CEL-SCI (CVM) 10-K 19 Dec 18 2018 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Sep. 30, 2018	Dec. 11, 2018	Mar. 31, 2018
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, 2018
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	Non-accelerated Filer
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		28,388,453
Entity Public Float			$ 22,293,400
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2,018

BALANCE SHEETS

BALANCE SHEETS - USD ($)	Sep. 30, 2018	Sep. 30, 2017
CURRENT ASSETS:
Cash and cash equivalents	$ 10,310,044	$ 2,369,438
Receivables	118,657	218,481
Prepaid expenses	364,622	826,429
Deposits - current portion	0	150,000
Inventory used for R&D and manufacturing	645,238	672,522
Total current assets	11,438,561	4,236,870
Plant, property and equipment	16,218,851	16,793,220
Patent costs, net	258,093	223,167
Deposits	1,670,917	1,670,917
Total Assets	29,586,422	22,924,174
CURRENT LIABILITIES:
Accounts payable	5,743,913	8,196,334
Accrued expenses	205,310	936,698
Due to employees	764,941	693,831
Notes payable, net of discounts	0	994,258
Derivative instruments, current portion	2,498,606	10,984
Other current liabilities	14,029	12,449
Total current liabilities	9,226,799	10,844,554
Derivative instruments, net of current portion	6,818,458	2,042,418
Lease liability	13,379,962	13,211,925
Deferred revenue	126,795	125,000
Other liabilities	33,492	37,254
Total liabilities	29,585,506	26,261,151
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY (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; 28,034,487 and 11,903,133 shares issued and outstanding at September 30, 2018 and 2017, respectively	280,346	119,031
Additional paid-in capital	331,312,184	296,298,401
Accumulated deficit	(331,591,614)	(299,754,409)
Total stockholders' equity (deficit)	916	(3,336,977)
TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY	$ 29,586,422	$ 22,924,174

BALANCE SHEETS (Parenthetical)

BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2018	Sep. 30, 2017
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	28,034,487	11,903,133
Common Stock Shares Outstanding	28,034,487	11,903,133

STATEMENTS OF OPERATIONS

STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Income Statement [Abstract]
Grant income	$ 476,556	$ 0
OPERATING EXPENSES:
Research and development	9,400,306	15,606,985
General & administrative	7,848,496	5,800,348
Total operating expenses	17,248,802	21,407,333
OPERATING LOSS	(16,772,246)	(21,407,333)
Other income	70,896	69,020
(Loss) gain on derivative instruments	(8,643,561)	11,007,215
Interest expense, net	(6,492,294)	(4,032,189)
Net loss	(31,837,205)	(14,363,287)
Modification of warrants	(14,368)	(63,768)
Net loss available to common shareholders	$ (31,851,573)	$ (14,427,055)
NET LOSS PER COMMON SHARE
BASIC	$ (1.87)	$ (1.83)
DILUTED	$ (1.87)	$ (1.91)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC	17,004,722	7,891,843
DILUTED	17,004,722	7,902,647

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
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
Shares issued for settlement of clinical research costs	$ 4,800	1,305,600		1,310,400
Shares issued for settlement of clinical research costs, 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
Sale of common stock	$ 76,906	11,508,752		11,585,658
Sale of common stock, Shares	7,690,623
Warrant exercises	$ 40,721	10,752,142		10,792,863
Warrant exercises, shares	4,072,109
Warrants issued with notes payable		947,616		947,616
401(k) contributions paid in common stock	$ 937	144,153		145,090
401(k) contributions paid in common stock, Shares	93,640
Conversion of notes payable to common stock	$ 11,950	2,363,066		2,375,016
Conversion of notes payable to common stock, Shares	1,194,930
Stock issued to nonemployees for service	$ 3,562	689,626		693,188
Stock issued to nonemployees for service, Shares	356,197
Shares issued for settlement of clinical research costs	$ 22,600	5,484,800		5,507,400
Shares issued for settlement of clinical research costs, shares	2,260,000
Equity based compensation - employees		2,743,267		2,743,267
Employee stock purchases	$ 4,639	380,361		385,000
Employee stock purchases, shares	463,855
Net loss			(31,837,205)	(31,837,205)
BALANCE at Sep. 30, 2018	$ 280,346	$ 331,312,184	$ (331,591,614)	$ 916
BALANCE, Shares at Sep. 30, 2018	28,034,487

STATEMENTS OF CASH FLOWS

STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (31,837,205)	$ (14,363,287)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	650,131	632,915
Share based payments for services	530,736	232,847
Share-based payments for interest	80,716	0
Equity based compensation	2,743,267	1,380,500
Common stock contributed to 401(k) plan	145,090	151,308
Shares issued for settlement of clinical research costs	5,507,400	1,310,400
Write off of prepaid research and development	471,157	0
Loss on retired equipment	0	1,187
Loss (gain) on derivative instruments	8,643,561	(11,007,215)
Amortization of debt discount	1,956,424	917,692
Inducement expense	291,234	0
Capitalized lease interest	168,037	200,902
(Increase)/decrease in assets:
Receivables	99,824	(129,307)
Prepaid expenses	153,102	151,909
Inventory used for R&D and manufacturing	27,284	336,120
Deposits	150,000	154,995
Increase/(decrease) in liabilities:
Accounts payable	(2,514,488)	5,420,816
Accrued expenses	(731,388)	558,026
Due to employees	71,110	256,303
Other liabilities	4,450	1,995
Net cash used in operating activities	(13,389,558)	(13,791,894)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of equipment	(1,015)	(10,525)
Expenditures for patent costs	(57,125)	(6,477)
Net cash used in investing activities	(58,140)	(17,002)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants	11,596,652	10,519,306
Proceeds from employee stock purchases	385,000	0
Proceeds from issuance of notes payable	0	2,745,000
Proceeds from exercise of warrants	9,412,964	0
Payments on obligations under capital lease	(6,312)	(3,968)
Net cash provided by financing activities	21,388,304	13,260,338
NET DECREASE IN CASH AND CASH EQUIVALENTS	7,940,606	(548,558)
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR	2,369,438	2,917,996
CASH AND CASH EQUIVALENTS, END OF YEAR	10,310,044	2,369,438
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Prepaid amount under consulting services paid with issuance of common stock	162,452	(3,339)
Conversion of accrued salaries and fees to notes payable	0	275,000
Conversion of notes payable to common stock	2,294,300	450,700
Exercise of derivative liabilities	1,379,899	0
Fair value of warrants issued in connection with public offering	0	(4,665,683)
Lease payments included in accounts payable at year end	415	1,890
Financing costs included in accounts payable at year end	46,599	35,605
Receivable due under the litigation funding arrangement offset by the same amount payable to the legal firm providing the services	0	(305,341)
Cash paid for interest expense	$ 1,750,897	$ 1,888,612

1. ORGANIZATION

1. ORGANIZATION	12 Months Ended
	Sep. 30, 2018
Notes To Financial Statements Abstract
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). The study was fully enrolled with 928 patients in September 2016. Currently the Company is waiting for the occurrence of 298 events (deaths) in the two main groups to determine final results. 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 other immune therapies. It is given before any other therapy has been administered because that is when the immune system is thought to be strongest. . i The Company is also investigating a different peptide-based immunotherapy as a vaccine for Rheumatoid Arthritis. The Company was recently awarded a Phase 2 Small Business Innovation Research (SBIR) grant in the amount of $1.5 million from the National Institutes of Health (NIH). This grant will provide funding to allow the Company to advance its first LEAPS product candidate for Rheumatoid Arthritis towards an Investigational New Drug (IND) application, by funding GMP manufacturing, IND enabling studies, and additional mechanism of action studies.

2. OPERATIONS AND FINANCING

2. OPERATIONS AND FINANCING	12 Months Ended
	Sep. 30, 2018
Notes To Financial Statements Abstract
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 2018 and 2017, the Company raised net proceeds of approximately $21.4 million and $13.3 million, respectively, through the sale of stock, the exercise of warrants 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 in the final stages of its 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 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 $50.6 million as of September 30, 2018 on direct costs for the Phase 3 clinical trial. The Company estimates it will incur additional expenses of approximately $8.4 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. This number may be affected by the rate of death accumulation in the study, foreign currency exchange rates and many other factors, some of which cannot be foreseen today. It is therefore possible that the cost of the Phase 3 clinical trial will be higher than currently estimated. Nine hundred twenty-eight (928) head and neck cancer patients have been enrolled and have completed treatment in the Phase 3 study. The study end point is a 10% increase in overall survival of patients between the two main comparator groups in favor of the group receiving the Multikine treatment regimen. The determination if the study end point is met will occur when there are a total of 298 deaths in those two groups. On October 31, 2013, the Company commenced arbitration proceedings against inVentiv Health Clinical, LLC, or inVentiv, its former clinical research organization (CRO), and now part of Syneos Health. The arbitration claim, initiated under the Commercial Rules of the American Arbitration Association, alleged (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. On June 25, 2018, the arbitrator ruled that inVentiv materially breached its contract with the Company and denied inVentiv all but one of its counterclaims ($429,649 for certain unpaid invoices) against the Company. The arbitrator awarded the Company $2,917,834 in damages. This is a final and binding decision and to the Company’s knowledge, marks the first ever decision in favor of a pharmaceutical/biomedical company against a CRO for breach of contract. However, pursuant to the terms of an agreement with an affiliate of Lake Whillans Litigation Finance, LLC, a firm that produced partial funding for the legal expenses incurred by the Company in the arbitration proceedings, all amounts received from inVentiv by virtue of the arbitration award will be paid to Lake Whillans Litigation Finance. As a result of the arbitrator’s ruling, the Company wrote off a prepaid asset in the amount of approximately $471,000, which will no longer be realized.

