstanding
August 2009 Notes. In the event we can prepay some, but not all of
the August 2009 Notes, will prepay to each holder of August 2009 Notes electing
to have its August 2009 Notes prepaid at that time an amount equal to such
holder’s pro-rata amount of all outstanding August 2009 Notes being
prepaid. Furthermore, pursuant to the terms of the Indenture, a
change of control is an event of default and, as a result, in the event the
trustee demands redemption of the August 2009 Notes upon such change of control,
then the trustee will have the right to require that we prepay all or a portion
of such August 2009 Note in cash at a price equal to the sum of (i) the greater
of (A) one hundred percent (100%) of the aggregate principal amount of such
holder’s August 2009 Note plus all accrued and unpaid interest and (B) the
aggregate principal amount of such holder’s August 2009 Note plus all accrued
but unpaid interest hereon, divided by the conversion price on the date the
prepayment price is demanded or otherwise due or the date the prepayment price
is paid in full (whichever is less), multiplied by the Daily VWAP on the date
the prepayment price is demanded or otherwise due, and the date the prepayment
price is paid in full (whichever is greater).
EVENTS
OF DEFAULT
The
following are events of default under the indenture for the August 2009
Notes:
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our
failure to pay the principal of any August 2009 Note or any other note,
when due whether at maturity or
otherwise;
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our
failure to pay an installment of interest on, or liquidated damages in
respect of any August 2009 Note or any other note, when
due;
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our
failure to comply with any covenant, condition or agreement set forth in
the August 2009 Notes or any other note, and such failure is not cured
within three (3) business days after notice of such
default;
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our
common stock is no longer listed on at least one of the OTC Bulletin
Board, the American Stock Exchange, the NASDAQ Capital Market, the NASDAQ
Global Market or the New York Stock Exchange, Inc. for a period of 20
consecutive trading days;
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our
notice to the holder, including by way of public announcement, at any
time, of our inability to comply or our intention not to comply with
proper requests for conversion of the August 2009 Notes into shares of
common stock;
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our
failure to (i) timely deliver the shares of common stock as and when
required, (ii) make the payment of any fees and/or liquidated damages
under the August 2009 Notes, indenture, purchase agreement or other
transaction document, which failure is not remedied within three (3)
business days after the incurrence
thereof;
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our
default in the performance or observance of any material covenant,
condition or agreement contained in the purchase agreement or any other
transaction document and such default is not fully cured within seven (7)
business days after we receive notice from the holder of the occurrence
thereof;
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at
any time following the issuance date we fail to have a sufficient number
of shares of common stock authorized, reserved and available for issuance
to satisfy the potential conversion in full (disregarding for this purpose
any and all limitations of any kind on such conversion) of any August 2009
Note;
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if
any material representation or warranty made by us or any of our
subsidiaries in the purchase agreement, or any other transaction document
shall prove to have been false or incorrect or breached in a material
respect on the date as of which
made;
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if
we shall, or shall announce an intention to, consider, pursue or
consummate a change of control (as defined below), or a change of control
shall be consummated, or we shall negotiate, consider, propose or enter
into any agreement, understanding or arrangement with respect to any
change of control. A “change of control” shall
mean:
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the
consolidation, merger or other business combination with or into another
person (other than (A) pursuant to a migratory merger effected solely for
the purpose of changing the jurisdiction of our incorporation or (B) a
consolidation, merger or other business combination in which holders of
our voting power immediately prior to the transaction continue after the
transaction to hold, directly or indirectly, the voting power of the
surviving entity or entities necessary to elect a majority of the members
of the board of directors (or their equivalent if other than a
corporation) of such entity or
entities);
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the
sale, transfer disposition or exclusive license of more than fifty percent
(50%) of our intellectual property or assets (based on the fair market
value as determined in good faith by the holders) other than inventory in
the ordinary course of business in one or a related series of
transactions; except for any such transaction described in this clause
that has been approved in writing by the holders of two-thirds of the then
outstanding principal amount of the August 2009 Notes;
or
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closing
of a purchase, tender or exchange offer made to the holders of more than
fifty percent (50%) of the outstanding shares of common stock in which
more than fifty percent (50%) of the outstanding shares of common stock
were tendered and accepted.
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if
we or any of our subsidiaries (A) default in any payment of any amount or
amounts of principal of or interest on any indebtedness (other than the
indebtedness under the August 2009 Notes) the aggregate principal amount
of which indebtedness is in excess of $250,000 or (B) default in the
observance or performance of any other agreement or condition relating to
any such indebtedness or contained in any instrument or agreement
evidencing, securing or relating thereto, or any other event shall occur
or condition exist, the effect of which default or other event or
condition is to cause, or to permit the holder or holders or beneficiary
or beneficiaries of such indebtedness to cause with the giving of notice
if required, such Indebtedness to become due prior to its stated
maturity;
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if
we or any of our subsidiaries shall (i) apply for or consent to the
appointment of, or the taking of possession by, a receiver, custodian,
trustee or liquidator of itself or of all or a substantial part of its
property or assets, (ii) make a general assignment for the benefit of its
creditors, (iii) commence a voluntary case under the United States
Bankruptcy Code or under the comparable laws of any foreign or domestic
jurisdiction, (iv) file a petition seeking to take advantage of any
bankruptcy, insolvency, moratorium, reorganization or other similar law
affecting the enforcement of creditors’ rights generally, (v) acquiesce in
writing to any petition filed against it in an involuntary case under
United States Bankruptcy Code or under the comparable laws of any foreign
or domestic jurisdiction, (vi) issue a notice of bankruptcy or winding
down of its operations or issue a press release regarding same, or (vii)
take any action under the laws of any foreign or domestic jurisdiction
analogous to any of the
foregoing;
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certain
events of bankruptcy, insolvency or reorganization with respect to
us;
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the
occurrence of an event of default under any of our other
notes;
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our
deregistering our shares of common stock and, as a result, such shares are
no longer publicly traded;
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our
consummation of a “going private” transaction and as a result our common
stock is no longer registered under Sections 12(b) or 12(g) of the
Exchange Act;
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if
there is any SEC or judicial stop trade order or trading suspension
stop-order or any restriction in place with the transfer agent for the
common stock restricting the trading of such common
stock;
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the
occurrence of a material adverse effect relating to us or any of our
subsidiaries taken as a whole;
or
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if
we issue, as payment on the August 2009 Notes, invalid
notes.
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If an
event of default has occurred and is continuing, the trustee of the August 2009
Notes or the holders may at any time at their option declare the entire
unpaid principal balance of August 2009 Notes, together with all accrued
interest, immediately due and payable, and the same shall be accelerated and due
and payable, without notice. In addition, upon an event of default as
described above, the trustee of the holders, in thier sole discretion, may
also (a) demand the redemption of the August 2009 Notes, (b) demand that the
principal amount of the August 2009 Notes then outstanding and, all accrued and
unpaid interest thereon be converted into shares of common stock at the
conversion price per share on the trading day immediately preceding the date on
which conversion is demanded, or (c) exercise or enforce any other of the
holder’s rights or remedies under the terms of the August 2009 Notes, the
purchase agreement, the other transaction documents or under the
law. If, upon an event of default, the trustee or the holders demand
redemption of the August 2009 Notes, then the trustee will have the right to
require that we prepay all or a portion of the August 2009 Notes in cash at a
price equal to the sum of (i) the greater of (A) one hundred percent (100%) of
the aggregate principal amount of the August 2009 Notes plus all accrued and
unpaid interest and (B) the aggregate principal amount of the August 2009 Notes
plus all accrued but unpaid interest hereon, divided by the conversion price on
the date the prepayment price is demanded or otherwise due or the date the
prepayment price is paid in full (whichever is less), multiplied by the Daily
VWAP on the date the prepayment price is demanded or otherwise due, and the date
the prepayment price is paid in full (whichever is greater).
After
any such acceleration, the holders of 66-2/3% of the then outstanding aggregate
principal amount of the August 2009 Notes, by written notice to the trustee, may
rescind or annul such acceleration in certain circumstances,
if:
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all
events of default, other than the non-payment of accelerated principal,
have been cured or waived; and
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certain
amounts due under the notes and to the trustee are
paid.
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The
indenture does not obligate the trustee to exercise any of its rights or powers
at the request or demand of the holders, unless the holders have offered to the
trustee security or indemnity that is reasonably satisfactory to the trustee
against the costs, expenses and liabilities that the trustee may incur to comply
with the request or demand. Subject to the indenture, applicable law and the
trustee’s rights to indemnification, the holders of 66-2/3% of the then
outstanding aggregate principal amount of the August 2009 Notes will have the
right to direct the time, method and place of conducting any proceeding for any
remedy available to the trustee or exercising any trust or power conferred on
the trustee.
No
holder will have any right to institute any proceeding under the indenture, or
for the appointment of a receiver or a trustee, or for any other remedy under
the indenture unless:
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the
holder gives the trustee written notice of a continuing event of
default;
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the
holders of not less than 25% in aggregate principal amount of the
outstanding August 2009 Notes make a written request to the trustee to
pursue the remedy;
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the
holder or holders offer and, if requested, provide the trustee indemnity
reasonably satisfactory to the trustee against any loss, liability or
expense; and
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the
trustee fails to comply with the request within 60 days after the trustee
receives the notice, request and offer of indemnity and does not receive,
during those 60 days, from holders of 66-2/3% of the then outstanding
aggregate principal amount of the August 2009 Notes, a direction that is
inconsistent with the request.
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However,
the above limitations, do not apply to a suit by a holder to
enforce:
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the
payment of any amounts due on that holder’s August 2009 Notes after the
applicable due date; or
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the
right to convert that holder’s August 2009 Notes into shares of our common
stock in accordance with the
indenture.
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Except
as provided in the indenture, the holders of 66-2/3% of the then outstanding
aggregate principal amount of the August 2009 Notes may, by notice to the
trustee, waive any past default or event of default and its consequences, other
than a default or event of default:
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in
the payment of principal of, or interest, on, any
note;
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arising
from our failure to convert any note into shares of our common stock in
accordance with the indenture; or
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in
respect of any provision under the indenture that cannot be modified or
amended without the consent of the holders of each outstanding note
affected.
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We
will promptly notify the trustee if a default or event of default occurs. In
addition, the indenture requires us to furnish to the trustee, on an annual
basis, a statement by our officers stating whether they are aware of any default
or event of default by us in performing any of our obligations under the
indenture or the August 2009 Notes and describing any such default or event of
default. If a default or event of default has occurred and the trustee has
received notice of the default or event of default in accordance with the
indenture, the trustee must mail to each holder a notice of the default or event
of default within 30 days after it occurs. However, the trustee need not mail
the notice if the default or event of default:
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has
been cured or waived; or
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is
not in the payment of any amounts due with respect to any note and the
trustee in good faith determines that withholding the notice is in the
best interests of holders.
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MODIFICATION
AND WAIVER
We may
amend or supplement the indenture or the August 2009 Notes with the consent of
the trustee and holders of at least two-thirds of the principal amount of the
then outstanding notes and, provided that any holder is materially adversely
affected in a different manner than the other holders by the proposed amendment
or supplement, such adversely affected holder has also provided their
consent. In addition, subject to certain exceptions, the holders of
at least two-thirds of the then outstanding principal amount of the then
outstanding notes may waive our compliance with any provision of the indenture
or August 2009 Notes. However, without the consent of the holders of each
outstanding note affected, no amendment, supplement or waiver
may:
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impair
the right to institute a suit for the enforcement of any payment on, or
with respect to, or of the conversion of, any
note;
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modify
the ranking provisions of the indenture in a manner adverse to the holders
of August 2009 Notes;
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adversely
affect the right of the holders of the August 2009 Notes to convert their
August 2009 Notes in accordance with the
indenture;
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reduce
the percentage in aggregate principal amount of outstanding August 2009
Notes whose holders must consent to a modification or amendment of the
indenture or the August 2009
Notes;
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reduce
the percentage in aggregate principal amount of outstanding August 2009
Notes whose holders must consent to a waiver of compliance with any
provision of the indenture or the August 2009 Notes or a waiver of any
default or event of default; or
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modify
the provisions of the indenture with respect to modification and waiver
(including waiver of a default or event of default), except to increase
the percentage required for modification or waiver or to provide for the
consent of each affected holder.
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We
may, with the trustee’s consent, amend or supplement the indenture or the August
2009 Notes without notice to or the consent of any holder of the August 2009
Notes to:
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evidence
the assumption of our obligations under the indenture and the August 2009
Notes by a successor upon our consolidation or merger or the sale,
transfer, lease, conveyance or other disposition of all or substantially
all of our property or assets in accordance with the
indenture;
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make
adjustments in accordance with the indenture to the right to convert the
August 2009 Notes upon certain reclassifications or changes in our common
stock and certain consolidations, mergers and binding share exchanges and
upon the sale, transfer, lease, conveyance or other disposition of all or
substantially all of our property or
assets;
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grant
additional security for our obligations in respect of the August 2009
Notes;
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make
provision with respect to adjustments to the conversion rate as required
by the indenture but not to increase the conversion rate in accordance
with the indenture; or
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surrender
any right or power conferred upon
us.
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In
addition, we and the trustee may enter into a supplemental indenture without the
consent of holders of the August 2009 Notes in order to cure any ambiguity,
defect, omission or inconsistency in the indenture in a manner that does not,
individually or in the aggregate with all other changes, adversely affect the
rights of any holder. We and the trustee may also enter into a supplemental
indenture without the consent of holders of the notes in order to conform the
indenture to the description of the notes contained in this
prospectus.
DISCHARGE
We may
generally satisfy and discharge our obligations under the indenture
by:
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delivering
all outstanding August 2009 Notes to the trustee for cancellation;
or
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depositing
with the trustee or the paying agent after the August 2009 Notes have
become due and payable, at stated maturity, cash sufficient to pay all
amounts due on all outstanding August 2009 Notes and paying all other sums
payable under the indenture; provided that such cash deposited with the
trustee is not subject to any liens other than a lien in favor of the
August 2009 Notes.
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In
addition, at the time of discharge we must have paid all other sums that are due
under the terms of the indenture and have delivered to the trustee an officer’s
certificate and opinion of counsel stating that we have complied with all
conditions precedent relating to satisfaction and discharge of the
indenture.
Notwithstanding
the foregoing, upon satisfaction and discharge of the indenture, the following
rights will survive: conversion rights, trustee’s payment rights and, in the
case of a deposit to pay all amounts due on all outstanding August 2009 Notes,
certain other provisions as set forth in the indenture.
CALCULATIONS
IN RESPECT OF AUGUST 2009 NOTES
We and
our agents are responsible for making all calculations called for under the
indenture and August 2009 Notes. These calculations include, but are not limited
to, the determination of the current market price of our common stock, the
number of shares issuable and the amount of any cash payable upon conversion of
the August 2009 Notes and amounts of interest payable on the August 2009 Notes
and adjustments to the conversion rate. We and our agents will make all of these
calculations in good faith, and, absent manifest error, these calculations will
be final and binding on all holders of August 2009 Notes. We will provide a copy
of these calculations to the trustee, as required, and, absent manifest error,
the trustee is entitled to rely on the accuracy of our calculations without
independent verification. To the extent information is required from the holders
to make any calculations under the indenture, the Company shall be entitled to
rely on representations made by the holders in making its
calculations.
REPORTING
The
indenture provides for us to file with the trustee, within 15 days after we are
required to file the same with the SEC, after giving effect, to the extent
applicable, any extension permitted by Rule 12b-25 under the Exchange Act,
copies of the annual reports and of the information, documents and other reports
(or copies of such portions of any of the foregoing as the SEC may from time to
time by rules and regulations prescribe) that we file with the SEC, pursuant to
Section 13 or Section 15(d) of the Exchange Act; provided, however, that we will
not be required to deliver to the trustee any materials for which we have sought
and obtained confidential treatment from the SEC. Documents filed by us with the
SEC via the EDGAR system will be deemed filed with the trustee as of the time
such documents are filed via EDGAR. If we are not required to file information,
documents or reports pursuant to Section 13 or Section 15(d) of the Exchange
Act, we will file with the trustee and, unless the SEC will not accept such a
filing, the SEC, in accordance with rules and regulations prescribed from time
to time by the SEC, no later than the date we would have been required to file
the same with the SEC, such periodic reports and other documents which may be
required pursuant to Section 13 of the Exchange Act in respect of a security
listed and registered on a national securities exchange as may be prescribed
from time to time in such rules and regulations. We will also comply with
Section 314(a) of the Trust Indenture Act of 1939, as
amended.
REPORTS
TO TRUSTEE
We will
regularly furnish to the trustee copies of our annual report to stockholders,
containing audited financial statements, and any other financial reports which
we furnish to our stockholders.
UNCLAIMED
MONEY
If
money deposited with the trustee or paying agent for the payment of principal
of, premium, if any, or accrued and unpaid interest on, the August 2009 Notes
remains unclaimed for two years, the trustee and paying agent will pay the money
back to us upon our written request. However, the trustee and paying agent have
the right to withhold paying the money back to us until they publish in a
newspaper of general circulation in the City of New York, or mail to each
holder, a notice stating that the money will be paid back to us if unclaimed
after a date no less than 30 days from the publication or mailing. After the
trustee or paying agent pays the money back to us, holders of August 2009 Notes
entitled to the money must look to us for payment as general creditors, subject
to applicable law, and all liability of the trustee and the paying agent with
respect to the money will cease.
PURCHASE
AND CANCELLATION
The
registrar, paying agent and conversion agent will forward to the trustee any
August 2009 Notes surrendered to them for transfer, exchange, payment or
conversion, and the trustee will promptly cancel those August 2009 Notes in
accordance with its customary procedures. We will not issue August 2009 Notes to
replace August 2009 Notes that we have paid or delivered to the trustee for
cancellation or that any holder has converted.
We
may, to the extent permitted by law, purchase August 2009 Notes in the open
market or by tender offer at any price or by private agreement. We may, at our
option and to the extent permitted by law, reissue, resell or surrender to the
trustee for cancellation any August 2009 Notes we purchase in this manner.
August 2009 Notes surrendered to the trustee for cancellation may not be
reissued or resold and will be promptly cancelled.
REPLACEMENT
OF AUGUST 2009 NOTES
We
will replace mutilated, lost, destroyed or stolen August 2009 Notes at the
holder’s expense upon delivery to the trustee of the mutilated August 2009 Notes
or evidence of the loss, destruction or theft of the August 2009 Notes
satisfactory to the trustee and us. In the case of a lost, destroyed or stolen
note, we or the trustee may require, at the expense of the holder, indemnity
reasonably satisfactory to us and the trustee.
TRUSTEE
AND TRANSFER AGENT
The
trustee for the August 2009 Notes is U.S. Bank National Association, and we have
appointed the trustee as the paying agent, registrar, conversion agent and
custodian with regard to the August 2009 Notes. The indenture permits the
trustee to deal with us and any of our affiliates with the same rights the
trustee would have if it were not trustee. However, under the Trust Indenture
Act of 1939, if the trustee acquires any conflicting interest and there exists a
default with respect to the August 2009 Notes, the trustee must eliminate the
conflict or resign. U.S. Bank National Association and its affiliates have in
the past provided and may from time to time in the future provide banking and
other services to us in the ordinary course of their
business.
The
holders of 66-2/3% of the then outstanding aggregate principal amount of the
August 2009 Notes have the right to direct the time, method and place of
conducting any proceeding for any remedy available to the trustee. If an event
of default occurs and is continuing, the trustee must exercise its rights and
powers under the indenture using the same degree of care and skill as a prudent
person would exercise or use under the circumstances in the conduct of his or
her own affairs. The indenture does not obligate the trustee to exercise any of
its rights or powers at the request or demand of the holders, unless the holders
have offered to the trustee security or indemnity that is reasonably
satisfactory to the trustee against the costs, expenses and liabilities that the
trustee may incur to comply with the request or demand.
The
transfer agent for our common stock is BNY Mellon Shareholder
Services.
LISTING
AND TRADING
The
August 2009 Notes and warrants are a new issue of securities, and there is
currently no established trading market for the August 2009 Notes and warrants.
An active or liquid market is not expected to develop for the August 2009 Notes
and warrants or, if developed, be maintained. We have not applied, and do not
intend to apply, for the listing of the August 2009 Notes and warrants on any
securities exchange. Our common stock is listed on the OTC Bulletin Board under
the ticker symbol “GETA.”
FORM,
DENOMINATION AND REGISTRATION OF AUGUST 2009 NOTES
General
The
August 2009 Notes will be issued in registered form, without interest coupons,
in denominations of integral multiples of $1,000 principal amount, in the form
of global securities, as further provided below. See “—Global securities” below
for more information.
See
“—Global securities” and “—Certificated securities” for a description of
additional transfer restrictions that apply to the August 2009
Notes.
We will
not impose a service charge in connection with any transfer or exchange of any
note, but we may in general require payment of a sum sufficient to cover any
transfer tax or similar governmental charge imposed in connection with the
transfer or exchange.
Global
securities
Global
securities will be deposited with the trustee as custodian for The Depository
Trust Company, or DTC, and registered in the name of DTC or a nominee of
DTC.
Investors
may hold their interests in a global security directly through DTC, if they are
DTC participants, or indirectly through organizations that are DTC
participants.
Except
in the limited circumstances described below and in “—Certificated securities,”
holders of August 2009 Notes will not be entitled to receive August 2009 Notes
in certificated form. Unless and until it is exchanged in whole or in part for
certificated securities, each global security may not be transferred except as a
whole by DTC to a nominee of DTC or by a nominee of DTC to DTC or another
nominee of DTC.
We
will apply to DTC for acceptance of the global securities in its book-entry
settlement system. The custodian and DTC will electronically record the
principal amount of August 2009 Notes represented by global securities held
within DTC. Beneficial interests in the global securities will be shown on
records maintained by DTC and its direct and indirect participants. So long as
DTC or its nominee is the registered owner or holder of a global security, DTC
or such nominee will be considered the sole owner or holder of the August 2009
Notes represented by such global security for all purposes under the indenture
and the August 2009 Notes. No owner of a beneficial interest in a global
security will be able to transfer such interest except in accordance with DTC’s
applicable procedures and the applicable procedures of its direct and indirect
participants. The laws of some jurisdictions may require that certain purchasers
of securities take physical delivery of such securities in definitive form.
These limitations and requirements may impair the ability to transfer or pledge
beneficial interests in a global security.
Payments
of principal, premium, if any, and interest under each global security will be
made to DTC or its nominee as the registered owner of such global security. We
expect that DTC or its nominee, upon receipt of any such payment, will
immediately credit DTC participants’ accounts with payments proportional to
their respective beneficial interests in the principal amount of the relevant
global security as shown on the records of DTC. We also expect that payments by
DTC participants to owners of beneficial interests will be governed by standing
instructions and customary practices, as is now the case with securities held
for the accounts of customers registered in the names of nominees for such
customers. Such payments will be the responsibility of such participants, and
none of us, the trustee, the custodian or any paying agent or registrar will
have any responsibility or liability for any aspect of the records relating to
or payments made on account of beneficial interests in any global security or
for maintaining or reviewing any records relating to such beneficial
interests.
DTC has
advised us that it is a limited-purpose trust company organized under the New
York Banking Law, a “banking organization” within the meaning of the New York
Banking Law, a member of the Federal Reserve System, a “clearing corporation”
within the meaning of the New York Uniform Commercial Code and a “clearing
agency” registered under the Exchange Act. DTC was created to hold the
securities of its participants and to facilitate the clearance and settlement of
securities transactions among its participants in such securities through
electronic book-entry changes in accounts of the participants, which eliminates
the need for physical movement of securities certificates.
DTC’s
participants include securities brokers and dealers (including Rodman &
Renshaw, LLC), banks, trust companies, clearing corporations and certain other
organizations, some of whom (and/or their representatives) own DTC. Access to
DTC’s book-entry system is also available to others, such as banks, brokers,
dealers and trust companies, that clear through or maintain a custodial
relationship with a participant, either directly or indirectly. The ownership
interest and transfer of ownership interests of each beneficial owner or
purchaser of each security held by or on behalf of DTC are recorded on the
records of the direct and indirect participants.
Certificated
securities
The
trustee will exchange each beneficial interest in a global security for one or
more certificated securities registered in the name of the owner of the
beneficial interest, as identified by DTC, only if:
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DTC
notifies us that it is unwilling or unable to continue as depositary for
that global security or ceases to be a clearing agency registered under
the Exchange Act and, in either case, we do not appoint a successor
depositary within 90 days of such notice or cessation;
or
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an
event of default has occurred and is continuing and the trustee has
received a request from DTC to issue certificated
securities.
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Same-day
settlement and payment
We
will make payments in respect of August 2009 Notes represented by global
securities by wire transfer of immediately available funds to DTC or its nominee
as registered owner of the global securities. We will make payments in respect
of August 2009 Notes that are issued in certificated form by wire transfer of
immediately available funds to the accounts specified by each holder of August
2009 Notes. However, if a holder of a certificated note does not specify an
account, then we will mail a check to that holder’s registered
address.
We
expect the August 2009 Notes will trade in DTC’s Same-Day Funds Settlement
System, and DTC will require all permitted secondary market trading activity in
the August 2009 Notes to be settled in immediately available funds. We expect
that secondary trading in any certificated securities will also be settled in
immediately available funds.
Transfers
between participants in DTC will be effected in the ordinary way in accordance
with DTC rules and will be settled in same-day funds.
Although
we understand that DTC has agreed to the above procedures to facilitate
transfers of interests in the global securities among DTC participants, DTC is
under no obligation to perform or to continue those procedures, and those
procedures may be discontinued at any time. None of us, the trustee will have
any responsibility for the performance by DTC or its direct or indirect
participants of their respective obligations under the rules and procedures
governing their operations.
We have
obtained the information we describe in this prospectus concerning DTC and its
book-entry system from sources that we believe to be reliable, but we do not
take any responsibility for the accuracy of this information.
GOVERNING
LAW
The
indenture and the August 2009 Notes will be governed by and construed in
accordance with the laws of the State of New York.
DESCRIPTION
OF THE WARRANTS
The material terms and provisions of
the warrants being offered pursuant to this prospectus are summarized
below. This summary is subject to, and qualified in its entirety by, the
terms of the warrants as set forth in the form of warrant filed as an exhibit
hereto.
The
warrants represent the right to purchase shares of common stock at an exercise
price of $1.00 per share. Each warrant may be exercised at any time and from
time to time on or after the six month anniversary of the date of its issuance,
until the two year anniversary of the date of its issuance.
A warrant
may be transferred by a holder without our consent upon surrender of the warrant
to us, properly endorsed by the holder executing an assignment in the form
attached to the warrant agreement.
