Delaware
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
02-0563870
(I.R.S.
Employer Identification No.)
|
|
Technology
Centre of New Jersey
675
US Highway One, Suite B113
North
Brunswick, New Jersey
(Address
of Principal Executive Offices)
|
08902
(Zip
Code)
|
|
(732)
545-1590
(Issuer’s
Telephone Number)
|
||
Securities
registered under Section 12(b) of the Exchange Act:
|
Common
Stock - $.001 par value
The
Common Stock is listed on the Over-The-Counter Bulletin Board
(OTC:BB)
|
|
Securities
registered under Section 12(g) of the Exchange Act:
|
[None]
|
PART
1
|
1
|
Item
1: Description of Business
|
1
|
Item
2: Description of Property.
|
33
|
Item
3: Legal Proceedings.
|
33
|
Item
4: Submission of Matters to a Vote of Security Holders.
|
34
|
PART
II
|
34
|
Item
5: Market For Common Equity, Related Stockholder Matters and Small
Business Issuer Purchases of Equity Securities.
|
34
|
Item
6: Management’s Discussion and Analysis or Plan of
Operation
|
34
|
Item
7: Financial Statements
|
47
|
Item
8: Changes In and Disagreements With Accountants on Accounting
and
Financial Disclosure
|
69
|
Item
8A: Controls And Procedures
|
69
|
Item
8 B: Other Information.
|
70
|
PART
III
|
70
|
Item
9: Directors, Executive Officers, Promoters, Control Persons and
Corporate
Governance; Compliance With Section 16(a) of the Exchange
Act.
|
70
|
Item
10: Executive Compensation
|
74
|
Item
11: Security Ownership of Certain Beneficial Owners and Management
and
Related Stockholder Matters.
|
82
|
Item
12: Certain Relationships and Related Transactions, and Director
Independence.
|
84
|
Item
13: Exhibits
|
86
|
Item
14: Principal Accountant Fees and Services
|
91
|
|
Indication
|
|
Stage
|
|
|
|
|
|
|
Lovaxin
C
|
|
Cervical
intraepithelial neoplasia (CIN), cervical cancer, head and neck
cancer.
|
|
Phase
I/II completed in the fiscal fourth quarter 2007. Phase II study
in CIN
anticipated to commence in 3rd
quarter fiscal 2008. The Gynecologic Oncology Group (GOG) of the
National
Cancer Institute has agreed to conduct a cervical cancer study timing
to
be determined.
|
|
|
|
|
|
Lovaxin
P
|
|
Prostate
cancer
|
|
Preclinical;
Phase I study anticipated to commence 2nd
quarter fiscal 2009
|
Lovaxin
B
|
|
Breast
cancer
|
|
Preclinical;
Phase I study anticipated to commence in mid fiscal
2009
|
|
|
|
|
|
|
·
|
Present
our completed Phase I/II clinical study of Lovaxin C which document
the
practicability of using this agent safely in the therapeutic treatment
of
cervical cancer;
|
|
·
|
Initiate
our Investigational New Drug Application (IND) with the FDA for our
Phase
II clinical study of Lovaxin C in the therapeutic treatment of
CIN;
|
|
·
|
Initiate
our Phase II clinical study of Lovaxin C in the therapeutic treatment
of
CIN;
|
|
·
|
Continue
the preclinical development work necessary to bring Lovaxin P into
clinical trials, and initiate that
trail;
|
|
·
|
Continue
the preclinical development work necessary to bring Lovaxin B into
clinical trials, and initiate that
trial;
|
|
·
|
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand and enhance our technology platform;
and
|
|
·
|
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies.
|
1.
|
Very
strong innate immune response
|
|
2.
|
Stimulates
inordinately strong killer T cell response
|
|
3.
|
Stimulates
helper T cells
|
|
4.
|
Stimulates
release of and/or up-regulates immuno-stimulatory cytokines, chemokines,
co-stimulatory molecules
|
|
5.
|
Adjuvant
activity creates a local tumor environment that supports anti-tumor
efficacy
|
|
6.
|
Minimizes
inhibitory T cells (T regs) and inhibitory cytokines and shifts to
Th-17
pathway
|
|
Stimulates
the development and maturation of all Antigen Presenting Cells and
effector T cells & reduces immature myeloid
cells
|
|
Indication
|
|
Stage
|
|
|
|
|
|
|
Lovaxin
C
|
|
Cervical
intraepithelial neoplasia (CIN), cervical cancer, head and neck
cancer
|
|
Phase
I/II completed in the fiscal fourth quarter 2007. Phase II study
in CIN
anticipated to commence in the 3rd
quarter fiscal 2008. The Gynecologic Oncology Group (GOG) of the
National
Cancer Institute has agreed to conduct a cervical cancer study timing
to
be determined.
|
Lovaxin
P
|
|
Prostate
cancer
|
|
Preclinical;
Phase I study anticipated to commence in the 2nd
quarter fiscal 2009
|
Lovaxin
B
|
|
Breast
cancer
|
|
Preclinical;
Phase I study anticipated to commence in mid fiscal 2009.
|
|
Patents
|
|
|
|
U.S.
Patent No. 6,051,237, issued April 18, 2000. Patent Application No.
08/336,372, filed November 8, 1994 for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector.” Expires April 18,
2017.
|
|
|
|
U.S.
Patent No. 6,565,852, issued May 20, 2003, Paterson, et al., CIP
Patent
Application No. 09/535,212, filed March 27, 2000 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector.” Expires November 8, 2014.
|
|
|
|
U.S.
Patent No. 6,099,848, issued August 8, 2000, Frankel et al., Patent
Application No. 08/972,902 “Immunogenic Compositions Comprising DAL/DAT
Double-Mutant, Auxotrophic, Attenuated Strains of Listeria and Their
Methods of Use.” Filed November 18, 1997. Expires November 18,
2017.
|
|
|
|
U.S.
Patent No. 6,504,020, issued January 7, 2003, Frankel et al. Divisional
Application No. 09/520,207 “Isolated Nucleic Acids Comprising Listeria DAL
And DAT Genes”. Filed March 7, 2000, Expires November 18,
2017.
|
|
|
|
U.S.
Patent No. 6,635,749, issued October 21, 2003, Frankel, et
al. Divisional U.S. Patent Application No. 10/136,253 for “Isolated
Nucleic Acids Comprising Listeria DAL and DAT Genes.” Filed May 1,
2002, Expires November 18,
2017.
|
|
U.S.
Patent No. 5,830,702, issued November 3, 1998, Portnoy, et al. Patent
Application No. 08/366,477, filed December 30, 1994 for “Live, Recombinant
Listeria SSP Vaccines and Productions of Cytotoxic T Cell Response”
Expires November 3, 2015.
|
|
|
|
US
Patent No. 6,767,542 issued July 27, 2004, Paterson, et al. Patent
Application No. 09/735,450 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed December 13, 2000. Expires March 29,
2020.
|
|
|
|
US
Patent No. 6,855,320 issued February 15, 2005, Paterson. Patent
Application No. 09/537,642 for “Fusion of Non-Hemolytic, Truncated Form of
Listeriolysin o to Antigens to Enhance Immunogenicity.” Filed March 29,
2000. Expires March 29, 2020.
|
|
|
|
US
Patent No. 7,135,188 issued November 14, 2006, Paterson, Patent
Application No. 10/441,851 for “Methods and compositions for immunotherapy
of cancer.” Filed May 20, 2003. Expires November 8,
2014.
|
|
U.S.
Patent Application No. 10/239,703 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed September 24, 2002, Paterson,
et al.
|
||
|
|
||
|
U.S.
Patent Application No. 20050048081, “Immunogenic Compositions Comprising
DAL/DAT Double Mutant, Auxotrophic Attenuated Strains Of Listeria
And
Their Methods Of Use,” Filed September 11, 2003, Frankel et
al.
|
||
|
|
||
|
U.S.
Patent Application No. 10/835,662, “Compositions and methods for enhancing
the immunogenicity of antigens,” Filed April 30, 2004, Paterson et al..
U.S. Patent Application No. 20060135457 Methods for constructing
antibiotic resistance free bacterial vaccines.Filed
June 22,
2006.
U.S.
Patent Application No. 20060104991 Methods for constructing antibiotic
resistance free bacterial vaccines Filed May 18, 2006.
|
|
|
||
|
U.S.
Patent Application No. 10/949,667, “Methods and compositions for
immunotherapy of cancer,” Filed September 24, 2004, Paterson et
al.
|
||
|
|
||
|
U.S.
Patent Application No. 11/223,945, “Listeria-based and LLO-based
vaccines,” Filed September 13, 2005, Paterson et al.
U.S.
Patent Application No. 11/727,889, “Compositions and Methods Comprising a
MAGE-B Antigen” Gravekamp, Paterson, Maciag. Filed March 28,
2007.
|
||
U.S.
Patent Application No. 11/798,177 “Compositions and Methods Comprising
KLK3 or SOLH1 Antigens” Filed May, 10,
2007.
|
|
U.S.
Patent Application No. 11/376,564, “Compositions and methods for enhancing
the immunogenicity of antigens,” Filed March 16, 2006, Paterson et
al.
|
|
|
|
|
|
U.S.
Patent Application No. 11/376,572, “Compositions and methods for enhancing
the immunogenicity of antigens,” Filed March 16, 2006, Paterson et
al.
|
|
|
|
|
|
U.S.
Patent Application No. 11/373,528, “Compositions and methods for Enhancing
Immunogenicity of Antigens, “Filed March 13, 2006,
|
|
|
|
|
|
U.S.
Patent Application No. 11/415,271, Methods and Compositions for Treatment
of Non-Hodgkin’s Lymphoma, “Filed May 2, 2006, Protein Vaccine
of.
|
|
|
|
|
|
U.S.
Patent Application No. 10/541,614 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004.
|
|
U.S.
Patent Application No. 11/203,408 for “Methods for Constructing Anitbiotic
Resistance Free Vaccines.” Filed August 15, 2005.
|
|
|
|
|
|
U.S.
Patent Application No. 11/203,415 for “Methods for Constructing Anitbiotic
Resistance Free Vaccines.” Filed August 15, 2005.
U.S.
Patent Application No. 20070003567 for “Compositions and methods for
Enhancing Immunogenicity of Antigens”. Filed January 4, 2007.
U.S.
Patent Application No. 20060269561 for “Compositions and Methods For
Treatment of Non-Hodgkins Lymphoma”. Filed November 30, 2006.
U.S.
Patent Application No. 20060210540 for “Compositions and Methods for
enhancing the immunogenicity of Antigens” Filed September 21, 2006. Use of
Protein Vaccine using Act A or LLO terminal fragments.
U.S.
Patent Application No. 20050118184 for, “Compositions and methods for
Enhancing Immunogenicity of Antigens” Filed June 2,
2005.
|
|
|
Patents
|
|
|
|
|
|
Australian
Patent No. 730296, Patent Application No. 14108/99 for “Bacterial Vaccines
Comprising Auxotrophic, Attenuated Strains of Listeria Expressing
Heterologous Antigens.” Issued November 13, 1998. Frankel, et al. Expires
November 13, 2018.
|
|
|
|
|
|
Canadian
Patent Application No. 2,309,790 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al. Issued January 9,
2007.
|
|
|
|
|
|
Japanese
Patent Application No. 515534/96, filed November 3, 1995 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector”, Paterson, et al. Issued August 10, 2007
|
|
|
|
|
|
Patent
Applications
|
|
|
|
|
|
Canadian
Patent Application No. 2,204,666, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson et al.
|
|
|
|
|
|
Canadian
Patent Application No. 2,404,164 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al.
|
|
|
|
|
|
European
Patent Application No. 01928324.1 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al.
|
|
|
|
|
|
European
Patent Application No. 98957980.0 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al.
|
|
|
|
|
|
Israel
Patent Application No. 151942 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al.
|
|
|
|
|
|
Japanese
Patent Application No. 2001-570290 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al.
|
|
|
|
|
|
PCT
International Patent Application No. PCT/US06/44681 for “Methods For
Producing, Growing, And Preserving Listeria
Vaccine Vectors.” Filed November 16, 2006, Rothman, et
al.
|
|
Canadian Patent Application No. 2,581,331 for “Listeria-Based and LLO-Based Vaccines.” Filed September 14, 2005. |
|
European
Patent Application No. 5811815.9 for “Listeria-Based and LLO-Based
Vaccines.” Filed September 14, 2005.
|
||
|
|
||
|
Japanese
Patent Application No. 2007-533537 for “Listeria-Based and LLO-Based
Vaccines.” Filed September 14, 2005.
