Blueprint
UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
FORM
10-Q/A
(Amendment No.1)
(Mark
One)
☑
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For the
quarterly period ended March 31, 2017
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For the
transition period from _______________ to
______________.
Commission
File Number 001-11889
CEL-SCI CORPORATION
Colorado
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84-0916344
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State
or other jurisdiction incorporation
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(IRS)
Employer Identification
Number
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8229
Boone Boulevard, Suite 802
Vienna, Virginia 22182
Address
of principal executive offices
(703) 506-9460
Registrant's
telephone number, including area code
Indicate
by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the Registrant was required to file such
reports) and (2) had been subject to such filing requirements for
the past 90 days. Yes ☑ No ☐
Indicate
by check mark whether the registrant has submitted electronically
and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☑ No
☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer”, “smaller reporting company” and "emerging
growth company" in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer
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☐
|
Accelerated filer
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☒
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Non-accelerated
filer
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☐
(Do not check if a smaller reporting company)
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Smaller reporting company
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☐
|
|
|
Emerging
growth company
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☐
|
If an
emerging growth company, indicate by checkmark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
☐
Indicate
by check mark whether the Registrant is a shell company (as defined
in Exchange Act Rule 12b-2 of the Exchange Act). Yes ☐ No
☑
Class of
Stock
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No Shares
Outstanding
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Date
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Common
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9,193,093
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May 8, 2017
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EXPLANATORY NOTE
In October 2008, the Company entered into an
agreement whereby the Company leased a building owned by a third
party. The Company accounted for the arrangement as an operating
lease under ASC 840, Accounting for
Leases.
In
November 2017, the Company determined that the lease should have
been treated as a financing obligation rather than an operating
lease.
Accordingly, this amended 10-Q is filed to correct
the manner in which the Company accounted for the lease. See
Note I.
Restatement to the accompanying financial statements,
for further
information.
In
addition, per share data, including earnings per share amounts, in
this amended 10-Q have been adjusted to reflect a 1 for 25 reverse
stock split which became effective on the NYSE American on June 15,
2017.
As
a result of the error described above, management has concluded
that the Company’s internal control over financial reporting
and its disclosure controls and procedures were not effective as of
the end of this reporting period. The effects of the material
weaknesses are discussed in more detail in Item 4, Controls and
Procedures.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item
1.
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Page
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Condensed Balance Sheets at March 31, 2017 and September 30, 2016
(unaudited)
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3
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Condensed Statements of Operations for the six months Ended March
31, 2017 and 2016 (unaudited)
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4
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Condensed Statements of Operations for the three months Ended March
31, 2017 and 2016 (unaudited)
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5
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Condensed Statements of Cash Flows for the six months Ended March
31, 2017 and 2016 (unaudited)
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6
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Notes to Condensed Financial Statements (unaudited)
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8
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Item 2.
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Management's Discussion and Analysis of Financial Condition and
Results of Operations
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26
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Item 3.
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Quantitative and Qualitative Disclosures about Market
Risks
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33
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Item 4.
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Controls and Procedures
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33
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PART II
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Item 2.
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Unregistered Sales of Equity Securities and Use of
Proceeds
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34
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Item 6.
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Exhibits
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34
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Signatures
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35
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CEL-SCI
CORPORATION
BALANCE
SHEETS
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RESTATED
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RESTATED
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MARCH 31,
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SEPTEMBER 30,
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ASSETS
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2017
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2016
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(UNAUDITED)
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CURRENT
ASSETS:
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Cash
and cash equivalents
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$1,529,802
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$2,917,996
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Receivables
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4,252
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394,515
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Prepaid
expenses
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720,466
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981,677
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Deposits
- current portion
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150,000
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154,995
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Inventory
used for R&D and manufacturing
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678,664
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1,008,642
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Total
current assets
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3,083,184
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5,457,825
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PROPERTY AND EQUIPMENT, net
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17,087,085
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17,350,836
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PATENT
COST, net
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239,214
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256,547
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DEPOSITS
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1,670,917
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1,820,917
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TOTAL
ASSETS
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$ 22,080,400
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$ 24,886,125
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LIABILITIES
AND STOCKHOLDERS' DEFICIT
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CURRENT
LIABILITIES:
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Accounts
payable
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$7,074,898
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$3,091,512
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Accrued
expenses
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509,841
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378,672
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Due
to employees
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607,289
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538,278
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Derivative
instruments, current portion
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208,493
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-
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Other
current liabilities
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7,792
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3,310
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Total
current liabilities
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8,408,313
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4,011,772
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Derivative
instruments, net of current portion
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3,228,252
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8,394,934
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Lease
liability
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13,110,357
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13,011,023
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Deferred
revenue
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125,000
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125,000
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Other
liabilities
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40,478
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22,609
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Total
liabilities
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24,912,400
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25,565,338
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COMMITMENTS
AND CONTINGENCIES
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STOCKHOLDERS'
DEFICIT
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Preferred
stock, $.01 par value-200,000 shares authorized;
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-0-
shares issued and outstanding
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-
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-
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Common
stock, $.01 par value - 600,000,000 shares authorized;
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8,655,685and
6,235,035 shares issued and outstanding
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at
March 31, 2017 and September 30, 2016, respectively
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86,557
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62,350
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Additional
paid-in capital
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287,377,903
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284,649,559
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Accumulated
deficit
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(290,296,460)
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(285,391,122)
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Total
stockholders' deficit
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(2,832,000)
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(679,213)
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TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
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$ 22,080,400
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$ 24,886,125
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See notes to financial
statements.
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SIX MONTHS ENDED MARCH 31, 2017 and 2016
(UNAUDITED)
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RESTATED
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RESTATED
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2017
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2016
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GRANT
INCOME AND OTHER
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$34,433
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$53,751
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OPERATING
EXPENSES:
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Research
and development
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10,126,875
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8,844,891
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General
& administrative
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2,752,123
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2,312,397
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Total
operating expenses
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12,878,998
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11,157,288
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OPERATING
LOSS
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(12,844,565)
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(11,103,537)
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GAIN
ON DERIVATIVE INSTRUMENTS
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8,879,612
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5,529,230
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INTEREST
EXPENSE, NET
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(940,385)
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(948,489)
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NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
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$ (4,905,338)
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$ (6,522,796)
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NET
LOSS PER COMMON SHARE
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BASIC
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$ (0.74)
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$ (1.43)
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DILUTED
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$ (0.78)
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$ (1.43)
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WEIGHTED
AVERAGE COMMON SHARES
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OUTSTANDING
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BASIC
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6,649,814
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4,562,831
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DILUTED
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6,682,592
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4,562,831
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See notes to financial statements.
THREE MONTHS ENDED MARCH 31, 2017 and 2016
(UNAUDITED)
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RESTATED
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RESTATED
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2017
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2016
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OTHER
INCOME
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$17,175
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$32,775
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OPERATING
EXPENSES:
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Research
and development
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6,578,618
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4,151,983
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General
& administrative
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1,345,114
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1,677,796
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Total
operating expenses
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7,923,732
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5,829,779
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OPERATING
LOSS
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(7,906,557)
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(5,797,004)
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LOSS
ON DERIVATIVE INSTRUMENTS
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(48,700)
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(2,593,730)
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INTEREST
EXPENSE, NET
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(471,234)
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(464,796)
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NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
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$ (8,426,491)
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$ (8,855,530)
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NET
LOSS PER COMMON SHARE
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BASIC
AND DILUTED
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$ (1.15)
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$ (1.87)
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WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
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BASIC
AND DILUTED
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7,319,761
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4,736,809
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See notes to financial statements.
SIX MONTHS ENDED MARCH 31, 2017 and 2016
(UNAUDITED)
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RESTATED
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RESTATED
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2017
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2016
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
loss
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$ (4,905,338)
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$ (6,522,796)
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Adjustments
to reconcile net loss to
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net
cash used in operating activities:
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Depreciation
and amortization
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318,357
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337,656
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Share-based
payments for services
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112,778
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472,061
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Equity
based compensation
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677,755
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845,100
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Common
stock contributed to 401(k) plan
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76,426
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82,146
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Loss
on retired equipment
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1,187
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115
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Gain
on derivative instruments
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(8,879,612)
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(5,529,230)
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Capitalized lease interest
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99,334
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112,217
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(Increase)/decrease
in assets:
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Receivables
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84,922
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62,080
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Prepaid
expenses
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219,543
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211,360
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Inventory
used for R&D and manufacturing
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329,978
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106,531
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Deposits
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154,995
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150,000
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Increase/(decrease)
in liabilities:
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Accounts
payable
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4,214,678
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(1,659,395)
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Accrued
expenses
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131,169
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559,944
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Deferred
revenue
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-
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(138)
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Due
to employees
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140,511
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(34,582)
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Deferred
rent liability
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(1,748)
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4,176
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Net
cash used in operating activities
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(7,225,065)
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(10,802,755)
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CASH
FLOWS FROM INVESTING ACTIVITIES:
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Purchases
of equipment
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(10,525)
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(21,644)
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Net
cash used in investing activities
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(10,525)
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(21,644)
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CASH
FLOWS FROM FINANCING ACTIVITIES:
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Proceeds
from issuance of common stock and warrants
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5,849,444
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12,258,287
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Payments
on related party loan
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-
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(1,104,057)
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Payments
on obligations under capital lease
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(2,048)
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(4,423)
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Net
cash provided by financing activities
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5,847,396
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11,149,807
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NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
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(1,388,194)
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325,408
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CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
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2,917,996
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5,726,682
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CASH
AND CASH EQUIVALENTS, END OF PERIOD
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$1,529,802
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$6,052,090
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See
notes to financial statements.
SIX MONTHS ENDED MARCH 31, 2017 and 2016
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
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RESTATED
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RESTATED
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2017
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2016
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Decrease
in receivable due under the litigation funding arrangement
offset
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by
the same amount payable to the legal firm providing the
services
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$305,341
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$298,693
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Capitalizable
patent costs included in accounts payable
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8,644
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6,813
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Capital
lease obligation included in accounts payable
|
1,500
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750
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Property
and equip acquired through capital lease
|
26,104
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-
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Fair
value of warrants issued in connection with public
offering
|
3,921,423
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5,060,771
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Financing
costs included in accounts payable
|
118,866
|
1,910
|
Prepaid
consulting services paid with issuance of common stock
|
(41,668)
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54,693
|
|
|
|
|
|
|
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Cash
paid for interest expense
|
$ 940,471
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$968,002
|
See notes to condensed financial statements.
CEL-SCI CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
SIX MONTHS ENDED MARCH 31, 2017 AND 2016 (UNAUDITED)
A.
