CEL-SCI (CVM) 10-K 16 Dec 19 2019 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Sep. 30, 2019	Dec. 11, 2019	Mar. 31, 2019
Document And Entity Information
Entity Registrant Name	CEL SCI CORP
Entity Central Index Key	0000725363
Document Type	10-K
Document Period End Date	Sep. 30, 2019
Amendment Flag	false
Current Fiscal Year End Date	--09-30
Is Entity a Well-known Seasoned Issuer?	No
Is Entity a Voluntary Filer?	No
Is Entity's Reporting Status Current?	Yes
Entity Filer Category	Accelerated Filer
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		35,379,956
Entity Public Float			$ 100,321,037
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2019

BALANCE SHEETS

BALANCE SHEETS - USD ($)	Sep. 30, 2019	Sep. 30, 2018
CURRENT ASSETS:
Cash and cash equivalents	$ 8,444,774	$ 10,310,044
Receivables	62,765	118,657
Prepaid expenses	524,953	364,622
Inventory used for R&D and manufacturing	782,363	645,238
Total current assets	9,814,855	11,438,561
Plant, property and equipment	15,825,636	16,218,851
Patent costs, net	311,586	258,093
Deposits	1,670,917	1,670,917
Total Assets	27,622,994	29,586,422
CURRENT LIABILITIES:
Accounts payable	1,586,478	5,743,913
Accrued expenses	34,432	205,310
Due to employees	709,442	764,941
Derivative instruments, current portion	674,442	2,498,606
Other current liabilities	14,956	14,029
Total current liabilities	3,019,750	9,226,799
Derivative instruments, net of current portion	5,813,868	6,818,458
Lease liability	13,508,156	13,379,962
Deferred revenue	125,000	126,795
Other liabilities	22,553	33,492
Total liabilities	22,489,327	29,585,506
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
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; 35,231,776 and 28,034,487 shares issued and outstanding at September 30, 2019 and 2018, respectively	352,318	280,346
Additional paid-in capital	358,507,603	331,312,184
Accumulated deficit	(353,726,254)	(331,591,614)
Total stockholders' equity	5,133,667	916
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 27,622,994	$ 29,586,422

BALANCE SHEETS (Parenthetical)

BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2019	Sep. 30, 2018
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	35,231,776	28,034,487
Common Stock Shares Outstanding	35,231,776	28,034,487

STATEMENTS OF OPERATIONS

STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Income Statement [Abstract]
Grant income	$ 462,754	$ 476,556
OPERATING EXPENSES:
Research and development	12,659,287	10,914,531
General & administrative	7,998,573	6,334,271
Total operating expenses	20,657,860	17,248,802
OPERATING LOSS	(20,195,106)	(16,772,246)
Other income	73,022	70,896
Loss on derivative instruments	(760,603)	(8,643,561)
Other non-operating gain (loss)	545,528	(2,276,604)
Interest expense, net	(1,797,481)	(4,215,690)
Net loss	(22,134,640)	(31,837,205)
Modification of warrants		(14,368)
Net loss available to common shareholders	$ (22,134,640)	$ (31,851,573)
NET LOSS PER COMMON SHARE
BASIC	$ (0.71)	$ (1.87)
DILUTED	$ (0.71)	$ (1.87)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC	31,174,394	17,004,722
DILUTED	31,174,394	17,004,722

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
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	11,715,335		11,792,241
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
Purchase of stock by officers and directors	$ 4,639	380,361		385,000
Purchase of stock by officers and directors	463,855
Stock issuance cost		(206,583)		(206,583)
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
Warrant exercises	$ 66,775	18,039,842		18,106,617
Warrant exercises, shares	6,677,519
401(k) contributions paid in common stock	$ 310	143,568		143,878
401(k) contributions paid in common stock, Shares	30,996
Stock issued to nonemployees for service	$ 1,999	876,589		878,588
Stock issued to nonemployees for service, Shares	199,977
Shares issued for settlement of clinical research costs	$ 1,851	3,398,149		3,400,000
Shares issued for settlement of clinical research costs, shares	185,095
Equity based compensation - employees	$ (75)	4,428,249		4,428,174
Equity based compensation - employees, Shares	(7,500)
Option exercises	$ 660	149,822		150,482
Option exercises, Shares	65,997
Purchase of stock by officers and directors	$ 452	291,545		291,997
Purchase of stock by officers and directors	45,205
Stock issuance cost		(132,345)		(132,345)
Net loss			(22,134,640)	(22,134,640)
BALANCE at Sep. 30, 2019	$ 352,318	$ 358,507,603	$ (353,726,254)	$ 5,133,667
BALANCE, Shares at Sep. 30, 2019	35,231,776

STATEMENTS OF CASH FLOWS

STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (22,134,640)	$ (31,837,205)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	633,529	650,131
Share based payments for services	856,025	530,736
Share-based payments for interest	0	80,716
Equity based compensation	4,428,174	2,743,267
Common stock contributed to 401(k) plan	143,878	145,090
Shares issued for settlement of clinical research costs	3,400,000	5,507,400
Loss prepaid research and development	0	471,157
Loss on derivative instruments	760,603	8,643,561
Amortization of debt discount	0	1,956,424
Inducement expense	0	291,234
Capitalized lease interest	128,194	168,037
(Increase)/decrease in assets:
Receivables	55,892	99,824
Prepaid expenses	(137,768)	153,102
Inventory used for R&D and manufacturing	(137,125)	27,284
Deposits	0	150,000
Increase/(decrease) in liabilities:
Accounts payable	(4,084,410)	(2,514,488)
Accrued expenses	(170,878)	(731,388)
Due to employees	(55,499)	71,110
Other liabilities	(6,660)	4,450
Net cash used in operating activities	(16,320,685)	(13,389,558)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of equipment	(177,779)	(1,015)
Expenditures for patent costs	(158,060)	(57,125)
Net cash used in investing activities	(335,839)	(58,140)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants	0	11,792,241
Proceeds from the purchase of stock by officers and directors	291,997	385,000
Payments of stock issuance costs	(163,364)	(195,589)
Proceeds from exercise of warrants	14,517,260	9,412,964
Payments on obligations under capital lease	(5,121)	(6,312)
Net cash provided by financing activities	14,791,254	21,388,304
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(1,865,270)	7,940,606
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR	10,310,044	2,369,438
CASH AND CASH EQUIVALENTS, END OF YEAR	8,444,774	10,310,044
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Plant, property and equipment purchases included in accounts payable	17,329	0
Prepaid amount under consulting services paid with issuance of common stock	22,563	162,452
Conversion of notes payable to common stock	0	2,294,300
Exercise of derivative liabilities	3,589,357	1,379,899
Lease payments included in accounts payable at year end	441	415
Stock issuance costs included in current liabilities	15,580	46,599
Cash paid for interest expense	$ 1,809,242	$ 1,750,897

1. ORGANIZATION

1. ORGANIZATION	12 Months Ended
	Sep. 30, 2019
Organization, Consolidation and Presentation of 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 Company expects to use the results to support applications to regulatory agencies around the world for worldwide commercial marketing approvals for Multikine for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. The Company’s investigational immune therapy, Multikine, is being used in a different way than other immune therapy is usually used. It is given before any other therapy has been administered because that is when the immune system is thought to be strongest. . i The Company is also investigating a different peptide-based immunotherapy as a vaccine for Rheumatoid Arthritis. The Company was awarded a Phase 2 Small Business Innovation Research (SBIR) grant in the amount of $1.5 million from the National Institutes of Health (NIH) in September 2017. This grant provides 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, 2019
Operations And Financing
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 2019 and 2018, the Company received net proceeds of approximately $14.8 million and $21.4 million, respectively, through the sale of stock and the exercise of warrants and options. 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 warrant exercises, 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 $55.8 million as of September 30, 2019 on direct costs for the Phase 3 clinical trial. The Company estimates it will incur additional expenses of approximately $4.5 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 from 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’s primary 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 were paid to Lake Whillans Litigation Finance. As a result of the arbitrator’s ruling, during the year ended September 30, 2018, the Company wrote off approximately $471,000, which will no longer be realized.