3. SUMMARY OF SIGNIFICANT ACCOU

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Sep. 30, 2018
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 On December 22, 2017, the “Tax Cuts and Jobs Act” (the “Tax Act”:), was signed into law by the President of the United States. The Tax Act includes significant changes to corporate taxation, including reduction of the U.S. corporate tax rate from 35% to 21%, effective January 1, 2018, limitation of the tax deduction for interest expense to 30% of earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks. The Company has accounted for certain income tax effects of the Act in applying FASB ASC 740 to the current reporting period. Because the Company records a valuation allowance for its entire deferred income tax asset, there was no impact to the amounts reported in the Company’s financial statements resulting from the Tax Act. 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 that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. Forfeitures of awards are recognized as they occur. 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 June 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-07, Compensation—Stock Compensation (Topic 718 grant date grantor grantee 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 February 2016, the FASB issued ASU 2016-02, Leases 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, 2018
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, 2018: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Reference Series S 10/11/13- 10/24/14 327,729 $ 31.25 10/11/2018 1 Series DD 12/8/2016 1,360,960 $ 4.50 12/10/2018 1 Series EE 12/8/2016 1,360,960 $ 4.50 12/10/2018 1 Series N 8/18/2008 85,339 $ 3.00 2/18/2020 2 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 * Series UU 6/11/2018 187,562 $ 2.80 6/11/2020 2 Series W 10/28/2015 688,930 $ 16.75 10/28/2020 * Series X 1/13/2016 120,000 $ 9.25 1/13/2021 * Series Y 2/15/2016 26,000 $ 12.00 2/15/2021 * Series ZZ 5/23/2016 20,000 $ 13.75 5/18/2021 * Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 * Series Z 5/23/2016 264,000 $ 13.75 11/23/2021 * 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 * 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 3,500 $ 2.50 8/22/2022 2 Series GG 2/23/2017 200,000 $ 3.00 8/23/2022 1 Series II 3/14/2017 216,500 $ 3.00 9/14/2022 1 Series RR 10/30/2017 555,370 $ 1.65 10/30/2022 2 Series KK 5/3/2017 213,870 $ 3.04 11/3/2022 1 Series SS 12/19/2017 960,530 $ 2.09 12/18/2022 2 Series TT 2/5/2018 1,296,877 $ 2.24 2/5/2023 2 Series PP 8/28/2017 172,500 $ 2.30 2/28/2023 2 Series WW 7/2/2018 195,000 $ 1.63 6/28/2023 2 Series VV 7/2/2018 3,900,000 $ 1.75 1/2/2024 2 Consultants 1/1/16 - 7/28/17 30,400 $ 2.18- $11.50 12/31/18- 7/27/27 3 *No current period changes to these warrants. 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 Series U 4/17/2014 17,821 $ 43.75 Series DD 12/8/2016 1,360,960 $ 4.50 Series EE 12/8/2016 1,360,960 $ 4.50 Series N 8/18/2008 85,339 $ 3.00 Series S 10/11/13- 10/24/14 1,037,120 $ 31.25 Series V 5/28/2015 810,127 $ 19.75 Series W 10/28/2015 688,930 $ 16.75 Series X 1/13/2016 120,000 $ 9.25 Series Y 2/15/2016 26,000 $ 12.00 Series ZZ 5/23/2016 20,000 $ 13.75 Series BB 8/26/2016 16,000 $ 13.75 Series Z 5/23/2016 264,000 $ 13.75 Series FF 12/8/2016 68,048 $ 3.91 Series CC 12/8/2016 680,480 $ 5.00 Series HH 2/23/2017 20,000 $ 3.13 Series AA 8/26/2016 200,000 $ 13.75 Series JJ 3/14/2017 30,000 $ 3.13 Series LL 4/30/2017 26,398 $ 3.59 Series MM 6/22/2017 893,491 $ 1.86 Series NN 7/24/2017 539,300 $ 2.52 Series OO 7/31/2017 60,000 $ 2.52 Series QQ 8/22/2017 87,500 $ 2.50 Series GG 2/23/2017 400,000 $ 3.00 Series II 3/14/2017 600,000 $ 3.00 Series KK 5/3/2017 395,970 $ 3.04 Series PP 8/28/2017 1,750,000 $ 2.30 Consultants 12/28/12- 7/28/17 42,000 $ 2.18- $70.00 *No current period changes to these warrants. 1. Warrant Liabilities The table below presents the warrant liabilities and their respective balances at September 30: 2018 2017 Series S warrants $ 33 $ 32,773 Series V warrants 770,436 72,912 Series W warrants 999,081 83,754 Series Z warrants 487,767 77,216 Series ZZ warrants 34,215 4,753 Series AA warrants 380,474 65,087 Series BB warrants 28,456 4,322 Series CC warrants 1,779,724 394,220 Series DD warrants 1,249,287 5,492 Series EE warrants 1,249,287 5,492 Series FF warrants 188,921 47,154 Series GG warrants 607,228 342,173 Series HH warrants 58,816 16,014 Series II warrants 660,135 511,636 Series JJ warrants 88,642 24,203 Series KK warrants 656,930 345,720 Series LL warrants 77,632 20,481 Total warrant liabilities $ 9,317,064 $ 2,053,402 The table below presents the (losses)/gains on the warrant liabilities for the years ended September 30: 2018 2017 Series S Warrants $ (751,378 ) $ 3,078,588 Series V warrants (697,526 ) 1,547,341 Series W warrants (915,327 ) 1,716,104 Series Z warrants (410,551 ) 893,388 Series ZZ warrants (29,461 ) 65,856 Series AA warrants (315,387 ) 698,574 Series BB warrants (24,134 ) 54,266 Series CC warrants (1,385,504 ) 666,203 Series DD warrants (1,243,795 ) 437,780 Series EE warrants (1,243,795 ) 685,915 Series FF warrants (141,767 ) 73,828 Series GG warrants (408,555 ) 272,464 Series HH warrants (42,802 ) 13,616 Series II warrants (462,519 ) 404,823 Series JJ warrants (64,439 ) 20,410 Series KK warrants (449,470 ) 25,564 Series LL warrants (57,151 ) 352,495 Net (loss) gain on warrant liabilities $ (8,643,561 ) $ 11,007,215 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 Warrant Liabilities 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. On July 10, 2018, the Company extended the expiration date of its Series DD and Series EE warrants to December 10, 2018. The Series DD and Series EE warrants were issued on December 8, 2016. These warrants had been previously extended to July 12, 2018. The modifications are reflected in the fair value measurement of the 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. 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. Exercise of Warrant Liabilities The following chart lists the warrant liabilities that were exercised during the year ended September 30, 2018. No warrants were exercised during the year ended September 30, 2017. Warrants Warrants Exercised Exercise Price Proceeds Series S 709,391 $ 1.75 $ 1,241,434 Series GG 200,000 $ 3.00 600,000 Series II 383,500 $ 3.00 1,150,500 Series KK 182,100 $ 3.04 552,674 1,474,991 $ 3,544,608 Expiration of Warrants On October 17, 2017, 17,821 Series U warrants, with an exercise price of $43.75, expired. The fair value of the Series U warrants was $0 on the date of expiration. On 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. 2. Equity Warrants Series VV and Series WW Warrants On July 2, 2018 the Company issued 3,900,000 registered shares of common stock at a purchase price of $1.30 per share in a registered direct offering. For each share of common stock purchased, the investors received an unregistered Series VV warrant to purchase one share of common stock. The Series VV warrants have an exercise price of $1.75 per share, will be exercisable on January 2, 2019 and expire on January 2, 2024. As part of this transaction, the Company also issued 195,000 Series WW warrants to the placement agent. These Series WW warrants have an exercise price of $1.63 per share, will be exercisable on January 2, 2018 and expire on June 28, 2023. The Company allocated the proceeds received to the shares and the warrants on a relative fair value basis. As a result of such allocation, the Company determined the relative fair value of the Series VV warrants to be approximately $1.88 million and the relative fair value of the Series WW warrants to be approximately $0.1 million. The Series VV and WW warrants qualify for equity treatment in accordance with ASC 815. Series UU Warrants On June 11, 2018, the Company issued 187,562 Series UU Warrants to holders of the outstanding Series MM and NN notes payable as an inducement to convert their notes into common stock (See Note F). The Series UU warrants are exercisable at a fixed price of $2.80 per share, will not be exercisable on December 11, 2018 and expire on June 11, 2020. Series TT Warrants On February 5, 2018, the Company sold 2,501,145 shares of its common stock at a price of $1.87 per share for total proceeds of approximately $4.7 million. The purchasers of the common stock also received Series TT warrants which allow the purchasers to acquire up to 1,875,860 shares of the Company’s common stock. The warrants are exercisable at a fixed price of $2.24 per share, were exercisable on August 6, 2018 and expire on February 5, 2023. The shares issued and those issuable upon the exercise of the warrants were restricted until they were registered on February 28, 2018. The Company allocated the proceeds received to the shares and the Series TT warrants on a relative fair value basis. As a result of such allocation, the Company determined the relative fair value of the Series TT warrants to be approximately $1.56 million. The Series TT warrants qualify for equity treatment in accordance with ASC 815. During the period from issuance through September 30, 2018, 578,983 Series TT Warrants were exercised for total proceeds of approximately $1.3 million. Series SS Warrants On December 19, 2017 the Company sold 1,289,478 shares of its common stock at a price of $1.90 per share for total proceeds of approximately $2.45 million. The purchasers of the common stock also received Series SS warrants which allow the purchasers to acquire up to 1,289,478 shares of the Company’s common stock. The warrants are exercisable at a fixed price of $2.09 per share, and will expire on December 18, 2022. Shares issuable upon the exercise of the warrants were restricted securities until they were registered on January 23, 2018. The Company allocated the proceeds received to the shares and the Series SS warrants on a relative fair value basis. As a result of such allocation, the Company determined the relative fair value of the Series SS warrants to be approximately $1.0 million. The Series SS warrants qualify for equity treatment in accordance with ASC 815. During the period from issuance through September 30, 2018, 328,948 Series SS warrants were exercised for total proceeds of approximately $0.7 million. Series RR Warrants On October 30, 2017, in consideration for an extension of the maturity date of the Series MM and Series NN convertible notes, the Company issued a total of 583,057 Series RR warrants to the note holders who agreed to the extension. Each Series RR warrant allows the holder to purchase one share of the Company’s common stock at an exercise price of $1.65 per share through the expiration date of October 30, 2022. The Series RR warrants were classified as equity warrants and are recorded at approximately $0.7 million, the relative fair value on the date of issuance, as described in Note 7. During the period from issuance through September 30, 2018, 27,687 Series RR warrants were exercised for total proceeds of approximately $46,000. 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 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 can be exercised 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. During the period from issuance through September 30, 2018, 1,577,500 and 84,000 Series PP and Series QQ warrants were exercised for total proceeds of approximately $3.6 and $0.2 million, respectively. 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, and expire on July 31, 2022. 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. 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. 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 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 August 4, 2018, the Series N warrants were modified. The modification extended the expiration date to February 18, 2020. The incremental cost of this modification was approximately $14,000, which was recorded as a deemed dividend. The warrants had previously been modified on July 17, 2017, when the expiration date was extended by one year to 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. On August 4, 2018 the expiration date of the Series N warrants was extended by eighteen months to expire on February 18, 2020. The incremental cost of this extension was approximately $14,000, which was recorded as a deemed dividend. Exercise of Equity Warrants The following chart lists the equity warrants that were exercised during the year ended September 30, 2018. Warrants Warrants Exercised Exercise Price Proceeds Series PP 1,577,500 $ 2.30 $ 3,628,250 Series QQ 84,000 $ 2.50 210,000 Series RR 27,687 $ 1.65 45,684 Series SS 328,948 $ 2.09 687,500 Series TT 578,983 $ 2.24 1,296,922 2,597,118 $ 5,868,356 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, 2018 and 2017 the Company issued 356,197 and 76,551 shares, respectively, of common stock to consultants of which 353,197 and 68,352 shares, respectively, were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $0.85 and $7.25 per share. The weighted average grant price was $1.95 and $2.67 for stock issued during the years and September 30, 2018 and 2017, respectively. Additionally, during the year ended September 30, 2017 the Company issued to consultants 20,000 options 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, 2018 and 2017, the Company recorded total expense of approximately $531,000 and $233,000, respectively, relating to these consulting agreements. At September 30, 2018 and 2017, approximately $207,000 and $45,000, respectively, are included in prepaid expenses. As of September 30, 2018, 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, 2018
Notes To Financial Statements Abstract
5. PLANT, PROPERTY AND EQUIPMENT	Plant, property and equipment consisted of the following at September 30: 2018 2017 Leased manufacturing facility $ 21,183,756 $ 21,183,756 Research equipment 3,162,150 3,169,158 Furniture and equipment 124,369 124,369 Leasehold improvements 131,910 131,910 24,602,186 24,609,193 Accumulated depreciation and amortization (8,383,335 ) (7,815,973 ) Net plant, property and equipment $ 16,218,851 $ 16,793,220 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, 2018 and 2017, accumulated depreciation on the manufacturing building is approximately $5.1 million and $4.6 million, respectively. Depreciation expense for the years ended September 30, 2018 and 2017 totaled approximately $575,000 and, $593,000, 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 $16,000 and $21,000 on September 30, 2018 and 2017, respectively. Amortization of the capital lease asset is included in general and administrative expenses on the Statements of Operations. 1

