Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Sep. 30, 2017 | Dec. 21, 2017 | Mar. 31, 2017 | |
Adjustment to Deferreds | |||
Entity Registrant Name | CEL SCI CORP | ||
Entity Central Index Key | 725,363 | ||
Document Type | 10-K | ||
Document Period End Date | Sep. 30, 2017 | ||
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 | Smaller Reporting Company | ||
Entity Common Stock, Shares Outstanding | 13,206,316 | ||
Entity Public Float | $ 17,625,571 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,017 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 2,369,438 | $ 2,917,996 |
Receivables | 218,481 | 394,515 |
Prepaid expenses | 826,429 | 981,677 |
Deposits - current portion | 150,000 | 154,995 |
Inventory used for R&D and manufacturing | 672,522 | 1,008,642 |
Total current assets | 4,236,870 | 5,457,825 |
Plant, property and equipment | 16,793,220 | 17,350,836 |
Patent costs, net | 223,167 | 256,547 |
Deposits | 1,670,917 | 1,820,917 |
Total Assets | 22,924,174 | 24,886,125 |
CURRENT LIABILITIES: | ||
Accounts payable | 8,196,334 | 3,091,512 |
Accrued expenses | 936,698 | 378,672 |
Due to employees | 693,831 | 538,278 |
Notes payable, net of discounts | 994,258 | 0 |
Derivative instruments, current portion | 10,984 | 0 |
Other current liabilities | 12,449 | 3,310 |
Total current liabilities | 10,844,554 | 4,011,772 |
Derivative instruments, net of current portion | 2,042,418 | 8,394,934 |
Lease liability | 13,211,925 | 13,011,023 |
Deferred revenue | 125,000 | 125,000 |
Other liabilities | 37,254 | 22,609 |
Total liabilities | 26,261,151 | 25,565,338 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' DEFICIT | ||
Preferred stock, $.01 par value- 200,000 shares authorized; -0- shares issued and outstanding | 0 | 0 |
Common stock, $.01 par value - 600,000,000 shares authorized; 11,903,133 and 6,248,035 shares issued and outstanding at September 30, 2017 and 2016, respectively | 119,031 | 62,480 |
Additional paid-in capital | 296,298,401 | 284,649,429 |
Accumulated deficit | (299,754,409) | (285,391,122) |
Total stockholders' deficit | (3,336,977) | (679,213) |
TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | $ 22,924,174 | $ 24,886,125 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2017 | Sep. 30, 2016 |
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 | 11,903,133 | 6,248,035 |
Common Stock Shares Outstanding | 11,903,133 | 6,248,035 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||
GRANT INCOME AND OTHER | $ 69,020 | $ 285,055 |
OPERATING EXPENSES: | ||
Research and development | 15,606,985 | 17,445,382 |
General & administrative | 5,800,348 | 6,486,501 |
Total operating expenses | 21,407,333 | 23,931,883 |
OPERATING LOSS | (21,338,313) | (23,646,828) |
Gain on derivative instruments | 11,007,215 | 14,013,726 |
Interest expense, net | (4,032,189) | (1,879,390) |
Net loss | (14,363,287) | (11,512,492) |
Modification of warrants | (63,768) | 0 |
Net loss available to common shareholders | $ (14,427,055) | $ (11,512,492) |
NET LOSS PER COMMON SHARE | ||
BASIC | $ (1.83) | $ (2.37) |
DILUTED | $ (1.91) | $ (2.37) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | ||
BASIC | 7,891,843 | 4,866,204 |
DILUTED | 7,902,647 | 4,866,204 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
BALANCE at Sep. 30, 2015 | $ 45,040 | $ 269,071,320 | $ (273,878,630) | $ (4,762,270) |
BALANCE, Shares at Sep. 30, 2015 | 4,503,975 | |||
Sale of common stock | $ 16,609 | 21,357,087 | 21,373,696 | |
Sale of common stock, Shares | 1,660,930 | |||
Issuance of warrants in connection with sale of common stock | (8,722,073) | (8,722,073) | ||
Warrants issued with notes payable | 0 | |||
Beneficial conversion feature on notes payable | 0 | |||
401(k) contributions paid in common stock | $ 163 | 161,408 | 161,571 | |
401(k) contributions paid in common stock, Shares | 16,340 | |||
Conversion of notes payable to common stock | 0 | |||
Stock issued to nonemployees for service | $ 500 | 689,813 | 690,313 | |
Stock issued to nonemployees for service, Shares | 49,953 | |||
Ergomed stock issuance | 0 | |||
Equity based compensation - employees | $ 168 | 2,012,515 | 2,012,683 | |
Equity based compensation - employees, Shares | 16,837 | |||
Equity based compensation - non-employees | 79,359 | 79,359 | ||
Net loss | (11,512,492) | (11,512,492) | ||
BALANCE at Sep. 30, 2016 | $ 62,480 | 284,649,429 | (285,391,122) | (679,213) |
BALANCE, Shares at Sep. 30, 2016 | 6,248,035 | |||
Sale of common stock | $ 47,389 | 10,482,917 | 10,530,306 | |
Sale of common stock, Shares | 4,738,920 | |||
Issuance of warrants in connection with sale of common stock | (4,665,683) | (4,665,683) | ||
Warrants issued with notes payable | 1,108,867 | 1,108,867 | ||
Beneficial conversion feature on notes payable | 1,108,867 | 1,108,867 | ||
401(k) contributions paid in common stock | $ 799 | 150,509 | 151,308 | |
401(k) contributions paid in common stock, Shares | 79,941 | |||
Conversion of notes payable to common stock | $ 2,667 | 448,033 | 450,700 | |
Conversion of notes payable to common stock, Shares | 266,686 | |||
Stock issued to nonemployees for service | $ 766 | 203,817 | 204,583 | |
Stock issued to nonemployees for service, Shares | 76,551 | |||
Ergomed stock issuance | $ 4,800 | 1,305,600 | 1,310,400 | |
Ergomed stock issuance, Shares | 480,000 | |||
Equity based compensation - employees | $ 130 | 1,481,120 | 1,481,250 | |
Equity based compensation - employees, Shares | 13,000 | |||
Equity based compensation - non-employees | 24,925 | 24,925 | ||
Net loss | (14,363,287) | (14,363,287) | ||
BALANCE at Sep. 30, 2017 | $ 119,031 | $ 296,298,401 | $ (299,754,409) | $ (3,336,977) |
BALANCE, Shares at Sep. 30, 2017 | 11,903,133 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (14,363,287) | $ (11,512,492) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 632,915 | 663,988 |
Share based payments for services | 232,847 | 751,651 |
Equity based compensation | 1,380,500 | 2,113,433 |
Common stock contributed to 401(k) plan | 151,308 | 161,571 |
Ergomed stock issuance | 1,310,400 | 0 |
Loss on retired equipment | 1,187 | 248 |
Gain on derivative instruments | (11,007,215) | (14,013,726) |
Amortization of debt discount | 917,692 | 0 |
Capitalized lease interest | 200,902 | 227,773 |
(Increase)/decrease in assets: | ||
Receivables | (129,307) | (1,960) |
Prepaid expenses | 151,909 | 15,999 |
Inventory used for R&D and manufacturing | 336,120 | 393,197 |
Deposits | 154,995 | 145,005 |
Increase/(decrease) in liabilities: | ||
Accounts payable | 5,420,816 | (2,389,931) |
Accrued expenses | 558,026 | 290,097 |
Deferred revenue | 0 | (1,639) |
Due to employees | 256,303 | 72,397 |
Deferred rent liability | 1,995 | 1,896 |
Net cash used in operating activities | (13,791,894) | (23,082,493) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of equipment | (10,525) | (31,405) |
Expenditures for patent costs | (6,477) | (2,819) |
Net cash used in investing activities | (17,002) | (34,224) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock and warrants | 10,519,306 | 21,420,301 |
Payment on related party loan | 0 | (1,104,057) |
Proceeds from notes payable | 2,745,000 | 0 |
Payments on obligations under capital lease | (3,968) | (8,213) |
Net cash provided by financing activities | 13,260,338 | 20,308,031 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (548,558) | (2,808,686) |
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR | 2,917,996 | 5,726,682 |
CASH AND CASH EQUIVALENTS, END OF YEAR | 2,369,438 | 2,917,996 |
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Receivable due under the litigation funding arrangement offset by the same amount payable to the legal firm providing the services | (305,341) | 305,341 |
Conversion of notes payable to common stock | 450,700 | 0 |
Lease payments included in accounts payable at year end | 1,890 | 815 |
Fair value of warrant liabilities on the date of issuance reclassed to liabilities | (4,665,683) | (8,722,073) |
Financing costs included in accounts payable at year end | 35,605 | 46,605 |
Prepaid amount under consulting services paid with issuance of common stock | (3,339) | 18,021 |
Conversion of accrued salaries and fees to notes payable | 275,000 | 0 |
Cash paid for interest expense | $ 1,888,612 | $ 1,900,567 |
1. ORGANIZATION
1. ORGANIZATION | 12 Months Ended |
Sep. 30, 2017 | |
Notes to Financial Statements | |
1. ORGANIZATION | CEL-SCI Corporation (the Company) was incorporated on March 22, 1983, in the state of Colorado, to finance research and development in biomedical science and ultimately to engage in marketing and selling products. The Company is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), is currently in a pivotal Phase 3 clinical trial involving head and neck cancer, for which the Company has received Orphan Drug Status from the United States Food and Drug Administration (FDA). If the primary endpoint of this global study is achieved, the results will be used to support applications to regulatory agencies around the world for worldwide commercial marketing approvals as a first line cancer therapy. The Company’s immune therapy, Multikine, is being used in a different way than immune therapy is usually used. It is given before any other therapy has been administered because that is when the immune system is thought to be strongest. . i Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this document 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. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress. Multikine has been cleared by the regulators in twenty four countries around the world, including the U.S. FDA, for a global Phase 3 clinical trial in advanced primary (not yet treated) head and neck cancer patients. On September 26, 2016, the Company received verbal notice from the FDA that the Phase 3 clinical trial has been placed on clinical hold. On August 10, 2017, the Company received a letter from the FDA stating that the clinical hold that had been imposed on the Phase 3 cancer study with Multikine has been removed and that all clinical trial activities for the Phase 3 study may resume. On December 7, 2017, the Company announced that the Independent Data Monitoring Committee (IDMC) has completed its review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the Clinical Research Organization (CRO) responsible for data management of this Phase 3 study. The IDMC made the following observation and recommendation: a) the IDMC saw no evidence of any significant safety questions and b) the IDMC recommends continuing the study. On December 11, 2017, the Company announced that the Phase 3 study was fully enrolled. The activities in the Phase 3 study are now focused on the follow-up of the patients enrolled to determine if there is a survival benefit in favor of Multikine. |
2. OPERATIONS AND FINANCING
2. OPERATIONS AND FINANCING | 12 Months Ended |
Sep. 30, 2017 | |
Notes to Financial Statements | |
2. 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 securities. 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. During fiscal year 2017 and 2016, the Company raised net proceeds of approximately $13.3 million and $21.4 million, respectively, through the sale of stock and the issuance of convertible notes. 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 currently running a large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. 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 that 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. Since the Company launched its Phase 3 clinical trial for Multikine, the Company has incurred expenses of approximately $45.9 million as of September 30, 2017 on direct costs for the Phase 3 clinical trial. The Company estimates it will incur additional expenses of approximately $13.0 million for the remainder of the Phase 3 clinical trial. It should be noted that this estimate is based only on the information currently available in the Company’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g., the manufacturing of the drug. Nine hundred twenty-eight (928) head and neck cancer patients have been enrolled and have completed treatment in the Phase 3 study. The study endpoint 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. On June 12, 2017, 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. As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock decreased from 230,127,331 (pre-split) shares to 9,201,645 (post-split) shares. In addition, by reducing the number of the Company’s outstanding shares, the Company’s loss per share in all prior periods increased by a factor of twenty five. 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. |