3. REVISION OF PRIOR PERIOD FIN

3. REVISION OF PRIOR PERIOD FINANCIAL STATEMENTS FOR CORRECTION OF IMMATERIAL ERRORS	12 Months Ended
	Sep. 30, 2019
Revision Of Prior Period Financial Statements For Correction Of Immaterial Errors
Revision of prior period finacial statements for Correction of Immaterial Errors	3. Revision of prior period financial statements for Correction of Immaterial Errors- In November 2019, CEL-SCI discovered an error in the classification of certain employee compensation on the statement of operations. Costs associated with employees considered to be in the research and development function of the business were incorrectly classified as general and administrative costs. The total amount of expenses recorded is not impacted by this error. This misclassification has no impact on the earnings of CEL-SCI or its financial position. The error does not impact total compensation costs, total operating costs, net operating loss, net loss, net loss per share, cash flows or stockholders’ deficit. Employee related expenses of approximately $1.5 million were incorrectly recorded as general and administrative expenses and should have been recorded as research and development expenses in the prior year. Prior year amounts have been revised in the current year financial statements to reflect this change. Year ended 9/30/2018 Originally Reported Reclassification Corrected Operating Expenses Research and development $ 9,400,306 $ 1,514,225 $10,914,531 General and administrative 7,848,496 (1,514,225) 6,334,271 Total Operating Expenses $ 17,248,802 $ - $17,248,802

4. SUMMARY OF SIGNIFICANT ACCOU

4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Sep. 30, 2019
Accounting Policies [Abstract]
4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	Cash and Cash Equivalents Prepaid Expenses Inventory Deposits Plant, property and equipment Patents Leases – Deferred Rent Derivative Instruments Grant Income Research and Development Costs Net Loss Per Common Share Concentration of Credit Risk Income Taxes Use of Estimates Fair Value Measurements Stock-Based Compensation Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non-Employees.” Accordingly, compensation is recognized when goods or services are received and may be measured using the Black-Scholes valuation model, based on the type of award. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options. The Company has Incentive Stock Option Plans, Non-Qualified Stock Options Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the “Plans.” All Plans have been approved by the Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period over which options granted are expected to be outstanding and has been determined using 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 February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as a right-of-use asset and a lease liability. Leases will be classified as operating or financing. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard ASU 2016-02 is effective for fiscal years and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements which allows entities to initially apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. ASU 2016-02 also requires expanded financial statement disclosures on leasing activities. These changes will become effective for the Company on October 1, 2019. The new lease guidance as codified in ASC 842, provides for several optional practical expedients in transition. The Company will adopt the following practical expedients: ● The optional transition method set forth in ASU 2018-11 noted above – Upon adopting the standard effective October 1, 2019, the Company will recognize a cumulative-effect adjustment to the opening balance of retained earnings without recasting comparative periods. ● The election to apply a “package of practical expedients,” which allows management to not reassess whether any expired or existing contracts are or contain leases under the new standard, or to reassess prior conclusions on lease identification, lease classification and the recording of initial direct costs. As required, these practical expedients must be elected as a package and must be applied to all leases. ● The option not to separate lease and non-lease components within the lease and account for all lease components as a single lease component. The Company estimates the impact of adopting ASC 842 on October 1, 2019 will be to record a $13.1 million right-to-use asset, to decrease property and equipment by approximately $13.4 million and to increase lease liabilities by approximately $0.3. This will result in an approximate $0.6 million adjustment to opening retained earnings as of October 1, 2019. Management is evaluating the appropriate lease classification and expects to complete this evaluation by the end of the first quarter of fiscal year 2020. The adoption of ASC 842 is not expected to result in significant changes to the Company’s statements of operations or cash flows. 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.

5. WARRANTS AND NON-EMPLOYEE OP

5. WARRANTS AND NON-EMPLOYEE OPTIONS	12 Months Ended
	Sep. 30, 2019
Derivative Instruments and Hedging Activities Disclosure [Abstract]
5. WARRANTS AND NON-EMPLOYEE OPTIONS	The following warrants and non-employee options are outstanding at September 30, 2019: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Series N 8/18/2008 $ 85,339 $ 3.00 2/18/2020 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 Series UU 6/11/2018 154,810 $ 2.80 6/11/2020 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 Series CC 12/8/2016 277,463 $ 5.00 12/8/2021 Series HH 2/23/2017 6,500 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series JJ 3/14/2017 9,450 $ 3.13 3/8/2022 Series LL 4/30/2017 26,398 $ 3.59 4/30/2022 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 Series NN 7/24/2017 473,798 $ 2.52 7/24/2022 Series OO 7/31/2017 50,000 $ 2.52 7/31/2022 Series RR 10/30/2017 457,116 $ 1.65 10/30/2022 Series SS 12/19/2017 482,644 $ 2.09 12/18/2022 Series TT 2/5/2018 559,689 $ 2.24 2/5/2023 Series VV 7/2/2018 82,500 $ 1.75 1/2/2024 Consultants 7/28/17 10,000 $ 2.18 7/27/2027 The following warrants and non-employee options were outstanding at September 30, 2018: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Series S 10/11/13- 10/24/14 327,729 $ 31.25 10/11/2018 Series DD 12/8/2016 1,360,960 $ 4.50 12/10/2018 Series EE 12/8/2016 1,360,960 $ 4.50 12/10/2018 Series N 8/18/2008 85,339 $ 3.00 2/18/2020 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 Series UU 6/11/2018 187,562 $ 2.80 6/11/2020 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 Series CC 12/8/2016 680,480 $ 5.00 12/8/2021 Series HH 2/23/2017 20,000 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series JJ 3/14/2017 30,000 $ 3.13 3/8/2022 Series LL 4/30/2017 26,398 $ 3.59 4/30/2022 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 Series NN 7/24/2017 539,300 $ 2.52 7/24/2022 Series OO 7/31/2017 60,000 $ 2.52 7/31/2022 Series QQ 8/22/2017 3,500 $ 2.50 8/22/2022 Series GG 2/23/2017 200,000 $ 3.00 8/23/2022 Series II 3/14/2017 216,500 $ 3.00 9/14/2022 Series RR 10/30/2017 555,370 $ 1.65 10/30/2022 Series KK 5/3/2017 213,870 $ 3.04 11/3/2022 Series SS 12/19/2017 960,530 $ 2.09 12/18/2022 Series TT 2/5/2018 1,296,877 $ 2.24 2/5/2023 Series PP 8/28/2017 172,500 $ 2.30 2/28/2023 Series WW 7/2/2018 195,000 $ 1.63 6/28/2023 Series VV 7/2/2018 3,900,000 $ 1.75 1/2/2024 Consultants 1/1/16 - 7/28/17 30,400 $ 2.18- $11.50 12/31/18- 7/27/27 1. Warrant Liabilities Warrant liabilities outstanding at September 30 are as follows: 2019 2018 Series S warrants $ - $ 33 Series V warrants 674,442 770,436 Series W warrants 1,193,507 999,081 Series Z warrants 1,109,545 487,767 Series ZZ warrants 77,638 34,215 Series AA warrants 916,908 380,474 Series BB warrants 63,966 28,456 Series CC warrants 1,710,898 1,779,724 Series DD warrants - 1,249,287 Series EE warrants - 1,249,287 Series FF warrants 446,185 188,921 Series GG warrants - 607,228 Series HH warrants 45,657 58,816 Series II warrants - 660,135 Series JJ warrants 66,599 88,642 Series KK warrants - 656,930 Series LL warrants 182,965 77,632 Total warrant liabilities $ 6,488,310 $ 9,317,064 The (losses)/gains on the warrant liabilities for the years ended September 30 are as follows: 2019 2018 Series S Warrants $ 33 $ (751,378 ) Series V warrants 95,994 (697,526 ) Series W warrants (194,426 ) (915,327 ) Series Z warrants (621,778 ) (410,551 ) Series ZZ warrants (43,423 ) (29,461 ) Series AA warrants (536,434 ) (315,387 ) Series BB warrants (35,510 ) (24,134 ) Series CC warrants (1,198,836 ) (1,385,504 ) Series DD warrants 1,249,287 (1,243,795 ) Series EE warrants 1,249,287 (1,243,795 ) Series FF warrants (257,264 ) (141,767 ) Series GG warrants 195,228 (408,555 ) Series HH warrants (24,465 ) (42,802 ) Series II warrants (442,040 ) (462,519 ) Series JJ warrants (35,301 ) (64,439 ) Series KK warrants (55,622 ) (449,470 ) Series LL warrants (105,333 ) (57,151 ) Net loss on warrant liabilities $ (760,603 ) $ (8,643,561 ) 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. Exercise of Warrant Liabilities The following warrants recorded as liabilities were exercised during the year ended September 30, 2019: Warrants Warrants Exercised Exercise Price Proceeds Series CC 403,017 $ 5.00 $ 2,015,085 Series GG 200,000 $ 3.00 600,000 Series HH 13,500 $ 3.13 42,188 Series II 216,500 $ 3.00 649,500 Series JJ 20,550 $ 3.13 64,219 Series KK 213,870 $ 3.04 649,095 1,067,437 $ 4,020,087 The following warrants recorded as liabilities were exercised during the year ended September 30, 2018: 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 December 10, 2018, 1,360,960 Series DD and 1,360,960 Series EE warrants with exercise prices of $4.50 expired. The expiration dates of these warrants had been previously extended and such modifications were reflected in the fair value measurement of the warrants on the dates of modification. On October 11, 2018, 327,729 Series S warrants, with an exercise price of $31.25, expired. The exercise price of these warrants had been previously repriced under temporarily revised terms and such modifications were reflected in the fair value measurement of the warrants. On October 17, 2017, 17,821 Series U warrants, with an exercise price of $43.75, expired. 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 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 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. During the year ended September 30, 2019, 3,817,500 and 195,000 Series VV and WW warrants were exercised, respectively, for total gross proceeds of approximately $7.0 million. During the year ended September 30, 2018 no Series VV or WW warrants were exercised. As of September 30, 2019, 82,500 Series VV and 0 Series WW warrants were outstanding. 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 8). The Series UU warrants are exercisable at a fixed price of $2.80 per share and expire on June 11, 2020. During the year ended September 30, 2019, 32,752 Series UU warrants were exercised for total gross proceeds of approximately $0.1 million. During the year ended September 30, 2018 no Series UU warrants were exercised. As of September 30, 2019, 154,810 Series UU warrants were outstanding. 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 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 years ended September 30, 2019 and 2018, 737,188 and 578,983, respectively, Series TT warrants were exercised for total gross proceeds of approximately $1.6 million and $1.3 million, respectively. As of September 30, 2019, 559,689 Series TT warrants were outstanding. 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. 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 years ended September 30, 2019 and 2018, 477,886 and 328,948, respectively, Series SS warrants were exercised for total gross proceeds of approximately $1.0 million and $0.7 million, respectively. As of September 30, 2019, 482,644 Series SS warrants were outstanding. 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 8. During the years ended September 30, 2019 and 2018, 98,254 and 27,687, respectively, Series RR warrants were exercised for total gross proceeds of approximately $160,000 and $50,000, respectively. As of September 30, 2019, 457,116 Series RR warrants were outstanding. 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 expiration date of the Series N warrants was extended to February 18, 2020. The incremental cost of this extension was approximately $14,000, which was recorded as a deemed dividend in the financial statements for the year ended September 30, 2018. Exercise of Equity Warrants The following equity warrants were exercised during the year ended September 30, 2019. Warrants Warrants Exercised Exercise Price Proceeds Series NN 65,502 $ 2.52 $ 165,065 Series OO 10,000 $ 2.52 25,200 Series PP 172,500 $ 2.30 396,750 Series QQ 3,500 $ 2.50 8,750 Series RR 98,254 $ 1.65 162,119 Series SS 477,886 $ 2.09 998,782 Series TT 737,188 $ 2.24 1,651,301 Series UU 32,752 $ 2.80 91,706 Series VV 3,817,500 $ 1.75 6,680,625 Series WW 195,000 $ 1.63 316,875 5,610,082 $ 10,497,173 The following equity warrants 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, 2019 and 2018 the Company issued 199,977 and 356,197 shares, respectively, of common stock to consultants of which 199,977 and 353,197 shares, respectively, were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $0.85 and $8.76 per share. The weighted average grant price was $4.25 and $1.95, respectively, for stock issued during the years and September 30, 2019 and 2018. During the years ended September 30, 2019 and 2018, the Company recorded total expense of approximately $856,000 and $531,000, respectively, relating to these consulting agreements. At September 30, 2019 and 2018, approximately $230,000 and $207,000, respectively, are included in prepaid expenses. During the year ended September 30, 2019, 10,000 options issued to consultants were exercised and 10,400 options expired. As of September 30, 2019, 10,000 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.