6. PATENTS

6. PATENTS	12 Months Ended
	Sep. 30, 2018
Accounting Policies [Abstract]
6. PATENTS	Patents consisted of the following at September 30: 2018 2017 Patents $ 1,644,759 $ 1,535,087 Accumulated amortization (1,386,666 ) (1,311,920 ) Patents, net $ 258,093 $ 223,167 During the years ended September 30, 2018 and 2017,there was no impairment of patent costs. Amortization expense for the years ended September 30, 2018 and 2017 totaled approximately $75,000 and $40,000, respectively. The total estimated future amortization is as follows: Years ending September 30, 2019 $ 42,000 2020 38,000 2021 35,000 2022 31,000 2023 21,000 Thereafter 91,000 $ 258,000

7. NOTES PAYABLE

7. NOTES PAYABLE	12 Months Ended
	Sep. 30, 2018
Notes Payable [Abstract]
7. NOTES PAYABLE	During the year ended September 30, 2017, the Company issued two series of convertible notes to individual investors, Series MM and Series NN (the Notes). The Notes had an aggregate principal amount of $1.5 million and $1.2 million, respectively, bore interest at 4% and were originally due on December 22, 2017. At the option of the note holders, the Series MM Notes could be converted into shares of the Company’s common stock at a fixed conversion rate of $1.69 and the Series NN Notes could be converted into shares of the Company’s common stock at a fixed conversion rate of $2.29. The purchasers of the convertible notes also received Series MM and Series NN warrants which allow the purchasers to acquire up to 893,491 and 539,300 shares of the Company’s common stock, respectively. The Series MM warrants are exercisable at a price of $1.86 per share and expire on June 22, 2022. The Series NN warrants are exercisable at a price of $2.52 per share and expire on July 24, 2022.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. Upon issuance, 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 Notes to be approximately $1.6 million, the Series MM warrants to be approximately $0.6 million, the Series NN warrants to be approximately $0.5 million, and recorded a debt discount in the amount of approximately $1.1 million. Pursuant to the guidance in ASC 815-40, Contracts in Entity’s Own Equity Debt with Conversion and Other Options On October 30, 2017, the Company extended the due dates of the Notes from December 22, 2017 to September 21, 20l8, and issued the note holders 583,057 of Series RR Warrants. The Series RR warrants expire on October 30, 2022 and are exercisable at a price of $1.65 per share. These Series RR warrants are classified as equity warrants and are recorded at approximately $0.7 million, the fair value on the date of issuance. Because the Company was experiencing financial difficulties at the time of the modification and the creditors granted the Company a concession they would not have otherwise considered in the form of a lower effective interest rate, this modification was accounted for under ASC 470-60, “ Troubled Debt Restructuring. On June 11, 2018, all remaining outstanding Series MM and Series NN notes were converted into common stock in accordance with the original agreements resulting in notes in the principal amount of $1,860,000 being converted into 937,804 shares of common stock. As an inducement to convert, the Company issued the note holders 187,562 Series UU warrants The Series UU warrants are exercisable at a fixed price of $2.80 per share, are exercisable on December 11, 2018 and expire on June 11, 2020. During the year ended September 30, 2018 and including the inducement, note holders converted all outstanding Notes in the principal amount of $2,294,300, into 1,166,105 shares of common stock. During the year ended September 30, 2017, note holders converted Notes in the principal amount of $450,700 into 266,686 shares of common stock. The unamortized debt discount relating to the converted notes was charged to interest expense. The total debt discount was amortized to interest expense using the effective interest method over the expected term of the Notes. During the years ended September 30, 2018 and 2017, the Company recorded approximately $2.0 million and $0.9 million in interest expense, respectively, relating to the amortization of the debt discount. At September 30, 2017, the remaining debt discount is approximately $1.3 million. On June 11, 2018, all note holders were given the option to receive the interest accrued on the Notes in cash or in shares converted at $2.80, the fair value of the shares on that date. Accrued interest in the amount of approximately $0.1 million was converted into 28,825 shares of common stock.

8. INCOME TAXES

8. INCOME TAXES	12 Months Ended
	Sep. 30, 2018
Income Tax Disclosure [Abstract]
8. INCOME TAXES	At September 30, 2018 and 2017, the Company had net deferred tax assets of $24.8 million and $99.0 million, respectively. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these assets, a full valuation allowance has been established to offset the net deferred tax assets. Pursuant to Section 382 of the Internal Revenue Code, or IRC, annual use of the Company’s net operating loss (NOL) carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company determined that because of various stock issuances used to finance its operations, an ownership change as defined in the provisions of Section 382 of the IRC occurred on February 5, 2018. Such ownership change resulted in annual limitations on the utilization of tax attributes, including NOL carryforwards and tax credits. The Company estimates that $188.9 million of its NOL carryforwards were effectively eliminated under Section 382 for federal income tax purposes. A portion of the remaining NOL carryforwards limited by Section 382 will become available each year. As a result of the Section 382 estimated analysis completed during 2018, the Company has included $18.6 million in the deferred tax asset schedule, which is the deferred tax asset relating to the unlimited portion of the NOL carryforwards. The Company’s Section 382 estimated analysis was completed through September 30, 2018. If additional changes in ownership occur subsequent to year end, additional NOL and tax credit carryforwards could be eliminated or restricted. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. T he Company had federal NOL carryforwards of approximately $18.6 million and $187.8 million at September 30, 2018 and 2017, respectively. The NOL carryforwards begin to expire during the year ended September 30, 2020 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, 2018 and 2017. The R&D credit begins to expire during the year ended September 30, 2020 and becomes fully expired during the fiscal year ended 2029. Significant components of the Company’s deferred tax assets as of September 30, 2018 and 2017 are listed below 2018 2017 NOL carryforwards $ 5,052,000 $ 70,752,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 3,097,000 6,292,000 Capitalized R&D 15,518,000 21,160,000 Vacation and other 544,000 121,000 Total deferred tax assets 25,432,000 99,546,000 Fixed assets and intangibles (634,000 ) (523,000 ) Total deferred tax liability (634,000 ) (523,000 ) Net deferred tax asset 24,798,000 99,023,000 Valuation allowance (24,798,000 ) (99,023,000 ) Ending Balance $ - $ - 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 for the years ended September 30: 2018 2017 Federal Rate 24.28 % 34.00 % Federal rate change (88.94 ) - State tax rate, net of federal benefit 4.47 6.44 State tax rate change - (3.91 ) Net operating loss – write-off (161.21 ) - Other adjustments (5.95 ) (3.39 ) Permanent differences (5.79 ) 25.49 Change in valuation allowance 233.14 (58.63 ) Effective tax rate 0.00 % 0.00 % The Company applies the provisions of ASC 740, “Accounting for Uncertainty in Income Taxes,” On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Act" or "Tax Reform"). Among other changes, the Act reduces the current corporate federal income tax rate from 35% to 21% effective January 1, 2018. As deferred tax assets and deferred tax liabilities are measured using the tax rates expected to apply to taxable income in the years during which the temporary differences are anticipated to be recovered or settled, the Company determined that it was necessary to revalue its deferred tax assets and deferred tax liabilities as of December 31, 2017.

