Colorado | 84-0916344 | |
State or other jurisdictionincorporation | (IRS) Employer Identification Number |
Large accelerated filer | o | Accelerated filer | þ |
Non-accelerated filer | o | Smaller reporting company | o |
(Do not check if a smaller reporting company) |
Class of Stock | No. Shares Outstanding | Date | ||
Common | 134,921,312 | May 2, 2016 |
PART I FINANCIAL INFORMATION
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Page | ||
3 | ||
4 | ||
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5 | ||
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6 | ||
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8 | ||
23 | ||
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27 | ||
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27 | ||
PART II
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28 | ||
28
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29
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MARCH 31,
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SEPTEMBER 30,
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|||||||
ASSETS
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2016
|
2015
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||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$ | 6,052,090 | $ | 5,726,682 | ||||
Receivables
|
654,827 | 87,214 | ||||||
Prepaid expenses
|
822,988 | 979,655 | ||||||
Deposits - current portion
|
150,000 | 150,000 | ||||||
Inventory used for R&D and manufacturing
|
1,295,308 | 1,401,839 | ||||||
Deferred rent - current portion
|
458,877 | 487,793 | ||||||
Total current assets
|
9,434,090 | 8,833,183 | ||||||
RESEARCH AND OFFICE EQUIPMENT, net
|
266,586 | 307,466 | ||||||
PATENT COSTS, net
|
273,189 | 291,564 | ||||||
DEFERRED RENT - net of current portion
|
3,724,054 | 4,044,473 | ||||||
DEPOSITS
|
1,820,917 | 1,970,917 | ||||||
TOTAL ASSETS
|
$ | 15,518,836 | $ | 15,447,603 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable
|
$ | 3,769,912 | $ | 5,128,682 | ||||
Accrued expenses
|
979,519 | 88,575 | ||||||
Due to employees
|
330,549 | 365,131 | ||||||
Related party loan
|
- | 1,104,057 | ||||||
Deferred rent - current portion
|
5,923 | 9,997 | ||||||
Lease obligation - current portion
|
4,583 | 9,028 | ||||||
Total current liabilities
|
5,090,486 | 6,705,470 | ||||||
Derivative instruments
|
13,218,128 | 13,686,587 | ||||||
Deferred revenue
|
126,501 | 126,639 | ||||||
Deferred rent - net of current portion
|
17,276 | 9,026 | ||||||
Deposits held
|
5,000 | 5,000 | ||||||
Total liabilities
|
18,457,391 | 20,532,722 | ||||||
COMMITMENTS AND CONTINGENCIES
|
||||||||
STOCKHOLDERS' DEFICIT
|
||||||||
Preferred stock, $.01 par value--200,000 shares authorized; -0- shares issued and outstanding
|
- | - | ||||||
Common stock, $.01 par value - 600,000,000 shares authorized, 134,876,033 shares and 112,360,568 shares issued and outstanding at March 31, 2016 and September 30, 2015, respectively
|
1,348,760 | 1,123,606 | ||||||
Additional paid-in capital
|
276,417,206 | 267,992,754 | ||||||
Accumulated deficit
|
(280,704,521 | ) | (274,201,479 | ) | ||||
Total stockholders' deficit
|
(2,938,555 | ) | (5,085,119 | ) | ||||
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT
|
$ | 15,518,836 | $ | 15,447,603 |
2016
|
2015
|
|||||||
GRANT INCOME AND OTHER
|
$ | 53,751 | $ | 334,458 | ||||
OPERATING EXPENSES:
|
||||||||
Research and development
|
9,798,089 | 9,974,409 | ||||||
General & administrative
|
2,312,397 | 8,115,133 | ||||||
Total operating expenses
|
12,110,486 | 18,089,542 | ||||||
OPERATING LOSS
|
(12,056,735 | ) | (17,755,084 | ) | ||||
GAIN (LOSS) ON DERIVATIVE INSTRUMENTS
|
5,529,230 | (2,619,826 | ) | |||||
INTEREST INCOME (EXPENSE), NET
|
24,463 | (26,644 | ) | |||||
NET LOSS
|
$ | (6,503,042 | ) | $ | (20,401,554 | ) | ||
NET LOSS PER COMMON SHARE
|
||||||||
BASIC AND DILUTED
|
$ | (0.06 | ) | $ | (0.27 | ) | ||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
|
||||||||
BASIC AND DILUTED
|
114,070,776 | 74,540,112 |
2016
|
2015
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GRANT AND OTHER INCOME
|
$ | 32,775 | $ | 197,620 | ||||
OPERATING EXPENSES:
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||||||||
Research and development
|
4,628,582 | 5,076,429 | ||||||
General & administrative
|
1,677,796 | 2,880,534 | ||||||
Total operating expenses
|
6,306,378 | 7,956,963 | ||||||
OPERATING LOSS
|
(6,273,603 | ) | (7,759,343 | ) | ||||
LOSS ON DERIVATIVE INSTRUMENTS
|
(2,593,730 | ) | (4,782,796 | ) | ||||
INTEREST INCOME (EXPENSE), NET
|
22,478 | (14,097 | ) | |||||
NET LOSS
|
$ | (8,844,855 | ) | $ | (12,556,236 | ) | ||
NET LOSS PER COMMON SHARE
|
||||||||
BASIC AND DILUTED
|
$ | (0.07 | ) | $ | (0.17 | ) | ||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
|
||||||||
BASIC AND DILUTED
|
118,420,327 | 75,847,869 |
2016
|
2015
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|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$ | (6,503,042 | ) | $ | (20,401,554 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
80,784 | 112,518 | ||||||