6. PLANT, PROPERTY AND EQUIPMEN

6. PLANT, PROPERTY AND EQUIPMENT	12 Months Ended
	Sep. 30, 2019
Property, Plant and Equipment [Abstract]
6. PLANT, PROPERTY AND EQUIPMENT	Plant, property and equipment consisted of the following at September 30: 2019 2018 Leased manufacturing facility $ 21,183,756 $ 21,183,756 Research equipment 3,320,358 3,162,151 Furniture and equipment 125,872 124,369 Leasehold improvements 149,239 131,910 24,779,225 24,602,186 Accumulated depreciation and amortization (8,953,589 ) (8,383,335 ) Net plant, property and equipment $ 15,825,636 $ 16,218,851 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 12, Commitments and Contingencies–Lease Obligations, for additional information. As of September 30, 2019 and 2018, accumulated depreciation on the manufacturing building is approximately $5.6 million and $5.1 million, respectively. Depreciation expense for the years ended September 30, 2019 and 2018 totaled approximately $588,000 and, $575,000, 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.

7. PATENTS

7. PATENTS	12 Months Ended
	Sep. 30, 2019
Finite-Lived Intangible Assets, Net [Abstract]
7. PATENTS	Patents consist of the following at September 30: 2019 2018 Patents $ 841,397 $ 742,698 Accumulated amortization (529,811 ) (484,605 ) Patents, net $ 311,586 $ 258,093 During the years ended September 30, 2019 and 2018, there was no impairment of patent costs. Amortization expense for the years ended September 30, 2019 and 2018 totaled approximately $45,000 and $75,000, respectively. The total estimated future amortization is as follows: Years ending September 30, 2020 51,000 2021 48,000 2022 44,000 2023 33,000 2024 26,000 Thereafter 110,000 $ 312,000

8. NOTES PAYABLE

8. NOTES PAYABLE	12 Months Ended
	Sep. 30, 2019
Notes Payable [Abstract]
8. 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) along with Series MM and Series NN warrants (See Note 5). 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. During the year ended September 30, 2018, note holders converted the remaining outstanding Notes with an aggregate principal amount of $2,294,300, into 1,166,105 shares of common stock. 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 As an inducement to convert, on June 11, 2018, 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 and expire on June 11, 2020. 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 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 October 2017 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. During the year ended September 30, 2018, the Company recorded approximately $2.0 million in interest expense relating to the amortization of the debt discount. 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.

9. INCOME TAXES

9. INCOME TAXES	12 Months Ended
	Sep. 30, 2019
Income Tax Disclosure [Abstract]
9. INCOME TAXES	At September 30, 2019 and 2018, the Company had net deferred tax assets of $28.8million and $24.8 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. No limitations on NOL carryforwards relating to change in ownership were imposed during the year ended September 30, 2019. The Company’s Section 382 estimated analysis was completed through September 30, 2018. If additional changes in ownership occur after 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 Significant components of the Company’s deferred tax assets as of are listed below 2019 2018 NOL carryforwards $ 9,698,000 $ 5,052,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 3,165,000 3,097,000 Capitalized R&D 14,777,000 15,518,000 Vacation and other 544,000 544,000 Total deferred tax assets 29,405,000 25,432,000 Fixed assets and intangibles (586,000 ) (634,000 ) Total deferred tax liability (586,000 ) (634,000 ) Net deferred tax asset 28,819,000 24,798,000 Valuation allowance (28,819,000 ) (24,798,000 ) 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: 2019 2018 Federal Rate 21.00 % 24.28 % Federal rate change (2.8 ) (88.94 ) State tax rate, net of federal benefit 5.31 4.47 Net operating loss – write-off - (161.21 ) Other adjustments (4.77 ) (5.95 ) Permanent differences (0.57 ) (5.79 ) Change in valuation allowance (18.17 ) 233.14 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.

10. STOCK COMPENSATION

10. STOCK COMPENSATION	12 Months Ended
	Sep. 30, 2019
Share-based Payment Arrangement [Abstract]
10. STOCK COMPENSATION	The Company recognized the following expenses for options issued or vested and restricted stock awarded during the year: Year Ended September 30, 2019 2018 Employees $ 4,428,174 $ 2,743,267 Non-employees $ 856,025 $ 530,736 During the years ended September 30, 2019 and 2018, non-employee stock compensation excluded approximately $230,000 and $207,000, respectively, for future services to be performed (Note 5). During the years ended September 30, 2019 and 2018 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. 2019 2018 Expected stock price volatility 87.6 – 92.84 % 89.90 – 94.32 % Risk-free interest rate 1.62 – 2.82 % 2.30 – 3.04 % Expected life of options 9.67 – 9.68 Years 9.67 – 9.70 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, 2019 is summarized as follows: Non-Qualified and Incentive Stock Option Plans Outstanding Exercisable Weighted Average Weighted Ave Remaining Weighted Weighted Ave Remaining Number of Shares Exercise Price Contractual Term (Years) Aggregate Intrinsic Value Number of Shares Average Exercise Price Contractual Term (Years) Aggregate Intrinsic Value 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 Vested 945,359 $ 2.56 Granted 3,271,362 $ 5.40 Exercised (a) 65,997 $ 2.28 65,997 $ 2.28 Forfeited 82,461 $ 17.89 Expired (b) 64,815 $ 71.86 64,815 $ 71.86 Cancelled Outstanding at September 30, 2019 6,218,216 $ 5.54 8.88 $ 29,562,594 1,392,241 $ 9.15 7.68 $ 7,869,555 (a) Includes 10,000 stock options exercised by consultants (b) Includes 10,400 stock options to consultants A summary of the status of the Company’s non-vested options for the two years ended September 30, 2019 is presented below: Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 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 Vested (945,359 ) Granted 3,271,362 Forfeited (82,461 ) Unvested at September 30, 2019 4,825,975 $ 3.79 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, 2019 is presented below: Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2017 468,000 $ 13.75 Vested (156,000 ) Unvested at September 30, 2018 312,000 $ 13.75 Forfeited (7,500 ) Vested - Unvested at September 30, 2019 304,500 $ 13.75 Stock Bonus Plans Stock Compensation Plans

11. EMPLOYEE BENEFIT PLAN

11. EMPLOYEE BENEFIT PLAN	12 Months Ended
	Sep. 30, 2019
Employee Benefit and Share-based Payment Arrangement, Noncash Expense [Abstract]
11. 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, 2019, 30,996 shares were issued to the Company’s 401(k) plan for a cost of approximately $144,000. 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.