The
warrants are subject to customary pro rata anti-dilution provisions for stock
splits or recapitalizations. The exercise price and the number of shares of
common stock are subject to adjustment in the event of stock splits, stock
dividends on our common stock, stock combinations or similar events affecting
our common stock. In addition, in the event we consummate any merger,
consolidation, sale or other reorganization event in which our common stock is
converted into or exchanged for securities, cash or other property or we
consummate a sale of substantially all of our assets, then following that event,
the holders of outstanding warrants may be entitled to receive upon exercise of
the warrants securities which the holders would have received if they had
exercised their warrants prior to such reorganization event or the repurchase of
the warrant by the Company for cash.
Upon
receipt of payment and the form of exercise properly completed and duly
executed, we will, as soon as practicable, issue the securities purchasable upon
exercise of the warrant. In addition, the warrants are subject to an issuance
cap that prevents the holder from exercising such warrants to the extent that
such exercise would result in the holder and the holder’s affiliates owning more
than 4.999% of our outstanding common stock after exercise.
Before
the exercise of their warrants, holders of warrants will not have any of the
rights of holders of the securities purchasable upon the exercise of the
warrants, and will not be entitled to, among other things, vote or receive
dividend payments or similar distributions on the securities purchasable upon
exercise.
Warrant
certificates may be exchangeable for new warrant certificates of different
denominations as indicated in the applicable warrant.
DESCRIPTION
OF CAPITAL STOCK
General
Our
authorized capital stock consists of 6,000,000,000 shares of common stock and
5,000,000 shares of preferred stock.
The
following descriptions are summaries of the material terms of our restated
certificate of incorporation and bylaws. Reference is made to the more detailed
provisions of, and the descriptions are qualified in their entirety by reference
to, the restated certificate of incorporation and bylaws and applicable law. Our
restated certificate of incorporation, as amended and our amended and restated
bylaws are incorporated by reference and copies are available upon request. See
“How to Get More Information” in this prospectus.
Common
Stock
Except as
required by law or by the restated certificate of incorporation, holders of
common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of the stockholders. Subject to preferences that may
be applicable to any then outstanding preferred stock, holders of common stock
are entitled to receive ratably such dividends as may be declared by the Board
of Directors out of funds legally available therefor. In the event of a
liquidation, dissolution or winding up of Genta, holders of our common stock and
our preferred stock are entitled to share ratably on an as-converted basis in
all assets remaining after payment of liabilities and the liquidation preference
of any then outstanding preferred stock. Holders of common stock have no right
to convert their common stock into any other securities. There are no redemption
or sinking fund provisions applicable to the common stock. All outstanding
shares of common stock are fully paid and non-assessable.
In
September 2005, the Board of Directors adopted a Stockholder Rights Plan and
declared a dividend of one preferred stock purchase right, or Right, for each
outstanding share of our common stock, payable to holders of record as of the
close of business on September 27, 2005. In addition, Rights shall be issued in
respect of all shares of common stock issued after such date, including the
shares issued hereunder, pursuant to the Plan. Generally, the rights become
exercisable upon the earlier of the close of business on the tenth business day
following the first public announcement that any person or group has become a
beneficial owner of 15% or more of our common stock and the close of business on
the tenth business day after the date of the commencement of a tender or
exchange offer by any person which would, if consummated, result in such person
becoming a beneficial owner of 15% or more of the our common stock. Each Right
shall be exercisable to purchase, for $25.00, subject to adjustment, one
one-hundredth of a newly registered share of Series G Participating Cumulative
Preferred Stock, par value $0.001 per share of the Company. The terms and
conditions of the Rights are set forth in a Rights Agreement dated September 20,
2005 between the Company and Mellon Investor Services, LLC, as Rights
Agent.
Preferred
Stock
The Board
of Directors has the authority, without further action by the stockholders, to
issue up to 5,000,000 shares of preferred stock in one or more series and to fix
the rights, preferences, privileges and restrictions thereof, including dividend
rights, conversion rights, voting rights, terms of redemption, liquidation
preferences and the number of shares constituting any series or the designation
of such series. The issuance of preferred stock could adversely affect the
voting power of holders of common stock and could have the effect of delaying,
deferring or preventing a change in control of Genta without further action by
the stockholders and may adversely affect the voting and other rights of the
holders of our common stock.
Series
A Convertible Preferred Stock
We are
authorized to issue 600,000 shares of Series A Convertible Preferred Stock. At
June 30, 2009, we had 7,700 shares of Series A Convertible Preferred Stock
issued and outstanding.
Each
share of Series A Convertible Preferred Stock is immediately convertible, into
shares of our common stock, at a rate determined by dividing the aggregate
liquidation preference of the series A convertible preferred stock by the
conversion price. The conversion price is subject to adjustment for
anti-dilution.
In the
event of a liquidation of Genta, the holders of Series A Convertible Preferred
Stock are entitled to a liquidation preference equal to $50.00 per
share.
Series
G Participating Cumulative Preferred Stock
Two
million shares of our Preferred Stock have been designated as Series G
Participating Cumulative Preferred Stock, none of which are issued and
outstanding. The Series G Participating Cumulative Preferred Stock are subject
to the Stockholder Rights Plan described above.
15% Senior Secured Convertible
Notes
On
June 5, 2008, we entered into a securities purchase agreement with certain
institutional and accredited investors, to place up to $40 million of senior
secured convertible notes, referred to herein as the notes, with such investors.
On June 9, 2008, we placed $20 million of such notes in the initial closing. The
notes bear interest at an annual rate of 15%, currently payable at quarterly
intervals in payment-in-kind notes, and after adjusting for the April 2, 2009
notes, are convertible into shares of our common stock at a conversion rate of
10,000 shares of common stock for every $1,000.00 of principal. Until February
17, 2009, the holders of the notes had the right, but not the obligation, to
purchase in whole or in part up to an additional $20 million of notes. We have
the right to force conversion of the notes in whole or in part if the closing
bid price of our common stock exceeds $0.50 for a period of 20 consecutive
trading days.
On
February 17, 2009, we amended the 2008 Notes to delete the second tranche option
to purchase an additional $20 million of 2008 Notes.
Certain
members of our senior management participated in the initial
closing.
The
issuance of common stock upon conversion of the convertible notes has adversely
affected the voting power of remaining holders of common stock and could result
in a change in control of Genta without further action by the
stockholders.
8% Senior Secured Convertible
Notes
On
April 2, 2009, we entered into a securities purchase agreement with certain
institutional and accredited investors, to place up to $12 million of senior
secured convertible notes, referred to herein as the notes, with such investors.
The Company closed with gross proceeds of approximately $6 million. The notes
bear interest at an annual rate of 8% payable at quarterly intervals in stock or
cash at our option, and are convertible into shares of our common stock at a
conversion rate of 10,000 shares of common stock for every $1,000.00 of
principal.
8%
Unsecured Subordinated Convertible Notes
On July 7, 2009, the Company entered
into a securities purchase agreement with certain institutional and accredited
investors, to place up to $10 million of Units, each unit consisting of (i) 70%
unsecured subordinated convertible notes, or the July 2009 Notes, and (ii) 30%
shares of the Company’s common stock. The Company also issued to the
investors two-year warrants to purchase common stock in an amount equal to 25%
of the number of shares of common stock issuable upon conversion of the July
2009 Notes purchased by each investor. The Company closed with gross
proceeds of approximately $3 million. The July 2009 Notes bear interest at an
annual rate of 8% payable semi-annually in cash or other notes, and are
convertible into shares of our common stock at a conversion rate of 10,000
shares of common stock for every $1,000.00 of principal. The Company
will have the right to force conversion of the July 2009 Notes, as well as all
its senior secured notes, in whole or in part if the daily volume weighted
average price of the Company’s common stock exceeds $0.50 for a period of 10
consecutive trading days and certain other conditions are met.
Delaware
Anti-Takeover Law
Under
Section 203 of the Delaware General Corporation Law certain “business
combinations” between a Delaware corporation, whose stock generally is publicly
traded or held of record by more than 2,000 stockholders, and an “interested
stockholder” are prohibited for a three-year period following the date that such
stockholder became an interested stockholder, unless:
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the
corporation has elected in its certificate of incorporation not to be
governed by Section 203 (we have not made such an
election);
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either
the business combination or the transaction which resulted in the
stockholder becoming an interested stockholder was approved by the board
of directors of the corporation before the other party to the business
combination became an interested
stockholder;
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upon
consummation of the transaction that made it an interested stockholder,
the interested stockholder owned at least 85% of the voting stock of the
corporation outstanding at the commencement of the transaction excluding
voting stock owned by directors who are also officers or held in employee
benefit plans in which the employees do not have the right to determine
confidentially whether shares held subject to the plan will be tendered in
a tender or exchange offer;
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on
or subsequent to such date the business combination is approved by the
board of directors and authorized at an annual or special meeting of
stockholders by the affirmative vote of at least 66-2/3% of the
outstanding voting stock which is not owned by the interested
stockholder.
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The
three-year prohibition also does not apply to certain business combinations
proposed by an interested stockholder following the announcement or notification
of certain extraordinary transactions involving the corporation and a person who
had not been an interested stockholder during the previous three years or who
became an interested stockholder with the approval of a majority of the
corporation’s directors. A “business combination” is defined to include mergers,
asset sales and other transactions resulting in financial benefit to a
stockholder. In general, an “interested stockholder” is a person who, together
with affiliates and associates, owns (or within three years, did own) 15% or
more of a corporation’s voting stock.
The
statute could prohibit or delay mergers or other takeover or change in control
attempts with respect to us and, accordingly, may discourage attempts to acquire
us even though such a transaction may offer our stockholders the opportunity to
sell their stock at a price above the prevailing market price.
Advance
Notice Requirements for Stockholder Proposals
Our
amended and restated bylaws provide that stockholders seeking to bring business
before an annual meeting of stockholders, or to nominate candidates for election
as directors at an annual meeting of stockholders, must provide timely notice
thereof in writing. To be timely, a stockholder’s notice must be delivered to
the secretary at our principal executive offices not less than 50 calendar days
nor more than 75 calendar days prior to the meeting; provided, that if less than
65 days’ notice or prior public disclosure of the date of the meeting is given
or made to stockholders, notice by the stockholder to be timely must be received
not later than the close of business on the 15th day following the day on which
notice of the date of the annual meeting was mailed or such public disclosure
was made. Our amended and restated bylaws also specify requirements as to the
form and content of a stockholder’s notice. These provisions may discourage
stockholders from bringing matters before an annual meeting of stockholders or
from making nominations for directors at an annual meeting of
stockholders.
Transfer
Agent Information
Our
transfer agent is BNY Mellon Securities LLC.
MATERIAL
U.S. FEDERAL INCOME TAX CONSEQUENCES
The
following is a general discussion of certain United States federal income tax
considerations relevant to holders of the notes and common stock into which the
notes may be converted. This discussion is based upon the Internal Revenue Code
of 1986, as amended (the “Code”), Treasury Regulations, Internal Revenue Service
(“IRS”) rulings and judicial decisions now in effect, all of which are subject
to change (possibly, with retroactive effect) or different interpretations.
There can be no assurance that the IRS will not challenge one or more of the tax
consequences described herein, and we have not obtained, nor do we intend to
obtain, a ruling from the IRS with respect to the United States federal income
tax consequences of acquiring or holding notes or common stock. This discussion
does not purport to deal with all aspects of United States federal income
taxation that may be relevant to a particular holder in light of the holder’s
circumstances (for example, persons subject to the alternative minimum tax
provisions of the Code or a holder whose “functional currency” is not the United
States dollar). Also, it is not intended to be wholly applicable to all
categories of investors, some of which (such as dealers in securities or
currencies, traders in securities that elect to use a mark-to-market method of
accounting, banks, thrifts, regulated investment companies, insurance companies,
tax-exempt organizations, and persons holding notes or common stock as part of a
hedging or conversion transaction or straddle or persons deemed to sell notes or
common stock under the constructive sale provisions of the Code) may be subject
to special rules. The discussion also does not discuss any aspect of state,
local or foreign law, or United States federal estate and gift tax law as
applicable to the holders of the notes and common stock into which the notes may
be converted. In addition, this discussion is limited to purchasers of notes who
hold the notes and common stock as “capital assets” within the meaning of
Section 1221 of the Code (generally, held for investment) and who purchased the
notes at the public offering price set forth on the front cover of this
prospectus supplement. This summary also assumes that the IRS will respect the
classification of the notes as indebtedness for United States federal income tax
purposes.
The
purchaser of the notes is advised to consult its own tax advisors regarding the
United States federal, state, local and foreign tax consequences of the
purchase, ownership and disposition of the notes and the common stock in its
particular situation.
As used
herein, the term “U.S. Holder” means a beneficial holder of a note or common
stock that for United States federal income tax purposes is (i) an individual
who is a citizen or resident (as defined in Section 7701(b) of the Code) of the
United States (unless such person is not treated as a resident of the United
States under an applicable income tax treaty), (ii) a corporation created or
organized under the laws of the United States or any political subdivision
thereof or other entity treated as a corporation for United States federal
income tax purposes, (iii) an estate the income of which is subject to United
States federal income taxation regardless of its source and (iv) in general, a
trust subject to the primary supervision of a court within the United States and
the control of a United States person as described in Section 7701(a)(30) of the
Code. A “Non-U.S. Holder” is any beneficial holder of a note or common stock
other than a U.S. Holder or an entity treated as a partnership for United States
tax purposes.
If a
partnership (including for this purpose any entity, domestic or foreign, treated
as a partnership for United States federal income tax purposes) is a beneficial
owner of the notes or common stock into which the notes may be converted, the
United States tax treatment of a partner in the partnership generally will
depend on the status of the partner and the activities of the partnership. As a
general matter, income earned through a foreign or domestic partnership is
attributed to its owners. A holder of the notes or common stock into which the
notes may be converted that is a partnership, and partners in such partnership,
should consult their own tax advisors about the United States federal income tax
consequences of holding and disposing of the notes and the common
stock.
Classification
of the Notes
The
proper treatment of the notes is subject to substantial uncertainty. The notes
have features that have not been addressed in any published authority and
consequently there can be no assurance that the Internal Revenue Service (the
“IRS”) might not successfully challenge the Company’s intended characterization
and tax reporting of the notes as described below. In particular, due to the
terms of the notes, there is substantial uncertainty as to the characterization
of the notes as debt for United States federal income tax purposes, and,
therefore, it is possible that the notes might be characterized as equity of the
Company. The Company, however, intends to treat the notes as debt for United
States federal income tax purposes. If the notes are not properly characterized
as debt, the notes will be treated as equity and subject to rules similar to
those described under “—U.S. Holders — The Common Sock” for U.S. Holders. For
Non-U.S. Holders, distributions out of the Company’s current or accumulated
earnings and profits generally are subject to withholding as further described
under the heading “— Non-U.S. Holders — Dividends.” In light of the substantial
uncertainty as to the United States federal income tax characterization of the
notes as debt or equity of the Company, prospective investors, particularly
those investors that would be Non-U.S. Holders, are urged to consult their own
tax advisors as to the United States federal, state, local and foreign tax
consequences of ownership and disposition of the notes.
Under the
indenture governing the notes, the Company will agree, and by acceptance of a
beneficial interest in a note each holder of a note will be deemed to have
agreed, to treat the notes as indebtedness for United States federal income tax
purpose that is subject to the Treasury regulations governing contingent payment
debt instruments (the “contingent payment debt regulations”) with a “comparable
yield” calculated in the manner described below.
However,
because the applicability of the contingent payment debt regulations to any
particular instruments, such as the notes, is uncertain, no assurance can be
given that the IRS will not assert that the notes should be treated differently.
Different treatment could affect the amount, timing and character of income,
gain or loss with respect to an investment in the notes.
Except as
otherwise stated in the discussion below, it is assumed that the notes will be
treated as debt for United States federal income tax purposes, rather than as
equity in the Company, that is subject to the contingent payment debt
regulations as described above. In light of the uncertainty and complexity of
the rules applicable to the notes, prospective investors are urged to consult
their tax advisors regarding the tax consequences of ownership and disposition
of the notes.
U.S.
Holders
Interest
Accruals on the Notes
Under the
contingent payment debt regulations, a U.S. Holder, regardless of its method of
accounting for United States federal income tax purpose, will be required to
accrue interest income on the notes on a constant yield basis at an assumed
yield (the “comparable yield”) determined at the time of issuance of the notes.
Accordingly, U.S. Holders generally will be required to include interest income,
in each year prior to maturity, in excess of the regular interest payments on
the notes. The comparable yield for the notes is based on the yield at which we
could issue a nonconvertible, fixed rate debt instrument with no contingent
payments, but with terms otherwise similar to those of the notes.
Solely
for purposes of determining the amount of interest income that a U.S. Holder
will be required to accrue, we are required to construct a “projected payment
schedule” in respect of the notes representing a series of payments the amount
and timing of which would produce a yield to maturity on the notes equal to the
comparable yield. Holders that wish to obtain the projected payment schedule may
do so by contacting the Company at (908) 286-9800.
The
comparable yield and the schedule of projected payments are not determined for
any purpose other than for the determination of a U.S. Holder’s interest
accruals and adjustments thereof in respect of the notes for United States
federal income tax purposes and do not constitute a projection or representation
regarding the actual amounts payable to U.S. Holders of the notes.
Pursuant
to the terms of the notes, we and every U.S. Holder agree (in the absence of an
administrative determination or judicial ruling to the contrary) to be bound by
our determination of the comparable yield and projected payment schedule and to
use such comparable yield and projected payment schedule in determining interest
accruals and adjustments in respect of the notes.
Based on
the comparable yield and the issue price for the notes, a U.S. Holder of a note
(regardless of its accounting method) will be required to accrue interest as the
sum of the daily portions of interest on the notes for each day in the taxable
year on which the U.S. Holder holds the note, adjusted upward or downward to
reflect the difference, if any, between the actual and projected amount of any
contingent payments on the notes (as set forth below). The issue price of the
notes is the first price at which a substantial amount of the notes is sold to
the public, excluding bond houses, brokers or similar persons or organizations
acting in the capacity of underwriters, placements agents or wholesalers (the
“issue price”).
The daily
portions of interest in respect of a note are determined by allocating to each
day in an accrual period the ratable portion of interest on the note that
accrues in the accrual period. The amount of interest on a note that accrues in
an accrual period is the product of the comparable yield on the note (adjusted
to reflect the length of the accrual period) and the adjusted issue price of the
note. The adjusted issue price of a note at the beginning of the first accrual
period will equal its issue price and for any accrual periods thereafter will be
(x) the sum of the issue price of such note and any interest previously accrued
thereon (disregarding any positive or negative adjustments described below)
minus (y) the amount of any projected payments on the notes for previous accrual
periods.
In
addition to the interest accrual discussed above, a U.S. Holder will be required
to recognize interest income equal to the amount of the excess of actual
payments over projected payments (a “positive adjustment”) in respect of a note
for a taxable year. For this purpose, the payments in a taxable year include the
fair market value of property (such as our common stock) received in that year.
If a U.S. Holder receives actual payments that are less than the projected
payments in respect of a note for a taxable year, the U.S. Holder will incur a
“negative adjustment” equal to the amount of such difference. This negative
adjustment will (i) first reduce the amount of interest in respect of the note
that a U.S. Holder would otherwise be required to include in the taxable year
and (ii) to the extent of any excess, give rise to an ordinary loss equal to
that portion of such excess that does not exceed the excess of (A) the amount of
all previous interest inclusions under the note over (B) the total amount of the
U.S. Holder’s net negative adjustments treated as ordinary loss on the note in
prior taxable years. A net negative adjustment is not subject to the 2% floor
limitation imposed on miscellaneous deductions under Section 67 of the Code. Any
negative adjustment in excess of the amounts described in (i) and (ii) will be
carried forward to offset future interest income in respect of the notes or to
reduce the amount realized on a sale, exchange or retirement of the
notes.
Sale,
Exchange, Conversion or Retirement of the Notes
Upon a
sale, exchange or retirement of a note for cash, a U.S. Holder will generally
recognize gain or loss. The calculation of the comparable yield and the schedule
of projected payments for the notes includes the receipt of our common stock
upon conversion as a contingent payment with respect to the notes. Accordingly,
the Company intends to treat the receipt of our common stock by a U.S. Holder
upon the conversion of a note as a payment under the contingent payment debt
regulations. As described above, holders have agreed to be bound by our
determination of the comparable yield and the schedule of projected
payments.
The
amount of gain or loss on a taxable sale, exchange, conversion or retirement
will be equal to the difference between the amount realized on the sale,
exchange, conversion or retirement (including the fair market value of our
common stock received, if any) and such U.S. Holder’s adjusted tax basis in the
note. A U.S. Holder’s adjusted tax basis in a note will generally be equal to
the U.S. Holder’s purchase price for the note, increased by any interest income
previously accrued by the U.S. Holder (determined without regard to any positive
or negative adjustments to interest accruals described above) and decreased by
the amount of any projected payments previously made on the note to the U.S.
Holder. A U.S. Holder generally will treat any gain as interest income and any
loss as ordinary loss to the extent of the excess of previous interest
inclusions over the total negative adjustments previously taken into account as
ordinary loss, and the balance as capital loss. The deductibility of capital
loss is subject to limitation.
A U.S.
Holder’s tax basis in our common stock received upon the conversion of a note
will equal the then current fair market value of such common stock. The U.S.
Holder’s holding period for our common stock received will commence on the day
immediately following the date of conversion.
Constructive
Distributions
The
conversion rate of the notes is subject to adjustment under certain
circumstances. Section 305 of the Code and the Treasury Regulations issued
thereunder may treat the holders of the notes as having received a constructive
distribution, resulting in a taxable dividend (subject to a possible dividends
received deduction in the case of corporate holders) to the extent of our
current and/or accumulated earnings and profits, if, and to the extent that
certain adjustments in the conversion rate, which may occur in limited
circumstances (particularly an adjustment to reflect a taxable dividend to
holders of common stock), increase the proportionate interest of a holder of
notes in our assets or earnings and profits, whether or not such holder ever
exercises its conversion privilege. Therefore, U.S. Holders may recognize
dividend income in the event of a deemed distribution even though they may not
receive any cash or property. Moreover, if there is not a full adjustment to the
conversion ratio of the notes to reflect a stock dividend or other event
increasing the proportionate interest of the holders of outstanding common stock
in our assets or earnings and profits, then such increase in the proportionate
interest of the holders of the common stock generally will be treated as a
distribution to such holders, taxable as a dividend (subject to a possible
dividends received deduction in the case of corporate holders) to the extent of
our current and/or accumulated earnings and profits. Adjustments to the
conversion rate made pursuant to a bona fide reasonable adjustment formula which
has the effect of preventing dilution in the interest of the holders of the debt
instruments, however, will generally not be considered to result in a
constructive dividend distribution.
The
Common Stock
Distributions
(including constructive distributions), if any, paid on the common stock that a
U.S. Holder receives upon conversion of a note generally will constitute a
taxable dividend, to the extent made from our current or accumulated earnings
and profits, as determined under United States federal income tax principles.
Any distribution in excess of our current and accumulated earnings and profits
will be treated first as a tax-free return of capital, which will reduce the
U.S. Holder’s adjusted tax basis in the shares (but not below zero). To the
extent such a distribution exceeds the U.S. Holder’s adjusted tax basis in the
shares, the distribution will generally be taxable as capital gain. Dividends
received by a corporate U.S. Holder may be eligible for a dividends received
deduction. For taxable years beginning before January 1, 2011, subject to
certain exceptions, dividends received by non-corporate shareholders (including
individuals) from domestic corporations generally are taxed at the same
preferential rates that apply to long-term capital gain.
Gain or
loss realized on the sale or exchange of common stock will equal the difference
between the amount realized on such sale or exchange and the U.S. Holder’s
adjusted tax basis in such common stock. Such gain or loss will generally be
long-term capital gain or loss if the holder has held or is deemed to have held
the common stock for more than twelve months. Generally, long-term capital gain
of non-corporate shareholders is eligible for a reduced rate of taxation. The
deductibility of capital losses is subject to certain limitations.
Non-U.S.
Holders
For
purposes of the following discussion, dividends and gain on the sale, exchange
or other disposition of a note or common stock will be considered to be “U.S.
trade or business income” if such income or gain is (i) effectively connected
with the conduct of a United States trade or business and (ii) in the case of a
Non-U.S. Holder eligible for the benefits of an applicable United States
bilateral income tax treaty, attributable to a permanent establishment (or, in
the case of an individual, a fixed base) in the United States.
Notes
All
payments on the notes made to a Non-U.S. Holder, including a payment in our
common stock or cash pursuant to a conversion or retirement, and any gain
realized on a sale or exchange of the notes will be exempt from United States
federal income and withholding tax, provided that:
• the
Non-U.S. Holder does not own, actually or constructively, 10% or more of the
total combined voting power of all classes of our stock entitled to vote, is not
a controlled foreign corporation related, directly or indirectly, to us through
stock ownership, and is not a bank receiving certain types of
interest;
• the
certification requirement described below has been fulfilled with respect to the
Non-U.S. Holder;
• such
payments are not effectively connected with the conduct by such Non-U.S. Holder
of a trade or business in the United States; and
• in the
case of gain realized on the sale, exchange, conversion or retirement of the
notes, we are not, and have not been within the shorter of the five-year period
preceding such sale, exchange, conversion or retirement and the period the
Non-U.S. Holder held the notes, a U.S. real property holding corporation. We
believe that we are not, and do not anticipate becoming, a U.S. real property
holding corporation for United States federal income tax
purposes.
However,
if a Non-U.S. Holder were deemed to have received a constructive dividend (see
“— U.S. Holders — Constructive Distributions” above), the Non-U.S. Holder
generally will be subject to United States withholding tax at a 30% rate,
subject to reduction by an applicable treaty, on the taxable amount of the
dividend. A Non-U.S. Holder who is subject to withholding tax under such
circumstances should consult his own tax advisor as to whether he can obtain a
refund for all or a portion of the withholding tax.
The
certification requirement referred to above will be fulfilled if the beneficial
owner of a note certifies to the Company on IRS Form W-8BEN (or any successor
thereto), under penalties of perjury, that it is not a U.S. person and provides
the required information.
If a
Non-U.S. Holder does not qualify for the United States withholding tax exemption
described above, then the Non-U.S. Holder generally will be subject to United
States withholding tax at a 30% rate, subject to reduction by an applicable
treaty, on all payments received on the notes (as described above). In order to
obtain a reduced rate of withholding, a Non-U.S. Holder must comply with
applicable certification requirements, which generally include furnishing a
properly executed IRS Form W-8BEN (or any successor thereto) or a substitute
form. Non-U.S. Holders who are subject to United States withholding tax under
such circumstances should consult their own tax advisors as to whether they can
obtain a refund for all or a portion of the withholding tax.