Issuance of common stock and options for services
|
472,061 | 300,129 | ||||||
Equity based compensation
|
845,100 | 3,951,854 | ||||||
Common stock contributed to 401(k) plan
|
82,146 | 80,647 | ||||||
Loss on retired equipment
|
115 | 313 | ||||||
(Gain) loss on derivative instruments
|
(5,529,230 | ) | 2,619,826 | |||||
(Increase)/decrease in assets:
|
||||||||
Receivables
|
62,080 | 44,388 | ||||||
Deferred rent
|
349,335 | 374,364 | ||||||
Prepaid expenses
|
211,360 | 120,986 | ||||||
Inventory used for R&D and manufacturing
|
106,531 | (115,485 | ) | |||||
Deposits
|
150,000 | 150,000 | ||||||
Increase/(decrease) in liabilities:
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||||||||
Accounts payable
|
(1,659,395 | ) | 542,834 | |||||
Accrued expenses
|
559,944 | (48,006 | ) | |||||
Due to employees
|
(34,582 | ) | 27,897 | |||||
Deferred rent liability
|
4,176 | (3,316 | ) | |||||
Deferred revenue
|
(138 | ) | 48 | |||||
Net cash used in operating activities
|
(10,802,755 | ) | (12,242,557 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchases of equipment
|
(21,644 | ) | (56,616 | ) | ||||
Expenditure for patent costs
|
- | (1,858 | ) | |||||
Net cash used in investing activities
|
(21,644 | ) | (58,474 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from issuance of common stock and warrants
|
12,258,287 | 6,405,932 | ||||||
Payments on related party loan
|
(1,104,057 | ) | - | |||||
Payments on obligations under capital lease
|
(4,423 | ) | (4,162 | ) | ||||
Net cash provided by financing activities
|
11,149,807 | 6,401,770 | ||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
325,408 | (5,899,261 | ) | |||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
5,726,682 | 8,513,620 | ||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 6,052,090 | $ | 2,614,359 |
2016
|
2015
|
|||||||
ACCOUNTS PAYABLE
|
||||||||
Increase in receivables
|
$ | 298,693 | $ | - | ||||
(Decrease) in research and office equipment
|
- | (2,345 | ) | |||||
Increase in patent costs
|
- | 2,257 | ||||||
Decrease in capital lease obligation
|
22 | 21 | ||||||
Increase in direct financing costs
|
1,910 | - | ||||||
(Increase) decrease in accounts payable
|
(300,625 | ) | 67 | |||||
$ | - | $ | - | |||||
ACCRUED EXPENSES
|
||||||||
Increase in receivables
|
$ | 331,000 | $ | - | ||||
(Increase) in accrued expenses
|
(331,000 | ) | - | |||||
$ | - | $ | - | |||||
ADDITIONAL PAID-IN CAPITAL
|
||||||||
(Increase) in derivative liabilities
|
$ | (5,060,771 | ) | $ | (460,737 | ) | ||
Decrease in common stock
|
- | 1,000 | ||||||
Increase in prepaid services
|
54,693 | 23,385 | ||||||
Decrease in additional paid-in capital
|
5,006,078 | 436,352 | ||||||
$ | - | $ | - | |||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
|
||||||||
Cash paid for interest expense
|
$ | 43,576 | $ | 83,308 |
|
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, 2015.
|
|
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, 2016 and the results of its operations for the six and three months then ended. The condensed balance sheet as of September 30, 2015 is derived from the September 30, 2015 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, 2016 are not necessarily indicative of the results to be expected for the entire year.
|
|
Summary of Significant Accounting Policies:
|
Name of Plan
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding Options
|
Shares Issued
|
Remaining Options/Shares Under Plans
|
||||||||||||
Incentive Stock Options Plans
|
1,960,000 | 1,685,966 | N/A | 11,334 | ||||||||||||
Non-Qualified Stock Option Plans
|
7,680,000 | 6,010,721 | N/A | 1,057,861 | ||||||||||||
Stock Bonus Plans
|
3,594,000 | N/A | 2,412,153 | 1,181,020 | ||||||||||||
Stock Compensation Plan
|
3,350,000 | N/A | 1,647,777 | 1,669,172 | ||||||||||||
Incentive Stock Bonus Plan
|
16,000,000 | N/A | 15,600,000 | 400,000 |
Name of Plan
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding Options
|
Shares Issued
|
Remaining Options/Shares Under Plans
|
||||||||||||
Incentive Stock Option Plans
|
1,960,000 | 1,690,665 | N/A | 6,635 | ||||||||||||
Non-Qualified Stock Option Plans
|
7,680,000 | 5,849,103 | N/A | 1,219,479 | ||||||||||||
Bonus Plans
|
3,594,000 | N/A | 1,643,714 | 1,949,459 | ||||||||||||
Stock Compensation Plan
|
3,350,000 | N/A | 1,423,999 | 1,892,950 | ||||||||||||
Incentive Stock Bonus Plan
|
16,000,000 | N/A | 15,600,000 | 400,000 |
Six Months Ended March 31,
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||||||||
2016
|
2015
|
|||||||
Granted
|
210,000 | 2,000 | ||||||
Forfeited
|
50,998 | 109,416 |
Three Months Ended March 31,
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||||||||
2016
|
2015
|
|||||||
Granted
|
60,000 | 1,000 | ||||||
Forfeited
|
28,032 | 11,916 |
Six Months Ended March 31,
|
||||||||
2016
|
2015
|
|||||||
Employees
|
$ | 845,100 | $ | 3,951,854 | ||||
Non-employees
|
$ | 472,061 | $ | 300,129 |
Three months Ended March 31,
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||||||||
2016
|
2015
|
|||||||
Employees
|
$ | 417,190 | $ | 892,063 | ||||