|
||
|
|
||
|
PCT
International Patent Application No. PCT/US07/06292 “Compositions and
Methods for Enhancing the Immunogenicity of Antigens.” Filed March 13,
2007
|
||
|
|
||
|
Australian
Patent Application No. 20044204751 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004.
|
||
|
|
||
|
Canadian
Patent Application No. 2512812 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004
|
||
|
|
||
|
European
Patent Application No. 1594560 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004
|
||
|
|
||
|
Hong
Kong Patent Application No. 6104227.1 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004
|
||
|
|
||
|
Israeli
Patent Application No. 169553 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004
|
||
|
|
||
|
Japanese
Patent Application No. 2006-500840 for “Enhancing the Immunogenicity of
Bioengineered Listeria Monocytogenes by Passing through Live Animal
Hosts.” Filed January 8, 2004
|
||
|
|
||
|
Australian
Patent No. 2005271247 for “Antibiotic Resistance Free DNA Vaccines.” Filed
August 15, 2005
|
||
|
|
||
|
Canadian
Patent Application No. 2577270 for “Antibiotic Resistance Free DNA
Vaccines.” Filed August 15, 2005
|
||
|
|
||
|
European
Patent Application No. 5810446.4 for “Antibiotic Resistance Free DNA
Vaccines.” Filed August 15, 2005
|
||
|
|
||
|
Japanese
Patent Application No. 2007-525862 for “Antibiotic Resistance Free DNA
Vaccines.” Filed August 15, 2005
|
||
|
|
||
|
Australian
Patent Application No. 2005271246 for “Methods for Constructing Antibiotic
Resistance Free Vaccines.” Filed August 15, 2005
|
||
|
|
||
|
Canadian
Patent Application No. 2,577,306 for “Methods for Constructing Antibiotic
Resistance Free Vaccines.” Filed August 15, 2005
|
||
|
|
||
|
European
Patent Application No. EP05808671.1 for “Methods for Constructing
Antibiotic Resistance Free Vaccines.” Filed August 15,
2005
|
||
|
|
||
|
Japanese
Patent Application No. 2007-525867 for “Methods for Constructing
Antibiotic Resistance Free Vaccines.” Filed August 15,
2005
|
||
|
|
||
|
PCT
International Patent Application.No. PCT/US06/43987 “LLO-Encoding
DNA/Nucleic Acid Vaccines and Methods Comprising Same.” Filed November 13,
2006
|
·
|
who
must be recruited as qualified
participants;
|
·
|
how
often, and how to administer the
drug;
|
·
|
what
tests to perform on the participants;
and
|
·
|
what
dosage of the drug to give to the
participants.
|
·
|
competition
from companies that have substantially greater assets and financial
resources than we have;
|
·
|
need
for acceptance of products;
|
·
|
ability
to anticipate and adapt to a competitive market and rapid technological
developments;
|
·
|
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
|
·
|
need
to rely on multiple levels of outside funding due to the length of
the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry;
and
|
·
|
dependence
upon key personnel including key independent consultants and
advisors.
|
·
|
competition
from companies that have substantially greater assets and financial
resources than we have;
|
·
|
need
for acceptance of products;
|
·
|
ability
to anticipate and adapt to a competitive market and rapid technological
developments;
|
·
|
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure;
|
·
|
need
to rely on multiple levels of outside funding due to the length of
the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry;
and
|
·
|
dependence
upon key personnel including key independent consultants and
advisors.
|
·
|
Preclinical
study results that may show the product to be less effective than
desired
(e.g., the study failed to meet its primary objectives) or to have
harmful
or problematic side effects;
|
·
|
Failure
to receive the necessary regulatory approvals or a delay in receiving
such
approvals. Among other things, such delays may be caused by slow
enrollment in clinical studies, length of time to achieve study endpoints,
additional time requirements for data analysis, or BLA preparation,
discussions with the FDA, an FDA request for additional preclinical
or
clinical data, or unexpected safety or manufacturing
issues.
|
·
|
Manufacturing
costs, formulation issues, pricing or reimbursement issues, or other
factors that make the product uneconomical;
and
|
·
|
The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
|
·
|
significant
time and effort from our management
team;
|
·
|
coordination
of our research and development programs with the research and development
priorities of our collaborators;
and
|
·
|
effective
allocation of our resources to multiple
projects.
|
·
|
decreased
demand for our product candidates,
|
·
|
injury
to our reputation,
|
·
|
withdrawal
of clinical trial participants,
|
·
|
costs
of related litigation,
|
·
|
substantial
monetary awards to patients or other
claimants,
|
·
|
loss
of revenues,
|
·
|
the
inability to commercialize product candidates,
and
|
·
|
increased
difficulty in raising required additional funds in the private and
public
capital markets.
|
·
|
price
and volume fluctuations in the overall stock market from time to
time;
|
·
|
fluctuations
in stock market prices and trading volumes of similar
companies;
|
·
|
actual
or anticipated changes in our net loss or fluctuations in our operating
results or in the expectations of securities
analysts;
|
·
|
general
economic conditions and trends;
|
·
|
major
catastrophic events;
|
·
|
sales
of large blocks of our stock;
|
·
|
departures
of key personnel;
|
·
|
changes
in the regulatory status of our product candidates, including results
of
our clinical trials;
|
·
|
events
affecting Penn or any future
collaborators;
|
·
|
announcements
of new products or technologies, commercial relationships or other
events
by us or our competitors;
|
·
|
regulatory
developments in the United States and other
countries;
|
·
|
failure
of our common stock to be listed or quoted on the Nasdaq Stock Market,
American Stock Exchange or other national market
system;
|
·
|
changes
in accounting principles; and
|
·
|
discussion
of us or our stock price by the financial and scientific press and
in
online investor communities.
|
·
|
with
a price of less than $5.00 per
share;
|
·
|
that
are not traded on a “recognized” national
exchange;
|
·
|
whose
prices are not quoted on the NASDAQ automated quotation system;
or
|
·
|
of
issuers with net tangible assets less than $2,000,000 (if the issuer
has
been in continuous operation for at least three years) or $5,000,000
(if
in continuous operation for less than three years), or with average
revenue of less than $6,000,000 for the last three
years.
|
·
|
obtain
from the investor information about his or her financial situation,
investment experience and investment
objectives;
|
·
|
reasonably
determine, based on that information, that transactions in penny
stocks
are suitable for the investor and that the investor has enough knowledge
and experience to be able to evaluate the risks of “penny stock”
transactions;
|
·
|
provide
the investor with a written statement setting forth the basis on
which the
broker-dealer made his or her determination;
and
|
·
|
receive
a signed and dated copy of the statement from the investor, confirming
that it accurately reflects the investor’s financial situation, investment
experience and investment
objectives.
|
·
|
The
issuance of new equity securities pursuant to a future
offering;
|
·
|
Changes
in interest rates;
|
·
|
Competitive
developments, including announcements by competitors of new products
or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital
commitments;
|
·
|
Variations
in quarterly operating results;
|
·
|
Change
in financial estimates by securities
analysts;
|
·
|
The
depth and liquidity of the market for our common
stock;
|
·
|
Investor
perceptions of our company and the technologies industries generally;
and
|
·
|
General
economic and other national
conditions.
|
|
Fiscal
2007
|
Fiscal
2006
|
|||||||||||
|
High
|
Low
|
High
|
Low
|
|||||||||
First
Quarter November 1-January 31
|
$
|
0.21
|
$
|
0.14
|
$
|
0.27
|
$
|
0.16
|
|||||
Second
Quarter February 1- April 30
|
$
|
0.54
|
$
|
0.15
|
$
|
0.37
|
$
|
0.21
|
|||||
Third
Quarter May 1 -July 31
|
$
|
0.36
|
$
|
0.24
|
$
|
0.30
|
$
|
0.17
|
|||||
Fourth
Quarter August 1, - October 31
|
$
|
0.27
|
$
|
0.10
|
$
|
0.25
|
$
|
0.13
|
Plan
Category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
(a)
|
|
Weighted-average
exercise price of outstanding options, warrants and rights
(b)
|
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column
(a))
(c)
|
|||||
Equity
compensation plans approved by security holders
|
7,511,442(2
|
)
|
$
|
0.22
|
470,083
|
|||||
Equity
compensation plans not approved by security holders
|
1,001,399(3
|
)
|
$
|
0.143
|
-
|
|||||
Total
|
8,512,841
|
470,083
|
·
|
Present
our completed Phase I/II clinical study of Lovaxin C which document
the
practicability of using this agent safely in the therapeutic treatment
of
cervical cancer;
|
·
|
Initiate
our Investigational New Drug Application (IND) with the FDA for our
Phase
II clinical study of Lovaxin C in the therapeutic treatment of
CIN;
|
·
|
Initiate
our Phase II clinical study of Lovaxin C in the therapeutic treatment
of
cervical intraepithelial neoplasia;
|
·
|
Continue
the development work necessary to bring Lovaxin P in the therapeutic
treatment of prostate cancer into clinical trials, and initiate that
trial;
|
·
|
Continue
the development work necessary to bring Lovaxin B in the therapeutic
treatment of breast cancer into clinical trials, and initiate that
trial;
|
·
|
Continue
the pre-clinical development of other product candidates, as well
as
continue research to expand our technology platform;
and
|
·
|
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies.
|
· |
Cost
incurred to date: approximately
$2,350,000
|
· |
Estimated
future costs: $150,000 Phase I and $3,000,000 - $4,000,000 Phase
II
|
· |
Anticipated
completion date of Phase II: Fiscal year
2009
|
· |
Uncertainties:
|
· |
the
FDA (or relevant foreign regulatory authority) may not approve the
study
|
· |
One
or more serious adverse events in patients enrolled in the
trial
|
· |
difficulty
in recruiting patients
|
· |
delays
in the program
|
· |
Commencement
of material cash flows:
|
· |
Unknown
at this stage and dependent upon a licensing deal or pursuant to
a
marketing collaboration subject to regulatory approval to market
and sell
the product.
|
·
|
Cost
incurred to date: $150,000
|
·
|
Estimated
future costs: $1,500,000
|
·
|
Anticipated
completion dates: fourth quarter of fiscal 2009 or
beyond
|
·
|
Risks
and uncertainties:
|
· |
Obtaining
favorable animal data
|
· |
Proving
low toxicity in animals
|
· |
Manufacturing
scale up to GMP level
|
· |
FDA
(or foreign regulatory authority) may not approve the
study
|
· |
The
occurrence of a severe or life threatening adverse event in a
patient
|
· |
Delays
in the program
|
·
|
Cost
incurred to date: $450,000
|
·
|
Estimated
future costs: $2,000,000
|
·
|
Anticipate
completion dates: Fiscal 2010 or
beyond
|
·
|
Risks
and uncertainties: See Lovaxin in P (above)
|
·
|
Commencement
of material cash flows:
|
· |
Unknown
at this stage, dependent upon a licensing deal or to a marketing
collaboration subject to regulatory approval to market and sell the
product.
|
·
|
Clinical
trial expenses decreased $20,132, or 5%, from $421,915 to $401,783
due to
the higher start-up expenses of our clinical trial in March 2006
partially
offset by the lower expenses incurred at the end of the trial in
fiscal
2007.
|
·
|
Wages,
salaries and related lab costs increased by $183,650, or 31%, from
$600,329 to $783,979 principally due to adding one research and
development staff at the end of fiscal 2006 and a higher bonus payment
in
fiscal 2007.
|
·
|
IND/NDA
and developmental consulting expenses increased $130,466 or 293%
from
$44,494 to $174,960 primarily due to costs related to the preparation
to
file an IND and establishing the Phase II clinical trial
protocol.
|
·
|
Subcontracted
expenses increased by $51,220, or 21%, from $249,315 to $300,535
reflecting the additional subcontract work performed by Dr. Paterson,
pursuant to certain grants.
|
·
|
Manufacturing
expenses increased $327,625, or 1253%, from $26,155 to $353,780;
primarily
the result of the fiscal 2007 manufacturing program in anticipation
of the
Lovaxin C Phase II clinical trial planned in fiscal
2008.
|
·
|
Toxicology
study expenses increased $30,722, or 92%, from $33,558 to $64,280;
principally as a result of the initiation of additional toxicology
studies
by Pharm Olam in connection with our Lovaxin C clinical trial in
anticipation of our IND filing in fiscal
2008.
|
·
|
Wages,
option expense and benefits increased by $453,409 or 119% from $382,526
to
$835,935 primarily due to hiring a CEO in fiscal 2007 previously
filled by
a consultant (LVEP) these costs did not occur in the fiscal
2006.
|
·
|
All
other costs increased by $84,319 or 24% from $354,042 to $438,361
primarily due to higher depreciation expense, insurance, accounting
and
other operating costs.
|
·
|
Consulting
fees and related expenses decreased by $86,813, or 104%, from $885,349
for
the twelve months ended October 31, 2006 to $798,536 for the same
period
in 2007 arising from a lower bonus expense and consulting fees primarily
for LVEP (prior Chief Executive Officer) and consultants partially
offset
by a $251,269 increase in option expense due to accelerated vesting
of the
previous CEO options (LVEP).
|
·
|
A
decrease in legal fees and public relations expenses of $23,666,
or 5%,
from $441,621 for the twelve-months ended October 31, 2006 to $417,955
for
the same period in 2007, primarily as a result of lower legal
costs.
|
·
|
Conference
expenses increased by $124,779 or 922% from $13,527 to $138,306 due
to
increased fund raising activities and communication
efforts.
|
·
|
Interest
income earned on investments decreased by $27,492 in fiscal year
2007 from
$90,899 in fiscal year 2006 to $63,407 in 2007.
|
·
|
Gain
on Note Retirements in the fiscal year 2007 totaled $1,532,477 compared
to
no gain recorded in fiscal 2006. There were two gains; the first
was a
gain due to the amendment and restatement of a license agreement
that
involved a note with Penn of $319,967 which was forgiven as well
as a gain
recorded on the early extinguishment of the Debentures with Cornell
Partners of $1,212,510. In the case of the debentures, the reacquisition
price was less than the net carrying value and therefore a gain on
extinguishment was recorded.
|
·
|
Change
in fair value of common stock warrants & embedded derivatives recorded
in fiscal 2007 improved by $3,961,924 from an expense recorded in
fiscal
2006 of ($2,802,078) to income of $1,159,846 in fiscal year 2007.