If a
Non-U.S. Holder of a note is engaged in a trade or business in the United
States, and if payments on the note are effectively connected with the conduct
of this trade or business, the Non-U.S. Holder, although exempt from U.S.
withholding tax, will generally be taxed in the same manner as a U.S. Holder
(see “— U.S. Holders” above), except that the Non-U.S. Holder will be required
to provide a properly executed IRS Form W-8ECI in order to claim an exemption
from withholding tax. These Non-U.S. Holders should consult their own tax
advisors with respect to other tax consequences of the ownership of the notes,
including the possible imposition of a branch profits tax at a rate of 30%,
subject to reduction by an applicable treaty, on their effectively connected
income.
As
discussed above, the proper treatment of the notes is subject to substantial
uncertainty. The notes have features that have not been addressed in any
published authority and consequently there can be no assurance that the IRS
might not successfully challenge the Company’s intended characterization and tax
reporting of the notes as debt and it is possible that the notes might be
characterized as equity of the Company. In such a case, payments with respect to
the notes will be treated as distributions with respect to stock of the Company
and will be characterized as dividends to the extent of the Company’s current or
accumulated earnings and profits. Dividends paid by the Company to Non-U.S
Holders do not qualify for the withholding exception described above and will be
subject to withholding as described below in “ — Non-U.S. Holders — Dividends.”
In light of the substantial uncertainty as to the United States federal income
tax characterization of the notes as debt or equity of the Company, prospective
investors are urged to consult their own tax advisors as to the United States
federal, state, local and foreign tax consequences of ownership and disposition
of the notes.
Dividends
In
general, dividends paid to a Non-U.S. Holder of common stock will be subject to
withholding of United States federal income tax at a 30 percent rate unless such
rate is reduced by an applicable income tax treaty. Dividends that are U.S.
trade or business income are generally subject to United States federal income
tax at regular income tax rates, but are not generally subject to the 30 percent
withholding tax or treaty-reduced rate if the Non-U.S. Holder files a properly
executed Form W-8ECI (or appropriate substitute form), as applicable with the
payor. Any U.S. trade or business income received by a Non-U.S. Holder that is a
corporation may also, under certain circumstances, be subject to an additional
“branch profits tax” at a 30 percent rate or such lower rate as may be
applicable under an income tax treaty. A Non-U.S. Holder of common stock who
wishes to claim the benefit of an applicable treaty rate must provide a properly
executed IRS Form W-8BEN (or appropriate substitute form), as applicable. In
addition, a Non-U.S. Holder may under certain circumstances be required to
obtain a United States taxpayer identification number and make certain
certifications to us. Special procedures are provided for payments through
qualified intermediaries. A Non-U.S. Holder of common stock that is eligible for
a reduced rate of United States withholding tax pursuant to an income treaty may
obtain a refund of amounts withheld at a higher rate by filing an appropriate
claim for a refund with the IRS. A Non-U.S. Holder should consult its tax
advisor regarding its entitlement to benefits under a relevant income tax
treaty.
Sale,
Exchange, Redemption or Other Disposition of Common Stock
Except as
described below and subject to the discussion concerning backup withholding, any
gain realized by a Non-U.S. Holder on the sale, exchange (other than by exercise
of the conversion privilege for our common stock), retirement or redemption of
common stock generally will not be subject to United States federal income tax,
unless (i) such gain is U.S. trade or business income, (ii) subject to certain
exceptions, the Non-U.S. Holder is an individual who holds the common stock as a
capital asset and is present in the United States for 183 days or more in the
taxable year of the disposition, (iii) the Non-U.S. Holder is subject to tax
pursuant to the provisions of United States tax law applicable to certain United
States expatriates (including certain former citizens or residents of the United
States), or (iv) we are a United States real property holding corporation within
the meaning of Section 897 of the Code. We do not believe that we are currently
a “United States real property holding corporation” within the meaning of
Section 897 of the Code, or that we will become one in the future.
Backup
Withholding and Information Reporting
Information
returns may be filed with the IRS in connection with payments on the notes, our
common stock and the proceeds from a sale or other disposition of the notes or
our common stock.
A U.S.
Holder may be subject to United States backup withholding tax on those payments
if it fails to provide its taxpayer identification number to the paying agent
and comply with certification procedures or otherwise establish an exemption
from backup withholding. A Non-U.S. Holder may be subject to United States
backup withholding tax on these payments unless the Non-U.S. Holder complies
with certification procedures to establish that it is not a U.S. person. The
certification procedures required of Non-U.S. holders to claim the exemption
from withholding tax on certain payments on the notes, described above, will
satisfy the certification requirements necessary to avoid the backup withholding
tax as well. The amount of any backup withholding from a payment will be allowed
as a credit against the holder’s United States federal income tax liability and
may entitle the holder to a refund, provided that the required information is
timely furnished to the IRS.
The preceding discussion of certain
United States federal income tax consequences is for general
information only and is not tax advice. Accordingly, the investor should
consult its own tax advisor as to particular tax consequences to it of purchasing,
holding and disposing of the notes and the common stock issuable upon
conversion of the notes, including the applicability and effect of any
state, local or foreign tax laws, and of any proposed changes in applicable
laws.
PLAN
OF DISTRIBUTION
Rodman
& Renshaw, LLC, which we refer to as the placement agent, has entered into a
placement agent agreement with us pursuant to which Rodman & Renshaw, LLC
has agreed to act as our exclusive placement agent in connection with this
offering. Among other things, the placement agent will assist us in identifying
and evaluating prospective qualified investors and approach qualified investors
regarding the offering. The placement agent intends to market the securities on
a “best efforts” agency basis exclusively to accredited institutional investors.
The placement agent will have no obligation to buy any of the securities from
us, nor will the placement agent be required to arrange the purchase or sale of
any specific number or dollar amount of the securities. We will enter into
subscription agreements directly with investors in connection with this
offering. There may be one or more closings of this offering.
The
placement agency agreement provides that the obligations of the placement agent
are subject to certain conditions precedent, including the absence of any
material adverse change in our business and the receipt of certain certificates,
opinions and letters from us, our officers, our counsel, and our independent
auditors. On the closing date (or each closing date, if there is more than one
closing), we will issue the securities to the investors and we will receive
funds in the amount of the aggregate purchase price.
On each
closing date, the following will occur:
|
•
|
we
will receive funds in the amount of the aggregate purchase price of the
securities being sold by us on such closing date, less the amount of the
fees we are paying to the placement
agent;
|
|
•
|
we
will cause to be delivered the convertible notes being sold on such
closing date in book-entry form and issue the warrants to the investors;
and
|
|
•
|
we
will pay the placement agent its fees and issue the placement agent its
warrants in accordance with the terms of the placement agency
agreement.
|
We
have agreed to (i) pay the placement agent a cash fee equal to 6% of the gross
proceeds of the offering of securities by us and (ii) grant the placement agent
6% warrant coverage on the August 2009 Notes. The following table
shows the total placement agent fee to be paid by us to the placement agent per
unit. These amounts are shown assuming all of the securities offered pursuant to
this prospectus are issued and sold by us.
|
|
Placement
Agent
Fee
Per Unit
|
|
|
Total
|
|
|
|
|
|
|
|
|
Rodman
& Renshaw, LLC
|
|
$ |
420.00 |
|
|
$ |
420,000 |
|
We are
offering pursuant to this prospectus up to $7 million units consisting of (i)
70% convertible notes in an aggregate principal amount of up to $4.9
million and (ii) 30% common stock in an aggregate principal amount of up to $2.1
million, 49,000,000 shares of common stock underlying the convertible notes, an
aggregate of up to $832,308 of convertible notes issuable as payment of interest
on the convertible notes, warrants to purchase 12,250,000 shares of common
stock, and 12,250,000 shares of common stock underlying the warrants, but there
can be no assurance that the offering will be fully subscribed. Accordingly, we
may sell substantially less than $7 million in units and warrants to purchase
12,250,000 shares of common stock, in which case our net proceeds would be
substantially reduced and the total placement agent’s fees may be substantially
less than the maximum total set forth above.
We
have also agreed to reimburse the placement agent for documented costs and
expenses incident to the performance of our obligations in connection with this
offering in the amount of 1% of gross offering proceeds, up to a maximum of
$25,000. We estimate that the total expenses of the offering by us,
excluding the placement agent’s fees, will be approximately
$185,000.
We have
agreed that we will not offer, sell, contract to sell, pledge or otherwise
dispose of, directly or indirectly, or file with the SEC a registration
statement under the Securities Act of 1933 relating to, any shares of our common
stock or securities convertible into or exchangeable or exercisable for any
shares of our common stock, or publicly disclose the intention to make any
offer, sale, pledge, disposition or filing, without the prior written consent of
Rodman & Renshaw, LLC for a period of 90 days after the date of this
prospectus, except issuances or the obligation to file a registration statement
pursuant to existing contractual rights or obligations or issuances pursuant to
the exercise of employee stock options or warrants outstanding on the date
hereof or pursuant to conversion of our convertible notes outstanding on the
date hereof.
We have
agreed to indemnify the placement agent and any sub-agents or selected dealers
against certain liabilities, including liabilities under the Securities Act of
1933, as amended, and liabilities arising from the placement agent’s engagement
as the placement agent in connection with this offering. We have also agreed to
contribute to payments the placement agent may be required to make in respect of
such liabilities.
The
placement agency agreement with the placement agent will be filed as an exhibit
to an amendment to the registration statement of which this prospectus is a part
or as an exhibit to a Current Report on Form 8-K, each of which will be filed
with the SEC in connection with the consummation of this offering.
The
placement agent has informed us that it will not engage in over-allotment,
stabilizing transactions or syndicate covering transactions in connection with
this offering, but the placement agent may enter into one or more sub-placement
agreements with securities dealers to assist with the distribution of securities
in the offering. Notwithstanding anything to the contrary contained herein, we
shall not be responsible for paying any fees or compensation to any persons
pursuant to such arrangements.
LEGAL
MATTERS
The
validity of the shares offered herein will be opined on for us by Morgan, Lewis
& Bockius, LLP, which has acted as our outside legal counsel in relation to
certain restricted tasks.
EXPERTS
The
consolidated financial statements as of and for the year ended December 31,
2008, and for the effects of the 1-for-50 reverse stock split on the 2007 and
2006 consolidated financial statements included in this prospectus have been
audited by Amper Politziner & Mattia, LLP, an independent registered public
accounting firm, as stated in their report appearing herein and elsewhere in the
registration statement (which report expresses an unqualified opinion on the
consolidated financial statements and includes an explanatory paragraph relating
to Genta Incorporated’s ability to continue as a going concern). Such
consolidated financial statements have been so included in reliance upon the
report of such firm given upon their authority as experts in accounting and
auditing.
The
consolidated financial statements as of December 31, 2007, and for each of the
two years in the period ended December 31, 2007, (prior to the effects of the
2009 reverse stock split), not presented herein, have been audited by
Deloitte & Touche LLP, an independent registered public accounting firm, as
stated in their report appearing herein and elsewhere in the Registration
Statement (which report expresses an unqualified opinion on the consolidated
financial statements and includes explanatory paragraphs relating to (1) Genta
Incorporated’s ability to continue as a going concern; (2) the adoption of
Financial Accounting Standards Board Interpretation No. 48, Accounting for Uncertainty in Income
Taxes — an Interpretation of FASB Statement No.
109, effective January 1, 2007 ); and (3) Deloitte & Touche LLP was
not engaged to audit, review, or apply any procedures to the adjustments to
retrospectively apply the effects of the 2009 reverse stock split and,
accordingly, does not express an opinion or any other form of assurance about
whether such retrospective adjustments are appropriate and have been properly
applied. Those retrospective adjustments were audited by other
auditors). Such report has been so included in reliance upon the
report of such firm given upon their authority as experts in accounting and
auditing.
HOW
TO GET MORE INFORMATION
We have
filed with the SEC a Registration Statement on Form S-1 under the Securities Act
with respect to the securities offered by this prospectus. This prospectus,
which forms a part of the Registration Statement, does not contain all the
information set forth in the Registration Statement, as permitted by the rules
and regulations of the SEC. For further information with respect to us and the
securities offered by this prospectus, reference is made to the Registration
Statement. Statements contained in this prospectus as to the contents of any
contract or other document that we have filed as an exhibit to the Registration
Statement are qualified in their entirety by reference to the exhibits for a
complete statement of their terms and conditions. The Registration Statement and
other information may be read and copied at the SEC’s Public Reference Room at
100 F Street N.E., Washington, D.C. 20549. The public may obtain information on
the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
The SEC maintains a web site at http://www.sec.gov that contains reports, proxy
and information statements, and other information regarding issuers that file
electronically with the SEC.
We will
also send you copies of the material we file with the SEC, free of charge, upon
your request. Please call or write our Investor Relations department
at:
Genta
Incorporated
Attention:
Investor Relations
200
Connell Drive
Berkeley
Heights, NJ 07922
(908)
286-9800
We make
available free of charge on our internet website (http://www.genta.com) our
annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on
Form 8-K and amendments to these reports filed or furnished pursuant to Section
13(a) or 15(d) of the Securities Exchange Act of 1934 as soon as reasonably
practicable after we electronically file such material with, or furnish it to,
the Securities and Exchange Commission. Our website and the information
contained therein or connected thereto shall not be deemed to be incorporated
into this prospectus or the Registration Statement of which it forms a
part.
Genta
Incorporated
Index
to Financial Statements
At
December 31, 2008
|
|
|
|
Reports
of Independent Registered Public Accounting Firms
|
F-2
|
Consolidated
Balance Sheets as of December 31, 2008 and 2007
|
F-4
|
Consolidated
Statements of Operations for the years ended December 31, 2008, 2007 and
2006
|
F-5
|
Consolidated
Statements of Stockholders’ (Deficit) /Equity for the years ended December
31, 2008, 2007 and 2006
|
F-6
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2008, 2007 and
2006
|
F-7
|
Notes
to Consolidated Financial Statements
|
F-8
|
|
|
At
March 31, 2009
|
|
|
|
Consolidated
Balance Sheets as of March 31, 2009 (unaudited) and December
31, 2008
|
F-26
|
Consolidated
Statements of Operations (unaudited) for three months ended March 31, 2009
and 2008
|
F-27
|
Consolidated
Statements of Cash Flows (unaudited) for three months ended March 31, 2009
and 2008
|
F-28
|
Notes
to Consolidated Financial Statements
|
F-29
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders of
Genta
Incorporated and Subsidiaries
We have
audited the accompanying consolidated balance sheet of Genta Incorporated and
Subsidiaries (the “Company”) as of December 31 2008, and the related
consolidated statement of operations, stockholders’ (deficit) equity, and cash
flows for the year then ended. These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an
opinion on these financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Genta Incorporated and
Subsidiaries as of December 31, 2008, and the results of their operations and
their cash flows for the year then ended December 31, 2008, in conformity with
U.S. generally accepted accounting principles.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 1
to the consolidated financial statements, the Company’s recurring losses from
operations and negative cash flows from operations raise substantial doubt about
its ability to continue as a going concern. Management’s plans
considering these matters are also described in Note 1 to the consolidated
financial statements. The consolidated financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.
We
have also audited the retroactive adjustments to the 2007 and 2006 consolidated
financial statements for the one-for-fifty reverse common stock split in 2009,
which is described in Note 1 to the consolidated financial
statements. In our opinion, such retrospective adjustments are
appropriate and have been properly applied. However, we were not
engaged to audit, review or apply any procedures to the 2007 and 2006
consolidated financial statements of the Company other than with respect to the
retrospective adjustments and, accordingly, we do not express an opinion or any
other form of assurance on the 2007 and 2006 consolidated financial statements
taken as a whole.
/s/
Amper, Politziner & Mattia, LLP
Edison,
New Jersey
February
12, 2009, except for the effects of the retroactive adjustment for the
one-for-fifty reverse common stock split described in Note 1 to the Consolidated
Financial Statements, which the date is June 26, 2009
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders of Genta Incorporated:
We
have audited, before the effects of the adjustments to retrospectively apply the
reverse stock split discussed in Note 1 to the consolidated financial
statements, the accompanying consolidated balance sheet of Genta Incorporated
and subsidiaries (the “Company”) as of December 31, 2007, and the related
consolidated statements of operations, stockholders’ (deficit) equity, and cash
flows for the years ended December 31, 2007 and 2006 (the 2007 and 2006
consolidated financial statements before the effects of the adjustments
discussed in Note 1 to the consolidated financial statements are not presented
herein). These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, such 2007 and 2006 consolidated financial statements, before the
effects of the adjustments to retrospectively apply the reverse stock split
discussed in Note 1 to the consolidated financial statements, present fairly, in
all material respects, the financial position of Genta Incorporated and
subsidiaries as of December 31, 2007, and the results of their operations and
their cash flows for the years ended December 31, 2007 and 2006, in conformity
with accounting principles generally accepted in the United States of
America.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company’s recurring losses from
operations and negative cash flows from operations raise substantial doubt about
its ability to continue as a going concern. Management’s plans concerning these
matters are also described in Note 1 to the consolidated financial statements.
The consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
As
discussed in Note 2 to the consolidated financial statements, the Company
adopted Financial Accounting Standards Board Interpretation No. 48, Accounting for Uncertainty in Income Taxes — an
Interpretation of FASB Statement No. 109, effective January 1,
2007.
We
were not engaged to audit, review, or apply any procedures to the adjustments to
retrospectively apply the effects of the reverse stock split discussed in Note 1
to the consolidated financial statements and, accordingly, we do not express an
opinion or any other form of assurance about whether such retrospective
adjustments are appropriate and have been properly applied. Those retrospective
adjustments were audited by other auditors.
/s/
DELOITTE & TOUCHE LLP
Parsippany,
New Jersey
March 17,
2008
GENTA
INCORPORATED
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except par value)
|
|
December
31,
2008
|
|
|
December
31,
2007
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
4,908 |
|
|
$ |
5,814 |
|
Marketable
securities (Note 3)
|
|
|
— |
|
|
|
1,999 |
|
Accounts
receivable — net of allowances of $12 at December 31, 2008 and $38 at
December 31, 2007
|
|
|
2 |
|
|
|
31 |
|
Inventory
(Note 4)
|
|
|
121 |
|
|
|
225 |
|
Prepaid
expenses and other current assets (Note 6)
|
|
|
973 |
|
|
|
19,170 |
|
Total
current assets
|
|
|
6,004 |
|
|
|
27,239 |
|
Property
and equipment, net (Note 7)
|
|
|
300 |
|
|
|
323 |
|
Deferred
financing costs on convertible note financing (Note
11)
|
|
|
911 |
|
|
|
— |
|
Deferred
financing costs — warrant (Note 11)
|
|
|
5,478 |
|
|
|
— |
|
Other
assets (Note 5)
|
|
|
— |
|
|
|
1,731 |
|
Total
assets
|
|
$ |
12,693 |
|
|
$ |
29,293 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ (DEFICIT)/EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses (Note 6 and Note 9)
|
|
$ |
11,224 |
|
|
$ |
25,850 |
|
Notes
payable (Note 10)
|
|
|
— |
|
|
|
512 |
|
Total
current liabilities
|
|
|
11,224 |
|
|
|
26,362 |
|
Long-term
liabilities:
|
|
|
|
|
|
|
|
|
Office
lease settlement obligation (Note 5)
|
|
|
1,979 |
|
|
|
— |
|
Convertible
notes due June 9, 2010, $15,540 outstanding, net of debt discount of
($11,186) (Note 11)
|
|
|
4,354 |
|
|
|
— |
|
Total
long-term liabilities
|
|
|
6,333 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies (Note 18)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
(deficit)/equity (Note 13):
|
|
|
|
|
|
|
|
|
Preferred
stock, 5,000 shares authorized:
|
|
|
|
|
|
|
|
|
Series
A convertible preferred stock, $.001 par value; 8 shares issued and
outstanding, liquidation value of $385 at December 31, 2008 and December
31, 2007, respectively
|
|
|
— |
|
|
|
— |
|
Series
G participating cumulative preferred stock, $.001 par value; 0 shares
issued and outstanding at December 31, 2008 and December 31, 2007,
respectively
|
|
|
— |
|
|
|
— |
|
Common
stock, $.001 par value; 6,000,000 and 250,000 shares authorized 9,734 and
611 shares issued and outstanding at December 31, 2008 and December 31,
2007, respectively
|
|
|
10 |
|
|
|
1 |
|
Additional
paid-in capital
|
|
|
939,252 |
|
|
|
441,189 |
|
Accumulated
deficit
|
|
|
(944,126 |
) |
|
|
(438,288 |
) |
Accumulated
other comprehensive income
|
|
|
— |
|
|
|
29 |
|
Total
stockholders’ (deficit)/equity
|
|
|
(4,864 |
) |
|
|
2,931 |
|
Total
liabilities and stockholders’ (deficit)/equity
|
|
$ |
12,693 |
|
|
$ |
29,293 |
|
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
Years
Ended December 31,
|
|
(In
thousands, except per share data)
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
Product
sales — net
|
|
$ |
363 |
|
|
$ |
580 |
|
|
$ |
708 |
|
Cost
of goods sold
|
|
|
102 |
|
|
|
90 |
|
|
|
108 |
|
Gross
margin
|
|
|
261 |
|
|
|
490 |
|
|
|
600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
19,991 |
|
|
|
13,491 |
|
|
|
28,064 |
|
Selling,
general and administrative
|
|
|
10,452 |
|
|
|
16,865 |
|
|
|
25,152 |
|
Settlement
of office lease obligation (Note 5)
|
|
|
3,307 |
|
|
|
— |
|
|
|
— |
|
Provision
for settlement of litigation (Note 6 and Note 18)
|
|
|
(340 |
) |
|
|
(4,240 |
) |
|
|
5,280 |
|
Write-off
of prepaid royalty (Note 8)
|
|
|
— |
|
|
|
— |
|
|
|
1,268 |
|
Total
operating expenses
|
|
|
33,410 |
|
|
|
26,116 |
|
|
|
59,764 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
(expense)/income, net:
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain
on maturity of marketable securities
|
|
|
31 |
|
|
|
159 |
|
|
|
310 |
|
Interest
income and other income, net
|
|
|
252 |
|
|
|
837 |
|
|
|
1,216 |
|
Interest
expense
|
|
|
(1,718 |
) |
|
|
(160 |
) |
|
|
(72 |
) |
Amortization
of deferred financing costs and debt discount (Note
11)
|
|
|
(11,229 |
) |
|
|
— |
|
|
|
— |
|
Fair
value — conversion feature liability (Note 11)
|
|
|
(460,000 |
) |
|
|
— |
|
|
|
— |
|
Fair
value — warrant liability (Note 11)
|
|
|
(2,000 |
) |
|
|
— |
|
|
|
— |
|
Total
other (expense)/income, net
|
|
|
(474,664 |
) |
|
|
836 |
|
|
|
1,454 |
|
Loss
before income taxes
|
|
|
(507,813 |
) |
|
|
(24,790 |
) |
|
|
(57,710 |
) |
Income
tax benefit (Note 12)
|
|
|
1,975 |
|
|
|
1,470 |
|
|
|
929 |
|
Net
loss
|
|
$ |
(505,838 |
) |
|
$ |
(23,320 |
) |
|
$ |
(56,781 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per basic and diluted common share
|
|
$ |
(455.09 |
) |
|
$ |
(39.36 |
) |
|
$ |
(125.88 |
) |
Shares
used in computing net loss per basic and diluted common
share
|
|
|
1,112 |
|
|
|
592 |
|
|
|
451 |
|
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ (DEFICIT)/EQUITY
For
the Years Ended December 31, 2008, 2007 and 2006
|
|
Convertible
Preferred
Stock
|
|
|
Common
Stock
|
|
|
Additional
Paid-in
|
|
|
Accumulated
|
|
|
Accumulated
Other
Comprehensive
|
|
|
Total
Stockholders’
|
|
(In
thousands)
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Income
(Loss)
|
|
|
(Deficit)/Equity
|
|
Balance
at January 1, 2006
|
|
|
10 |
|
|
$ |
— |
|
|
|
381 |
|
|
$ |
|
|
|
$ |
373,824 |
|
|
$ |
(358,187 |
) |
|
$ |
60 |
|
|
$ |
15,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(56,781 |
) |
|
|
— |
|
|
|
(56,781 |
) |
Net
change in value of marketable securities
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(29 |
) |
|
|
(29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock, net of issuance costs of $3,125
|
|
|
— |
|
|
|
— |
|
|
|
63 |
|
|
|
|
|
|
|
37,725 |
|
|
|
— |
|
|
|
— |
|
|
|
37,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in connection with conversion of Series A preferred
stock
|
|
|
(2 |
) |
|
|
— |
|
|
|
—- |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock, net of issuance costs of $925
|
|
|
— |
|
|
|
— |
|
|
|
67 |
|
|
|
— |
|
|
|
14,875 |
|
|
|
— |
|
|
|
— |
|
|
|
14,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in connection with exercise of stock
options
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
156 |
|
|
|
— |
|
|
|
— |
|
|
|
156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,999 |
|
|
|
— |
|
|
|
— |
|
|
|
2,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2006
|
|
|
8 |
|
|
|
— |
|
|
|
511 |
|
|
|
|
|
|
|
429,579 |
|
|
|
(414,968 |
) |
|
|
31 |
|
|
|
14,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(23,320 |
) |
|
|
— |
|
|
|
(23,320 |
) |
Net
change in value of marketable securities
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock, net of issuance costs of $562
|
|
|
— |
|
|
|
— |
|
|
|
100 |
|
|
|
1 |
|
|
|
10,237 |
|
|
|
— |
|
|
|
— |
|
|
|
10,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,373 |
|
|
|
— |
|
|
|
— |
|
|
|
1,373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2007
|
|
|
8 |
|
|
|
— |
|
|
|
611 |
|
|
|
1 |
|
|
|
441,189 |
|
|
|
(438,288 |
) |
|
|
29 |
|
|
|
2,931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(505,838 |
) |
|
|
— |
|
|
|
(505,838 |
) |
Net
change in value of marketable securities
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(29 |
) |
|
|
(29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock, net of issuance costs of $183
|
|
|
— |
|
|
|
— |
|
|
|
123 |
|
|
|
|
|
|
|
2,876 |
|
|
|
— |
|
|
|
— |
|
|
|
2,876 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock as interest payment on Senior Convertible Promissory
Note
|
|
|
— |
|
|
|
— |
|
|
|
80 |
|
|
|
|
|
|
|
647 |
|
|
|
— |
|
|
|
— |
|
|
|
647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock on voluntary conversions of Senior Convertible Promissory
Note
|
|
|
— |
|
|
|
— |
|
|
|
8,920 |
|
|
|
9 |
|
|
|
4,451 |
|
|
|
— |
|
|
|
— |
|
|
|
4,460 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfer
of warrant liability to paid-in-capital
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9,600 |
|
|
|
— |
|
|
|
— |
|
|
|
9,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfer
conversion feature liability to paid-in-capital
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
480,000 |
|
|
|
— |
|
|
|
— |
|
|
|
480,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vesting
of restricted stock
|
|
|
— |
|
|
|
— |
|
|
|
- |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
489 |
|
|
|
— |
|
|
|
— |
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2008
|
|
|
8 |
|
|
$ |
— |
|
|
|
9,734 |
|
|
$ |
10 |
|
|
$ |
939,252 |
|
|
$ |
(944,126 |
) |
|
$ |
— |
|
|
$ |
(4,864 |
) |
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
Years
Ended December 31,
|
|
(In
thousands)
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
Operating
activities:
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(505,838 |
) |
|
$ |
(23,320 |
) |
|
$ |
(56,781 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
154 |
|
|
|
170 |
|
|
|
942 |
|
Loss
on disposition of equipment
|
|
|
10 |
|
|
|
— |
|
|
|
— |
|
Amortization
of deferred financing costs and debt discount (Note 11)
|
|
|
11,229 |
|
|
|
— |
|
|
|
— |
|
Share-based
compensation (Note 14)
|
|
|
489 |
|
|
|
1,373 |
|
|
|
2,999 |
|
Provision
for sales returns
|
|
|
79 |
|
|
|
(133 |
) |
|
|
(300 |
) |
Gain
on maturity of marketable securities
|
|
|
(31 |
) |
|
|
(159 |
) |
|
|
(310 |
) |
Interest
payment settled in shares of common stock (Note 19)
|
|
|
647 |
|
|
|
— |
|
|
|
— |
|
Provision
for settlement of litigation, net (Note 6)
|
|
|
(340 |
) |
|
|
(4,240 |
) |
|
|
5,280 |
|
Write-off
of prepaid royalty (Note 8)
|
|
|
— |
|
|
|
— |
|
|
|
1,268 |
|
Change
in fair value — conversion feature liability (Note 11)
|
|
|
460,000 |
|
|
|
— |
|
|
|
— |
|
Change
in fair value — warrant liability (Note 11)
|
|
|
2,000 |
|
|
|
— |
|
|
|
— |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
— |
|
|
|
— |
|
Accounts
receivable
|
|
|
29 |
|
|
|
(14 |
) |
|
|
42 |
|
Inventory
|
|
|
104 |
|
|
|
83 |
|
|
|
88 |
|
Prepaid
expenses and other current assets
|
|
|
198 |
|
|
|
627 |
|
|
|
(142 |
) |
Accounts
payable and accrued expenses
|
|
|
5,615 |
|
|
|
(6,071 |
) |
|
|
2,264 |
|
Other
assets
|
|
|
— |
|
|
|
(42 |
) |
|
|
(40 |
) |
Net
cash used in operating activities
|
|
|
(25,655 |
) |
|
|
(31,726 |
) |
|
|
(44,690 |
) |
Investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of marketable securities
|
|
|
— |
|
|
|
(13,900 |
) |
|
|
(56,784 |
) |
Maturities
of marketable securities
|
|
|
2,000 |
|
|
|
32,000 |
|
|
|
49,091 |
|
Release
of restricted cash deposits (Note 5)
|
|
|
1,731 |
|
|
|
— |
|
|
|
— |
|
Purchase
of property and equipment
|
|
|
(141 |
) |
|
|
(222 |
) |
|
|
(136 |
) |
Net
cash provided by (used in) investing activities
|
|
|
3,590 |
|
|
|
17,878 |
|
|
|
(7,829 |
) |
Financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from sale of common stock, net (Note 13)
|
|
|
2,876 |
|
|
|
10,238 |
|
|
|
52,691 |
|
Issuance
of note payable (Note 10)
|
|
|
— |
|
|
|
1,155 |
|
|
|
1,174 |
|
Repayments
of note payable (Note 10)
|
|
|
(512 |
) |
|
|
(1,285 |
) |
|
|
(1,261 |
) |
Issuance
of convertible notes net of financing cost of $1,205 (Note
11)
|
|
|
18,795 |
|
|
|
— |
|
|
|
— |
|
Issuance
of common stock upon exercise of stock options (Note 15)
|
|
|
— |
|
|
|
— |
|
|
|
155 |
|
Net
cash provided by financing activities
|
|
|
21,159 |
|
|
|
10,108 |
|
|
|
52,759 |
|
Increase
(decrease) in cash and cash equivalents
|
|
|
(906 |
) |
|
|
(3,740 |
) |
|
|
240 |
|
Cash
and cash equivalents at beginning of year
|
|
|
5,814 |
|
|
|
9,554 |
|
|
|
9,314 |
|
Cash
and cash equivalents at end of year
|
|
$ |
4,908 |
|
|
$ |
5,814 |
|
|
$ |
9,554 |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
For
the years ended December 31, 2008, 2007 and 2006
1.
