Blueprint
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
(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, 2018
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
|
|
84-0916344
|
State or other
jurisdiction incorporation
|
|
(IRS)
Employer Identification Number
|
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, or a smaller
reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller
reporting company” and “emerging growth company”
in Rule 12b-2 of the Exchange Act. (Check One):
Large accelerated filer
|
☐
|
Accelerated filer
|
☐
|
Non-accelerated
filer
|
☐
|
Smaller reporting company
|
☒
|
(Do not
check if a smaller reporting company)
|
Emerging
growth company
|
☐
|
If an
emerging growth company, indicate by check mark 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
|
|
No. Shares
Outstanding
|
|
Date
|
Common
|
|
16,895,106
|
|
May 14,
2018
|
TABLE
OF CONTENTS
PART I FINANCIAL INFORMATION
Item 1.
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Page
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Condensed Balance Sheets at March 31, 2018 and September 30, 2017 (unaudited)
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3
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|
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Condensed Statements of Operations for the six months
ended March 31, 2018 and 2017
(unaudited)
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4
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Condensed Statements of Operations for the three months
ended March 31, 2018 and 2017
(unaudited)
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5
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Condensed Statements of Cash Flows for the six months
ended March 31, 2018 and 2017
(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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23
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Item 3.
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Quantitative and Qualitative Disclosures about Market
Risks
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25
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Item 4.
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Controls and Procedures
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25
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PART II
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|
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Item 2.
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Unregistered Sales of Equity Securities and Use of
Proceeds
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26
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Item 6.
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Exhibits
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26
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Signatures
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27
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CEL-SCI CORPORATION
CONDENSED BALANCE SHEETS
(UNAUDITED)
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MARCH 31,
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SEPTEMBER 30,
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ASSETS
|
2018
|
2017
|
|
|
|
Current
Assets:
|
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Cash
and cash equivalents
|
$3,062,189
|
$2,369,438
|
Receivables
|
136,783
|
218,481
|
Prepaid
expenses
|
879,592
|
826,429
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Deposits
- current portion
|
-
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150,000
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Inventory
used for R&D and manufacturing
|
630,311
|
672,522
|
|
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Total
current assets
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4,708,875
|
4,236,870
|
|
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Plant,
property and equipment, net
|
16,503,718
|
16,793,220
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Patent
costs, net
|
206,847
|
223,167
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Deposits
|
1,670,917
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1,670,917
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|
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Total
Assets
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$23,090,357
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$22,924,174
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|
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LIABILITIES
AND STOCKHOLDERS' DEFICIT
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Current
Liabilities:
|
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Accounts
payable
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$7,687,172
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$8,196,334
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Accrued
expenses
|
902,732
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936,698
|
Due
to employees
|
1,054,803
|
693,831
|
Notes
payable
|
1,176,660
|
994,258
|
Derivative
instruments, current portion
|
20,919
|
10,984
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Other
current liabilities
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14,576
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12,449
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|
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Total
current liabilities
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10,856,862
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10,844,554
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|
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Derivative
instruments, net of current portion
|
1,835,898
|
2,042,418
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Lease
liability
|
13,295,489
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13,211,925
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Deferred
revenue
|
125,000
|
125,000
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Other
liabilities
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35,383
|
37,254
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|
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Total
liabilities
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26,148,632
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26,261,151
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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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-
|
Common
stock, $.01 par value - 600,000,000 shares authorized;
|
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16,624,552
and 11,903,133 shares issued and outstanding
|
|
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at
March 31, 2018 and September 30, 2017, respectively
|
166,246
|
119,031
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Additional
paid-in capital
|
307,425,853
|
296,298,401
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Accumulated
deficit
|
(310,650,374)
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(299,754,409)
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|
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Total
stockholders' deficit
|
(3,058,275)
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(3,336,977)
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TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$23,090,357
|
$22,924,174
|
See
notes to condensed financial statements.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2018 and 2017
(UNAUDITED)
|
2018
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2017
|
|
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|
Grant
and other income
|
$245,859
|
$34,433
|
|
|
|
Operating
Expenses:
|
|
|
Research
and development
|
5,288,311
|
10,126,875
|
General
& administrative
|
4,074,723
|
2,752,123
|
|
|
|
Total
operating expenses
|
9,363,034
|
12,878,998
|
|
|
|
Operating
loss
|
(9,117,175)
|
(12,844,565)
|
|
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|
Gain
on derivative instruments
|
196,585
|
8,879,612
|
|
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Interest
expense, net
|
(1,975,375)
|
(940,385)
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|
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Net
loss available to common shareholders
|
$(10,895,965)
|
$(4,905,338)
|
|
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Net
loss per common share
|
|
|
Basic
|
$(0.81)
|
$(0.74)
|
Diluted
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$(0.81)
|
$(0.78)
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|
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Weighted
average common shares outstanding
|
|
|
Basic
|
13,403,878
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6,649,814
|
Diluted
|
13,403,878
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6,682,592
|
See notes to condensed financial statements.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2018 and 2017
(UNAUDITED)
|
2018
|
2017
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|
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|
Grant
and other income
|
$131,962
|
$17,175
|
|
|
|
Operating
Expenses:
|
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|
Research
and development
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2,962,297
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6,578,618
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General
& administrative
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1,375,410
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1,345,114
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|
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Total
operating expenses
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4,337,707
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7,923,732
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Operating
loss
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(4,205,745)
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(7,906,557)
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Gain
(loss) on derivative instruments
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1,154,815
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(48,700)
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Interest
expense, net
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(1,657,205)
|
(471,234)
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Net
loss available to common shareholders
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$(4,708,135)
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$(8,426,491)
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Net
loss per common share
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|
Basic
and diluted
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$(0.31)
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$(1.15)