This
change primarily resulted from this early extinguishment of the debenture
on October 17, 2007 and a decrease in fair value as recorded in fiscal
2007 compared to fiscal 2006.
|
·
|
Interest
expense increased by $169,894, or 39% from fiscal year 2006 of ($437,299)
to ($607,193) for fiscal year 2007. Interest expense, relates primarily
to
our then outstanding secured convertible debenture that commenced
at the
closing dates of February 2 and March 8, 2006 and were extinguished
on
October 17, 2007.
|
·
|
Clinical
trial expenses increased $328,389, or 351%, from $93,525 to $421,915
due
to the start-up of our clinical trial in March
2006.
|
·
|
Wages,
salaries and related lab costs increased by $409,542, or 215%, from
$190,804 to $600,329 principally due to our expanded research and
development staffing in early 2006.
|
·
|
Subcontracted
expenses increased by $107,949, or 76.3%, from $141,366 to $249,315
reflecting the additional subcontract work performed by Dr. Paterson
at
Penn, pursuant to certain grants.
|
·
|
Manufacturing
expenses decreased $383,387, or 93.6%, from $409,542 to $26,155;
the
result of the fiscal 2005 manufacturing program in anticipation of
the
Lovaxin C for toxicology and clinical trials required in early
2006.
|
·
|
Toxicology
study expenses decreased $259,548, or 88.6%, from $293,105 to $33,558;
principally as a result of the initiation in the earlier period of
toxicology studies by Pharm Olam in connection with our Lovaxin C
product
candidates in anticipation of the clinical studies in 2006.
|
·
|
Consulting
fees and related expenses increased by $580,197, or 190%, from $305,153
for the twelve months ended October 31, 2005 to $885,349 for the
same
period in 2006 arising from a higher bonus expense, stock expense,
consulting fees and the fair value of options primarily for the Chief
Executive Officer(s) and
consultants.
|
·
|
An
increase in legal fees and public relations expenses of $391,611,
or 364%,
from $107,370 for the twelve-months ended October 31, 2005 to $498,611
for
the same period in 2006, primarily as a result of an increase in
the costs
arising from being publicly held.
|
·
|
A
decrease in offering and analyst expenses of $132,498 incurred in
fiscal
2005 while none were incurred in 2006.
|
Page
|
||
Advaxis,
Inc.
|
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
47
|
|
|
|
|
Balance
Sheet as of October 31, 2007
|
49
|
|
|
|
|
Statements
of Operations for the years ended October 31, 2006 and 2007 and the
period
from
|
|
|
March
1, 2002 (Inception) to October 31, 2007
|
50
|
|
|
|
|
Statements
of Stockholders’ Equity (Deficiency) for the Period from March 1, 2002
(Inception) to
|
|
|
October
31, 2007
|
51
|
|
|
|
|
Statements
of Cash Flows for the years ended October 31, 2006 and 2007 and the
period
from
|
|
|
March
1, 2002 (Inception) to October 31, 2007
|
52
|
|
|
|
|
Notes
to the Financial Statements
|
54
|
October
31, 2007
|
||||
ASSETS
|
||||
Current
Assets:
|
|
|||
Cash
|
$
|
4,041,984
|
||
Prepaid
expenses
|
199,917
|
|||
Total Current Assets
|
4,241,901
|
|||
|
||||
Property
and Equipment (net of accumulated depreciation of $55,953)
|
116,442
|
|||
Intangible
Assets (net of accumulated amortization of $149,132)
|
1,098,135
|
|||
Other
Assets
|
3,876
|
|||
|
|
|||
TOTAL
ASSETS
|
$
|
5,460,354
|
||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
$
|
787,297
|
||
Accrued
expenses
|
305,023
|
|||
Notes
payable - current portion
|
80,409
|
|||
Total
Current Liabilities
|
1,172,729
|
|||
|
||||
Notes
payable - net of current portion
|
19,646
|
|||
Total
Liabilities
|
$
|
1,192,375
|
||
|
||||
Shareholders’
Equity
|
||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; no shares issued
and
outstanding
|
-
|
|||
Common
Stock - $0.001 par value; authorized 500,000,000 shares, issued and
outstanding 107,957,777
|
107,957
|
|||
Additional
Paid-In Capital
|
16,276,648
|
|||
Deficit
accumulated during the development stage
|
(12,116,626
|
)
|
||
Total
Shareholders' Equity
|
4,267,979
|
|||
TOTAL
LIABILITIES & SHAREHOLDERS’ EQUITY
|
$
|
5,460,354
|
|
Year
Ended
October
31,
|
Year
Ended
October
31,
|
Period
from
March
1, 2002 (Inception) to
October
31,
|
|||||||
|
2006
|
2007
|
2007
|
|||||||
|
|
|
|
|||||||
Revenue
|
$
|
431,961
|
$
|
154,201
|
$
|
1,259,436
|
||||
Research
& Development Expenses
|
1,404,164
|
2,128,096
|
5,376,144
|
|||||||
General
& Administrative Expenses
|
2,077,062
|
2,629,094
|
6,972,887
|
|||||||
Total
Operating expenses
|
3,481,226
|
4,757,190
|
12,349,031
|
|||||||
Loss
from Operations
|
(3,049,265
|
)
|
(4,602,989
|
)
|
(11,089,595
|
)
|
||||
Other
Income (expense):
|
||||||||||
Interest
expense
|
(437,299
|
)
|
(607,193
|
)
|
(1,073,220
|
)
|
||||
Other
Income
|
90,899
|
63,406
|
199,828
|
|||||||
Gain
on note retirement
|
-
|
1,532,477
|
1,532,477
|
|||||||
Net
changes in fair value of common stock warrant liability and embedded
derivative liability
|
(2,802,078
|
)
|
1,159,846
|
(1,642,232
|
)
|
|||||
Net
loss
|
(6,197,744
|
)
|
(2,454,453
|
)
|
(12,072,742
|
)
|
||||
Dividends
attributable to preferred shares
|
|
43,884
|
||||||||
Net
loss applicable to Common Stock
|
$
|
(6,197,744
|
)
|
$
|
(2,454,453
|
)
|
$
|
(12,116,626
|
)
|
|
Net
loss per share, basic and diluted
|
$
|
(0.16
|
)
|
$
|
(0.05
|
)
|
||||
Weighted
average number of shares outstanding basic and diluted
|
38,646,769
|
46,682,291
|
Preferred
Stock
|
Common
Stock
|
Deficit
Accumulated
|
||||||||||||||||||||
Number
of Shares of Outstanding
|
Amount
|
Number
of shares of outstanding
|
Amount
|
Additional
Paid-in Capital
|
During
the Development Stage
|
Shareholders’
Equity (Deficiency)
|
||||||||||||||||
Preferred
stock issued
|
3,418
|
$
|
235,000
|
$
|
235,000
|
|||||||||||||||||
Common
Stock Issued
|
40,000
|
$
|
40
|
$
|
(40
|
)
|
||||||||||||||||
Options
granted to consultants and professionals
|
10,493
|
10,493
|
||||||||||||||||||||
Net
Loss
|
(166,936
|
)
|
(166,936
|
)
|
||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(3,481
|
)
|
(235,000
|
)
|
15,557,723
|
15,558
|
219,442
|
|||||||||||||||
Balance
at December 31, 2002
|
15,597,723
|
$
|
15,598
|
$
|
229,895
|
$
|
(166,936
|
)
|
$
|
78,557
|
||||||||||||
|
||||||||||||||||||||||
Note
payable converted into preferred stock
|
232
|
15,969
|
15,969
|
|||||||||||||||||||
Options
granted to consultants and professionals
|
8,484
|
8,484
|
||||||||||||||||||||
Net
loss
|
(909,745
|
)
|
(909,745
|
)
|
||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(232
|
)
|
(15,969
|
)
|
15,969
|
|||||||||||||||||
Balance
at December 31, 2003
|
15,597,723
|
$
|
15,598
|
$
|
254,348
|
$
|
(1,076,681
|
)
|
$
|
(806,735
|
)
|
|||||||||||
|
||||||||||||||||||||||
Stock
dividend on preferred stock
|
638
|
43,884
|
(43,884
|
)
|
||||||||||||||||||
Net
loss
|
(538,076
|
)
|
(538,076
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
5,315
|
5,315
|
||||||||||||||||||||
Retroactive
restatement to reflect re-capitalization on Nov. 12, 2004
|
(638
|
)
|
(43,884
|
)
|
43,884
|
|||||||||||||||||
Balance
at October 31, 2004
|
15,597,723
|
$
|
15,598
|
$
|
303,547
|
$
|
(1,658,641
|
)
|
$
|
(1,339,496
|
)
|
|||||||||||
Common
Stock issued to Placement Agent on re-capitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Effect
of re-capitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
64,924
|
64,924
|
||||||||||||||||||||
Conversion
of Note payable to Common Stock
|
2,136,441
|
2,136
|
611,022
|
613,158
|
||||||||||||||||||
Issuance
of Common Stock for cash, net of shares to Placement Agent
|
17,450,693
|
17,451
|
4,335,549
|
4,353,000
|
||||||||||||||||||
Issuance
of common stock to consultants
|
586,970
|
587
|
166,190
|
166,777
|
||||||||||||||||||
Issuance
of common stock in connection with the registration
statement
|
409,401
|
408
|
117,090
|
117,498
|
||||||||||||||||||
Issuance
costs
|
(329,673
|
)
|
(329,673
|
)
|
||||||||||||||||||
Net
loss
|
(1,805,789
|
)
|
(1,805,789
|
)
|
||||||||||||||||||
Restatement
to reflect re- capitalization on Nov. 12, 2004 including cash paid
of
$44,940
|
(88,824
|
)
|
(88,824
|
)
|
||||||||||||||||||
Balance
at October 31, 2005
|
37,686,428
|
$
|
37,686
|
$
|
5,178,319
|
$
|
(3,464,430
|
)
|
$
|
1,751,575
|
||||||||||||
|
||||||||||||||||||||||
Options
granted to consultants and professionals
|
172,831
|
172,831
|
||||||||||||||||||||
Options
granted to employees and directors
|
71,667
|
71,667
|
||||||||||||||||||||
Conversion
of debenture to Common Stock
|
1,766,902
|
1,767
|
298,233
|
300,000
|
||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
229,422
|
229
|
54,629
|
54,858
|
||||||||||||||||||
Issuance
of common stock to consultants
|
556,240
|
557
|
139,114
|
139,674
|
||||||||||||||||||
Net
loss
|
(6,197,744
|
)
|
(6,197,744
|
)
|
||||||||||||||||||
Balance
at October 31, 2006
|
40,238,992
|
40,239
|
5,914,793
|
(9,662,173
|
)
|
(3,707,141
|
)
|
|||||||||||||||
Common
Stock issued
|
55,226,334
|
55,228
|
8,725,674
|
8,780,902
|
||||||||||||||||||
Offering
Expenses
|
(2,243,535
|
)
|
(2,243,535
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
268,577
|
268,577
|
||||||||||||||||||||
Options
granted to employees and directors
|
222,501
|
222,501
|
||||||||||||||||||||
Conversion
of debenture to Common Stock
|
10,974,202
|
10,974
|
1,593,026
|
1,600,000
|
||||||||||||||||||
Issuance
of Common Stock to employees and directors
|
446,417
|
416
|
73,384
|
73,800
|
||||||||||||||||||
Issuance
of common stock to consultants
|
1,100,001
|
1,100
|
220,678
|
221,778
|
||||||||||||||||||
Warrants