Non-employees
|
$ | 142,866 | $ | 110,985 |
Warrant
|
Issue Date
|
Shares Issuable upon Exercise of Warrant
|
Exercise Price
|
Expiration Date
|
Refer-ence
|
||||||||||
Series R
|
12/6/12
|
2,625,000 | $ | 4.00 |
12/6/16
|
1 | |||||||||
Series S
|
10/11/13 -10/24/14
|
25,928,010 | $ | 1.25 |
10/11/18
|
1 | |||||||||
Series U
|
4/17/14
|
445,514 | $ | 1.75 |
10/17/17
|
1 | |||||||||
Series V
|
5/28/15
|
20,253,164 | $ | 0.79 |
5/28/20
|
1 | |||||||||
Series W
|
10/28/15
|
17,223,248 | $ | 0.67 |
10/28/20
|
1 | |||||||||
Series X
|
1/13/16
|
3,000,000 | $ | 0.37 |
1/13/21
|
2 | |||||||||
Series Y
|
2/15/16
|
650,000 | $ | 0.48 |
2/15/19
|
2 | |||||||||
Series N
|
8/18/08
|
2,844,627 | $ | 0.53 |
8/18/17
|
||||||||||
Series P
|
2/10/12
|
590,001 | $ | 4.50 |
3/6/17
|
||||||||||
Consultants
|
12/2/11- 1/1/16
|
440,000 | $ | 0.37- $3.50 |
10/27/16- 12/31/18
|
3 |
Warrant
|
Issue Date
|
Shares Issuable upon Exercise of Warrants
|
Exercise Price
|
Expiration Date
|
Refer-ence
|
||||||||||
Series N
|
8/18/08
|
2,844,627 | 0.53 |
8/18/17
|
|||||||||||
Series Q
|
6/21/12
|
1,200,000 | 5.00 |
12/22/15
|
1 | ||||||||||
Series R
|
12/6/12
|
2,625,000 | 4.00 |
12/6/16
|
1 | ||||||||||
Series S
|
10/11/13- 10/24/14
|
25,928,010 | 1.25 |
10/11/18
|
1 | ||||||||||
Series U
|
4/17/14
|
445,514 | 1.75 |
10/17/17
|
1 | ||||||||||
Series V
|
5/28/15
|
20,253,164 | 0.79 |
5/28/20
|
1 | ||||||||||
Series P
|
2/10/12
|
590,001 | 4.50 |
3/6/17
|
|||||||||||
Consultants
|
10/14/05 – 7/1/15
|
238,000 | 0.66 – 20.00 |
10/14/15 - 6/30/18
|
3 |
1.
|
Derivative Liabilities
|
March 31,
2016
|
September 30,
2015
|
|||||||
Series S warrants
|
$ | 4,215,894 | $ | 7,363,555 | ||||
Series U warrants
|
17,821 | 44,551 | ||||||
Series V warrants
|
4,455,696 | 6,278,481 | ||||||
Series W warrants
|
4,528,717 | - | ||||||
|
||||||||
Total derivative liabilities
|
$ | 13,218,128 | $ | 13,686,587 |
Six Months Ended March 31, | ||||||||
2016
|
2015
|
|||||||
Series A through E warrants
|
$ | - | $ | 6,105 | ||||
Series R warrants
|
- | 26,250 | ||||||
Series S warrants
|
3,147,660 | (2,638,874 | ) | |||||
Series U warrants
|
26,731 | (13,307 | ) | |||||
Series V warrants
|
1,822,785 | - | ||||||
Series W warrants
|
532,054 | - | ||||||
|
||||||||
Gain (loss) on derivative instruments
|
$ | 5,529,230 | $ | (2,619,826 | ) |
Three Months Ended March 31, | ||||||||
2016
|
2015
|
|||||||
Series R warrants
|
$ | - | $ | (105,000 | ) | |||
Series S warrants
|
321,507 | (4,589,257 | ) | |||||
Series U warrants
|
(4,455 | ) | (88,539 | ) | ||||
Series V warrants
|
(1,417,721 | ) | - | |||||
Series W warrants
|
(1,493,061 | ) | - | |||||
|
||||||||
(Loss) on derivative instruments
|
$ | (2,593,730 | ) | $ | (4,782,796 | ) |
2.
|
Equity-based warrants
|
3.
|
Options and shares issued to consultants
|
|
●
|
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
|
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
|
$ | 4,215,895 | $ | - | $ | 9,002,233 | $ | 13,218,128 |
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
|
$ | 7,363,555 | $ | - | $ | 6,323,032 | $ | 13,686,587 |
(6 months ended)
|
(12 months ended)
|
|||||||
March 31, 2016
|
September 30, 2015
|
|||||||
Beginning balance
|
$ | 6,323,032 | $ | 307,894 | ||||
Issuances
|
5,060,771 | 8,003,220 | ||||||
Realized and unrealized gains
|
(2,381,570 | ) | (1,988,082 | ) | ||||
Ending balance
|
$ | 9,002,233 | $ | 6,323,032 |
Six months ending September 30, 2016
|
$ | 18,172 | ||
Year ending September 30,
|
||||
2017
|
36,547 | |||
2018
|
36,213 | |||
2019
|
34,510 | |||
2020
|
31,317 | |||
2021
|
28,017 | |||
Thereafter
|
88,413 | |||
Total
|
$ | 273,189 |
Six Months Ended March 31,
|
||||||||
2016
|
2015
|
|||||||
Net Loss
|
$ | (6,503,042 | ) | $ | (20,401,554 | ) | ||
Weighted Average Shares
|
114,070,776 | 74,540,112 | ||||||
Basic and Diluted LPS
|
$ | (0.06 | ) | $ | (0.27 | ) |
Three Months Ended March 31,
|
||||||||
2016
|
2015
|
|||||||
Net Loss
|
$ | (8,844,855 | ) | $ | (12,556,236 | ) | ||
Weighted Average Shares
|
118,420,327 | 75,847,869 | ||||||
Basic and Diluted LPS
|
$ | (0.07 | ) | $ | (0.17 | ) |
2016
|
2015
|
|||||||
Options and Warrants
|
78,710,846 | 38,777,508 | ||||||
Convertible Debt
|
- | 276,014 | ||||||
Unvested Restricted Stock
|
15,100,000 | 15,600,000 | ||||||
Total
|
93,810,846 | 54,653,522 |
Six months ended March 31,
|
Three months ended March 31,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
MULTIKINE
|
$ | 9,601,627 | $ | 9,732,470 | (a) | $ | 4,527,201 | $ | 4,930,809 | (a) | ||||||
LEAPS
|
196,462 | 241,939 | 101,381 | 145,620 | ||||||||||||
TOTAL
|
$ | 9,798,089 | $ | 9,974,409 | $ | 4,628,582 | $ | 5,076,429 |
(a)
|
The above Multikine expense amounts include depreciation relating to research and development equipment, which in prior years was included as a separate line item on the Statement of Operations. For the six and three months ended March 31, 2015, depreciation expense totaling $84,044, and $40,885, respectively, were reclassified to Multikine research and development expenses to be consistent with the current year presentation.