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Weighted
average common shares outstanding
|
|
|
Basic
and diluted
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15,210,296
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7,319,761
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See notes to condensed financial statements.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED MARCH 31, 2018 and 2017
(UNAUDITED)
|
2018
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2017
|
|
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Net
loss
|
$(10,895,965)
|
$(4,905,338)
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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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308,259
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318,357
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Share-based
payments for services
|
157,991
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112,778
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Equity
based compensation
|
1,727,915
|
677,755
|
Common
stock contributed to 401(k) plan
|
72,400
|
76,426
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Ergomed
stock issuance
|
1,247,400
|
-
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Loss
on retired equipment
|
-
|
1,187
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Gain
on derivative instruments
|
(196,585)
|
(8,879,612)
|
Amortization
of debt discount
|
1,023,084
|
-
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Capitalized
lease interest
|
83,564
|
99,334
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(Increase)/decrease
in assets:
|
|
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Receivables
|
81,698
|
84,922
|
Prepaid
expenses
|
42,748
|
219,543
|
Inventory
used for R&D and manufacturing
|
42,211
|
329,978
|
Deposits
|
150,000
|
154,995
|
Increase/(decrease)
in liabilities:
|
|
|
Accounts
payable
|
(541,767)
|
4,214,678
|
Accrued
expenses
|
(33,966)
|
131,169
|
Due
to employees
|
360,972
|
140,511
|
Deferred
rent liability
|
2,638
|
(1,748)
|
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Net
cash used in operating activities
|
(6,367,403)
|
(7,225,065)
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CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
Purchases
of equipment
|
-
|
(10,525)
|
Expenditures
for patent costs
|
(1,113)
|
-
|
|
|
|
Net
cash used in investing activities
|
(1,113)
|
(10,525)
|
|
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CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
Proceeds
from issuance of common stock and warrants
|
7,065,137
|
5,849,444
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Payments
on obligations under capital lease
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(3,870)
|
(2,048)
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|
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Net
cash provided by financing activities
|
7,061,267
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5,847,396
|
|
|
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
692,751
|
(1,388,194)
|
|
|
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CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
2,369,438
|
2,917,996
|
|
|
|
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$3,062,189
|
$1,529,802
|
See notes to condensed financial statements.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED MARCH 31, 2018 and 2017
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
|
2018
|
2017
|
Decrease
in receivable due under the litigation funding arrangement
offset
|
|
|
by
the same amount payable to the legal firm providing the
services
|
$-
|
$305,341
|
Capitalizable
patent costs included in accounts payable
|
$8,137
|
$8,644
|
Capital
lease obligation included in accounts payable
|
$402
|
$1,500
|
Property
and equipment acquired through capital lease
|
$-
|
$26,104
|
Fair
value of warrants issued in connection with public
offering
|
$-
|
$3,921,423
|
Financing
costs included in accounts payable
|
$68,374
|
$118,866
|
Prepaid
consulting services paid with issuance of common stock
|
$95,911
|
$(41,668)
|
Notes
payable converted into common shares
|
$184,300
|
$-
|
|
|
|
|
|
|
Cash
paid for interest expense
|
$872,087
|
$940,471
|
See notes to condensed financial statements.
CEL-SCI CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
THREE MONTHS ENDED MARCH 31, 2018 AND 2017 (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, 2017.
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, 2018 and the results of its operations for the six months then
ended. The condensed balance sheet as of September 30, 2017 is
derived from the September 30, 2017 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 six and three months
ended March 31, 2018 and 2017 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. Management
accrues CRO expenses and clinical trial study expenses based on
services performed and relies on the CROs to provide estimates of
those costs applicable to the completion stage of a study.
Estimated accrued CRO costs are subject to revisions as such
studies progress to completion. The Company charges revisions to
estimated expense in the period in which the facts that give rise
to the revision become known.
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, 2018 and September 30, 2017.
On
December 22, 2017, the “Tax Cuts and Jobs Act” (the
“Tax Act”:), was signed into law by the President of
the United States (U.S.). The Tax Act includes significant changes
to corporate taxation, including reduction of the U.S. corporate
tax rate from 35% to 21%, effective January 1, 2018, limitation of
the tax deduction for interest expense to 30% of earnings (except
for certain small businesses), limitation of the deduction for net
operating losses to 80% of current year taxable income and
elimination of net operating loss carrybacks. The Company has
accounted for certain income tax effects of the Act in applying
FASB ASC 740 to the current reporting period. Because the Company
records a valuation allowance for its entire deferred income tax
asset, there was no impact to the amounts reported in the
Company’s financial statements resulting from the Tax
Act.
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 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 re-measured at fair value at the end of each
interim period.
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. Upon occupancy 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.
Forfeitures are accounted for when they occur. The expected term of
options represents the period 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 May 2017, the FASB issued ASU
2017-09, Compensation – Stock
Compensation (Topic 718), which
affects any entity that changes the terms or conditions of a
share-based payment award. This Update amends the definition
of modification by qualifying that modification accounting does not
apply to changes to outstanding share-based payment awards that do
not affect the total fair value, vesting requirements, or
equity/liability classification of the awards. The amendments
in this Update are effective for all entities for annual periods,
and interim periods within those annual periods, beginning after
December 15, 2017. Early adoption is permitted, including adoption
in any interim period, for (1) public business entities for
reporting periods for which financial statements have not yet been
issued and (2) all other entities for reporting periods for which
financial statements have not yet been made available for issuance.
The amendments in this Update should be applied prospectively to an
award modified on or after the adoption date. The Company
adopted the provisions of ASU 2017-09 effective January 1,
2018. There was no impact on the financial position or results
operations for the six and three months ended March 31,
2018.
In July 2017, the FASB issued ASU
2017-11, Earnings Per Share (Topic
260), Distinguishing Liabilities from Equity (Topic 480), and
Derivative and Hedging (Topic 815). The amendments in Part I of this Update change
the classification analysis of certain equity-linked financial
instruments (or embedded features) with down-round features. When
determining whether certain financial instruments should be
classified as liabilities or equity instruments, a down-round
feature no longer precludes equity classification when assessing
whether the instrument is indexed to an entity’s own stock.
The amendments also clarify existing disclosure requirements for
equity-classified instruments. As a result, a freestanding
equity-linked financial instrument (or embedded conversion option)
no longer would be accounted for as a derivative liability at fair
value as a result of the existence of a down-round feature. For
freestanding equity classified financial instruments, the
amendments require entities that present earnings per share
(“EPS”) in accordance with Topic 260 to recognize the
effect of the down-round feature when it is triggered. That effect
is treated as a dividend and as a reduction of income available to
common shareholders in basic EPS. Convertible instruments with
embedded conversion options that have down-round features are now
subject to the specialized guidance for contingent beneficial
conversion features (in Subtopic 470-20, Debt—Debt with
Conversion and Other Options),
including related EPS guidance (in Topic 260). The amendments in
Part II of this Update re-characterize the indefinite deferral of
certain provisions of Topic 480 that now are presented as pending
content in the Accounting Standards Codification, to a scope
exception. Those amendments do not have an accounting effect. For
public business entities, the amendments in Part I of this Update
are effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2018. Early adoption is
permitted, including adoption in an interim period. If an entity
early adopts the amendments in an interim period, any adjustments
should be reflected as of the beginning of the fiscal year that
includes that interim period. The amendments in Part I of this
Update should be applied either retrospectively to outstanding
financial instruments with a down-round feature by means of a
cumulative-effect adjustment to the statement of financial position
as of the beginning of the first fiscal year and interim period(s)
in which the pending content that links to this paragraph is
effective or retrospectively to outstanding financial instruments
with a down-round feature for each prior reporting period presented
in accordance with the guidance on accounting changes in paragraphs
250-10-45-5 through 45-10. The amendments in Part II of this Update
do not require any transition guidance because those amendments do
not have an accounting effect. The Company does not expect the
adoption of this standard to have a significant impact on its EPS
calculations, as it does not have any free-standing equity based
financial instruments with down-round
provisions.