issued on conjunction with issuance of common stock
|
1,505,550
|
1,505,550
|
||||||||||||||||||||
Net
loss
|
(2,454,453
|
)
|
(2,454,453
|
)
|
||||||||||||||||||
Balance
at October 31, 2007
|
107,957,977
|
$
|
107,957
|
$
|
16,276,648
|
$
|
(12,116,626
|
)
|
$
|
4,267,979
|
|
|
|
Period
from
|
|||||||
|
|
|
March
1
|
|||||||
|
|
|
2002
|
|||||||
|
Year
ended
|
Year
ended
|
(Inception)
to
|
|||||||
|
October
31,
|
October
31,
|
October
31,
|
|||||||
|
2006
|
2007
|
2007
|
|||||||
OPERATING
ACTIVITIES
|
|
|
|
|||||||
Net
loss
|
$
|
(6,197,744
|
)
|
$
|
(2,454,453
|
)
|
$
|
(12,072,742
|
)
|
|
Adjustments
to reconcile net loss
|
||||||||||
to
net cash used in operating activities:
|
||||||||||
Non-cash
charges to consultants and employees for options and stock
|
439,027
|
786,656
|
1,497,866
|
|||||||
Amortization
of deferred financing costs
|
82,313
|
177,687
|
260,000
|
|||||||
Non-cash
interest expense
|
230,218
|
280,060
|
510,278
|
|||||||
Loss
(Gain) on change in value of warrants and embedded
derivative
|
2,802,078
|
(1,159,846
|
)
|
1,642,232
|
||||||
Value
of penalty shares issued
|
-
|
-
|
117,498
|
|||||||
Depreciation
expense
|
17,009
|
31,512
|
55,953
|
|||||||
Amortization
expense of intangibles
|
45,068
|
54,577
|
152,303
|
|||||||
Gain
on note retirement
|
-
|
(1,532,477
|
)
|
(1,532,477
|
)
|
|||||
(Increase)
decrease in prepaid expenses
|
(38,100
|
)
|
(161,817
|
)
|
(199,917
|
)
|
||||
Decrease
(increase) in other assets
|
-
|
724
|
(3,876
|
)
|
||||||
Increase
in accounts payable
|
158,335
|
99,076
|
1,224,503
|
|||||||
Increase
(decrease) in accrued expenses
|
522,467
|
(217,444
|
)
|
288,834
|
||||||
Increase
(Decrease) in interest payable
|
123,934
|
(117,951
|
)
|
18,291
|
||||||
(Decrease)
in Deferred Revenue
|
20,350
|
(20,350
|
)
|
-
|
||||||
Net
cash used in operating activities
|
(1,795,045
|
)
|
(4,234,046
|
)
|
(8,041,254
|
)
|
||||
INVESTING
ACTIVITIES
|
||||||||||
Cash
paid on acquisition of Great Expectations
|
-
|
-
|
(44,940
|
)
|
||||||
Purchase
of property and equipment
|
(8,606
|
)
|
(37,632
|
)
|
(126,815
|
)
|
||||
Cost
of intangible assets
|
(250,389
|
)
|
(358,336
|
)
|
(1,325,390
|
)
|
||||
Net
cash used in Investing Activities
|
(258,995
|
)
|
(395,968
|
)
|
(1,497,145
|
)
|
||||
FINANCING
ACTIVITIES
|
||||||||||
Proceeds
from (repayment of) convertible secured debenture
|
3,000,000
|
(2,040,000
|
)
|
960,000
|
||||||
Cash
paid for deferred financing costs
|
(260,000
|
)
|
-
|
(260,000
|
)
|
|||||
Proceeds
from notes payable
|
-
|
600,000
|
1,271,224
|
|||||||
Payment
on notes payable
|
-
|
(92,087
|
)
|
(92,087
|
)
|
|||||
Net
proceeds of issuance of Preferred Stock
|
-
|
-
|
235,000
|
|||||||
Payment
on cancellation of Warrants
|
-
|
(600,000
|
)
|
(600,000
|
)
|
|||||
Net
proceeds of issuance of Common Stock
|
-
|
8,042,917
|
12,066,244
|
|||||||
Net
cash provided by Financing Activities
|
2,740,000
|
5,910,830
|
13,580,381
|
|||||||
Net
increase in cash
|
685,960
|
1,280,818
|
4,041,984
|
|||||||
Cash
at beginning of period
|
2,075,206
|
2,761,166
|
-
|
|||||||
Cash
at end of period
|
$
|
2,761,166
|
4,041,984
|
$
|
4,041,984
|
Period
from
|
||||||||||
|
|
|
March
1, 2002
|
|||||||
|
Year
ended
|
Year
ended
|
(Inception)
to
|
|||||||
|
October 31,
|
October
31,
|
October
31,
|
|||||||
|
2006
|
2007
|
2007
|
|||||||
Equipment
acquired under notes payable
|
$
|
-
|
$
|
45,580
|
$
|
45,580
|
||||
Common
Stock issued to Founders
|
$
|
-
|
$
|
-
|
$
|
40
|
||||
Notes
payable and accrued interest converted to Preferred Stock
|
$
|
-
|
$
|
-
|
$
|
15,969
|
||||
Stock
dividend on Preferred Stock
|
$
|
-
|
$
|
-
|
$
|
43,884
|
||||
Notes
payable and accrued interest converted to Common
Stock
|
$
|
300,000
|
$
|
1,600,000
|
$
|
2,513,158
|
||||
Intangible
assets acquired with notes payable
|
$
|
-
|
$
|
-
|
$
|
360,000
|
||||
Debt
discount in connection with recording the original value of the embedded
derivative liability
|
$
|
512,865
|
$
|
-
|
$
|
512,865
|
||||
Allocation
of the original secured convertible debentures to warrants
|
$
|
214,950
|
$
|
-
|
$
|
214,950
|
||||
Warrants
issued in connection with issuance of
Common Stock
|
$
|
-
|
$
|
1,505,550
|
$
|
1,505,550
|
1.
|
PRINCIPAL
BUSINESS ACTIVITY AND
|
|
SUMMARY
OF SIGNIFICANT
|
|
ACCOUNTING
POLICIES:
|
October
31, 2007
|
October
31, 2006
|
||||||
Warrants
|
87,713,770
|
25,009,220
|
|||||
Stock
Options
|
8,512,841
|
6,959,077
|
|||||
Convertible
Debt (1.)
|
-
|
14,210,526
|
|||||
Total
|
96,226,611
|
46,178,823
|
|
March
1, 2002
(date
of inception) to
October
31, 2007
|
|||
Net
Loss as reported
|
$
|
(12,072,742
|
)
|
|
Add:
Stock based option expense included in recorded net loss
|
89,217
|
|||
Deduct
stock option compensation expense determined under fair value based
method
|
(328,176
|
)
|
||
Adjusted
Net Loss
|
$
|
(12,311,701
|
)
|
|
Year
Ended
|
|
Year
Ended
|
|
|
October
31, 2006
|
|
October
31, 2007
|
|
Expected
volatility
|
127.37%
|
|
119.0%
|
|
Expected
Life
|
7.7
years
|
|
7.0
years
|
|
Dividend
yield
|
0
|
|
0
|
|
Risk-free
interest rate
|
4.6%
|
|
4.3%
|
Trademarks
|
$
|
87,857
|
||
Patents
|
663,283
|
|||
License
|
496,127
|
|||
Less:
Accumulated Amortization
|
(149,132
|
)
|
||
|
||||
|
$
|
1,098,135
|
Year
ending October 31,
|
|
|||
2008
|
$
|
58,000
|
||
2009
|
58,000
|
|||
2010
|
58,000
|
|||
2011
|
58,000
|
|||
2012
|
58,000
|
Salaries
and other compensation
|
$
|
182,737
|
||
Consulting
|
84,619
|
|||
Clinical
Research Organization
|
37,667
|
|||
|
$
|
305,023
|
Two
notes payable with interest at 8% per annum, due on December 17,
2008. The
lender has served notice demanding repayment on the due date pursuant
to
the November 2004 recapitalization and financing agreement
|
$
|
65,577
|
||
Installment
purchase agreement on equipment with interest at 11.75% per
annum
|
34,478
|
|||
Total
|
100,055
|
|||
Less
current portion
|
(80,409
|
)
|
||
|
$
|
19,646
|
Principal
$
|
Discount
$
|
Interest
$
|
Warrant
Liability
$
|
Embedded
Derivative
Liability
$
|
||||||||||||
Original
(Fiscal Year 2006)
|
3,000,000
|
(727,815
|
)(1)
|
-
|
-
|
-
|
||||||||||
Fiscal
year 2006
|
(300,000
|
)(2)
|
230,218
|
(3)
|
119,934
|
714,600
|
(4)
|
2,815,293
|
(4)
|
|||||||
Book
Value at October 31,2006
|
2,700,000
|
(497,597
|
)
|
119,934
|
714,600
|
2,815,293
|
||||||||||
Fiscal
year 2007
|
(1,000,000
|
)(2)
|
280,062
|
(3)
|
130,065
|
15,240
|
(5)
|
(1,175,086
|
)(5)
|
|||||||
Book
Value at October 31, 2007
|
1,700,000
|
(217,535
|
)
|
249,999
|
729,840
|
1,640,207
|
||||||||||
Cash
paid at October 17,0207
|
(1,700,000
|
)
|
-
|
(249,999
|
)
|
(600,000
|
)
|
(340,000
|
)
|
|||||||
Gain
(Loss)
|
-
|
(
217,535
|
)
|
-
|
129,840
|
1,300,207
|
1. |
Embedded
derivative’s warrant value at origination of debenture
|
2. |
Principal
converted into common stock
|
3. |
Amortized
discount to interest expense
|
4.
|
Change
in Fair value of the Company’s common stock warrants from inception
expensed to the statement of
operations.
|
5. |
Change
in fair value for fiscal 2007 until
extinguishment
|
Shares
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life In Years
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding
as of October 31, 2005
|
4,842,539
|
$
|
0.27
|
8.4
|
6,867
|
||||||||
Granted
|
2,233,179
|
$
|
0.22
|
12,000
|
|||||||||
Cancelled
or Expired
|
(116,641
|
)
|
$
|
0.37
|
|||||||||
Outstanding
as of October 31, 2006
|
6,959,077
|
$
|
0.25
|
8.1
|
18,867
|
||||||||
Granted
|
2,910,001
|
$
|
0.15
|
||||||||||
Cancelled
or Expired
|
(1,356,237
|
)
|
0.22
|
||||||||||
Outstanding
as of October 31, 2007
|
8,512,841
|
$
|
0.22
|
7.8
|
$
|
167,572
|
|||||||
Vested
& Exercisable at October 31, 2007
|
5,432,536
|
$
|
0.24
|
7.4
|
$
|
62,422
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||||||||
Range
of
Exercise
Prices
|
Number
Outstanding
(000’s)
|
Weighted-
Average
Remaining
Contractual
Life (in Years)
|
Weighted-
Average
Exercise
Price
per
Share
|
Aggregate
Intrinsic
Value
|
Number
Exercisable
(000’s)
|
Weighted-
Average
Exercise
Price
per
Share
|
Aggregate
Intrinsic
Value
|
|||||||||||||||||
$
|
0.14-0.17
|
3,150
|
8.9
|
$
|
0.15
|
$
|
164,550
|
1,075
|
$
|
0.14
|
$
|
60,000
|
||||||||||||
0.18-0.21
|
1,739
|
6.8
|
0.21
|
3,022
|
1,679
|
0.21
|
2,422
|
|||||||||||||||||
0.22-0.25
|
310
|
8.5
|
0.25
|
0
|
133
|
0.25
|
0
|
|||||||||||||||||
0.26-0.29
|
2,992
|
7.5
|
0.28
|
0
|
2,224
|
0.28
|
0
|
|||||||||||||||||
0.30-0.43
|
322
|
5.1
|
0.37
|
|
322
|
0.37
|
|
|||||||||||||||||
Total
|
8,513
|
7.8
|
$
|
0.22
|
$
|
167,572
|
5,433
|
$
|
0.24
|
$
|
62,422
|
Number
of Shares
|
Weighted
Average Exercise Price at Grant Date
|
Weighted
Average Remaining Contractual Term
(in
years)
|
||||||||
Non-vested
shares at October 31, 2006
|
3,203,167
|
$
|
0.25
|
9.0
|
||||||
Options
granted
|
2,910,001
|
$
|
0.15
|
8.9
|
||||||
Options
vested
|
(3,032,863
|
)
|
$
|
0.19
|
8.5
|
|||||
Non-vested
shares at October 31, 2007
|
3,080,305
|
$
|
0.19
|
8.5
|
Net
operating losses
|
$
|
3,736,212
|
||
Stock
based compensation
|
378,517
|
|||
Less
valuation allowance
|
(4,114,729
|
)
|
||
Deferred
tax asset
|
$
|
-0-
|
|
Year ended
October
31, 2005
|
Year ended
October
31, 2006
|
Period
from
March
1, 2002
(inception)
to
October
31, 2006
|
|||||||
|
|
|
|
|||||||
Provision
at federal statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||
Valuation
allowance
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
||||
|
-0-
|
%
|
-0-
|
%
|
-0-
|
%
|
Name
|
|
Age
|
|
Position
|
|
|
|
|
|
Thomas
Moore (1)
|
|
56
|
|
Chief
Executive Officer and Chairman of the Board of
Directors
|
|
|
|
|
|
Dr.