Organization and Business
Genta
Incorporated (“Genta” or the “Company”) is a biopharmaceutical company engaged
in pharmaceutical (drug) research and development, its sole reportable segment.
The Company is dedicated to the identification, development and
commercialization of novel drugs for the treatment of cancer and related
diseases.
The
Company has had recurring annual operating losses since its inception.
Management expects that such losses will continue at least until its lead
product, Genasense® (oblimersen sodium) Injection, receives approval for and
begins commercial sale in one or more indications. Achievement of profitability
for the Company is currently dependent on the timing of Genasense® regulatory
approval. Any adverse events with respect to approvals by the U.S. Food and Drug
Administration (‘‘FDA’’) and/or European Medicines Agency (‘‘EMEA’’) could
negatively impact the Company’s ability to obtain additional funding or identify
potential partners.
The
Company has prepared its financial statements under the assumption that it is a
going concern. The Company’s recurring losses and negative cash flows from
operation raise substantial doubt about its ability to continue as a going
concern. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
The
Company had $4.9 million of cash and cash equivalents on hand at December 31,
2008. Net cash used in operating activities during 2008 was $25.7 million, which
represents an average monthly outflow of $2.1 million.
On June
5, 2008, the Company entered into a securities purchase agreement with certain
institutional and accredited investors to place up to $40 million of senior
secured convertible notes with such investors. On June 9, 2008, the Company
placed $20 million of such notes in the initial closing.
The
2-year notes bear interest at an annual rate of 15% payable at quarterly
intervals in stock or cash at the Company’s option, and are convertible into
shares of Genta common stock at a conversion rate of 2,000 shares of common
stock for every $1,000 of principal. Holders of the notes have the right, but
not the obligation, for the 12 months following the initial closing date to
purchase in whole or in part up to an additional $20 million of the notes. The
Company shall have the right to force conversion of the notes in whole or in
part if the closing bid price of the Company’s common stock exceeds $0.50 for a
period of 20 consecutive trading days. Certain members of senior management of
Genta participated in this offering. The notes are secured by a first lien on
all assets of Genta.
The notes
included certain events of default, including a requirement that the Company
obtain stockholder approval within a specified period of time to amend its
certificate of incorporation to authorize additional shares of common stock. On
October 6, 2008, at the Annual Meeting of Stockholders, the Company’s
stockholders approved an amendment to Genta’s Restated Certificate of
Incorporation, as amended, to increase the total number of authorized shares of
capital stock available for issuance from 255,000,000, consisting of 250,000,000
shares of Common Stock and 5,000,000 shares of Preferred Stock, to
6,005,000,000, consisting of 6,000,000,000 shares of Common Stock and 5,000,000
shares of Preferred Stock.
The
Company will require additional cash in order to maximize its commercial
opportunities and continue its clinical development opportunities. The Company
has had discussions with other companies regarding partnerships for the further
development and global commercialization of Genasense®. Additional alternatives
available to the Company to subsequently sustain its operations include
financing arrangements with potential corporate partners, debt financing,
asset-based loans, royalty-based financings, equity financing and other sources.
However, there can be no assurance that any such collaborative agreements or
other sources of funding will be available on favorable terms, if at all.
Presently, with no further financing, management projects that the Company will
run out of funds in August 2009. The Company currently does not have any
additional financing in place. There can be no assurance that the Company can
obtain financing, if at all, on terms acceptable to it.
If the
Company is unable to raise additional funds, it will need to do one or more of
the following:
|
•
|
delay,
scale back or eliminate some or all of the Company’s research and product
development programs and sales and marketing
activity;
|
|
•
|
license
third parties to develop and commercialize products or technologies that
the Company would otherwise seek to develop and commercialize
themselves;
|
|
•
|
attempt
to sell the Company;
|
On
June 26, 2009, the Company effected a one-for-fifty reverse stock
split of its common stock. It did not reduce the number of shares that the
Company is authorized to issue or change the par value of the common stock. All
references to common share values in these consolidated financial statements
have been restated to reflect this split.
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
consolidated financial statements are presented on the basis of accounting
principles generally accepted in the United States of America. Such financial
statements include the accounts of the Company and all majority-owned
subsidiaries.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make certain estimates and
assumptions that affect reported earnings, financial position and various
disclosures. Actual results could differ from those estimates.
Cash
and Cash Equivalents
Cash and
cash equivalents consist of highly liquid instruments with maturities of three
months or less from the date acquired and are stated at cost that approximates
their fair market value. At December 31, 2008, the amounts on deposit that
exceeded the $250,000 federally insured limit was $3.9 million.
Revenue
Recognition
The
Company recognizes revenue from product sales when title to product and
associated risk of loss has passed to the customer and the Company is reasonably
assured of collecting payment for the sale. All revenue from product sales are
recorded net of applicable allowances for returns, rebates and other applicable
discounts and allowances. The Company allows return of its product for up to
twelve months after product expiration.
Research
and Development
Research
and development costs are expensed as incurred, including raw material costs
required to manufacture products for clinical trials.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
Income
Taxes
The
Company uses the liability method of accounting for income taxes. Deferred
income taxes are determined based on the estimated future tax effects of
differences between the financial statement and tax bases of assets and
liabilities given the provisions of the enacted tax laws. Management records
valuation allowances against net deferred tax assets, if based upon the
available evidence, it is more likely than not that some or all of the deferred
tax assets will not be realized. The ultimate realization of deferred tax assets
is dependent upon the generation of future taxable income and when temporary
differences become deductible. The Company considers, among other available
information, uncertainties surrounding the recoverability of deferred tax
assets, scheduled reversals of deferred tax liabilities, projected future
taxable income and other matters in making this assessment. The Company reviewed
its deferred tax assets and at both December 31, 2008 and December 31, 2007,
recorded a valuation allowance to reduce these assets to zero to reflect that,
more likely than not, they will not be realized. Utilization of the Company’s
net operating loss (NOL) and research and development (R&D) credit
carryforwards may be subject to a substantial annual limitation due to ownership
change limitations that may have occurred or that could occur in the future, as
required by Section 382 of the Internal Revenue Code of 1986, as amended (the
Code), as well as similar state provisions. These ownership changes may limit
the amount of NOL and R&D credit carryforwards that can be utilized annually
to offset future taxable income and tax, respectively. In general, an “ownership
change” as defined by Section 382 of the Code results from a transaction or
series of transactions over a three-year period resulting in an ownership change
of more than 50 percentage points of the outstanding stock of a company by
certain stockholders or public groups.
In July
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes-an interpretation
of FASB Statement No. 109” (“FIN 48”), which clarifies the accounting and
disclosure for uncertainty in tax positions, as defined. The Company adopted the
provisions of FIN 48 as of January 1, 2007 and has analyzed filing positions in
all of the federal and state jurisdictions where it is required to file income
tax returns, as well as all open tax years in these jurisdictions.
The State
of New Jersey has taken the position that amounts reimbursed to Genta by Aventis
Pharmaceutical Inc. for co-development expenditures during an audit period of
2000 through 2004 were subject to Alternative Minimum Assessment (AMA),
resulting in a liability at December 31, 2008 of $841,000, (see Note 13 to the
Company’s Consolidated Financial Statements). The Company believes the State’s
position is unjustified and is pursuing this matter before the New Jersey Tax
Court. Other than this matter, the Company believes that its income tax filing
positions and deductions will be sustained on audit and does not anticipate any
adjustments that will result in a material change to its financial position.
Therefore, no reserves for uncertain income tax positions have been recorded
pursuant to FIN 48. In addition, the Company did not record a cumulative effect
adjustment related to the adoption of FIN 48. If such adjustment was recorded,
it would have been fully offset by a change in a valuation
allowance.
The
Company’s policy for recording interest and penalties associated with audits is
that penalties and interest expense are recorded in interest expense in the
Company’s Consolidated Statements of Operations.
Stock
Options
The
Company’s share-based payments including grants of employee stock options are
recognized in the Consolidated Statement of Operations based on their fair
values. The amount of compensation cost is measured based on the grant-date fair
value of the equity instrument issued. The Company utilizes a Black-Scholes
option-pricing model to measure the fair value of stock options granted to
employees. See Note 15 to our Consolidated Financial Statements for a further
discussion on share-based compensation.
Deferred
Financing Costs and Other Debt-Related Costs
Deferred
financing costs are amortized over the term of its associated debt instrument.
The Company evaluates the terms of the debt instruments to determine if any
embedded derivatives or beneficial conversion features exist. The Company
allocates the aggregate proceeds of the notes payable between the warrants and
the notes based on their relative fair values in accordance with Accounting
Principle Board No. 14 (APB 14), “Accounting for Convertible Debt and Debt
Issued with Stock Purchase Warrants.” The fair value of the warrant issued to
the placement agent is calculated utilizing the Black-Scholes option-pricing
model. The Company is amortizing the resultant discount or other features over
the term of the notes through its earliest maturity date using the effective
interest method. Under this method, the interest expense recognized each period
will increase significantly as the instrument approaches its maturity date. If
the maturity of the debt is accelerated because of defaults or conversions, then
the amortization is accelerated.
See accompanying notes to consolidated
financial statements.
Net
Loss Per Common Share
Net
loss per common share for the year ended December 31, 2008, 2007 and 2006,
respectively, are based on the weighted average number of shares of common stock
outstanding during the periods. Basic and diluted loss per share are identical
for all periods presented as potentially dilutive securities have been excluded
from the calculation of the diluted net loss per common share because the
inclusion of such securities would be antidilutive. The potentially dilutive
securities include 32 million, 46,000 and 42,000 in 2008, 2007 and 2006,
respectively, reserved for the conversion of convertible notes, convertible
preferred stock and the exercise of outstanding options and
warrants.
Recent
Accounting Pronouncements
In June
2008 the FASB issued EITF 07-5, “Determining Whether an Instrument (or Embedded
Feature) Is Indexed to an Entity’s Own Stock”. EITF 07-5 provides guidance in
assessing whether an equity-linked financial instrument (or embedded feature) is
indexed to an entity’s own stock for purposes of determining whether the
appropriate accounting treatment falls under the scope of SFAS 133, “Accounting
For Derivative Instruments and Hedging Activities” and/or EITF 00-19,
“Accounting For Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company’s Own Stock”. EITF 07-05 is effective as of the beginning
of our 2009 fiscal year. The Company does not expect the adoption of EITF 07-05
to have a material impact on its consolidated financial position or results of
operations.
In May
2008, the FASB issued FASB Staff Position (“FSP”) APB 14-1, Accounting for
Convertible Debt Instruments That May Be Settled in Cash upon Conversion
(Including Partial Cash Settlement). FSP APB14-1 will require us to account
separately for the liability and equity components of our convertible debt. The
debt would be recognized at the present value of its cash flows discounted using
our nonconvertible debt borrowing rate at the time of issuance. The equity
component would be recognized as the difference between the proceeds from the
issuance of the note and the fair value of the liability. The FSP also requires
accretion of the resultant debt discount over the expected life of the debt. The
FSP is effective for fiscal years beginning after December 15, 2008, and interim
periods within those years. Entities are required to apply the FSP
retrospectively for all periods presented. We are currently evaluating FSP APB
14-1 and have not yet determined the impact its adoption will have on our
consolidated financial statements. However, the impact of this new accounting
treatment may be significant and may result in a significant increase to
non-cash interest expense beginning in fiscal year 2009 for financial statements
covering past and future periods.
In May
2008, the Financial Accounting Standards Board (FASB) issued SFAS No. 162,
“The Hierarchy of Generally
Accepted Accounting Principles”. The statement is intended to improve
financial reporting by identifying a consistent hierarchy for selecting
accounting principles to be used in preparing financial statements that are
prepared in conformance with generally accepted accounting principles. The
statement is effective 60 days following the Securities and Exchange
Commission’s (SEC) approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, “The Meaning of Present Fairly in Conformity with
GAAP”, and is not expected to have any impact on the Company’s financial
statements.
In March
2008, the FASB issued SFAS 161, “Disclosures about Derivative
Instruments and Hedging
Activities, an
amendment of FASB SFAS 133” (“SFAS 161”), which requires enhanced
disclosures for derivative and hedging activities. SFAS 161 will become
effective for financial statements issued for fiscal years and interim periods
beginning after November 15, 2008. The implementation of this standard did not
have a material effect on the Company’s consolidated financial
statements.
In
December 2007, the FASB issued SFAS 141(R), “Business Combinations” (“SFAS
141(R)”), which replaces SFAS 141. SFAS 141(R) establishes principles and
requirements for how an acquirer in a business combination recognizes and
measures in its financial statements the identifiable assets acquired, the
liabilities assumed, and any controlling interest; recognizes and measures the
goodwill acquired in the business combination or a gain from a bargain purchase;
and determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business
combination. SFAS 141(R) is to be applied prospectively to business combinations
for which the acquisition date is on or after an entity’s fiscal year that
begins after December 15, 2008. The standard will have an impact on our
financial statements when an acquisition occurs.
See accompanying notes to consolidated
financial statements.
GENTA
INCORPORATED
In
December 2007, the FASB issued SFAS 160, “Noncontrolling Interests in
Consolidated Financial
Statements — an amendment of ARB No. 51” (“SFAS 160”). SFAS 160
establishes new accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a subsidiary.
Specifically, this statement requires the recognition of a noncontrolling
interest (minority interest) as equity in the consolidated financial statements
and separate from the parent’s equity. The amount of net income attributable to
the noncontrolling interest will be included in consolidated net income on the
face of the income statement. SFAS 160 clarifies that changes in a parent’s
ownership interest in a subsidiary that do not result in deconsolidation are
equity transactions if the parent retains its controlling financial interest. In
addition, this statement requires that a parent recognize a gain or loss in net
income when a subsidiary is deconsolidated. SFAS 160 also includes expanded
disclosure requirements regarding the interests of the parent and its
noncontrolling interest. SFAS 160 is effective for fiscal years, and interim
periods within those fiscal years, beginning on or after December 15, 2008. The
implementation of this standard did not have a material effect on the Company’s
consolidated financial statements.
In
December 2007, the SEC issued Staff Accounting Bulletin 110 (“SAB 110”), which
permits entities, under certain circumstances, to continue to use the
“simplified” method of estimating the expected term of plain options as
discussed in SAB No. 107 and in accordance with SFAS 123R. The guidance in this
release was effective January 1, 2008. The implementation of this standard did
not have a material effect on the Company’s consolidated financial
statements.
In
December 2007, the FASB issued EITF Issue No. 07-1, “Accounting for Collaborative Arrangements,”
which is effective for calendar year companies on January 1, 2009. The Task
Force clarified the manner in which costs, revenues and sharing payments made
to, or received by, a partner in a collaborative arrangement should be presented
in the income statement and set forth certain disclosures that should be
required in the partners’ financial statements. The implementation of this
standard did not have a material effect on the Company’s consolidated financial
statements.
In June
2007, the FASB issued EITF Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for
Goods or Services Received for Use in Future Research and Development
Activities,” which was effective for calendar year companies on January
1, 2008. The Task Force concluded that nonrefundable advance payments for goods
or services that will be used or rendered for future research and development
activities should be deferred and capitalized. Such amounts should be recognized
as an expense as the related goods are delivered or the services are performed,
or when the goods or services are no longer expected to be provided. The
implementation of this standard did not have a material effect on the Company’s
consolidated financial statements.
In
February 2007, the FASB issued SFAS 159, “The Fair Value Option for
Financial Assets and Financial
Liabilities” (“SFAS 159”). SFAS 159 permits all entities to choose to
elect, at specified election dates, to measure eligible financial instruments at
fair value. An entity shall report unrealized gains and losses on items for
which the fair value option has been elected in earnings at each subsequent
reporting date and recognize upfront costs and fees related to those items in
earnings as incurred and not deferred. SFAS 159 applied to fiscal years
beginning after November 15, 2007, with early adoption permitted for an entity
that also elected to apply the provisions of SFAS 157, “Fair Value Measurements”. The
implementation of this standard did not have a material effect on the Company’s
consolidated financial statements.
In
September 2006, the FASB issued SFAS 157, “Fair Value Measurements”.
SFAS 157 defines fair value, establishes a framework for measuring fair value in
accordance with accounting principles generally accepted in the United States of
America and expands disclosures about fair value measurements. SFAS 157 applies
under other accounting pronouncements that require or permit fair value
measurements. The Company was required to adopt SFAS 157 beginning January 1,
2008. In February 2008, the FASB released FASB Staff Position (FSP FAS 157-2 —
Effective Date of FASB Statement No. 157), which delayed the effective date of
SFAS No. 157 for all non-financial assets and liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (at least annually). The adoption of SFAS No. 157 for the Company’s
financial assets and liabilities did not have a material impact on its
consolidated financial statements. The Company does not expect that adoption of
SFAS No. 157 for the Company’s non-financial assets and liabilities, effective
January 1, 2009, will have a material impact on its financial
statements.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
3.
Marketable Securities
The
carrying amounts of the Company’s marketable securities, which are primarily
securities of government-backed agencies, approximate fair value due to the
short-term nature of these instruments. The fair value of available-for-sale
marketable securities was as follows ($ thousands):
|
|
December
31,
2007
|
|
Cost
|
|
$ |
1,970 |
|
Gross
unrealized gains
|
|
|
29 |
|
Gross
unrealized losses
|
|
|
— |
|
Fair
value
|
|
$ |
1,999 |
|
The fair
value of each marketable security was compared to its cost and therefore,
unrealized gains of approximately $29,000 were recognized in accumulated other
comprehensive income in the Company’s Consolidated Balance Sheets at December
31, 2007.
4.
Inventory
Inventories
are stated at the lower of cost or market with cost being determined using the
first-in, first-out (FIFO) method. Inventories consisted of the following ($
thousands):
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
Raw
materials
|
|
$ |
24 |
|
|
$ |
24 |
|
Work
in process
|
|
|
— |
|
|
|
— |
|
Finished
goods
|
|
|
97 |
|
|
|
201 |
|
|
|
$ |
121 |
|
|
$ |
225 |
|
The
Company has substantial quantities of Genasense® drug supply which are recorded
at zero cost. Such inventory would be available for the commercial launch of
this product, should Genasense® be approved.
5.
Settlement of Office Lease Obligation and Operating Leases
In May
2008, the Company entered into an amendment of its Lease Agreement with The
Connell Company (Connell), whereby the lease for one floor of office space in
Berkeley Heights, New Jersey was terminated. Connell received a termination
payment of $1.3 million, comprised solely of the Company’s security deposits and
the Company agreed to a future payment from the Company of $2.0 million upon the
earlier of July 1, 2009 or the receipt of at least $5.0 million in upfront cash
from a business development deal. In January 2009, the Company entered into an
amendment of its agreement with Connell whereby the Company’s future payment of
$2.0 million is now payable on January 1, 2011. The Company will pay 6.0%
interest in arrears to Connell from July 1, 2009 through the new payment
date.
At
December 31, 2007, the Company had maintained $1.7 million in restricted cash
balances with financial institutions related to lease obligations on its
corporate facilities. These amounts were included in other assets in the
Company’s Consolidated Balance Sheets.
Future
minimum obligations under operating leases at December 31, 2008 are as follows
($ thousands):
2009
|
|
$ |
706 |
|
2010
|
|
|
146 |
|
2011
|
|
|
2,007 |
|
2012
|
|
|
— |
|
2013
|
|
|
— |
|
Thereafter
|
|
|
— |
|
|
|
$ |
2,859 |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
Annual
rent expense incurred by the Company in 2008, 2007 and 2006 was $4.8 million,
$2.6 million and $2.5 million, respectively. The annual rent expense in 2008 of
$4.8 million includes the termination agreement with Connell for $3.3
million.
6. Provision for Settlement of
Litigation, net
The
Company reached an agreement to settle a class action litigation in
consideration for issuance of 40,000 shares of common stock of the Company
(adjusted for any subsequent event that results in a change in the number of
shares outstanding as of January 31, 2007) and $18.0 million in cash for the
benefit of plaintiffs and the stockholder class, (see Note 19 to the
Consolidated Financial Statements). A Court order approving the settlement was
issued on May 27, 2008 and the settlement became final on June 27, 2008. The
Company also entered into release and settlement agreements with its insurance
carriers, pursuant to which insurance will cover the settlement fee and various
costs incurred in connection with the action. Under FASB Statement No. 5, “Accounting for Contingencies”
and FASB Interpretation No. 14, “Reasonable Estimation of the Amount of a Loss,
an interpretation of FASB Statement No. 5,” the Company recorded an
expense of $5.3 million, comprised of 40,000 shares of the Company’s common
stock valued at a market price of $132.00 on December 31, 2006. At December 31,
2007, the revised estimated value of the common shares portion of the litigation
settlement was $1.0 million, based on a closing price of Genta’s common stock of
$26.00 per share, resulting in a reduction in the provision of $4.2 million
recognized in the year ended December 31, 2007. At June 27, 2008, the date that
the settlement became final, the revised value of the common stock portion of
the litigation settlement was $0.7 million, based on a closing price of Genta’s
common stock of $17.50 per share, resulting in a reduction in the provision of
$0.3 million for the year ended December 31, 2008. The liability for the
settlement of litigation, originally recorded at $23.2 million at December 31,
2006, was measured at $19.0 million at December 31, 2007 and $0.7 million at
December 31, 2008 and is included in accounts payable and accrued expenses in
the Company’s Consolidated Balance Sheets. An insurance receivable of $18.0
million was included in prepaid expenses and other current assets in the
Company’s Consolidated Balance Sheets at December 31, 2007. As a result of the
Court approving the settlement on May 27, 2008 and it being deemed final on June
27, 2008, the Company no longer had any interest in the insurance proceeds held
in escrow or the associated liability.