In August 2017, the FASB issued ASU
2017-12, Derivatives and Hedging (Topic
850), the objective of which is
to improve the financial reporting of hedging relationships to
better portray the economic results of an entity’s risk
management activities in its financial statements. In addition, the
amendments in this Update make certain targeted improvements to
simplify the application and disclosure of the hedge accounting
guidance in current general accepted accounting
principles. For public business entities, the amendments
in this Update are effective for fiscal years beginning after
December 15, 2018, and interim periods within those fiscal years.
For all other entities, the amendments are effective for fiscal
years beginning after December 15, 2019, and interim periods
beginning after December 15, 2020. Early adoption is permitted in
any period after issuance. For cash flow and net
investment hedges existing at the date of adoption, an entity
should apply a cumulative-effect adjustment related to eliminating
the separate measurement of ineffectiveness to accumulated
other comprehensive income with a corresponding adjustment to the
opening balance of retained earnings as of the beginning of the
fiscal year that an entity adopts the amendments in this Update.
The amended presentation and disclosure guidance is required only
prospectively. The Company is currently evaluating the
impact the adoption of the standard will have on the
Company’s financial position or results of
operations.
In February 2016, the FASB issued ASU
2016-02, Leases, which will require most long-term leases 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 impact the
adoption of the standard will have on the Company’s financial
position or results of operations.
In
March 2016, the FASB issued ASU 2016-09 Compensation—Stock Compensation (Topic
718): Improvements to Employee Share-Based Payment
Accounting. The guidance simplified the accounting and
financial reporting of the income tax impact of share-based
compensation arrangements. This guidance requires excess tax
benefits to be recorded as a discrete item within income tax
expense rather than additional paid-in-capital. In addition, excess
tax benefits are required to be classified as cash from operating
activities rather than cash from financing activities. The Company
adopted the provisions of ASU 2016-09 effective October 1,
2017. The Company elected to apply the cash flow guidance of ASU
2016-09 retrospectively to all prior periods with no impact to
historical periods. The Company also adopted a change in accounting
policy to recognize forfeitures of awards as they occur instead of
estimating potential forfeitures with no material impact on
historical periods.
The
Company has considered all other recently issued accounting
pronouncements and does not believe the adoption of such
pronouncements will have a material impact on its financial
statements.
B.
OPERATIONS AND FINANCING
The
Company has incurred significant costs since its inception for 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. To date, the Company has not
generated any revenue from product sales. 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 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, 2018, the Company raised approximately $7.1 million in
net proceeds from private offerings. 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 may have to curtail its operations until such
time as it is able to raise the required funding. The financial
statements have been prepared assuming the Company will continue as
a going concern, but due to the Company’s negative working
capital, stockholders’ deficit, 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.
As of March 31, 2018, the Company has incurred
expenses of approximately $48.7 million on direct costs for the
Phase 3 clinical trial since its launch of the Phase 3 clinical
trial for Multikine. The Company estimates it will incur additional
expenses of approximately $10.5 million for the remainder of the
Phase 3 clinical trial. 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, including manufacturing of the drug. This number may be
affected by the 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. Nine
hundred twenty-eight (928) head and neck cancer patients have been
enrolled and have completed treatment in the Phase 3 study. The
study end point is a 10% increase in overall survival of patients
between the two main comparator groups in favor of the group
receiving the Multikine treatment regimen. The determination if the
study end point is met will occur when there are a total of 298
deaths in those two groups.
The
Company’s shareholders approved a reverse split of the
Company’s common stock which became effective on the NYSE
American on June 15, 2017. On that date, every twenty-five issued
and outstanding shares of the Company’s common stock
automatically converted into one outstanding share of common stock.
As a result of the reverse stock split, the number of outstanding
shares of common stock decreased from 230,127,331 (pre-split)
shares to 9,201,645 (post-split) shares. The reduction in the
number of outstanding shares resulted in an increase in the
Company’s loss per share by a factor of twenty-five, in all
prior periods. The reverse stock split affected all stockholders of
the Company’s common stock uniformly, and did not affect any
stockholder’s percentage of ownership interest. The par value
of the Company’s stock remained unchanged at $0.01 per
share and the number of
authorized shares of common stock remained the same after the
reverse stock split.
Stock
options, stock bonuses and compensation granted by the Company as
of March 31, 2018 are as follows:
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding
Options
|
Shares Issued
|
Remaining Options/Shares Under
Plans
|
|
|
|
|
|
Incentive Stock
Options Plans
|
138,400
|
123,558
|
N/A
|
385
|
Non-Qualified Stock
Option Plans
|
1,187,200
|
1,100,814
|
N/A
|
45,341
|
Stock Bonus
Plans
|
383,760
|
N/A
|
248,475
|
135,252
|
Stock Compensation
Plan
|
134,000
|
N/A
|
115,590
|
18,410
|
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, 2017 are as follows:
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding
Options
|
Shares Issued
|
Remaining Options/Shares Under
Plans
|
|
|
|
|
|
Incentive Stock
Option Plans
|
138,400
|
124,758
|
N/A
|
454
|
Non-Qualified Stock
Option Plans
|
1,187,200
|
1,115,086
|
N/A
|
42,830
|
Bonus
Plans
|
383,760
|
N/A
|
206,390
|
177,337
|
Stock Compensation
Plan
|
134,000
|
N/A
|
115,590
|
18,410
|
Incentive Stock
Bonus Plan
|
640,000
|
N/A
|
624,000
|
16,000
|
Stock option
activity:
|
Six Months Ended March 31,
|
|
2018
|
2017
|
Granted
|
10,300
|
-
|
Expired
|
24,379
|
15,281
|
Forfeited
|
1,393
|
1,061
|
|
Three Months Ended March 31,
|
|
2018
|
2017
|
Granted
|
-
|
-
|
Expired
|
584
|
200
|
Forfeited
|
6,856
|
1,061
|
Stock-Based Compensation Expense
|
Six months Ended March 31,
|
|
2018
|
2017
|
Employees
|
$1,727,915
|
$677,755
|
Non-employees
|
$157,991
|
$112,778
|
|
Three months Ended March 31,
|
|
2018
|
2017
|
Employees
|
$279,817
|
$365,380
|
Non-employees
|
$115,649
|
$34,225
|
Employee
compensation expense includes the expense related to options issued
or vested and restricted stock. The increase in employee’s
expense in 2018 is primarily due to an increase of approximately
$1.1 million in equity based compensation related to the
Company’s shareholder approved 2014 Incentive Stock Bonus
Plan. Non-employee expense includes the expense related to options
and stock issued to consultants expensed over the period of their
service contracts. Stock based compensation expense is included in
general and administrative expenses on the statements of
operations.