James Patton (2)
|
|
50
|
|
Director
|
|
|
|
|
|
Roni
A. Appel (1) (4)
|
|
40
|
|
Director
|
|
|
|
|
|
Dr.
Thomas McKearn (3)
|
|
56
|
|
Director
|
|
|
|
|
|
Richard
Berman (2) (3) (4)
|
|
63
|
|
Director
|
|
|
|
|
|
Martin
R. Wade III
|
|
56
|
|
Director
|
|
|
|
|
|
Dr.
John Rothman
|
|
59
|
|
Vice
President, Clinical Development
|
|
|
|
|
|
Fred
Cobb
|
|
60
|
|
Vice
President, Finance and Principal Financial
Officer
|
|
·
|
reviewing
the results of the audit engagement with the independent registered
public
accounting firm;
|
|
·
|
identifying
irregularities in the management of our business in consultation
with our
independent accountants, and suggesting an appropriate course of
action;
|
|
·
|
reviewing
the adequacy, scope, and results of the internal accounting controls
and
procedures;
|
|
·
|
reviewing
the degree of independence of the auditors, as well as the nature
and
scope of our relationship with our independent registered public
accounting firm;
|
|
·
|
reviewing
the auditors’ fees; and
|
|
·
|
recommending
the engagement of auditors to the full board of
directors.
|
|
·
|
identifying
and recommending to the board of directors individuals qualified
to serve
as directors of the Company and on the committees of the
board;
|
|
·
|
advising
the board with respect to matters of board composition, procedures
and
committees;
|
|
·
|
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally
including review of possible conflicts and transactions with persons
affiliated with Directors or members of management; and
|
|
·
|
overseeing
the annual evaluation of the board and our
management.
|
·
|
honest
and ethical conduct, including the ethical handling of actual or
apparent
conflicts of interest between personal and professional
relationships;
|
|
|
·
|
full,
fair, accurate, timely and understandable disclosure in reports and
documents that a we file with, or submit to, the SEC and in other
public
communications made by us;
|
|
·
|
compliance
with applicable governmental laws, rules and
regulations;
|
|
·
|
the
prompt internal reporting of violations of the code to an appropriate
person or persons identified in our code of ethics; and
|
|
·
|
accountability
for adherence to our code of
ethics.
|
Name
and Principal Position
|
Year
Ended October 31,
|
Salary
($)
|
Bonus
($)
|
Stock
Award(s) ($)
|
Option
Award(s) ($)
|
Non-Equity
Incentive Plan Compensation (#)
|
Nonqualified
Deferred Compensation Earnings
($)
|
All
Other Compensation
|
Total
($)
|
|||||||||||||||||||
Thomas
Moore*
|
2007
|
$
|
220,769
|
(1)
|
$
|
-
|
(2)
|
$
|
172,500
|
(3)
|
$
|
129,813
|
(4)
|
$
|
|
-
|
$
|
23,976
|
(5)
|
$
|
547,058
|
|||||||
CEO
and Chairman
|
2006
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||
2005
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||
Dr.
John Rothman
|
2007
|
$
|
173,923
|
$
|
45,000
|
(6)
|
$
|
35,508
|
(7)
|
$
|
23,128
|
(8)
|
-
|
-
|
$
|
27,497
|
(9)
|
$
|
305,057
|
|||||||||
VP
Clinical Development
|
2006
|
$
|
176,538
|
$
|
10,000
|
(10)
|
$
|
14,800
|
(11)
|
$
|
19,894
|
(12)
|
-
|
-
|
$
|
23,328
|
(13)
|
$
|
244,552
|
|||||||||
2005
|
-
|
$
|
126,867
|
-
|
-
|
-
|
-
|
-
|
$
|
126,867
|
||||||||||||||||||
Fred
Cobb
|
2007
|
$
|
144,731
|
$
|
28,000
|
(14)
|
$
|
16,360
|
(15)
|
$
|
13,863
|
(16)
|
-
|
-
|
$
|
9,358
|
(17)
|
$
|
212,311
|
|||||||||
VP
Finance
|
2006
|
$
|
97,298
|
-
|
$
|
|
(18)
|
$
|
4,592
|
(19)
|
-
|
-
|
$
|
1,292
|
(20)
|
$
|
103,181
|
|||||||||||
2005
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||
Dr.
Vafa Shahabi
|
2007
|
$
|
119,154
|
$
|
20,000
|
(21)
|
$
|
16,360
|
(22)
|
$
|
14,529
|
(23)
|
-
|
-
|
$
|
4,396
|
(24)
|
$
|
174,438
|
|||||||||
Director
Research &
|
2006
|
$
|
104,702
|
-
|
$
|
14,800
|
(25)
|
$
|
7,999
|
(26)
|
-
|
-
|
$
|
3,288
|
(27)
|
$
|
130,789
|
|||||||||||
Development
|
2005
|
$
|
67,390
|
-
|
-
|
-
|
-
|
-
|
-
|
$
|
67,390
|
|||||||||||||||||
Roni
Appel
|
2007
|
$
|
229,167
|
(28)
|
$
|
250,000
|
(29)
|
$
|
200,000
|
(30)
|
$
|
251,269
|
(31)
|
-
|
-
|
$
|
35,590
|
(32)
|
$
|
966,026
|
||||||||
Former
President, CEO,
|
2006
|
$
|
243,042
|
$
|
20,000
|
(33)
|
$
|
44,048
|
(34)
|
$
|
131,229
|
(35)
|
-
|
-
|
$
|
53,774
|
(36)
|
$
|
492,092
|
|||||||||
Secretary,
CFO and
|
2005
|
$
|
136,500
|
-
|
$
|
3,014
|
(37)
|
-
|
-
|
-
|
$
|
14,480
|
(38)
|
$
|
185,567
|
|||||||||||||
Director
|
||||||||||||||||||||||||||||
J.
Todd Derbin
|
2007
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
-
|
||||||||||||||
Former
President and
|
2006
|
$
|
73,197
|
(39)
|
-
|
$
|
3,833
|
(40)
|
$
|
11,975
|
(41)
|
-
|
-
|
$
|
4,043
|
(42)
|
$
|
93,048
|
||||||||||
CEO
|
2005
|
$
|
225,000
|
-
|
$
|
45,000
|
(43)
|
117,429
|
(41)
|
-
|
-
|
-
|
$
|
387,429
|
1.
|
In
fiscal year 2007 his base annual compensation was $250,000 and as
of
November 1, 2007 it was increased to $350,000 based on the closing
of the
raise milestone per his employment agreement (the
“agreement”).
|
2.
|
There
was no bonus provided in his agreement.
|
3.
|
Per
his agreement he also earned 750,000 shares of the Company’s common stock
valued at $0.23 per share (closing market price on October 17, 2007)
based
on the closing of the raise milestone. The stock has not yet been
issued.
|
4.
|
Per
his agreement he was also granted 2,400,000 options of the Company’s
common stock at a market price $0.143/share (December 15, 2006) vesting
monthly over a 24 month period of which 1,200,001 are based on the
grant
date fair value price of $0.1363 (valued using Black Sholes
model).
|
5.
|
Based
on the Company’s cost of his coverage for health care and the payment of
interest earned on his Bridge loan to the Company.
|
6.
|
Cash
bonus earned in fiscal year 2006 paid in fiscal year
2007.
|
7.
|
Compensation
paid in stock in lieu of cash. The calculation prorates $30,000 on
a
monthly basis divided by the average monthly stock price with the
minimum
set at $0.20/share. The value is based on the market price when the
shares
are issued.
|
8.
|
Based
on the vesting of options for three grants (810,000 granted) of the
Company’s common stock at a market price ranging from $0.287/share to
$0.165/share vesting monthly over a 4 year period based on the grant
date
fair value price ranging from $0.25 to $0.10 (valued using Black
Sholes
model).
|
9.
|
Based
on the Company’s cost of his coverage for health care and the 401K Company
match.
|
10.
|
Cash
bonus earned in fiscal year 2005 paid in fiscal year
2006.
|
11.
|
Compensation
in stock in lieu of cash. Earned 80,000 shares of common stock
in fiscal 2005 issued in fiscal 2006.
|
12.
|
Based
on the vesting of options for two grants (510,000 granted) of the
Company’s common stock at a market price ranging from $0.287/share to
$0.165/share vesting monthly over a 4 year period based on the grant
date
fair value price ranging from $0.25 to $0.10 (valued using Black
Sholes
model).
|
13.
|
Based
on the Company’s cost of his coverage for health care and the 401K Company
match.
|
14.
|
Cash
bonus earned in fiscal year 2006 paid in fiscal year
2007.
|
15.
|
Compensation
paid in stock in lieu of cash. The calculation prorates $20,000 on
a
monthly basis divided by the average monthly stock price with the
minimum
set at $0.20/share. The value is based on the market price when the
shares
are issued.
|
16.
|
Based
on the vesting of options for three grants (450,000 granted) of the
Company’s common stock at a market price ranging from $0.26/share to
$0.16/share vesting monthly over a 4 year period based on the grant
date
fair value price ranging from $0.25 to $0.154 (valued using Black
Sholes
model).
|
17.
|
Based
on the Company’s cost of the 401K Company match.
|
18.
|
Compensation
in stock in lieu of cash. The calculation prorates $20,000 on a monthly
basis divided by the average monthly stock price with the minimum
set at
$0.20/share. The program commenced in July 2006 therefore this amount
represents only a 4 months accrual but no stock was issued in Fiscal
2006.
|
19.
|
Based
on the vesting of options for two grants (300,000 granted) of the
Company’s common stock at a market price ranging from $0.26/share to
$0.16/share vesting monthly over a 4 year period based on the grant
date
fair value price ranging from $0.25 to $0.154 (valued using Black
Sholes
model).
|
20.
|
Based
on the Company’s cost of the 401K Company match.
|
21.
|
Cash
bonus earned in fiscal year 2006 paid in fiscal year
2007.
|
22.
|
Compensation
paid in stock in lieu of cash. The calculation prorates $20,000 on
a
monthly basis divided by the average monthly stock price with the
minimum
set at $0.20/share. The value is based on the market price when the
shares
are issued.
|
23.
|
Based
on the vesting of options for three grants (400,000 granted) of the
Company’s common stock at a market price ranging from $0.287/share to
$0.16/share vesting monthly over a 4 year period based on the grant
date
fair value price ranging from $0.23 to $0.10 (valued using Black
Sholes
model).
|
24.
|
Based
on the Company’s cost of the 401K Company match.
|
25.
|
Includes
compensation in stock in lieu of cash. Earned 80,000 shares of common
stock in fiscal 2005 issued in fiscal 2006.
|
26.
|
Based
on the vesting of options for three grants (400,000 granted) of the
Company’s common stock at a market price ranging from $0.287/share to
$0.16/share vesting monthly over a 4 year period based on the grant
date
fair value price ranging from $0.23 to $0.10 (valued using Black
Sholes
model).
|
27.
|
Based
on the Company’s cost of the 401K Company match.
|
28.
|
Mr.
Appel served as consultant (LVEP) in the capacity of Secretary and
CFO in
2004 and 2005. He was appointed President and CEO on January 1, 2006.