9. STOCK COMPENSATION

9. STOCK COMPENSATION	12 Months Ended
	Sep. 30, 2018
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, 2018 2017 Employees $ 2,743,267 $ 1,380,500 Non-employees $ 530,736 $ 232,847 Stock compensation expenses were recorded as general and administrative expense. During the years ended September 30, 2018 and 2017, non-employee stock compensation excluded approximately $207,000 and $45,000, respectively, for future services to be performed (Note 12). During the years ended September 30, 2018 and 2017 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. 2018 2017 Expected stock price volatility 89.90 – 94.32% 88.54 – 90.67% Risk-free interest rate 2.30 – 3.04% 2.18 – 2.29% Expected life of options 9.67 – 9.70 Years 9.69 – 10 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, 2018 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 September 30, 2016 343,575 $ 59.22 5.35 $ 0 232,931 $ 66.28 4.76 $ 0 Vested 63,812 $ 18.45 Granted (a) 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 Vested 334,111 $ 7.63 Granted 1,958,108 $ 2.50 Exercised Forfeited 5,426 $ 3.79 Expired 32,399 $ 67.73 32,399 $ 67.73 Cancelled Outstanding at September 30, 2018 3,160,127 $ 7.30 8.88 $ 4,761,973 577,694 $ 26.18 6.74 $ 604,763 (a) 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, 2018 is presented below: Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 2016 110,644 $ 36.96 Vested (63,812 ) Granted 932,825 Forfeited (15,795 ) Unvested at September 30, 2017 963,862 $ 4.91 Vested (334,111 ) Granted 1,958,108 Forfeited (5,426 ) Unvested at September 30, 2018 2,582,433 $ 2.48 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, 2018 is presented below: Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2016 604,000 $ 13.75 Vested (136,000 ) Unvested at September 30, 2017 468,000 $ 13.75 Vested (156,000 ) Unvested at September 30, 2018 312,000 $ 13.75 Stock Bonus Plans Stock Compensation Plans

10. EMPLOYEE BENEFIT PLAN

10. EMPLOYEE BENEFIT PLAN	12 Months Ended
	Sep. 30, 2018
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. During the year ended September 30, 2018, 93,640 shares were issued to the Company’s 401(k) plan for a cost of approximately $145,000. During the year ended September 30, 2017, 79,941 shares were issued to the Company’s 401(k) plan for a cost of approximately $151,000.

11. COMMITMENTS AND CONTINGENCI

11. COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Sep. 30, 2018
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 were being credited against future invoices in $150,000 annual increments through December 2017. As of September 30, 2018, all advance payments have been expensed. In April 2013, the Company entered into a co-development and revenue sharing agreement with Ergomed. Under the agreement, Ergomed will contribute up to $10 million towards the Company’s Phase III clinical 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 supported the Phase 1 study 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. 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, 2018 and 2017, the leased building asset has a net book value of approximately $16.1 million and $16.6 million, respectively, and the landlord liability has a balance of $13.4 million and $13.2 million, respectively. 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, 2018 and 2017. Approximate future minimum lease payments under the San Tomas lease as of September 30, 2018 are as follows: Years ending September 30, 2019 $ 1,808,000 2020 1,872,000 2021 1,937,000 2022 2,004,000 2023 2,073,000 Thereafter 11,685,000 Total future minimum lease obligation 21,379,000 Less: imputed interest on financing obligation (7,999,000 ) Net present value of lease financing obligation $ 13,380,000 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, 2018 and 2017 was approximately $71,000 and $69,000, respectively. The Company leases its research and development laboratory under a 60 month lease which expires February 28, 2022. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate of approximately $13,000 per month. As of September 30, 2018 and 2017, the Company has recorded a deferred rent liability of approximately $12,000 and $5,000, respectively. The Company leases its office headquarters under a 60 month lease which expires June 30, 2020. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate approximately $8,000 per month. As of September 30, 2018 and 2017, the Company has recorded a deferred rent liability of approximately $14,000 and $18,000, respectively. The Company leases office equipment under a capital lease arrangement. The term of the capital lease is 60 months and it expires on October 31, 2021. The monthly lease payment is $505. The lease bears annual interest at approximately 6.25%. Approximate future minimum annual lease payments due under non-cancelable operating leases, excluding the San Tomas lease, for the years ending after September 30, 2018 are as follows: Years ending September 30, 2019 $ 258,000 2020 238,000 2021 163,000 2022 69,000 Thereafter - Total future minimum lease obligation $ 728,000 Rent expense, for the years ended September 30, 2018 and 2017, excluding the rent paid on the San Tomas lease, was approximately $253,000 and $245,000, respectively. Vendor Obligations Further, the Company has contingent obligations with 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 $8.4 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, 2018
Related Party Transactions [Abstract]
12. RELATED PARTY TRANSACTIONS	On August 13, 2018, four officers of the Company (Geert Kersten, Patricia Prichep, Daniel Zimmerman and John Cipriano) purchased 463,855 restricted shares of the Company’s common stock from the Company for $385,000, or $0.83 per share. The shares are subject to the conditions of Rule 144 under the Securities Act of 1933. 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. 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 would 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 October 30, 2017, in consideration for an extension of the maturity date of the Series MM and Series NN convertible notes, the Company issued a total of 583,057 Series RR warrants to the note holders who agreed to the extension. Mr. Kersten, the trust and Ms. Prichep received 73,965, 54,585 and 5,459 Series RR warrants, respectively. The Series RR warrants were classified as equity warrants in accordance with ASC 815 and the fair value of the portion attributable to Mr. Kersten, the trust and Ms. Prichep was calculated to be approximately $151,000 on the date of issuance. On June 11, 2018, to induce conversion of the Series MM and NN Notes, all note holders, including Mr. Kersten and Ms. Prichep were issued Series UU warrants in an amount equal to 20% of the shares into which the Notes were convertible. This resulted in the issuance of 29,586, 21,834 and 2,183 Series UU warrants to Mr. Kersten, the trust and Ms. Prichep, respectively. The Series UU warrants have an exercise price of $2.80 per share and expired on June 11, 2018. These terms are identical to the other recipients of the Series UU Warrants. At that time, all outstanding Notes were converted, including those held by the related parties. The Company recognized an expense equal to the fair value of the consideration transferred in the transaction in excess of the fair value of consideration issuable under the original conversion terms. The portion of the expense attributed to the fair value of the Series UU warrants issued to Mr. Kersten, the trust and Ms. Prichep was approximately $83,000 and is included as interest expense on the Statement of Operations. The Series UU warrants qualify for equity treatment in accordance with ASC 815. The Series MM and NN Notes accrued interest at 4%. Upon conversion, the officers elected to receive the accrued interest in shares of common stock instead of cash. On the conversion date, the officers converted approximately $19,000 in accrued interest into 6,930 shares of common stock. No other interest payments were made to officers during the years ended September 30, 2018 and 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 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.

13. STOCKHOLDERS EQUITY

13. STOCKHOLDERS EQUITY	12 Months Ended
	Sep. 30, 2018
Notes To Financial Statements Abstract
13. STOCKHOLDERS' EQUITY	Sales of Securities On July 2, 2018, the Company closed on a registered direct offering and concurrent private placement with institutional investors. The Company received net proceeds of approximately $4.7 million. The Company issued approximately 3,900,000 registered shares of common stock at a purchase price of $1.30 per share. Concurrently in a private placement, the Company issued to the investors warrants to purchase up to 3,900,000 shares of its common stock. For each share of common stock purchased in the registered direct offering, the investors in the private placement received an unregistered warrant to purchase one share of common stock. The warrants have an exercise price of $1.75 per share, will be exercisable on January 2, 2019, and will expire on January 2, 2024. The Company also issued 195,000 Series WW warrants to the placement agent. These Series WW warrants have an exercise price of $1.63 per share, will be exercisable on January 2, 2018 and expire on July 2, 2023. The Company allocated the proceeds received to the shares and the warrants on a relative fair value basis. As a result of such allocation, the Company determined the relative fair value of the Series VV warrants to be approximately $1.88 million and the relative fair value of the Series WW warrants to be approximately $0.1 million. The Series VV and WW warrants qualify for equity treatment in accordance with ASC 815. On February 5, 2018, the Company sold 2,501,145 shares of its common stock at a price of $1.87 per share for total proceeds of approximately $4.7 million. The common stock was restricted until registered. The purchasers of the common stock also received Series TT warrants which allow the purchasers to acquire up to 1,875,860 shares of the Company’s common stock. The warrants are exercisable at a fixed price of $2.24 per share, were exercisable on August 6, 2018 and expire on February 5, 2023. The shares and warrants were registered on February 28, 2018. The Company allocated the proceeds received to the shares and the Series TT warrants on a relative fair value basis. As a result of such allocation, the Company determined the relative fair value of the Series TT warrants to be approximately $1.56 million. The Series TT warrants qualify for equity treatment in accordance with ASC 815. During the period from issuance through September 30, 2018, 578,983 Series TT Warrants were exercised for total proceeds of approximately $1.3 million. On December 19, 2017 the Company sold 1,289,478 shares of its common stock at a price of $1.90 per share for total proceeds of approximately $2.45 million. The common stock was restricted until registered. The purchasers of the common stock also received warrants which allow the purchasers to acquire up to 1,289,478 shares of the Company’s common stock. The warrants are exercisable at a fixed price of $2.09 per share, were exercisable on December 20, 2017 and will expire on December 18, 2022. The shares and warrants were registered on January 23, 2018. The Company allocated the proceeds received to the shares and the Series SS warrants on a relative fair value basis. As a result of such allocation, the Company determined the relative fair value of the Series SS warrants to be approximately $1.0 million. The Series SS warrants qualify for equity treatment in accordance with ASC 815. During the period from issuance through September 30, 2018, 328,948 Series SS warrants were exercised for total proceeds of approximately $0.7 million. 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 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. Other Equity Transactions Periodically, the Company has entered into Securities Purchase Agreements with Ergomed plc, one of the Company’s Clinical Research Organizations responsible for managing the Company’s Phase 3 clinical trial, to facilitate a partial payment of the accounts payable balances due Ergomed. Under the Agreements, the Company issued Ergomed shares of common stock 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. Upon issuance, the Company expenses the full value of the shares as interest expense and subsequently offsets the expense as amounts are realized through the resale by Ergomed and reduces accounts payable to Ergomed. During the year ended September 30, 2018, the Company issued Ergomed 2,260,000 shares valued at approximately $5.5 million. During the year ended September 30, 2017, the Company issued Ergomed 480,000 shares valued at approximately $1.3 million. During the years ended September 30, 2018 and 2017, Ergomed credited the Company approximately $3.2 million and $0.1 million for the resale of shares. As a result, the Company has recorded a net interest expense of $2.3 million and $1.2 million for the years ended September 30, 2018 and 2017, respectively. As of September 30, 2018, Ergomed holds 918,900 shares and may resell the shares or return the shares to the Company for cancellation until December 31, 2018. As of September 30, 2017, Ergomed held 415,208 shares, all of which were resold during the year ended September 30, 2018.