Warrants and Non-employee Options
The
following chart presents the outstanding warrants and non-employee
options, listed by expiration date at March 31, 2018:
Warrant
|
|
Issue Date
|
|
Shares Issuable upon
Exercise of Warrants
|
|
Exercise
Price
|
|
Expiration Date
|
|
Reference
|
|
|
|
|
|
|
|
|
|
|
|
Series DD
|
|
12/8/2016
|
|
1,360,960
|
|
$4.50
|
|
7/1/2018
|
|
1
|
Series EE
|
|
12/8/2016
|
|
1,360,960
|
|
$4.50
|
|
7/1/2018
|
|
1
|
Series N
|
|
8/18/2008
|
|
85,339
|
|
$3.00
|
|
8/18/2018
|
|
*
|
Series S
|
|
10/11/13- 10/24/14
|
|
1,037,120
|
|
$3.00
|
|
10/11/2018
|
|
1
|
Series V
|
|
5/28/2015
|
|
810,127
|
|
$19.75
|
|
5/28/2020
|
|
1
|
Series W
|
|
10/28/2015
|
|
688,930
|
|
$16.75
|
|
10/28/2020
|
|
1
|
Series X
|
|
1/13/2016
|
|
120,000
|
|
$9.25
|
|
1/13/2021
|
|
*
|
Series Y
|
|
2/15/2016
|
|
26,000
|
|
$12.00
|
|
2/15/2021
|
|
*
|
Series ZZ
|
|
5/23/2016
|
|
20,000
|
|
$13.75
|
|
5/18/2021
|
|
1
|
Series BB
|
|
8/26/2016
|
|
16,000
|
|
$13.75
|
|
8/22/2021
|
|
1
|
Series Z
|
|
5/23/2016
|
|
264,000
|
|
$13.75
|
|
11/23/2021
|
|
1
|
Series FF
|
|
12/8/2016
|
|
68,048
|
|
$3.91
|
|
12/1/2021
|
|
1
|
Series CC
|
|
12/8/2016
|
|
680,480
|
|
$5.00
|
|
12/8/2021
|
|
1
|
Series HH
|
|
2/23/2017
|
|
20,000
|
|
$3.13
|
|
2/16/2022
|
|
1
|
Series AA
|
|
8/26/2016
|
|
200,000
|
|
$13.75
|
|
2/22/2022
|
|
1
|
Series JJ
|
|
3/14/2017
|
|
30,000
|
|
$3.13
|
|
3/8/2022
|
|
1
|
Series LL
|
|
4/30/2017
|
|
26,398
|
|
$3.59
|
|
4/30/2022
|
|
1
|
Series MM
|
|
6/22/2017
|
|
893,491
|
|
$1.86
|
|
6/22/2022
|
|
*
|
Series NN
|
|
7/24/2017
|
|
539,300
|
|
$2.52
|
|
7/24/2022
|
|
*
|
Series OO
|
|
7/31/2017
|
|
60,000
|
|
$2.52
|
|
7/31/2022
|
|
*
|
Series QQ
|
|
8/22/2017
|
|
87,500
|
|
$2.50
|
|
8/22/2022
|
|
*
|
Series GG
|
|
2/23/2017
|
|
400,000
|
|
$3.00
|
|
8/23/2022
|
|
1
|
Series II
|
|
3/14/2017
|
|
600,000
|
|
$3.00
|
|
9/14/2022
|
|
1
|
Series RR
|
|
10/30/2017
|
|
583,057
|
|
$1.65
|
|
10/30/2022
|
|
2
|
Series KK
|
|
5/3/2017
|
|
395,970
|
|
$3.04
|
|
11/3/2022
|
|
1
|
Series SS
|
|
12/19/2017
|
|
1,289,478
|
|
$2.09
|
|
12/18/2022
|
|
2
|
Series TT
|
|
2/5/2018
|
|
1,875,860
|
|
$2.24
|
|
2/5/2023
|
|
2
|
Series PP
|
|
8/28/2017
|
|
1,750,000
|
|
$2.30
|
|
2/28/2023
|
|
*
|
Consultants
|
|
7/1/15- 7/28/17
|
|
38,400
|
|
$2.18- $16.50
|
|
6/30/18- 7/27/27
|
|
3
|
*No
current period changes occurred relating to these
warrants.
1.