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Basis of Presentation
The
accompanying condensed financial statements of CEL-SCI Corporation
(the Company) are unaudited and certain information and footnote
disclosures normally included in the annual financial statements
prepared in accordance with accounting principles generally
accepted in the United States of America have been omitted pursuant
to the rules and regulations of the Securities and Exchange
Commission. While management of the Company believes that the
disclosures presented are adequate to make the information
presented not misleading, these interim condensed financial
statements should be read in conjunction with the financial
statements and notes included in the Company’s annual report
on Form 10-K for the year ended September 30, 2016.
In the
opinion of management, the accompanying unaudited condensed
financial statements contain all accruals and adjustments (each of
which is of a normal recurring nature) necessary for a fair
presentation of the Company’s financial position as of March
31, 2017 and the results of its operations for the six months then
ended. The condensed balance sheet as of September 30, 2016 is
derived from the September 30, 2016 audited financial statements.
Significant accounting policies have been consistently applied in
the interim financial statements and the annual financial
statements. The results of operations for the three and six months
ended March 31, 2017 and 2016 are not necessarily indicative of the
results to be expected for the entire year.
The
financial statements have been prepared assuming that the Company
will continue as a going concern, but due to recurring losses from
operations and future liquidity needs, there is substantial doubt
about the Company’s ability to continue as a going concern.
The financial statements do not include any adjustments that might
result from the outcome of this uncertainty. Refer to discussion in
Note B.
Summary of Significant Accounting Policies:
Research and Office Equipment and Leasehold
Improvements - Research and office equipment is recorded at
cost and depreciated using the straight-line method over estimated
useful lives of five to seven years. Leasehold improvements are
depreciated over the shorter of the estimated useful life of the
asset or the term of the lease. Repairs and maintenance which do
not extend the life of the asset are expensed when incurred. The
fixed assets are reviewed on a quarterly basis to determine if any
of the assets are impaired.
Patents - Patent expenditures are
capitalized and amortized using the straight-line method over the
shorter of the expected useful life or the legal life of the patent
(17 years). In the event changes in technology or other
circumstances impair the value or life of the patent, appropriate
adjustment in the asset value and period of amortization is made.
An impairment loss is recognized when estimated future undiscounted
cash flows expected to result from the use of the asset, and from
its disposition, is less than the carrying value of the asset. The
amount of the impairment loss would be the difference between the
estimated fair value of the asset and its carrying
value.
Research and Development Costs -
Research and development costs are expensed as
incurred.
Income Taxes - The Company uses the
asset and liability method of accounting for income taxes. Under
the asset and liability method, deferred tax assets and liabilities
are recognized for future tax consequences attributable to
differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases and
operating and tax loss carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply
to taxable income in the years in which those temporary differences
are expected to be recovered or settled. The effect on deferred tax
assets and liabilities of a change in tax rates is recognized in
income in the period that includes the enactment date. The Company
records a valuation allowance to reduce the deferred tax assets to
the amount that is more likely than not to be recognized.
A full valuation
allowance was recorded against the deferred tax assets as of March
31, 2017 and September 30, 2016.
Derivative Instruments
– The Company has entered into
financing arrangements that consist of freestanding derivative
instruments that contain embedded derivative features. The Company
accounts for these arrangements in accordance with
Accounting Standards Codification (ASC) 815, “Accounting for Derivative
Instruments and Hedging Activities.” In accordance
with accounting principles generally accepted in the United States
(U.S. GAAP), derivative instruments and hybrid instruments are
recognized as either assets or liabilities in the balance sheet and
are measured at fair value with gains or losses recognized in
earnings or other comprehensive income depending on the nature of
the derivative or hybrid instruments. The Company determines the
fair value of derivative instruments and hybrid instruments based
on available market data using appropriate valuation models, giving
consideration to all of the rights and obligations of each
instrument. The derivative liabilities are remeasured at fair value
at the end of each interim period as long as they are
outstanding.
Deferred Rent– Certain of the
Company’s operating leases provide for minimum annual
payments that adjust over the life of the lease. The
aggregate minimum annual payments are expensed on a straight-line
basis over the minimum lease term. The Company recognizes a
deferred rent liability for rent escalations when the amount of
straight-line rent exceeds the lease payments, and reduces the
deferred rent liability when the lease payments exceed the
straight-line rent expense. For tenant improvement allowances
and rent holidays, the Company records a deferred rent liability
and amortizes the deferred rent over the lease term as a reduction
to rent expense.
Leases – Leases are categorized
as either operating or capital leases at inception. Operating lease
costs are recognized on a straight-line basis over the term of the
lease. An asset and a corresponding liability for the capital lease
obligation are established for the cost of capital leases. The
capital lease obligation is amortized over the life of the lease.
For build-to-suit leases, the Company establishes an asset and
liability for the estimated construction costs incurred to the
extent that it is involved in the construction of structural
improvements or takes construction risk prior to the commencement
of the lease. Uponoccupancy of facilities under build-to-suit
leases, the Company assesses whether these arrangements qualify for
sales recognition under the sale-leaseback accounting guidance. If
a lease does not meet the criteria to qualify for a sale-leaseback
transaction, the established asset and liability remain on the
Company's balance sheet.
Stock-Based Compensation –
Compensation cost for all stock-based awards is measured at fair
value as of the grant date in accordance with the provisions of ASC
718 “Compensation – Stock Compensation.” The fair
value of stock options is calculated using the Black-Scholes option
pricing model. The Black-Scholes model requires various judgmental
assumptions including volatility and expected option life. The
stock-based compensation cost is recognized on the straight line
allocation method as expense over the requisite service or vesting
period.
Equity
instruments issued to non-employees are accounted for in accordance
with ASC 505-50, “Equity-Based Payments to Non
Employees.” Accordingly, compensation is recognized when
goods or services are received and is measured using the
Black-Scholes valuation model. The Black-Scholes model requires
various judgmental assumptions regarding the fair value of the
equity instruments at the measurement date and the expected life of
the options.
The
Company has Incentive Stock Option Plans, Non-Qualified Stock
Option Plans, a Stock Compensation Plan, Stock Bonus Plans and an
Incentive Stock Bonus Plan. In some cases, these Plans are
collectively referred to as the "Plans". All Plans have been
approved by the stockholders.
The
Company’s stock options are not transferable, and the actual
value of the stock options that an employee may realize, if any,
will depend on the excess of the market price on the date of
exercise over the exercise price. The Company has based its
assumption for stock price volatility on the variance of daily
closing prices of the Company’s stock. The risk-free interest
rate assumption was based on the U.S. Treasury rate at date of the
grant with term equal to the expected life of the option.
Historical data was used to estimate option exercise and employee
termination within the valuation model. The expected term of
options represents the period of time that options granted are
expected to be outstanding and has been determined based on an
analysis of historical exercise behavior. If any of the assumptions
used in the Black-Scholes model change significantly, stock-based
compensation expense for new awards may differ materially in the
future from that recorded in the current period.
Vesting
of restricted stock granted under the Incentive Stock Bonus Plan is
subject to service, performance and market conditions and meets the
classification of equity awards. These awards were measured at
market value on the grant-dates for issuances where the attainment
of performance criteria is likely and at fair value on the
grant-dates, using a Monte Carlo simulation for issuances where the
attainment of performance criteria is uncertain. The total
compensation cost will be expensed over the estimated requisite
service period.
New Accounting Pronouncements
In
February 2016, the Financial Accounting Standards Board (FASB)
issued ASU 2016-02, Leases, which will require most leases (with
the exception of leases with terms of less than one year) to be
recognized on the balance sheet as an asset and a lease liability.
Leases will be classified as an operating lease or a financing
lease. Operating leases are expensed using the straight-line method
whereas financing leases will be treated similarly to a capital
lease under the current standard. The new standard will be
effective for annual and interim periods, within those fiscal
years, beginning after December 15, 2018, but early adoption is
permitted. The new standard must be presented using the modified
retrospective method beginning with the earliest comparative period
presented. The Company is currently evaluating the effect of the
new standard on its financial statements and related
disclosures.
No
other recently issued guidance is expected to have a material
impact on the Company’s financial statements.
B.
OPERATIONS AND FINANCING
The
Company has incurred significant costs since its inception in
connection with the acquisition of certain patented and unpatented
proprietary technology and know-how relating to the human
immunological defense system, patent applications, research and
development, administrative costs, construction of laboratory
facilities, and clinical trials. The Company has funded such
costs with proceeds from loans and the public and private sale of
its common stock. The Company will be required to raise
additional capital or find additional long-term financing in order
to continue with its research efforts. Currently, the partial
clinical hold has had a significant impact on the Company’s
market capital, and as such, may impact the Company’s ability
to attract new capital. To date, the Company has not generated any
revenue from product sales. The ability of the Company to
complete the necessary clinical trials and obtain US Food &
Drug Administration (FDA) approval for the sale of products to be
developed on a commercial basis is uncertain. Ultimately, the
Company must complete the development of its products, obtain the
appropriate regulatory approvals and obtain sufficient revenues to
support its cost structure.
The
Company is currently running a large multi-national Phase 3
clinical trial for head and neck cancer with its partners TEVA
Pharmaceuticals and Orient Europharma. During the six months ended
March 31, 2017, the Company raised approximately $5.8 million net
proceeds from multiple financings. To finance the study beyond the
next twelve months, the Company plans to raise additional capital
in the form of corporate partnerships, debt and/or equity
financings. The Company believes that it will be able to obtain
additional financing because it has done so consistently in the
past and because Multikine is a product in the Phase 3 clinical
trial stage. However, there can be no assurance that the Company
will be successful in raising additional funds on a timely basis or
that the funds will be available to the Company on acceptable terms
or at all. If the Company does not raise the necessary
amounts of money, it will either have to slow or delay the Phase 3
clinical trial or even significantly curtail its operations until
such time as it is able to raise the required funding. The Phase 3
study is currently on partial clinical hold by the FDA. The
financial statements have been prepared assuming that the Company
will continue as a going concern, but due to recurring losses from
operations and future liquidity needs, there is substantial doubt
about the Company’s ability to continue as a going concern.
The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Since
the Company launched its Phase 3 clinical trial for Multikine, the
Company has spent approximately $36.6 million as of March 31, 2017
on direct costs for the Phase 3 clinical trial. The total
remaining cash cost of the clinical trial is estimated to be
approximately $12.9 million. It should be noted that this
estimate is based only on the information currently available in
the Company’s contracts with the Clinical Research
Organizations responsible for managing the Phase 3 clinical trial
and does not include other related costs, e.g. the manufacturing of
the drug. This number can be affected by the speed of
enrollment, foreign currency exchange rates and many other factors,
some of which cannot be foreseen. In the summer of 2016, the
Company filed an amendment to the original Phase 3 protocol for it
head and neck cancer study with the FDA to allow for this expansion
in patient enrollment.
In
April 2017 CEL-SCI announced that in light of new information the
Company decided to withdraw the study protocol amendment for
additional patients that was submitted to the FDA in the summer of
2016. It is now possible that we may not need to add more patients
to the study or that only a smaller number of patients need to be
added to the study to complete it in a reasonable period of time.