7. Property and Equipment,
Net
Property
and equipment is comprised of the following ($ thousands):
|
|
Estimated
|
|
|
December
31,
|
|
|
|
Useful Lives
|
|
|
2008
|
|
|
2007
|
|
Computer
equipment
|
|
|
3 |
|
|
$ |
2,298 |
|
|
$ |
2,855 |
|
Software
|
|
|
3 |
|
|
|
3,206 |
|
|
|
3,211 |
|
Furniture
and fixtures
|
|
|
5 |
|
|
|
899 |
|
|
|
936 |
|
Leasehold
improvements
|
|
Life
of lease
|
|
|
|
463 |
|
|
|
420 |
|
Equipment
|
|
|
5 |
|
|
|
182 |
|
|
|
182 |
|
|
|
|
|
|
|
|
7,048 |
|
|
|
7,604 |
|
Less
accumulated depreciation and amortization
|
|
|
|
|
|
|
(6,748 |
) |
|
|
(7,281 |
) |
|
|
|
|
|
|
$ |
300 |
|
|
$ |
323 |
|
8.
Write-off of Prepaid Royalty
In
December 2000, the Company recorded $1.3 million as the fair value for its
commitment to issue shares of common stock to a major university as
consideration for an amendment to a license agreement initially executed in
August 1991 related to antisense technology licensed from the university. The
amendment provided for a reduction in the royalty percentage rate to be paid to
the university based on the volume of sales of the Company’s products containing
the antisense technology licensed from such university. These shares were issued
in 2001. The Company planned to amortize the prepaid royalties upon the
commercialization of Genasense®. In December 2006, the Company received a
non-approvable notice from the FDA for its NDA for the use of Genasense® plus
chemotherapy in patients with CLL. As a result, in December 2006, the Company
accounted for the impairment of these prepaid royalties by recording a write-off
of this asset.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
9.
Workforce reduction
In
December 2006, due to FDA’s non-approval of the Company’s NDA for CLL, the
Company initiated a series of steps that are designed to conserve cash in order
to focus on its oncology development operations. The Company reduced its
workforce by 34 positions, or approximately 35%, including the elimination of 18
positions classified as research and development, 9 in sales and marketing and 7
in administration. Severance costs of $0.7 million were recognized in operating
expenses in December 2006, including $0.3 million in research and development
expenses and $0.4 million in selling, general and administrative expenses in the
Company’s Consolidated Statements of Operations. Payment of the severance began
in January 2007 and was completed by June 30, 2007.
10.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses is comprised of the following ($
thousands):
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
Accounts
payable
|
|
$ |
4,654 |
|
|
$ |
2,519 |
|
Accrued
compensation
|
|
|
574 |
|
|
|
488 |
|
Reserve
for settlement of litigation obligation
|
|
|
700 |
|
|
|
19,040 |
|
License
obligations to Daiichi Sankyo
|
|
|
2,125 |
|
|
|
— |
|
State
of New Jersey (AMA) tax liability
|
|
|
841 |
|
|
|
776 |
|
Other
accrued expenses
|
|
|
2,330 |
|
|
|
3,027 |
|
|
|
$ |
11,224 |
|
|
$ |
25,850 |
|
The
carrying amount of accounts payable approximates fair value due to the
short-term nature of these instruments.
11.
Notes Payable
During
2007, the Company issued notes payable to finance premiums for its corporate
insurance policies of $1.1 million. Payments were scheduled for seven or ten
equal monthly installments for the notes initiated in 2007. The notes payable
balance at December 31, 2007 was $0.5 million. The carrying amount of notes
payable approximates fair value due to the short-term nature of these
instruments.
12.
Convertible Notes and Warrant
On
June 5, 2008, the Company entered into a securities purchase agreement with
certain institutional and accredited investors to place up to $40.0 million of
senior secured convertible notes with such investors. On June 9, 2008, the
Company placed $20.0 million of such notes in the initial closing. The notes are
due June 9, 2010 and bear interest at an annual rate of 15% payable at quarterly
intervals in stock or cash at the Company’s option, and are convertible into
shares of Genta common stock at a conversion rate of 2,000 shares of common
stock for every $1,000 of principal. At the time the notes were issued, the
Company recorded a debt discount (beneficial conversion) relating to the
conversion feature in the amount of $20.0 million. The aggregate intrinsic value
of the difference between the market price of the Company’s share of stock on
June 9, 2008 and the conversion price of the notes was in excess of the face
value of the $20.0 million notes, and thus, a full debt discount was recorded in
an amount equal to the face value of the debt. The Company is amortizing the
resultant debt discount over the term of the notes through its maturity date
using the effective interest method. In addition, the notes prohibit the Company
from consummating any additional financing transaction without the approval of
holders of more than two-thirds of the principal amount of the notes. The
Company is in compliance with all debt-related covenants at December 31,
2008.
Through
December 31, 2008, holders of the convertible notes have voluntarily converted
approximately $4.5 million, resulting in an issuance of 8.9 million shares of
common stock.
The notes
included certain events of default, including a requirement that the Company
obtain stockholder approval within a specified period of time to amend its
certificate of incorporation to authorize additional shares of common
stock.
Upon the
occurrence of an event of default, holders of the notes have the right to
require the Company to prepay all or a portion of their notes as calculated as
the greater of (a) 150% of the aggregate principal amount of the note plus
accrued interest or (b) the aggregate principal amount of the note plus accrued
interest divided by the conversion price; multiplied by a weighted average price
of the Company’s common stock. Pursuant to a general security agreement, entered
into concurrently with the notes (the “Security Agreement”), the notes are
secured by a first lien on all assets of the Company, subject to certain
exceptions set forth in the Security Agreement.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
In
addition, in connection with the placement of the senior secured convertible
notes, the Company issued a warrant to its private placement agent to purchase
800,000 shares of common stock at an exercise price of $1.00 per share. The
warrant was valued at $7.6 million, using a Black-Scholes valuation model. In
addition, the Company incurred a financing fee of $1.2 million. The deferred
financing costs, including the financing fee and the initial value of the
warrant, are being amortized over the two-year term of the convertible notes. At
December 31, 2008, the unamortized balances of the financing fee and the warrant
are $0.9 million and $5.5 million, respectively.
The
Company concluded that it should initially account for conversion options
embedded in convertible notes in accordance with SFAS No. 133 “Accounting for Derivative
Instruments and Hedging Activities” (“SFAS 133”) and EITF 00-19 “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s
Own Stock” (“EITF 00-19”). SFAS 133 generally requires companies to
bifurcate conversion options embedded in convertible notes from their host
instruments and to account for them as free standing derivative financial
instruments in accordance with EITF 00-19. EITF 00-19 states that if the
conversion option requires net cash settlement in the event of circumstances
that are not solely within the Company’s control, that the notes should be
classified as a liability measured at fair value on the balance sheet. In this
case, if the Company was not successful in obtaining approval of its
stockholders to increase the number of authorized shares to accommodate the
potential number of shares that the notes convert into, the Company would have
been required to cash settle the conversion option.
Upon the
issuance date, there were an insufficient number of authorized shares of common
stock in order to permit conversion of all of the issued convertible notes. In
accordance with EITF 00-19, when there are insufficient authorized shares to
allow for settlement of convertible financial instruments, the conversion
obligation for the notes should be classified as a liability and measured at
fair value on the balance sheet. Accordingly, at June 9, 2008, in connection
with the $20.0 million initial closing, the convertible features of the notes
were recorded as derivative liabilities of $380.0 million. At the recording of
the initial closing, the fair value of the conversion feature, $380.0 million,
exceeded the proceeds of $20.0 million. The difference of $360.0 million was
charged to expense as the change in the fair market value of conversion
liability. Accordingly, the Company recorded an initial discount of $20.0
million equal to the face value of the notes, which is being amortized over the
two-year term of the notes.
On
October 6, 2008, at the Annual Meeting of Stockholders, the Company’s
stockholders approved an amendment to Genta’s Restated Certificate of
Incorporation, as amended, to increase the total number of authorized shares of
capital stock available for issuance from 255,000,000, consisting of 250,000,000
shares of Common Stock and 5,000,000 shares of Preferred Stock, to
6,005,000,000, consisting of 6,000,000,000 shares of Common Stock and 5,000,000
shares of Preferred Stock. The notes were re-measured and credited to permanent
equity, resulting in total expense for the year ended December 31, 2008 of
$460.0 million.
The
conversion option was valued at June 9, 2008 and October 6, 2008 using the
Black-Scholes valuation model with the following assumptions:
|
|
October 6, 2008
|
|
|
June 9, 2008
|
|
Price
of Genta common stock
|
|
$ |
12.50 |
|
|
$ |
10.00 |
|
Volatility
|
|
|
137.4 |
% |
|
|
125.6 |
% |
Risk-free
interest rate
|
|
|
1.36 |
% |
|
|
2.73 |
% |
Remaining
contractual lives
|
|
|
1.68 |
|
|
|
2.00 |
|
The
Company also classified the warrant obligation as a liability to be measured at
fair value on the balance sheet, in accordance with EITF 00-19. Accordingly, at
June 9, 2008, the Company recorded the warrant liability at a fair value of $7.6
million based upon the Black-Scholes valuation model. On October 6, 2008, we
re-measured the warrant liability and credited it to permanent equity, resulting
in total expense for the year ended December 31, 2008 of $2.0
million.
|
|
October 6, 2008
|
|
|
June 9, 2008
|
|
Price
of Genta common stock
|
|
$ |
12.50 |
|
|
$ |
10.00 |
|
Volatility
|
|
|
128.6 |
% |
|
|
115.0 |
% |
Risk-free
interest rate
|
|
|
2.32 |
% |
|
|
3.41 |
% |
Remaining
contractual lives
|
|
|
4.68 |
|
|
|
5.00 |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
13.
Income Taxes
Significant
components of the Company’s deferred tax assets as of December 31, 2008 and 2007
and related valuation reserves are presented below ($ thousands):
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
Deferred
tax assets:
|
|
|
|
|
|
|
Deferred
compensation
|
|
$ |
772 |
|
|
$ |
772 |
|
Net
operating loss carryforwards
|
|
|
135,990 |
|
|
|
130,111 |
|
Research
and development credit and Orphan Drug credit
carryforwards
|
|
|
51,288 |
|
|
|
41,484 |
|
Purchased
technology and license fees
|
|
|
0 |
|
|
|
4,850 |
|
Depreciation
and amortization, net
|
|
|
193 |
|
|
|
261 |
|
Share-based
compensation expense
|
|
|
911 |
|
|
|
892 |
|
Provision
for settlement of litigation, net
|
|
|
308 |
|
|
|
458 |
|
Write-off
of prepaid royalties
|
|
|
558 |
|
|
|
558 |
|
New
Jersey Alternative Minimum Assessment (AMA) Tax
|
|
|
730 |
|
|
|
730 |
|
New
Jersey research and development credits
|
|
|
4,979 |
|
|
|
5,612 |
|
Provision
for excess inventory
|
|
|
714 |
|
|
|
714 |
|
Reserve
for product returns
|
|
|
0 |
|
|
|
2 |
|
Accrued
liabilities
|
|
|
1,576 |
|
|
|
355 |
|
Other,
net
|
|
|
197 |
|
|
|
323 |
|
Total
deferred tax assets
|
|
|
198,216 |
|
|
|
187,122 |
|
Valuation
allowance for deferred tax assets
|
|
|
(190,884 |
) |
|
|
(187,122 |
) |
Net
deferred tax assets
|
|
$ |
7,332 |
|
|
$ |
— |
|
Deferred
tax liabilities:
|
|
|
|
|
|
|
|
|
Deferred
financing costs
|
|
$ |
(4,922 |
) |
|
$ |
— |
|
Debt
discount
|
|
|
(2,410 |
) |
|
|
— |
|
Total
deferred tax liabilities
|
|
$ |
(7,332 |
) |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
Net
deferred tax assets (liabilities)
|
|
$ |
— |
|
|
$ |
— |
|
A full
valuation allowance has been provided at December 31, 2008 and 2007,
respectively, to reserve for deferred tax assets, as it appears more likely than
not that net deferred tax assets will not be realized.
Effective
January 1, 2007 the company adopted FIN 48. As of December 31, 2008 and 2007,
the Company recorded a liability for $841,000 and $776,000, respectively, of
unrecognized tax benefits (UTB’s), of which $841,000 and $776,000 is included in
accounts payable and accrued expenses on the Company’s Consolidated Balance
Sheets, respectively. In addition, as of December 31, 2008 and 2007, the Company
reduced its deferred tax assets by $1,312,000 and $1,033,000, respectively.
However, the Company recorded a full valuation allowance on its net deferred tax
assets and reduced its valuation allowance on these respective amounts. The
amount of UTB’s that would have an impact on the effective tax rate, if
recognized, is $533,000.
A
reconciliation of the total amount of unrecognized tax benefits (UTB’s) is as
follows:
($
in thousands)
|
|
2008
|
|
|
2007
|
|
Unrecognized
tax benefits: January 1
|
|
$ |
1,567 |
|
|
$ |
1,388 |
|
|
|
|
|
|
|
|
|
|
Gross
increases: Tax positions taken in prior periods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
decreases: Tax positions taken in prior periods
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Increases- Current period tax positions
|
|
$ |
278 |
|
|
$ |
179 |
|
|
|
|
|
|
|
|
|
|
Lapse
of Statute of Limitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrecognized
tax benefits: December 31
|
|
$ |
1,845 |
|
|
$ |
1,567 |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
The
Company files corporate tax returns at the federal level and in the State of New
Jersey. The open tax years that are subject to examination for these
jurisdictions are 2005 through 2008 for federal returns and 2002 through 2008
for tax returns for the State of New Jersey.
New
Jersey has enacted legislation permitting certain corporations located in the
state to sell state tax loss carryforwards and state research and development
credits. The Company sold portions of its New Jersey net operating losses and
received approximate payments of $2.0 million in 2008 and $1.5 million in 2007,
recognized as income tax benefits.
If still
available under New Jersey law, the Company will attempt to sell its tax loss
carryforwards in 2008. We cannot be assured that the New Jersey program will
continue in 2008, nor can we estimate what percentage of our saleable tax
benefits New Jersey will permit us to sell, how much money will be received in
connection with the sale, or if the Company will be able to find a buyer for its
tax benefits.
The
Company’s Federal tax returns have never been audited. In January 2006, the
State of New Jersey concluded its fieldwork with respect to a tax audit for the
years 2000 through 2004. The State of New Jersey took the position that amounts
reimbursed to Genta by Aventis Pharmaceutical Inc. for co-development
expenditures during the audit period were subject to Alternative Minimum
Assessment (AMA), resulting in a liability at that time of approximately
$533,000. Although the Company and its outside tax advisors believe the State’s
position on the AMA liability is unjustified, there is little case law on the
matter and it is probable that the Company will be required to ultimately pay
the liability. As of December 31, 2008, the Company had accrued a tax liability
of $533,000, penalties of $27,000 and interest of $281,000 related to this
assessment. The Company appealed this decision to the State and in February
2008, the State notified the Company that its appeal had not been granted. The
Company believes the State’s position is unjustified and is pursuing this matter
before the New Jersey Tax Court. Upon close of the audit the Company’s UTB’s
should decrease by approximately $841,000.
The
Company recorded $65,000, $139,000 and $66,000 in interest expense related to
the State of New Jersey assessment during 2008, 2007 and 2006,
respectively.
At
December 31, 2008, the Company has federal and state net operating loss
carryforwards of approximately $324.8 million and $241.9 million, respectively.
The federal tax loss carryforward balance at December 31, 2008 begins to expire
in 2009 and completely expires in 2028. The Company also has Research and
Development credit and Orphan Drug credit carryforwards totaling $49.7 million;
the balance at December 31, 2008 begins to expire in 2009 and completely expires
in 2028.
14. Stockholders’
(Deficit)/Equity
Common
Stock
On
October 6, 2008, at the Annual Meeting of Stockholders, the Company’s
stockholders approved an amendment to Genta’s Restated Certificate of
Incorporation, as amended, to increase the total number of authorized shares of
capital stock available for issuance from 255,000,000, consisting of 250,000,000
shares of Common Stock and 5,000,000 shares of Preferred Stock, to
6,005,000,000, consisting of 6,000,000,000 shares of Common Stock and 5,000,000
shares of Preferred Stock.
In
February 2008, the Company sold 122,000 shares of the Company’s common stock at
a price of $25.00 per share, raising approximately $3.1 million, before
estimated fees and expenses.
At the
Company’s Annual Meeting of Stockholders on July 11, 2007, the Company’s
stockholders authorized its Board of Directors to effect a reverse stock split
of all outstanding shares of common stock, and the Board of Directors
subsequently approved the implementation of a reverse stock split at a ratio of
one for six shares.
In
March 2007, the Company sold 100,000 shares of the Company’s common stock at a
price of $108.00 per share, raising $10.2 million, net of fees and
expenses.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
Preferred
Stock Purchase Right
In 2005
the Board of Directors adopted a Stockholder Rights Plan and declared a dividend
of one preferred stock purchase right (a “Right”) for each outstanding share of
common stock of the Company, payable to holders of record as of the close of
business on September 27, 2005. Generally, the rights become exercisable upon
the earlier of the close of business on the tenth business day following the
first public announcement that any person or group has become a beneficial owner
of 15% or more of the Company’s common stock and the close of business on the
tenth business day after the date of the commencement of a tender or exchange
offer by any person which would, if consummated, result in such person becoming
a beneficial owner of 15% or more of the Company’s common stock. Each Right
shall be exercisable to purchase, for $25.00, subject to adjustment, one
one-hundredth of a newly registered share of Series G Participating Cumulative
Preferred Stock, par value $0.001 per share of the Company.
Series
A Preferred Stock
Each
share of Series A Preferred Stock is immediately convertible into shares of the
Company’s common stock, at a rate determined by dividing the aggregate
liquidation preference of the Series A Preferred Stock by the conversion price.
The conversion price is subject to adjustment for antidilution. As of December
31, 2008 and December 31, 2007, each share of Series A Preferred Stock was
convertible into 3.0699 and 0.0469 shares of common stock, respectively. At
December 31, 2008 and December 31, 2007, the Company had 7,700 shares of Series
A Convertible Preferred Stock issued and outstanding.
In the
event of a liquidation of the Company, the holders of the Series A Preferred
Stock are entitled to a liquidation preference equal to $50 per share, or $0.4
million at December 31, 2008.
Series
G Preferred Stock
The
Company has 5.0 million shares of preferred stock authorized, of which 2.0
million shares has been designated Series G Participating Cumulative
Preferred.
Warrant
In
connection with the June 2008 convertible note financing, the Company issued a
common stock purchase warrant to its private placement agent. The warrant is
exercisable into 800,000 shares of common stock at an exercise price of $1.00
per share.
Common
Stock Reserved
At
December 31, 2008, the Company had 9.7 million shares of common stock
outstanding, 68,000 shares reserved for the conversion of convertible preferred
stock and the exercise of outstanding options, 0.8 million shares reserved for
the conversion of an outstanding warrant and 31.1 million shares reserved for
the conversion of senior convertible notes, and 3,000 additional shares of
common stock authorized for issuance and remaining to be granted under the
Company’s Non-Employee Directors’ 1998 Stock Option Plan, as amended and
restated.
15.
Share-Based Compensation
The
Company estimates the fair value of each option award on the date of the grant
using the Black-Scholes option valuation model. Expected volatilities are based
on the historical volatility of the Company’s common stock over a period
commensurate with the options’ expected term. The expected term represents the
period of time that options granted are expected to be outstanding and is
calculated in accordance with the Securities and Exchange Commission (“SEC”)
guidance provided in the SEC’s Staff Accounting Bulletin 107 (“SAB 107”), using
a “simplified” method. The Company has used the simplified method and will
continue to use the simplified method as it does not have sufficient historical
exercise data to provide a reasonable basis upon which to estimate an expected
term. The risk-free interest rate assumption is based upon observed interest
rates appropriate for the expected term of the Company’s stock options. The
post-vesting forfeiture rate is estimated using historical option cancellation
information. The post-vesting forfeiture rate assumption was 40% for the years
ended December 31, 2007 and 2006, respectively, and was increased to 50% for the
year ended December 31, 2008 based on actual historical forfeitures. The
following table summarizes the weighted-average assumptions used in the
Black-Scholes model for options granted during the years ended December 31,
2008, 2007 and 2006, respectively:
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
Expected
volatility
|
|
|
115.7 |
% |
|
|
102 |
% |
|
|
97 |
% |
Expected
dividends
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Expected
term (in years)
|
|
|
6.25 |
|
|
|
6.25 |
|
|
|
6.25 |
|
Risk-free
rate
|
|
|
2.7 |
% |
|
|
4.8 |
% |
|
|
4.6 |
% |
The
share-based compensation expense recognized for the years ended December 31,
2008, 2007 and 2006, respectively, follows:
($
thousands, except per share data)
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development expenses
|
|
$ |
151 |
|
|
$ |
521 |
|
|
$ |
997 |
|
Selling,
general and administrative
|
|
|
338 |
|
|
|
852 |
|
|
|
2,002 |
|
Total
share-based compensation expense
|
|
$ |
489 |
|
|
$ |
1,373 |
|
|
$ |
2,999 |
|
Share-based
compensation expense, per basic and diluted common
share
|
|
$ |
0.44 |
|
|
$ |
2.32 |
|
|
$ |
6.65 |
|
16.
Stock Option Plans
As of
December 31 2008, the Company has two outstanding share-based compensation
plans, which are described below:
1998
Stock Incentive Plan
Pursuant
to the Company’s 1998 Stock Incentive Plan, as amended (the “1998 Plan”), 68,000
shares were provided for the grant of stock options to employees, directors,
consultants and advisors of the Company. Option awards were granted with an
exercise price at not less than the fair market price of the Company’s common
stock on the date of the grant; those option awards generally vested over a
four-year period in equal increments of 25%, beginning on the first anniversary
of the date of the grant. All options granted had contractual terms of ten years
from the date of the grant. As of May 27, 2008, the authorization to provide
grants under the 1998 Plan expired.
The
following table summarizes the option activity under the 1998 Plan as of
December 31, 2008 and changes during the three years then ended:
|
|
Number
of Shares
(in thousands)
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
(in years)
|
|
|
Aggregate
Intrinsic
Value
(in thousands)
|
|
Stock
Options
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2005
|
|
|
31 |
|
|
|
1,512.00 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
9 |
|
|
|
582.00 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
(1 |
) |
|
|
1,266.00 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2006
|
|
|
39 |
|
|
$ |
1,311.00 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
6 |
|
|
|
70.00 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
(2 |
) |
|
|
819.00 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2007
|
|
|
43 |
|
|
$ |
1,152.50 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
(6 |
) |
|
|
888.00 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2008
|
|
|
37 |
|
|
$ |
1,191.50 |
|
|
|
3.8 |
|
|
$ |
— |
|
Vested
and exercisable at December 31, 2008.
|
|
|
26 |
|
|
$ |
1,109.50 |
|
|
|
1.7 |
|
|
$ |
— |
|
There is
no intrinsic value to outstanding stock options as the exercise prices of all
outstanding options are above the market price of the Company’s stock at
December 31, 2008.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
As of
December 31, 2008, there was approximately $0.2 million of total unrecognized
compensation cost related to non-vested share-based compensation granted under
the 1998 Plan, which is expected to be recognized over a weighted-average period
of 1.2 years.
The
following table summarizes the restricted stock unit (RSU) activity under the
1998 Plan as of December 31, 2008 and changes during the two years then
ended:
Restricted Stock
Units
|
|
Number
of Shares
(in thousands)
|
|
|
Weighted
Average
Grant
Date Fair
Value per Share
|
|
Outstanding
nonvested RSUs at January 1, 2007
|
|
|
0 |
|
|
$ |
— |
|
Granted
|
|
|
1 |
|
|
$ |
71.00 |
|
Vested
|
|
|
0 |
|
|
$ |
— |
|
Forfeited
or expired
|
|
|
(1 |
) |
|
$ |
71.00 |
|
Outstanding
nonvested RSUs at December 31, 2007
|
|
|
0 |
|
|
$ |
71.00 |
|
Granted
|
|
|
10 |
|
|
$ |
20.50 |
|
Vested
|
|
|
0 |
|
|
$ |
71.00 |
|
Forfeited
or expired
|
|
|
(5 |
) |
|
$ |
20.50 |
|
Outstanding
nonvested RSUs at December 31, 2008
|
|
|
5 |
|
|
$ |
20.50 |
|
As of
December 31, 2008, there was approximately $24,000 of total unrecognized
compensation cost related to non-vested share-based compensation resulting from
RSUs granted under the 1998 Plan, which is expected to be recognized over the
six months ended June 30, 2009.
1998 Non-Employee Directors’
Plan
Pursuant
to the Company’s 1998 Non-Employee Directors’ Plan as amended (the “Directors’
Plan”), 12,000 shares have been provided for the grant of non-qualified stock
options to the Company’s non-employee members of the Board of Directors. Option
awards must be granted with an exercise price at not less than the fair market
price of the Company’s common stock on the date of the grant. Initial option
grants vest over a three-year period in equal increments, beginning on the first
anniversary of the date of the grant. Subsequent grants, generally vest on the
date of the grant. All options granted have contractual terms of ten years from
the date of the grant.
The fair
value of each option award is estimated on the date using the same valuation
model used for options granted under the 1998 Plan.
The
following table summarizes the option activity under the Directors’ Plan as of
December 31, 2008 and changes during the three years then ended:
|
|
Number
of Shares
(in thousands)
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
(in years)
|
|
|
Aggregate
Intrinsic
Value
(in thousands)
|
|
Stock
Options
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2005
|
|
|
4 |
|
|
$ |
1,878.00 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
0 |
|
|
|
621.00 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
0 |
|
|
|
300.00 |
|
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
(2 |
) |
|
|
2,049.00 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2006
|
|
|
2 |
|
|
$ |
1,851.00 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
0 |
|
|
|
90.00 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
0 |
|
|
|
2,004.00 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2007
|
|
|
2 |
|
|
$ |
1,530.50 |
|
|
|
|
|
|
|
|
|
Granted.
|
|
|
0 |
|
|
|
12.50 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
0 |
|
|
|
2,091.00 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2008
|
|
|
2 |
|
|
$ |
1,130.50 |
|
|
|
6.2 |
|
|
$ |
— |
|
Vested
and exercisable at December 31, 2008.
|
|
|
2 |
|
|
$ |
1,130.50 |
|
|
|
6.2 |
|
|
$ |
— |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
There
is no intrinsic value to outstanding stock options as the exercise prices of all
outstanding options are above the market price of the Company’s stock at
December 31, 2008. The weighted-average grant-date fair value of options granted
during the year ended December 31, 2008 was $12.50.