14. FAIR VALUE MEASUREMENTS

14. FAIR VALUE MEASUREMENTS	12 Months Ended
	Sep. 30, 2018
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, 2018: Quoted Prices in Active Markets for Identical Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative Instruments $ 33 $ - $ 9,317,031 $ 9,317,064 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 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: 2018 2017 Beginning balance $ 2,020,629 $ 5,283,573 Issuances - 4,665,683 Exercises (595,780 ) - Net realized and unrealized derivative loss (gain) 7,892,182 (7,928,627 ) Ending balance $ 9,317,031 $ 2,020,629 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock as well as U.S. Treasury Bill rates are observable in active markets. At September 30, 2018, the Company’s Level 3 derivative instruments have a weighted average fair value of $1.50 per share and a weighted average exercise price of $8.50 per share. Fair values were determined using a weighted average risk free interest rate of 2.68% and 121% volatility. The instruments have a weighted average time to maturity of 2.3 years. 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.

15. NET LOSS PER COMMON SHARE

15. NET LOSS PER COMMON SHARE	12 Months Ended
	Sep. 30, 2018
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, 2018 2017 Loss per share - basic Net loss available to common shareholders - basic $ (31,851,573 ) $ (14,427,055 ) Weighted average shares outstanding - basic 17,004,722 7,891,843 Basic loss per common share $ (1.87 ) $ (1.83 ) Loss per share - diluted Net loss available to common shareholders - basic $ (31,851,573 ) $ (14,427,055 ) Gain on derivatives (1) - (677,287 ) Net loss available to common shareholders - diluted $ (31,851,573 ) $ (15,104,342 ) Weighted average shares outstanding - basic 17,004,722 7,891,843 Incremental shares underlying dilutive "in the money" warrants (1) - 10,804 Weighted average shares outstanding - diluted 17,004,722 7,902,647 Diluted loss per common share $ (1.87 ) $ (1.91 ) (1) Includes series GG & II for the year ended September 30, 2017 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 2018 2017 Options and Warrants 11,794,603 2,538,130 Convertible Debt - 1,166,106 Unvested Restricted Stock 312,000 604,000 Total 12,106,603 4,308,236

16. SUBSEQUENT EVENTS

16. SUBSEQUENT EVENTS	12 Months Ended
	Sep. 30, 2018
Subsequent Events [Abstract]
16. SUBSEQUENT EVENTS	In accordance with ASC 855, “ Subsequent Events

3. SUMMARY OF SIGNIFICANT ACC_2

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)	12 Months Ended
	Sep. 30, 2018
Summary Of Significant Accounting Policies Policies Abstract
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	The deposits are required by the lease agreement for the manufacturing facility and by the clinical research organization (CRO) agreements.
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 as services are performed and relies on the CROs to provide estimates of those costs according to the completion stage of a study. Estimated accrued CRO costs are subject to revisions as the clinical trial studies progress toward completion. The Company adjusts the estimated expense in the period in which the facts that give rise to the change 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, 2018.
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, 2018 and 2017. On December 22, 2017, the “Tax Cuts and Jobs Act” (the “Tax Act”:), was signed into law by the President of the United States. The Tax Act includes significant changes to corporate taxation, including reduction of the U.S. corporate tax rate from 35% to 21%, effective January 1, 2018, limitation of the tax deduction for interest expense to 30% of earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks. The Company has accounted for certain income tax effects of the Act in applying FASB ASC 740 to the current reporting period. Because the Company records a valuation allowance for its entire deferred income tax asset, there was no impact to the amounts reported in the Company’s financial statements resulting from the Tax Act.
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 that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. Forfeitures of awards are recognized as they occur. 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 June 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-07, Compensation—Stock Compensation (Topic 718 grant date grantor grantee 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 February 2016, the FASB issued ASU 2016-02, Leases 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 _2

4. WARRANTS AND NON-EMPLOYEE OPTIONS (Tables)	12 Months Ended
	Sep. 30, 2018
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, 2018: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Reference Series S 10/11/13- 10/24/14 327,729 $ 31.25 10/11/2018 1 Series DD 12/8/2016 1,360,960 $ 4.50 12/10/2018 1 Series EE 12/8/2016 1,360,960 $ 4.50 12/10/2018 1 Series N 8/18/2008 85,339 $ 3.00 2/18/2020 2 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 * Series UU 6/11/2018 187,562 $ 2.80 6/11/2020 2 Series W 10/28/2015 688,930 $ 16.75 10/28/2020 * Series X 1/13/2016 120,000 $ 9.25 1/13/2021 * Series Y 2/15/2016 26,000 $ 12.00 2/15/2021 * Series ZZ 5/23/2016 20,000 $ 13.75 5/18/2021 * Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 * Series Z 5/23/2016 264,000 $ 13.75 11/23/2021 * 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 * 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 3,500 $ 2.50 8/22/2022 2 Series GG 2/23/2017 200,000 $ 3.00 8/23/2022 1 Series II 3/14/2017 216,500 $ 3.00 9/14/2022 1 Series RR 10/30/2017 555,370 $ 1.65 10/30/2022 2 Series KK 5/3/2017 213,870 $ 3.04 11/3/2022 1 Series SS 12/19/2017 960,530 $ 2.09 12/18/2022 2 Series TT 2/5/2018 1,296,877 $ 2.24 2/5/2023 2 Series PP 8/28/2017 172,500 $ 2.30 2/28/2023 2 Series WW 7/2/2018 195,000 $ 1.63 6/28/2023 2 Series VV 7/2/2018 3,900,000 $ 1.75 1/2/2024 2 Consultants 1/1/16 - 7/28/17 30,400 $ 2.18- $11.50 12/31/18- 7/27/27 3 *No current period changes to these warrants. 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 Series U 4/17/2014 17,821 $ 43.75 Series DD 12/8/2016 1,360,960 $ 4.50 Series EE 12/8/2016 1,360,960 $ 4.50 Series N 8/18/2008 85,339 $ 3.00 Series S 10/11/13- 10/24/14 1,037,120 $ 31.25 Series V 5/28/2015 810,127 $ 19.75 Series W 10/28/2015 688,930 $ 16.75 Series X 1/13/2016 120,000 $ 9.25 Series Y 2/15/2016 26,000 $ 12.00 Series ZZ 5/23/2016 20,000 $ 13.75 Series BB 8/26/2016 16,000 $ 13.75 Series Z 5/23/2016 264,000 $ 13.75 Series FF 12/8/2016 68,048 $ 3.91 Series CC 12/8/2016 680,480 $ 5.00 Series HH 2/23/2017 20,000 $ 3.13 Series AA 8/26/2016 200,000 $ 13.75 Series JJ 3/14/2017 30,000 $ 3.13 Series LL 4/30/2017 26,398 $ 3.59 Series MM 6/22/2017 893,491 $ 1.86 Series NN 7/24/2017 539,300 $ 2.52 Series OO 7/31/2017 60,000 $ 2.52 Series QQ 8/22/2017 87,500 $ 2.50 Series GG 2/23/2017 400,000 $ 3.00 Series II 3/14/2017 600,000 $ 3.00 Series KK 5/3/2017 395,970 $ 3.04 Series PP 8/28/2017 1,750,000 $ 2.30 Consultants 12/28/12- 7/28/17 42,000 $ 2.18- $70.00 *No current period changes to these warrants.
Derivative Liabilities	The table below presents the warrant liabilities and their respective balances at September 30: 2018 2017 Series S warrants $ 33 $ 32,773 Series V warrants 770,436 72,912 Series W warrants 999,081 83,754 Series Z warrants 487,767 77,216 Series ZZ warrants 34,215 4,753 Series AA warrants 380,474 65,087 Series BB warrants 28,456 4,322 Series CC warrants 1,779,724 394,220 Series DD warrants 1,249,287 5,492 Series EE warrants 1,249,287 5,492 Series FF warrants 188,921 47,154 Series GG warrants 607,228 342,173 Series HH warrants 58,816 16,014 Series II warrants 660,135 511,636 Series JJ warrants 88,642 24,203 Series KK warrants 656,930 345,720 Series LL warrants 77,632 20,481 Total warrant liabilities $ 9,317,064 $ 2,053,402 The table below presents the (losses)/gains on the warrant liabilities for the years ended September 30: 2018 2017 Series S Warrants $ (751,378 ) $ 3,078,588 Series V warrants (697,526 ) 1,547,341 Series W warrants (915,327 ) 1,716,104 Series Z warrants (410,551 ) 893,388 Series ZZ warrants (29,461 ) 65,856 Series AA warrants (315,387 ) 698,574 Series BB warrants (24,134 ) 54,266 Series CC warrants (1,385,504 ) 666,203 Series DD warrants (1,243,795 ) 437,780 Series EE warrants (1,243,795 ) 685,915 Series FF warrants (141,767 ) 73,828 Series GG warrants (408,555 ) 272,464 Series HH warrants (42,802 ) 13,616 Series II warrants (462,519 ) 404,823 Series JJ warrants (64,439 ) 20,410 Series KK warrants (449,470 ) 25,564 Series LL warrants (57,151 ) 352,495 Net (loss) gain on warrant liabilities $ (8,643,561 ) $ 11,007,215
Exercise of Warrant Liabilities	Warrants Warrants Exercised Exercise Price Proceeds Series S 709,391 $ 1.75 $ 1,241,434 Series GG 200,000 $ 3.00 600,000 Series II 383,500 $ 3.00 1,150,500 Series KK 182,100 $ 3.04 552,674 1,474,991 $ 3,544,608
Exercise of Equity Warrants	Warrants Warrants Exercised Exercise Price Proceeds Series PP 1,577,500 $ 2.30 $ 3,628,250 Series QQ 84,000 $ 2.50 210,000 Series RR 27,687 $ 1.65 45,684 Series SS 328,948 $ 2.09 687,500 Series TT 578,983 $ 2.24 1,296,922 2,597,118 $ 5,868,356