Should additional patients be needed, we will submit a future study
amendment to the FDA to seek their clearance to
proceed.
We are
diligently continuing to work with the FDA to have the partial
clinical hold lifted. We have been in a continuing dialogue with
them to try to resolve their questions and to supply them with
supplemental information. On February 8, 2017 we had a Type A
meeting with the FDA. The Action Items for CEL-SCI to pursue per
the minutes from the FDA meeting were the following:
1)
Provide
an updated Investigator's Brochure and current procedures for
compliance with requirements under 21 CFR 312 Subpart D to address
the partial clinical hold.
2)
Provide
a list of major protocol deviations, which CEL-SCI believes will
affect study results, and provide a plan to identify major protocol
deviations across all patients enrolled in the Phase 3
protocol.
We have
supplied our response to those Action Items to the FDA. In
accordance with the partial clinical hold, we are continuing to
follow the 928 patients enrolled in the study, and this includes
following patients until the targeted 298 deaths between the 2
comparison groups is observed. This number of deaths is required to
evaluate if the study’s primary endpoint is
achieved.
If the
partial clinical hold is not lifted, the Phase 3 study will not be
able to be completed to its prespecified endpoints in a timely
manner, if at all, and, if the Phase 3 study cannot be completed to
its prespecified endpoints, the study would not be able to be used
as the pivotal study supporting a marketing application in the
United States, and at least one entirely new Phase 3 pivotal study
would need to be conducted to provide the pivotal study supporting
a marketing application in the United States. Even if the partial
clinical hold is lifted, if it is not lifted in a timely fashion,
the nature and duration of the partial clinical hold could
irreparably harm the data from the Phase 3 study such that it may
no longer be able to be used as the pivotal study supporting a
marketing application in the United States. Even if the partial
clinical hold is lifted in a timely fashion, it remains possible
that the regulatory authorities could determine that the Phase 3
study is not sufficient to be used as a single pivotal study
supporting a marketing application in the United
States.
Stock
options, stock bonuses and compensation granted by the Company as
of March 31, 2017 are as follows:
Name of
Plan
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding
Options
|
Shares Issued
|
Remaining Options/Shares Under
Plans
|
|
|
|
|
|
Incentive Stock
Options Plans
|
138,400
|
65,959
|
N/A
|
60,453
|
Non-Qualified Stock
Option Plans
|
387,200
|
261,270
|
N/A
|
96,825
|
Stock Bonus
Plans
|
223,760
|
N/A
|
177,939
|
45,788
|
Stock Compensation
Plan
|
134,000
|
N/A
|
87,590
|
45,088
|
Incentive Stock
Bonus Plan
|
640,000
|
N/A
|
624,000
|
16,000
|
Stock
options, stock bonuses and compensation granted by the Company as
of September 30, 2016 are as follows:
Name of
Plan
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding
Options
|
Shares Issued
|
Remaining Options/Shares Under
Plans
|
|
|
|
|
|
Incentive Stock
Option Plans
|
138,400
|
65,959
|
N/A
|
60,453
|
Non-Qualified Stock
Option Plans
|
387,200
|
277,613
|
N/A
|
82,370
|
Bonus
Plans
|
223,760
|
N/A
|
126,448
|
97,278
|
Stock Compensation
Plan
|
134,000
|
N/A
|
79,401
|
53,276
|
Incentive Stock
Bonus Plan
|
640,000
|
N/A
|
624,000
|
16,000
|
Stock option
activity:
|
Six Months Ended March 31,
|
|
2017
|
2016
|
Granted
|
-
|
8,400
|
Expired
|
15,281
|
-
|
Forfeited
|
1,061
|
2,040
|
|
Three Months Ended March 31,
|
|
2017
|
2016
|
Granted
|
-
|
2,400
|
Expired
|
200
|
-
|
Forfeited
|
1,061
|
1,121
|
No
shares of restricted stock were forfeited from the Incentive Stock
Bonus Plan during the six and three months ended March 31, 2017 and
2016.
Stock-Based Compensation Expense
|
Six Months Ended March 31,
|
|
2017
|
2016
|
Employees
|
$677,755
|
$845,100
|
Non-employees
|
$112,778
|
$472,061
|
|
Three Months Ended March 31,
|
|
2017
|
2016
|
Employees
|
$365,380
|
$417,190
|
Non-employees
|
$34,225
|
$142,866
|
Employee
compensation expense includes the expense related to options issued
or vested and restricted stock. Non-employee expense includes the
expense related to options and stock issued to consultants expensed
over the period of their service contracts.
Warrants and Non-employee Options
The
following chart presents the outstanding warrants and non-employee
options, listed by expiration date at March 31, 2017:
Warrant
|
|
Issue
Date
|
Shares Issuable upon Exercise of
Warrant
|
Exercise Price
|
Expiration
Date
|
Refer-ence
|
|
|
|
|
|
|
|
Series
DD
|
|
12/8/16
|
1,360,960
|
$ 4.50
|
6/8/17
|
1
|
Series
N
|
|
8/18/08
|
113,785
|
$ 13.18
|
8/18/17
|
|
Series
EE
|
|
12/8/16
|
1,360,960
|
$ 4.50
|
9/8/17
|
1
|
Series
U
|
|
4/17/14
|
17,821
|
$ 43.75
|
10/17/17
|
1
|
Series
S
|
|
10/11/13-
10/24/14
|
1,037,120
|
$ 31.25
|
10/11/18
|
1
|
Series
V
|
|
5/28/15
|
810,127
|
$ 19.75
|
5/28/20
|
1
|
Series
W
|
|
10/28/15
|
688,930
|
$ 16.75
|
10/28/20
|
1
|
Series
X
|
|
1/13/16
|
120,000
|
$ 9.25
|
1/13/21
|
|
Series
Y
|
|
2/15/16
|
26,000
|
$ 12.00
|
2/15/21
|
|
Series
ZZ
|
|
5/23/16
|
20,000
|
$ 13.75
|
5/18/21
|
1
|
Series
BB
|
|
8/26/16
|
16,000
|
$ 13.75
|
8/22/21
|
1
|
Series
Z
|
|
5/23/16
|
264,000
|
$ 13.75
|
11/23/21
|
1
|
Series
FF
|
|
12/8/16
|
68,048
|
$ 3.91
|
12/1/21
|
1
|
Series
CC
|
|
12/8/16
|
680,480
|
$ 5.00
|
12/8/21
|
1
|
Series
HH
|
|
2/23/17
|
20,000
|
$ 3.13
|
2/16/22
|
1
|
Series
AA
|
|
8/26/16
|
200,000
|
$ 13.75
|
2/22/22
|
1
|
Series
JJ
|
|
3/14/17
|
30,000
|
$ 3.13
|
3/8/22
|
1
|
Series
GG
|
|
2/23/17
|
400,000
|
$ 3.00
|
8/23/22
|
1
|
Series
II
|
|
3/14/17
|
600,000
|
$ 3.00
|
9/14/22
|
1
|
Consultants
|
|
12/28/12-
7/1/16
|
22,800
|
$ 9.25- $70.00
|
4/24/17-
6/30/19
|
2
|
1.
Derivative Liabilities
The
table below presents the warrant liabilities and their respective
balances at the balance sheet dates:
|
March 31,
2017
|
September 30,
2016
|
Series S
warrants
|
$531,525
|
$3,111,361
|
Series U
warrants
|
-
|
-
|
Series V
warrants
|
202,532
|
1,620,253
|
Series W
warrants
|
190,443
|
1,799,858
|
Series Z
warrants
|
142,341
|
970,604
|
Series ZZ
warrants
|
9,414
|
70,609
|
Series AA
warrants
|
116,996
|
763,661
|
Series BB
warrants
|
8,250
|
58,588
|
Series CC
warrants
|
630,554
|
-
|
Series DD
warrants
|
29,324
|
-
|
Series EE
warrants
|
179,169
|
-
|
Series FF
warrants
|
73,816
|
-
|
Series GG
warrants
|
506,426
|
-
|
Series HH
warrants
|
24,290
|
-
|
Series II
warrants
|
755,040
|
-
|
Series JJ
warrants
|
36,625
|
-
|
|
|
|
Total warrant
liabilities
|
$3,436,745
|
$8,394,934
|
The
table below presents the gains on the warrant liabilities for the
six months ended March 31:
|
2017
|
2016
|
Series S
warrants
|
$2,579,836
|
$3,147,660
|
Series U
warrants
|
-
|
26,731
|
Series V
warrants
|
1,417,721
|
1,822,785
|
Series W
warrants
|
1,609,415
|
532,054
|
Series Z
warrants
|
828,263
|
-
|
Series ZZ
warrants
|
61,195
|
-
|
Series AA
warrants
|
646,665
|
-
|
Series BB
warrants
|
50,338
|
-
|
Series CC
warrants
|
429,869
|
-
|
Series DD
warrants
|
413,948
|
-
|
Series EE
warrants
|
512,238
|
-
|
Series FF
warrants
|
47,166
|
-
|
Series GG
warrants
|
108,211
|
-
|
Series HH
warrants
|
5,340
|
-
|
Series II
warrants
|
161,419
|
-
|
Series JJ
warrants
|
7,988
|
-
|
|
|
|
Net gain on warrant
liabilities
|
$8,879,612
|
$5,529,230
|
The
table below presents the gains and (losses) on the warrant
liabilities for the three months ended March 31:
|
2017
|
2016
|
Series S
warrants
|
$(41,485)
|
$321,507
|
Series U
warrants
|
-
|
(4,455)
|
Series V
warrants
|
-
|
(1,417,721)
|
Series W
warrants
|
(58,189)
|
(1,493,061)
|
Series Z
warrants
|
(40,524)
|
-
|
Series ZZ
warrants
|
(2,689)
|
-
|
Series AA
warrants
|
(32,904)
|
-
|
Series BB
warrants
|
(2,334)
|
-
|
Series CC
warrants
|
(174,623)
|
-
|
Series DD
warrants
|
43,029
|
-
|
Series EE
warrants
|
(2,365)
|
-
|
Series FF
warrants
|
(19,574)
|
-
|
Series GG
warrants
|
108,211
|
-
|
Series HH
warrants
|
5,340
|
-
|
Series II
warrants
|
161,419
|
-
|
Series JJ
warrants
|
7,988
|
-
|
|
|
|
Net loss on warrant
liabilities
|
$(48,700)
|
$(2,593,730)
|
The
Company reviews all outstanding warrants in accordance with the
requirements of ASC 815. This topic provides that an entity should
use a two-step approach to evaluate whether an equity-linked
financial instrument (or embedded feature) is indexed to its own
stock, including evaluating the instrument’s contingent
exercise and settlement provisions. The warrant agreements provide
for adjustments to the exercise price for certain dilutive events.