Stock
option grants for a combination of both the 1998 Plan and the 1998 Directors
Plan were as follows:
Year
|
|
Options
Granted
(in Thousands)
|
|
|
Weighted
Average Grant Date
Per Share Fair Value
|
|
2008
|
|
|
0 |
|
|
$ |
12.50 |
|
2007
|
|
|
7 |
|
|
|
71.00 |
|
2006
|
|
|
9 |
|
|
|
585.00 |
|
An
analysis of all options outstanding as of December 31, 2008 is presented below,
(option figures are in thousands):
Range
of
Prices
|
|
Options
Outstanding
|
|
|
Weighted
Average
Remaining
Life in Years
|
|
|
Weighted
Average
Exercise Price
|
|
|
Options
Exercisable
|
|
|
Weighted
Average
Exercise
Price of
Options Exercisable
|
|
$12.50
- $99.00
|
|
|
4 |
|
|
|
9.0 |
|
|
$ |
39.00 |
|
|
|
1 |
|
|
$ |
43.00 |
|
$136.50
- $477.00
|
|
|
3 |
|
|
|
7.4 |
|
|
|
353.50 |
|
|
|
1 |
|
|
|
347.50 |
|
$483.00
- $648.00
|
|
|
6 |
|
|
|
7.0 |
|
|
|
612.00 |
|
|
|
3 |
|
|
|
604.50 |
|
$729.00
- $800.50
|
|
|
16 |
|
|
|
0.9 |
|
|
|
800.00 |
|
|
|
16 |
|
|
|
800 |
|
$1,719.00
- $2,805.00
|
|
|
4 |
|
|
|
2.8 |
|
|
|
2,162.00 |
|
|
|
4 |
|
|
|
2,162.00 |
|
$2,964.00
- $5,475
|
|
|
6 |
|
|
|
4.2 |
|
|
|
3,314.50 |
|
|
|
2 |
|
|
|
3,761.50 |
|
|
|
|
39 |
|
|
|
3.9 |
|
|
$ |
1,188.50 |
|
|
|
27 |
|
|
|
1,111.00 |
|
2007
Stock Incentive Plan
On
September 17, 2007, the Company’s Board of Directors approved the Company’s 2007
Stock Incentive Plan (the “2007 Plan”), pursuant to which 170,000 shares of the
Company’s common stock would be authorized for issuance, subject to approval of
the Company’s stockholders. On September 17, 2007 and September 20, 2007, the
Board of Directors approved the issuance of a combined total of 108,000 options
under the 2007 Plan. Awards granted under the plan prior to stockholder approval
of the plan were subject to and conditioned upon receipt of such approval on or
before September 17, 2008. The Company did not obtain stockholder approval of
this plan; the plan was terminated and awards granted pursuant to the plan were
terminated. The Company did not recognize compensation expense for grants under
the 2007 Plan because grants of these options were contingent upon stockholder
approval, and therefore, a grant date as defined in SFAS 123R had not
occurred.
Acquisition
Bonus Program
On
September 17, 2007, the Board of Directors approved an Acquisition Bonus
Program. Under the program, participants were eligible to share in a portion of
the proceeds realized from a change in control of the Company that occurred
prior to the earlier of (i) December 31, 2008 or (ii) the approval by the
Company’s stockholders of the 2007 Stock Incentive Plan.
The
Acquisition Bonus Program expired on December 31, 2008.
17.
Employee Savings Plan
In 2001,
the Company initiated sponsorship of the Genta Incorporated Savings and
Retirement Plan, a defined contribution plan under Section 401(k) of the
Internal Revenue Code. The Company’s matching contribution to the Plan was $0.2
million, $0.3 million, and $0.4 million for 2008, 2007 and 2006,
respectively.
18.
Comprehensive Loss
An
analysis of comprehensive loss is presented below:
|
|
Years Ended December 31,
|
|
($
in thousands)
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(505,838 |
) |
|
$ |
(23,320 |
) |
|
$ |
(56,781 |
) |
Change
in market value on available-for-sale marketable
securities
|
|
|
(29 |
) |
|
|
29 |
|
|
|
31 |
|
Total
comprehensive loss
|
|
$ |
(505,867 |
) |
|
$ |
(23,291 |
) |
|
$ |
(56,750 |
) |
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
19.
Commitments and Contingencies
Litigation
and Potential Claims
In
February 2007, a complaint against the Company was filed in the Superior Court
of New Jersey by Howard H. Fingert, M.D., a former employee of the Company. The
complaint alleges, among other things, breach of contract as to the Company’s
stock option plan and as to a consulting agreement allegedly entered into by the
Company and Dr. Fingert subsequent to termination of Dr. Fingert’s employment
with the Company, breach of implied covenant of good faith and fair dealing with
respect to the Company’s stock option plan and the alleged consulting agreement,
promissory estoppel with respect to the exercise of stock options and provision
of consulting services after termination of employment, and fraud and negligent
misrepresentation with respect to the exercise of stock options and provision of
consulting services after termination of employment. The complaint sought
monetary damages, including punitive and consequential damages. The Company and
Fingert settled this complaint in January 2009, and the Company accrued the
settlement amount as of December 31, 2008. The settlement did not constitute an
admission of guilt or liability.
In
November 2007, a complaint against the Company was filed in the United States
District Court for the District of New Jersey by Ridge Clearing &
Outsourcing Solutions, Inc. The complaint alleges, among other things, that the
Company caused or contributed to losses suffered by a Company stockholder which
have been incurred by Ridge. The Company and Ridge settled this complaint in
September 2008. The settlement did not constitute an admission of guilt or
liability.
In
September 2008, several stockholders of the Company, on behalf of themselves and
all others similarly situated, filed a class action complaint against us, our
Board of Directors, and certain of our executive officers in Superior Court of
New Jersey, captioned Collins v. Warrell, Docket No. L-3046-08. The complaint
alleges that in issuing convertible notes, our Board of Directors, and certain
officers breached their fiduciary duties, and we aided and abetted the breach of
fiduciary duty. Defendants filed a motion to dismiss on December 29, 2008.
Plaintiffs’ opposition is due on or before February 13, 2009, and Defendants’
reply is due March 16, 2009. It is possible that oral argument on the motion
will be held on March 20, 2009. Discovery has begun. We, the Board of Directors
and Officers deny these allegations and intend to vigorously defend this
lawsuit.
In
November 2008, a complaint against the Company and its transfer agent, BNY
Mellon Shareholder Services, was filed in the Supreme Court of the State of New
York by an individual stockholder. The complaint alleges that the Company and
its transfer agent caused or contributed to losses suffered by the stockholder.
The Company denies the allegations of the complaint and intends to vigorously
defend this lawsuit.
20. Supplemental Disclosure of Cash
Flows Information and Non-cash Investing and Financing
Activities
In
accordance with the terms of the convertible notes, the Company elected to pay
interest due on the notes on December 9, 2008 in shares of its common stock to
all noteholders where the issuance of the shares would not cause the noteholder
to beneficially own more than 4.999% of the Company’s outstanding common stock.
Accordingly, the Company issued 800,000 shares and $0.1 million to satisfy the
interest payment on December 9, 2008.
Through
December 31, 2008, holders of the convertible notes have voluntarily converted
approximately $4.5 million of their notes, resulting in an issuance of 9.0
million shares of common stock.
No
interest was paid for the twelve months ended December 31, 2007 and 2006,
respectively.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
21.
Selected Quarterly Financial Data (Unaudited)
2008
|
|
Quarter
Ended
|
|
($
thousands, except per share data)
|
|
Mar. 31
|
|
|
Jun. 30
|
|
|
Sep. 30
|
|
|
Dec. 31
|
|
Revenues
|
|
$ |
117 |
|
|
$ |
131 |
|
|
$ |
115 |
|
|
$ |
— |
|
Gross
margin
|
|
|
92 |
|
|
|
102 |
|
|
|
89 |
|
|
|
(23 |
) |
Operating
expenses
|
|
|
9,816 |
|
|
|
10,268 |
|
|
|
7,563 |
|
|
|
5,763 |
|
Other
income/(expense), net
|
|
|
67 |
|
|
|
(728,198 |
) |
|
|
220,087 |
|
|
|
33,380 |
|
Net
(loss)/income
|
|
|
(9,657 |
) |
|
|
(738,364 |
) |
|
|
212,613 |
|
|
|
29,569 |
|
Net
(loss)/income per basic common share**
|
|
$ |
(14.29 |
) |
|
$ |
(1,004.58 |
) |
|
$ |
289.22 |
|
|
$ |
12.90 |
|
Net
(loss)/income per diluted common share
|
|
$ |
(14.29 |
) |
|
$ |
(1,004.58 |
) |
|
$ |
5.12 |
|
|
$ |
1.08 |
|
2007
|
|
Quarter
Ended
|
|
($
thousands, except per share data)
|
|
Mar. 31
|
|
|
Jun. 30
|
|
|
Sep. 30
|
|
|
Dec. 31
|
|
Revenues
|
|
$ |
94 |
|
|
$ |
105 |
|
|
$ |
115 |
|
|
$ |
266 |
|
Gross
margin
|
|
|
72 |
|
|
|
79 |
|
|
|
95 |
|
|
|
244 |
|
Operating
expenses-net
|
|
|
5,875 |
|
|
|
8,594 |
|
|
|
8,046 |
|
|
|
3,601 |
|
Net
loss
|
|
|
(5,605 |
) |
|
|
(8,235 |
) |
|
|
(7,732 |
) |
|
|
(1,748 |
) |
Net
loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$ |
(10.50 |
) |
|
$ |
(13.45 |
) |
|
$ |
(12.63 |
) |
|
$ |
(2.85 |
) |
**
|
Net
(loss)/income per basic common share and net (loss)/income per diluted
common share are calculated independently for each quarter and the full
year based upon respective average shares outstanding. Therefore, the sum
of the quarterly amounts does not equal the annual amounts
reported.
|
The
Company has experienced significant quarterly fluctuations in operating results
and it expects that these fluctuations will continue.
Quarterly
results in 2008 have been impacted by the accounting for the convertible note
and warrant issued in June 2008, (see note 12 to the Consolidated Financial
Statements).
During
the fourth quarter of 2007, the Company revised its estimate of certain accrued
expenses in the amount of $4.7 million, since such amount was no longer deemed
probable.
Restatement
During
the Company’s year-end close, it was discovered that the $18.0 million escrow
deposit relating to the insurance proceeds and the corresponding liability to
settle a 2004 class action lawsuit against the Company should not have been
included on the Company’s Consolidated balance sheets as of June 30, 2008 and
September 30, 2008. As a result of the Court approving the settlement on May 27,
2008, and it being deemed final on June 27, 2008, the Company no longer had any
interest in the insurance proceeds held in escrow or the associated
liability.
In lieu
of filing amendments to the Reports on Form 10Q for the periods ended June 30,
2008 and September 30, 2008, the Company is providing the following unaudited
balance sheet captions to show the effect of the restatement. There was no
income statement effect resulting from the restatement and the only effect on
the Company’s statement of cash flows is a non-cash supplemental
disclosure.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
|
|
Quarter
ended
|
|
|
|
June 30, 2008
|
|
|
September 30, 2008
|
|
($
thousands)
|
|
(restated)
|
|
|
(restated)
|
|
Selected
Balance Sheet Data:
|
|
|
|
|
|
|
Current
assets
|
|
$ |
17,230 |
|
|
$ |
9,450 |
|
Total
assets
|
|
|
26,029 |
|
|
|
17,113 |
|
Current
liabilities
|
|
|
767,403 |
|
|
|
12,827 |
|
Total
liabilities
|
|
|
767,986 |
|
|
|
546,310 |
|
|
|
(as
previously reported)
|
|
|
(as
previously reported)
|
|
|
|
|
|
|
|
|
Current
assets
|
|
$ |
35,230 |
|
|
$ |
27,450 |
|
Total
assets
|
|
|
44,029 |
|
|
|
35,113 |
|
Current
liabilities
|
|
|
785,403 |
|
|
|
30,827 |
|
Total
liabilities
|
|
|
785,986 |
|
|
|
564,310 |
|
22.
Related Party Transactions
Dr.
Daniel Von Hoff, one of Genta’s directors, holds the position of Physician in
Chief and Director of Translational Research at the Translational Genomics
Research Institute (Tgen), which provides preclinical testing services under
direction of and by contract to Genta. During 2008, Tgen performed services for
which it was compensated by Genta in the amount of approximately $36,419. The
Company believes that the payment of these services was on terms no less
favorable than would have otherwise been provided by an ‘‘unrelated’’ party. In
the opinion of the Board of Directors, Dr. Von Hoff’s relationship with Tgen
will not interfere with Dr. Von Hoff’s exercise of independent judgment in
carrying out his responsibilities as a Director of Genta.
On June
5, 2008, the Company entered into a securities purchase agreement with certain
institutional and accredited investors to place up to $40 million of senior
secured convertible notes with such investors. On June 9, 2008, the Company
placed $20 million of such notes in an initial closing. Each of Dr. Raymond
Warrell, our Chief Executive Officer and Chairman, and Dr. Loretta Itri, our
President, Pharmaceutical Development and Chief Medical Officer, participated in
the initial closing by purchasing $1,950,000 and $300,000, respectively, of such
notes. The remaining members of the Board of Directors independently discussed
Dr. Warrell and Dr. Itri’s participation in the transaction and resolved that
such participation would not interfere with Dr. Warrell or Dr. Itri’s exercise
of independent judgment in carrying out their responsibilities in their
respective positions. In connection with the June 2008 convertible note
financing and in accordance with the Audit Committee Charter, the Audit
Committee reviewed and approved the June 2008 convertible note financing with
Dr. Warrell and Dr. Itri.
23.
Subsequent Events
From
January 1, 2009 through February 4, 2009, holders of convertible notes have
voluntarily converted approximately $4.6 million of their notes, resulting in an
issuance of 9.0 million shares of common stock.
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except par value data)
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
|
|
|
|
2009
|
|
|
December
31,
|
|
|
|
(unaudited)
|
|
|
2008
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
598 |
|
|
$ |
4,908 |
|
Accounts
receivable - net of allowances of $10 at March 31, 2009 and $12 at
December 31, 2008, respectively
|
|
|
8 |
|
|
|
2 |
|
Inventory
(Note 3)
|
|
|
121 |
|
|
|
121 |
|
Prepaid
expenses and other current assets
|
|
|
843 |
|
|
|
973 |
|
Total
current assets
|
|
|
1,570 |
|
|
|
6,004 |
|
Property
and equipment, net
|
|
|
269 |
|
|
|
300 |
|
Deferred
financing costs and debt discount (Note 6)
|
|
|
5,298 |
|
|
|
6,389 |
|
Total
assets
|
|
$ |
7,137 |
|
|
$ |
12,693 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$ |
11,080 |
|
|
$ |
11,224 |
|
Total
current liabilities
|
|
|
11,080 |
|
|
|
11,224 |
|
Long-term
liabilities:
|
|
|
|
|
|
|
|
|
Office
lease settlement obligation (Note 4)
|
|
|
1,979 |
|
|
|
1,979 |
|
Convertible
notes due June 9, 2010, $10,654 and $15,540 outstanding, net of debt
discount of ($5,991) and ($11,186) at March 31, 2009 and December
31, 2008, respectively (Note 6)
|
|
|
4,663 |
|
|
|
4,354 |
|
Total
long-term liabilities
|
|
|
6,642 |
|
|
|
6,333 |
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies (Note 9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
deficit:
|
|
|
|
|
|
|
|
|
Preferred
stock, 5,000 shares authorized:
|
|
|
|
|
|
|
|
|
Series
A convertible preferred stock, $.001 par value; 8 shares issued and
outstanding, liquidation value of $385 at March 31, 2009 and December 31,
2008, respectively
|
|
|
- |
|
|
|
- |
|
Series
G participating cumulative preferred stock, $.001 par value; 0 shares
issued and outstanding at March 31, 2009 and December 31, 2008,
respectively
|
|
|
- |
|
|
|
- |
|
Common
stock, $.001 par value; 6,000,000 and 6,000,000 shares authorized, 20,282
and 9,734 shares issued and outstanding at March 31, 2009 and December 31,
2008, respectively
|
|
|
20 |
|
|
|
10 |
|
Additional
paid-in capital
|
|
|
944,588 |
|
|
|
939,252 |
|
Accumulated
deficit
|
|
|
(955,193 |
) |
|
|
(944,126 |
) |
Total
stockholders' deficit
|
|
|
(10,585 |
) |
|
|
(4,864 |
) |
Total
liabilities and stockholders' deficit
|
|
$ |
7,137 |
|
|
$ |
12,693 |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended March 31,
|
|
(In
thousands, except per share data)
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Product
sales - net
|
|
$ |
62 |
|
|
$ |
117 |
|
Cost
of goods sold
|
|
|
- |
|
|
|
25 |
|
Gross
margin
|
|
|
62 |
|
|
|
92 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
2,298 |
|
|
|
6,438 |
|
Selling,
general and administrative
|
|
|
2,172 |
|
|
|
3,638 |
|
Reduction
in liability for settlement of litigation (Note 5)
|
|
|
- |
|
|
|
(260 |
) |
Total
operating expenses
|
|
|
4,470 |
|
|
|
9,816 |
|
|
|
|
|
|
|
|
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
|
Gain
on maturity of marketable securities
|
|
|
- |
|
|
|
31 |
|
Interest
and other income, net
|
|
|
15 |
|
|
|
61 |
|
Interest
expense
|
|
|
(387 |
) |
|
|
(25 |
) |
Amortization
of deferred financing costs and debt discount (Note 6)
|
|
|
(6,287 |
) |
|
|
- |
|
Total
other income/(expense), net
|
|
|
(6,659 |
) |
|
|
67 |
|
Net
loss
|
|
$ |
(11,067 |
) |
|
$ |
(9,657 |
) |
|
|
|
|
|
|
|
|
|
Net
loss per basic and diluted share
|
|
$ |
(0.61 |
) |
|
$ |
(14.29 |
) |
Shares
used in computing net loss per basic and diluted share
|
|
|
17,999 |
|
|
|
676 |
|
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Three
Months Ended March 31,
|
|
(In
thousands)
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Operating
activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(11,067 |
) |
|
$ |
(9,657 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
38 |
|
|
|
41 |
|
Amortization
of deferred financing costs and debt discount
|
|
|
6,287 |
|
|
|
|
|
Share-based
compensation
|
|
|
73 |
|
|
|
145 |
|
Gain
on maturity of marketable securities
|
|
|
- |
|
|
|
(31 |
) |
Reduction
in liability for settlement of litigation
|
|
|
- |
|
|
|
(260 |
) |
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(6 |
) |
|
|
(19 |
) |
Inventory
|
|
|
- |
|
|
|
25 |
|
Prepaid
expenses and other current assets
|
|
|
130 |
|
|
|
419 |
|
Accounts
payable and accrued expenses
|
|
|
242 |
|
|
|
3,110 |
|
Other
assets
|
|
|
- |
|
|
|
(13 |
) |
Net
cash used in operating activities
|
|
|
(4,303 |
) |
|
|
(6,240 |
) |
Investing
activities:
|
|
|
|
|
|
|
|
|
Maturities
of marketable securities
|
|
|
- |
|
|
|
2,000 |
|
Purchase
of property and equipment
|
|
|
(7 |
) |
|
|
- |
|
Net
cash provided by (used in) investing activities
|
|
|
(7 |
) |
|
|
2,000 |
|
Financing
activities:
|
|
|
|
|
|
|
|
|
Repayments
of note payable
|
|
|
- |
|
|
|
(322 |
) |
Issuance
of common stock, net
|
|
|
- |
|
|
|
2,857 |
|
Net
cash provided by financing activities
|
|
|
- |
|
|
|
2,535 |
|
Decrease
in cash and cash equivalents
|
|
|
(4,310 |
) |
|
|
(1,705 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
4,908 |
|
|
|
5,814 |
|
Cash
and cash equivalents at end of period
|
|
$ |
598 |
|
|
$ |
4,109 |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
March
31, 2009
(Unaudited)
|
1.
|
Organization
and Business
|
Genta
Incorporated (the “Company” or “Genta”) is a biopharmaceutical company engaged
in pharmaceutical (drug) research and development, its sole reportable segment.
The Company is dedicated to the identification, development and
commercialization of novel drugs for the treatment of cancer and related
diseases.
The
Company has had recurring annual operating losses since its inception.
Management expects that such losses will continue at least until its lead
product, Genasense®
(oblimersen sodium) Injection, receives approval for commercial sale in one or
more indications. Achievement of profitability for the Company is currently
dependent on the timing of Genasense®
regulatory approval. Any adverse events with respect to approval by the U.S.
Food and Drug Administration (‘‘FDA’’) and/or European Medicines Agency
(‘‘EMEA’’) could negatively impact the Company’s ability to obtain additional
funding or identify potential partners.
The
Company has prepared its financial statements under the assumption that it is a
going concern. The Company’s recurring losses and negative cash flows from
operation raise substantial doubt about its ability to continue as a going
concern. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
On
June 9, 2008, the Company placed $20 million of senior secured convertible
notes, or the 2008 Notes, with certain institutional and accredited investors.
The notes bear interest at an annual rate of 15% payable at quarterly intervals
in other senior secured convertible promissory notes to the holder, and
originally were convertible into shares of Genta common stock at a conversion
rate of 2,000 shares of common stock for every $1,000.00 of principal. As a
result of issuing convertible notes on April 2, 2009 (see below), these notes
are presently convertible into shares of Genta common stock at a conversion rate
of 10,000 shares of common stock for every $1,000.00 of principal. Certain
members of senior management of Genta participated in this offering. The notes
are secured by a first lien on all assets of Genta.
On
April 2, 2009, the Company entered into a securities purchase agreement with
certain accredited institutional investors to place up to $12 million of senior
secured convertible notes, or the 2009 Notes, and corresponding warrants to
purchase common stock. The Company closed on approximately $6 million of such
notes and warrants on April 2, 2009. The 2009 Notes bear interest at an annual
rate of 8% payable semi-annually in other senior secured convertible promissory
notes to the holder, and will be convertible into shares of the Company’s common
stock at a conversion rate of 10,000 shares of common stock for every $1,000.00
of principal amount outstanding. In addition, the 2009 Notes include certain
events of default, including a requirement that the Company effect a reverse
stock split of its Common Stock within 105 days of April 2, 2009. The notes and
warrants are convertible into approximately 77,940,000 shares. There are
currently not enough shares of common stock authorized under the Company’s
certificate of incorporation to cover the shares underlying the 2009 Notes and
warrants and the 2008 Notes.
On
June 26, 2009, the Company effected a one-for-fifty reverse stock split of
its common stock. It did not reduce the number of shares that the Company is
authorized to issue or change the par value of the common stock. All references
to common share values in these consolidated financial statements have been
restated to reflect this split
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
The
Company will require additional cash in order to maximize its commercial
opportunities and continue its clinical development opportunities. The Company
has had discussions with other companies regarding partnerships for the further
development and global commercialization of Genasense®.
Additional alternatives available to the Company to subsequently sustain its
operations include development and commercialization partnerships on other
products in our pipeline, financing arrangements with potential corporate
partners, debt financing, asset sales, asset-based loans, royalty-based
financings, equity financing and other sources. However, there can be no
assurance that any such collaborative agreements or other sources of funding
will be available on favorable terms, if at all.
Net
cash used in operating activities during the three months ended March 31, 2009
was $4.3 million. Presently, with no further financing, management projects that
the Company will run out of funds in August 2009. The terms of the 2009 Notes
enable those noteholders, at their option, to purchase additional notes with
similar terms. The Company does not have any additional financing in place.
There can be no assurance that the Company can obtain financing, if at all, on
terms acceptable to it.
If the
Company is unable to raise additional funds, it will need to do one or more of
the following:
|
·
|
delay,
scale back or eliminate some or all of the Company’s research and product
development programs and sales and marketing
activity;
|
|
·
|
license
or sell to third parties products or technologies that the Company would
otherwise seek to develop and commercialize
themselves;
|
|
·
|
attempt
to sell the Company;
|
|
2.
|
Summary
of Significant Accounting Policies
|
Basis
of Presentation
The
consolidated financial statements are presented on the basis of accounting
principles generally accepted in the United States of America. The accompanying
consolidated financial statements included herein have been prepared pursuant to
the rules and regulations of the Securities and Exchange Commission. Certain
information and footnote disclosures normally included in financial statements
have been condensed or omitted from this report, as is permitted by such rules
and regulations; however, the Company believes that the disclosures are adequate
to make the information presented not misleading. The unaudited consolidated
financial statements and related disclosures have been prepared with the
presumption that users of the interim financial information have read or have
access to the audited financial statements for the preceding fiscal year.
Accordingly, these financial statements should be read in conjunction with the
audited consolidated financial statements and the related notes thereto included
in the Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2008. Results for interim periods are not necessarily indicative of results
for the full year. The Company has experienced significant quarterly
fluctuations in operating results and it expects those fluctuations will
continue.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make certain estimates and
assumptions that affect reported earnings, financial position and various
disclosures. Actual results could differ from those estimates.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
Cash
and Cash Equivalents
Cash and
cash equivalents consist of highly liquid instruments with maturities of three
months or less from the date acquired and are stated at cost that approximates
their fair market value. At March 31, 2009, the amounts on deposit that exceeded
the $250,000 federally insured limit was $0.3 million.
Revenue
Recognition
Genta
recognizes revenue from product sales when title to product and associated risk
of loss has passed to the customer and the Company is reasonably assured of
collecting payment for the sale. All revenue from product sales are recorded net
of applicable allowances for returns, rebates and other applicable discounts and
allowances. The Company allows return of its product for up to twelve months
after product expiration.
Research
and Development
Research
and development costs are expensed as incurred, including raw material costs
required to manufacture products for clinical trials.
Income
Taxes
The
Company uses the liability method of accounting for income taxes. Deferred
income taxes are determined based on the estimated future tax effects of
differences between the financial statement and tax bases of assets and
liabilities given the provisions of the enacted tax laws. Management records
valuation allowances against net deferred tax assets, if based upon the
available evidence, it is more likely than not that some or all of the deferred
tax assets will not be realized. The Company generated additional net operating
losses during the three months ended March 31, 2009 and continues to maintain a
full valuation allowance against its net deferred tax assets. Utilization of the
Company’s net operating loss (NOL) and research and development (R&D) credit
carryforwards may be subject to a substantial annual limitation due to ownership
change limitations that may have occurred or that could occur in the future, as
required by Section 382 of the Internal Revenue Code of 1986, as amended (the
Code), as well as similar state provisions. These ownership changes may limit
the amount of NOL and R&D credit carryforwards that can be utilized annually
to offset future taxable income and tax, respectively. In general, an “ownership
change” as defined by Section 382 of the Code results from a transaction or
series of transactions over a three-year period resulting in an ownership change
of more than 50 percentage points of the outstanding stock of a company by
certain stockholders or public groups.