Derivative Liabilities
The
table below presents the warrant liabilities and their respective
balances at the balance sheet dates:
|
March 31,
2018
|
September 30,
2017
|
|
|
|
Series S
warrants
|
$20,847
|
$32,773
|
Series V
warrants
|
76,457
|
72,912
|
Series W
warrants
|
107,885
|
83,754
|
Series Z
warrants
|
69,122
|
77,216
|
Series ZZ
warrants
|
4,564
|
4,753
|
Series AA
warrants
|
56,411
|
65,087
|
Series BB
warrants
|
4,029
|
4,322
|
Series CC
warrants
|
352,301
|
394,220
|
Series DD
warrants
|
36
|
5,492
|
Series EE
warrants
|
36
|
5,492
|
Series FF
warrants
|
39,853
|
47,154
|
Series GG
warrants
|
304,754
|
342,173
|
Series HH
warrants
|
13,331
|
16,014
|
Series II
warrants
|
461,028
|
511,636
|
Series JJ
warrants
|
20,193
|
24,203
|
Series KK
warrants
|
308,796
|
345,720
|
Series LL
warrants
|
17,174
|
20,481
|
|
|
|
Total warrant
liabilities
|
$1,856,817
|
$2,053,402
|
The
table below presents the gains and (losses) on the warrant
liabilities for the six months ended March 31:
|
2018
|
2017
|
Series S
Warrants
|
$11,927
|
$2,579,836
|
Series V
warrants
|
(3,547)
|
1,417,721
|
Series W
warrants
|
(24,131)
|
1,609,415
|
Series Z
warrants
|
8,095
|
828,263
|
Series ZZ
warrants
|
189
|
61,195
|
Series AA
warrants
|
8,676
|
646,665
|
Series BB
warrants
|
293
|
50,338
|
Series CC
warrants
|
41,919
|
429,869
|
Series DD
warrants
|
5,456
|
413,948
|
Series EE
warrants
|
5,456
|
512,238
|
Series FF
warrants
|
7,301
|
47,166
|
Series GG
warrants
|
37,419
|
108,211
|
Series HH
warrants
|
2,683
|
5,340
|
Series II
warrants
|
50,608
|
161,419
|
Series JJ
warrants
|
4,010
|
7,988
|
Series KK
warrants
|
36,924
|
-
|
Series LL
warrants
|
3,307
|
-
|
Net gain on warrant
liabilities
|
$196,585
|
$8,879,612
|
The
table below presents the gains and (losses) on the warrant
liabilities for the three months ended March 31:
|
2018
|
2017
|
Series S
Warrants
|
$(1,141)
|
$(41,485)
|
Series V
warrants
|
94,766
|
-
|
Series W
warrants
|
105,336
|
(58,189)
|
Series Z
warrants
|
63,630
|
(40,524)
|
Series ZZ
warrants
|
3,532
|
(2,689)
|
Series AA
warrants
|
56,036
|
(32,904)
|
Series BB
warrants
|
2,924
|
(2,334)
|
Series CC
warrants
|
238,740
|
(174,623)
|
Series DD
warrants
|
(27)
|
43,029
|
Series EE
warrants
|
(27)
|
(2,365)
|
Series FF
warrants
|
25,348
|
(19,574)
|
Series GG
warrants
|
152,551
|
108,211
|
Series HH
warrants
|
8,345
|
5,340
|
Series II
warrants
|
229,414
|
161,419
|
Series JJ
warrants
|
12,552
|
7,988
|
Series KK
warrants
|
151,951
|
-
|
Series LL
warrants
|
10,885
|
-
|
Net gain (loss) on
warrant liabilities
|
$1,154,815
|
$(48,700)
|
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 in the
accompanying statements of operations.
Changes in Liability Classified Warrants
On
January 12, 2018, the exercise price of the Company’s
outstanding Series S warrants that are publicly traded under the
symbol “CVM WS” on the NYSE American, was changed to
$3.00 per share for a three month period which will end on April
12, 2018. On April 3, 2018, the price was reduced to $1.75 and was
extended through June 11, 2018. (See Note J, “Subsequent
Events”). After this date, the exercise price will revert
back to $31.25 per share of common stock. This modification was
reflected in the fair value measurement of the warrants.
Twenty-five (25) Series S warrants are required to purchase one
share of common stock. The Series S warrants expire on October 11,
2018.
On
February 23, 2018, the Company extended the expiration date of its
Series DD and Series EE warrants to July 1, 2018. This modification
was reflected in the fair value measurement of the
warrants.
On
October 17, 2017, 17,821 Series U warrants, with an exercise price
of $43.75 expired. The fair value of the Series U 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.
2.
Issuance of Equity Warrants
Series TT Warrants
On
February 5, 2018, the Company sold 2,501,145 shares of its common
stock at a price of $1.87 per share for total proceeds of
approximately $4.7 million. The common stock is restricted unless
registered. The purchasers of the common stock also received Series
TT warrants which allow the purchasers to acquire up to 1,875,860
shares of the Company’s common stock. The warrants are
exercisable at a fixed price of $2.24 per share, will not be
exercisable for 6 months and one day and expire on February 5,
2023. Shares issuable upon the exercise of the warrants are
restricted securities unless registered. The shares and warrants
were registered on February 28, 2018. The Company allocated the proceeds received to the
shares and the Series TT warrants on a relative fair value basis.
As a result of such allocation, the Company determined the relative
fair value of the Series TT warrants to be approximately $1.56
million. The Series TT warrants qualify for equity treatment in
accordance with ASC 815.
Series SS Warrants
On
December 19, 2017 the Company received subscription agreements for
the purchase of 1,289,478 shares of its common stock at a price of
$1.90 in the principal amount of $2.45 million. The
purchasers of the common stock also received Series SS warrants
which allow the purchasers to acquire up to 1,289,478 shares of the
Company’s common stock. The warrants are
exercisable at a fixed price of $2.09 per share, are exercisable on
June 20, 2018 and will expire on December 18, 2022. Shares issuable
upon the exercise of the warrants will be restricted securities
unless registered. The shares and warrants were registered on
January 23, 2018. The Company allocated the proceeds received to
the shares and the Series SS warrants on a relative fair value
basis. As a result of such allocation, the Company determined the
relative fair value of the Series SS warrants to be approximately
$1.0 million. The Series SS warrants qualify for equity treatment
in accordance with ASC 815.
Series RR Warrants
On
October 30, 2017, holders of convertible notes in the principal
amount of $1.1 million issued in June 2017 and holders of
convertible notes in the principal amount of $1.2 million issued in
July 2017 agreed to extend the maturity date of these notes to
September 21, 2018. In consideration for the extension
of the maturity date of the convertible notes, the Company issued a
total of 583,057 Series RR warrants to the convertible note holders
that agreed to the extension. Each Series RR warrant
entitles the holder to purchase one share of the Company’s
common stock. The Series RR warrants may be exercised at
any time on or before October 30, 2022 at an exercise price of
$1.65 per share. The Series RR warrants were recorded at
approximately $0.7 million, the relative fair value on the date of
issuance, as described in Note F.
3.
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, 2018, the Company issued 137,787 and 124,082 shares
of common stock respectively, all of which were restricted shares.
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 weighted average
grant date fair value of the shares issued to consultants during
the six months ended March 31, 2018 and 2017, was $1.84 and $4.45
respectively. 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, 2018, the Company recorded
total expense of approximately $158,000 and $116,000, respectively,
relating to these consulting agreements. 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. At March 31, 2018 and September 30, 2017,
approximately $141,000 and $45,000, respectively, are included in
prepaid expenses. As of March 31, 2018, the Company had 38,400
options outstanding, which were issued to consultants as payment
for services. All off these options were vested and all were issued
from the Non-Qualified Stock Option plans.