Under the provisions of ASC 815, the warrants are not considered
indexed to the Company’s stock because future equity
offerings or sales of the Company’s stock are not an input to
the fair value of a “fixed-for-fixed” option on equity
shares, and equity classification is therefore
precluded.
In
accordance with ASC 815, derivative liabilities must be measured at
fair value upon issuance and re-valued at the end of each reporting
period through expiration. Any change in fair value between the
respective reporting dates is recognized as a gain or
loss.
Issuance of additional Warrants
On
March 14, 2017, the Company sold 600,000 registered
shares of common stock and 600,000 Series II warrants
to purchase 600,000 unregistered shares of common
stock at combined offering price of $2.50 per
share. The Series II warrants have an exercise price of
$3.00 per share, are exercisable on September 14,
2017, and expire September 14, 2022. In addition, the Company issued
30,000 Series JJ warrants to purchase
30,000 shares of unregistered common stock to the
placement agent. The Series JJ warrants have an exercise price
$3.13, are exercisable on September 14, 2017 and
expire on March 8, 2022. The net proceeds from this
offering were approximately $1.3 million. The
fair value of the Series II and JJ warrants of approximately $1.0
million on the date of issuance was recorded as a warrant
liability.
On
February 23, 2017, the Company sold 400,000 registered
shares of common stock and 400,000 Series GG warrants
to purchase 400,000 unregistered shares of common
stock at a combined price of $2.50 per share.
The Series GG warrants have an exercise price of $3.00
per share, are exercisable on August 23, 2017, and expire August
23, 2022. In addition, the Company
issued 20,000 Series HH warrants to purchase
20,000 shares of unregistered common stock to the
placement agent. The Series HH warrants have an exercise price
$3.13, are exercisable on August 23, 2017 and expire
on February 16, 2022. The net proceeds from this
offering were approximately $0.8 million. The
fair value of the Series GG and HH warrants of approximately $0.6
million on the date of issuance was recorded as a warrant
liability.
On December 8, 2016, the Company sold
1,360,960 shares of common stock and warrants to
purchase common stock at a price of $3.13 in a public
offering. The warrants consist of 680,480 Series CC
warrants to purchase 680,480 shares of common stock,
1,360,960 Series DD warrants to purchase
1,360,960 shares of common stock and
1,360,960 Series EE warrants to purchase
1,360,960 shares of common stock. The Series CC
warrants are immediately exercisable, expire in five-years from the
offering date and have an exercise price of $5.00 per
share. The Series DD warrants are immediately exercisable, expire
in six-months from the offering date and have an exercise price of
$4.50 per share. The Series EE warrants are
immediately exercisable, expire in nine-months from the offering
date and have an exercise price of $4.50 per share. In
addition, the Company issued 68,048 Series FF warrants
to purchase 68,048 shares of common stock to the
placement agent. The FF warrants are exercisable at any time on or
after June 8, 2017 and expire on December 1, 2021 and have an
exercise price $3.91. The net proceeds from
this offering was approximately $3.7 million.
The fair value of the Series CC, DD, EE and FF warrants of
approximately $2.3 million on the date of issuance was recorded as
a warrant liability.
Expiration of Warrants
On
March 16, 2017, 23,600 Series P warrants, with an
exercise price of $112.50, expired. The fair value of
the Series P warrants was $0 on the date of
expiration.
On
December 6, 2016, 105,000 Series R warrants, with an
exercise price of $100.00, expired. The fair value of
the Series R warrants was $0 on the date of
expiration.
On
December 22, 2015, 48,000 Series Q warrants, with an
exercise price of $125.00, expired. The fair value of
the Series Q warrants was $0 on the date of
expiration.
2.
Options and shares issued to Consultants
The
Company typically enters into consulting arrangements in exchange
for common stock or stock options. During the six and three months
ended March 31, 2017, the Company issued 18,999 and
4,100 shares of common stock, respectively, of which
10,800 and 0 were restricted shares. The common stock
was issued with stock prices ranging between $2.25 and
$7.25 per share. During the six and three months ended
March 31, 2016, the Company issued 32,151 and
14,451 shares of common stock, of which
23,200 and 9,600 were restricted shares.
The common stock was issued with stock prices ranging between
$9.25 and $17.75 per share. Additionally,
during the six and three months ended March 31, 2016, the Company
issued a consultant 8,400 and 2,400
options, respectively, to purchase common stock at prices between
$9.25 and $15.00 per share with fair
values ranging between $4.75 and $7.50
per share. These options are fully vested. The aggregate values of
the issuances of restricted common stock and common stock options
are recorded as prepaid expenses and are charged to general and
administrative expenses over the periods of service.
During
the six and three months ended March 31, 2017, the Company recorded
total expense of approximately $113,000 and $34,000, respectively,
relating to these consulting agreements. During the six and three
months ended March 31, 2016, the Company recorded total expense of
approximately $472,000 and $143,000, respectively, relating to
these consulting agreements. At March 31, 2017 and September 30,
2016, approximately $7,000 and $48,000, respectively, are included
in prepaid expenses. As of March 31, 2017, 22,800
options were outstanding, which were issued to consultants as
payment for services. Of these 22,800 outstanding
options, 18,800 were vested, all of which were issued
from the Non-Qualified Stock Option plans.
D.
FAIR VALUE MEASUREMENTS
In
accordance with ASC 820-10, “Fair Value Measurements,”
the Company determines fair value as the price that would be
received to sell an asset or paid to transfer a liability in an
orderly transaction between market participants at the measurement
date. The Company generally applies the income approach to
determine fair value. This method uses valuation techniques to
convert future amounts to a single present amount. The measurement
is based on the value indicated by current market expectations with
respect to those future amounts.
ASC
820-10 establishes a fair value hierarchy that prioritizes the
inputs used to measure fair value. The hierarchy gives the highest
priority to active markets for identical assets and liabilities
(Level 1 measurement) and the lowest priority to unobservable
inputs (Level 3 measurement). The Company classifies fair value
balances based on the observability of those inputs. The three
levels of the fair value hierarchy are as follows:
●
Level 1 –
Observable inputs such as quoted prices in active markets for
identical assets or liabilities
●
Level 2 –
Inputs other than quoted prices that are observable for the asset
or liability, either directly or indirectly. These include quoted
prices for similar assets or liabilities in active markets, quoted
prices for identical or similar assets or liabilities in markets
that are not active and amounts derived from valuation models where
all significant inputs are observable in active
markets
●
Level 3 –
Unobservable inputs that reflect management’s
assumptions
For
disclosure purposes, assets and liabilities are classified in their
entirety in the fair value hierarchy level based on the lowest
level of input that is significant to the overall fair value
measurement. The Company’s assessment of the significance of
a particular input to the fair value measurement requires judgment
and may affect the placement within the fair value hierarchy
levels.
The
table below sets forth the assets and liabilities measured at fair
value on a recurring basis, by input level, in the condensed
balance sheet at March 31, 2017:
|
Quoted Prices in Active Markets for Identical Assets
or Liabilities (Level 1)
|
Significant Other Observable Inputs (Level
2)
|
Significant Unobservable Inputs (Level
3)
|
Total
|
|
|
|
|
|
Derivative
instruments
|
$531,525
|
$-
|
$2,905,220
|
$3,436,745
|
The
table below sets forth the assets and liabilities measured at fair
value on a recurring basis, by input level, in the condensed
balance sheet at September 30, 2016:
|
Quoted Prices in Active Markets for Identical Assets
or Liabilities (Level 1)
|
Significant Other Observable Inputs (Level
2)
|
Significant Unobservable Inputs (Level
3)
|
Total
|
|
|
|
|
|
Derivative
instruments
|
$3,111,361
|
$-
|
$5,283,573
|
$8,394,934
|
The
following sets forth the reconciliation of beginning and ending
balances related to fair value measurements using significant
unobservable inputs (Level 3) for the six months ended March 31,
2017 and the year ended September 30, 2016:
|
(Six Months Ended)
|
(Year Ended)
|
|
March 31, 2017
|
September 30, 2016
|
|
|
|
Beginning
balance
|
$5,283,573
|
$6,323,032
|
Issuances
|
3,921,423
|
8,722,073
|
Realized and
unrealized gains
|
(6,299,776)
|
(9,761,532)
|
Ending
balance
|
$2,905,220
|
$5,283,573
|
The
fair values of the Company’s derivative instruments disclosed
above under Level 3 are primarily derived from valuation models
where significant inputs such as historical price and volatility of
the Company’s stock, as well as U.S. Treasury Bill rates, are
observable in active markets.
E.
RELATED PARTY TRANSACTIONS
Effective August
31, 2016, Maximilian de Clara, the Company’s then President
and a director, resigned for health reasons. In payment for past
services, the Company agreed to issue Mr. de Clara
26,000 shares of restricted stock; 13,000
shares upon his resignation and 13,000 on August 31,
2017. At March 31, 2017 and September 30, 2016, the fair value
accrued for unissued shares was approximately $29,000 and $101,000,
respectively.
On
January 13, 2016, the de Clara Trust demanded payment on a note
payable, of which the balance, including accrued and unpaid
interest, was approximately $1.1 million. The de Clara Trust was
established by Maximilian de Clara, the Company’s former
President and a director. The Company’s Chief Executive
Officer, Geert Kersten, is a beneficiary of the de Clara Trust.
When the de Clara Trust demanded payment on the note, the Company
sold 120,000 shares of its common stock and
120,000 Series X warrants to the de Clara Trust for
approximately $1.1 million. Each warrant allows the de Clara Trust
to purchase one share of the Company's common stock at a price of
$9.25 per share at any time on or before January 13,
2021.
No
interest payments were made to Mr. de Clara during the six and
three months ended March 31, 2017. During the six and three months
ended March 31, 2016, the Company paid approximately $43,000 and
$10,000, respectively, in interest expense to Mr. de
Clara.
F.
COMMITMENTS AND CONTINGENCIES
Clinical Research Agreements
In
March 2013, the Company entered into an agreement with Aptiv
Solutions, Inc. (which was subsequently acquired by ICON Inc.) to
provide certain clinical research services in accordance with a
master service agreement. The Company will reimburse ICON for costs
incurred. The agreement required the Company to make $600,000 in
advance payments which are being credited against future invoices
in $150,000 annual increments through December 2017. As of March
31, 2017, the total balance advanced is $150,000, which is
classified as a current asset.