|
CEL-SCI CORPORATION | |||
Date: May 10, 2016
|
By:
|
/s/ Geert Kersten | |
Geert Kersten, Principal Executive Officer* | |||
May 10, 2016
|
By:
|
/s/ Geert Kersten | |
Geert Kersten | |||
Principal Executive Officer | |||
May 10, 2016
|
By:
|
/s/ Geert Kersten | |
Geert Kersten | |||
Principal Executive Officer | |||
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of the Company.
|
Document and Entity Information - shares |
6 Months Ended | |
---|---|---|
Mar. 31, 2016 |
May. 02, 2016 |
|
Document And Entity Information | ||
Entity Registrant Name | CEL SCI CORP | |
Entity Central Index Key | 0000725363 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --09-30 | |
Is Entity a Well-known Seasoned Issuer? | No | |
Is Entity a Voluntary Filer? | No | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 134,921,312 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2016 |
BALANCE SHEETS (Parenthetical) - $ / shares |
Mar. 31, 2016 |
Sep. 30, 2015 |
---|---|---|
Stockholders Equity | ||
Preferred Stock Shares Par Value | $ 0.01 | $ 0.01 |
Preferred Stock Shares Authorized | 200,000 | 200,000 |
Preferred Stock Shares Issued | 0 | 0 |
Preferred Stock Shares Outstanding | 0 | 0 |
Common Stock Shares Par Value | $ 0.01 | $ 0.01 |
Common Stock Shares Authorized | 600,000,000 | 600,000,000 |
Common Stock Shares Issued | 134,876,033 | 112,360,568 |
Common Stock Shares Outstanding | 134,876,033 | 112,360,568 |
STATEMENTS OF OPERATIONS - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
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Income Statement [Abstract] | ||||
GRANT INCOME AND OTHER | $ 32,775 | $ 197,620 | $ 53,751 | $ 334,458 |
OPERATING EXPENSES: | ||||
Research and development | 4,628,582 | 5,076,429 | 9,798,089 | 9,974,409 |
General & administrative | 1,677,796 | 2,880,534 | 2,312,397 | 8,115,133 |
Total operating expenses | 6,306,378 | 7,956,963 | 12,110,486 | 18,089,542 |
OPERATING LOSS | (6,273,603) | (7,759,343) | (12,056,735) | (17,755,084) |
GAIN (LOSS) ON DERIVATIVE INSTRUMENTS | (2,593,730) | (4,782,796) | 5,529,230 | (2,619,826) |
INTEREST INCOME (EXPENSE), NET | 22,478 | (14,097) | 24,463 | (26,644) |
NET LOSS | $ (8,844,855) | $ (12,556,236) | $ (6,503,042) | $ (20,401,554) |
NET LOSS PER COMMON SHARE | ||||
BASIC and DILUTED | $ (0.07) | $ (0.17) | $ (0.06) | $ (0.27) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | ||||
BASIC AND DILUTED | 118,420,327 | 75,847,869 | 114,070,776 | 74,540,112 |
A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
6 Months Ended | |||
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Mar. 31, 2016 | ||||
Notes to Financial Statements | ||||
A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Basis of Presentation
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. Research and office equipment 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 in the period identified. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from its disposition, is less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.
Research and Development Costs - Research and development costs are expensed as incurred.
Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized. A full valuation allowance was recorded against the deferred tax assets as of March 31, 2016 and September 30, 2015.
Derivative Instruments The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, Accounting for Derivative Instruments and Hedging Activities. In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument. The derivative liabilities are remeasured at fair value at the end of each interim reporting period as long as they are outstanding.
Deferred Rent (Asset) Consideration paid, including deposits, related to operating leases is recorded as a deferred rent asset and amortized as rent expense over the lease term. Interest on deferred rent is calculated at 3% on the funds deposited on the manufacturing facility and is included in deferred rent. This interest income will be used to offset future rent.
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 Companys 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 Companys common stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.
Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.
Reclassification Certain prior year items have been reclassified to conform to the current year presentation. Such reclassifications include approximately $145,000 between related party notes payable and additional paid-in capital to reflect the modification of the note payable to the de Clara Trust in July 2015, which was accounted for as an extinguishment. |
B. NEW ACCOUNTING PRONOUNCEMENTS |
6 Months Ended |
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Mar. 31, 2016 | |
Accounting Changes and Error Corrections [Abstract] | |
B. NEW ACCOUNTING PRONOUNCEMENTS | In January 2016, the FASB issued Accounting Standards Update (ASU) No. 2016-01, Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance is intended to improve the recognition and measurement of financial instruments. The new guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted for specific provisions within the guidance. Management does not expect the new standard to have a material effect on its financial statements and related disclosures.