12. COMMITMENTS AND CONTINGENCI

12. COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]
12. COMMITMENTS AND CONTINGENCIES	Clinical Research Agreements 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 building 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, 2019 and 2018, the leased building asset has a net book value of approximately $15.6 million and $16.1 million, respectively, and the landlord liability has a balance of $13.5 million and $13.4 million, respectively. The leased building 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, 2019 and 2018. Approximate future minimum lease payments under the San Tomas lease as of September 30, 2019 are as follows: Years ending September 30, 2020 $ 1,872,000 2021 1,937,000 2022 2,004,000 2023 2,073,000 2024 2,145,000 Thereafter 9,540,000 Total future minimum lease obligation 19,571,000 Less: imputed interest on financing obligation (6,063,000 ) Net present value of lease financing obligation $ 13,508,000 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, 2019 and 2018 was approximately $73,000 and $71,000, 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, 2019 and 2018, the Company has recorded a deferred rent liability of approximately $14,000 and $12,000, 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, 2019 and 2018, the Company has recorded a deferred rent liability of approximately $7,000 and $14,000, 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%. Amortization of this capital lease is combined with depreciation expense. Approximate future minimum annual lease payments due under non-cancelable operating leases, excluding the San Tomas lease, for the years ending after September 30, 2019 are as follows: Years ending September 30, 2020 $ 238,000 2021 163,000 2022 69,000 Total future minimum lease obligation $ 470,000 Rent expense, for the years ended September 30, 2019 and 2018, excluding the rent paid on the San Tomas lease, was approximately $253,000 for both fiscal years. 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 $4.5 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 from 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.

13. RELATED PARTY TRANSACTIONS

13. RELATED PARTY TRANSACTIONS	12 Months Ended
	Sep. 30, 2019
Related Party Transactions [Abstract]
13. RELATED PARTY TRANSACTIONS	On October 30, 2017, in consideration for an extension of the maturity date of the Series MM and Series NN convertible notes, which had been issued in the prior year, the Company issued a total of 583,057 Series RR warrants to the note holders who agreed to the extension. Geert Kersten, the Company’s Chief Executive Officer, a trust in which Mr. Kersten holds a beneficial interest and Patricia B. Prichep, the Company’s Senior Vice President of Operations 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. The terms of the related party notes and warrants were identical to the other participants. On June 11, 2018, Mr. Kersten, the trust and Ms. Prichep converted the outstanding notes payable balances of $250,000, $250,000 and $25,000, respectively, into 147,929, 109,170 and 10,917 shares, respectively, of common stock in accordance with the original conversion terms, which were identical to those of the other participants. To induce conversion of the Series MM and NN Notes, all note holders, including Mr. Kersten, the trust 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 had 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. 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 for the year ended September 30, 2018. The Series UU warrants qualified 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 in June 2018, 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, 2019 and 2018. During the year ended September 30, 2019, officers and a director of the Company purchased 45,205 restricted shares of the Company’s common stock at an aggregate market value of approximately $292,000. During the year ended September 30, 2018, officers of the Company purchased 463,855 restricted shares of the Company’s common stock from the Company for an aggregate fair market value of $385,000. The shares are subject to the conditions of Rule 144 under the Securities Act of 1933.

14. STOCKHOLDERS EQUITY

14. STOCKHOLDERS EQUITY	12 Months Ended
	Sep. 30, 2019
STOCKHOLDERS' EQUITY
14. STOCKHOLDERS' EQUITY	Exercise of Warrants During the years ended September 30, 2019 and 2018, the Company received proceeds of approximately $14.5 million and $9.4 million, respectively, from the exercise of warrants, as detailed in Note 5. Upon exercise, 6,677,519 and 4,072,109 shares of common stock, respectively, were issued during the years ended September 30, 2019 and 2018. 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 and 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 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 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 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. 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 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 expire on December 18, 2022. 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. Other Equity Transactions The Company has entered into Securities Purchase Agreements with Ergomed plc, one of its Clinical Research Organizations responsible for managing the Company’s Phase 3 clinical trial, to facilitate a partial payment of the amounts due Ergomed. Under the Agreements, the Company issued Ergomed shares of common stock that would reduce Ergomed’s bills in an amount equal to the net proceeds from the sales of the shares issued to Ergomed. Upon issuance, the Company expenses the full value of the shares as Other non-operating gain/loss and subsequently offsets the expense as amounts are realized through the sale by Ergomed and reduces accounts payable to Ergomed. Any amounts received from the sale of the shares in excess of the amounts due Ergomed will be applied towards the satisfaction of any future amounts owed. During the year ended September 30, 2019 and 2018, the Company issued Ergomed 750,000 and 2,260,000 shares, respectively. On December 31, 2018, the expiration date of the prior agreement, Ergomed returned 564,905 unsold shares for cancellation. The following table summarizes the Other Non-Operating Gains (Loss) for the years ended September 30 relating to these agreements: 2019 2018 Amount realized through the resale of shares $ 3,945,528 $ 3,230,796 Fair value of shares upon issuance 3,400,000 5,507,400 Other non-operating gain (loss) $ 545,528 $ (2,276,604 ) As of September 30, 2019, Ergomed holds 198,000 shares for resale. As of September 30, 2018, Ergomed held 918,900 shares.

15. FAIR VALUE MEASUREMENTS

15. FAIR VALUE MEASUREMENTS	12 Months Ended
	Sep. 30, 2019
Fair Value Disclosures [Abstract]
15. 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, 2019: Quoted Prices in Active Markets for Identical Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative Instruments $ - $ - $ 6,488,310 $ 6,488,310 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 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: 2019 2018 Beginning balance $ 9,317,031 $ 2,020,629 Issuances - - Exercises (3,589,357 ) (595,780 ) N Net realized and unrealized derivative loss (gain) 760,636 7,892,182 Ending balance $ 6,488,310 $ 9,317,031 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, 2019, the Company’s Level 3 derivative instruments have a weighted average fair value of $2.72 per share and a weighted average exercise price of $15.17 per share. Fair values were determined using a weighted average risk free interest rate of 1.85% and 103% volatility. The instruments have a weighted average time to maturity of 1.86 years. 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.

16. NET LOSS PER COMMON SHARE

16. NET LOSS PER COMMON SHARE	12 Months Ended
	Sep. 30, 2019
NET LOSS PER COMMON SHARE
16. 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, 2019 2018 Loss per share – basic and diluted Net loss available to common shareholders $ (22,134,640 ) $ (31,851,573 ) Weighted average shares outstanding 31,174,394 17,004,722 Basic and diluted loss per common share $ (0.71 ) $ (1.87 ) In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2019 2018 Options and Warrants 7,164,544 11,794,603 Unvested Restricted Stock 304,500 312,000 Total 7,469,044 12,106,603 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, 2019 2018 Loss per share – basic and diluted Net loss available to common shareholders $ (22,134,640 ) $ (31,851,573 ) Weighted average shares outstanding 31,174,394 17,004,722 Basic and diluted loss per common share $ (0.71 ) $ (1.87 )

17. SUBSEQUENT EVENTS

17. SUBSEQUENT EVENTS	12 Months Ended
	Sep. 30, 2019
Subsequent Events [Abstract]
17. SUBSEQUENT EVENTS	In accordance with ASC 855, “ Subsequent Events