In April 2013, the Company entered into a
co-development and revenue sharing agreement with Ergomed. Under
the agreement, Ergomed will contribute up to $10 million towards
the study in the form of offering discounted clinical services in
exchange for a single digit percentage of milestone and royalty
payments, up to a specific maximum amount. In October 2015,
the Company entered into a second co-development and revenue sharing agreement with
Ergomed for an additional $2 million, for a total of $12
million. The Company accounted for the co-development and revenue
sharing agreement in accordance with ASC 808 “Collaborative
Arrangements”. The Company determined the payments to Ergomed
are within the scope of ASC 730 “Research and
Development.” Therefore, the Company records the discount on
the clinical services as a credit to research and development
expense on its Statements of Operations. Since the Company entered
into the co-development and revenue sharing agreement with Ergomed,
it has incurred research and development expenses of approximately
$23.2 million related to Ergomed’s services. This amount is
net of Ergomed’s co-development contribution of approximately
$7.7 million. During the six and three months ended March 31, 2017,
the Company recorded, net of Ergomed’s co-development
contribution, approximately $4.1 million and $2.8 million,
respectively, as research and development expense related to
Ergomed’s services. During the six and three months ended
March 31, 2016, the Company recorded, net of Ergomed’s
co-development contribution, approximately $3.8 million and $1.8
million, respectively, as research and development expense related
to Ergomed’s services.
In
October 2013, the Company entered into two co-development and
profit sharing agreements with Ergomed. One agreement
supports the Phase 1 study being conducted at the University of
California, San Francisco, or UCSF, for the development of
Multikine as a potential treatment for peri-anal warts in HIV/HPV
co-infected men and women. The Phase 1 study originally
started after the Company signed a cooperative research and
development agreement with the U.S. Naval Medical Center, San
Diego. In August 2016, the U.S. Navy discontinued this Phase 1
study because of difficulties in enrolling patients. The other
agreement focuses on the development of Multikine as a potential
treatment for cervical dysplasia in HIV/HPV co-infected women.
Ergomed will assume up to $3 million in clinical and regulatory
costs for each study.
The
Company is currently involved in a pending arbitration proceeding,
CEL-SCI Corporation v. inVentiv Health Clinical, LLC (f/k/a
PharmaNet LLC) and PharmaNet GmbH (f/k/a PharmaNet AG).
The Company initiated the proceedings
against inVentiv Health Clinical, LLC, or inVentiv, the former
third-party CRO, and are seeking payment for damages related to
inVentiv’s prior involvement in the Phase 3 clinical trial of
Multikine. The arbitration claim, initiated under the Commercial
Rules of the American Arbitration Association, alleges (i) breach
of contract, (ii) fraud in the inducement, and (iii) common law
fraud. Currently, the Company is seeking at least $50 million in
damages in its amended statement of claim.
In an
amended statement of claim, the Company asserted the claims set
forth above as well as an additional claim for professional
malpractice. The arbitrator subsequently granted
inVentiv’s motion to dismiss the professional malpractice
claim based on the “economic loss doctrine” which,
under New Jersey law, is a legal doctrine that, under certain
circumstances, prohibits bringing a negligence-based claim
alongside a claim for breach of contract. The arbitrator
denied the remainder of inVentiv’s motion, which had sought
to dismiss certain other aspects of the amended statement of
claim. In particular, the arbitrator rejected
inVentiv’s argument that several aspects of the amended
statement of claim were beyond the arbitrator’s
jurisdiction.
In
connection with the pending arbitration proceedings, inVentiv has
asserted counterclaims against the Company for (i) breach of
contract, seeking at least $2 million in damages for services
allegedly performed by inVentiv; (ii) breach of contract, seeking
at least $1 million in damages for the alleged use of
inVentiv’s name in connection with publications and
promotions in violation of the parties’ contract; (iii)
opportunistic breach, restitution and unjust enrichment, seeking at
least $20 million in disgorgement of alleged unjust profits
allegedly made by the Company as a result of the purported breaches
referenced in subsection (ii); and (iv) defamation, seeking at
least $1 million in damages for allegedly defamatory statements
made about inVentiv. The Company believes inVentiv’s
counterclaims are meritless and
intends to vigorously defend against them. However, if such defense
is unsuccessful, and inVentiv successfully asserts any of its
counterclaims, such an adverse determination could have a material
adverse effect on the Company’s business, results, financial
condition and liquidity.
In
October 2015 the Company signed an arbitration funding agreement
with a company established by Lake Whillans Litigation Finance,
LLC, a firm specializing in funding litigation expenses. Pursuant
to the agreement, an affiliate of Lake Whillans provides the
Company with up to $5 million in funding for litigation expenses to
support its arbitration claims against inVentiv. The funding is
available to the Company to fund the expenses of the ongoing
arbitration and will only be repaid if the Company receives
proceeds from the arbitration. During the three months ended
December 31, 2015, the Company recognized a gain of approximately
$1.1 million on the derecognition of legal fees to record the
transfer of the liability that existed prior to the execution of
the financing agreement from the Company to Lake Whillans. The gain
on derecognition of legal fees is recorded as a reduction of
general and administration expenses on the Statement of Operations.
All related legal fees are directly billed to and paid by Lake
Whillans. As part of the agreement with Lake Whillans, the law firm
agreed to cap its fees and expenses for the arbitration at $5
million.
The
arbitration has been going on longer than expected, but it is
finally nearing its end. The hearing (the “trial”)
started on September 26, 2016 and was originally scheduled to end
in November/December of 2016. Instead it is still ongoing, but we
expect it to end during the second quarter of 2017.
Lease Agreements
The
Company leases a manufacturing facility near
Baltimore, Maryland (the San Tomas lease). The
building was remodeled in accordance with the Company’s
specifications so that it can be used by the Company
to manufacture Multikine for the Company’s Phase 3 clinical
trial and sales of the drug if approved by the FDA. The lease is
for a term of twenty years and requires annual base rent to
escalate each year at 3%. The Company is required to pay all real
estate and personal property taxes, insurance premiums, maintenance
expenses, repair costs and utilities. The lease allows the Company,
at its election, to extend the lease for two ten-year periods or to
purchase the building at the end of the 20-year lease. The
Company contributed approximately $9.3 million towards the
tenant-directed improvements, of which $3.2 million is being
refunded during years six through twenty through reduced rental
payments. The landlord paid approximately $11.9 million towards the
purchase of the building, land and the tenant-directed
improvements. The Company placed the building in service in October
2008.
The
leased building is being depreciated using a straight line method
over the 20 year lease term to a residual value. The landlord
liability is being amortized over the 20 years using the effective
interest method.
Lease
payments allocated to the landlord liability are accounted for as
debt service payments on that liability using the finance method of
accounting per ASC 840-40-55.
The
Company was required to deposit the equivalent of one year of base
rent in accordance with the lease. When the Company meets the
minimum cash balance required by the lease, the deposit will be
returned to the Company. The approximate $1.7 million deposit is
included in non-current assets at March 31, 2017 and September 30,
2016.
Future minimum
lease payments under the San Tomas lease as of March 31, 2017 are
as follows:
Six months ending
September 30, 2017
|
$ 846,000
|
Year
ending September 30,
|
|
2018
|
1,747,000
|
2019
|
1,808,000
|
2020
|
1,872,000
|
2021
|
1,937,000
|
2022
|
2,004,000
|
Thereafter
|
13,758,000
|
Total future
minimum lease obligation
|
23,972,000
|
Less imputed
interest on financing obligation
|
(10,862,000)
|
Net present value
of lease financing obligation
|
$ 13,110,000
|
The
Company subleases a portion of its rental space on a month-to-month
term lease, which requires a 30 day notice for termination. The
Company receives approximately $6,000 per month in rent for the
sub-leased space.
The
Company leases its research and development laboratory under a 60
month lease which expires February 28, 2022. The operating lease
includes escalating rental payments. The Company is recognizing the
related rent expense on a straight line basis over the full 60
month term of the lease at the rate of approximately $13,000 per
month. As of March 31, 2017 and September 30, 2016, the Company has
recorded a deferred rent liability of approximately $1,000 and
$2,000, respectively.
The
Company leases its office headquarters under a 60 month lease which
expires June 30, 2020. The operating lease includes escalating
rental payments. The Company is recognizing the related rent
expense on a straight line basis over the full 60 month term of the
lease at the rate approximately $8,000 per month. As of March 31,
2017 and September 30, 2016, the Company has recorded a deferred
rent liability of approximately $18,000.
As of March 31,
2017, material contractual obligations, excluding the San Tomas
lease, consisting of operating lease payments are as
follows:
Six months ending
September 30, 2017
|
$ 123,000
|
Year ending
September 30,
|
|
2018
|
251,000
|
2019
|
258,000
|
2020
|
238,000
|
2021
|
163,000
|
2022
|
69,000
|
Total
|
$ 1,102,000
|
The
Company leases office equipment under a capital lease arrangement.
The term of the capital lease is 60 months and expires on October
31, 2021. The monthly lease payment is $505. The lease bears
interest at approximately 6.25% per annum. The Company’s
previous equipment lease expired on September 30,
2016.
During
the six and three months ended March 31, 2017 and 2016, no patent
impairment charges were recorded. For the six and three months
ended March 31, 2017, amortization of patent costs totaled
approximately $19,000 and $10,000, respectively. For the six and
three months ended March 31, 2016, amortization of patent costs
totaled approximately $18,000 and $9,000, respectively. The total
estimated future amortization expense is approximately as
follows:
Six months ending
September 30, 2017
|
$18,308
|
Year ending
September 30,
|
|
2018
|
36,487
|
2019
|
34,784
|
2020
|
31,590
|
2021
|
28,290
|
2022
|
24,488
|
Thereafter
|
65,267
|
Total
|
$239,214
|
The
following tables provide the details of the basic and diluted loss
per-share (LPS) computations:
|
Six Months Ended March 31, 2017
|
|
Net Loss –
Restated(1)
|
Weighted Average Shares
|
LPS
|
|
|
|
|
Basic
loss per share
|
$ (4,905,338)
|
6,649,814
|
$ (0.74)
|
Gain on derivatives(2)
|
(330,124)
|
32,778
|
|
|
|
|
|
Dilutive
loss per share
|
$ (5,235,462)
|
6,682,592
|
$ (0.78)
|
(1)
See
Note I - Restatement
|
|
|
|
(2)
Includes series FF, GG, HH, II and JJ warrants
|
|
|
|
|
Three Months Ended March 31, 2017
|
|
Net Loss –
Restated(1)
|
Weighted Average Shares
|
LPS
|
|
|
|
|
Basic
and dilutive loss per share
|
$ (8,426,491)
|
7,319,761
|
$ (1.15)
|
(1) See
Note I - Restatement
|
|
|
|
|
Six Months Ended March 31, 2016
|
|
Net Loss –
Restated(1)
|
Weighted Average Shares
|
LPS
|
|
|
|
|
Basic
and dilutive loss per share
|
$ (6,522,796)
|
4,562,831
|
$ (1.43)
|
(1) See
Note I - Restatement
|
|
|
|
|
Three Months Ended March 31, 2016
|
|
Net Loss –
Restated(1)
|
Weighted Average Shares
|
LPS
|
|
|
|
|
Basic
and dilutive loss per share
|
$ (8,855,530)
|
4,736,809
|
$ (1.87)
|
(1) See
Note I - Restatement
|
|
|
|
The
gain on derivatives priced lower than the average market price
during the period is excluded from the numerator and the related
shares are excluded from the denominator in calculating diluted
loss per share.