5. PLANT, PROPERTY AND EQUIPM_2

5. PLANT, PROPERTY AND EQUIPMENT (Tables)	12 Months Ended
	Sep. 30, 2018
Notes To Financial Statements Abstract
Plant, property and equipment	2018 2017 Leased manufacturing facility $ 21,183,756 $ 21,183,756 Research equipment 3,162,150 3,169,158 Furniture and equipment 124,369 124,369 Leasehold improvements 131,910 131,910 24,602,186 24,609,193 Accumulated depreciation and amortization (8,383,335 ) (7,815,973 ) Net plant, property and equipment $ 16,218,851 $ 16,793,220

6. PATENTS (Tables)

6. PATENTS (Tables)	12 Months Ended
	Sep. 30, 2018
Net Loss Per Common Share Tables
Schedule of Patents	2018 2017 Patents $ 1,644,759 $ 1,535,087 Accumulated amortization (1,386,666 ) (1,311,920 ) Patents, net $ 258,093 $ 223,167
Schedule of total estimated future amortization	Years ending September 30, 2019 $ 42,000 2020 38,000 2021 35,000 2022 31,000 2023 21,000 Thereafter 91,000 $ 258,000

8. INCOME TAXES (Tables)

8. INCOME TAXES (Tables)	12 Months Ended
	Sep. 30, 2018
Income Tax Disclosure [Abstract]
Net deferred tax asset	2018 2017 NOL carryforwards $ 5,052,000 $ 70,752,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 3,097,000 6,292,000 Capitalized R&D 15,518,000 21,160,000 Vacation and other 544,000 121,000 Total deferred tax assets 25,432,000 99,546,000 Fixed assets and intangibles (634,000 ) (523,000 ) Total deferred tax liability (634,000 ) (523,000 ) Net deferred tax asset 24,798,000 99,023,000 Valuation allowance (24,798,000 ) (99,023,000 ) Ending Balance $ - $ -
Reconciliation of effective tax rate	2018 2017 Federal Rate 24.28 % 34.00 % Federal rate change (88.94 ) - State tax rate, net of federal benefit 4.47 6.44 State tax rate change - (3.91 ) Net operating loss – write-off (161.21 ) - Other adjustments (5.95 ) (3.39 ) Permanent differences (5.79 ) 25.49 Change in valuation allowance 233.14 (58.63 ) Effective tax rate 0.00 % 0.00 %

9. STOCK COMPENSATION (Tables)

9. STOCK COMPENSATION (Tables)	12 Months Ended
	Sep. 30, 2018
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Employees and non-employees stock compensation	Year Ended September 30, 2018 2017 Employees $ 2,743,267 $ 1,380,500 Non-employees $ 530,736 $ 232,847
Assumptions for Option Pricing	2018 2017 Expected stock price volatility 89.90 – 94.32% 88.54 – 90.67% Risk-free interest rate 2.30 – 3.04% 2.18 – 2.29% Expected life of options 9.67 – 9.70 Years 9.69 – 10 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 September 30, 2016 343,575 $ 59.22 5.35 $ 0 232,931 $ 66.28 4.76 $ 0 Vested 63,812 $ 18.45 Granted (a) 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 Vested 334,111 $ 7.63 Granted 1,958,108 $ 2.50 Exercised Forfeited 5,426 $ 3.79 Expired 32,399 $ 67.73 32,399 $ 67.73 Cancelled Outstanding at September 30, 2018 3,160,127 $ 7.30 8.88 $ 4,761,973 577,694 $ 26.18 6.74 $ 604,763
Schedule of non-vested options	Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 2016 110,644 $ 36.96 Vested (63,812 ) Granted 932,825 Forfeited (15,795 ) Unvested at September 30, 2017 963,862 $ 4.91 Vested (334,111 ) Granted 1,958,108 Forfeited (5,426 ) Unvested at September 30, 2018 2,582,433 $ 2.48
Schedule of restricted stock units	Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2016 604,000 $ 13.75 Vested (136,000 ) Unvested at September 30, 2017 468,000 $ 13.75 Vested (156,000 ) Unvested at September 30, 2018 312,000 $ 13.75

11. COMMITMENTS AND CONTINGEN_2

11. COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Sep. 30, 2018
Commitments And Contingencies Tables
Future minimum lease payments under the San Tomas lease	Years ending September 30, 2019 $ 1,808,000 2020 1,872,000 2021 1,937,000 2022 2,004,000 2023 2,073,000 Thereafter 11,685,000 Total future minimum lease obligation 21,379,000 Less: imputed interest on financing obligation (7,999,000 ) Net present value of lease financing obligation $ 13,380,000
Schedule of future minimum annual rental payments due under non-cancelable operating leases	Years ending September 30, 2019 $ 258,000 2020 238,000 2021 163,000 2022 69,000 Thereafter - Total future minimum lease obligation $ 728,000

14. FAIR VALUE MEASUREMENTS (Ta

14. FAIR VALUE MEASUREMENTS (Tables)	12 Months Ended
	Sep. 30, 2018
Fair Value Measurements Tables Abstract
Measured at fair value on a recurring basis	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, 2018: Quoted Prices in Active Markets for Identical Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative Instruments $ 33 $ - $ 9,317,031 $ 9,317,064 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
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	2018 2017 Beginning balance $ 2,020,629 $ 5,283,573 Issuances - 4,665,683 Exercises (595,780 ) - Net realized and unrealized derivative loss (gain) 7,892,182 (7,928,627 ) Ending balance $ 9,317,031 $ 2,020,629

15. NET LOSS PER COMMON SHARE (

15. NET LOSS PER COMMON SHARE (Tables)	12 Months Ended
	Sep. 30, 2018
Net Loss Per Common Share Tables Abstract
Earnings per share	Year ended September 30, 2018 2017 Loss per share - basic Net loss available to common shareholders - basic $ (31,851,573 ) $ (14,427,055 ) Weighted average shares outstanding - basic 17,004,722 7,891,843 Basic loss per common share $ (1.87 ) $ (1.83 ) Loss per share - diluted Net loss available to common shareholders - basic $ (31,851,573 ) $ (14,427,055 ) Gain on derivatives (1) - (677,287 ) Net loss available to common shareholders - diluted $ (31,851,573 ) $ (15,104,342 ) Weighted average shares outstanding - basic 17,004,722 7,891,843 Incremental shares underlying dilutive "in the money" warrants (1) - 10,804 Weighted average shares outstanding - diluted 17,004,722 7,902,647 Diluted loss per common share $ (1.87 ) $ (1.91 ) (1) Includes series GG & II for the year ended September 30, 2017
Antidilutive securities	2018 2017 Options and Warrants 11,794,603 2,538,130 Convertible Debt - 1,166,106 Unvested Restricted Stock 312,000 604,000 Total 12,106,603 4,308,236

3. SUMMARY OF SIGNIFICANT ACC_3

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details)	Sep. 30, 2018USD ($)
Disclosure A.Organization And Summary Of Significant Accounting Policies Details Abstract
Fully Insured Amount of non-interest bearing cash balances	$ 250,000