He
resigned his position of President, CEO and Secretary on December
15, 2006
and resigned from his CFO position on September 7, 2006. Pursuant
to the
consulting agreement, dated as of January 19, 2005, and amended on
April
15, 2005, October 31, 2005, and December 15, 2006, the consultant
continues as a director and consultant to the Company and over the
24
month term of the agreement, as amended, is to devote 50% of his
time to
perform consulting services over the first 12 months of the consulting
period and be paid at a annual rate of $250,000 with benefits. He
is to
receive severance payments over an additional 12 months of $10,416.67
per
month and be reimbursed for family health care. Mr. Appel’s compensation
was paid through our consulting agreement with LVEP.
|
29.
|
Represents
a 2006 cash bonus of $250,000 paid in calendar and fiscal year 2007
per
his amended consulting agreement dated December 15,
2006.
|
30.
|
Include
the 1,000,000 shares of common stock awarded on December 15, 2006
and
issued on January 3, 2007 per his amended consulting agreement dated
December 15, 2006.
|
31.
|
Based
on the vesting, accelerated vesting (as per his amended agreement
of
December 15, 2006) and changes in the fair value of options for two
grants: (i) 1,114,344 granted at $0.287/share and (ii) 1,173,179
granted
at $0.217/share of the Company’s common stock at the fair market value of
$0.1785/share and $0.1834/share, respectively using Black Sholes
model.
|
32.
|
Other:
reimbursements for payroll taxes, healthcare cost, workers compensation,
401K match and employment related cost.
|
33.
|
Represents
2005 bonus of $20,000 cash paid in 2006
|
34.
|
Represents
2005 bonus in stock 238,528 shares paid in 2006 at
$.185/share.
|
35.
|
Based
on the vesting for two grants: (i) 1,114,344 granted at $0.287/share
and
(ii) 1,173,179 granted at $0.217/share of the Company’s common stock at
the fair market value of $0.1790/share and $0.1806/share, respectively
using Black Sholes model.
|
36.
|
Based
on the Company’s cost of his coverage for health care, payroll taxes and
401K Company match.
|
37.
|
Assumed
company stock of 10,500 shares in lieu of bonus a
$0.287/share.
|
38.
|
Healthcare
and visa expenses
|
39.
|
Mr.
Derbin resigned as President and CEO on December 31, 2005 and as
a
Director September 7, 2006.
|
40.
|
His
2005 bonus of $3,850 was paid in 2006 by issuance of 17,422 shares
of
Company’s Common Stock based on $0.22 per share.
|
41.
|
Based
on the vesting of grants and its fair market value using the Black
Sholes
model. All vested options expired unused as of January 1,
2007.
|
42.
|
Health
care insurance
|
43.
|
His
2004 bonus of $45,000 was paid in 2005 by issuance of 156,974 shares
of
common stock valued at $0.287 per
share.
|
Name
|
Year
|
Fees
Earned or Paid in Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan Compensation
($)
|
Nonqualified
Deferred Compensation Earnings
($)
|
All
other Compensation
($)
|
Total
($)
|
|||||||||||||||||
Thomas
A. Moore
|
2007
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
2006
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
2005
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Roni
A. Appel
|
2007
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
2006
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
2005
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Dr.
James Patton
|
2007
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
2006
|
|||||||||||||||||||||||||
2005
|
479
|
479
|
|||||||||||||||||||||||
Dr.
Thomas McKearn
|
2007
|
-
|
-
|
11,424
|
(1)
|
-
|
-
|
-
|
11,424
|
||||||||||||||||
2006
|
-
|
-
|
9,143
|
(1)
|
-
|
-
|
-
|
9,143
|
|||||||||||||||||
2005
|
-
|
-
|
4,242
|
(1)
|
-
|
-
|
-
|
4,242
|
|||||||||||||||||
Martin
R. Wade III
|
2007
|
-
|
-
|
11,424
|
(1)
|
-
|
-
|
-
|
11,424
|
||||||||||||||||
2006
|
6,971
|
(1)
|
6,971
|
||||||||||||||||||||||
2005
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Richard
Berman
|
2007
|
-
|
8,640
|
(2)
|
10,000
|
(3)
|
-
|
-
|
-
|
18,640
|
|||||||||||||||
2006
|
11,680
|
(2)
|
10,000
|
(3)
|
21,680
|
||||||||||||||||||||
2005
|
-
|
-
|
11,000
|
(3)
|
-
|
-
|
-
|
11,000
|
1.
|
Based
on the vesting of 150,000 options of the Company’s common stock granted on
3/29/2006 at a market price of $0.261 share. Vests quarterly over
a three
year period at a fair value of $0.1434 share value Black Scholes
Model at
grant date. In 2005 and 2006 based on vesting of 150,000 options
of the
Company’s common stock granted on 10/1/2003 at a market price of $0.1952
share. Vests quarterly over a three year period at a fair value of
$0.14
per share (Black Scholes Model).
|
2.
|
Receives
$2,000 a month in shares of the Company’s stock valued at $0.50 share. The
value of the stock based on 4,000 shares times the average monthly
values.
|
3.
|
Based
on the vesting of 400,000 options of the Company’s common stock granted on
2/1/2005 at a exercise price of $0.287 share and the fair value of
$0.100/share. Vests quarterly over a four year period at a (value
is Black
Scholes model at grant date.)
|
Name
|
Year
|
Number
Of Securities Underlying Options Granted
|
Percent
Of Total Options Granted To Employees In Fiscal
Period
|
Exercise Price
|
Expiration Date
|
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation
For Option
Term($)
|
||||||||||||||||
|
|
|
5%
|
10%
|
||||||||||||||||||
Thomas
Moore
|
2007
|
2,400,000
|
(1)
|
82
|
%
|
0.143
|
12/15/2016
|
$
|
215,756
|
$
|
545,919
|
|||||||||||
CEO
Chairman
|
2006
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
2005
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||
Dr.
John Rothman
|
2007
|
300,000
|
10
|
%
|
$
|
0.165
|
2/15/2017
|
$
|
31,119
|
$
|
78,738
|
|||||||||||
Vice
President Clinical
|
2006
|
150,000
|
7
|
%
|
$
|
0.26
|
3/29/2016
|
$
|
24,528
|
$
|
62,167
|
|||||||||||
|
2005
|
360,000
|
11
|
%
|
$
|
0.29
|
3/1/2015
|
$
|
64,988
|
$
|
164,692
|
|||||||||||
Fred
Cobb
|
2007
|
150,000
|
5
|
%
|
$
|
0.165
|
2/15/2017
|
$
|
15,559
|
$
|
39,369
|
|||||||||||
Vice
President Finance
|
2006
|
150,000
|
7
|
%
|
$
|
0.26
|
2/20/2016
|
$
|
19,811
|
$
|
50,212
|
|||||||||||
2006
|
150,000
|
7
|
%
|
$
|
0.16
|
9/20/2006
|
$
|
15,094
|
$
|
38,257
|
||||||||||||
Dr.
Vafa Shahabi
|
2007
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Director
of Research &
|
2006
|
100,000
|
5
|
%
|
$
|
0.24
|
7/1/2016
|
$
|
15,094
|
$
|
38,257
|
|||||||||||
Development
|
2006
|
150,000
|
7
|
%
|
$
|
0.16
|
9/20/2016
|
$
|
15,094
|
$
|
38,257
|
|||||||||||
|
2005
|
150,000
|
5
|
%
|
$
|
0.29
|
3/1/2015
|
$
|
22,641
|
$
|
57,385
|
|||||||||||
Roni
Appel *
|
2007
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Secretary
and Chief
|
2006
|
1,173,179
|
(2)
|
53
|
%
|
$
|
0.217
|
12/31/2015
|
$
|
160,113
|
$
|
405,809
|
||||||||||
Executive
Officer
|
2005
|
1,114,344
|
(3)
|
34
|
%
|
$
|
0.29
|
3/31/2015
|
$
|
201,165
|
$
|
509,788
|
||||||||||
J.
Todd Derbin (4
)*
|
2007
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
President,
Chief Executive Officer,
|
2006
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
and
Director
|
2005
|
427,796
|
13
|
%
|
$
|
0.29
|
2/1/2015
|
$
|
78,034
|
$
|
197,753
|
(1)
|
As
of December 15, 2006, 2,400,000 options were granted per his employment
agreement.
|
|
(2)
|
As
of January 1, 2007, 1,356,237 previously granted and vested but
unexercised options were forfeited.
|
|
(3)
|
Reflects
a grant in January 2006 post fiscal year end increasing the number
of
options to 5% of the outstanding shares and options of the Company
as of
December 31, 2005.
|
|
(4)
|
As
of January 1, 2007 all options granted to Mr. Derbin expired
unexercised.
|
|
*
|
Resigned
|
|
|
|
Number
Of Securities
Underlying
Unexercised Options
At
Fiscal
Year-End (1)
|
Value
Of Unexercised
In-The-Money
Options
At
Fiscal Year-End($) (2)
|
|||||||||||||||
Name
|
Year
|
Shares
Acquired On Exercise
|
Exercisable
|
Unexercisable
|
Exercisable
|
Unexercisable
|
|||||||||||||
|
|||||||||||||||||||
Thomas
Moore
|
2007
|
0
|
1,000,000
|
(3)
|
57,000
|
$
|
1,400,000
|
$
|
79,800
|
||||||||||
CEO
and Chairman
|
2006
|
||||||||||||||||||
2005
|
0
|
-
|
-
|
-
|
-
|
||||||||||||||
Dr.
John Rothman
|
2007
|
0
|
281,250
|
528,750
|
$
|
-
|
$
|
10,500
|
|||||||||||
VP
Clinical Development
|
2006
|
0
|
135,000
|
375,000
|
$
|
-
|
$
|
-
|
|||||||||||
2005
|
0
|
-
|
360,000
|
$
|
-
|
$
|
-
|
||||||||||||
|
|||||||||||||||||||
Fred
Cobb
|
2007
|
0
|
150,000
|
300,000
|
$
|
1,500
|
$
|
12,750
|
|||||||||||
Vice
President Finance
|
2006
|
0
|
-
|
300,000
|
$
|
-
|
$
|
6,000
|
|||||||||||
2005
|
0
|
-
|
-
|
-
|
-
|
||||||||||||||
|
|||||||||||||||||||
Dr.
Vafa Shahabi
|
2007
|
0
|
162,500
|
237,500
|
$
|
1,500
|
$
|
4,500
|
|||||||||||
Director
Research &
|
2006
|
0
|
56,250
|
343,750
|
$
|
-
|
$
|
6,000
|
|||||||||||
Development
|
2005
|
0
|
-
|
150,000
|
$
|
-
|
$
|
-
|
|||||||||||
Roni
Appel (4 )
|
2007
|
0
|
2,379,090
|
-
|
-
|
-
|
|||||||||||||
Secretary,
Chief Financial
|
2006
|
0
|
997,045
|
1,382,045
|
$
|
-
|
$
|
-
|
|||||||||||
Officer,
and Director
|
2005
|
0
|
254,075
|
951,835
|
$
|
-
|
$
|
-
|
|||||||||||
J.
Todd Derbin
|
2007
|
0
|
-
|
-
|
$
|
0
|
$
|
0
|
|||||||||||
President,
Chief Executive
|
2006
|
0
|
1,356,236
|
(5)
|
-
|
$
|
4,445
|
-
|
|||||||||||
Officer,
and Director
|
2005
|
0
|
1,273,135
|
83,101
|
$
|
47,033
|
$
|
4,017
|
(1)
|
Certain
of the options are immediately exercisable of the date of grant but
any
shares purchased are subject to repurchase by us at the original
exercise
price paid per share if the optionee ceases service with us before
vesting
in such shares
|
|
|
(2)
|
The
price at end of fiscal year ending October 31, 2007 and 2006 is based
on
the closing price of $0.20 per share for both dates. In 2005 the
price is
based on a price per share of $0.25, the highest-bid price on October
31,
2005 quoted on the OTC:BB.
|
(3)
|
As
of December 15, 2006 he was granted 2,400,000 options at a strike
price of
$0.143 vesting monthly over a 24 month period per his hiring
agreement.
|
(4)
|
As
of December 15, 2006 all Mr. Appel’s options become fully vested and are
exercisable until the end of the
contract.
|
(5)
|
As
of January 1, 2007 all these options were unexercised and
forfeited.
|
·
|
each
person who is known by us to be the owner of record or beneficial
owner of
more than 5% of our outstanding Common Stock and each person who
owns less
than 5% but is significant
nonetheless;
|
·
|
each
of our directors;
|
·
|
our
chief executive officer and each of our executive officers;
and
|
·
|
all
of our directors and executive officers as a
group.
|
Name
and Address of Beneficial Owner
|
Number
of Shares of Registrant
Common
Stock Beneficially
Owned
as of October 31, 2007
|
Percentage
of Class
Beneficially
Owned*
|
|||||
4,616,668
|
(3)
|
4.2
|
|||||
J.