3. SUMMARY OF SIGNIFICANT ACCOU
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Sep. 30, 2017 | |
Summary Of Significant Accounting Policies | |
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Cash and Cash Equivalents Prepaid Expenses Inventory Deposits Plant, property and equipment Patents Leases – Deferred Rent Derivative Instruments Grant Income Research and Development Costs Net Loss Per Common Share Concentration of Credit Risk Income Taxes Use of Estimates Fair Value Measurements Stock-Based Compensation 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 may be measured using the Black-Scholes valuation model, based on the type of award. 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 Options 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 Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance or market conditions and meets the classification of equity awards. These awards were measured at fair market value on the grant-dates for issuances where the attainment of performance criteria is probable 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. Recent Accounting Pronouncements In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718) 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) Debt—Debt with Conversion and Other Options In August 2017, the FASB issued ASU 2017-12, Derivatives and Hedging (Topic 850) In February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. 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. |
4. WARRANTS AND NON-EMPLOYEE OP
4. WARRANTS AND NON-EMPLOYEE OPTIONS | 12 Months Ended |
Sep. 30, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
4. WARRANTS AND NON-EMPLOYEE OPTIONS | The following chart represents the warrants and non-employee options outstanding at September 30, 2017: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Refer-ence Series U 4/17/2014 17,821 $43.75 10/17/2017 1 Series DD 12/8/2016 1,360,960 $4.50 12/1/2017 1 Series EE 12/8/2016 1,360,960 $4.50 12/1/2017 1 Series N 8/18/2008 85,339 $3.00 8/18/2018 2 Series S 10/11/13- 10/24/14 1,037,120 $31.25 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 2 Series Y 2/15/2016 26,000 $12.00 2/15/2021 2 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 2 Series NN 7/24/2017 539,300 $2.52 7/24/2022 2 Series OO 7/31/2017 60,000 $2.52 7/31/2022 2 Series QQ 8/22/2017 87,500 $2.50 8/22/2022 2 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 KK 5/3/2017 395,970 $3.04 11/3/2022 1 Series PP 8/28/2017 1,750,000 $2.30 2/28/2023 2 Consultants 12/28/12- 7/28/17 42,000 $2.18- $70.00 12/27/17- 7/27/27 3 The following chart represents the warrants and non-employee options outstanding at September 30, 2016: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Refer-ence Series N 8/18/08 113,785 $13.18 8/18/17 2 Series R 12/6/12 105,000 $100.00 12/6/16 1 Series U 4/17/14 17,821 $43.75 10/17/17 1 Series S 10/11/13 -10/24/14 1,037,120 $31.25 10/11/18 1 Series V 5/28/15 810,127 $19.75 5/28/20 1 Series W 10/28/15 688,930 $16.75 10/28/20 1 Series X 1/13/16 120,000 $9.25 1/13/21 2 Series Y 2/15/16 26,000 $12.00 2/15/21 2 Series ZZ 5/23/16 20,000 $13.75 5/18/21 1 Series Z 5/23/16 264,000 $13.75 11/23/21 1 Series AA 8/26/16 200,000 $13.75 2/22/22 1 Series BB 8/26/16 16,000 $13.75 8/22/21 1 Series P 2/10/12 23,600 $112.50 3/6/17 2 Consultants 12/2/11- 7/1/16 25,600 $9.25- $87.50 10/27/16- 6/30/19 3 1. Warrant Liabilities The table below presents the warrant liabilities and their respective balances at September 30: 2017 2016 Series S warrants $ 32,773 $ 3,111,361 Series U warrants - - Series V warrants 72,912 1,620,253 Series W warrants 83,754 1,799,858 Series Z warrants 77,216 970,604 Series ZZ warrants 4,753 70,609 Series AA warrants 65,087 763,661 Series BB warrants 4,322 58,588 Series CC warrants 394,220 - Series DD warrants 5,492 - Series EE warrants 5,492 - Series FF warrants 47,154 - Series GG warrants 342,173 - Series HH warrants 16,014 - Series II warrants 511,636 - Series JJ warrants 24,203 - Series KK warrants 345,720 - Series LL warrants 20,481 - Total warrant liabilities $ 2,053,402 $ 8,394,934 The table below presents the gains on the warrant liabilities for the years ended September 30: 2017 2016 Series S Warrants $ 3,078,588 $ 4,252,193 Series U warrants - 44,552 Series V warrants 1,547,341 4,658,228 Series W warrants 1,716,104 3,260,913 Series Z warrants 893,388 997,226 Series ZZ warrants 65,856 75,229 Series AA warrants 698,574 672,246 Series BB warrants 54,266 53,139 Series CC warrants 666,203 - Series DD warrants 437,780 - Series EE warrants 685,915 - Series FF warrants 73,828 - Series GG warrants 272,464 - Series HH warrants 13,616 - Series II warrants 404,823 - Series JJ warrants 20,410 - Series KK warrants 25,564 - Series LL warrants 352,495 - Net gain on warrant liabilities $ 11,007,215 $ 14,013,726 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 periods is recognized as a gain or loss in the statement of operations. Issuance of Fiscal 2017 Warrant Liabilities On April 30, 2017, the Company entered into a securities purchase agreement with an institutional investor whereby it sold 527,960 shares of its common stock for net proceeds of approximately $1.4 million, or $2.875 per share, in a registered direct offering. In a concurrent private placement, the Company also issued to the purchaser of the Company’s common stock Series KK warrants to purchase 395,970 shares of common stock. The warrants can be exercised at a price of $3.04 per share at any time on or after November 3, 2017 and expire on November 3, 2022. In addition, the Company issued 26,398 Series LL warrants to the placement agent as part of its compensation. The Series LL warrants are exercisable on October 30, 2017 at a price of $3.59 per share and expire on April 30, 2022. The fair value of the Series KK and LL warrants of approximately $0.7 million on the date of issuance was recorded as a warrant liability. On March 14, 2017, the Company sold 600,000 registered shares of common stock and 600,000 Series II warrants to purchase 600,000 unregistered shares of common stock at combined offering price of $2.50 per share. The Series II warrants have an exercise price of $3.00 per share and expire September 14, 2022. In addition, the Company issued 30,000 Series JJ warrants to purchase 30,000 shares of unregistered common stock to the placement agent. The Series JJ warrants have an exercise price $3.13 and expire on March 8, 2022. The net proceeds from this offering were approximately $1.3 million. The fair value of the Series II and JJ warrants of approximately $1.0 million on the date of issuance was recorded as a warrant liability. On February 23, 2017, the Company sold 400,000 registered shares of common stock and 400,000 Series GG warrants to purchase 400,000 unregistered shares of common stock at a combined price of $2.50 per share. The Series GG warrants have an exercise price of $3.00 per share and expire August 23, 2022. In addition, the Company issued to the placement agent 20,000 Series HH warrants to purchase 20,000 shares of unregistered common stock. The Series HH warrants have an exercise price $3.13 and expire on February 16, 2022. The net proceeds from this offering were approximately $0.8 million. The fair value of the Series GG and HH warrants of approximately $0.6 million on the date of issuance was recorded as a warrant liability. On December 8, 2016, the Company sold 1,360,960 shares of common stock and warrants to purchase common stock at a price of $3.13 in a public offering. The warrants consist of 680,480 Series CC warrants to purchase 680,480 shares of common stock, 1,360,960 Series DD warrants to purchase 1,360,960 shares of common stock and 1,360,960 Series EE warrants to purchase 1,360,960 shares of common stock. The Series CC warrants were immediately exercisable, expire in five-years from the offering date and have an exercise price of $5.00 per share. The Series DD warrants were immediately exercisable and have an exercise price of $4.50 per share. On June 5, 2017 and June 29, 2017, the expiration date of the Series DD warrants was extended from June 8, 2017 to July 10, 2017 and then to August 10, 2017. On August 29, 2017, the expiration date of the Series DD warrants was extended to December 1, 2017. The Series EE warrants are immediately exercisable and have an exercise price of $4.50 per share. On August 29, 2017, the initial expiration date of the Series EE warrants was extended from September 8, 2017 to December 1, 2017. In addition, the Company issued 68,048 Series FF warrants to purchase 68,048 shares of common stock to the placement agent. The FF warrants expire on December 1, 2021 and have an exercise price $3.91. Net proceeds from this offering were approximately $3.7 million. The fair value of the Series CC, DD, EE and FF warrants of approximately $2.3 million on the date of issuance was recorded as a warrant liability. . Series AA and BB Warrants On August 26, 2016, the Company closed a registered direct offering of 400,000 shares of common stock and 200,000 Series AA warrants to purchase 200,000 shares of common stock. The common stock and warrants were sold at a combined per unit price of $12.50 for proceeds of approximately $4.5 million, net of placement agent’s commissions and offering expenses. The Series AA warrants may be exercised at any time after February 22, 2017 and on or before February 22, 2022 at a price of $13.75 per share. The Company also issued 16,000 Series BB warrants to the placement agent as part of its compensation. The Series BB warrants may be exercised at any time on or after February 22, 2017 and on or before August 22, 2021 at a price of $13.75 per share. The fair value of the Series AA and Series BB warrants of approximately $1.5 million on the date of issuance was recorded as a warrant liability. Series Z and ZZ Warrants On May 23, 2016, the Company closed a registered direct offering of 400,000 shares of common stock and 264,000 Series Z warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $12.50 for net proceeds of approximately $4.6 million, net of placement agent’s commissions and offering expenses. The Series Z warrants may be exercised at any time on or after November 23, 2016 and on or before November 23, 2021 at a price of $13.75 per share. The Company also issued 20,000 Series ZZ warrants to the placement agent as part of its compensation. The Series ZZ warrants may be exercised at any time on or after November 23, 2016 and on or before May 18, 2021 at a price of $13.75 per share. The fair value of the Series Z and Series ZZ warrants of approximately $2.1 million on the date of issuance was recorded as a warrant liability. Series W Warrants On October 28, 2015, the Company closed an underwritten public offering of 688,930 shares of common stock and 688,930 Series W warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $16.75 for net proceeds of approximately $10.5 million, net of underwriting discounts and commissions and offering expenses. The Series W warrants are immediately exercisable at a price of $16.75 and expire on October 28, 2020. The fair value at issuance of the Series W warrants of approximately $5.1 million was recorded as warrant liability. Expiration of Warrants On March 16, 2017, 23,600 Series P warrants, with an exercise price of $112.50, expired. The fair value of the Series P warrants was $0 on the date of expiration. On December 6, 2016, 105,000 Series R warrants, with an exercise price of $100.00, expired. The fair value of the Series R warrants was $0 on the date of expiration. On December 22, 2015, 48,000 Series Q warrants, with an exercise price of $125.00, expired. The fair value of the Series Q warrants was $0 on the date of expiration. 