4. WARRANTS AND NON-EMPLOYEE _3

4. WARRANTS AND NON-EMPLOYEE OPTIONS (Details) - $ / shares	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
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 UU [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jun. 11, 2018
Shares Issuable upon Exercise of Warrant	187,562
Exercise Price	$ 2.8
Expiration Date	Jun. 11, 2020
Series DD [Member]
STOCKHOLDERS' EQUITY
Issue Date	Dec. 8, 2016	Dec. 8, 2016
Shares Issuable upon Exercise of Warrant	1,360,960	1,360,960
Exercise Price	$ 4.5	$ 4.50
Expiration Date	Dec. 10, 2018	Dec. 1, 2017
Series EE [Member]
STOCKHOLDERS' EQUITY
Issue Date	Dec. 8, 2016	Dec. 8, 2016
Shares Issuable upon Exercise of Warrant	1,360,960	1,360,960
Exercise Price	$ 4.5	$ 4.50
Expiration Date	Dec. 10, 2018	Dec. 1, 2017
Series N [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 18, 2008	Aug. 18, 2008
Shares Issuable upon Exercise of Warrant	85,339	85,339
Exercise Price	$ 3	$ 3
Expiration Date	Feb. 18, 2020	Aug. 18, 2018
Series S [Member]
STOCKHOLDERS' EQUITY
Shares Issuable upon Exercise of Warrant	327,729	1,037,120
Exercise Price	$ 31.25	$ 31.25
Expiration Date	Oct. 11, 2018	Oct. 11, 2018
Issue Start date	Oct. 11, 2013	Oct. 11, 2013
Issue End Date	Oct. 24, 2014	Oct. 24, 2014
Series V [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 28, 2015	May 28, 2015
Shares Issuable upon Exercise of Warrant	810,127	810,127
Exercise Price	$ 19.75	$ 19.75
Expiration Date	May 28, 2020	May 28, 2020
Series W [Member]
STOCKHOLDERS' EQUITY
Issue Date	Oct. 28, 2015	Oct. 28, 2015
Shares Issuable upon Exercise of Warrant	688,930	688,930
Exercise Price	$ 16.75	$ 16.75
Expiration Date	Oct. 28, 2020	Oct. 28, 2020
Series X [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jan. 13, 2016	Jan. 13, 2016
Shares Issuable upon Exercise of Warrant	120,000	120,000
Exercise Price	$ 9.25	$ 9.25
Expiration Date	Jan. 13, 2021	Jan. 13, 2021
Series Y [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 15, 2016	Feb. 15, 2016
Shares Issuable upon Exercise of Warrant	26,000	26,000
Exercise Price	$ 12	$ 12
Expiration Date	Feb. 15, 2021	Feb. 15, 2021
Series ZZ [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 23, 2016	May 23, 2016
Shares Issuable upon Exercise of Warrant	20,000	20,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	May 18, 2021	May 18, 2021
Series BB [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 26, 2016	Aug. 26, 2016
Shares Issuable upon Exercise of Warrant	16,000	16,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	Aug. 22, 2021	Aug. 22, 2021
Series Z [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 23, 2016	May 23, 2016
Shares Issuable upon Exercise of Warrant	264,000	264,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	Nov. 23, 2021	Nov. 23, 2021
Series FF [Member]
STOCKHOLDERS' EQUITY
Issue Date	Dec. 8, 2016	Dec. 8, 2016
Shares Issuable upon Exercise of Warrant	68,048	68,048
Exercise Price	$ 3.91	$ 3.91
Expiration Date	Dec. 1, 2021	Dec. 1, 2021
Series CC [Member]
STOCKHOLDERS' EQUITY
Issue Date	Dec. 8, 2016	Dec. 8, 2016
Shares Issuable upon Exercise of Warrant	680,480	680,480
Exercise Price	$ 5	$ 5
Expiration Date	Dec. 8, 2021	Dec. 8, 2021
Series HH [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 23, 2017	Feb. 23, 2017
Shares Issuable upon Exercise of Warrant	20,000	20,000
Exercise Price	$ 3.13	$ 3.13
Expiration Date	Feb. 16, 2022	Feb. 16, 2022
Series AA [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 26, 2016	Aug. 26, 2016
Shares Issuable upon Exercise of Warrant	200,000	200,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	Feb. 22, 2022	Feb. 22, 2022
Series JJ [Member]
STOCKHOLDERS' EQUITY
Issue Date	Mar. 14, 2017	Mar. 14, 2017
Shares Issuable upon Exercise of Warrant	30,000	30,000
Exercise Price	$ 3.13	$ 3.13
Expiration Date	Mar. 8, 2022	Mar. 8, 2022
Series LL [Member]
STOCKHOLDERS' EQUITY
Issue Date	Apr. 30, 2017	Apr. 30, 2017
Shares Issuable upon Exercise of Warrant	26,398	26,398
Exercise Price	$ 3.59	$ 3.59
Expiration Date	Apr. 30, 2022	Apr. 30, 2022
Series MM [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jun. 22, 2017	Jun. 22, 2017
Shares Issuable upon Exercise of Warrant	893,491	893,491
Exercise Price	$ 1.86	$ 1.86
Expiration Date	Jun. 22, 2022	Jun. 22, 2022
Series NN [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jul. 24, 2017	Jul. 24, 2017
Shares Issuable upon Exercise of Warrant	539,300	539,300
Exercise Price	$ 2.52	$ 2.52
Expiration Date	Jul. 24, 2022	Jul. 24, 2022
Series OO [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jul. 31, 2017	Jul. 31, 2017
Shares Issuable upon Exercise of Warrant	60,000	60,000
Exercise Price	$ 2.52	$ 2.52
Expiration Date	Jul. 31, 2022	Jul. 31, 2022
Series QQ [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 22, 2017	Aug. 22, 2017
Shares Issuable upon Exercise of Warrant	3,500	87,500
Exercise Price	$ 2.5	$ 2.50
Expiration Date	Aug. 22, 2022	Aug. 22, 2022
Series GG [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 23, 2017	Feb. 23, 2017
Shares Issuable upon Exercise of Warrant	200,000	400,000
Exercise Price	$ 3	$ 3
Expiration Date	Aug. 23, 2022	Aug. 23, 2022
Series II [Member]
STOCKHOLDERS' EQUITY
Issue Date	Mar. 14, 2017	Mar. 14, 2017
Shares Issuable upon Exercise of Warrant	216,500	600,000
Exercise Price	$ 3	$ 3
Expiration Date	Sep. 14, 2022	Sep. 14, 2022
Series KK [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 3, 2017	May 3, 2017
Shares Issuable upon Exercise of Warrant	213,870	395,970
Exercise Price	$ 3.04	$ 3.04
Expiration Date	Nov. 3, 2022	Nov. 3, 2022
Series PP [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 28, 2017	Aug. 28, 2017
Shares Issuable upon Exercise of Warrant	172,500	1,750,000
Exercise Price	$ 2.3	$ 2.30
Expiration Date	Feb. 28, 2023	Feb. 28, 2023
Consultants [Member]
STOCKHOLDERS' EQUITY
Shares Issuable upon Exercise of Warrant	30,400	42,000
Issue Start date	Jan. 1, 2016	Dec. 28, 2012
Issue End Date	Jul. 28, 2017	Jul. 28, 2017
Expiration start date	Dec. 31, 2018	Dec. 27, 2017
Expiration end date	Jul. 27, 2027	Jul. 27, 2027
Exercise Price Minimum	$ 2.18	$ 2.18
Exercise Price Maximum	$ 11.50	$ 70
Series RR [Member]
STOCKHOLDERS' EQUITY
Issue Date	Oct. 30, 2017
Shares Issuable upon Exercise of Warrant	555,370
Exercise Price	$ 1.65
Expiration Date	Oct. 30, 2022
Series SS [Member]
STOCKHOLDERS' EQUITY
Issue Date	Dec. 19, 2017
Shares Issuable upon Exercise of Warrant	960,530
Exercise Price	$ 2.09
Expiration Date	Dec. 18, 2022
Series TT [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 5, 2018
Shares Issuable upon Exercise of Warrant	1,296,877
Exercise Price	$ 2.24
Expiration Date	Feb. 5, 2023
Series WW [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jul. 2, 2018
Shares Issuable upon Exercise of Warrant	195,000
Exercise Price	$ 1.63
Expiration Date	Jun. 28, 2023
Series VV [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jul. 2, 2018
Shares Issuable upon Exercise of Warrant	3,900,000
Exercise Price	$ 1.75
Expiration Date	Jan. 2, 2024

4. WARRANTS AND NON-EMPLOYEE _4

4. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Total warrant liabilities	$ 9,317,064	$ 2,053,402
Net (loss) gain on warrant liabilities	(8,643,561)	11,007,215
Series S [Member]
Total warrant liabilities	33	32,773
Net (loss) gain on warrant liabilities	(751,378)	3,078,588
Series V [Member]
Total warrant liabilities	770,436	72,912
Net (loss) gain on warrant liabilities	(697,526)	1,547,341
Series W [Member]
Total warrant liabilities	999,081	83,754
Net (loss) gain on warrant liabilities	(915,327)	1,716,104
Series Z [Member]
Total warrant liabilities	487,767	77,216
Net (loss) gain on warrant liabilities	(410,551)	893,388
Series ZZ [Member]
Total warrant liabilities	34,215	4,753
Net (loss) gain on warrant liabilities	(29,461)	65,856
Series AA [Member]
Total warrant liabilities	380,474	65,087
Net (loss) gain on warrant liabilities	(315,387)	698,574
Series BB [Member]
Total warrant liabilities	28,456	4,322
Net (loss) gain on warrant liabilities	(24,134)	54,266
Series CC [Member]
Total warrant liabilities	1,779,724	394,220
Net (loss) gain on warrant liabilities	(1,385,504)	666,203
Series DD [Member]
Total warrant liabilities	1,249,287	5,492
Net (loss) gain on warrant liabilities	(1,243,795)	437,780
Series EE [Member]
Total warrant liabilities	1,249,287	5,492
Net (loss) gain on warrant liabilities	(1,243,795)	685,915
Series FF [Member]
Total warrant liabilities	188,921	47,154
Net (loss) gain on warrant liabilities	(141,767)	73,828
Series GG [Member]
Total warrant liabilities	607,228	342,173
Net (loss) gain on warrant liabilities	(408,555)	272,464
Series HH [Member]
Total warrant liabilities	58,816	16,014
Net (loss) gain on warrant liabilities	(42,802)	13,616
Series II [Member]
Total warrant liabilities	660,135	511,636
Net (loss) gain on warrant liabilities	(462,519)	404,823
Series JJ [Member]
Total warrant liabilities	88,642	24,203
Net (loss) gain on warrant liabilities	(64,439)	20,410
Series KK [Member]
Total warrant liabilities	656,930	345,720
Net (loss) gain on warrant liabilities	(449,470)	25,564
Series LL [Member]
Total warrant liabilities	77,632	20,481
Net (loss) gain on warrant liabilities	$ (57,151)	$ 352,495

4. WARRANTS AND NON-EMPLOYEE _5

4. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 2) (USD $)	12 Months Ended
	Sep. 30, 2018USD ($)$ / sharesshares
Warrants Exercised | shares	1,474,991
Proceeds | $	$ 3,544,608
Series GG [Member]
Warrants Exercised | shares	200,000
Exercise Price | $ / shares	$ 3
Proceeds | $	$ 600,000
Series II [Member]
Warrants Exercised | shares	383,500
Exercise Price | $ / shares	$ 3
Proceeds | $	$ 1,150,500
Series KK [Member]
Warrants Exercised | shares	182,100
Exercise Price | $ / shares	$ 3.04
Proceeds | $	$ 552,674
Series S [Member]
Warrants Exercised | shares	709,391
Exercise Price | $ / shares	$ 1.75
Proceeds | $	$ 1,241,434

4. WARRANTS AND NON-EMPLOYEE _6

4. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 3) (USD $)	12 Months Ended
	Sep. 30, 2018USD ($)$ / sharesshares
Equity Warrants Exercised | shares	2,597,118
Proceeds from Equity Warrants Exercised | $	$ 5,868,356
Series PP [Member]
Equity Warrants Exercised | shares	1,577,500
Equity Warrants Exercise Price | $ / shares	$ 2.3
Proceeds from Equity Warrants Exercised | $	$ 3,628,250
Series QQ [Member]
Equity Warrants Exercised | shares	84,000
Equity Warrants Exercise Price | $ / shares	$ 2.5
Proceeds from Equity Warrants Exercised | $	$ 210,000
Series RR [Member]
Equity Warrants Exercised | shares	27,687
Equity Warrants Exercise Price | $ / shares	$ 1.65
Proceeds from Equity Warrants Exercised | $	$ 45,684
Series SS [Member]
Equity Warrants Exercised | shares	328,948
Equity Warrants Exercise Price | $ / shares	$ 2.09
Proceeds from Equity Warrants Exercised | $	$ 687,500
Series TT [Member]
Equity Warrants Exercised | shares	578,983
Equity Warrants Exercise Price | $ / shares	$ 2.24
Proceeds from Equity Warrants Exercised | $	$ 1,296,922