Todd Derbin(1)
|
974,090
|
(4)
|
0.9
|
||||
Roni
Appel(1)(2)
|
6,355,378
|
(5)
|
5.8
|
||||
Richard
Berman(1)
|
379,000
|
(6)
|
0.4
|
||||
Dr.
James Patton(1)
|
3,145,666
|
(7)
|
2.9
|
||||
Dr.
Thomas McKearn(1)
|
503,796
|
(8)
|
0.5
|
||||
Martin
R. Wade III(1)
|
87,500
|
(9)
|
0.1
|
||||
Dr.
John Rothman(2)
|
633,708
|
(10)
|
0.6
|
||||
Fredrick
Cobb(2)
|
232,708
|
(11)
|
0.2
|
||||
Estate
of Scott Flamm(1)
|
3,114,867
|
(12)
|
2.9
|
||||
The
Trustees of the University of Pennsylvania Center for Technology
Transfer,
University of Pennsylvania
3160
Chestnut Street, Suite 200
Philadelphia,
PA 19104-6283
|
6,339,282
|
(13)
|
5.9
|
||||
Centrecourt
Asset Management
350
Madison Avenue
New
York, NY 10017
|
10,000,000
|
(14)
|
9.3
|
||||
Platinum
Long Term Growth VII.
152
West 57th Street, 54th Floor
New
York, NY 10019
|
6,666,667
|
(15)
|
6.2
|
||||
Casterigg
Master Investments, Ltd.
Sandell
Asset Management Corp.
40
W. 57 th
Street
26
th
Floor
New
York, NY 10019
|
6,633,333
|
(16)
|
9.99
|
||||
All
Directors and Officers as a Group (8 people)
|
15,954,424
|
(17)
|
14.7
|
(1)
|
Director,
except for Mr. Derbin who served as a Director until his resignation
on
September 6, 2006 and Mr. Flamm served as a Director until his death
in
January 2006
|
(2)
|
Officer,
Mr. Appel ceased to be an officer on December 15, 2006
|
(3)
|
Represents
2,666,667 shares, and 1,200,001 options exercisable within 60 days
of
October 31, 2007 and 750,000 shares authorized but not issued as of
this date owned by Mr. Moore but does not reflect 2,100,000 warrants
because such warrants are not exercisable within 60 days due to the
ownership in 4.99% restriction under the current circumstances,
exercisable within the 60 Day Period.
|
(4)
|
Reflects
469,982 shares, and 504,108 warrants to purchase shares. Mr. Derbin
resigned from the board effective September 6, 2006.
|
(5)
|
Represents
3,976,288 shares, and 2,379,090 options owned by Mr. Appel (Includes
91,567 transferred from Carmel.) but does not reflect 675,897 warrants
because such warrants are not exercisable within 60 days due to the
ownership in 4.99% restriction under the current circumstances,
exercisable within the 60 Day Period. (The 675,897 includes 576,071
warrants transferred from Carmel.) Per the Third Amended LVEP Consulting
agreement dated December 15, 2006 Mr. Appel was issued 1,000,000
shares
and all his previously granted options unvested became fully vested
and
exercisable for the remainder of their term.
|
(6)
|
Reflects
92,000 shares issued, 12,000 shares earned not issued and 275,000
options
exercisable within 60 days of October 31, 2007.
|
(7)
|
Reflects
2,820,576 shares, and 73,253 options exercisable within 60 days of
October
31, 2007 and 251,837 warrants.
|
(8)
|
Reflects
179,290 shares, 170,263 options exercisable within 60 days of October
31,
2007 and 154,243 warrants.
|
(9)
|
Reflects
options exercisable within 60 days of October 31, 2007.
|
(10)
|
Reflects
275,775 shares issued, 44,808 shares earned but not issued and 313,125
options exercisable within 60 days of October 31, 2007.
|
(11)
|
Reflects
90,336 shares issued, 29,872 shares earned but not issued and 112,500
options exercisable within 60 days of October 31, 2007.
|
(12)
|
Reflects
125,772 shares, 91,567 options and 214,489 warrants owned by the
estate
and 2,621,325 shares beneficially owned by Flamm Family Partners
LP, of
which the estate is a partner and reflects 61,714 warrants. It excludes
98,664 shares and 143,796 warrants owned by an immediate family
member.
|
(13)
|
Shares
only
|
(14)
|
Reflects
an aggregate of 10,000,000 shares owned by CAMOFI Master COC and
CAMHZN
Master LDC, but does not include 15,816,666 warrants. Centrecourt
Asset
Management, LLC is the investment manager of such purchaser. All
warrants
provide they may not be exercised if following the exercise, the
holder
will be deemed to be the beneficial owner of more than 9.99% of our
outstanding shares of common stock. Based on information set forth
in a
Schedule 13G filed with the SEC on October 17, 2007 by Richard
Smithline reporting sole power to vote or direct the vote over 25,839,769
shares and the sole power to dispose or to direct the disposition
of
25,839,769 shares (comprised of 8,023,103 shares of Common Stock
and
12,653,332 shares of Common Stock underlying Warrants held by CAMOFI,
of
which Mr. Smithline is a director and 2,000,000 shares of Common
Stock and
3,163,334 shares of Common Stock underlying Warrants held by CAMHZN
Master
LDC, of which Mr. Smithline is a director). Centrecourt: 25,839,769
shares
(comprised of 8,023,103 shares of Common Stock and 12,653,332 shares
of
Common Stock underlying Warrants held by CAMOFI, of which Centrecourt
is
the investment manager and 2,000,000 shares of Common Stock and 3,163,334
shares of Common Stock underlying Warrants held by CAMHZN Master
LDC, of
which Centrecourt is the investment manager). CAMOFI Master LDC has
the
sole power to vote of direct the vote over 20,676,435 shares (comprised
of
8,023,103 shares of Common Stock and 12,653,332 shares of Common
Stock
underlying Warrants). Percent of Class: Mr. Smithline, Centrecourt
and
CAMOFI are 9.99%, 9.99% and 9.99%, respectively. Pursuant to the
terms of
the Warrant Agreements, Advaxis, Inc. has agreed that the number
of shares
of Common Stock that may be acquired by the holder of any Warrants
upon
any conversion thereof (or otherwise in respect thereof) shall be
limited
to the extent necessary to insure that, following such conversion
(or
other issuance), the total number of shares of Common Stock then
beneficially owned by such a holder does not exceed 9.99% of the
total
number issued and outstanding shares of Common Stock. If not for
the 9.99%
restriction described above, the ownership percentages held by each
Mr.
Smithline, Centrecourt and CAMOFI would be 21.3%, 21.3% and 17.5%,
respectively.
|
(15)
|
Reflects
6,666,667 shares and but excludes 5,000,000 warrants. All warrants
provide
they may not be exercised if following the exercise, the holder will
be
deemed to be the beneficial owner of more than 4.99% of our outstanding
shares of common stock.
|
(16)
|
Reflects
6,633,333 shares but excludes 4,975,000 warrants. All warrants provide
they may not be exercised if following the exercise, the holder will
be
deemed to be the beneficial owner of more than 4.99% of our outstanding
shares of common stock. Based on information set forth in a Schedule
13G
filed with the SEC on October 12, 2007 by Casterigg Master Investments
Ltd. reporting sole power to vote or direct the vote over 6,666,667
shares
and the sole power to dispose or to direct the disposition of 6,666,667
shares or 6.18% of class. As of the date of this filing, each of
Castlerigg Master Investments Ltd., Sandell Asset Management Corp.,
Castlerigg International Limited, Castlerigg International holdings
Limited and Thomas E. Sandell may be deemed the beneficial owner
of the
6,666,667 shares of Common Stock held by Castlerigg Master Investments
Ltd. In addition to the 6,666,667 shares of Common Stock beneficially
owned by Castlerigg Master Investments Ltd., Casterigg Master Investments
Ltd. Holds warrants to purchase 5,000,000 shares of Common Stock
of the
Company. However, pursuant to the terms of the warrants, Castlerigg
Master
Investments cannon exercise any of these warrants until such time
as
Castlerigg Master Investments Ltd. Would not beneficially own, after
any
exercise, more than 4.99% of the outstanding Common Stock (the
“Blocker”).
|
(17)
|
Includes
an aggregate of 4,610,732 options, 406,079 warrants and 836,681earned
but
not issued shares.
|
EXHIBIT
NUMBER
|
DESCRIPTION
OF EXHIBIT
|
|
Exhibit
2.1
|
Agreement
Plan and Merger of Advaxis, Inc. (a Colorado corporation) and Advaxis,
Inc. (a Delaware corporation). Incorporated by reference to Annex
B to DEF
14A Proxy Statement filed with the SEC on May 15, 2006.
|
|
Exhibit
3.1(i)
|
Amended
and Restated Articles of Incorporation. Incorporated by reference
to Annex
C to DEF 14A Proxy Statement filed with the SEC on May 15, 2006.
|
|
Exhibit
3.1(ii)
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 10.4
to
Quarterly Report Form 10-QSB filed with the SEC on December 15,
2006.
|
|
Exhibit
4.1
|
Form
of common stock certificate. Incorporated by reference to Exhibit
4.1 to
Current Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
Exhibit
4.2
|
Form
of warrant to purchase shares of Registrant’s common stock at the price of
$0.20 per share (the “$0.20 Warrant”). Incorporated by reference to
Exhibit 4.2 to Current Report on Form 8-K filed with the SEC on
October
23, 2007.
|
|
Exhibit
4.3
|
Form
of warrant to purchase shares of Registrant’s common stock at the price of
$0.001 per share (the “$.001 Warrant”). Incorporated by reference to
Exhibit 4.3 to Current Report on Form 8-K filed with the SEC on
October
23, 2007.
|
|
Exhibit
4.4
|
Form
of warrant issued in the August 2007 financing. Incorporated by
reference
to Exhibit 10.1 to Current Report on Form 8-K field with the SEC
on August
27, 2007.
|
|
Exhibit
4.5
|
Form
of note issued in the August 2007 financing. Incorporated by reference
to
Exhibit 10.2 to Current Report on Form 8-K field with the SEC on
August
27, 2007.
|
|
Exhibit
4.6
|
Form
of warrant issued in the November 2004 Private Placement . Incorporated
by
reference to Exhibit 3.1 to Current Report on Form 8-K filed with
the SEC
on November 18, 2004.
|
|
Exhibit
10.1
|
Securities
Purchase Agreement between Registrant and the purchasers in the
private
placement (the “SPA”), dated as of October 17, 2007, and Disclosure
Schedules thereto. Incorporated by reference to Exhibit 10.1 to
Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
Exhibit
10.2
|
Securities
Purchase Agreement dated February 2, 2006 between Company and Cornell
Capital Partners, LP. Incorporated by reference to Exhibit 10.09
to Report
on Form 8K filed with the SEC on February 8, 2006.
|
|
Exhibit
10.3
|
Registration
Rights Agreement between Registrant and the parties to the SPA,
dated as
of October 17, 2007. Incorporated by reference to Exhibit 10.2
to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
Exhibit
10.4
|
Placement
Agency Agreement between Registrant and Carter Securities, LLC,
dated as
of October 17, 2007. Incorporated by reference to Exhibit 10.3
to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
Exhibit
10.5
|
Engagement
Letter between Registrant and Carter Securities, LLC, dated August
15,
2007. Incorporated by reference to Exhibit 10.3(a) to Current Report
on
Form 8-K filed with the SEC on October 23, 2007.
|
|
Exhibit
10.6
|
Agreement
between Registrant and YA Global Investments, L.P. f/k/a Cornell
Capital
Partners, L.P., dated August 23, 2007. Incorporated by reference
to
Exhibit 10.4 to Current Report on Form 8-K filed with the SEC on
October
23, 2007.
|
|
Exhibit
10.7
|
Memorandum
of Agreement between Registrant and CAMHZN Master LDC and CAMOFI
Master
LDC, purchasers of the Units consisting of Common Stock, $0.20
Warrants,
and $0.001 Warrants, dated October 17, 2007. Incorporated by reference
to
Exhibit 10.5 to Current Report on Form 8-K filed with the SEC on
October
23, 2007.
|
|
Exhibit
10.8
|
Advisory
Agreement between Registrant and Centrecourt Asset Management LLC,
dated
August 1, 2007. Incorporated by reference to Exhibit 10.6 to Current
Report on Form 8-K filed with the SEC on October 23,
2007.