2. Equity Warrants Series PP and Series QQ Warrants On August 22, 2017, the Company entered into a securities purchase agreement with institutional investors whereby it sold 1,750,000 shares of its common stock for net proceeds of approximately $3.2 million, or $2.00 per share, in a registered direct offering. In a concurrent private placement, the Company also issued to the purchasers of the Company’s common stock Series PP warrants to purchase 1,750,000 shares of common stock. The warrants can be exercised at a price of $2.30 per share at any time on or after February 28, 2018 and expire on February 28, 2023. In addition, the Company issued 87,500 Series QQ warrants to the placement agent as part of its compensation. The Series QQ warrants are exercisable on February 22, 2018 at a price of $2.50 per share and expire on August 22, 2022. The Series PP and Series QQ warrants qualify for equity treatment in accordance with ASC 815. The relative fair value of the warrants was approximately $1.4 million. Series OO Warrants On July 26, 2017, the Company entered into a securities purchase agreement with an investor whereby it sold 100,000 shares of its common stock for gross proceeds of $229,000, or $2.29 per share, in a registered offering. In a concurrent private placement, the Company also issued to the purchaser of the common stock Series OO warrants to purchase 60,000 shares of the Company’s common stock. The warrants can be exercised at a price of $2.52 per share, commencing six months after the date of issuance and ending five years after the date of issuance. The Series OO warrants qualify for equity treatment in accordance with ASC 815. The relative fair value of the warrants was approximately $62,000. Series NN Warrants On July 24, 2017, in connection with the issuances of convertible notes (See Note 7), the Company issued the note holders Series NN warrants which entitle the purchasers to acquire up to an aggregate of 539,300 shares of the Company’s common stock. The 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. Proceeds from the sale of notes payable and the issuance of the warrants were approximately $1.2 million. The Company allocated the proceeds received to the notes and the Series NN warrants on a relative fair value basis. As a result of such allocation, the Company determined the initial carrying value of the Series NN warrants to be approximately $0.5 million. The Series NN warrants qualify for equity treatment in accordance with ASC 815. Series MM Warrants On June 22, 2017, in connection with the issuance of convertible notes (see Note 7), the Company issued the note holders Series MM warrants, which entitle the purchasers to acquire up to an aggregate of 893,491 shares of the Company’s common stock. The Series MM warrants are exercisable at a 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. Proceeds from the sale of notes payable and the issuance of the warrants were $1.5 million. The Company allocated proceeds received to the Notes and the Series MM warrants on a relative fair value basis. As a result of such allocation, the Company determined the initial carrying value of the Series MM warrants to be approximately $0.6 million. The Series MM warrants qualify for equity treatment in accordance with ASC 815. Series X Warrants In January 2016, the Company sold 120,000 shares of its common stock and 120,000 Series X warrants to the de Clara Trust for approximately $1.1 million. 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 $9.25 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 approximately $417,000. Series Y Warrants On February 15, 2016, the Company sold 52,000 shares of its common stock and 26,000 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 $12.00 per share at any time on or before February 15, 2021. The Series Y warrants qualify for equity treatment in accordance with ASC 815. The relative fair value on the date of issuance of the warrants was approximately $144,000. Series N Warrants Series N warrants were previously issued in connection with a financing and were subsequently transferred to the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. On July 17, 2017, the Series N warrants held in the de Clara Trust were modified. The modification extended the expiration date by one year to expire on August 18, 2018; the 113,785 warrants outstanding were reduced by 25% to 85,339 warrants outstanding; and the exercise price was reduced to $3.00 per share. The incremental cost of this modification was approximately $64,000, which was recorded as a deemed dividend. 3. Options and Shares Issued to Consultants The Company typically enters into consulting arrangements in exchange for common stock or stock options. During the years ended September 30, 2017 and 2016 the Company issued 76,551 and 49,954 shares, respectively, of common stock to consultants of which 68,352 and 31,360 shares, respectively, were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $1.73 and $7.25 per share. Additionally, during the years ended September 30, 2017 and 2016 the Company issued to consultants 20,000 and 16,400 options, respectively, to purchase common stock with an exercise price of $2.18 per share and a fair value of $1.87 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 years ended September 30, 2017 and 2016, the Company recorded total expense of approximately $233,000 and $752,000, respectively, relating to these consulting agreements. At September 30, 2017 and 2016, approximately $45,000 and $48,000, respectively, are included in prepaid expenses. As of September 30, 2017, 42,000 options issued to consultants as payment for services remained outstanding, all of which were issued from the Non-Qualified Stock Option plans and are fully vested. |
5. PLANT, PROPERTY AND EQUIPMEN
5. PLANT, PROPERTY AND EQUIPMENT | 12 Months Ended |
Sep. 30, 2017 | |
Notes to Financial Statements | |
5. PLANT, PROPERTY AND EQUIPMENT | Plant, property and equipment consisted of the following at September 30: 2017 2016 Leased manufacturing facility $ 21,183,756 $ 21,183,756 Research equipment 3,169,158 3,158,633 Furniture and equipment 124,369 133,499 Leasehold improvements 131,910 131,910 24,609,193 24,607,798 Accumulated depreciation and amortization (7,815,973) (7,256,962) Net plant, property and equipment $ 16,793,220 $ 17,350,836 The Company is not the legal owner of the manufacturing building, but is deemed to be the owner for accounting purposes, based on the accounting guidance for build-to-suit leases. See Note 11, Commitments and Contingencies–Lease Obligations, for additional information. As of September 30, 2017 and 2016, accumulated depreciation on the manufacturing building is approximately $4.6 million and $4.1 million, respectively. Depreciation expense for the years ended September 30, 2017 and 2016 totaled approximately $593,000 and, $626,000, respectively. Depreciation expense includes depreciation on the leased manufacturing building of approximately $514,000, which is included in research and development costs on the Statements of Operations. During the year ended September 30, 2017, the Company purchased an asset under a lease classified as a capital lease. That asset has a net book value of approximately $21,000 on September 30, 2017. Amortization of the capital lease asset is included in general and administrative expenses on the Statements of Operations. |
6. PATENTS
6. PATENTS | 12 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
6. PATENTS | Patents consisted of the following at September 30: 2017 2016 Patents $ 1,535,087 $ 1,528,610 Accumulated amortization (1,311,920) (1,272,063) Patents, net $ 223,167 $ 256,547 During the years ended September 30, 2017 and 2016,there was no impairment of patent costs. Amortization expense for the years ended September 30, 2017 and 2016 totaled approximately $40,000 and $38,000, respectively. The total estimated future amortization is as follows: Years ending September 30, 2018 $ 37,000 2019 35,000 2020 32,000 2021 28,000 2022 25,000 Thereafter 66,000 $ 223,000 |
7. NOTES PAYABLE
7. NOTES PAYABLE | 12 Months Ended |
Sep. 30, 2017 | |
Notes Payable [Abstract] | |
7. NOTES PAYABLE | On July 24, 2017, the Company issued Series NN convertible 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 Series NN Notes bear interest at 4% per year and are due on December 22, 2017. At the option of the note holders, the Series NN Notes can be converted into shares of the Company’s common stock at a fixed conversion rate of $2.29, the closing price on July 21, 2017. The purchasers of the convertible notes also received Series NN warrants which entitle the purchasers to acquire up to 539,300 shares of the Company’s common stock. The warrants are exercisable at a price of $2.52 per share and expire on July 24, 2022. Shares issuable upon the exercise of the warrants were restricted securities unless registered. The shares were registered effective September 1, 2017. The Series NN Notes were issued together with Series NN warrants, as discussed in the preceding section. Upon issuance of the Series NN Notes and Series NN warrants, the Company allocated proceeds received to the notes and warrants on a relative fair value basis. As a result of such allocation, the Company determined the initial carrying value of the Series NN Notes to be approximately $0.7 million, the initial carrying value of the Series NN warrants to be approximately $0.5 million, and recorded a debt discount in the amount of approximately $0.5 million. On June 22, 2017, CEL-SCI issued Series MM convertible notes in the aggregate principal amount of $1.5 million to six individual investors. The Series MM Notes bear interest at 4% per year and are due on December 22, 2017. At the option of the note holders, the Series MM Notes can be converted into shares of the Company’s common stock at a fixed conversion rate of $1.69. 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 could result in the issuance of 893,491 shares of the Company’s common stock. The purchasers of the convertible notes also received Series MM warrants which entitle the purchasers to acquire up to 893,491 shares of the Company’s common stock. The warrants are exercisable at a price of $1.86 per share and expire on June 22, 2022. Shares issuable upon the exercise of the warrants were restricted securities unless registered. The shares were registered effective August 8, 2017. The Series MM Notes were issued together with Series MM warrants, as discussed in the preceding section. Upon issuance of the Series MM Notes and Series MM warrants, the Company allocated proceeds received to the notes and warrants on a relative fair value basis. As a result of such allocation, the Company determined the initial carrying value of the Series MM Notes to be approximately $0.9 million, the initial carrying value of the Series MM warrants to be approximately $0.6 million, and recorded a debt discount in the amount of approximately $0.6 million. During the quarter ended September 30, 2017, two note holders converted their Series MM notes into shares of common stock. The face value of the converted notes was $450,700. The unamortized debt discount relating to the converted notes was charged to interest expense. Pursuant to the guidance in ASC 815-40, Contracts in Entity’s Own Equity Debt with Conversion and Other Options The total debt discount on both Series MM and NN notes is being amortized to interest expense using the effective interest method over the expected term of the notes. At September 30, 2017, the remaining debt discount is approximately $1.3 million. During the year ended September 30, 2017, the Company recorded approximately $941,000 in interest expense related to the Series MM and NN notes, of which approximately $23,000 was recorded as accrued interest, and approximately $918,000 was recorded as amortization of the debt discount. The Series MM and Series NN notes are secured by a first lien on all of the Company’s assets. |
8. INCOME TAXES
8. INCOME TAXES | 12 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