In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures.
In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2016 but early adoption is permitted. The Company is currently evaluating the effect of the new amendment on its financial statements and related disclosures.
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. |
C. STOCKHOLDERS EQUITY |
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Notes to Financial Statements | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
C. STOCKHOLDERS' EQUITY | Stock options, stock bonuses and compensation granted by the Company as of March 31, 2016 are as follows:
Stock options, stock bonuses and compensation granted by the Company as of September 30, 2015 are as follows:
Stock option activity:
No shares of restricted stock were forfeited from the Incentive Stock Bonus Plan during the six and three months ended March 31, 2016. During the six and three months ended March 31, 2015, 100,000 shares of non-vested restricted stock were forfeited.
Stock-Based Compensation Expense
Employee compensation expense includes the expense related to options issued or vested and restricted stock. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of their service contract.
Derivative Liabilities, Warrants and Other Options
The following chart presents the derivative liabilities, warrants and other options outstanding during the quarter ended March 31, 2016:
The following chart presents the derivative liabilities, warrants and other options outstanding at September 30, 2015:
The table below presents the derivative instruments and their respective balances at the balance sheet dates:
The gains and (losses) on the derivative instrument are as follows:
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 instruments 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 Companys stock because future equity offerings or sales of the Companys stock are not an input to the fair value of a fixed-for-fixed option on equity shares, and equity classification is therefore precluded.
In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss.
Issuance of additional Warrants
On October 28, 2015, the Company closed an underwritten public offering of 17,223,248 shares of common stock and 17,223,248 Series W warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $0.67 for net proceeds of approximately $10.6 million, net of underwriting discounts and commissions and offering expenses. The Series W warrants are immediately exercisable at a price of $0.67 and expire on October 28, 2020. The initial cost of the Series W warrants of $5,060,771 was recorded as warrant liability.
Expiration of Warrants
On December 22, 2015, 1,200,000 Series Q warrants, with an exercise price of $5.00, expired. The fair value of the Series Q warrants was $0 on the date of expiration.
In January 2016, the Company sold 3,000,000 shares of its common stock and 3,000,000 Series X warrants to the de Clara Trust for $1,110,000. The de Clara Trust is controlled by Geert Kersten, the Company's Chief Executive Officer and a director. Each Series X warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $0.37 per share at any time on or before January 13, 2021. The Series X warrants qualify for equity treatment in accordance with ASC 815. The relative fair value of the warrants was calculated to be $416,871 and was recorded as a debit and a credit to additional paid-in capital.
In February 2016, the Company sold 1,300,000 shares of its common stock and 650,000 Series Y warrants to a private investor for $624,000. Each Series Y warrant allows the holder to purchase one share of the Company's common stock at a price of $0.48 per share at any time on or before February 15, 2019. The Series Y warrants qualify for equity treatment in accordance with ASC 815. The relative fair value of the warrants was calculated to be $126,361 and was recorded as a debit and a credit to additional paid-in capital.
The Company typically enters into consulting arrangements in exchange for restricted stock or stock options. During the six and three months ended March 31, 2016, the Company issued 803,778 and 361,286 shares of common stock, respectively, of which 580,000 and 240,000 were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $0.37 and $0.71 per share. During the six and three months ended March 31, 2015, the Company issued 423,984 and 127,492 shares of common stock, respectively, of which 69,000 and 25,000 were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $0.57 and $1.11 per share.
Additionally, during the six and three months ended March 31, 2016, the Company issued 210,000 and 60,000 options, respectively, to purchase common stock with a fair value ranging between $0.19 and $0.30 per share. During the six and three months ended March 31, 2015, the Company issued 40,000 options to purchase common stock with a fair value of $0.50 per share. 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, 2016, the Company recorded total expense of $472,061 and $142,866, respectively, relating to these consulting agreements. During the six and three months ended March 31, 2015, the Company recorded total expense of $300,129 and $110,986, respectively, relating to these consulting agreements. At March 31, 2016 and September 30, 2015, $85,022 and $30,329, respectively, are included in prepaid expenses. As of March 31, 2016, 440,000 options issued to consultants as payment for services remained outstanding, all of which were issued from the Non-Qualified Stock Option plans. |
D. FAIR VALUE MEASUREMENTS |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
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 Companys 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, 2016:
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, 2015:
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, 2016 and the year ended September 30, 2015:
The fair values of the Companys derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Companys stock, as well as U.S. Treasury Bill rates, are observable in active markets. |
E. RELATED PARTY LOAN |
6 Months Ended |
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Mar. 31, 2016 | |
Notes to Financial Statements | |
E. RELATED PARTY LOAN | On January 12, 2016, the Company owed the de Clara Trust $1,105,989, which amount included accrued and unpaid interest. On January 13, 2016, the de Clara Trust demanded payment on the note payable. At the same time the Company sold 3,000,000 shares of its common stock and 3,000,000 Series X warrants to the de Clara Trust for $1,110,000. Each warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $0.37 per share at any time on or before January 13, 2021.
Prior to the repayment, on June 29, 2015, the Company had extended the maturity date of the note to July 6, 2017, lowered the interest rate from 15% to 9% and changed the conversion price from $4.00 to $0.59, the closing stock price on the previous trading day. The Company determined these modifications to be substantive and accounted for the modification as an extinguishment of the pre-modification note and issuance of the post-modification note. The Company recorded an extinguishment loss and a premium on the note payable of $165,943. The premium was credited to additional paid-in capital.