|
|
Exhibit
10.9
|
Share
and Exchange Agreement, dated as of August 25, 2004, by and among
the
Company, Advaxis and the shareholders of Advaxis. Incorporated
by
reference to Exhibit 10.1 to Current Report on Form 8K filed with
the SEC
on November 18, 2004.
|
|
Exhibit
10.10
|
Security
Agreement dated February 2, 2006 between Company and Cornell Capital
Partners, L.P. Incorporated by reference to Exhibit 10.06 to Current
Report on Form 8-K filed with the SEC on February 8,
2006.
|
|
Exhibit
10.11
|
Investor
Registration Rights Agreement dated February 2, 2006 between Company
and
Cornell Capital Partners, LP. Incorporated by reference to Exhibit
10.05
to Current Report on Form 8-K filed with the SEC on February 8,
2006.
|
|
Exhibit
10.12
|
Form
of Securities Purchase Agreement related to the November 2004 Private
Placement, by and among the Company and the purchasers listed as
signatories thereto. Incorporated by reference to Exhibit 10.2
to Current
Report on Form 8-K filed with the SEC on November 18,
2004.
|
|
Exhibit
10.13
|
Form
of Registration Rights Agreement related to the November 2004 Private
Placement, by and among the Company and the persons listed as signatories
thereto. Incorporated by reference to Exhibit 10.3 to Current Report
on
Form 8-K filed with the SEC on November 18, 2004.
|
|
Exhibit
10.14
|
Amended
and Restated Employment Agreement, dated December 20, 2004, by
and between
the Company and J.Todd Derbin. Incorporated by reference to Exhibit
10.1
to Current Report on Form 8-K filed with the SEC on December 23,
2004.
|
|
Exhibit
10.15
|
2004
Stock Option Plan of the Company. Incorporated by reference to
Exhibit 4.1
to Report on Form S-8 filed with the SEC on December 1,
2005.
|
|
Exhibit
10.16
|
2005
Stock Option Plan of the Company. Incorporated by reference to
Annex A to
DEF 14A Proxy Statement filed with the SEC on May 15, 2006.
|
Exhibit
10.17
|
License
Agreement, between University of Pennsylvania and the Company dated
as of
June 17, 2002, as Amended and Restated on February 13, 2007. Incorporated
by reference to Exhibit 10.11 to Report on From 10-QSB filed with
the SEC
on February 13, 2007.
|
|
Exhibit
10.18
|
Sponsored
Research Agreement dated November 1, 2006 by and between University
of
Pennsylvania (Dr. Paterson Principal Investigator) and the Company.
Incorporated by reference to Exhibit 10.44 to Quarterly Report
on 10-QSB
filed with the SEC on February 13, 2007.
|
|
Exhibit
10.19
|
Non-Exclusive
License and Bailment, dated as of March 17, 2004, between The Regents
of
the University of California and Advaxis, Inc. Incorporated by
reference
to Exhibit 10.8 to Post-Effective Amendment filed on January 5,
2006 to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
Exhibit
10.20
|
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
LLC. and the Company. Incorporated by reference to Exhibit 10.9
to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.21(a)
|
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between LVEP
Management LLC and the Company. Incorporated by reference to Exhibit
10.27
to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.21(b)
|
Second
Amendment dated October, 31, 2005 to Consultancy Agreement between
LVEP
Management LLC and the Company. Incorporated by reference to Exhibit
10.2
to Current Report on Form 8-K filed with the SEC on November 9,
2005.
|
|
Exhibit
10.21(c)
|
Third
Amendment dated December 15, 2006 to Consultancy Agreement between
LVEP
Management LLC and the Company. Incorporated by reference to Exhibit
9.01
to Current Report on Form 8-K filed with the SEC on December 15,
2006.
|
|
Exhibit
10.22
|
Government
Funding Agreement, dated as of April 5, 2004, by and between David
Carpi
and Advaxis, Inc. Incorporated by reference to Exhibit 10.10 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.23
|
Amended
and Restated Consulting and Placement Agreement, dated as of May
28, 2003,
by and between David Carpi and Advaxis, Inc., as amended. Incorporated
by
reference to Exhibit 10.11 to Post-Effective Amendment filed on
January 5,
2006 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
Exhibit
10.23(i)
|
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc. Incorporated by reference to Exhibit
10.12 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.24
|
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy A.
Cavagnaro
and Advaxis, Inc. Incorporated by reference to Exhibit 10.13 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.25
|
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges,
Inc.
and Advaxis, Inc. Incorporated by reference to Exhibit 10.14 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.26
|
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel Consulting
Corporation and Advaxis, Inc. Incorporated by reference to Exhibit
10.15
to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.27
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and
Advaxis,
Inc. Incorporated by reference to Exhibit 10.16 to the amendment
filed on
June 9, 2005 to Registration Statement on Form SB-2 (File No.
333-122504).
|
|
Exhibit
10.28
|
Securities
Purchase Agreement, dated as of January 12, 2005, by and between
the
Company and Harvest Advaxis LLC. Incorporated by reference to Exhibit
10.1
to Current Report on Form 8-K filed with the SEC on January 18,
2005.
|
|
Exhibit
10.28(i)
|
Registration
Rights Agreement, dated as of January 12, 2005, by and between
the Company
and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.2
to
Current Report on Form 8-K filed with the SEC on January 18,
2005.
|
Exhibit
10.28(ii)
|
Letter
Agreement, dated as of January 12, 2005 by and between the Company
and
Robert T. Harvey. Incorporated by reference to Exhibit 10.3 to
Current
Report on Form 8-K filed with the SEC on January 18,
2005.
|
|
Exhibit
10.29
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Dr. David
Filer
and the Company. Incorporated by reference to Exhibit 10.20 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.30
|
Consultancy
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the Company. Incorporated by reference to
Exhibit
10.21 to Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.31
|
Agreement,
dated February 1, 2004, by and between Strategic Growth International
Inc.
and the Company. Incorporated by reference to Exhibit 10.22 to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.32
|
Letter
Agreement, dated February 10, 2005, by and between Richard Berman
and the
Company. Incorporated by reference to Exhibit 10.23 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on
Form SB-2
(File No. 333-122504).
|
|
Exhibit
10.33
|
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi
and the
Company. Incorporated by reference to Exhibit 10.24 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on
Form SB-2
(File No. 333-122504).
|
|
Exhibit
10.34
|
Employment
Agreement, dated March 1, 2005, by and between John Rothman and
the
Company. Incorporated by reference to Exhibit 10.25 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on
Form SB-2
(File No. 333-122504).
|
|
Exhibit
10.35
|
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the Company. Incorporated by reference to
Exhibit
10.26 to the amendment filed on June 9, 2005 to Registration Statement
on
Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.36
|
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Bio-Manufacturing PLC and the Company. Incorporated by reference
to
Exhibit 10.28 to Post-Effective Amendment filed on January 5, 2006
to
Registration Statement on Form SB-2 (File No.
333-122504).
|
|
Exhibit
10.37
|
Letter
Agreement between the Company and Investors Relations Group Inc.,
dated
September 27, 2005. Incorporated by reference to Exhibit 10.31
to
Post-Effective Amendment filed on January 5, 2006 to Registration
Statement on Form SB-2 (File No. 333-122504).
|
|
Exhibit
10.38
|
Consultancy
Agreement between the Company and Freemind Group LLC, dated October
17,
2005. Incorporated by reference to Exhibit 10.32 to Post-Effective
Amendment filed on January 5, 2006 to Registration Statement on
Form SB-2
(File No. 333-122504).
|
|
Exhibit
10.39
|
Employment
Agreement dated August 21, 2007 between the Company and Thomas
A. Moore.
Incorporated by reference to Exhibit 10.3 to Current Report on
Form 8-K
filed with the SEC on August 27,
2007.
|
Exhibit
10.40
|
Employment
Agreement dated February 9, 2006 between the Company and Frederick
D.
Cobb. Filed on March 9, 2006 with the initial filing of the Registration
Statement on Form SB-2 (File No. 333-132298)
|
|
Exhibit
10.41
|
Resignation
Agreement between J. Todd Derbin and the Company dated October
31, 2005.
Incorporated by reference to Exhibit 10.1 report to Form 8-K filed
with
the SEC on November 9, 2005.
|
|
Exhibit
10.42
|
Consulting
Agreement dated June 1, 2006 between the Company and Biologics Consulting
Group Inc. Incorporated by reference to Exhibit 10.40 to Quarterly
Report
on Form 10-QSB field with the SEC on February 13, 2007.
|
|
Exhibit
10.42(i)**
|
Consulting
Agreement dated June 1, 2006 between the Company and Biologics
Consulting
Group Inc. Amended on June 1, 2007.
|
|
Exhibit
10.43
|
Third
Lease Amendment Agreement dated October 1, 2006 by and between
the New
Jersey Economic Development Authority and the Company. Incorporated
by
reference to Exhibit 10.43 to Quarterly Report on Form 10-QSB filed
with
the SEC on February 13, 2007.
|
|
Exhibit
10.43(i)**
|
Fourth
Lease Amendment Agreement dated October 1, 2006 by and between
the New
Jersey Economic Development Authority and the Company on October
1,
2007.
|
|
Exhibit
10.44**
|
Master
Contract Service Agreement between the Company and MediVector,
Inc. dated
May 20, 2007.
|
Exhibit
10.45**
|
Letter
Agreement, dated November 28, 2007, between Crystal Research Associates,
LLC and the Company.
|
|
Exhibit
10.46**
|
Service
Schedule, dated September 21, 2007, to the Strategic Collaboration
and
Long Term Vaccine Supply Agreement, dated October 31, 2005, between
the
Company and Cobra Biomanufacturing Plc.
|
|
Exhibit
10.47**
|
Service
Schedule, dated May 22, 2007, to the Strategic Collaboration and
Long Term
Vaccine Supply Agreement, dated October 31, 2005, between the Company
and
Cobra Biomanufacturing Plc.
|
|
Exhibit
10.48**
|
Consulting
Agreement, dated May 1, 2007 between the Company and Bridge Ventures,
Inc.
|
|
Exhibit
10.49**
|
Consulting
Agreement, dated August 1, 2007 between the Company and Dr.
Filer.
|
|
Exhibit
14.1
|
Code
of Ethics. Incorporated by reference to Exhibit 14.1 to Current
Report on
Form 8-K filed with the SEC on November 18, 2004.
|
|
Exhibit
23.1**
|
Consent
of McGladrey & Pullen, LLP.
|
|
Exhibit
24.1
|
Power
of Attorney (Included on the signature page)
|
|
Exhibit
31.1**
|
Rule 13a-14(a)/15d-14(a)
Certification by the Chief Executive Officer (filed
herewith).
|
|
Exhibit
31.2**
|
Rule 13a-14(a)/15d-14(a)
Certification by the Principal Financial Officer (filed
herewith).
|
|
Exhibit
32.1**
|
Certification
by the Chief Executive Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (filed herewith).
|
|
Exhibit
32.2**
|
Certification
by the Principal Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (filed
herewith).
|
|
Fiscal
Year 2007
|
Fiscal
year 2006
|
|||||
Audit
Fees-McGladrey and Pullen LLP
|
$
|
35,000
|
$
|
0
|
|||
Audit
Fees-Goldstein Golub Kessler LLP
|
$
|
22,653
|
$
|
35,000
|
|||
Audit-Related
Fees- Goldstein Golub Kessler LLP
|
7,300
|
20,855
|
|||||
Total
|
$
|
64,953
|
$
|
55,855
|
|
|
|
|
ADVAXIS,
INC.
|
|
|
|
|
|
By:
|
/s/
Thomas Moore
|
|
Thomas
Moore, Chief Executive Officer and Chairman of the
Board
|
|
|
|
SIGNATURE
|
|
TITLE
|
|
DATE
|
|
/s/
Thomas Moore
|
|
Chief
Executive Officer and Chairman of the Board
|
|
January
16, 2008
|
|
Thomas
Moore
|
(Principal
Executive Officer)
|
||||
/s/ Fredrick
Cobb
|
Vice
President, Finance
|
January
16, 2008
|
|||
Fredrick
Cobb
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
/s/ Roni
Appel
|
|
Director
|
|
January
16, 2008
|
|
Roni
Appel
|
|||||
/s/
Thomas McKearn
|
|
Director
|
|
January
16, 2008
|
|
Thomas
McKearn
|
|||||
/s/
James Patton
|
Director
|
January
16, 2008
|
|||
James
Patton
|
|
|
|
|
|
/s/
Richard Berman
|
Director
|
January
16, 2008
|
|||
Richard
Berman
|
|
|
|
|
|
/s/
Martin Wade III
|
Director
|
January
16, 2008
|
|||
Martin
Wade
|
|
|
|
|