5. PLANT, PROPERTY AND EQUIPM_3

5. PLANT, PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2018	Sep. 30, 2017
Plant Property And Equipment
Leased manufacturing facility	$ 21,183,756	$ 21,183,756
Research equipment	3,162,150	3,169,158
Furniture and equipment	124,369	124,369
Leasehold improvements	131,910	131,910
Gross	24,602,186	24,609,193
Less: Accumulated depreciation and amortization	(8,383,335)	(7,815,973)
Net research and office equipment	$ 16,218,851	$ 16,793,220

5. PLANT, PROPERTY AND EQUIPM_4

5. PLANT, PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Research And Office Equipment Details Narrative Abstract
Depreciation expense	$ 575,000	$ 593,000

6. PATENTS (Details)

6. PATENTS (Details) - USD ($)	Sep. 30, 2018	Sep. 30, 2017
Finite-Lived Intangible Assets, Net [Abstract]
Patents	$ 1,644,759	$ 1,535,087
Accumulated amortization	(1,386,666)	(1,311,920)
Net Patents	$ 258,093	$ 223,167

6. PATENTS (Details 1)

6. PATENTS (Details 1) - USD ($)	Sep. 30, 2018	Sep. 30, 2017
Patents Details Abstract
2,019	$ 42,000
2,020	38,000
2,021	35,000
2,022	31,000
2,023	21,000
Thereafter	91,000
Total	$ 258,093	$ 223,167

6. PATENTS (Details Narrative)

6. PATENTS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Patents Details Narrative Abstract
Amortization of patent costs	$ 75,000	$ 40,000

8. INCOME TAXES Net deferred ta

8. INCOME TAXES Net deferred tax asset (Details) - USD ($)	Sep. 30, 2018	Sep. 30, 2017
Income Taxes Net Deferred Tax Asset
Net operating loss carryforwards	$ 5,052,000	$ 70,752,000
R&D credit	1,221,000	1,221,000
Stock-based compensation	3,097,000	6,292,000
Capitalized R&D	15,518,000	21,160,000
Vacation and other	544,000	121,000
Total deferred tax assets	25,432,000	99,546,000
Fixed assets and intangibles	(634,000)	(523,000)
Total deferred tax liability	(634,000)	(523,000)
Net deferred tax asset	24,798,000	99,023,000
Valuation allowance	(24,798,000)	(99,023,000)
DeferredTaxAssetsLiabilitiesNet	$ 0	$ 0

8. INCOME TAXES Reconciliation

8. INCOME TAXES Reconciliation of effective tax rate (Details)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Income Taxes Reconciliation Of Effective Tax Rate
Federal Rate	24.28%	34.00%
Federal rate change	(88.94%)	0.00%
State tax rate, net of federal benefit	4.47%	6.44%
State tax rate change	0.00%	(3.91%)
Net operating loss – write-off	(161.21%)
Other adjustments	(5.95%)	(3.39%)
Permanent differences	(5.79%)	25.49%
Change in valuation allowance	233.14%	(58.63%)
Effective tax rate	0.00%	0.00%

9. STOCK COMPENSATION Awards (D

9. STOCK COMPENSATION Awards (Details) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Stock Compensation Awards Details
Employees	$ 2,743,267	$ 1,380,500
Non-employees	$ 530,736	$ 232,847

9. STOCK COMPENSATION Assumptio

9. STOCK COMPENSATION Assumptions (Details)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Stock Compensation Assumptions Details
Expected stock price volatility, min	89.90%	88.54%
Expected stock price volatility, max	94.32%	90.67%
Risk-free interest rate, min	2.30%	2.18%
Risk-free interest rate, max	3.04%	2.29%
Expected life of options, min	9 years 244 days	9 years 8 months 8 days
Expected life of options, max	9 years 251 days	10 years
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, 2018	Sep. 30, 2017
Outstanding
Number of Options Outstanding, Beginning	1,239,844	343,575
Number of Options Granted	1,958,108	932,825
Number of Options Forfeited	5,426	15,795
Number of Options Expired	32,399	20,761
Number of Options Outstanding, Ending	3,160,127	1,239,844
Weighted Average Exercise Price Outstanding, Beginning	$ 16.44	$ 59.22
Weighted Average Exercise Price Granted	2.50	2.17
Weighted Average Exercise Price Forfeited	3.79	9.46
Weighted Average Exercise Price Expired	67.73	88.80
Weighted Average Exercise Price Outstanding, Ending	$ 7.30	$ 16.44
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	8 years 6 months	5 years 4 months 6 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	8 years 321 days	8 years 6 months
Aggregate Intrinsic Value Outstanding, Beginning	$ 1,400	$ 0
Aggregate Intrinsic Value Outstanding, Ending	$ 4,761,973	$ 1,400
Exercisable
Number of Options Outstanding, Beginning	275,982	232,931
Number of Options Vested	334,111	63,812
Number of Options Expired	32,399	20,761
Number of Options Outstanding, Ending	577,694	275,982
Weighted Average Exercise Price Outstanding, Beginning	$ 53.53	$ 66.28
Weighted Average Exercise Price Vested	7.63	18.45
Weighted Average Exercise Price Expired	67.73	88.80
Weighted Average Exercise Price Outstanding, Ending	$ 26.18	$ 53.53
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	4 years 10 months 28 days	4 years 9 months 4 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	6 years 270 days	4 years 10 months 28 days
Aggregate Intrinsic Value Outstanding, Ending	$ 604,763

9. STOCK COMPENSATION Nonvested

9. STOCK COMPENSATION Nonvested Options (Details) - $ / shares	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Stock Compensation Nonvested Options Details
Number of unvested options, Beginning	963,862	110,644
Vested options	(334,111)	(63,812)
Granted options	1,958,108	932,825
Forfeited options	(5,426)	(15,795)
Number of unvested options, Ending	2,582,433	963,862
Weighted Average Grant Date Fair Value, Beginning	$ 4.91	$ 36.96
Weighted Average Grant Date Fair Value, Ending	$ 2.48	$ 4.91

9. STOCK COMPENSATION RSU (Deta

9. STOCK COMPENSATION RSU (Details) - Restricted Stock Awards [Member] - $ / shares	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Number of unvested shares, Beginning	468,000	604,000
Vested shares	(156,000)	(136,000)
Number of unvested shares, Ending	312,000	468,000
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, 2018	Sep. 30, 2017
Stock Compensation
Expense relating to the restricted stock	$ 1,400,000	$ 633,000
Unrecognized compensation expense	$ 1,000,000

10. EMPLOYEE BENEFIT PLAN (Deta

10. EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Employee Benefits and Share-based Compensation, Noncash [Abstract]
Expense for Company's contribution to employee benefit plan	$ 145,000	$ 151,000

11. COMMITMENTS AND CONTINGEN_3

11. COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2018USD ($)
Commitments And Contingencies Details
2,019	$ 1,808,000
2,020	1,872,000
2,021	1,937,000
2,022	2,004,000
2,023	2,073,000
Thereafter	11,685,000
Total future minimum lease obligation	21,379,000
Less imputed interest on financing obligation	(7,999,000)
Net present value of lease financing obligation	$ 13,380,000

11. COMMITMENTS AND CONTINGEN_4

11. COMMITMENTS AND CONTINGENCIES (Details 1)	Sep. 30, 2018USD ($)
Commitments And Contingencies Details
2,019	$ 258,000
2,020	238,000
2,021	163,000
2,022	69,000
Thereafter	0
Total minimum lease payments:	$ 728,000

11. COMMITMENTS AND CONTINGEN_5

11. COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Research and development expense	$ 9,400,306	$ 15,606,985
Rent expense, including amortization of deferred rent	253,000	245,000
R & D deferred rent liability	12,000	5,000
Deferred rent liability	14,000	18,000
Ergomed Collaborative Arrangement
Research and development expense	$ 3,100,000	$ 5,800,000

14. FAIR VALUE MEASUREMENTS (De

14. FAIR VALUE MEASUREMENTS (Details) - USD ($)	Sep. 30, 2018	Sep. 30, 2017
Derivative instruments	$ 9,317,064	$ 2,053,402
Level 1
Derivative instruments	33	32,773
Level 2
Derivative instruments	0	0
Level 3
Derivative instruments	$ 9,317,031	$ 2,020,629

14. FAIR VALUE MEASUREMENTS (_2

14. FAIR VALUE MEASUREMENTS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Fair Value Measurements Details 1Abstract
Beginning balance	$ 2,029,629	$ 5,283,573
Issuances	0	4,665,683
Exercises	(595,780)	0
Net realized and unrealized derivative (gain)/loss	7,892,182	(7,928,627)
Ending balance	$ 9,317,031	$ 2,029,629

15. NET LOSS PER COMMON SHARE_2

15. NET LOSS PER COMMON SHARE (Details) - USD ($)	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
NET LOSS PER COMMON SHARE
Net loss - available to common shareholders	$ (31,851,573)	$ (14,427,055)
Less: Gain on derivative Instruments	0	(677,287)
Net loss - diluted	$ (31,851,573)	$ (15,104,342)
Weighted average number of shares - basic	17,004,722	7,891,843
Less: gain on derivatives	0	10,804
Weighted average number of shares - diluted	17,004,722	7,902,647
Loss per share - basic	$ (1.87)	$ (1.83)
Loss per share - diluted	$ (1.87)	$ (1.91)

15. NET LOSS PER COMMON SHARE_3

15. NET LOSS PER COMMON SHARE (Details 1) - shares	12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
NET LOSS PER COMMON SHARE
Options and Warrants	11,794,603	2,538,130
Convertible Debt	0	1,166,106
Unvested Restricted Stock	312,000	604,000
Total	12,106,603	4,308,236