Other Equity Transactions
Effective January
1, 2018, the Company entered into a Securities Purchase Agreement
with Ergomed plc, the Company’s Clinical Research Provider,
to facilitate a partial payment of the accounts payable balances
due Ergomed. Under the Agreement, the Company issued Ergomed
660,000 shares, with a fair market value of approximately $1.3
million, as a forbearance fee in exchange for Ergomed’s
agreement to provisionally forbear collection of the payables in an
amount equal to the net proceeds from the resales of the shares
issued to Ergomed. During the quarter ended March 31, 2018, the
Company recorded the full amount of the expense upon issuance,
offset by amounts realized through the resale by Ergomed of 269,333
shares for approximately $0.5 million and the corresponding
reduction of the payables resulting in a net expense of
approximately $0.8 million. As of March 31, 2018, Ergomed holds the
remaining 390,667 shares and may resell the shares or return the
shares to the Company for cancellation until December 31,
2018.
On
August 15, 2017, the Company entered into a similar Securities
Purchase Agreement with Ergomed plc, whereby the Company issued
Ergomed 480,000 shares, with a fair market value of approximately
$1.3 million, as a forbearance fee in exchange for Ergomed’s
agreement to provisionally forbear collection of the payables in an
amount equal to the net proceeds from the resales of the shares
issued to Ergomed. During the year ended September 30, 2017, the
Company recorded the full amount of the expense upon issuance,
offset by amounts realized through the resale of 64,792 shares and
the corresponding reduction of the payables, for a net expense of
$1.2 million. During the quarter ended December 31, 2017, the
Company realized approximately $0.7 million through the resale of
the remaining 415,208 shares and reduced the payables and interest
expense by that amount.
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, 2018:
|
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
|
$20,846
|
$-
|
$1,835,971
|
$1,856,817
|
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, 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
|
$32,773
|
$-
|
$2,020,629
|
$2,053,402
|
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,
2018 and the year ended September 30, 2017:
|
6 months ended
|
12 months ended
|
|
March 31,
2018
|
September 30,
2017
|
|
|
|
Beginning
balance
|
$2,020,629
|
$5,283,573
|
Issuances
|
-
|
4,665,683
|
Realized and
unrealized gains
|
(184,658)
|
(7,928,627)
|
Ending
balance
|
$1,835,971
|
$2,020,629
|
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
On July
24, 2017, the Company issued convertible notes (Series NN Notes) in
the aggregate principal amount of $1.2 million to 12 individual
investors. A trust in which Geert Kersten, the Company’s
Chief Executive Officer, holds a beneficial interest participated
in the offering and purchased a note in the principal amount of
$250,000. Patricia B. Prichep, the Company’s Senior Vice
President of Operations, participated in the offering and purchased
a note in the principal amount of $25,000. The terms of the
trust’s note and Ms. Prichep’s note were identical to
the other participants. The number of shares of the Company’s
common stock issued upon conversion will be determined by dividing
the principal amount to be converted by $2.29, which would result
in the issuance of 109,170 shares to the trust and 10,917 shares to
Ms. Prichep upon conversion. Along with the other purchasers of the
convertible notes, the trust and Ms. Prichep also received Series
NN warrants to purchase up to 109,170 and 10,917 shares,
respectively, of the Company’s common stock. The Series NN
warrants are exercisable at a fixed price of $2.52 per share and
expire on July 24, 2022. Shares issuable upon the exercise of the
notes and warrants were restricted securities unless registered.
The shares were registered effective September 1,
2017.
On June 22, 2017, CEL-SCI issued convertible notes
(Series MM Notes) in the aggregate principal amount of $1.5 million
to six individual investors. Geert Kersten, the
Company’s Chief Executive Officer, participated in the
offering and purchased a note in the principal amount of $250,000.
The terms of Mr. Kersten’s note were identical to the other
participants. The number of shares of the Company’s common
stock issued upon conversion will be determined by dividing the
principal amount to be converted by $1.69, which would result in
the issuance of 147,929 shares to Mr. Kersten upon conversion.
Along with the other purchasers of the convertible notes, Mr.
Kersten also received Series MM warrants to purchase up to 147,929
shares of the Company’s common stock. The Series MM warrants
are exercisable at a fixed price of $1.86 per share and expire on
June 22, 2022. Shares issuable upon the exercise of the notes and
warrants were restricted securities unless registered. The shares
were registered effective August 8, 2017.
On
October 30, 2017, the due dates of the Series NN and Series MM
Notes were extended from December 22, 2017 to September 21, 2018 in
exchange for Series RR warrants. Mr. Kersten, the Trust and Ms.
Prichep received 73,965, 54,585 and 5,459 Series RR warrants,
respectively. See Note F.
Approximately
$9,000 in accrued interest was due the officers at March 31, 2018.
No interest payments were made to officers during the six months
ended March 31, 2018.
On October 30, 2017, the Company extended
the due dates of the Series MM and Series NN Notes (the
“Notes”) from December 22, 2017 to September 21, 20l8,
and issued the note holders 583,057 of Series RR Warrants. The
Series RR warrants expire on October 30, 2022 and are exercisable
at a price of $1.65 per share, which was the closing price of the
Company’s common stock on October 27, 2017. These Series RR
warrants are classified as equity warrants and are recorded at
approximately $0.7 million, the fair value on the date of
issuance.
Because the Company is experiencing financial
difficulties and the creditors granted the Company a concession
they would not have otherwise considered in the form of a lower
effective interest rate, this modification was accounted for under
ASC 470-60, “Troubled Debt
Restructuring.” The
Company calculated the future cash flows of the restructured debt
to be greater than the carrying value of the debt and accounted for
the change in debt prospectively, using the effective interest rate
that equated the carrying amount to the future cash flows.
The carrying value of the debt on the date of restructuring was
approximately $0.7 million, which was net of a discount of
approximately $1.6 million. The discount is being amortized to
interest expense over the life of the Notes using the effective
interest method. During the six and three months ended March 31,
2018, the Company recorded approximately $1.0 and $0.4 million in
interest expense, respectively, relating to the amortization of the
debt discount. As of March 31, 2018, after conversions, the
carrying value of the Notes is approximately $1.2 million, net of a
discount of approximately $1.0 million. The Notes bear interest at
4% and can be converted into shares of the Company’s common
stock at a fixed conversion rate of $1.69 for the Series MM Notes
and $2.29 for the Series NN Notes.
During
the six months ended March 31, 2018, note holders converted notes
in the principal amount of $184,300, into 88,124 shares of common
stock. During the three months ended March 31, 2018, note holders
converted notes in the principal amount of $109,300, into 55,373
shares of common stock. The unamortized debt discounts relating to
the converted Notes were charged to interest expense.
The
Series MM and Series NN Notes are secured by a first lien on all of
the Company’s assets.
G.
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, 2018, all advance payments have been expensed.