4. SUMMARY OF SIGNIFICANT ACC_2

4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Sep. 30, 2019
Accounting 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 12.
Deferred Rent	Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease. The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense. For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.
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, and considering 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 from the Company’s 2014 Incentive Stock Bonus Plan, 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, 2019.
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, 2019 and 2018.
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 15 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 over which options granted are expected to be outstanding and has been determined using 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 February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as a right-of-use asset and a lease liability. Leases will be classified as operating or financing. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard ASU 2016-02 is effective for fiscal years and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements which allows entities to initially apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. ASU 2016-02 also requires expanded financial statement disclosures on leasing activities. These changes will become effective for the Company on October 1, 2019. The new lease guidance as codified in ASC 842, provides for several optional practical expedients in transition. The Company will adopt the following practical expedients: ● The optional transition method set forth in ASU 2018-11 noted above – Upon adopting the standard effective October 1, 2019, the Company will recognize a cumulative-effect adjustment to the opening balance of retained earnings without recasting comparative periods. ● The election to apply a “package of practical expedients,” which allows management to not reassess whether any expired or existing contracts are or contain leases under the new standard, or to reassess prior conclusions on lease identification, lease classification and the recording of initial direct costs. As required, these practical expedients must be elected as a package and must be applied to all leases. ● The option not to separate lease and non-lease components within the lease and account for all lease components as a single lease component. The Company estimates the impact of adopting ASC 842 on October 1, 2019 will be to record a $13.1 million right-to-use asset, to decrease property and equipment by approximately $13.4 million and to increase lease liabilities by approximately $0.3. This will result in an approximate $0.6 million adjustment to opening retained earnings as of October 1, 2019. Management is evaluating the appropriate lease classification and expects to complete this evaluation by the end of the first quarter of fiscal year 2020. The adoption of ASC 842 is not expected to result in significant changes to the Company’s statements of operations or cash flows. 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.

3. REVISION OF PRIOR PERIOD F_2

3. REVISION OF PRIOR PERIOD FINANCIAL STATEMENTS FOR CORRECTION OF IMMATERIAL ERRORS (Tables)	12 Months Ended
	Sep. 30, 2019
Revision Of Prior Period Financial Statements For Correction Of Immaterial Errors
Revision of prior period finacial statements for Correction of Immaterial Errors	Year ended 9/30/2018 Originally Reported Reclassification Corrected Operating Expenses Research and development $ 9,400,306 $ 1,514,225 $ 10,914,531 General and administrative 7,848,496 (1,514,225 ) 6,334,271 Total Operating Expenses $ 17,248,802 $ - $ 17,248,802

5. WARRANTS AND NON-EMPLOYEE _2

5. WARRANTS AND NON-EMPLOYEE OPTIONS (Tables)	12 Months Ended
	Sep. 30, 2019
Derivative Instruments and Hedging Activities Disclosure [Abstract]
Derivative liabilities, warrants and other options outstanding	The following warrants and non-employee options are outstanding at September 30, 2019: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Series N 8/18/2008 $ 85,339 $ 3.00 2/18/2020 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 Series UU 6/11/2018 154,810 $ 2.80 6/11/2020 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 Series CC 12/8/2016 277,463 $ 5.00 12/8/2021 Series HH 2/23/2017 6,500 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series JJ 3/14/2017 9,450 $ 3.13 3/8/2022 Series LL 4/30/2017 26,398 $ 3.59 4/30/2022 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 Series NN 7/24/2017 473,798 $ 2.52 7/24/2022 Series OO 7/31/2017 50,000 $ 2.52 7/31/2022 Series RR 10/30/2017 457,116 $ 1.65 10/30/2022 Series SS 12/19/2017 482,644 $ 2.09 12/18/2022 Series TT 2/5/2018 559,689 $ 2.24 2/5/2023 Series VV 7/2/2018 82,500 $ 1.75 1/2/2024 Consultants 7/28/17 10,000 $ 2.18 7/27/2027 The following warrants and non-employee options were outstanding at September 30, 2018: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Series S 10/11/13- 10/24/14 327,729 $ 31.25 10/11/2018 Series DD 12/8/2016 1,360,960 $ 4.50 12/10/2018 Series EE 12/8/2016 1,360,960 $ 4.50 12/10/2018 Series N 8/18/2008 85,339 $ 3.00 2/18/2020 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 Series UU 6/11/2018 187,562 $ 2.80 6/11/2020 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 Series CC 12/8/2016 680,480 $ 5.00 12/8/2021 Series HH 2/23/2017 20,000 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series JJ 3/14/2017 30,000 $ 3.13 3/8/2022 Series LL 4/30/2017 26,398 $ 3.59 4/30/2022 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 Series NN 7/24/2017 539,300 $ 2.52 7/24/2022 Series OO 7/31/2017 60,000 $ 2.52 7/31/2022 Series QQ 8/22/2017 3,500 $ 2.50 8/22/2022 Series GG 2/23/2017 200,000 $ 3.00 8/23/2022 Series II 3/14/2017 216,500 $ 3.00 9/14/2022 Series RR 10/30/2017 555,370 $ 1.65 10/30/2022 Series KK 5/3/2017 213,870 $ 3.04 11/3/2022 Series SS 12/19/2017 960,530 $ 2.09 12/18/2022 Series TT 2/5/2018 1,296,877 $ 2.24 2/5/2023 Series PP 8/28/2017 172,500 $ 2.30 2/28/2023 Series WW 7/2/2018 195,000 $ 1.63 6/28/2023 Series VV 7/2/2018 3,900,000 $ 1.75 1/2/2024 Consultants 1/1/16 - 7/28/17 30,400 $ 2.18- $11.50 12/31/18- 7/27/27
Derivative Liabilities	Warrant liabilities outstanding at September 30 are as follows: 2019 2018 Series S warrants $ - $ 33 Series V warrants 674,442 770,436 Series W warrants 1,193,507 999,081 Series Z warrants 1,109,545 487,767 Series ZZ warrants 77,638 34,215 Series AA warrants 916,908 380,474 Series BB warrants 63,966 28,456 Series CC warrants 1,710,898 1,779,724 Series DD warrants - 1,249,287 Series EE warrants - 1,249,287 Series FF warrants 446,185 188,921 Series GG warrants - 607,228 Series HH warrants 45,657 58,816 Series II warrants - 660,135 Series JJ warrants 66,599 88,642 Series KK warrants - 656,930 Series LL warrants 182,965 77,632 Total warrant liabilities $ 6,488,310 $ 9,317,064 The (losses)/gains on the warrant liabilities for the years ended September 30 are as follows: 2019 2018 Series S Warrants $ 33 $ (751,378 ) Series V warrants 95,994 (697,526 ) Series W warrants (194,426 ) (915,327 ) Series Z warrants (621,778 ) (410,551 ) Series ZZ warrants (43,423 ) (29,461 ) Series AA warrants (536,434 ) (315,387 ) Series BB warrants (35,510 ) (24,134 ) Series CC warrants (1,198,836 ) (1,385,504 ) Series DD warrants 1,249,287 (1,243,795 ) Series EE warrants 1,249,287 (1,243,795 ) Series FF warrants (257,264 ) (141,767 ) Series GG warrants 195,228 (408,555 ) Series HH warrants (24,465 ) (42,802 ) Series II warrants (442,040 ) (462,519 ) Series JJ warrants (35,301 ) (64,439 ) Series KK warrants (55,622 ) (449,470 ) Series LL warrants (105,333 ) (57,151 ) Net loss on warrant liabilities $ (760,603 ) $ (8,643,561 )
Exercise of Warrant Liabilities	The following warrants recorded as liabilities were exercised during the year ended September 30, 2019: Warrants Warrants Exercised Exercise Price Proceeds Series CC 403,017 $ 5.00 $ 2,015,085 Series GG 200,000 $ 3.00 600,000 Series HH 13,500 $ 3.13 42,188 Series II 216,500 $ 3.00 649,500 Series JJ 20,550 $ 3.13 64,219 Series KK 213,870 $ 3.04 649,095 1,067,437 $ 4,020,087 The following warrants recorded as liabilities were exercised during the year ended September 30, 2018: 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	The following equity warrants were exercised during the year ended September 30, 2019. Warrants Warrants Exercised Exercise Price Proceeds Series NN 65,502 $ 2.52 $ 165,065 Series OO 10,000 $ 2.52 25,200 Series PP 172,500 $ 2.30 396,750 Series QQ 3,500 $ 2.50 8,750 Series RR 98,254 $ 1.65 162,119 Series SS 477,886 $ 2.09 998,782 Series TT 737,188 $ 2.24 1,651,301 Series UU 32,752 $ 2.80 91,706 Series VV 3,817,500 $ 1.75 6,680,625 Series WW 195,000 $ 1.63 316,875 5,610,082 $ 10,497,173 The following equity warrants 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