8. INCOME TAXES | At September 30, 2017 and 2016, the Company had federal net operating loss carryforwards of approximately $187.8 million and $169.7 million, respectively. The NOLs begin to expire during the fiscal year ending September 30, 2019 and become fully expired by the end of the fiscal year ended 2037. In addition, the Company has a general business credit as a result of the credit for increasing research activities (“R&D credit”) of approximately $1.2 million at September 30, 2017 and 2016. The R&D credit begins to expire during the fiscal year ending September 30, 2020 and is fully expired during the fiscal year ended 2029. Deferred taxes consisted of the following at September 30: 2017 2016 Net operating loss carryforwards $ 70,752,000 $ 64,366,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 6,292,000 6,379,000 Capitalized R&D 21,160,000 18,508,000 Vacation and other 121,000 179,000 Total deferred tax assets 99,546,000 90,653,000 Fixed assets and intangibles (523,000) (49,000) Total deferred tax liability (523,000) (49,000) Net deferred tax asset 99,023,000 90,604,000 Valuation allowance (99,023,000) (90,604,000) Ending Balance $ - $ - In assessing the realization of deferred tax assets, management considered whether it was more likely than not that some, or all, of the deferred tax asset will be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income. Management has considered the history of the Company’s operating losses and believes that the realization of the benefit of the deferred tax assets cannot be reasonably assured. In addition, under Internal Revenue Code Section 382, the Company’s ability to utilize these net operating loss carryforwards may be limited or eliminated in the event of future changes in ownership. The Company has no federal or state current or deferred tax expense or benefit. The Company’s effective tax rate differs from the applicable federal statutory tax rate. The reconciliation of these rates is as follows at September 30: 2017 2016 Federal Rate 34.00% 34.00% State tax rate, net of federal benefit 6.44 3.92 State tax rate change (3.91) (22.00) Other adjustments (3.39) (0.03) Permanent differences (1) 25.49 44.90 Change in valuation allowance (58.63) (60.79) Effective tax rate 0.00% 0.00% (1) Primarily due to the approximate $11 million and $14 million gain on derivative instruments from the change in fair value of the Company’s warrant liabilities during the years ended September 30, 2017 and 2016, respectively. The Company applies the provisions of ASC 740, “Accounting for Uncertainty in Income Taxes,” |
9. STOCK COMPENSATION
9. STOCK COMPENSATION | 12 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
9. STOCK COMPENSATION | The Company recognized the following expenses for options issued or vested and restricted stock awarded during the year: Year Ended September 30, 2017 2016 Employees $1,380,500 $2,113,433 Non-employees $ 232,847 $ 751,651 Stock compensation expenses were recorded as general and administrative expense. During the years ended September 30, 2017 and 2016, non-employee stock compensation excluded approximately $45,000 and $48,000, respectively, for future services to be performed (Note 12). During the years ended September 30, 2017 and 2016 the fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions. 2017 2016 Expected stock price volatility 88.54 – 90.67% 75.58 – 80.9% Risk-free interest rate 2.18 – 2.29% 0.71 – 1.56% Expected life of options 9.69 – 10 Years 3.0 – 9.69 Years Expected dividend yield - - Non-Qualified Stock Option Plans Incentive Stock Option Plans Activity in the Company’s Non-Qualified and Incentive Stock Option Plans for the two years ended September 30, 2017 is summarized as follows: Non-Qualified and Incentive Stock Option Plans Outstanding Exercisable Weighted Weighted Weighted Ave Aggregate Weighted Ave Aggregate Number of Average Remaining Contractual Intrinsic Number of Average Remaining Contractual Intrinsic Shares Exercise Price Term (Years) Value Shares Exercise Price Term (Years) Value Outstanding at October 1, 2015 301,511 $67.75 5.98 $50 181,102 $78.75 5.01 $0 Vested 56,069 $31.75 Granted (a) 48,544 $12.00 Exercised Forfeited 2,240 $21.50 Expired 4,240 $145.00 4,240 $145.00 Cancelled Outstanding at September 30, 2016 343,575 $59.22 5.35 $0 232,931 $66.28 4.76 $0 Vested 63,812 $18.45 Granted (b) 932,825 $2.17 Exercised Forfeited 15,795 $9.46 Expired 20,761 $88.80 20,761 $88.80 Cancelled Outstanding at September 30, 2017 1,239,844 $16.44 8.50 $1,400 275,982 $53.53 4.91 $0 (a) Includes 16,400 stock options granted to consultants (b) Includes 20,000 stock options granted to consultants A summary of the status of the Company’s non-vested options for the two years ended September 30, 2017 is presented below: Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 2015 120,409 $ 43.09 Vested (56,069) Granted 48,544 Forfeited (2,240) Unvested at September 30, 2016 110,644 $ 36.96 Vested (63,812) Granted 932,825 Forfeited (15,795) Unvested at September 30, 2017 963,862 $ 4.91 Incentive Stock Bonus Plan A summary of the status of the Company’s restricted common stock issued from the Incentive Stock Bonus Plan for the two years ended September 30, 2017 is presented below: Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2015 604,000 $13.75 Vested - Unvested at September 30, 2016 604,000 $13.75 Vested (136,000) Unvested at September 30, 2017 468,000 $13.75 Stock Bonus Plans Stock Compensation Plans |
10. EMPLOYEE BENEFIT PLAN
10. EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Sep. 30, 2017 | |
Retirement Benefits [Abstract] | |
10. EMPLOYEE BENEFIT PLAN | The Company maintains a defined contribution retirement plan, qualifying under Section 401(k) of the Internal Revenue Code, subject to the Employee Retirement Income Security Act of 1974, as amended, and covering substantially all Company employees. Each participant’s contribution is matched by the Company with shares of common stock that have a value equal to 100% of the participant’s contribution, not to exceed the lesser of $10,000 or 6% of the participant’s total compensation. The Company’s contribution of common stock is valued each quarter based upon the closing bid price of the Company’s common stock. Total expense, including plan maintenance, for the years ended September 30, 2017 and 2016, in connection with this Plan was approximately $163,000 and $168,000, respectively. |
11. COMMITMENTS AND CONTINGENCI
11. COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
11. 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 advance payments which are being credited against future invoices in $150,000 annual increments through December 2017. As of September 30, 2017, the total balance advanced is $150,000 and 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 In October 2013, the Company entered into two co-development and profit sharing agreements with Ergomed. One agreement supports the Phase 1 study being conducted at UCSF for the development of Multikine as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. The other agreement focuses on the development of Multikine as a potential treatment for cervical dysplasia in HIV/HPV co-infected women. Ergomed will assume up to $3 million in clinical and regulatory costs for each study. The Company is currently involved in a pending arbitration proceeding, CEL-SCI Corporation v. inVentiv Health Clinical, LLC (f/k/a PharmaNet LLC) and PharmaNet GmbH (f/k/a PharmaNet AG). The Company initiated the proceedings against inVentiv Health Clinical, LLC, or inVentiv, the former third-party CRO, and is seeking payment for damages related to inVentiv’s prior involvement in the ongoing Phase 3 clinical trial of Multikine. The arbitration claim, initiated under the Commercial Rules of the American Arbitration Association, alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. Currently, the Company is seeking at least $50 million in damages in its amended statement of claim. In an amended statement of claim, the Company asserted the claims set forth above as well as an additional claim for professional malpractice. The arbitrator subsequently granted inVentiv’s motion to dismiss the professional malpractice claim based on the “economic loss doctrine” which, under New Jersey law, is a legal doctrine that, under certain circumstances, prohibits bringing a negligence-based claim alongside a claim for breach of contract. The arbitrator denied the remainder of inVentiv’s motion, which had sought to dismiss certain other aspects of the amended statement of claim. In particular, the arbitrator rejected inVentiv’s argument that several aspects of the amended statement of claim were beyond the arbitrator’s jurisdiction. In connection with the pending arbitration proceedings, inVentiv has asserted counterclaims against the Company for (i) breach of contract, seeking at least $2 million in damages for services allegedly performed by inVentiv; (ii) breach of contract, seeking at least $1 million in damages for the Company’s 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. However, if inVentiv successfully asserts any of its counterclaims, such an adverse determination could have a material adverse effect on the Company’s business, results, financial condition and liquidity. In October 2015 the Company signed an arbitration funding agreement with a company established by Lake Whillans Litigation Finance, LLC, a firm specializing in funding litigation expenses. Pursuant to the agreement, an affiliate of Lake Whillans provides the Company with funding for litigation expenses to support its arbitration claims against inVentiv. The funding is available to the Company to fund the expenses of the ongoing arbitration and will only be repaid when the Company receives proceeds from the arbitration. During the year ended September 30, 2016, the Company recognized a gain of approximately $1.1 million on the derecognition of legal fees to record the transfer of the liability that existed prior to the execution of the financing agreement from the Company to Lake Whillans. The gain on derecognition of legal fees is recorded as a reduction of general and administration expenses on the Statement of Operations. All related legal fees are directly billed to and paid by Lake Whillans. As part of the agreement with Lake Whillans, the law firm agreed to cap its fees and expenses for the arbitration at $5 million. The arbitration has been going on longer than expected, but it is finally nearing its end. The hearing (the “trial”) started on September 26, 2016. The last witness in the arbitration hearing testified on Wednesday, November 8, 2017, and no further witnesses or testimony are expected. With that final witness, the testimony phase of the arbitration concluded. All that remains at the trial level are closing statements and post-trial submissions. Lease Agreements The Company leases a manufacturing facility near Baltimore, Maryland under an operating lease (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 asset was placed in service in October 2008. Because the terms of the original lease agreements required the Company to be responsible for cost overruns, if there had been any, but of which there were none, the Company was deemed to be the owner of the building for accounting purposes under the build-to-suit guidance in ASC 840-40-55. In addition to the tenant improvements the Company incurred and capitalized on its balance sheet, the Company 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 Leases, Sale-Leaseback Transactions, As of September 30, 2017 and 2016, the leased building asset has a net book value of approximately $16.6 million and $17.1 million and the landlord liability as a balance of $13.2 million and $13.0 million. The leased asset is being depreciated using a straight line method of the 20 year lease term to a residual value. The landlord liability is being amortized over the 20 years using the effective interest method. The Company was required to deposit the equivalent of one year of base rent in accordance with the San Tomas 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 on September 30, 2017 and 2016. Approximate future minimum lease payments under the San Tomas lease as of September 30, 2017 are as follows: Years ending September 30, 2018 $ 1,747,000 2019 1,808,000 2020 1,872,000 2021 1,937,000 2022 2,004,000 Thereafter 13,758,000 Total future minimum lease obligation 23,126,000 Less: imputed interest on financing obligation (9,914,000) Net present value of lease financing obligation $ 13,212,000 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 sublease rent for the years ended September 30, 2017 and 2016 was approximately $69,000 and $67,000, respectively, and is recorded in grant income and other in the statements of operations. The Company leases its research and development laboratory under a 60 month lease which expires February 28, 2017. In September 2016, the lease was extended through 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 September 30, 2017 and 2016, the Company has recorded a deferred rent liability of approximately $5,000 and $2,000, respectively. The Company leases its office headquarters under a 60 month lease which expires June 30, 2020. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate approximately $8,000 per month. As of September 30, 2017 and 2016, the Company has recorded a deferred rent liability of approximately $18,000. The Company leases office equipment under a capital lease arrangement. The terms of the capital lease is 60 months and expires on October 31, 2021. The monthly lease payment is $505. The lease bears interest at approximately 6.25% per annum. The Company’s previous equipment lease expired on September 30, 2016. Approximate future minimum annual lease payments due under non-cancelable operating leases, excluding the San Tomas lease, for the years ending after September 30, 2017 are as follows: Years ending September 30, 2018 $ 251,000 2019 258,000 2020 238,000 2021 163,000 2022 69,000 Thereafter - Total future minimum lease obligation $ 979,000 Rent expense, for the years ended September 30, 2017 and 2016, excluding the rent paid on the San Tomas lease, was approximately $245,000 and $234,000, respectively. The Company’s three leases expire between June 2020 and October 2028. Vendor Obligations Further, the Company has contingent obligations with other vendors for work that will be completed in relation to the Phase 3 trial. The timing of these obligations cannot be determined at this time. CEL-SCI estimates it will incur additional expenses of approximately $13.0 million for the remainder of the Phase 3 clinical trial. It should be noted that this estimate is based only on the information currently available in CEL-SCI’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g. the manufacturing of the drug. |
12. RELATED PARTY TRANSACTIONS
12. RELATED PARTY TRANSACTIONS | 12 Months Ended |
Sep. 30, 2017 | |
Related Party Transactions [Abstract] | |
12. 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 notes 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. No interest payments were made to officers during the year ended September 30, 2017. Effective August 31, 2016, the Company issued Maximilian de Clara, the Company’s then President and a director, through the de Clara Trust, 26,000 shares of restricted stock in payment of past services. The de Clara Trust was established by Maximilian de Clara, the Company’s former President and a director. The shares were issued as follows; 13,000 shares upon his resignation on August 31, 2016 and 13,000 on August 31, 2017. The total value of the shares issued was approximately $176,000, of which approximately $24,000 was expensed during the year ended September 30, 2017 and $152,000 was expensed during the year ended September 30, 2016. On September 30, 2016, the fair value accrued for unissued shares was approximately $101,000. On January 13, 2016, the de Clara Trust demanded payment on a note payable, of which the balance, including accrued and unpaid interest, was approximately $1.1 million. The Company’s Chief Executive Officer, Geert Kersten, is a beneficiary of the de Clara Trust. When the de Clara Trust demanded payment on the note, the Company sold 120,000 shares of its common stock and 120,000 Series X warrants to the de Clara Trust for approximately $1.1 million. Each warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $9.25 per share at any time on or before January 13, 2021. No interest payments were made to Mr. de Clara or the de Clara Trust during the year ended September 30, 2017. During the year ended September 30, 2016, the Company paid approximately $43,000 interest expense to Mr. de Clara. |
13. STOCKHOLDERS EQUITY
13. STOCKHOLDERS EQUITY | 12 Months Ended |
Sep. 30, 2017 | |
Notes to Financial Statements | |
13. STOCKHOLDERS' EQUITY | On August 22, 2017, the Company entered into a securities purchase agreement with institutional investors whereby it sold 1,750,000 shares of its common stock for net proceeds of approximately $3.2 million, or $2.00 per share, in a registered direct offering. In a concurrent private placement, the Company also issued to the purchasers of the Company’s common stock Series PP warrants to purchase 1,750,000 shares of common stock. In addition, the Company issued 87,500 Series QQ warrants to the placement agent as part of its compensation. See Note 4 for more information with respect to the Series PP & QQ warrants. On August 15, 2017, the Company entered into a Securities Purchase Agreement with Ergomed plc, the Company’s Clinical Research Provider, to facilitate the payment of some of the accounts payable balances due Ergomed. Under the Agreement, 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. The Company recorded the full amount of the expense upon issuance and will credit any amounts realized through reduction of the payables. During the quarter ended September 30, 2017, 64,792 shares were resold and the Company reduced the expense by approximately $107,000. The net expense of $1.2 million recorded during the quarter is included in interest expense. On July 26, 2017, the Company entered into a securities purchase agreement with an investor whereby it sold 100,000 shares of its common stock for gross proceeds of $229,000, or $2.29 per share, in a registered offering. In a concurrent private placement, the Company also issued to the purchaser of that common stock Series OO warrants to purchase 60,000 shares of the Company’s common stock. See Note 4 for more information with respect to the Series OO warrants. On April 30, 2017, the Company entered into a securities purchase agreement with an institutional investor whereby it sold 527,960 shares of its common stock for net proceeds of approximately $1.4 million, or $2.875 per share, in a registered direct offering. In a concurrent private placement, the Company also issued to the purchaser of the Company’s common stock, Series KK warrants to purchase 395,970 shares of common stock. In addition, the Company issued 26,398 Series LL warrants to the Placement Agent as part of its compensation. See Note 4 for more information with respect to the Series KK and LL warrants. On March 14, 2017, the Company sold 600,000 registered shares of common stock and 600,000 Series II warrants to purchase 600,000 unregistered shares of common stock at combined offering price of $2.50 per share. In addition, the Company issued 30,000 Series JJ warrants to purchase 30,000 shares of unregistered common stock to the placement agent. The net proceeds from this offering were approximately $1.3 million. See Note 4 for more information with respect to the Series II and JJ warrants. On February 23, 2017, the Company sold 400,000 registered shares of common stock and 400,000 Series GG warrants to purchase 400,000 unregistered shares of common stock at a combined price of $2.50 per share. In addition, the Company issued to the placement agent, 20,000 Series HH warrants to purchase 20,000 shares of unregistered common stock. The net proceeds from this offering were approximately $0.8 million. See Note 4 for more information with respect to the Series GG and HH warrants. On December 8, 2016, the Company sold 1,360,960 shares of common stock and warrants to purchase common stock at a price of $3.13 in a public offering. The warrants consist of 680,480 Series CC warrants to purchase 680,480 shares of common stock, 1,360,960 Series DD warrants to purchase 1,360,960 shares of common stock and 1,360,960 Series EE warrants to purchase 1,360,960 shares of common stock. In addition, the Company issued 68,048 Series FF warrants to purchase 68,048 shares of common stock to the placement agent. Net proceeds from this offering were approximately $3.7 million. See Note 4 for more information with respect to the Series CC, DD, EE and FF warrants. On August 26, 2016, the Company closed a registered direct offering of 400,000 shares of common stock and Series AA warrants to purchase up to 200,000 shares of common stock. Each share of common stock was sold together with a Series AA warrant to purchase one-half of a share of common stock for the combined purchase price of $13.75. The Company also issued 16,000 Series BB warrants to the placement agent as part of its compensation. The Company received proceeds from the sale of Series AA and Series BB shares and warrants of approximately $4.5 million, net of placement agent’s commissions and offering expenses. See Note 4 for more information with respect to the Series AA and BB warrants. On May 23, 2016, the Company closed a registered direct offering of 400,000 shares of common stock and 264,000 Series Z warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $13.75 for net proceeds of approximately $4.6 million, net of placement agent’s commissions and offering expenses. The Company also issued 20,000 Series ZZ warrants to the placement agent as part of its compensation. The Series ZZ warrants may be exercised at any time on or after November 23, 2016 and on or before May 18, 2021 at a price of $13.75 per share. See Note 4 for more information with respect to the Series Z and ZZ warrants. On October 28, 2015, the Company closed an underwritten public offering of 688,930 shares of common stock and 688,930 Series W warrants to purchase shares of common stock. The common stock and warrants were sold at a combined price of $16.75 for net proceeds of approximately $10.5 million, net of underwriting commissions and offering expenses. See Note 4 for more information with respect to the Series W warrants. |
14. FAIR VALUE MEASUREMENTS
14. FAIR VALUE MEASUREMENTS | 12 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
14. FAIR VALUE MEASUREMENTS | In accordance with the provisions of ASC 820, “ Fair Value Measurements ASC 820 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: o Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities o 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 o 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 liabilities measured at fair value on a recurring basis, by input level, on the balance sheet at September 30, 2017: Quoted Prices in Active Markets for Identical 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 table below sets forth the liabilities measured at fair value on a recurring basis, by input level, on the balance sheet at September 30, 2016: Quoted Prices in Active Markets for Identical Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative Instruments $ 3,111,361 $ - $ 5,283,573 $ 8,394,934 The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3), as of September 30: 2017 2016 Beginning balance $ 5,283,573 $ 6,323,032 Issuances 4,665,683 8,722,073 Net realized and unrealized derivative gain (7,928,627 ) (9,761,532 ) Ending balance $ 2,029,629 $ 5,283,573 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock as well as U.S. Treasury Bill rates are observable in active markets. At September 30, 2017, the Company’s Level 3 derivative instruments have a weighted average fair value of $0.29 per share and a weighted average exercise price of $5.41 per share. Fair values were determined using a weighted average risk free interest rate of 1.85% and 80% volatility. The instruments have a weighted average time to maturity of 4.55 years. At September 30, 2016, the Company’s Level 3 derivative instruments have a weighted average fair value of $2.50 per share and a weighted average exercise price of $21.50 per share. Fair values were determined using a weighted average risk free interest rate of 1.04% and 75% volatility. |
15. NET LOSS PER COMMON SHARE
15. NET LOSS PER COMMON SHARE | 12 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