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 Company’s Phase 3 Clinical Trial 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 $26.6 million related to
Ergomed’s services. This amount is net of Ergomed’s
discount of approximately $8.9 million. During the six and three
months ended March 31, 2018, the Company recorded, net of
Ergomed’s discount, approximately $1.7 million and $0.8
million, respectively, as research and development expense related
to Ergomed’s services. During the six and three months ended
March 31, 2017, the Company recorded, net of Ergomed’s
discount, approximately $4.1 million and $2.8 million,
respectively, as research and development expense related to
Ergomed’s services.
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 is seeking payment for damages related to
inVentiv’s prior involvement in the Phase 3 clinical trial of
Multikine. In the summer of 2017, inVentiv Health, Inc., the
ultimate parent company of the respondents in the arbitration,
merged with INC Research Holdings, Inc. The combined company was
renamed Syneos Health in January 2018. 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 has defended 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 provided the
Company with up to $5 million in funding for litigation expenses to
support its arbitration claims against inVentiv. The funding was
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. 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
hearing (the “trial”) started on September 26, 2016.
The last witness in the arbitration hearing testified on November
8, 2017, and no further witnesses or testimony are expected. With
that final witness, the testimony phase of the arbitration
concluded. All that remained after November 8, 2017 at the trial
level were closing statements and post-trial submissions. Closing
arguments in the arbitration against the former clinical research
organization (CRO) for our Phase 3 trial concluded on April 25,
2018. The parties are now awaiting a decision from the
arbitrator.
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
Company was deemed to be the owner of the building for accounting
purpose under the build-to-suit guidance in ASC 840-40-55. In
addition to tenant improvements the Company incurred, the Company
also recorded an asset for tenant-directed improvements and for the
costs paid by the lessor to purchase the building and to perform
improvements, as well as a corresponding liability for the landlord
costs. Upon completion of the improvements, the Company did not
meet the “sale-leaseback” criteria under ASC 840-40-25,
Accounting for Lease, Sale-Leaseback Transactions, and therefore,
treated the lease as a financing obligation. Thus, the asset and
corresponding liability were not de-recognized. As of March 31,
2018 and September 30, 2017, the leased building asset has a net
book value of approximately $16.4 and $16.6 million, respectively,
and the landlord liability has a balance of approximately $13.3 and
$13.2 million, respectively. The leased building is being
depreciated using a straight line method over the 20 year lease
term to a residual value. Depreciation on the leased building was
approximately $0.2 million and $0.1 million, respectively, for the
six and three months ended March 31, 2018 and 2017. Accumulated
depreciation was approximately $4.8 million and $4.6 million as of
March 31, 2018 and September 30, 2017, respectively. 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, 2018 and September 30,
2017.
Approximate
future minimum lease payments under the San Tomas lease as of March
31, 2018 are as follows:
Six months
ending September 30, 2018
|
$876,000
|
Year ending
September 30,
|
|
2019
|
1,808,000
|
2020
|
1,872,000
|
2021
|
1,937,000
|
2022
|
2,004,000
|
2023
|
2,073,000
|
Thereafter
|
11,685,000
|
Total future
minimum lease obligation
|
22,255,000
|
Less imputed
interest on financing obligation
|
(8,960,000)
|
Net present
value of lease financing obligation
|
$13,295,000
|
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, 2018 and September 30, 2017, the Company has
recorded a deferred rent liability of approximately $9,000 and
$5,000, 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,
2018 and September 30, 2017, the Company has recorded a deferred
rent liability of approximately $16,000 and $18,000,
respectively.
As of
March 31, 2018, material contractual obligations, excluding the San
Tomas lease, consisting of non-cancelable operating lease payments
are as follows:
Six months ending
September 30, 2018
|
$127,000
|
Year ending
September 30,
|
|
2019
|
258,000
|
2020
|
238,000
|
2021
|
163,000
|
2022
|
69,000
|
Total
|
$855,000
|
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.
H. PATENTS
During
the six and three months ended March 31, 2018 and 2017, no patent
impairment charges were recorded. For the six and three months
ended March 31, 2018, amortization of patent costs totaled
approximately $19,000 and $9,000, respectively. For the six and
three months ended March 31, 2017 amortization of patent costs
totaled approximately $19,000 and $10,000, respectively.
Approximate estimated future amortization expense is as
follows:
Six months ending
September 30, 2018
|
$18,000
|
Year ending
September 30,
|
|
2019
|
35,000
|
2020
|
32,000
|
2021
|
29,000
|
2022
|
25,000
|
2023
|
15,000
|
Thereafter
|
53,000
|
Total
|
$207,000
|
I.
LOSS PER COMMON
SHARE
The
following table provides the details of the basic and diluted loss
per-share computations:
|
Six months ended March 31,
|
Three months ended March 31,
|
|
2018
|
2017
|
2018
|
2017
|
Loss per share - basic
|
|
|
|
|
Net
loss available to common shareholders - basic
|
$(10,895,965)
|
$(4,905,338)
|
$(4,708,135)
|
$(8,426,491)
|
Weighted
average shares outstanding - basic
|
13,403,878
|
6,649,814
|
15,210,296
|
7,319,761
|
Basic
loss per common share
|
$(0.81)
|
$(0.74)
|
$(0.31)
|
$(1.15)
|
|
|
|
|
|
Loss per share - diluted
|
|
|
|
|
Net
loss available to common shareholders - basic
|
$(10,895,965)
|
$(4,905,338)
|
$(4,708,135)
|
$(8,426,491)
|
Gain
on derivatives
|
-
|
(330,124)
|
-
|
-
|
Net
loss available to common shareholders - diluted
|
$(10,895,965)
|
$(5,235,462)
|
$(4,708,135)
|
$(8,426,491)
|
|
|
|
|
|
Weighted
average shares outstanding - basic
|
13,403,878
|
6,649,814
|
15,210,296
|
7,319,761
|
Incremental shares underlying dilutive "in the
money" warrants (1)
|
-
|
32,778
|
-
|
-
|
Weighted
average shares outstanding - diluted
|
13,403,878
|
6,682,592
|
15,210,296
|
7,319,761
|
Diluted
loss per common share
|
$(0.81)
|
$(0.78)
|
$(0.31)
|
$(1.15)
|
|
|
|
|
|
(1) Includes series FF, GG, HH,
II and JJ for the six months ended March 31,
2017
|
|
|
|
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:
|
2018
|
2017
|
|
|
|
Options
and Warrants
|
12,381,730
|
8,037,799
|
Unvested
Restricted Stock
|
312,000
|
604,000
|
Convertible
debt
|
1,077,982
|
-
|
Total
|
13,771,712
|
8,641,799
|
J.