6. PLANT, PROPERTY AND EQUIPM_2

6. PLANT, PROPERTY AND EQUIPMENT (Tables)	12 Months Ended
	Sep. 30, 2019
Property, Plant and Equipment [Abstract]
Plant, property and equipment	2019 2018 Leased manufacturing facility $ 21,183,756 $ 21,183,756 Research equipment 3,320,358 3,162,151 Furniture and equipment 125,872 124,369 Leasehold improvements 149,239 131,910 24,779,225 24,602,186 Accumulated depreciation and amortization (8,953,589 ) (8,383,335 ) Net plant, property and equipment $ 15,825,636 $ 16,218,851

7. PATENTS (Tables)

7. PATENTS (Tables)	12 Months Ended
	Sep. 30, 2019
Finite-Lived Intangible Assets, Net [Abstract]
Schedule of Patents	2019 2018 Patents $ 841,397 $ 742,698 Accumulated amortization (529,811 ) (484,605 ) Patents, net $ 311,586 $ 258,093
Schedule of total estimated future amortization	Years ending September 30, 2020 51,000 2021 48,000 2022 44,000 2023 33,000 2024 26,000 Thereafter 110,000 $ 312,000

9. INCOME TAXES (Tables)

9. INCOME TAXES (Tables)	12 Months Ended
	Sep. 30, 2019
Income Tax Disclosure [Abstract]
Net deferred tax asset	2019 2018 NOL carryforwards $ 9,698,000 $ 5,052,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 3,165,000 3,097,000 Capitalized R&D 14,777,000 15,518,000 Vacation and other 544,000 544,000 Total deferred tax assets 29,405,000 25,432,000 Fixed assets and intangibles (586,000 ) (634,000 ) Total deferred tax liability (586,000 ) (634,000 ) Net deferred tax asset 28,819,000 24,798,000 Valuation allowance (28,819,000 ) (24,798,000 ) Ending Balance $ - $ -
Reconciliation of effective tax rate	2019 2018 Federal Rate 21.00 % 24.28 % Federal rate change (2.8 ) (88.94 ) State tax rate, net of federal benefit 5.31 4.47 Net operating loss – write-off - (161.21 ) Other adjustments (4.77 ) (5.95 ) Permanent differences (0.57 ) (5.79 ) Change in valuation allowance (18.17 ) 233.14 Effective tax rate 0.00 % 0.00 %

10. STOCK COMPENSATION (Tables)

10. STOCK COMPENSATION (Tables)	12 Months Ended
	Sep. 30, 2019
Share-based Payment Arrangement [Abstract]
Employees and non-employees stock compensation	Year Ended September 30, 2019 2018 Employees $ 4,428,174 $ 2,743,267 Non-employees $ 856,025 $ 530,736
Assumptions for Option Pricing	2019 2018 Expected stock price volatility 87.67 – 92.84 % 89.90 – 94.32 % Risk-free interest rate 1.62 – 2.82 % 2.30 – 3.04 % Expected life of options 9.67 – 9.68 Years 9.67 – 9.70 Years Expected dividend yield - -
Stock Option Plans	Non-Qualified and Incentive Stock Option Plans Outstanding Exercisable Weighted Average Weighted Ave Remaining Weighted Weighted Ave Remaining Number of Shares Exercise Price Contractual Term (Years) Aggregate Intrinsic Value Number of Shares Average Exercise Price Contractual Term (Years) Aggregate Intrinsic Value 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 Vested 945,359 $ 2.56 Granted 3,271,362 $ 5.40 Exercised (a) 65,997 $ 2.28 65,997 $ 2.28 Forfeited 82,461 $ 17.89 Expired (b) 64,815 $ 71.86 64,815 $ 71.86 Cancelled Outstanding at September 30, 2019 6,218,216 $ 5.54 8.88 $ 29,562,594 1,392,241 $ 9.15 7.68 $ 7,869,555
Schedule of non-vested options	Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 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 Vested (945,359 ) Granted 3,271,362 Forfeited (82,461 ) Unvested at September 30, 2019 4,825,975 $ 3.79
Schedule of restricted stock units	Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2017 468,000 $ 13.75 Vested (156,000 ) Unvested at September 30, 2018 312,000 $ 13.75 Forfeited (7,500 ) Vested - Unvested at September 30, 2019 304,500 $ 13.75

12. COMMITMENTS AND CONTINGEN_2

12. COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]
Future minimum lease payments under the San Tomas lease	Years ending September 30, 2020 $ 1,872,000 2021 1,937,000 2022 2,004,000 2023 2,073,000 2024 2,145,000 Thereafter 9,540,000 Total future minimum lease obligation 19,571,000 Less: imputed interest on financing obligation (6,063,000 ) Net present value of lease financing obligation $ 13,508,000
Schedule of future minimum annual rental payments due under non-cancelable operating leases	Years ending September 30, 2020 $ 238,000 2021 163,000 2022 69,000 Total future minimum lease obligation $ 470,000

15. FAIR VALUE MEASUREMENTS (Ta

15. FAIR VALUE MEASUREMENTS (Tables)	12 Months Ended
	Sep. 30, 2019
Fair Value Disclosures [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, 2019: Quoted Prices in Active Markets for Identical Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative Instruments $ - $ - $ 6,488,310 $ 6,488,310 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
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	2019 2018 Beginning balance $ 9,317,031 $ 2,020,629 Issuances - - Exercises (3,589,357 ) (595,780 ) N Net realized and unrealized derivative loss (gain) 760,636 7,892,182 Ending balance $ 6,488,310 $ 9,317,031

16. NET LOSS PER COMMON SHARE (

16. NET LOSS PER COMMON SHARE (Tables)	12 Months Ended
	Sep. 30, 2019
NET LOSS PER COMMON SHARE
Earnings per share	Year ended September 30, 2019 2018 Loss per share – basic and diluted Net loss available to common shareholders $ (22,134,640 ) $ (31,851,573 ) Weighted average shares outstanding 31,174,394 17,004,722 Basic and diluted loss per common share $ (0.71 ) $ (1.87 )
Antidilutive securities	2019 2018 Options and Warrants 7,164,544 11,794,603 Unvested Restricted Stock 304,500 312,000 Total 7,469,044 12,106,603

3. REVISION OF PRIOR PERIOD F_3

3. REVISION OF PRIOR PERIOD FINANCIAL STATEMENTS FOR CORRECTION OF IMMATERIAL ERRORS (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Research and development	$ 12,659,287	$ 10,914,531
General and administrative	7,998,573	6,334,271
Total Operating Expenses	$ 20,657,860	17,248,802
Previously Reported [Member]
Research and development		9,400,306
General and administrative		7,848,496
Total Operating Expenses		17,248,802
Reclassification [Member]
Research and development		1,514,225
General and administrative		(1,514,225)
Total Operating Expenses		$ 0

4. SUMMARY OF SIGNIFICANT ACC_3

4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	Sep. 30, 2019USD ($)
Accounting Policies [Abstract]
Fully insured amount of non-interest bearing cash balances	$ 250,000