In
accordance with the contingently issuable shares guidance of FASB
ASC Topic 260, Earnings Per
Share, the calculation of diluted net earnings (loss) per
share excludes the following securities because their inclusion
would have been anti-dilutive as of March 31:
|
2017
|
2016
|
Options
and Warrants
|
8,037,799
|
3,148,434
|
Unvested
Restricted Stock
|
604,000
|
604,000
|
Total
|
8,641,799
|
3,752,434
|
In October 2008, the Company entered into a lease
arrangement whereby the Company leased a building owned by a third
party, but to which the owner made tenant-directed improvements.
Upon commencement of the lease, the Company accounted for the
arrangement as an operating lease under ASC 840,
Accounting for
Leases, whereby the total
minimum lease payment obligations under the leases were recognized
as monthly rent expense on a straight-line basis over the term of
the lease. The cost of the tenant improvements incurred were
capitalized as deferred rent and amortized over the 20-year lease
term.
However, in November 2017, the Company discovered
an error in the way it accounted for the lease for the building
since it was determined that, as the terms of the original lease
required the Company to be responsible for possible cost overruns,
(but of which there were none), the Company was deemed to be the
owner of the leased building for accounting purposes only under ASC
840-40-55. In addition to the costs it incurred and capitalized for
the tenant improvements, the Company should have reflected an asset
on its balance sheet for the costs paid by the lessor to purchase
and improve the building, as well as a corresponding liability.
Upon completion of the improvements, the Company did not meet the
“sale-leaseback” criteria under ASC 840-40-25,
Accounting for
Leases, Sale-Leaseback Transactions due to the Company’s significant continuing
involvement with the facility which is considered to be other than
a normal leaseback as defined in ASC 840-40-25 and therefore should
have treated the lease as a financing obligation and the asset and
corresponding liability should not be
derecognized.
The
corrections to the historical financial statements to apply ASC
840-40-25 do not affect the total cash payments the Company has
made or is obligated to make under the lease agreement, nor does it
change the total expense to be recognized over the lease term.
However, the timing and nature of expense is different under this
treatment as compared to operating lease treatment. Specifically,
the Company should have recognized depreciation, expense on the
building it is deemed to own and interest expense on the associated
lease financing obligation, instead of rental
expense.
The
accompanying financial statements for six and three months ended
March 31, 2017 have been restated to reflect the correction of the
error for the lease accounting. Accumulated deficit at September
30, 2016, was reduced by $276,855. The following is a summary of
the restatements:
|
March 31, 2017
|
|
PREVIOUSLY REPORTED
|
ADJUSTMENT
|
RESTATED
|
Total
current assets
|
$ 3,483,223
|
$ (400,039)
|
$ 3,083,184
|
Other
assets
|
5,242,616
|
13,754,600
|
18,997,216
|
Total
assets
|
8,725,839
|
13,354,561
|
22,080,400
|
Total
liabilities
|
11,802,043
|
13,110,357
|
24,912,400
|
Stockholders'
deficit
|
(3,076,204)
|
244,204
|
(2,832,000)
|
|
September 30, 2016
|
|
PREVIOUSLY REPORTED
|
ADJUSTMENT
|
RESTATED
|
Total
current assets
|
$ 5,887,646
|
$ (429,821)
|
$ 5,457,825
|
Other
assets
|
5,710,601
|
13,717,699
|
19,428,300
|
Total
assets
|
11,598,247
|
13,287,878
|
24,886,125
|
Total
liabilities
|
12,554,315
|
13,011,023
|
25,565,338
|
Stockholders'
deficit
|
(956,068)
|
276,855
|
(679,213)
|
|
Six Months Ended March
31,
|
|
2017
|
2016
|
|
PREVIOUSLY REPORTED
|
ADJUSTMENT
|
RESTATED
|
PREVIOUSLY REPORTED
|
ADJUSTMENT
|
RESTATED
|
Research
and development expenses
|
$ 11,080,073
|
$ (953,198)
|
$ 10,126,875
|
$ 9,798,089
|
$ (953,198)
|
$ 8,844,891
|
Total
operating expenses
|
13,832,196
|
(953,198)
|
12,878,998
|
12,110,486
|
(953,198)
|
11,157,288
|
Operating
loss
|
(13,797,763)
|
953,198
|
(12,844,565)
|
(12,056,735)
|
953,198
|
(11,103,537)
|
Interest
income (expense), net
|
45,464
|
(985,849)
|
(940,385)
|
24,463
|
(972,952)
|
(948,489)
|
Net
loss
|
(4,872,687)
|
(32,651)
|
(4,905,338)
|
(6,503,042)
|
(19,754)
|
(6,522,796)
|
|
|
|
|
|
|
|
Net
loss per share - basic
|
$ (0.73)
|
|
$ (0.74)
|
$ (1.43)
|
|
$ (1.43)
|
Net
loss per share - diluted
|
$ (0.78)
|
|
$ (0.78)
|
$ (1.43)
|
|
$ (1.43)
|
|
Three Months Ended March
31,
|
|
2017
|
2016
|
|
PREVIOUSLY REPORTED
|
ADJUSTMENT
|
RESTATED
|
PREVIOUSLY REPORTED
|
ADJUSTMENT
|
RESTATED
|
Research
and development expenses
|
$ 7,055,217
|
$ (476,599)
|
$ 6,578,618
|
$ 4,628,582
|
$ (476,599)
|
$ 4,151,983
|
Total
operating expenses
|
8,400,331
|
(476,599)
|
7,923,732
|
6,306,378
|
(476,599)
|
5,829,779
|
Operating
loss
|
(8,383,156)
|
476,599
|
(7,906,557)
|
(6,273,603)
|
476,599
|
(5,797,004)
|
Interest
income (expense), net
|
22,367
|
(493,601)
|
(471,234)
|
22,478
|
(487,274)
|
(464,796)
|
Net
loss
|
(8,409,489)
|
(17,002)
|
(8,426,491)
|
(8,844,855)
|
(10,675)
|
(8,855,530)
|
|
|
|
|
|
|
|
Net
loss per share - basic and diluted
|
$ (1.15)
|
|
$ (1.15)
|
$ (1.87)
|
|
$ (1.87)
|
|
Accumulated Deficit
|
PREVIOUSLY
REPORTED, SEPTEMBER 30, 2016
|
$ (285,667,977)
|
ADJUSTMENT
|
276,855
|
RESTATED
BALANCE, SEPTEMBER 30, 2016
|
(285,391,122)
|
|
|
Net
loss - RESTATED
|
(4,905,338)
|
BALANCE,
MARCH 31, 2017
|
$ (290,296,460)
|
On
April 30, 2017, the Company entered into a securities purchase
agreement with an institutional investor whereby it sold
527,960 shares of its common stock for aggregate gross
proceeds of approximately $1.51 million, or $2.88 per
share, in a registered direct offering. In a concurrent private
placement, the Company also issued to the purchaser of the
Company’s common stock, Series KK warrants to purchase
395,970 shares of common stock. The warrants can be
exercised at a price of $3.04 per share, commencing
six months after the date of issuance and ending five and a half
years after the date of issuance. In addition, the Company agreed
to issue 26,398 Series LL warrants to the Placement
Agent as part of its compensation. The Series LL warrants are
subject to a 180-day lock-up and may be exercised at any time on or
after October 30, 2017 and on or before April 30, 2022 at a price
of $3.59 per share.
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Correction
of an Error
The
historical financial information in this report have been restated.
In November 2017, the Company discovered an error in the way it
accounted for the operating lease for its manufacturing facility.
In October 2008, the Company entered into a lease arrangement
whereby the Company leased a building owned by a third party, but
to which the owner made tenant-directed improvements. Upon
commencement of the lease, the Company accounted for the
arrangement as an operating lease under ASC 840, Accounting
forLeases, whereby the total minimum lease payment obligations
under the leases were recognized as monthly rent expense on a
straight-line basis over the term of the lease. The cost of the
tenant improvements incurred were capitalized as deferred rent and
amortized over the 20-year lease term.
In
November 2017, it was determined that because the terms of the
original lease agreement required the Company to be responsible for
possible cost overruns, if there were any, but of which there were
none, the Company was deemed to be the owner of the leased building
for accounting purposes only under ASC 840-40-55. In addition to
the costs it incurred and capitalized for the tenant improvements,
the Company should have reflected an asset on its balance sheet for
the costs paid by the lessor to purchase the building and improve
it, as well as a corresponding liability. Upon completion of the
improvements, the Company did not meet the
“sale-leaseback” criteria under ASC 840-40-25,
Accounting for Leases, Sale-Leaseback Transactions due to the
Company’s significant continuing involvement with the
facility which is considered to be other than a normal leaseback as
defined in ASC 840-40-25 and therefore should have treated the
lease as a financing obligation and the asset and corresponding
liability should not be derecognized.
The
correction to the historical financial statements to apply ASC
840-40-25 does not affect the total cash payments the Company has
made or is obligated to make under the lease agreement, nor does it
change the total expense to be recognized over the lease term.
However, the timing and nature of expense is different under this
treatment as compared to operating lease treatment. Specifically,
the Company should have recognized depreciation, expense on the
asset it is deemed to own and interest expense on the associated
lease financing obligation, instead of rental
expense.
The
accompanying Management's Discussion and Analysis of Financial
Condition and Results of Operations gives effect to the restatement
adjustments made to the previously reported financial statements
for the three months ended December 31, 2016 and 2015. For
additional information and a detailed discussion of the
restatement, see Note I of the financial statements included in
this Report.
Liquidity and Capital Resources
The
Company’s lead investigational therapy, Multikine® (Leukocyte
Interleukin, Injection), is cleared for a Phase 3 clinical trial in
advanced primary head and neck cancer. Multikine has been cleared
by the regulators in twenty four countries around the world,
including the U.S. FDA.
On
September 26, 2016, the Company received verbal notice from FDA
that the Phase 3 clinical trial in advanced primary head and neck
cancer has been placed on clinical hold. At such time, enrollment
in the Phase 3 study was 928 patients. In accordance with the
partial clinical hold, the Company is continuing to follow the 928
patients enrolled in the study, and this includes following
patients until the targeted 298 deaths between the 2 comparison
groups is observed. This number of deaths is required to evaluate
if the study’s primary endpoint is achieved.
On
October 21, 2016, the Company received a partial clinical hold
letter from FDA and, on November 18, 2016, the Company submitted a
response to FDA’s partial clinical hold letter.