During the six and three months ended March 31, 2016, the Company paid $43,334 and $10,213, respectively, in interest expense to Mr. de Clara. During the six and three months ended March 31, 2015, the Company paid $82,804 and $41,402, respectively, in interest expense to Mr. de Clara. |
F. OPERATIONS AND FINANCING |
6 Months Ended |
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Mar. 31, 2016 | |
Notes to Financial Statements | |
F. OPERATIONS AND FINANCING | The Company has incurred significant costs since its inception in connection with the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials. The Company has funded such costs with proceeds from loans and the public and private sale of its common stock. The Company will be required to raise additional capital or find additional long-term financing in order to continue with its research efforts. To date, the Company has not generated any revenue from product sales. The ability of the Company to complete the necessary clinical trials and obtain US Food & Drug Administration (FDA) approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure.
The Company is currently running a large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. During the six months ended March 31, 2016, the Company raised $12.3 million net proceeds from public and private sales of common stock and warrants. To finance the study for the next twelve months and beyond, the Company plans to raise additional capital in the form of corporate partnerships, as well as 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, the operating plan may change as a result of many factors currently unknown to the Company, and the Company may need additional funds sooner than planned. There can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it will either have to slow the development delay the Phase 3 clinical trial or even significantly curtail its operations until such time as it is able to raise the required funding.
Since the Company launched its Phase 3 clinical trial for Multikine, the Company has spent approximately $29.4 million as of March 31, 2016 on direct costs for the Phase 3 clinical trial.
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 Companys ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
G. COMMITMENTS AND CONTINGENCIES |
6 Months Ended |
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Mar. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
G. COMMITMENTS AND CONTINGENCIES | Clinical Research Agreements
In March 2013, the Company entered into an agreement with Aptiv Solutions to provide certain clinical research services in accordance with a master service agreement. The Company will reimburse Aptiv for costs incurred. The agreement required the Company to make $600,000 in advanced payments which are being credited back in $150,000 annual increments through December 2017. As of March 31, 2016, the total balance advanced is $300,000, of which $150,000 is classified as a current asset.
In April 2013, the Company entered into a co-development and revenue sharing agreement with Ergomed. Under the agreement, Ergomed will contribute up to $10 million towards the study in the form of offering discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. In October 2015 the Company entered into a second co-development and revenue sharing agreement with Ergomed for an additional $2 million, for a total of $12 million. The Company accounted for the co-development and revenue sharing agreement in accordance with ASC 808 Collaborative Arrangements. The Company determined the payments to Ergomed are within the scope of ASC 730 Research and Development. Therefore, the Company will record 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 $15.7 million related to Ergomeds services. This amount is net of Ergomeds discount of approximately $5.3 million. During the six and three months ended March 31, 2016, the Company recorded, net of Ergomeds discount, approximately $3.8 million and $1.8 million, respectively, as research and development expense related to Ergomeds services. During the six and three months ended March 31, 2015, the Company recorded, net of Ergomeds discount, approximately $3.2 million and $1.6 million, respectively, as research and development expense related to Ergomeds services.
In October 2013, the Company entered into two co-development and profit sharing agreements with Ergomed. One agreement supports the Phase I study being conducted at the Naval Medical Center, San Diego under a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy for the development of Multikine as a potential treatment in HIV/HPV co-infected men and women with peri-anal warts. The other agreement focuses on the development of Multikine in HIV/HPV co-infected women with cervical dysplasia. Ergomed will assume up to $3 million in clinical and regulatory costs for each study.
On October 31, 2013, the Company commenced arbitration proceedings against inVentiv Health Clinical, LLC, or inVentiv, the Companys former clinical research organization (CRO). 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. Based upon further analysis, however, the Company believes that its damages (direct and consequential) presently total over $150 million.
On December 12, 2013, the former CRO filed a counterclaim, alleging breach of contract on the part of CEL-SCI and seeking at least $2,000,000 in damages. On December 20, 2013, the former CRO moved to dismiss certain claims. On June 24, 2014, the arbitrator denied the motion to dismiss.
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 inVentivs motion to dismiss the professional malpractice claim based on the economic loss doctrine under New Jersey law, 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 inVentivs motion, which had sought to dismiss certain other aspects of the amended statement of claim. In particular, the arbitrator rejected inVentivs argument that several aspects of the amended statement of claim were beyond the arbitrators 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 Companys alleged use of inVentivs 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 inVentivs counterclaims are meritless and intends to vigorously defend against them. However, if such defense is unsuccessful, and inVentiv successfully asserts any of its counterclaims, such an adverse determination could have a material adverse effect on the Companys business, results, financial condition and liquidity.
In October 2015, CEL-SCI signed a 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 will provide CEL-SCI with up to $5,000,000 in funding for litigation expenses to support its $50,000,000 arbitration claims against inVentiv. The funding will be available to CEL-SCI if and when needed to fund the expenses of the ongoing arbitration and will only be repaid when CEL-SCI receives proceeds from the arbitration. Invoices received by CEL-SCI are recorded as a debit to legal expense and a credit to accounts payable. When the invoice is settled and Lake Whillans has made the payment to the Companys law firm, the Companys liability is released and is removed from the balance sheet through a credit to the gain on derecognition of legal fees, which is netted against legal fees. At March 31, 2016, $629,693 in legal fees were included in current liabilities because they had not yet been settled. These fees are expected to be paid by Lake Whillans and therefore, the Company has also recorded a receivable for the same amount. Excluding these fees, Lake Whillans has paid $2,624,108 in legal fees on behalf of the Company. As of March 31, 2016, the Company has recognized a gain of $3,253,802 on the derecognition of legal fees, which has been netted against legal fees and is recorded as a reduction of general and administration expenses on the Statement of Operations. As of March 31, 2016, Lake Whillans has committed to fund $2,375,892 in future legal fees. As part of the agreement with Lake Whillans, the law firm agreed to cap their fees and expenses for the arbitration at $5,000,000.