The
Company’s Federal tax returns have never been audited. In January 2006, the
State of New Jersey concluded its fieldwork with respect to a tax audit for the
years 2000 through 2004. The State of New Jersey took the position that amounts
reimbursed to Genta by Aventis Pharmaceutical Inc. for co-development
expenditures during the audit period were subject to Alternative Minimum
Assessment (AMA), resulting in a liability at that time of approximately
$533,000. Although the Company and its outside tax advisors believe the State’s
position on the AMA liability is unjustified, there is little case law on the
matter and it is probable that the Company will be required to ultimately pay
the liability. As of March 31, 2009, the Company had accrued a tax liability of
$533,000, penalties of $27,000 and interest of $294,000 related to this
assessment. The Company appealed this decision to the State and on February 13,
2008, the State notified the Company that its appeal had not been granted. On
April 25, 2008, the Company filed a complaint with the Tax Court of the State of
New Jersey to appeal the assessment. A pretrial conference has been scheduled
with an assigned judge for May 5, 2009. It is anticipated that a trial will
commence in the second half of 2009.
The
Company’s policy for recording interest and penalties associated with audits is
that penalties and interest expense are recorded in interest expense in the
Company’s Consolidated Statements of Operations. The Company recorded $13,000
and $18,000 in interest expense related to the State of New Jersey assessment
during the three months ended March 31, 2009 and 2008,
respectively.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
Stock
Options
Stock
Options are accounted for using the fair value recognition provisions of
Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment, (‘‘SFAS
123R’’), using the modified prospective transition method. Under the standard,
all share-based payments, including grants of employee stock options, are
recognized in the Consolidated Statement of Operations based on their fair
values. The amount of compensation cost is measured based on the grant-date fair
value of the equity instrument issued. The Company utilizes a Black-Scholes
option-pricing model to measure the fair value of stock options granted to
employees. See Note 7 and Note 8 to the Consolidated Financial Statements for a
further discussion on share-based compensation.
Deferred
Financing Costs
Deferred
financing costs are amortized over the term of its associated debt instrument.
The Company evaluates the terms of debt instruments to determine if any embedded
derivatives or beneficial conversion features exist. The Company allocates the
aggregate proceeds of debt instruments between warrants and notes based on their
relative fair values in accordance with Accounting Principle Board No. 14 (APB
14), “Accounting for
Convertible Debt and Debt Issued with Stock Purchase Warrants.” The fair
value of the warrant issued to the placement agent is calculated utilizing the
Black-Scholes option-pricing model. The Company is amortizing the resultant
discount or other features over the term of the notes through its earliest
maturity date using the effective interest method. Under this method, interest
expense recognized each period will increase significantly as the instrument
approaches its maturity date. If the maturity of the debt is accelerated because
of defaults or conversions, then the amortization is accelerated.
Net
Loss Per Common Share
Net
loss per common share for the three months ended March 31, 2009 and 2008,
respectively, are based on the weighted average number of shares of common stock
outstanding during the periods. Basic and diluted net loss per share are
identical for the three months ended March 31, 2009 and 2008,
respectively, as potentially dilutive securities have been excluded from
the calculation of the diluted net loss per common share, as the inclusion of
such securities would be antidilutive. At March 31, 2009 and 2008, respectively,
the potentially dilutive securities include approximately 42.5 million shares
and approximately 46,000 shares reserved for the conversion of convertible
notes, convertible preferred stock and the exercise of outstanding options and
warrants.
Recent
Accounting Pronouncements
In April
2009, the Financial Accounting Standards Board (FASB) issued FASB Staff Position
SFAS 141(R)-1, Accounting for
Assets Acquired and Liabilities Assumed in a Business Combination That Arise
from Contingencies, to amend and clarify the initial recognition and
measurement, subsequent measurement and accounting, and related disclosures
arising from contingencies in a business combination under SFAS 141(R). Under
the new guidance, assets acquired and liabilities assumed in a business
combination that arise from contingencies should be recognized at fair value on
the acquisition date if fair value can be determined during the measurement
period. If fair value can not be determined, companies should typically account
for the acquired contingencies using existing guidance. The implementation of
this standard did not have a material effect on the Company’s consolidated
financial statements.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
In June
2008, the FASB ratified EITF 07-5, “Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own Stock”. EITF 07-5
addresses how an entity should evaluate whether an instrument or embedded
feature is indexed to its own stock, accounting for situations where the
currency of the linked instrument differs from the host instrument and
accounting for market-based employee stock options. EITF 07-5 is effective for
fiscal years beginning after December 15, 2008 and early adoption is not
permitted. The implementation of this standard did not have a material effect on
the Company’s consolidated financial statements.
In May
2008, the FASB issued FSP APB 14-1, Accounting for Convertible Debt That
May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement), which is effective for the Company January 1, 2009. The FSP
includes guidance that convertible debt instruments that may be settled in cash
upon conversion should be separated between its liability and equity components,
with each component being accounted for in a manner that will reflect the
entity’s nonconvertible debt borrowing rate when interest costs are recognized
in subsequent periods. This guidance does not apply to the Company since its
existing convertible debt instruments are settled only in stock upon conversion,
and as a result does not have an impact on the Company’s unaudited Consolidated
Financial Statements.
In April
2008, the FASB issued FASB Staff Position 142-3, “Determination of the Useful Life of
Intangible Assets” (“FSP 142-3”), which amends the factors that should be
considered in developing renewal or extension assumptions used to determine the
useful life of a recognized intangible asset under SFAS No. 142, “Goodwill and Other Intangible
Assets” (“SFAS No. 142”). The objective of FSP 142-3 is to improve
the consistency between the useful life of a recognized intangible asset under
SFAS No. 142 and the period of expected cash flows used to measure the fair
value of the asset under SFAS No. 141(R), “Business Combinations” and
other principles of generally accepted accounting principles. FSP 142-3
applies to all intangible assets, whether acquired in a business combination or
otherwise, and shall be effective for financial statements issued for fiscal
years beginning after December 15, 2008, and interim periods within those fiscal
years and applied prospectively to intangible assets acquired after the
effective date. The implementation of this standard did not have a material
effect on the Company’s consolidated financial statements.
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles”. The statement is intended to improve financial
reporting by identifying a consistent hierarchy for selecting accounting
principles to be used in preparing financial statements that are prepared in
conformance with generally accepted accounting principles. The statement is
effective 60 days following the Securities and Exchange Commission’s (SEC)
approval of the Public Company Accounting Oversight Board amendments to AU
Section 411, “The Meaning of
Present Fairly in Conformity with GAAP”, and is not expected to have any
impact on the Company’s consolidated financial statements.
In March
2008, the FASB issued SFAS 161, “Disclosures about Derivative
Instruments and Hedging Activities, an amendment of FASB SFAS
133” (“SFAS 161”), which requires enhanced disclosures for derivative and
hedging activities. SFAS 161 became effective for financial statements issued
for fiscal years and interim periods beginning after November 15, 2008. The
implementation of this standard did not have a material effect on the Company’s
consolidated financial statements.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
In
December 2007, the FASB issued SFAS 160, “Noncontrolling Interests in
Consolidated Financial Statements — an amendment of ARB No. 51” (“SFAS
160”). SFAS 160 establishes new accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. Specifically, this statement requires the recognition of a
noncontrolling interest (minority interest) as equity in the consolidated
financial statements and separate from the parent’s equity. The amount of net
income attributable to the noncontrolling interest will be included in
consolidated net income on the face of the income statement. SFAS 160 clarifies
that changes in a parent’s ownership interest in a subsidiary that do not result
in deconsolidation are equity transactions if the parent retains its controlling
financial interest. In addition, this statement requires that a parent recognize
a gain or loss in net income when a subsidiary is deconsolidated. SFAS 160 also
includes expanded disclosure requirements regarding the interests of the parent
and its noncontrolling interest. SFAS 160 is effective for fiscal years, and
interim periods within those fiscal years, beginning on or after December 15,
2008. The implementation of this standard did not have a material effect on the
Company’s consolidated financial statements.
In
September 2006, the FASB issued SFAS 157, “Fair Value Measurements”.
SFAS 157 defines fair value, establishes a framework for measuring fair
value in accordance with accounting principles generally accepted in the United
States of America and expands disclosures about fair value measurements. SFAS
157 applies under other accounting pronouncements that require or permit fair
value measurements. The Company was required to adopt SFAS 157 beginning
January 1, 2008. In February 2008, the FASB released FASB Staff Position 157-2
– Effective Date of FASB
Statement No. 157, which delayed the effective date of SFAS No. 157 for
all non-financial assets and liabilities, except those that are recognized or
disclosed at fair value in the financial statements on a recurring basis (at
least annually). In October 2008, the FASB released FASB Staff Position 157-3 –
Determining the Fair Value of
a Financial Asset When the Market for That Asset Is Not Active. In April 2009, the FASB
released FASB Staff Position 157-4 Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly. The adoption
of SFAS No. 157 for the Company’s financial assets and liabilities did not have
a material impact on its consolidated financial statements and the adoption of
SFAS No. 157 for the Company’s non-financial assets and liabilities, effective
January 1, 2009, did not have a material effect on the Company’s consolidated
financial statements.
Inventories
are stated at the lower of cost or market with cost being determined using the
first-in, first-out (FIFO) method. Inventories consisted of the following ($
thousands):
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2009
|
|
|
2008
|
|
Raw
materials
|
|
$ |
24 |
|
|
$ |
24 |
|
Finished
goods
|
|
|
97 |
|
|
|
97 |
|
|
|
$ |
121 |
|
|
$ |
121 |
|
During
the three months ended March 31, 2009, sales of Ganite® were
from product that had been previously accounted for as excess
inventory.
The
Company has substantial quantities of Genasense® drug
supply which are recorded at zero cost. Such inventory would be available for
the commercial launch of this product, should Genasense® be
approved.
4.
|
Office
Lease Settlement Obligation
|
In
January 2009, the Company entered into an amendment of its lease agreement with
The Connell Company, whereby the Company’s future payment of $2.0 million,
related to an earlier amendment of its lease for office space, is payable on
January 1, 2011. The Company will pay 6.0% interest in arrears to Connell from
July 1, 2009 through the new payment date.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
5.
|
Reduction
in Liability for Settlement of
Litigation
|
In
2008 the Company reached an agreement to settle a class action litigation claim
in consideration for issuance of 40,000 shares of common stock of the Company
(adjusted for any subsequent event that results in a change in the number of
shares outstanding as of January 31, 2007) and $18.0 million in cash for the
benefit of plaintiffs and the stockholder class. A Court order approving the
settlement was issued in May 2008 and the settlement became final in June 2008.
The Company also entered into release and settlement agreements with its
insurance carriers, pursuant to which insurance will cover the settlement fee
and various costs incurred in connection with the action. Under FASB Statement
No. 5, “Accounting for
Contingencies” and FASB Interpretation No. 14, “Reasonable Estimation of the Amount
of a Loss, an interpretation of FASB Statement No. 5,” the Company
recorded an expense comprised of 2.0 million shares of the Company’s common
stock on December 31, 2006 and continued to mark this liability to market until
June 27, 2008. At March 31, 2008, the revised value of the common stock portion
of the litigation settlement resulted in a reduction in the provision of $0.3
million.
6.
|
Convertible
Notes and Warrant
|
On
June 9, 2008, the Company placed $20 million of senior secured convertible
notes, or the 2008 Notes, with certain institutional and accredited investors.
The notes bear interest at an annual rate of 15% payable at quarterly intervals
in other senior secured convertible promissory notes to the holder, and
originally were convertible into shares of Genta common stock at a conversion
rate of 2,000 shares of common stock for every $1,000.00 of principal. As a
result of issuing convertible notes on April 2, 2009, (see Note 11), these notes
are presently convertible into shares of Genta common stock at a conversion rate
of 10,000 shares of common stock for every $1,000,00 of principal. Certain
members of senior management of Genta participated in this offering. The notes
prohibit the Company from consummating any additional financing transaction
without the approval of holders of more than two-thirds of the principal amount
of the notes. The Company is in compliance with all debt-related covenants at
March 31, 2009.
At the
time the notes were issued, the Company recorded a debt discount (beneficial
conversion) relating to the conversion feature in the amount of $20.0 million.
The aggregate intrinsic value of the difference between the market price of the
Company’s share of stock on June 9, 2008 and the conversion price of the notes
was in excess of the face value of the $20.0 million notes, and thus, a full
debt discount was recorded in an amount equal to the face value of the debt. The
Company is amortizing the resultant debt discount over the term of the notes
through their maturity date using the effective interest method.
From
January 1, 2009 through March 31, 2009, holders of the convertible notes
voluntarily converted approximately $5.3 million, resulting in an issuance of
10.5 million shares of common stock. At March 31, 2009, approximately
$10.7 million of the convertible notes were outstanding.
Upon the
occurrence of an event of default, holders of the notes have the right to
require the Company to prepay all or a portion of their notes as calculated as
the greater of (a) 150% of the aggregate principal amount of the note plus
accrued interest or (b) the aggregate principal amount of the note plus accrued
interest divided by the conversion price; multiplied by a weighted average price
of the Company’s common stock. Pursuant to a general security agreement, entered
into concurrently with the notes (the “Security Agreement”), the notes are
secured by a first lien on all assets of the Company, subject to certain
exceptions set forth in the Security Agreement.
In
addition, in connection with the placement of the senior secured convertible
notes, the Company issued a warrant to its private placement agent to purchase
800,000 shares of common stock at an exercise price of $1.00 per share and
incurred a financing fee of $1.2 million. The deferred financing costs,
including the financing fee and the initial value of the warrant, are being
amortized over the two-year term of the convertible notes. At March 31, 2009,
the unamortized balances of the financing fee and the warrant are $0.8 million
and $4.5 million, respectively.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
7.
|
Share-Based
Compensation
|
The
Company estimates the fair value of each option award on the date of the grant
using the Black-Scholes option valuation model. Expected volatilities are based
on the historical volatility of the Company’s common stock over a period
commensurate with the options’ expected term. The expected term represents the
period of time that options granted are expected to be outstanding and is
calculated in accordance with the SEC guidance provided in the SEC’s Staff
Accounting Bulletin 107, (“SAB 107”) and Staff Accounting Bulletin 110 (“SAB
110”), using a “simplified” method. The Company will continue to use the
simplified method as it does not have sufficient historical exercise data to
provide a reasonable basis upon which to estimate an expected term. The
risk-free interest rate assumption is based upon observed interest rates
appropriate for the expected term of the Company’s stock options. There were no
grants of stock options during the three months ended March 31, 2009 and 2008,
respectively.
Share-based
compensation expense recognized for the three months ended March 31, 2009 and
2008, respectively, was comprised as follows:
|
|
Three
Months Ended March 31,
|
|
($
thousands, except per share data)
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
Research
and development expenses
|
|
$ |
21 |
|
|
$ |
44 |
|
Selling,
general and administrative
|
|
|
52 |
|
|
|
101 |
|
Total
share-based compensation expense
|
|
$ |
73 |
|
|
$ |
145 |
|
Share-based
compensation expense, per basic and diluted common
share
|
|
$ |
0.00 |
|
|
$ |
0.21 |
|
As of
March 31, 2009, the Company has two outstanding share-based compensation plans,
which are described below:
1998
Stock Incentive Plan
Pursuant
to the Company’s 1998 Stock Incentive Plan, as amended (the “1998 Plan”), 68,000
shares had been provided for the grant of stock options to employees, directors,
consultants and advisors of the Company. Option awards were granted with an
exercise price at not less than the fair market price of the Company’s common
stock on the date of the grant; those option awards generally vested over a
four-year period in equal increments of 25%, beginning on the first anniversary
of the date of the grant. All options granted had contractual terms of ten years
from the date of the grant. As of May 27, 2008, the authorization to provide
grants under the 1998 Plan expired.
The
following table summarizes the option activity under the 1998 Plan as of March
31, 2009 and changes during the three months then ended:
Stock Options
|
|
Number of
Shares
(in
thousands)
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
(in years)
|
|
|
Aggregate
Intrinsic
Value
(in
thousands)
|
|
Outstanding
at December 31, 2008
|
|
|
37 |
|
|
$ |
1,191.50 |
|
|
|
|
|
|
|
Granted
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
(2 |
) |
|
|
38.00 |
|
|
|
|
|
|
|
Outstanding
at March 31, 2009
|
|
|
35 |
|
|
$ |
1,266.50 |
|
|
|
3.2 |
|
|
$ |
- |
|
Vested
and exercisable at March 31, 2009
|
|
|
26 |
|
|
$ |
1,088.50 |
|
|
|
1.8 |
|
|
$ |
- |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
There is
no intrinsic value to outstanding stock options as the exercise prices of all
outstanding options are above the market price of the Company’s stock at March
31, 2009. The amount of aggregate intrinsic value may change based on the market
value of the Company’s stock.
As of
March 31, 2009, there was approximately $0.1 million of total unrecognized
compensation cost related to non-vested share-based compensation resulting from
stock options granted under the 1998 Plan, which is expected to be recognized
over a weighted-average period of 0.9 years.
The
following table summarizes the restricted stock unit (RSU) activity under the
1998 Plan as of March 31, 2009 and changes during the three months then
ended:
Restricted Stock Units
|
|
Number of Shares
(in thousands)
|
|
|
Weighted Average
Grant Date Fair
Value per Share
|
|
Outstanding
nonvested RSUs at January 1, 2009
|
|
|
5 |
|
|
$ |
20.50 |
|
Granted
|
|
|
- |
|
|
|
- |
|
Vested
|
|
|
(3 |
) |
|
$ |
20.50 |
|
Forfeited
or expired
|
|
|
0 |
|
|
$ |
20.50 |
|
Outstanding
nonvested RSUs at March 31, 2009
|
|
|
2 |
|
|
$ |
20.50 |
|
As of
March 31, 2009, there was approximately $8,000 of total unrecognized
compensation cost related to non-vested share-based compensation resulting from
RSUs granted under the 1998 Plan, which is expected to be recognized over the
next three months.
1998
Non-Employee Directors’ Plan
Pursuant
to the Company’s 1998 Non-Employee Directors’ Plan as amended (the “Directors’
Plan”), 12,000 shares have been provided for the grant of non-qualified stock
options to the Company’s non-employee members of the Board of Directors. Option
awards must be granted with an exercise price at not less than the fair market
price of the Company’s common stock on the date of the grant. Initial option
grants vest over a three-year period in equal increments, beginning on the first
anniversary of the date of the grant. Subsequent grants generally vest on the
date of the grant. All options granted have contractual terms of ten years from
the date of the grant.
The fair
value of each option award is estimated on the date using the same valuation
model used for options granted under the 1998 Plan.
The
following table summarizes the option activity under the Directors’ Plan as of
March 31, 2009 and changes during the three months then ended:
Stock Options
|
|
Number of
Shares
(in
thousands)
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
(in years)
|
|
|
Aggregate
Intrinsic
Value
(in
thousands)
|
|
Outstanding
at January 1, 2009
|
|
|
2 |
|
|
$ |
1,130.50 |
|
|
|
|
|
|
|
Granted
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Outstanding
at March 31, 2009
|
|
|
2 |
|
|
$ |
1,130.50 |
|
|
|
6.0 |
|
|
$ |
- |
|
Vested
and exercisable at March 31, 2009
|
|
|
2 |
|
|
$ |
1,130.50 |
|
|
|
6.0 |
|
|
$ |
- |
|
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
There is
no intrinsic value to outstanding stock options as the exercise prices of all
outstanding options are above the market price of the Company’s stock at March
31, 2009. The amount of aggregate intrinsic value may change based on the market
value of the Company’s stock.
9.
|
Commitments
and Contingencies
|
Litigation
and Potential Claims
In
September 2008, several shareholders of the Company, on behalf of themselves and
all others similarly situated, filed a class action complaint against the
Company, the Board of Directors, and certain of its executive officers in
Superior Court of New Jersey, captioned Collins v. Warrell, Docket No.
L-3046-08. The complaint alleged that in issuing convertible notes, the Board of
Directors, and certain officers breached their fiduciary duties, and the Company
aided and abetted the breach of fiduciary duty. On March 20, 2009, the
Superior Court of New Jersey granted the motion of the Company to dismiss the
class action complaint and dismissed the complaint with prejudice. The
plaintiffs have filed a notice of appeal to the Appellate Division of the
Superior Court from the order dismissing this case.
In
November 2008, a complaint against the Company and its transfer agent, BNY
Mellon Shareholder Services, was filed in the Supreme Court of the State of New
York by an individual stockholder. The complaint alleges that the Company and
its transfer agent caused or contributed to losses suffered by the stockholder.
The Company denies the allegations of this complaint and intends to vigorously
defend this lawsuit.
10.
|
Supplemental
Disclosure of Cash Flows Information and Non-cash Investing and Financing
Activities
|
No
interest or income taxes were paid with cash during the three months ended March
31, 2009 and 2008, respectively. On March 9, 2009, the Company issued
approximately $386,000 of convertible notes in lieu of interest due on its 2008
Notes.
From
January 1, 2009 through March 31, 2009, holders of the Company’s convertible
notes voluntarily converted approximately $5.3 million, resulting in an issuance
of 10.5 million shares of common stock.
From
April 1, 2009 through April 30, 2009, holders of June 2008 convertible notes
have voluntarily converted approximately $3 million of their notes, resulting in
an issuance of approximately 30 million shares of common stock. At April 30,
2009, approximately $7.7 million of the convertible notes were
outstanding.
On
April 2, 2009, the Company entered into a securities purchase agreement with
certain accredited institutional investors to place up to $12 million of senior
secured convertible notes, or the April 2009 Notes, and corresponding warrants
to purchase common stock. The Company closed on approximately $6 million of such
notes and warrants on April 2, 2009. The April 2009 Notes bear interest at an
annual rate of 8% payable semi-annually in other senior secured convertible
promissory notes to the holder, and will be convertible into shares of the
Company’s common stock at a conversion rate of 10,000 shares of common stock for
every $1,000.00 of principal amount outstanding. In addition, the 2009 Notes
include certain events of default, including a requirement that the Company
effect a reverse stock split of the Company’s Common Stock within 105 days of
April 2, 2009. The notes and warrants are convertible into approximately
77,940,000 shares.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
There are
currently not enough shares of Common Stock authorized under the Company’s
certificate of incorporation to cover the shares underlying the April 2009 Notes
and warrants and the 2008 Notes. The Company will initially account for
conversion options embedded in convertible notes in accordance with SFAS No. 133
“Accounting for Derivative
Instruments and Hedging Activities” (“SFAS 133”) and EITF 00-19 “Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own
Stock” (“EITF 00-19”). SFAS 133 generally requires companies to bifurcate
conversion options embedded in convertible notes from their host instruments and
to account for them as free standing derivative financial instruments in
accordance with EITF 00-19. EITF 00-19 states that if the conversion option
requires net cash settlement in the event of circumstances that are not solely
within the Company’s control, that the notes should be classified as a liability
measured at fair value on the balance sheet. In this case, if the Company is not
successful in obtaining approval of its stockholders to increase the number of
authorized shares to accommodate the potential number of shares that the notes
convert into, the Company will be required to cash settle the conversion
option.
In
accordance with EITF 00-19, when there are insufficient authorized shares to
permit exercise of all of the issued convertible notes and warrants, the
conversion obligation for the notes and the warrant obligations will be
classified as liabilities and measured at fair value on the balance sheet. The
conversion feature liability and the warrant liability will be accounted for
using mark-to-market accounting at each reporting date until all the criteria
for permanent equity have been met.
At the
time the notes were issued, the Company recorded a debt discount (beneficial
conversion) relating to the conversion feature in the amount of $6.0 million.
The aggregate intrinsic value of the difference between the market price of a
share of the Company’s stock on April 2, 2009 and the conversion price of the
notes was in excess of the face value of the $6.0 million notes, and thus, a
full debt discount was recorded in an amount equal to the face value of the
note. The Company will amortize the resultant debt discount over the term of the
notes through their maturity date.
See
accompanying notes to consolidated financial statements.
GENTA
INCORPORATED
Up
to $7.0 million of an aggregate principal amount of Units consisting of 70% (or
$4.9 million) Convertible Notes and 30% (or $2.1 million) Common
Stock
Up to 49,000,000 shares of Common
Stock underlying the Convertible Notes
$832,308
Convertible Notes issuable as payment of interest on the Convertible
Notes
8,323,080
shares of Common Stock underlying the Convertible Notes issuable as payment of
interest on the Convertible Notes
Warrants
to purchase 12,250,000 shares of Common Stock
12,250,000
shares of Common Stock underlying the Warrants
PROSPECTUS
July
29, 2009
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
ITEM
13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The
following table sets forth estimated expenses expected to be incurred in
connection with the issuance and distribution of the securities being
registered. Genta will pay all expenses in connection with this
offering.
SEC
Registration Fee
|
|
$ |
905.00 |
|
Printing
and Engraving Expenses
|
|
$ |
25,000.00 |
|
Accounting
Fees and Expenses
|
|
$ |
50,000.00 |
|
Legal
Fees and Expenses
|
|
$ |
100,000.00 |
|
Miscellaneous
|
|
$ |
9,095.00 |
|
TOTAL
|
|
$ |
185,000.00 |
|
All
expenses, other than the SEC Registration Fee, are estimated.
ITEM
14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our
Certificate of Incorporation includes an indemnification provision under which
we have agreed to indemnify directors and officers of Genta from and against
certain claims arising from or related to future acts or omissions as a director
or officer of Genta. Insofar as indemnification for liabilities arising under
the Securities Act may be permitted to directors, officers and controlling
persons of Genta pursuant to the foregoing, or otherwise, Genta has been advised
that in the opinion of the SEC such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable.
ITEM
15. RECENT SALES OF UNREGISTERED SECURITIES
During
the three year period preceding the date of the filing of this registration
statement, we have issued securities in the transaction described below without
registration under the Securities Act of 1933. These securities were offered and
sold by us in reliance upon exemptions from the registration requirements
provided by Section 4(2) of the Securities Act of 1933 or Regulation D under the
Securities Act as transactions by an issuer not involving a public
offering.
On
July 7, 2009, we placed approximately $3 million of units, each unit consisting
of (i) 70% unsecured subordinated convertible notes, or the July 2009 Notes, and
(ii) 30% shares of the Company’s common stock, par value $0.001 per share and
two-year warrants to purchase common stock in an amount equal to 25% of the
number of shares of common stock issuable upon conversion of the notes purchased
by each investor at such closing. The investors consisted of: Arcus
Ventures Fund, Baker Biotech Fund I, L.P., Baker Biotech Fund I, L.P., 14159,
L.P., Baker Brothers Life Sciences, L.P., Boxer Capital LLC, Cat Trail Private
Equity Fund LLC, Cranshire Capital LP, BAM Opportunity Fund, L.P., Rockmore
Investment Master Fund Ltd., Rodman & Renshaw LLC, RRC Biofund and Tang
Capital Partners, LP. The July 2009 Notes are convertible into shares of
our common stock at a conversion rate of 10,000 shares of common stock for every
$1,000.00 of principal and the warrants are convertible into shares of our
common stock at an exercise price of $1.00 per share. However, no July 2009 Note
may be converted into a number of shares equal to or greater than 9.999% of the
total outstanding shares of common stock at the time of conversion and no
warrant may be converted into a number of shares equal to or greater than 4.999%
of the total outstanding shares of common stock at the time of
conversion.