15. NET LOSS PER COMMON SHARE | Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants, restricted stock and shares issuable on convertible debt, have not been included in the computation of diluted net loss per share for all periods presented, as the result would be anti-dilutive. For the years presented, the gain on derivative instruments is not included in net loss available to common shareholders for purposes of computing dilutive loss per share because its effect is anti-dilutive. The following table provides a reconciliation of the numerators and denominators of the basic and diluted per-share computations: Year Ended September 30, 2017 Net Loss Weighted Average Shares LPS Basic loss per share $ (14,427,055 ) 7,891,843 $ (1.83 ) Less: gain on derivatives(1) (677,287 ) 10,804 Dilutive loss per share $ (15,104,342 ) 7,902,647 $ (1.91 ) (1) Includes series GG and II warrants Year Ended September 30, 2016 Net Loss Weighted Average Shares LPS Basic and dilutive loss per share $ (11,512,492 ) 4,866,204 $ (2.37 ) The gain on derivative instruments that contain exercise prices lower than the average market share 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 2017 2016 Options and Warrants 2,538,130 3,675,281 Convertible Debt 1,166,106 - Unvested Restricted Stock 604,000 604,000 Total 4,308,236 4,279,281 |
16. SUBSEQUENT EVENTS
16. SUBSEQUENT EVENTS | 12 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
16. SUBSEQUENT EVENTS | In accordance with ASC 855, “ Subsequent Events On December 19, 2017 the Company received subscription agreements for the purchase of 1,289,478 shares of CEL-SCI common stock at a price of $1.90 in the principal amount of $2,450,000 from 19 investors. The common stock will be restricted unless registered. The purchasers of the common stock also received warrants which entitle 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, will not be exercisable for 6 months and one day and will expire on December 18, 2022. Shares issuable upon the exercise of the warrants will be restricted securities unless registered. On December 18, 2017 CEL-SCI Corporation appointed Robert Watson to its Board of Directors. On November 2, 2017, holders of convertible notes in the principal amount of $1.1 million sold in June 2017 and holders of convertible notes in the principal amount of $1.2 million sold 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 716,400 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. |
3. SUMMARY OF SIGNIFICANT ACC23
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES) | 12 Months Ended |
Sep. 30, 2017 | |
Summary Of Significant Accounting Policies Policies | |
Cash and Cash Equivalents | For purposes of the statements of cash flows, cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months as cash and cash equivalents. |
Prepaid Expenses | Prepaid expenses are payments for future services to be rendered and are expensed over the time period for which the service is rendered. Prepaid expenses may also include payment for goods to be received within one year of the payment date. |
Inventory | Inventory consists of manufacturing production advances and bulk purchases of laboratory supplies to be consumed in the manufacturing of the Company’s product for clinical studies. Inventories are stated at the lower of cost or market, where cost is determined using the first-in, first out method applied on a consistent basis. |
Deposits | |
Plant, Property and Equipment | The leased manufacturing facility is recorded at total project costs incurred and is depreciated over the 20-year useful life of the building. 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 plant, property and equipment are reviewed on a quarterly basis to assess impairment, if any. |
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 to 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 disposition, are 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. |
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. See Note 11. |
Deferred Rent (Asset) | 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. |
Derivative Instruments | The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features, specifically, the settlement provisions in the warrant agreements preclude the warrants from being treated as equity. 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 on 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 reporting period as long as they are outstanding. |
Grant Income | The Company's grant arrangements are handled on a reimbursement basis. Grant income under the arrangements is recognized when costs are incurred. |
Research and Development Costs | Research and development expenditures 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. |
Net Loss Per Common Share | The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (ASC 260). Basic and diluted net loss per common share was determined by dividing net loss applicable to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock units, convertible preferred stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive. |
Concentration of Credit Risk | Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and cash equivalents. The Company maintains its cash and cash equivalents with high quality financial institutions. At times, these accounts may exceed federally insured limits. The Company has not experienced any losses in such bank accounts. The Company believes it is not exposed to significant credit risk related to cash and cash equivalents. All non-interest bearing cash balances were fully insured up to $250,000 at September 30, 2017. |
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 September 30, 2017 and 2016. |
Use of Estimates | The preparation of financial statements in conformity U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying disclosures. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Estimates are used in accounting for, among other items, inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, deferred tax assets and the related valuation allowance, and the valuation of derivative liabilities. |
Fair Value Measurements | The Company evaluates financial assets and liabilities subject to fair value measurements in accordance with a fair value hierarchy to prioritize the inputs used to measure fair value. A financial instrument’s level within the fair value hierarchy is based on the lowest level of input significant to the fair value measurement, where Level 1 is the highest and Level 3 is the lowest. See Note 14 for the definition of levels and the classification of assets and liabilities in those levels. |
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 may be measured using the Black-Scholes valuation model, based on the type of award. 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 Options 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 Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance or market conditions and meets the classification of equity awards. These awards were measured at fair market value on the grant-dates for issuances where the attainment of performance criteria is probable 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. |
Recent Accounting Pronouncements | In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718) 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) Debt—Debt with Conversion and Other Options In August 2017, the FASB issued ASU 2017-12, Derivatives and Hedging (Topic 850) In February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. 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. |
4. WARRANTS AND NON-EMPLOYEE 24
4. WARRANTS AND NON-EMPLOYEE OPTIONS (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative liabilities, warrants and other options outstanding | The following chart represents the warrants and non-employee options outstanding at September 30, 2017: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Refer-ence Series U 4/17/2014 17,821 $43.75 10/17/2017 1 Series DD 12/8/2016 1,360,960 $4.50 12/1/2017 1 Series EE 12/8/2016 1,360,960 $4.50 12/1/2017 1 Series N 8/18/2008 85,339 $3.00 8/18/2018 2 Series S 10/11/13- 10/24/14 1,037,120 $31.25 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 2 Series Y 2/15/2016 26,000 $12.00 2/15/2021 2 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 2 Series NN 7/24/2017 539,300 $2.52 7/24/2022 2 Series OO 7/31/2017 60,000 $2.52 7/31/2022 2 Series QQ 8/22/2017 87,500 $2.50 8/22/2022 2 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 KK 5/3/2017 395,970 $3.04 11/3/2022 1 Series PP 8/28/2017 1,750,000 $2.30 2/28/2023 2 Consultants 12/28/12- 7/28/17 42,000 $2.18- $70.00 12/27/17- 7/27/27 3 The following chart represents the warrants and non-employee options outstanding at September 30, 2016: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Refer-ence Series N 8/18/08 113,785 $13.18 8/18/17 2 Series R 12/6/12 105,000 $100.00 12/6/16 1 Series U 4/17/14 17,821 $43.75 10/17/17 1 Series S 10/11/13 -10/24/14 1,037,120 $31.25 10/11/18 1 Series V 5/28/15 810,127 $19.75 5/28/20 1 Series W 10/28/15 688,930 $16.75 10/28/20 1 Series X 1/13/16 120,000 $9.25 1/13/21 2 Series Y 2/15/16 26,000 $12.00 2/15/21 2 Series ZZ 5/23/16 20,000 $13.75 5/18/21 1 Series Z 5/23/16 264,000 $13.75 11/23/21 1 Series AA 8/26/16 200,000 $13.75 2/22/22 1 Series BB 8/26/16 16,000 $13.75 8/22/21 1 Series P 2/10/12 23,600 $112.50 3/6/17 2 Consultants 12/2/11- 7/1/16 25,600 $9.25- $87.50 10/27/16- 6/30/19 3 |
Derivative Liabilities | The table below presents the warrant liabilities and their respective balances at September 30: 2017 2016 Series S warrants $ 32,773 $ 3,111,361 Series U warrants - - Series V warrants 72,912 1,620,253 Series W warrants 83,754 1,799,858 Series Z warrants 77,216 970,604 Series ZZ warrants 4,753 70,609 Series AA warrants 65,087 763,661 Series BB warrants 4,322 58,588 Series CC warrants 394,220 - Series DD warrants 5,492 - Series EE warrants 5,492 - Series FF warrants 47,154 - Series GG warrants 342,173 - Series HH warrants 16,014 - Series II warrants 511,636 - Series JJ warrants 24,203 - Series KK warrants 345,720 - Series LL warrants 20,481 - Total warrant liabilities $ 2,053,402 $ 8,394,934 The table below presents the gains on the warrant liabilities for the years ended September 30: 2017 2016 Series S Warrants $ 3,078,588 $ 4,252,193 Series U warrants - 44,552 Series V warrants 1,547,341 4,658,228 Series W warrants 1,716,104 3,260,913 Series Z warrants 893,388 997,226 Series ZZ warrants 65,856 75,229 Series AA warrants 698,574 672,246 Series BB warrants 54,266 53,139 Series CC warrants 666,203 - Series DD warrants 437,780 - Series EE warrants 685,915 - Series FF warrants 73,828 - Series GG warrants 272,464 - Series HH warrants 13,616 - Series II warrants 404,823 - Series JJ warrants 20,410 - Series KK warrants 25,564 - Series LL warrants 352,495 - Net gain on warrant liabilities $ 11,007,215 $ 14,013,726 |
5. PLANT, PROPERTY AND EQUIPM25
5. PLANT, PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Notes to Financial Statements | |
Plant, property and equipment | 2017 2016 Leased manufacturing facility $ 21,183,756 $ 21,183,756 Research equipment 3,169,158 3,158,633 Furniture and equipment 124,369 133,499 Leasehold improvements 131,910 131,910 24,609,193 24,607,798 Accumulated depreciation and amortization (7,815,973) (7,256,962) Net plant, property and equipment $ 16,793,220 $ 17,350,836 |
6. PATENTS (Tables)
6. PATENTS (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Common Share Tables | |
Schedule of Patents | 2017 2016 Patents $ 1,535,087 $ 1,528,610 Accumulated amortization (1,311,920) (1,272,063) Patents, net $ 223,167 $ 256,547 |
Schedule of total estimated future amortization | Years ending September 30, 2018 $ 37,000 2019 35,000 2020 32,000 2021 28,000 2022 25,000 Thereafter 66,000 $ 223,000 |
8. INCOME TAXES (Tables)
8. INCOME TAXES (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Net deferred tax asset | 2017 2016 Net operating loss carryforwards $ 70,752,000 $ 64,366,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 6,292,000 6,379,000 Capitalized R&D 21,160,000 18,508,000 Vacation and other 121,000 179,000 Total deferred tax assets 99,546,000 90,653,000 Fixed assets and intangibles (523,000) (49,000) Total deferred tax liability (523,000) (49,000) Net deferred tax asset 99,023,000 90,604,000 Valuation allowance (99,023,000) (90,604,000) Ending Balance $ - $ - |
Reconciliation of effective tax rate | 2017 2016 Federal Rate 34.00% 34.00% State tax rate, net of federal benefit 6.44 3.92 State tax rate change (3.91) (22.00) Other adjustments (3.39) (0.03) Permanent differences (1) 25.49 44.90 Change in valuation allowance (58.63) (60.79) Effective tax rate 0.00% 0.00% |
9. STOCK COMPENSATION (Tables)
9. STOCK COMPENSATION (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Employees and non-employees stock compensation | Year Ended September 30, 2017 2016 Employees $1,380,500 $2,113,433 Non-employees $ 232,847 $ 751,651 |