SUBSEQUENT
EVENTS
On
April 3, 2018, the exercise price of the Company’s
outstanding Series S warrants, which are publicly traded under the
symbol “CVM WS” on the NYSE American, was changed to
$1.75 per share for a two month period which will end on June 11,
2018. The exercise price had previously been changed to $3.00 for a
three month temporary period ending on April 12, 2018. After June
11, 2018, the exercise price will revert back to $31.25 per share
of common stock. Twenty-five (25) Series S warrants are required to
purchase one share of common stock. The Series S warrants expire on
October 11, 2018.
Closing
arguments in the arbitration against the former clinical research
organization (CRO) for our Phase 3 trial concluded on April 25,
2018. The parties are now awaiting a decision from the
arbitrator.
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
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.
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.
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.
Since the Company launched its Phase 3 clinical trial for
Multikine, the Company has incurred expenses of approximately $48.7
million as of March 31, 2018 on direct costs for the Phase 3
clinical trial. The Company estimates it will incur additional
expenses of approximately $10.5 million for the remainder of the
Phase 3 clinical trial. 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, such as the manufacturing of the drug. This number may be
affected by the 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.
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. The study is
now fully enrolled with 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.
During
the six months ended March 31, 2018, the Company’s cash
increased by approximately $0.7 million. Significant
components of this increase include net proceeds from the sale of
the Company’s stock of approximately $7.1 million offset by
net cash used to fund the Company’s regular operations,
including its Phase 3 clinical trial, of approximately $6.4
million. 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.
On
February 5, 2018, the Company sold 2,501,145 shares common stock at
a price of $1.87 for total proceeds of approximately $4.7 million.
The purchasers of the common stock also received Series TT warrants
which allow the purchasers to acquire up to 1,875,860 shares of the
Company’s common stock. The warrants are exercisable on
August 6, 2018 at a fixed price of $2.24 per share and expire on
February 5, 2023.
On December 19, 2017, the Company sold 1,289,478 shares of common
stock at a price of $1.90 for total proceeds of approximately of
$2.45 million. The purchasers of the common stock received
Series SS warrants which allow the purchasers to acquire 1,289,478
shares of the Company’s common stock. The warrants
are exercisable at a fixed price of $2.09 per share, are
exercisable on June 20, 2018 and will expire on December 18,
2022.
Inventory at March 31, 2018 remained constant, only decreasing by
approximately $42,000 as compared to September 30, 2017. In
addition, receivables decreased by approximately $82,000, primarily
due to the timing of payments by the Company’s partners for
reimbursed clinical study costs related to the Phase 3 clinical
trial.
Results of Operations and Financial Condition
During
the six months ended March 31, 2018, research and development
expenses decreased by approximately $4.8 million compared to the
six months ended March 31, 2017. During the three months ended
March 31, 2018, research and development expenses decreased by
approximately $3.6 million compared to the three months ended March
31, 2017. The majority of the Company’s research and
development expense relates to its on-going Phase 3 clinical trial.
Clinical trial costs tend to be higher during the enrollment phase
of the study and because the study is fully enrolled, the expenses
incurred over the last six months have decreased.
During
the six months ended March 31, 2018, general and administrative
expenses increased by approximately $1.3 million compared to the
six months ended March 31, 2017. This increase is primarily due to
an increase of approximately $1.0 million in equity based
compensation related to the Company’s shareholder approved
2014 Incentive Stock Bonus Plan, and a net increase of
approximately $0.3 million in other general and administrative
expenses primarily for accounting fees and public relations
services. During the three months ended March 31, 2018, general and
administrative expenses remained constant with expenses incurred
during the three months ended March 31, 2017.
The
gain on derivative instruments of approximately $0.2 million and
$1.2 million for the six and three months ended March 31, 2018,
respectively, were the result of the change in fair value of the
derivative liabilities during the respective periods. These changes
were caused by fluctuation in the share price of the
Company’s common stock. 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.
Net
interest expense increased by approximately $1.0 million for the
six months ended March 31, 2018 compared to the six months ended
March 31, 2017. The increase is primarily due to additional
interest items that were not in effect during the six months ended
March 31, 2017. These items include approximately $1.0 million
relating to the amortization of discounts on notes payable issued
in June and July 2017 and restructured in October 2017 and accrued
interest on those notes. The current period impact of the financing
arrangement with Ergomed (as explained in Note C to the financial
statements which are part of this report) which was de minimus as
the $1.3 million value of the shares issued and charged to interest
expense in January 2018 was offset by $1.3 million recovered upon
resale of those shares and shares issued in the August 2017
Agreement discussed in Note C Net interest expense increased by
approximately $1.2 million for the three months ended March 31,
2018 compared to the three months ended March 31, 2017. The
increase is primarily due to additional interest items that were
not in effect during the three months ended March 31, 2017. These
items include approximately $0.4 million relating to the
amortization of the discounts on notes payable and the accrued
interest on those notes, and approximately $0.8 million in net
interest expense relating to the financing arrangement with Ergomed
(as explained in Note C to the financial statements which are part
of this report) The $1.3 million value of the shares issued and
charged to interest expense in January 2018 was offset by
approximately $0.5 million in proceeds from the resale of the
shares, resulting in a net charge to interest expense of
approximately $0.8 million during the three months ended March 31,
2018.
Research and Development Expenses
The
Company’s research and development efforts during the six
months ended March 31, 2018 involved 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,
|
|
2018
|
2017
|
2018
|
2017
|
MULTIKINE
|
$4,989,721
|
$9,950,673
|
$2,769,787
|
$6,487,667
|
LEAPS
|
298,590
|
176,202
|
192,510
|
90,951
|
TOTAL
|
$5,288,311
|
$10,126,875
|
$2,962,297
|
$6,578,618
|
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 for the year ended September 30, 2017. 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, 2018. 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. Based on the
evaluation, the Chief Executive and Chief Financial Officer
concluded that the Company’s disclosure controls and
procedures were effective as of March 31, 2018.
Changes
in Internal Control over Financial Reporting
The
Company’s management, with the participation of the
Company’s Chief Executive and Chief Financial Officer, has
made changes to the Company’s Internal Controls to address
the material weaknesses as discussed in the Company’s
September 30, 2017 10-K.
PART II
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds.
During
the six months ended March 31, 2018 the Company issued 137,787
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 the Company’s 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 certificates representing these shares
bear 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. 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:
May 15, 2018
|
By:
|
/s/ Geert
Kersten
|
|
|
|
Geert
Kersten
|
|
|
|
Principal
Executive Officer*
|
|
* Also
signing in the capacity of the Principal Accounting and Financial
Officer.