5. WARRANTS AND NON-EMPLOYEE _3

5. WARRANTS AND NON-EMPLOYEE OPTIONS (Details) - $ / shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
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	Feb. 18, 2020
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 UU [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jun. 11, 2018	Jun. 11, 2018
Shares Issuable upon Exercise of Warrant	154,810	187,562
Exercise Price	$ 2.8	$ 2.8
Expiration Date	Jun. 11, 2020	Jun. 11, 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	277,463	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	6,500	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	9,450	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	473,798	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	50,000	60,000
Exercise Price	$ 2.52	$ 2.52
Expiration Date	Jul. 31, 2022	Jul. 31, 2022
Series RR [Member]
STOCKHOLDERS' EQUITY
Issue Date	Oct. 30, 2017	Oct. 30, 2017
Shares Issuable upon Exercise of Warrant	457,116	555,370
Exercise Price	$ 1.65	$ 1.65
Expiration Date	Oct. 30, 2022	Oct. 30, 2022
Series SS [Member]
STOCKHOLDERS' EQUITY
Issue Date	Dec. 19, 2017	Dec. 19, 2017
Shares Issuable upon Exercise of Warrant	482,644	960,530
Exercise Price	$ 2.09	$ 2.09
Expiration Date	Dec. 18, 2022	Dec. 18, 2022
Series TT [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 5, 2018	Feb. 5, 2018
Shares Issuable upon Exercise of Warrant	559,689	1,296,877
Exercise Price	$ 2.24	$ 2.24
Expiration Date	Feb. 5, 2023	Feb. 5, 2023
Series VV [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jul. 2, 2018	Jul. 2, 2018
Shares Issuable upon Exercise of Warrant	82,500	3,900,000
Exercise Price	$ 1.75	$ 1.75
Expiration Date	Jan. 2, 2024	Jan. 2, 2024
Consultants [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jul. 28, 2017
Shares Issuable upon Exercise of Warrant	10,000	30,400
Exercise Price	$ 2.18
Expiration Date	Jul. 27, 2027
Consultants [Member] | Minimum [Member]
STOCKHOLDERS' EQUITY
Issue Date		Jan. 1, 2016
Exercise Price		$ 2.18
Expiration Date		Dec. 31, 2018
Consultants [Member] | Maximum [Member]
STOCKHOLDERS' EQUITY
Issue Date		Jul. 28, 2017
Exercise Price		$ 11.50
Expiration Date		Jul. 27, 2027
Series S [Member]
STOCKHOLDERS' EQUITY
Shares Issuable upon Exercise of Warrant		327,729
Exercise Price		$ 31.25
Expiration Date		Oct. 11, 2018
Series S [Member] | Minimum [Member]
STOCKHOLDERS' EQUITY
Issue Date		Oct. 11, 2013
Series S [Member] | Maximum [Member]
STOCKHOLDERS' EQUITY
Issue Date		Oct. 24, 2014
Series DD [Member]
STOCKHOLDERS' EQUITY
Issue Date		Dec. 8, 2016
Shares Issuable upon Exercise of Warrant		1,360,960
Exercise Price		$ 4.5
Expiration Date		Dec. 10, 2018
Series EE [Member]
STOCKHOLDERS' EQUITY
Issue Date		Dec. 8, 2016
Shares Issuable upon Exercise of Warrant		1,360,960
Exercise Price		$ 4.5
Expiration Date		Dec. 10, 2018
Series QQ [Member]
STOCKHOLDERS' EQUITY
Issue Date		Aug. 22, 2017
Shares Issuable upon Exercise of Warrant		3,500
Exercise Price		$ 2.5
Expiration Date		Aug. 22, 2022
Series GG [Member]
STOCKHOLDERS' EQUITY
Issue Date		Feb. 23, 2017
Shares Issuable upon Exercise of Warrant		200,000
Exercise Price		$ 3
Expiration Date		Aug. 23, 2022
Series II [Member]
STOCKHOLDERS' EQUITY
Issue Date		Mar. 14, 2017
Shares Issuable upon Exercise of Warrant		216,500
Exercise Price		$ 3
Expiration Date		Sep. 14, 2022
Series KK [Member]
STOCKHOLDERS' EQUITY
Issue Date		May 3, 2017
Shares Issuable upon Exercise of Warrant		213,870
Exercise Price		$ 3.04
Expiration Date		Nov. 3, 2022
Series PP [Member]
STOCKHOLDERS' EQUITY
Issue Date		Aug. 28, 2017
Shares Issuable upon Exercise of Warrant		172,500
Exercise Price		$ 2.3
Expiration Date		Feb. 28, 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

5. WARRANTS AND NON-EMPLOYEE _4

5. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Total warrant liabilities	$ 6,488,310	$ 9,317,064
Net (loss) gain on warrant liabilities	(760,603)	(8,643,561)
Series S [Member]
Total warrant liabilities	0	33
Net (loss) gain on warrant liabilities	33	(751,378)
Series V [Member]
Total warrant liabilities	674,442	770,436
Net (loss) gain on warrant liabilities	95,994	(697,526)
Series W [Member]
Total warrant liabilities	1,193,507	999,081
Net (loss) gain on warrant liabilities	(194,426)	(915,327)
Series Z [Member]
Total warrant liabilities	1,109,545	487,767
Net (loss) gain on warrant liabilities	(621,778)	(410,551)
Series ZZ [Member]
Total warrant liabilities	77,638	34,215
Net (loss) gain on warrant liabilities	(43,423)	(29,461)
Series AA [Member]
Total warrant liabilities	916,908	380,474
Net (loss) gain on warrant liabilities	(536,434)	(315,387)
Series BB [Member]
Total warrant liabilities	63,966	28,456
Net (loss) gain on warrant liabilities	(35,510)	(24,134)
Series CC [Member]
Total warrant liabilities	1,710,898	1,779,724
Net (loss) gain on warrant liabilities	(1,198,836)	(1,385,504)
Series DD [Member]
Total warrant liabilities	0	1,249,287
Net (loss) gain on warrant liabilities	1,249,287	(1,243,795)
Series EE [Member]
Total warrant liabilities	0	1,249,287
Net (loss) gain on warrant liabilities	1,249,287	(1,243,795)
Series FF [Member]
Total warrant liabilities	446,185	188,921
Net (loss) gain on warrant liabilities	(257,264)	(141,767)
Series GG [Member]
Total warrant liabilities	0	607,228
Net (loss) gain on warrant liabilities	195,228	(408,555)
Series HH [Member]
Total warrant liabilities	45,657	58,816
Net (loss) gain on warrant liabilities	(24,465)	(42,802)
Series II [Member]
Total warrant liabilities	0	660,135
Net (loss) gain on warrant liabilities	(442,040)	(462,519)
Series JJ [Member]
Total warrant liabilities	66,599	88,642
Net (loss) gain on warrant liabilities	(35,301)	(64,439)
Series KK [Member]
Total warrant liabilities	0	656,930
Net (loss) gain on warrant liabilities	(55,622)	(449,470)
Series LL [Member]
Total warrant liabilities	182,965	77,632
Net (loss) gain on warrant liabilities	$ (105,333)	$ (57,151)

5. WARRANTS AND NON-EMPLOYEE _5

5. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 2) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Warrants Exercised	1,067,437	1,474,991
Proceeds	$ 4,020,087	$ 3,544,608
Series GG [Member]
Warrants Exercised	200,000	200,000
Exercise Price	$ 3	$ 3
Proceeds	$ 600,000	$ 600,000
Series HH [Member]
Warrants Exercised	13,500
Exercise Price	$ 3.13
Proceeds	$ 42,188
Series II [Member]
Warrants Exercised	216,500	383,500
Exercise Price	$ 3	$ 3
Proceeds	$ 649,500	$ 1,150,500
Series JJ [Member]
Warrants Exercised	20,550
Exercise Price	$ 3.13
Proceeds	$ 64,219
Series KK [Member]
Warrants Exercised	213,870	182,100
Exercise Price	$ 3.04	$ 3.04
Proceeds	$ 649,095	$ 552,674
Series CC [Member]
Warrants Exercised	403,017
Exercise Price	$ 5
Proceeds	$ 2,015,085
Series S [Member]
Warrants Exercised		709,391
Exercise Price		$ 1.75
Proceeds		$ 1,241,434

5. WARRANTS AND NON-EMPLOYEE _6

5. WARRANTS AND NON-EMPLOYEE OPTIONS (Details 3) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Equity Warrants Exercised	5,610,082	2,597,118
Proceeds from Equity Warrants Exercised	$ 10,497,173	$ 5,868,356
Series NN [Member]
Equity Warrants Exercised	65,502
Equity Warrants Exercise Price	$ 2.52
Proceeds from Equity Warrants Exercised	$ 165,065
Series OO [Member]
Equity Warrants Exercised	10,000
Equity Warrants Exercise Price	$ 2.52
Proceeds from Equity Warrants Exercised	$ 25,200
Series PP [Member]
Equity Warrants Exercised	172,500	1,577,500
Equity Warrants Exercise Price	$ 2.3	$ 2.3
Proceeds from Equity Warrants Exercised	$ 396,750	$ 3,628,250
Series QQ [Member]
Equity Warrants Exercised	3,500	84,000
Equity Warrants Exercise Price	$ 2.5	$ 2.5
Proceeds from Equity Warrants Exercised	$ 8,750	$ 210,000
Series RR [Member]
Equity Warrants Exercised	98,254	27,687
Equity Warrants Exercise Price	$ 1.65	$ 1.65
Proceeds from Equity Warrants Exercised	$ 162,119	$ 45,684
Series SS [Member]
Equity Warrants Exercised	477,886	328,948
Equity Warrants Exercise Price	$ 2.09	$ 2.09
Proceeds from Equity Warrants Exercised	$ 998,782	$ 687,500
Series TT [Member]
Equity Warrants Exercised	737,188	578,983
Equity Warrants Exercise Price	$ 2.24	$ 2.24
Proceeds from Equity Warrants Exercised	$ 1,651,301	$ 1,296,922
Series UU [Member]
Equity Warrants Exercised	32,752
Equity Warrants Exercise Price	$ 2.8
Proceeds from Equity Warrants Exercised	$ 91,706
Series VV [Member]
Equity Warrants Exercised	3,817,500
Equity Warrants Exercise Price	$ 1.75
Proceeds from Equity Warrants Exercised	$ 6,680,625
Series WW [Member]
Equity Warrants Exercised	195,000
Equity Warrants Exercise Price	$ 1.63
Proceeds from Equity Warrants Exercised	$ 316,875