Assumptions for Option Pricing | 2017 2016 Expected stock price volatility 88.54 – 90.67% 75.58 – 80.9% Risk-free interest rate 2.18 – 2.29% 0.71 – 1.56% Expected life of options 9.69 – 10 Years 3.0 – 9.69 Years Expected dividend yield - - |
Stock Option Plans | Outstanding Exercisable Weighted Weighted Weighted Ave Aggregate Weighted Ave Aggregate Number of Average Remaining Contractual Intrinsic Number of Average Remaining Contractual Intrinsic Shares Exercise Price Term (Years) Value Shares Exercise Price Term (Years) Value Outstanding at October 1, 2015 301,511 $67.75 5.98 $50 181,102 $78.75 5.01 $0 Vested 56,069 $31.75 Granted (a) 48,544 $12.00 Exercised Forfeited 2,240 $21.50 Expired 4,240 $145.00 4,240 $145.00 Cancelled Outstanding at September 30, 2016 343,575 $59.22 5.35 $0 232,931 $66.28 4.76 $0 Vested 63,812 $18.45 Granted (b) 932,825 $2.17 Exercised Forfeited 15,795 $9.46 Expired 20,761 $88.80 20,761 $88.80 Cancelled Outstanding at September 30, 2017 1,239,844 $16.44 8.50 $1,400 275,982 $53.53 4.91 $0 |
Schedule of non-vested options | Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 2015 120,409 $ 43.09 Vested (56,069) Granted 48,544 Forfeited (2,240) Unvested at September 30, 2016 110,644 $ 36.96 Vested (63,812) Granted 932,825 Forfeited (15,795) Unvested at September 30, 2017 963,862 $ 4.91 |
Schedule of restricted stock units | Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2015 604,000 $13.75 Vested - Unvested at September 30, 2016 604,000 $13.75 Vested (136,000) Unvested at September 30, 2017 468,000 $13.75 |
11. COMMITMENTS AND CONTINGEN29
11. COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Commitments And Contingencies Tables | |
Future minimum lease payments under the San Tomas lease | Years ending September 30, 2018 $ 1,747,000 2019 1,808,000 2020 1,872,000 2021 1,937,000 2022 2,004,000 Thereafter 13,758,000 Total future minimum lease obligation 23,126,000 Less: imputed interest on financing obligation (9,914,000) Net present value of lease financing obligation $ 13,212,000 |
Schedule of future minimum annual rental payments due under non-cancelable operating leases | Years ending September 30, 2018 $ 251,000 2019 258,000 2020 238,000 2021 163,000 2022 69,000 Thereafter - Total future minimum lease obligation $ 979,000 |
14. FAIR VALUE MEASUREMENTS (Ta
14. FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements Tables | |
Measured at fair value on a recurring basis | Quoted Prices in Active Markets for Identical 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 Quoted Prices in Active Markets for Identical Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative Instruments $ 3,111,361 $ - $ 5,283,573 $ 8,394,934 |
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) | 2017 2016 Beginning balance $ 5,283,573 $ 6,323,032 Issuances 4,665,683 8,722,073 Net realized and unrealized derivative gain (7,928,627 ) (9,761,532 ) Ending balance $ 2,029,629 $ 5,283,573 |
15. NET LOSS PER COMMON SHARE (
15. NET LOSS PER COMMON SHARE (Tables) | 12 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Common Share Tables Abstract | |
Earnings per share | Year Ended September 30, 2017 Net Loss Weighted Average Shares LPS Basic loss per share $ (14,427,055 ) 7,891,843 $ (1.83 ) Less: gain on derivatives(1) (677,287 ) 10,804 Dilutive loss per share $ (15,104,342 ) 7,902,647 $ (1.91 ) (1) Includes series GG and II warrants Year Ended September 30, 2016 Net Loss Weighted Average Shares LPS Basic and dilutive loss per share $ (11,512,492 ) 4,866,204 $ (2.37 ) |
Antidilutive securities | 2017 2016 Options and Warrants 2,538,130 3,675,281 Convertible Debt 1,166,106 - Unvested Restricted Stock 604,000 604,000 Total 4,308,236 4,279,281 |
3. SUMMARY OF SIGNIFICANT ACC32
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | Sep. 30, 2017USD ($) |
Summary Of Significant Accounting Policies Details | |
Fully Insured Amount of non-interest bearing cash balances | $ 250,000 |
4. WARRANTS AND NON-EMPLOYEE 33
4. WARRANTS AND NON-EMPLOYEE OPTIONS (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Series N [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 18, 2008 | |
Shares Issuable upon Exercise of Warrant | 113,785 | |
Exercise Price | $ 13.18 | |
Expiration Date | Aug. 18, 2017 | |
SeriesRMember | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Dec. 6, 2012 | |
Shares Issuable upon Exercise of Warrant | 105,000 | |
Exercise Price | $ 100 | |
Expiration Date | Dec. 6, 2016 | |
Series U [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Apr. 17, 2014 | |
Shares Issuable upon Exercise of Warrant | 17,821 | |
Exercise Price | $ 43.75 | |
Expiration Date | Oct. 17, 2017 | |
Series S [Member] | ||
STOCKHOLDERS' EQUITY | ||
Shares Issuable upon Exercise of Warrant | 1,037,120 | |
Exercise Price | $ 31.25 | |
Expiration Date | Oct. 11, 2018 | |
Issue Start date | Oct. 11, 2013 | |
Issue End Date | Oct. 24, 2014 | |
Series V [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 28, 2015 | |
Shares Issuable upon Exercise of Warrant | 810,127 | |
Exercise Price | $ 19.75 | |
Expiration Date | May 28, 2020 | |
Series W [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Oct. 28, 2015 | |
Shares Issuable upon Exercise of Warrant | 688,930 | |
Exercise Price | $ 16.75 | |
Expiration Date | Oct. 28, 2020 | |
Series X [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Jan. 13, 2016 | |
Shares Issuable upon Exercise of Warrant | 120,000 | |
Exercise Price | $ 9.25 | |
Expiration Date | Jan. 13, 2021 | |
Series Y [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Feb. 15, 2016 | |
Shares Issuable upon Exercise of Warrant | 26,000 | |
Exercise Price | $ 12 | |
Expiration Date | Feb. 15, 2021 | |
Series ZZ [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 23, 2016 | |
Shares Issuable upon Exercise of Warrant | 20,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | May 18, 2021 | |
Series Z [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 23, 2016 | |
Shares Issuable upon Exercise of Warrant | 264,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | Nov. 23, 2021 | |
Series AA [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 26, 2016 | |
Shares Issuable upon Exercise of Warrant | 200,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | Feb. 22, 2022 | |
Series BB [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 26, 2016 | |
Shares Issuable upon Exercise of Warrant | 16,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | Aug. 22, 2021 | |
Series P [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Feb. 10, 2012 | |
Shares Issuable upon Exercise of Warrant | 23,600 | |
Exercise Price | $ 112.50 | |
Expiration Date | Mar. 6, 2017 | |
Consultants [Member] | ||
STOCKHOLDERS' EQUITY | ||
Shares Issuable upon Exercise of Warrant | 25,600 | |
Issue Start date | Dec. 2, 2011 | |
Issue End Date | Jul. 1, 2016 | |
Expiration start date | Oct. 27, 2016 | |
Expiration end date | Jun. 30, 2019 | |
Exercise Price Minimum | $ 9.25 | |
Exercise Price Maximum | $ 87.50 | |
Series U [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Apr. 17, 2014 | |
Shares Issuable upon Exercise of Warrant | 17,821 | |
Exercise Price | $ 43.75 | |
Expiration Date | Oct. 17, 2017 | |
Series DD [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Dec. 8, 2016 | |
Shares Issuable upon Exercise of Warrant | 1,360,960 | |
Exercise Price | $ 4.50 | |
Expiration Date | Dec. 1, 2017 | |
Series EE [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Dec. 8, 2016 | |
Shares Issuable upon Exercise of Warrant | 1,360,960 | |
Exercise Price | $ 4.50 | |
Expiration Date | Dec. 1, 2017 | |
Series N [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 18, 2008 | |
Shares Issuable upon Exercise of Warrant | 85,339 | |
Exercise Price | $ 3 | |
Expiration Date | Aug. 18, 2018 | |
Series S [Member] | ||
STOCKHOLDERS' EQUITY | ||
Shares Issuable upon Exercise of Warrant | 1,037,120 | |
Exercise Price | $ 31.25 | |
Expiration Date | Oct. 11, 2018 | |
Issue Start date | Oct. 11, 2013 | |
Issue End Date | Oct. 24, 2014 | |
Series V [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 28, 2015 | |
Shares Issuable upon Exercise of Warrant | 810,127 | |
Exercise Price | $ 19.75 | |
Expiration Date | May 28, 2020 | |
Series W [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Oct. 28, 2015 | |
Shares Issuable upon Exercise of Warrant | 688,930 | |
Exercise Price | $ 16.75 | |
Expiration Date | Oct. 28, 2020 | |
Series X [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Jan. 13, 2016 | |
Shares Issuable upon Exercise of Warrant | 120,000 | |
Exercise Price | $ 9.25 | |
Expiration Date | Jan. 13, 2021 | |
Series Y [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Feb. 15, 2016 | |
Shares Issuable upon Exercise of Warrant | 26,000 | |
Exercise Price | $ 12 | |
Expiration Date | Feb. 15, 2021 | |
Series ZZ [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 23, 2016 | |
Shares Issuable upon Exercise of Warrant | 20,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | May 18, 2021 | |
Series BB [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 26, 2016 | |
Shares Issuable upon Exercise of Warrant | 16,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | Aug. 22, 2021 | |
Series Z [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 23, 2016 | |
Shares Issuable upon Exercise of Warrant | 264,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | Nov. 23, 2021 | |
Series FF [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Dec. 8, 2016 | |
Shares Issuable upon Exercise of Warrant | 68,048 | |
Exercise Price | $ 3.91 | |
Expiration Date | Dec. 1, 2021 | |
Series CC [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Dec. 8, 2016 | |
Shares Issuable upon Exercise of Warrant | 680,480 | |
Exercise Price | $ 5 | |
Expiration Date | Dec. 8, 2021 | |
Series HH [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Feb. 23, 2017 | |
Shares Issuable upon Exercise of Warrant | 20,000 | |
Exercise Price | $ 3.13 | |
Expiration Date | Feb. 16, 2022 | |
Series AA [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 26, 2016 | |
Shares Issuable upon Exercise of Warrant | 200,000 | |
Exercise Price | $ 13.75 | |
Expiration Date | Feb. 22, 2022 | |
Series JJ [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Mar. 14, 2017 | |
Shares Issuable upon Exercise of Warrant | 30,000 | |
Exercise Price | $ 3.13 | |
Expiration Date | Mar. 8, 2022 | |
Series LL [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Apr. 30, 2017 | |
Shares Issuable upon Exercise of Warrant | 26,398 | |
Exercise Price | $ 3.59 | |
Expiration Date | Apr. 30, 2022 | |
Series MM [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Jun. 22, 2017 | |
Shares Issuable upon Exercise of Warrant | 893,491 | |
Exercise Price | $ 1.86 | |
Expiration Date | Jun. 22, 2022 | |
Series NN [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Jul. 24, 2017 | |
Shares Issuable upon Exercise of Warrant | 539,300 | |
Exercise Price | $ 2.52 | |
Expiration Date | Jul. 24, 2022 | |
Series OO [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Jul. 31, 2017 | |
Shares Issuable upon Exercise of Warrant | 60,000 | |
Exercise Price | $ 2.52 | |
Expiration Date | Jul. 31, 2022 | |
Series QQ [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 22, 2017 | |
Shares Issuable upon Exercise of Warrant | 87,500 | |
Exercise Price | $ 2.50 | |
Expiration Date | Aug. 22, 2022 | |
Series GG [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Feb. 23, 2017 | |
Shares Issuable upon Exercise of Warrant | 400,000 | |
Exercise Price | $ 3 | |
Expiration Date | Aug. 23, 2022 | |
Series II [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Mar. 14, 2017 | |
Shares Issuable upon Exercise of Warrant | 600,000 | |
Exercise Price | $ 3 | |
Expiration Date | Sep. 14, 2022 | |
Series KK [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | May 3, 2017 | |
Shares Issuable upon Exercise of Warrant | 395,970 | |
Exercise Price | $ 3.04 | |
Expiration Date | Nov. 3, 2022 | |
Series PP [Member] | ||
STOCKHOLDERS' EQUITY | ||
Issue Date | Aug. 28, 2017 | |
Shares Issuable upon Exercise of Warrant | 1,750,000 | |
Exercise Price | $ 2.30 | |
Expiration Date | Feb. 28, 2023 | |
Consultants [Member] | ||
STOCKHOLDERS' EQUITY | ||
Shares Issuable upon Exercise of Warrant | 42,000 | |