On
April 2, 2009, we placed approximately $6 million of such senior secured
convertible notes and warrants to certain institutional investors. The investors
consisted of: Arcus Ventures Fund, Baker Biotech Fund I, L.P., Baker Biotech
Fund I, L.P., 14159, L.P., Baker Brothers Life Sciences, L.P., Boxer Capital
LLC, Cat Trail Private Equity Fund LLC, Cranshire Capital LP, Enable Growth
Partners LP, Rockmore Investment Master Fund Ltd., Rodman & Renshaw LLC, RRC
Biofund and Tang Capital Partners, LP. The notes are convertible into shares of
our common stock at a conversion rate of 10,000 shares of common stock for every
$1,000.00 of principal and the warrants are convertible into shares of our
common stock at an exercise price of $0.50 per share. However, no note or
warrant may be converted into a number of shares equal to or greater than 4.999%
of the total outstanding shares of common stock at the time of
conversion.
GENTA
INCORPORATED
On
June 9, 2008, we placed $20 million of such senior secured convertible notes to
certain institutional and accredited investors. The investors consisted of:
Arcus Ventures Fund, Baker Biotech Fund I, L.P., Baker Biotech Fund I, L.P.,
14159, L.P., Baker Brothers Life Sciences, L.P., Boxer Capital LLC, Bristol
Investment Fund, Ltd., Carl Berg, Cat Trail Private Equity Fund LLC, Cranshire
Capital LP, Enable Growth Partners LP, Eric Bannasch, Firebird Global Master
Fund II, Ltd, Highbridge International LLC, Iroquois Master Fund Ltd., Loretta
Itri, Perceptive Life Sciences Master Fund LTD, RA Capital Biotech Fund II, LP,
RA Capital Biotech Fund, LP, Radcliffe SPC, Ltd, Raymond P. Warrell, Jr.,
Rockmore Investment Master Fund Ltd., Rodman & Renshaw LLC, RRC Biofund,
Trustees of the Tang Family Trust, Noa Young Tang and Tang Capital Partners, LP.
The notes were convertible into shares of our common stock at a conversion rate
of 2,000 shares of common stock for every $1,000.00 of principal; however, no
note may be converted into a number of shares equal to or greater than 4.999% of
the total outstanding shares of common stock at the time of conversion. As a
result of the April 2009 convertible note offering, the June 2008 notes are
convertible into shares of our common stock at a conversion rate of 10,000
shares of common stock for every $1,000.00 of principal
All
purchasers described above represented to us in connection with their purchase
that they were accredited investors and were acquiring the securities for
investment and not distribution, that they could bear the risks of the
investment and could hold the securities for an indefinite period of time. The
purchasers received written disclosures that the securities had not been
registered under the Securities Act and that any resale must be made pursuant to
a registration or an available exemption from such
registration.
GENTA
INCORPORATED
ITEM
16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Exhibit
Number
|
|
Description of Document
|
3.1.a
|
|
Restated
Certificate of Incorporation of the Company (incorporated by reference to
Exhibit 3(i).1 to the Company’s Annual Report on Form 10-K for the year
ended December 31, 1995, Commission File No. 0-19635)
|
|
|
|
3.1.b
|
|
Certificate
of Designations of Series D Convertible Preferred Stock of the Company
(incorporated by reference to Exhibit 3(i) to the Company’s Current Report
on Form 8-K filed on February 28, 1997, Commission File No.
0-19635)
|
|
|
|
3.1.c
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3(i).3 to the Company’s Annual
Report on Form 10-K for the year ended December 31, 1999, Commission File
No. 0-19635)
|
|
|
|
3.1.d
|
|
Amended
Certificate of Designations of Series D Convertible Preferred Stock of the
Company (incorporated by reference to Exhibit 3(i).4 to the Company’s
Annual Report on Form 10-K for the year ended December 31, 1999,
Commission File No. 0-19635)
|
|
|
|
3.1.e
|
|
Certificate
of Increase of Series D Convertible Preferred Stock of the Company
(incorporated by reference to Exhibit 3(i).5 to the Company’s Annual
Report on Form 10-K for the year ended December 31, 1999, Commission File
No. 0-19635)
|
|
|
|
3.1.f
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3(i).4 to the Company’s Annual
Report on Form 10-K for the year ended December 31, 1998, Commission File
No. 0-19635)
|
|
|
|
3.1.g
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3(i).3 to the Company’s Annual
Report on Form 10-K for the year ended December 31, 1998, Commission File
No. 0-19635)
|
|
|
|
3.1.h
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3(i).8 to the Company’s Annual
Report on Form 10-K for the year ended December 31, 1999, Commission File
No. 0-19635)
|
|
|
|
3.1.i
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.1.i to the Company’s Registration
Statement on Form S-1, Commission File No. 333-110238)
|
|
|
|
3.1.j
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.1.j to the Company’s Registration
Statement on Form S-1, Commission File No. 333-110238)
|
|
|
|
3.1.k
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.1.k to the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2004, Commission File
No. 0-19635)
|
|
|
|
3.1.l
|
|
Certificate
of Designation of Series G Participating Cumulative Preferred Stock of the
Company (incorporated by reference to Exhibit 3.1 to the Company’s Current
Report on Form 8-K filed on September 21, 2005, Commission File No.
0-19635)
|
|
|
|
3.1.m
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.1 to the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2006, Commission File
No. 0-19635)
|
|
|
|
3.1.n
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.1 to the Company’s Current Report
on Form 8-K, filed on July 13, 2007, Commission File No.
0-19635)
|
|
|
|
3.1.o
|
|
Certificate
of Amendment of Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.1 to the Company’s Current Report
on Form 8-K, filed on June 29, 2009, Commission File No.
0-19635)
|
|
|
|
3.2
|
|
Amended
and Restated Bylaws of the Company (incorporated by reference to Exhibit
3.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2004, Commission File No.
0-19635)
|
GENTA
INCORPORATED
Exhibit
Number
|
|
Description of Document
|
4.1
|
|
Specimen
Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the
Company’s Registration Statement on Form S-1, Commission File No.
333-110238)
|
|
|
|
4.2
|
|
Rights
Agreement, dated September 20, 2005, between the Company and Mellon
Investor Services LLC, as Rights Agent (incorporated by reference to
Exhibit 4.1 of the Company’s Current Report on Form 8-K filed on September
21, 2005, Commission File No. 0-19635)
|
|
|
|
4.3
|
|
Form
of Senior Secured Convertible Promissory Note (incorporated by reference
to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed on June
10, 2008, Commission File No. 0-19635)
|
|
|
|
4.4
|
|
Common
Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 of the
Company’s Quarterly Report on Form 10-Q for the quarter ended June 30,
2008, Commission File No. 0-19635)
|
|
|
|
4.5
|
|
Form
of Senior Secured Convertible Promissory Note (incorporated by reference
to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed on April
6, 2009, Commission File No. 0-19635)
|
|
|
|
4.6
|
|
Form
of Warrant (incorporated by reference to Exhibit 4.2 of the Company’s
Current Report on Form 8-K filed on April 6, 2009, Commission File No.
0-19635)
|
|
|
|
4.7
|
|
Form
of Common Stock Purchase Warrant (filed herewith)
|
|
|
|
4.8
|
|
Form
of Indenture (filed herewith)
|
|
|
|
4.9
|
|
Form
of Note (included in Exhibit 4.8)
|
|
|
|
4.10
|
|
Form
of Unsecured Subordinated Convertible Promissory Note (incorporated by
reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed
on July 8, 2009, Commission File No. 0-19635)
|
|
|
|
4.11
|
|
Form
of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2
of the Company’s Current Report on Form 8-K filed on July 8, 2009,
Commission File No. 0-19635)
|
|
|
|
5.1
|
|
Opinion
of Morgan Lewis & Bockius LLP as to the legality of the securities
being registered (filed herewith)
|
|
|
|
10.1
|
|
Non-Employee
Directors’ 1998 Stock Option Plan, as amended and restated (incorporated
by reference to Exhibit 99.B to the Company’s Definitive Proxy Statement
on Schedule 14A filed on April 30, 2004, Commission File No.
0-19635)
|
|
|
|
10.2
|
|
1998
Stock Incentive Plan, as amended and restated, effective March 19, 2004
(incorporated by reference to Exhibit 99.A to the Company’s Definitive
Proxy Statement on Schedule 14A filed on April 30, 2004, Commission File
No. 0-19635)
|
|
|
|
10.3
|
|
Form
of Indemnification Agreement entered into between the Company and its
directors and officers (incorporated by reference to Exhibit 10.7 to the
Company’s Registration Statement on Form S-1, Commission File No.
0-19635)
|
|
|
|
10.4
|
|
Asset
Purchase Agreement, dated as of March 19, 1999, among JBL Acquisition
Corp., JBL Scientific Incorporated and the Company (incorporated by
reference to Exhibit 10.2 to the Company’s Quarterly Report filed on Form
10-Q for the quarter ended March 31, 1999, Commission File No.
0-19635)
|
|
|
|
10.5
|
|
Stock
Option Agreement, dated as of October 28, 1999, between the Company and
Raymond P. Warrell, Jr., M.D. (incorporated by reference to Exhibit 10.71
to the Company’s Annual Report on Form 10-K for the year ended December
31, 1999, Commission File No. 0-19635)
|
|
|
|
10.6
|
|
Letter
Agreement, dated March 4, 1999, from SkyePharma Plc to the Company
(incorporated by reference to Exhibit 10.72 to the Company’s Annual Report
on Form 10-K for the year ended December 31, 1999, Commission File No.
0-19635)
|
GENTA
INCORPORATED
Exhibit
Number
|
|
Description of Document
|
10.7
|
|
Subscription
Agreement executed in connection with the November 26, 2001 sale of common
stock to Franklin Small-Mid Cap Growth Fund, Franklin Biotechnology
Discovery Fund, and SF Capital Partners Ltd., and the November 30, 2001
sale of common stock to SF Capital Partners Ltd. (incorporated by
reference to Exhibit 10.73 to the Company’s Annual Report on Form 10-K for
the year ended December 31, 2001, Commission File No.
0-19635)
|
|
|
|
10.8
|
|
Agreement
of Lease dated June 28, 2000 between The Connell Company and the Company
(incorporated by reference to Exhibit 10.76 to the Company’s Annual Report
on Form 10-K for the year ended December 31, 2001, Commission File No.
0-19635)
|
|
|
|
10.8A
|
|
Amendment
of Lease, dated June 19, 2002 between The Connell Company and the Company
(incorporated by reference to Exhibit 10.10 to the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2002, Commission File
No. 0-19635)
|
|
|
|
10.9*
|
|
U.S.
Commercialization Agreement dated April 26, 2002, by and between Genta
Incorporated and Aventis Pharmaceuticals Inc. (incorporated by reference
to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the
quarter ended June, 30, 2002, Commission File No.
0-19635)
|
|
|
|
10.9A*
|
|
Amendment
No. 1 dated March 14, 2003 to the U.S. Commercialization Agreement between
Genta Incorporated and Aventis Pharmaceuticals Inc. (incorporated by
reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q
for the quarter ended March 31, 2003, Commission File No.
0-19635)
|
|
|
|
10.10*
|
|
Ex-U.S.
Commercialization Agreement, dated April 26, 2002, by and between Genta
Incorporated and Garliston Limited (incorporated by reference to Exhibit
10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
June, 30, 2002, Commission File No. 0-19635)
|
|
|
|
10.11*
|
|
Global
Supply Agreement, dated April 26, 2002, by and among Genta Incorporated,
Aventis Pharmaceuticals Inc. and Garliston Limited (incorporated by
reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2002, Commission File No.
0-19635)
|
|
|
|
10.12*
|
|
Securities
Purchase Agreement, dated April 26, 2002, by and between Genta
Incorporated and Garliston Limited (incorporated by reference to Exhibit
10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2002, Commission File No. 0-19635)
|
|
|
|
10.13
|
|
Standstill
and Voting Agreement, dated April 26, 2002, by and between Genta
Incorporated and Garliston Limited (incorporated by reference to Exhibit
10.5 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2002, Commission File No. 0-19635)
|
|
|
|
10.14
|
|
Registration
Rights Agreement, dated April 26, 2002, by and between Genta Incorporated
and Garliston Limited (incorporated by reference to Exhibit 10.6 to the
Company’s Quarterly Report on Form 10-Q for the quarter ended June 30,
2002, Commission File No. 0-19635)
|
|
|
|
10.15
|
|
Convertible
Note Purchase Agreement, dated April 26, 2002, by and between Genta
Incorporated and Garliston Limited (incorporated by reference to Exhibit
10.7 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2002, Commission File No. 0-19635)
|
|
|
|
10.16*
|
|
5.63%
Convertible Promissory Note, due April 26, 2009 (incorporated by reference
to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2002, Commission File No.
0-19635)
|
|
|
|
10.17*
|
|
Subordination
Agreement, dated April 26, 2002, by and between Genta Incorporated and
Garliston Limited (incorporated by reference to Exhibit 10.9 to the
Company’s Quarterly Report on Form 10-Q for the quarter ended June 30,
2002, Commission File No. 0-19635)
|
|
|
|
10.18*
|
|
Manufacture
and Supply Agreement, dated December 20, 2002, between Genta Incorporated
and Avecia Biotechnology Inc. (incorporated by reference to Exhibit 10.88
to the Company’s Annual Report on Form 10-K for the year ended December
31, 2002, Commission File No. 0-19635)
|
|
|
|
10.19*
|
|
License
Agreement dated August 1, 1991, between Genta Incorporated and the
Trustees of the University of Pennsylvania (incorporated by reference to
Exhibit 99.1 to the Company’s Current Report on Form 8-K filed on October
28, 2003, Commission File No. 0-19635)
|
|
|
|
10.19A*
|
|
Amendment
to License Agreement, dated December 19, 2000, between Genta Incorporated
and the Trustees of the University of Pennsylvania (incorporated by
reference to Exhibit 99.2 to the Company’s Current Report on Form 8-K
filed on October 28, 2003, Commission File No. 0-19635)
|
GENTA
INCORPORATED
Exhibit
Number
|
|
Description of Document
|
10.19AA*
|
|
Second
Amendment to License Agreement, dated October 22, 2003, between Genta
Incorporated and the Trustees of the University of Pennsylvania
(incorporated by reference to Exhibit 99.3 to the Company’s Current Report
on Form 8-K filed on October 28, 2003, Commission File No. 0-19635)
|
|
|
|
10.20
|
|
Settlement
Agreement and Release, dated October 22, 2003, between Genta Incorporated
and the Trustees of the University of Pennsylvania (incorporated by
reference to Exhibit 99.4 to the Company’s Current Report on Form 8-K
filed on October 28, 2003, Commission File No. 0-19635)
|
|
|
|
10.21
|
|
Securities
Purchase Agreement, dated December 14, 2004, among the Company, Riverview
Group, LLC and Smithfield Fiduciary LLC (incorporated by reference to
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December
16, 2004, Commission File No. 0-19635)
|
|
|
|
10.22
|
|
Form
of Subscription Agreement, dated August 5, 2005 among the Company and the
purchasers of the Shares (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on August 8, 2005, Commission
File No. 0-19635)
|
|
|
|
10.23
|
|
Placement
Agency Agreement, dated August 5, 2005 between the Company and Piper
Jaffray & Co. (incorporated by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K filed on August 8, 2005, Commission
File No. 0-19635)
|
|
|
|
10.24
|
|
Form
of Subscription Agreement, dated March 6, 2006 by and among the Company
and the Purchasers (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on March 7, 2006, Commission
File No. 0-19635)
|
|
|
|
10.25
|
|
Form
of Placement Agent Agreement, dated March 6, 2006 by and among the
Company, Cowen & Co., LLC and Rodman & Renshaw, LLC (incorporated
by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K
filed on March 7, 2006, Commission File No. 0-19635)
|
|
|
|
10.26
|
|
Form
of Confirmation of Purchase, dated March 10, 2006 by and between the
Company and certain Investors (incorporated by reference to Exhibit 10.34
to the Company’s Annual Report on Form 10-K for the year ended December
31, 2005, Commission File No. 0-19635)
|
|
|
|
10.27
|
|
Form
of Amendment No. 1 to Placement Agent Agreement, dated as of March 10,
2006 by and among the Company, Cowen & Co., LLC and Rodman &
Renshaw, LLC (incorporated by reference to Exhibit 10.35 to the Company’s
Annual Report on Form 10-K for the year ended December 31, 2005,
Commission File No. 0-19635)
|
|
|
|
10.28
|
|
Development
and License Agreement, dated March 22, 2006 by and between the Company and
Emisphere Technologies, Inc. * (incorporated by reference to Exhibit 10.5
to the company’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2006, Commission File No. 0-19635)
|
|
|
|
10.29
|
|
1998
Stock Incentive Plan, as amended and restated, effective April 5, 2006
(incorporated by reference to the company’s Definitive Proxy statement on
Schedule 14A filed on April 28, 2006, Commission File No.
0-19635)
|
|
|
|
10.30
|
|
Employment
Agreement, dated as of March 28, 2006, between the Company and Loretta M.
Itri, M.D. (incorporated by reference to Exhibit 10.1 to the Company’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2006,
Commission File No. 0-19635)
|
|
|
|
10.31
|
|
Form
of Securities Purchase Agreement, dated September 19, 2006, between the
Company and each Purchaser (incorporated by reference to Exhibit 10.1 to
the Company’s Current Report on Form 8-K, filed on September 20, 2006,
Commission File No. 0-19635)
|
|
|
|
10.32
|
|
Form
of Placement Agent Agreement, dated September 19, 2006, by and between the
Company and Rodman & Renshaw LLC (incorporated by reference to Exhibit
10.2 to the Company’s Current Report on Form 8-K, filed on September 20,
2006, Commission File No. 0-19635)
|
|
|
|
10.33
|
|
Supply
and Distribution Agreement between the Company and IDIS Limited, dated
March 6, 2007 (incorporated by reference to Exhibit 10.3 to the Company’s
Quarterly Report on Form 10-Q, filed on May 8, 2007, Commission File No.
0-19635)
|
GENTA
INCORPORATED
Exhibit
Number
|
|
Description of Document
|
10.34
|
|
Form
of Purchase Agreement by and among the Company and the Purchasers, dated
March 13, 2007 (incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K, filed on March 14, 2007, Commission File No.
0-19635)
|
|
|
|
10.35
|
|
Placement
Agent Agreement, by and between the Company and Rodman & Renshaw, LLC,
dated February 23, 2007 (incorporated by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K, filed on March 14, 2007, Commission
File No. 0-19635)
|
|
|
|
10.36
|
|
Form
of Acquisition Bonus Program Agreement (incorporated by reference to
Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on
September 21, 2007, Commission File No. 0-19635)
|
|
|
|
10.37*
|
|
Project
Contract with ICON Clinical Research, L.P., dated November 19, 2007
(incorporated by reference to Exhibit 10.37 to the Company’s Annual Report
on Form 10-K for the year ended December 31, 2007, Commission File No.
0-19635)
|
|
|
|
10.38
|
|
Amended
and Restated Employment Agreement, dated as of November 30, 2007, between
the Company and Raymond P. Warrell, Jr. M.D. (incorporated by reference to
Exhibit 10.38 to the Company’s Annual Report on Form 10-K for the year
ended December 31, 2007, Commission File
No. 0-19635)
|
|
|
|
10.39
|
|
Form
of Securities Purchase Agreement, dated February 8, 2008, by and between
the Company each Purchaser (incorporated by reference to Exhibit 10.1 to
the Company’s Current Report on Form 8-K, filed on February 11, 2008,
Commission File No. 0-19635)
|
|
|
|
10.40
|
|
Placement
Agent Agreement, dated February 8, 2008, by and between the Company and
Rodman & Renshaw, LLC (incorporated by reference to Exhibit 10.2 to
the Company’s Current Report on Form 8-K, filed on February 11, 2008,
Commission File No. 0-19635)
|
|
|
|
10.41
|
|
License
Agreement, dated March 7, 2008, between the Company and Daiichi Sankyo
(incorporated by reference to Exhibit 10.1 to the Company’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2008, Commission File
No. 0-19635)
|
|
|
|
10.42
|
|
Securities
Purchase Agreement, dated June 5, 2008, by and among the Company and
certain accredited investors set forth therein (incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on June
10, 2008, Commission File No. 0-19635)
|
|
|
|
10.43
|
|
General
Security Agreement, dated June 9, 2008, by and among the Company, certain
additional grantors as set forth therein and Tang Capital Partners, L.P.
as agent (incorporated by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K, filed on June 10, 2008, Commission File No.
0-19635)
|
|
|
|
10.44
|
|
Amendment
to the Lease Agreement, dated May 27, 2008, between the Company and The
Connell Company (incorporated by reference to Exhibit 10.1 to the
Company’s Quarterly Report on Form 10-Q for the quarter ended June 30,
2008, Commission File No. 0-19635)
|
|
|
|
10.45**
|
|
Supply
Agreement, dated May 1, 2008, between the Company and Avecia Biotechnology
(incorporated by reference to Exhibit 10.1 to the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2008, Commission File
No. 0-19635)
|
|
|
|
10.46**
|
|
Form
of Securities Purchase Agreement, dated April 2, 2009, by and among the
Company and certain accredited investors set forth therein (incorporated
by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K,
filed on April 6, 2009, Commission File No. 0-19635)
|
|
|
|
10.47
|
|
Form
of Amended and Restated General Security Agreement, dated April 2, 2009,
by and among the Company and certain accredited investors set forth
therein (incorporated by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K, filed on April 6, 2009, Commission File No.
0-19635)
|
|
|
|
10.48**
|
|
Form
of Consent Agreement, dated April 2, 2009, by and among the Company and
certain accredited investors set forth therein (incorporated by reference
to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed on
April 6, 2009, Commission File No.
0-19635)
|
GENTA
INCORPORATED
Exhibit
Number
|
|
Description of Document
|
10.49
|
|
Form
of Securities Purchase Agreement, dated July 7, 2009, by and among the
Company and certain accredited investors set forth therein (incorporated
by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K,
filed on July 8, 2009, Commission File No. 0-19635)
|
|
|
|
10.50
|
|
Form
of Registration Rights Agreement, dated July 7, 2009, by and among the
Company and certain accredited investors set forth therein (incorporated
by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K,
filed on July 8, 2009, Commission File No. 0-19635)
|
|
|
|
10.51
|
|
Form
of Consent Agreement, dated July 7, 2009, by and among the Company and
certain accredited investors set forth therein (incorporated by reference
to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed on July
8, 2009, Commission File No. 0-19635)
|
|
|
|
16.1
|
|
Letter
from Deloitte & Touche LLP, dated July 16, 2008, regarding change in
certifying accountant (incorporated by reference to Exhibit 16.1 to the
Company’s Current Report on Form
8-K, filed on July 22, 2008, Commission File No.
0-19365)
|
|
|
|
21
|
|
Subsidiaries
of the Registrant (filed herewith)
|
|
|
|
23.1
|
|
Consent
of Amper Politziner & Mattia, LLP (filed herewith)
|
|
|
|
23.2
|
|
Consent
of Deloitte & Touche LLP (filed herewith)
|
|
|
|
23.3
|
|
Consent
of Morgan Lewis & Bockius LLP (included in Exhibit
5.1)
|
|
|
|
24.1
|
|
Power
of Attorney (incorporated by reference to Exhibit 24.1 to the Company’s
Registration Statement on Form S-1 filed on August 29, 2008, Commission
File No. 333-153278)
|
|
|
|
25.1
|
|
Form
T-1 Statement of Eligibility and Qualification under the Trust Indenture
Act of 1939 of the Trustee under the
Indenture |
*
|
The
Company has been granted confidential treatment of certain portions of
this exhibit.
|
**
|
The
Company has requested confidential treatment of certain portions of this
exhibit.
|
GENTA
INCORPORATED
ITEM
17. UNDERTAKINGS.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
The
undersigned registrant hereby undertakes that:
|
1.
|
For
purposes of determining any liability under the Securities Act of 1933,
the information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4)
or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared
effective.
|
|
2.
|
For
the purpose of determining any liability under the Securities Act of 1933,
each post-effective amendment that contains a form of prospectus shall be
deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering
thereof.
|
GENTA
INCORPORATED
SIGNATURES
Pursuant
to the requirements of the Act, Genta Incorporated certifies that it has
reasonable grounds to believe that it meets all of the requirements for filing
on Form S-1 and has duly caused this Amendment No. 4 to the Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in Berkeley Heights, State of New Jersey, on July 29,
2009.
|
GENTA
INCORPORATED
|
|
|
|
July
29, 2009
|
By:
|
/s/ Raymond P. Warrell, Jr.,
M.D.
|
|
|
Name:
Raymond P. Warrell, Jr., M.D.
|
|
|
Title:
Chairman and Chief Executive Officer
|
|
|
(principal
executive officer)
|
|
|
|
July
29, 2009
|
By:
|
/s/ Gary Siegel
|
|
|
Name:
Gary Siegel
|
|
|
Title:
Vice President, Finance
|
|
|
(principal
financial and accounting
officer)
|
GENTA
INCORPORATED
Pursuant
to the requirements of the Act, this Amendment No. 4 to the Registration
Statement has been signed below by the following persons in the capacities
indicated.
Signatures
|
|
Title
|
Date
|
|
|
|
|
/s/ Raymond P. Warrell, Jr.,
M.D.
|
|
Chairman
and Chief Executive Officer
|
July
29, 2009
|
Raymond
P. Warrell, Jr., M.D.
|
|
(principal
executive officer)
|
|
|
|
|
|
/s/ Gary Siegel
|
|
Vice
President, Finance
|
July
29, 2009
|
Gary
Siegel
|
|
(principal
financial and accounting officer)
|
|
|
|
|
|
*
|
|
Director
|
July
29, 2009
|
Martin
J. Driscoll
|
|
|
|
|
|
|
|
*
|
|
Director
|
July
29, 2009
|
Christopher
J. Parios
|
|
|
|
|
|
|
|
*
|
|
Director
|
July
29, 2009
|
Daniel
D. Von Hoff, M.D.
|
|
|
|
|
|
|
|
*
|
|
Director
|
July
29, 2009
|
Douglas G. Watson |
|
|
|
|
|
|
|
By:
|
/s/ Raymond P. Warrell, Jr.,
M.D.
|
|
Attorney-in-fact
|
July
29, 2009
|
Raymond
P. Warrell, Jr., M.D.
|
|
|
|