The arbitration hearing on the merits (the trial) is expected to commence in the summer of 2016.
Lease Agreements
In August 2007, the Company leased a building near Baltimore, Maryland. The building was remodeled in accordance with the Companys specifications so that it can be used by the Company to manufacture Multikine for the Companys 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 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 was required to deposit the equivalent of one year of base rent in accordance with the contract. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The $1,670,917 deposit is included in non-current assets at March 31, 2016 and September 30, 2015.
The Company subleases a portion of its rental space on a month to month term lease, which requires a 30 day notice for termination. Effective February 1, 2016, the parties agreed to a 3% rental increase. As of that date, the Company receives $5,628 per month in rent for the subleased space.
The Company leases its research and development laboratory under a 60 month lease which expires February 28, 2017. 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 $11,360 per month. As of March 31, 2016 and September 30, 2015, the Company has recorded a deferred rent liability of $5,354 and $6,484, respectively.
The Company leases 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 $8,134 per month. As of March 31, 2016 and September 30, 2015, the Company has recorded a deferred rent liability of $17,845 and $12,539, respectively.
The Company leased office equipment under a capital lease arrangement. The term of the capital lease is 48 months and expires on September 30, 2016. The monthly lease payment is $1,025. The lease bears interest at approximately 6% per annum. |
H. PATENTS |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
H. PATENTS | During the six and three months ended March 31, 2016 and 2015, no patent impairment charges were recorded. For the six and three months ended March 31, 2016, amortization of patent costs totaled $18,375 and $9,136, respectively. For the six and three months ended March 31, 2015, amortization of patent costs totaled $19,803 and $10,690, respectively. Amortization of patent costs is included in general and administrative expenses on the Statement of Operations. The Company estimates that future amortization expense will be as follows:
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I. LOSS PER COMMON SHARE |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
I. LOSS PER COMMON SHARE | The following tables provide the details of the basic and diluted loss per-share (LPS) computations:
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:
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J. SUBSEQUENT EVENTS |
6 Months Ended |
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Mar. 31, 2016 | |
Subsequent Events [Abstract] | |
J. SUBSEQUENT EVENTS | The Company has evaluated subsequent events through the date these financial statements were filed and determined there are no subsequent events that require disclosure. |
A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES) |
6 Months Ended | ||
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Mar. 31, 2016 | |||
A. Summary Of Significant Accounting Policies Policies | |||
Basis of Presentation |
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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. Research and office equipment are reviewed on a quarterly basis to determine if any of the assets are impaired. |
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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 in the period identified. 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. |
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Research and Development Costs | Research and development costs are expensed as incurred. |
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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, 2016 and September 30, 2015. |
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Derivative Instruments | The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, Accounting for Derivative Instruments and Hedging Activities. In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument. The derivative liabilities are remeasured at fair value at the end of each interim reporting period as long as they are outstanding. |
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Deferred Rent (Asset) | Consideration paid, including deposits, related to operating leases is recorded as a deferred rent asset and amortized as rent expense over the lease term. Interest on deferred rent is calculated at 3% on the funds deposited on the manufacturing facility and is included in deferred rent. This interest income will be used to offset future rent. |
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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 Companys 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 Companys common stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.
Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period. |
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Reclassification | Certain prior year items have been reclassified to conform to the current year presentation. Such reclassifications include approximately $145,000 between related party notes payable and additional paid-in capital to reflect the modification of the note payable to the de Clara Trust in July 2015, which was accounted for as an extinguishment. |
C. STOCKHOLDERS EQUITY (Tables) |
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C. Stockholders Equity Tables | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options, stock bonuses and compensation granted by the Company | Stock options, stock bonuses and compensation granted by the Company as of March 31, 2016 are as follows:
Stock options, stock bonuses and compensation granted by the Company as of September 30, 2015 are as follows:
Stock option activity:
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Schedule of employees and non-employees stock compensation |
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Derivative Liabilities, Warrants and Other Options | The following chart presents the derivative liabilities, warrants and other options outstanding during the quarter ended March 31, 2016:
The following chart presents the derivative liabilities, warrants and other options outstanding at September 30, 2015:
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Tabular disclosure of derivative liabilities at fair value |