Issue Start date | Dec. 28, 2012 | |
Issue End Date | Jul. 28, 2017 | |
Expiration start date | Dec. 27, 2017 | |
Expiration end date | Jul. 27, 2027 | |
Exercise Price Minimum | $ 2.18 | |
Exercise Price Maximum | $ 70 |
4. WARRANTS AND NON-EMPLOYEE 34
4. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 1) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Total warrant liabilities | $ 2,053,402 | $ 8,394,934 |
Net gain on warrant liabilities | 11,007,215 | 14,013,726 |
Series S [Member] | ||
Total warrant liabilities | 32,773 | 3,111,361 |
Net gain on warrant liabilities | 3,078,588 | 4,252,193 |
Series U [Member] | ||
Total warrant liabilities | 0 | 0 |
Net gain on warrant liabilities | 0 | 44,552 |
Series V [Member] | ||
Total warrant liabilities | 72,912 | 1,620,253 |
Net gain on warrant liabilities | 1,547,341 | 4,658,228 |
Series V [Member] | ||
Total warrant liabilities | 83,754 | 1,799,858 |
Net gain on warrant liabilities | 1,716,104 | 3,260,913 |
Series Z [Member] | ||
Total warrant liabilities | 77,216 | 970,604 |
Net gain on warrant liabilities | 893,388 | 997,226 |
Series ZZ [Member] | ||
Total warrant liabilities | 4,753 | 70,609 |
Net gain on warrant liabilities | 65,856 | 75,229 |
Series AA [Member] | ||
Total warrant liabilities | 65,087 | 763,661 |
Net gain on warrant liabilities | 698,574 | 672,246 |
Series BB [Member] | ||
Total warrant liabilities | 4,322 | 58,588 |
Net gain on warrant liabilities | 54,266 | 53,139 |
Series CC [Member] | ||
Total warrant liabilities | 394,220 | 0 |
Net gain on warrant liabilities | 666,203 | 0 |
Series DD [Member] | ||
Total warrant liabilities | 5,492 | 0 |
Net gain on warrant liabilities | 437,780 | 0 |
Series EE [Member] | ||
Total warrant liabilities | 5,492 | 0 |
Net gain on warrant liabilities | 685,915 | 0 |
Series FF [Member] | ||
Total warrant liabilities | 47,154 | 0 |
Net gain on warrant liabilities | 73,828 | 0 |
Series GG [Member] | ||
Total warrant liabilities | 342,173 | 0 |
Net gain on warrant liabilities | 272,464 | 0 |
Series HH [Member] | ||
Total warrant liabilities | 16,014 | 0 |
Net gain on warrant liabilities | 13,616 | 0 |
Series II [Member] | ||
Total warrant liabilities | 511,636 | 0 |
Net gain on warrant liabilities | 404,823 | 0 |
Series JJ [Member] | ||
Total warrant liabilities | 24,203 | 0 |
Net gain on warrant liabilities | 20,410 | 0 |
Series KK [Member] | ||
Total warrant liabilities | 345,720 | 0 |
Net gain on warrant liabilities | 25,564 | 0 |
Series LL [Member] | ||
Total warrant liabilities | 20,481 | 0 |
Net gain on warrant liabilities | $ 352,495 | $ 0 |
5. PLANT, PROPERTY AND EQUIPM35
5. PLANT, PROPERTY AND EQUIPMENT (Details) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Plant Property And Equipment Details | ||
Leased manufacturing facility | $ 21,183,756 | $ 21,183,756 |
Research equipment | 3,169,158 | 3,158,633 |
Furniture and equipment | 124,369 | 133,499 |
Leasehold improvements | 131,910 | 131,910 |
Gross | 24,609,193 | 24,607,798 |
Less: Accumulated depreciation and amortization | (7,815,973) | (7,256,962) |
Net research and office equipment | $ 16,793,220 | $ 17,350,836 |
5. PLANT, PROPERTY AND EQUIPM36
5. PLANT, PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Plant Property And Equipment Details Narrative | ||
Depreciation expense | $ 593,000 | $ 626,000 |
6. PATENTS (Details)
6. PATENTS (Details) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Finite-Lived Intangible Assets, Net [Abstract] | ||
Patents | $ 1,535,087 | $ 1,528,610 |
Accumulated amortization | (1,311,920) | (1,272,063) |
Net Patents | $ 223,167 | $ 256,547 |
6. PATENTS (Details 1)
6. PATENTS (Details 1) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Patents Details 1 | ||
2,018 | $ 37,000 | |
2,019 | 35,000 | |
2,020 | 32,000 | |
2,021 | 28,000 | |
2,022 | 25,000 | |
Thereafter | 66,000 | |
Total | $ 223,167 | $ 256,547 |
6. PATENTS (Details Narrative)
6. PATENTS (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Patents Details Narrative | ||
Amortization of patent costs | $ 40,000 | $ 38,000 |
8. INCOME TAXES Net deferred ta
8. INCOME TAXES Net deferred tax asset (Details) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Income Taxes Net Deferred Tax Asset Details | ||
Net operating loss carryforwards | $ 70,752,000 | $ 64,366,000 |
R&D credit | 1,221,000 | 1,221,000 |
Stock-based compensation | 6,292,000 | 6,379,000 |
Capitalized R&D | 21,160,000 | 18,508,000 |
Vacation and other | 121,000 | 179,000 |
Total deferred tax assets | 99,546,000 | 90,653,000 |
Fixed assets and intangibles | (523,000) | (49,000) |
Total deferred tax liability | (523,000) | (49,000) |
Net deferred tax asset | 99,023,000 | 90,604,000 |
Valuation allowance | (99,023,000) | (90,604,000) |
DeferredTaxAssetsLiabilitiesNet | $ 0 | $ 0 |
8. INCOME TAXES Reconciliation
8. INCOME TAXES Reconciliation of effective tax rate (Details) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Income Taxes Reconciliation Of Effective Tax Rate Details | ||
Federal Rate | 34.00% | 34.00% |
State tax rate, net of federal benefit | 6.44% | 3.92% |
State tax rate change | (3.91%) | (22.13%) |
Other adjustments | (3.39%) | (0.03%) |
Permanent differences | 25.49% | 45.08% |
Change in valuation allowance | (58.63%) | (60.84%) |
Effective tax rate | 0.00% | 0.00% |
9. STOCK COMPENSATION Awards (D
9. STOCK COMPENSATION Awards (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Compensation Awards Details | ||
Employees | $ 1,380,500 | $ 2,113,433 |
Non-employees | $ 232,847 | $ 751,651 |
9. STOCK COMPENSATION Assumptio
9. STOCK COMPENSATION Assumptions (Details) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Compensation Assumptions Details | ||
Expected stock price volatility, min | 88.54% | 75.58% |
Expected stock price volatility, max | 90.67% | 80.90% |
Risk-free interest rate, min | 2.18% | 0.71% |
Risk-free interest rate, max | 2.29% | 1.056% |
Expected life of options, min | 9 years 8 months 8 days | 3 years |
Expected life of options, max | 10 years | 9 years 8 months 8 days |
Expected dividend yield | 0.00% | 0.00% |
9. STOCK COMPENSATION Non-Quali
9. STOCK COMPENSATION Non-Qualified and Incentive Stock Option Plans (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Outstanding | ||
Number of Options Outstanding, Beginning | 343,575 | 301,511 |
Number of Options Granted | 932,825 | 48,544 |
Number of Options Forfeited | 15,795 | 2,240 |
Number of Options Expired | 20,761 | 4,240 |
Number of Options Outstanding, Ending | 1,239,844 | 343,575 |
Weighted Average Exercise Price Outstanding, Beginning | $ 59.22 | $ 67.75 |
Weighted Average Exercise Price Granted | 2.17 | 12 |
Weighted Average Exercise Price Forfeited | 9.46 | 21.50 |
Weighted Average Exercise Price Expired | 88.80 | 145 |
Weighted Average Exercise Price Outstanding, Ending | $ 16.44 | $ 59.22 |
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning | 5 years 4 months 6 days | 5 years 11 months 23 days |
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending | 8 years 6 months | 5 years 4 months 6 days |
Aggregate Intrinsic Value Outstanding, Beginning | $ 0 | $ 50 |
Aggregate Intrinsic Value Outstanding, Ending | $ 1,400 | $ 0 |
Exercisable | ||
Number of Options Outstanding, Beginning | 232,931 | 181,102 |
Number of Options Vested | 63,812 | 56,069 |
Number of Options Expired | 20,761 | 4,240 |
Number of Options Outstanding, Ending | 275,982 | 232,931 |
Weighted Average Exercise Price Outstanding, Beginning | $ 66.28 | $ 78.75 |
Weighted Average Exercise Price Vested | 18.45 | 31.75 |
Weighted Average Exercise Price Expired | 88.80 | 145 |
Weighted Average Exercise Price Outstanding, Ending | $ 53.53 | $ 66.28 |
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning | 4 years 9 months 4 days | 5 years 4 days |
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending | 4 years 10 months 28 days | 4 years 9 months 4 days |
9. STOCK COMPENSATION Nonvested
9. STOCK COMPENSATION Nonvested Options (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Compensation Nonvested Options Details | ||
Number of unvested options, Beginning | 110,644 | 120,409 |
Vested options | (63,812) | (56,069) |
Granted options | 932,825 | 48,544 |
Forfeited options | (15,795) | (2,240) |
Number of unvested options, Ending | 963,862 | 110,644 |
Weighted Average Grant Date Fair Value, Beginning | $ 36.96 | $ 43.09 |
Weighted Average Grant Date Fair Value, Ending | $ 4.91 | $ 36.96 |
9. STOCK COMPENSATION RSU (Deta
9. STOCK COMPENSATION RSU (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Weighted Average Grant Date Fair Value, Ending | $ 4.91 | $ 36.96 |
Restricted Stock Awards [Member] | ||
Number of unvested shares, Beginning | 604,000 | 604,000 |
Vested shares | (136,000) | 0 |
Number of unvested shares, Ending | 468,000 | 604,000 |
Weighted Average Grant Date Fair Value, Ending | $ 13.75 | $ 13.75 |
9. STOCK COMPENSATION (Details
9. STOCK COMPENSATION (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Compensation Details Narrative | ||
Expense relating to the restricted stock | $ 633,000 | $ 634,000 |
Unrecognized compensation expense | $ 2,500,000 |
10. EMPLOYEE BENEFIT PLAN (Deta
10. EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Employee Benefits and Share-based Compensation, Noncash [Abstract] | ||
Expense for Company's contribution to employee benefit plan | $ 163,000 | $ 168,000 |
11. COMMITMENTS AND CONTINGEN49
11. COMMITMENTS AND CONTINGENCIES (Details) | Sep. 30, 2017USD ($) |
Commitments And Contingencies Details | |
2,018 | $ 1,747,000 |
2,019 | 1,808,000 |
2,020 | 1,872,000 |
2,021 | 1,937,000 |
2,022 | 2,004,000 |
Thereafter | 13,758,000 |
Total future minimum lease obligation | 23,126,000 |
Less imputed interest on financing obligation | (9,914,000) |
Net present value of lease financing obligation | $ 13,212,000 |
11. COMMITMENTS AND CONTINGEN50
11. COMMITMENTS AND CONTINGENCIES (Details 1) | Sep. 30, 2017USD ($) |
Commitments And Contingencies Details | |
2,018 | $ 251,000 |
2,019 | 258,000 |
2,020 | 238,000 |
2,021 | 163,000 |
2,022 | 69,000 |
Thereafter | 0 |
Total minimum lease payments: | $ 979,000 |
11. COMMITMENTS AND CONTINGEN51
11. COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Research and development expense | $ 15,606,985 | $ 17,445,382 |
R & D deferred rent liability | 5,000 | 2,000 |
Deferred rent liability | 18,000 | 18,000 |
Ergomed Collaborative Arrangement | ||
Research and development expense | 5,800,000 | 7,200,000 |
San Tomas | ||
Rent expense, including amortization of deferred rent | $ 245,000 | $ 234,000 |
14. FAIR VALUE MEASUREMENTS (De
14. FAIR VALUE MEASUREMENTS (Details) - USD ($) | Sep. 30, 2017 | Sep. 30, 2016 |
Derivative instruments | $ 2,053,402 | $ 8,394,934 |
Level 1 | ||
Derivative instruments | 32,773 | 3,111,361 |
Level 2 | ||
Derivative instruments | 0 | 0 |
Level 3 | ||
Derivative instruments | $ 2,020,629 | $ 5,283,573 |
14. FAIR VALUE MEASUREMENTS (53
14. FAIR VALUE MEASUREMENTS (Details 1) - USD ($) | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Fair Value Measurements Details 1 | ||
Beginning balance | $ 5,283,573 | $ 6,323,032 |
Issuances | 4,665,683 | 8,722,073 |
Net realized and unrealized derivative (gain)/loss | (7,928,627) | (9,761,532) |
Ending balance | $ 2,029,629 | $ 5,283,573 |
15. NET LOSS PER COMMON SHARE54
15. NET LOSS PER COMMON SHARE (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | ||
Net Loss Per Common Share Details | |||
Net loss - available to common shareholders | $ (14,427,055) | $ (11,512,492) | |
Less: Gain on derivative Instruments | [1] | (677,287) | |
Net loss - diluted | $ (15,104,342) | ||
Weighted average number of shares - basic | 7,891,843 | 4,866,204 | |
Less: gain on derivatives | [1] | 10,804 | |
Weighted average number of shares - diluted | 7,902,647 | 4,866,204 | |
Weighted average number of shares - basic and diluted | 4,866,204 | ||
Loss per share - basic | $ (1.83) | $ (2.37) | |
Loss per share - diluted | $ (1.91) | (2.37) | |
LPS - Basic and Diluted | $ (2.37) | ||
[1] | Includes series GG and II warrants. |
15. NET LOSS PER COMMON SHARE55
15. NET LOSS PER COMMON SHARE (Details 1) - shares | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Net Loss Per Common Share Details 1 | ||
Options and Warrants | 2,538,130 | 3,675,281 |
Convertible Debt | 1,166,106 | 0 |
Unvested Restricted Stock | 604,000 | 604,000 |
Total | 4,308,236 | 4,279,281 |