In its
partial clinical hold letter, FDA identified the following specific
deficiencies: a) FDA stated that there is an unreasonable and
significant risk of illness or injury to human subjects and cited
among other things the absence of prompt reports by the Company to
the FDA of IDMC recommendations to close the study entirely (made
in spring of 2014) or at least to close it to accrual of new
patients (made in spring of 2016); b) FDA stated that the
investigator brochure is misleading, erroneous, and materially
incomplete; and c) FDA stated that the plan or protocol is
deficient in design to meet its stated objectives. In its partial
clinical hold letter, FDA also identified the information needed to
resolve these deficiencies. In addition, FDA’s partial
clinical hold letter included two requests relating to quality
information regarding the Company’s investigational final
drug product, which were noted by FDA as non-hold issues. The
Company believes that its response submitted to FDA on November 18,
2016, addressed each of the deficiencies identified by FDA
including detailing its belief that, under the applicable FDA
guidance, there was no obligation to report the cited IDMC
recommendations to the FDA at the time they were issued, and it
also requested a face-to-face meeting with FDA, and outlined the
Company’s commitment to diligently work with FDA in an effort
to have the partial clinical hold for the study
lifted.
On
December 8, 2016, FDA advised us that the Agency was denying the
Company’s request for a meeting at that time because
FDA’s review of the Company’s November 18, 2016
response was ongoing. The Company also was advised that the Company
would be receiving a letter addressing its November 18, 2016
response by December 18, 2016.
On
December 16, 2016, FDA issued an Incomplete Response To Hold letter
to the Company indicating that based on the Agency’s
preliminary review of the Company’s November 18, 2016
submission, FDA has determined that it is not a complete response
to all of the issues listed in FDA’s clinical hold letter.
FDA identified the following specific deficiencies: a) FDA stated
that the Company did not provide the information identified as
necessary to address FDA’s statement that patients enrolled
in the study are exposed to unreasonable and significant risk of
illness or injury to human subjects; b) FDA stated that the Company
did not provide the information identified as necessary to address
FDA’s statement that continued enrollment of patients in the
study exposes the patients to unreasonable risks and FDA
furthermore stated that the study is unlikely to demonstrate that
the addition of the Company’s investigational drug Multikine
to the standard of care is superior to standard of care and thus
should be terminated for futility; (c) FDA stated that the Company
did not provide the information identified as necessary to address
FDA’s statement that the investigator brochure is misleading,
erroneous, and materially incomplete; (d) FDA stated that the
Company did not provide the information identified as necessary to
address FDA’s statement that the proposed revised clinical
protocol is inadequate in design to meet its stated objectives and
FDA furthermore stated that this deficiency cannot be addressed by
further revisions to the protocol. In its incomplete response to
hold letter, FDA also identified the steps the Company must take to
address these deficiencies. In addition, FDA’s incomplete
response to hold letter noted with respect to FDA’s two
requests relating to quality information regarding the
Company’s investigational final drug product, which the
Company had been instructed by FDA to submit separately from the
response to the partial clinical hold, which again were noted by
FDA as non-hold issues, that the Company’s November 18, 2016,
submission had not included the information addressing these two
requests.
In
early January 2017, in preparation for the request for a Type A
meeting with FDA and resolution of the partial clinical hold
issues, the Company prepared a comprehensive submission to FDA
detailing its belief, accompanied by what the Company believes to
be appropriate supporting data, records, and information reflecting
that the Company has taken the steps necessary to address the
specific deficiencies identified by the FDA, including: a)
demonstrating that patients enrolled in the study are not exposed
to unreasonable and significant risk of illness or injury; b)
demonstrating that continued enrollment of patients in the study
does not expose the patients to unreasonable risks and that the
study should not be terminated for futility; (c) demonstrating that
a supplemented investigator brochure is not misleading, erroneous,
or materially incomplete; (d) demonstrating that the proposed
revised clinical protocol is adequate in design to meet its stated
objectives and that this deficiency can be addressed by the
proposed revisions to the protocol.
On
February 8, 2017, the Company met with the FDA to allow an open and
frank discussion of the clinical hold issues raised by the FDA and
to secure the FDA’s input and clarification on how to address
the partial hold issues. On March 1, 2017 the Company received the
written minutes of this meeting from the FDA. The Action Items for
the Company to pursue per the minutes from the FDA were the
following: 1) provide an updated Investigator’s Brochure and
current procedures for compliance with requirements under 21 CFR
312 Subpart D to address the partial clinical hold, and 2) provide
a list of major protocol deviations, which the Company believes
will affect study results, and provide a plan to identify major
protocol deviations across all patients enrolled in the Phase 3
protocol.
In
April 2017, the Company supplied the response to those Action Items
to the FDA. It is its belief that addressing the Action Items will
support a favorable decision by the FDA to lift the partial
clinical hold. While the Company thinks that it has understood the
Action Items, it is possible that the Company has not understood
all issues involved or that the FDA could issue additional comments
or could raise additional concerns when reviewing its responses to
the Action Items. All of the Company’s work is subject to the
FDA's review of the Company’s submission upon its completion
and may or may not result in the lifting of the partial clinical
hold.
Subject
to the partial clinical hold, the Company’s estimate that the
total remaining cash cost of the Phase 3 clinical trial, excluding
any costs that will be paid by our partners, would be approximately
$12.9 million. This is in addition to the approximately $36.6
million that the Company already had spent on the trial as of March
31, 2017. This number may be affected by the rate of any future
patient enrollment, if needed, rate of death accumulation in the
study, foreign currency exchange rates, and many other factors,
some of which cannot be foreseen today. It is therefore possible
that the cost of the Phase 3 clinical trial will be higher than
currently estimated. If FDA will only lift the partial clinical
hold with termination of the current study and initiation of a new
clinical trial, any such new trial can only be initiated if
permitted by FDA and as appropriate other regulatory authorities
around the world after the requisite submissions are made to them,
and the additional duration and costs of the Phase 3 clinical
program would likely exceed those already incurred in connection
with the Phase 3 clinical trial. If there is a need to conduct an
additional Phase 3 pivotal study, any such requirement would have
significant and severe material consequences for us and could
impact our ability to continue as a going concern.
Currently
the Company is not looking to enroll additional patients. The
Company will not be able to enroll any additional patients in the
Phase 3 study unless FDA lifts the partial clinical hold. In
addition, in the spring of 2016, the IDMC recommended to us that
new patient enrollment should stop in the Phase 3 study, but
patients already on study should continue to be treated and
followed. Although the Company had expected to work through the
concerns raised by the IDMC while the Company worked through the
partial clinical hold with FDA, the IDMC informed us on December
13, 2016, that because the study is on partial clinical hold
imposed by FDA, the IDMC has no formal recommendation regarding
continuation of the trial at this time. Another IDMC meeting was
held on February 6, 2017. Due to the fact that the study is still
on partial clinical hold imposed by the FDA, the IDMC had no formal
recommendation regarding continuation of the trial at that time. If
the partial clinical hold is not lifted by FDA or if it is
determined by FDA that the study has been compromised, the study
may be terminated, or if the partial clinical hold is lifted by FDA
but the IDMC continues to recommend that enrollment not be allowed
to continue, the study may be terminated by the
Company.
If the
partial clinical hold is not lifted, the Phase 3 study may not be
able to be completed to its prespecified endpoints in a timely
manner, if at all, and, if the Phase 3 study cannot be completed to
its prespecified endpoints, the study would not be able to be used
as the pivotal study supporting a marketing application in the
United States, and at least one entirely new Phase 3 pivotal study
would need to be conducted to provide the pivotal study supporting
a marketing application in the United States. Even if the partial
clinical hold is lifted, if it is not lifted in a timely fashion,
the nature and duration of the partial clinical hold could
irreparably harm the data from the Phase 3 study such that it may
no longer be able to be used as the pivotal study supporting a
marketing application in the United States. Even if the partial
clinical hold is lifted in a timely fashion, it remains possible
that the regulatory authorities could determine that the Phase 3
study is not sufficient to be used as a single pivotal study
supporting a marketing application in the United
States.
Multikine
is also being used in a Phase I study at UCSF in HIV/HPV
co-infected men and women with peri-anal warts.
Multikine
(Leukocyte Interleukin, Injection) is the full name of this
investigational therapy, which, for simplicity, is referred to in
the remainder of this report as Multikine. Multikine is the
trademark that the Company has registered for this investigational
therapy, and this proprietary name is subject to FDA review in
connection with the Company’s future anticipated regulatory
submission for approval. Multikine has not been licensed or
approved by the FDA or any other regulatory agency. Neither has its
safety or efficacy been established for any use.
The
Company also owns and is developing a pre-clinical technology
called LEAPS (Ligand Epitope Antigen Presentation
System).
All of
the Company’s projects are under development. As a result,
the Company cannot predict when it will be able to generate any
revenue from the sale of any of its products.
Since
inception, the Company has financed its operations through the sale
of equity securities, convertible notes, loans and certain research
grants. The Company’s expenses will continue to exceed its
revenues as it continues the development of Multikine and brings
other drug candidates into clinical trials. Until such time as the
Company becomes profitable, any or all of these financing vehicles
or others may be utilized to assist the Company’s capital
requirements.
Capital
raised by the Company has been expended primarily for patent
applications, research and development, administrative costs, and
the construction of the Company’s laboratory facilities. The
Company does not anticipate realizing significant revenues until it
enters into licensing arrangements regarding its technology and
know-how or until it receives regulatory approval to sell its
products (which could take a number of years). As a result the
Company has been dependent upon the proceeds from the sale of its
securities to meet all of its liquidity and capital requirements
and anticipates having to do so in the future.
The
Company will be required to raise additional capital or find
additional long-term financing in order to continue with its
research efforts. The ability to raise capital may be dependent
upon market conditions that are outside the control of the Company.
Additionally, the partial clinical hold may also impact the
Company’s ability to attract new capital. The ability of the
Company to complete the necessary clinical trials and obtain FDA
approval for the sale of products to be developed on a commercial
basis is uncertain. Ultimately, the Company must complete the
development of its products, obtain the appropriate regulatory
approvals and obtain sufficient revenues to support its cost
structure. The Company is taking cost-cutting initiatives, as well
as exploring other sources of funding to finance operations over
the next 12 months. However there can be no assurance that the
Company will be able to raise sufficient capital to support its
operations.
In
April 2013, the Company announced that it had replaced the CRO
running its Phase 3 clinical trial. This was necessary since the
patient enrollment in the study dropped off substantially following
a takeover of the CRO which caused most of the members of the
CRO’s study team to leave the CRO. The Company announced that
it had hired two CRO’s who will manage the global Phase 3
study; ICON and Ergomed, who are both international leaders in
managing oncology trials. Both CRO’s helped the Company
expand the trial to over 80 clinical sites globally. As of March
31, 2017, the study has enrolled 928 patients.
Under a
co-development agreement, Ergomed will contribute up to $12 million
towards the study where it will perform clinical services in
exchange for a single digit percentage of milestone and royalty
payments, up to a specified maximum amount, only from sales for
head and neck cancer. Ergomed, a privately-held firm headquartered
in Europe with global operations, has entered into numerous similar
co-development agreements, including one with Genzyme (purchased by
Sanofi in 2011 for over $20 billion). Ergomed will be responsible
for the new patient enrollment.