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Schedule Of Gains and (Losses) on Derivative Liabilities |
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D. FAIR VALUE MEASUREMENTS (Tables) |
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D. Fair Value Measurements Tables | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Measured at fair value on a recurring basis | 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, 2016:
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, 2015:
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Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) |
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H. PATENTS (Tables) |
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H. Patents Tables | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of total estimated future amortization |
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I. LOSS PER COMMON SHARE (Tables) |
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I. Loss Per Common Share Tables | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computation of dilutive net loss per share |
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Antidilutive securities |
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C. STOCKHOLDERS EQUITY (Details) - shares |
Mar. 31, 2016 |
Sep. 30, 2015 |
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Incentive Stock Option Plans | ||
Total Shares Reserved Under Plans | 1,960,000 | 1,960,000 |
Shares Reserved for Outstanding Options | 1,685,966 | 1,690,665 |
Remaining Options/Shares Under Plans | 11,334 | 6,635 |
NonQualifiedStockOptionPlansMember | ||
Total Shares Reserved Under Plans | 7,680,000 | 7,680,000 |
Shares Reserved for Outstanding Options | 6,010,721 | 5,849,103 |
Remaining Options/Shares Under Plans | 1,057,861 | 1,219,479 |
Stock Bonus Plans | ||
Total Shares Reserved Under Plans | 3,594,000 | 3,594,000 |
Shares Issued | 2,412,153 | 1,643,714 |
Remaining Options/Shares Under Plans | 1,181,020 | 1,949,459 |
Stock Compensation Plan | ||
Total Shares Reserved Under Plans | 3,350,000 | 3,350,000 |
Shares Issued | 1,647,777 | 1,423,999 |
Remaining Options/Shares Under Plans | 1,669,172 | 1,892,950 |
Incentive Stock Bonus Plan | ||
Total Shares Reserved Under Plans | 16,000,000 | 16,000,000 |
Shares Issued | 15,600,000 | 15,600,000 |
Remaining Options/Shares Under Plans | 400,000 | 400,000 |
C. STOCKHOLDERS EQUITY (Details 1) - shares |
3 Months Ended | 6 Months Ended | ||
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Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
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C. Stockholders Equity Details 1 | ||||
Granted | 60,000 | 1,000 | 210,000 | 2,000 |
Forfeited | 28,032 | 11,916 | 50,998 | 109,416 |
C. STOCKHOLDERS EQUITY (Details 2) - USD ($) |
3 Months Ended | 6 Months Ended | ||
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Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
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C. Stockholders Equity Details 2 | ||||
Employees | $ 417,190 | $ 892,063 | $ 845,100 | $ 3,951,854 |
Non-employees | $ 142,866 | $ 110,985 | $ 472,061 | $ 300,129 |
C. STOCKHOLDERS EQUITY (Details 4) - USD ($) |
3 Months Ended | 6 Months Ended | |||
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Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
Sep. 30, 2015 |
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C. Stockholders Equity Details 4 | |||||
Series S warrants | $ 4,215,894 | $ 4,215,894 | $ 7,363,555 | ||
Series U warrants | 17,821 | 17,821 | 44,551 | ||
Series V warrants | 4,455,696 | 4,455,696 | 6,278,481 | ||
Series W warrants | 4,528,717 | 4,528,717 | 0 | ||
Total derivative liabilities | 13,218,128 | 13,218,128 | $ 13,686,587 | ||
Series A through E warrants | 0 | $ 6,105 | |||
Series R warrants | 0 | $ (105,000) | 0 | 26,250 | |
Series S warrants | 321,507 | (4,589,257) | 3,147,660 | (2,638,874) | |
Series U warrants | (4,455) | (88,539) | 26,731 | (13,307) | |
Series V warrants | (1,417,721) | 0 | 1,822,785 | 0 | |
Series W warrants | (1,493,061) | 0 | 532,054 | 0 | |
Net gain (loss) on derivative instruments | $ (2,593,730) | $ (4,782,796) | $ 5,529,230 | $ (2,619,826) |
D. FAIR VALUE MEASUREMENTS (Details) - USD ($) |
Mar. 31, 2016 |
Sep. 30, 2015 |
---|---|---|
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) | ||
Derivative instruments | $ 4,215,895 | $ 7,363,555 |
Significant Other Observable Inputs (Level 2) | ||
Derivative instruments | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Derivative instruments | 9,002,233 | 6,323,032 |
Total | ||
Derivative instruments | $ 13,218,128 | $ 13,686,587 |
D. FAIR VALUE MEASUREMENTS (Details 1) - USD ($) |
6 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2016 |
Sep. 30, 2015 |
|
D. Fair Value Measurements Details 1 | ||
Beginning balance | $ 6,323,032 | $ 307,894 |
Issuances | 5,060,771 | 8,003,220 |
Realized and unrealized (gains) losses | (2,381,570) | (1,988,082) |
Ending balance | $ 9,002,233 | $ 6,323,032 |
E. RELATED PARTY LOAN (Details Narrative) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
|
E. Related Party Loan Details Narrative | ||||
Interest expense paid to Mr. de Clara | $ 10,213 | $ 41,402 | $ 43,334 | $ 82,804 |
H. PATENTS (Details) - USD ($) |
Mar. 31, 2016 |
Sep. 30, 2015 |
---|---|---|
H. Patents Details | ||
Six months ending September 30, 2016 | $ 18,172 | |
Year ending September 30, 2017 | 36,547 | |
Year ending September 30, 2018 | 36,213 | |
Year ending September 30, 2019 | 34,510 | |
Year ending September 30, 2020 | 31,317 | |
Year ending September 30, 2021 | 28,017 | |
Thereafter | 88,413 | |
Total | $ 273,189 | $ 291,564 |
H. PATENTS (Details Narrative) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
|
H. Patents Details Narrative | ||||
Patent impairment charges | $ 0 | $ 0 | $ 0 | $ 0 |
Amortization of patent costs | $ 9,136 | $ 10,690 | $ 18,375 | $ 19,803 |
I. LOSS PER COMMON SHARE (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
Mar. 31, 2016 |
Mar. 31, 2015 |
|
I. Loss Per Common Share Details | ||||
Net Loss | $ (8,844,855) | $ (12,556,236) | $ (6,503,042) | $ (20,401,554) |
Weighted Average Shares - Basic and Diluted | 118,420,327 | 75,847,869 | 114,070,776 | 74,540,112 |
EPS-Basic and Diluted | $ (0.07) | $ (0.17) | $ (0.06) | $ (0.27) |
I. LOSS PER COMMON SHARE (Details 1) - shares |
6 Months Ended | |
---|---|---|
Mar. 31, 2016 |
Mar. 31, 2015 |
|
I. Loss Per Common Share Details 1 | ||
Options and Warrants | 78,710,846 | 38,777,508 |
Convertible Debt | 0 | 276,014 |
Unvested Restricted Stock | 15,100,000 | 15,600,000 |
Total | 93,810,846 | 54,653,522 |
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