During
the six months ended March 31, 2017, the Company’s cash
decreased by approximately $1.4 million. Significant
components of this decrease include net proceeds from the sale of
the Company’s stock of approximately $5.8 million offset by
net cash used to fund the Company’s regular operations,
including its Phase 3 clinical trial, of approximately $7.2
million, purchases of equipment of approximately $10,000 and
payments on capital leases of approximately $2,000. During the six
months ended March 31, 2016, the Company’s cash increased by
approximately $325,000. Significant components of this
increase include net proceeds from the sale of the Company’s
stock of approximately $12.2 million offset by net cash used to
fund the Company’s regular operations, including its Phase 3
clinical trial, of approximately $10.8 million, the approximate
$1.1 million repayment of the related party loan, purchases of
equipment of approximately $22,000 and payments on capital leases
of approximately $4,000.
On
March 14, 2017, the Company sold 600,000 registered
shares of common stock and 600,000 Series II warrants
to purchase 600,000 unregistered shares of common
stock at combined offering price of $2.50 per
share. The Series II warrants have an exercise price of
$3.00 per share, are exercisable on September 14,
2017, and expire September 14, 2022. In addition, the Company issued
30,000 Series JJ warrants to purchase
30,000 shares of unregistered common stock to the
placement agent. The Series JJ warrants have an exercise price
$3.13, are exercisable on September 14, 2017 and
expire on March 8, 2022. The net proceeds from this
offering were approximately
$1.3 million.
On
February 23, 2017, the Company sold 400,000 registered
shares of common stock and 400,000 Series GG warrants
to purchase 400,000 unregistered shares of common
stock at a combined price of $2.50 per share.
The Series GG warrants have an exercise price of $3.00
per share, are exercisable on August 23, 2017, and expire August
23, 2022. In addition, the Company
issued 20,000 Series HH warrants to purchase
20,000 shares of unregistered common stock to the
placement agent. The Series HH warrants have an exercise price
$3.13, are exercisable on August 23, 2017 and expire
on February 16, 2022. The net proceeds from this
offering were approximately
$0.8 million.
On December 8, 2016, the Company sold 1,360,960 shares
of common stock and warrants to purchase common stock at a price of
$3.13 in a public offering. The warrants consist of
680,480 Series CC warrants to purchase
680,480 shares of common stock, 1,360,960
Series DD warrants to purchase 1,360,960 shares of
common stock and 1,360,960 Series EE warrants to
purchase 1,360,960 shares of common stock. The Series
CC warrants are immediately exercisable, expire in five-years and
have an exercise price of $5.00 per share. The Series
DD warrants are immediately exercisable, expire in six-months and
have an exercise price of $4.50 per share. The Series
EE warrants are immediately exercisable, expire in nine-months and
have an exercise price of $4.50 per share. In
addition, the Company issued 68,048 Series FF warrants
to purchase 68,048 shares of common stock to the
placement agent. The FF warrants are exercisable at any time on or
after June 8, 2017 and expire on December 1, 2021 and have an
exercise price $3.91. The net proceeds to CEL-SCI from
this offering was approximately $3.7 million, excluding any future
proceeds that may be received from the exercise of the
warrants.
Inventory decreased by approximately $330,000 at March 31, 2017 as
compared to September 30, 2016, due to the timing of supplies
purchased and used in the manufacturing of Multikine for the Phase
3 clinical trial. In addition, receivables decreased by
approximately $390,000, primarily due to the timing of payments
reimbursed under the litigation funding arrangement noted
above.
Results of Operations and Financial Condition
During
the six months ended March 31, 2017, research and development
expenses increased by approximately $1.3 million compared to the
six months ended March 31, 2016. During the three months ended
March 31, 2017, research and development expenses increased by
approximately $2.4 million compared to the three months ended March
31, 2016. The Company is continuing the Phase 3 clinical trial
subject to the partial clinical hold, and research and development
fluctuates based on the activity level of the clinical trial. The
level of research and development expenses during the past 6 months
was particularly high. Based on the most recent bills and the fact
that currently we are not adding more patients to the study, we do
not expect future research and development expenses to remain at
this level.
During
the six months ended March 31, 2017, general and administrative
expenses increased by approximately $440,000, compared to the six
ended March 31, 2016. This increase is primarily due to an
approximate $1.1 million gain on de-recognition of legal fees to
record the transfer of the liability from the Company to Lake
Whillans that existed prior to the execution of the financing
agreement. The gain on de-recognition of legal fees is recorded as
a reduction of general and administrative expenses in the six
months ended March 31, 2016. The remaining difference is due to an
approximate $527,000 decrease in employee and non-employee stock
compensation due to the decrease in the market value of the common
stock and 13,152 fewer shares issued to non-employees
in the six months ended March 31, 2016 and approximately $133,000
in net other reductions of general and administrative
expenses.
The
gain on derivative instruments of approximately $8.9 million for
the six months ended March 31, 2017 and the loss on derivative
instruments of approximately $49,000 for the three months ended
March 31, 2017 were the result of the change in fair value of the
derivative liabilities during the respective periods. These changes
were caused by fluctuations in the share price of the
Company’s common stock. The gain on derivative instruments of
approximately $5.5 million for the six months ended March 31, 2016
and the loss on derivate instruments of approximately $2.6 million
for the three months ended March 31, 2016 were the results of the
changes in fair value of the derivative liabilities during the
respective periods. These changes were caused by fluctuations in
the share price of the Company’s common stock.
Net
interest expense decreased by approximately
$8,000 for the six months ended March 31, 2017
compared to March 31, 2016 and consisted
primarily of interest expense relating to the
lease liability offset by interest income earned on the
Company’s cash balances. Net interest expense increased
by approximately $6,000 for the three months
ended March 31, 2017 compared to March 31, 2016, and
consisted primarily of interest expense relating
to the lease liability offset by interest income earned on
the Company’s cash balances
Research and Development Expenses
The
Company’s research and development efforts involve Multikine
and LEAPS. The table below shows the research and development
expenses associated with each project.
|
Six months ended March 31,
|
Three months ended March 31,
|
|
2017
|
2016
|
2017
|
2016
|
MULTIKINE -
Restated
|
$ 9,950,673
|
$ 8,648,429
|
$ 6,487,667
|
$ 4,050,602
|
LEAPS
|
176,202
|
196,462
|
90,951
|
101,381
|
|
|
|
|
|
TOTAL -
Restated
|
$ 10,126,875
|
$ 8,844,891
|
$ 6,578,618
|
$ 4,151,983
|
Clinical
and other studies necessary to obtain regulatory approval of a new
drug involve significant costs and require several years to
complete. The extent of the Company’s clinical trials and
research programs are primarily based upon the amount of capital
available to the Company and the extent to which the Company has
received regulatory approvals for clinical trials. The inability of
the Company to conduct clinical trials or research, whether due to
a lack of capital or regulatory approval, will prevent the Company
from completing the studies and research required to obtain
regulatory approval for any products which the Company is
developing. Without regulatory approval, the Company will be unable
to sell any of its products. Since all of the Company’s
projects are under development, the Company cannot predict when it
will be able to generate any revenue from the sale of any of its
products.
Critical Accounting Estimates and Policies
Management’s discussion and analysis of the Company’s
financial condition and results of operations is based on its
unaudited condensed financial statements. The preparation of these
financial statements is based on the selection of accounting
policies and the application of significant accounting estimates,
some of which require management to make judgments, estimates and
assumptions that affect the amounts reported in the financial
statements and notes. The Company believes some of the more
critical estimates and policies that affect its financial condition
and results of operations are in the areas of operating leases and
stock-based compensation. For more information regarding the
Company’s critical accounting estimates and policies, see
Part II, Item 7 of the Company’s Annual Report on Form
10-K and 10-K/A for the year ended September 30, 2016. The
application of these critical accounting policies and estimates has
been discussed with the Audit Committee of the Company’s
Board of Directors.
Item
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISKS
The
Company does not believe that it has any significant exposures to
market risk.
Item
4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under
the direction and with the participation of the Company’s
management, including the Company’s Chief Executive and Chief
Financial Officer, the Company has conducted an evaluation of the
effectiveness of the design and operation of its disclosure
controls and procedures as of March 31, 2017. The Company maintains
disclosure controls and procedures that are designed to ensure that
information required to be disclosed in its periodic reports with
the Securities and Exchange Commission is recorded, processed,
summarized and reported within the time periods specified in the
SEC’s rules and regulations, and that such information is
accumulated and communicated to the Company’s management,
including its principal executive officer and principal financial
officer, as appropriate, to allow timely decisions regarding
required disclosure. The Company’s disclosure controls and
procedures are designed to provide a reasonable level of assurance
of reaching its desired disclosure control objectives. As
explained in Note I to the accompanying financial statements which
are part of this report, in November 2017, the Company discovered
an error in the way it accounted for the lease for its
manufacturing facility. Management has concluded that the
correction of the error for this lease, the lack of impairment
assessment for the related asset, and the operating effectiveness
of the financial close process are control deficiencies that
constitute material weaknesses. Based on the
above, the Company’s Chief
Executive and Financial Officer concluded that the Company’s
disclosure controls and procedures were not effective
as of March 31, 2017.
Changes in Internal Control over Financial Reporting
The
Company’s management, with the participation of the Chief
Executive and Chief Financial Officer, has evaluated whether any
change in the Company’s internal control over financial
reporting occurred during the first six months of fiscal year 2017.
There was no change in the Company’s internal control over
financial reporting during the six months ended March 31,
2017.
PART II
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds.
During
the three months ended March 31, 2017 the Company issued no
restricted shares of common stock to consultants for investor
relations services.
The
Company relied upon the exemption provided by Section 4(a)(2) of
the Securities Act of 1933 with respect to the issuance of these
shares. The individuals who acquired these shares were
sophisticated investors and were provided full information
regarding our business and operations. There was no general
solicitation in connection with the offer or sale of these
securities. The individuals who acquired these shares acquired them
for their own accounts. The certificate representing these shares
bears a restricted legend providing that they cannot be sold except
pursuant to an effective registration statement or an exemption
from registration. No commission or other form of remuneration was
given to any person in connection with the issuance of these
shares.
Item 6.
(a) Exhibits
Number
|
|
Exhibit
|
|
|
|
|
|
Rule 13a-14(a)
Certifications
|
|
|
|
|
|
Section 1350
Certifications
|
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
|
CEL-SCI
CORPORATION
|
|
|
|
|
|
Date:
December 11, 2017 |
By:
|
/s/
Geert
Kersten
|
|
|
|
Geert
Kersten |
|
|
|
Geert Kersten,
Principal Executive Officer* |
|
* Also
signing in the capacity of the Principal Accounting and Financial
Officer.