6. PLANT, PROPERTY AND EQUIPM_3

6. PLANT, PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Property, Plant and Equipment [Abstract]
Leased manufacturing facility	$ 21,183,756	$ 21,183,756
Research equipment	3,320,358	3,162,150
Furniture and equipment	125,872	124,369
Leasehold improvements	149,239	131,910
Gross	24,779,225	24,602,186
Less: Accumulated depreciation and amortization	(8,953,589)	(8,383,335)
Net research and office equipment	$ 15,825,636	$ 16,218,851

6. PLANT, PROPERTY AND EQUIPM_4

6. PLANT, PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Property, Plant and Equipment [Abstract]
Accumulated Depreciation - Building	$ 5,600,000	$ 5,100,000
Depreciation expense	$ 588,000	$ 575,000

7. PATENTS (Details)

7. PATENTS (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Finite-Lived Intangible Assets, Net [Abstract]
Patents	$ 841,397	$ 742,698
Accumulated amortization	(529,811)	(484,605)
Net Patents	$ 311,586	$ 258,093

7. PATENTS (Details 1)

7. PATENTS (Details 1) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Finite-Lived Intangible Assets, Net [Abstract]
2020	$ 51,000
2021	48,000
2022	44,000
2023	33,000
2024	26,000
Thereafter	110,000
Total	$ 311,586	$ 258,093

7. PATENTS (Details Narrative)

7. PATENTS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Finite-Lived Intangible Assets, Net [Abstract]
Amortization of patent costs	$ 45,000	$ 75,000

9. INCOME TAXES (Details)

9. INCOME TAXES (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Income Tax Disclosure [Abstract]
Net operating loss carryforwards	$ 9,698,000	$ 5,052,000
R&D credit	1,221,000	1,221,000
Stock-based compensation	3,165,000	3,097,000
Capitalized R&D	14,777,000	15,518,000
Vacation and other	544,000	544,000
Total deferred tax assets	29,405,000	25,432,000
Fixed assets and intangibles	(586,000)	(634,000)
Total deferred tax liability	(586,000)	(634,000)
Net deferred tax asset	28,819,000	24,798,000
Valuation allowance	(28,819,000)	(24,798,000)
Deferred Tax Assets Liabilities Net	$ 0	$ 0

9. INCOME TAXES (Details 1)

9. INCOME TAXES (Details 1)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Income Tax Disclosure [Abstract]
Federal Rate	21.00%	24.28%
Federal rate change	(2.80%)	(88.94%)
State tax rate, net of federal benefit	5.31%	4.47%
Net operating loss – write-off	0.00%	(161.21%)
Other adjustments	(4.77%)	(5.95%)
Permanent differences	(0.57%)	(5.79%)
Change in valuation allowance	(18.17%)	233.14%
Effective tax rate	0.00%	0.00%

10. STOCK COMPENSATION (Details

10. STOCK COMPENSATION (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Payment Arrangement [Abstract]
Employees	$ 4,428,174	$ 2,743,267
Non-employees	$ 856,025	$ 530,736

10. STOCK COMPENSATION (Detai_2

10. STOCK COMPENSATION (Details 1)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Payment Arrangement [Abstract]
Expected stock price volatility, min	87.67%	89.90%
Expected stock price volatility, max	92.84%	94.32%
Risk-free interest rate, min	1.62%	2.30%
Risk-free interest rate, max	2.82%	3.04%
Expected life of options, min	9 years 8 months 1 day	9 years 244 days
Expected life of options, max	9 years 8 months 5 days	9 years 251 days
Expected dividend yield	0.00%	0.00%

10. STOCK COMPENSATION (Detai_3

10. STOCK COMPENSATION (Details 2) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Outstanding
Number of Options Outstanding, Beginning	3,160,127	1,239,844
Number of Options Vested	0	0
Number of Options Granted	3,271,362	1,958,108
Number of Options Exercised	65,997	0
Number of Options Forfeited	82,461	5,426
Number of Options Expired	64,815	32,399
Number of Options Cancelled	0	0
Number of Options Outstanding, Ending	6,218,216	3,160,127
Weighted Average Exercise Price Outstanding, Beginning	$ 7.30	$ 16.44
Weighted Average Exercise Price Vested	0	0
Weighted Average Exercise Price Granted	5.40	2.5
Weighted Average Exercise Price Exercised	2.28	0
Weighted Average Exercise Price Forfeited	17.89	3.79
Weighted Average Exercise Price Expired	71.86	67.73
Weighted Average Exercise Price Outstanding, Ending	$ 5.54	$ 7.30
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	8 years 10 months 17 days	8 years 6 months
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	8 years 10 months 17 days	8 years 10 months 17 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 4,761,973	$ 1,400
Aggregate Intrinsic Value Outstanding, Ending	$ 29,562,594	$ 4,761,973
Exercisable
Number of Options Outstanding, Beginning	577,694	275,982
Number of Options Vested	945,359	334,111
Number of Options Granted	0	0
Number of Options Exercised	65,997	0
Number of Options Forfeited	0	0
Number of Options Expired	64,815	32,399
Number of Options Cancelled	0	0
Number of Options Outstanding, Ending	1,392,241	577,694
Weighted Average Exercise Price Outstanding, Beginning	$ 26.18	$ 53.53
Weighted Average Exercise Price Vested	2.56	7.63
Weighted Average Exercise Price Granted	0	0
Weighted Average Exercise Price Exercised	2.28	0
Weighted Average Exercise Price Forfeited	0	0
Weighted Average Exercise Price Expired	71.86	67.73
Weighted Average Exercise Price Outstanding, Ending	$ 9.15	$ 26.18
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	6 years 8 months 27 days	4 years 10 months 28 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	7 years 8 months 5 days	6 years 8 months 27 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 604,763	$ 0
Aggregate Intrinsic Value Outstanding, Ending	$ 7,869,555	$ 604,763

10. STOCK COMPENSATION (Detai_4

10. STOCK COMPENSATION (Details 3) - $ / shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Payment Arrangement [Abstract]
Number of unvested options, Beginning	2,582,433	963,862
Vested options	(945,359)	(334,111)
Granted options	3,271,362	1,958,108
Forfeited options	(82,461)	(5,426)
Number of unvested options, Ending	4,825,975	2,582,433
Weighted Average Grant Date Fair Value, Beginning	$ 2.48	$ 4.91
Weighted Average Grant Date Fair Value, Ending	$ 3.79	$ 2.48

10. STOCK COMPENSATION (Detai_5

10. STOCK COMPENSATION (Details 4) - Restricted Stock Awards [Member] - $ / shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Number of unvested shares, Beginning	312,000	468,000
Forfeited	(7,500)	0
Vested shares	0	(156,000)
Number of unvested shares, Ending	304,500	312,000
Weighted Average Grant Date Fair Value, Ending	$ 13.75	$ 13.75

10. STOCK COMPENSATION (Detai_6

10. STOCK COMPENSATION (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Payment Arrangement [Abstract]
Expense relating to the restricted stock	$ 300,000	$ 1,400,000
Unrecognized compensation expense	700,000
Grant date fair value remaining outstanding	$ 8,600,000

11. EMPLOYEE BENEFIT PLAN (Deta

11. EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Employee Benefit and Share-based Payment Arrangement, Noncash Expense [Abstract]
Expense for Company's contribution to employee benefit plan	$ 144,000	$ 145,000

12. COMMITMENTS AND CONTINGEN_3

12. COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2019USD ($)
Commitments and Contingencies Disclosure [Abstract]
2020	$ 1,872,000
2021	1,937,000
2022	2,004,000
2023	2,073,000
2024	2,145,000
Thereafter	9,540,000
Total future minimum lease obligation	19,571,000
Less imputed interest on financing obligation	(6,063,000)
Net present value of lease financing obligation	$ 13,508,000

12. COMMITMENTS AND CONTINGEN_4

12. COMMITMENTS AND CONTINGENCIES (Details 1)	Sep. 30, 2019USD ($)
Commitments and Contingencies Disclosure [Abstract]
2020	$ 238,000
2021	163,000
2022	69,000
Total minimum lease payments:	$ 470,000

12. COMMITMENTS AND CONTINGEN_5

12. COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Rent expense, including amortization of deferred rent	$ 253,000	$ 253,000
R & D deferred rent liability	14,000	12,000
Deferred rent liability	7,000	14,000
Building book value	15,600,000	16,100,000
Ergomed Collaborative Arrangement
Research and development expense	$ 2,800,000	$ 3,100,000

15. FAIR VALUE MEASUREMENTS (De

15. FAIR VALUE MEASUREMENTS (Details) - USD ($)	Sep. 30, 2019	Sep. 30, 2018
Derivative instruments	$ 6,488,310	$ 9,317,064
Level 1
Derivative instruments	0	33
Level 2
Derivative instruments	0	0
Level 3
Derivative instruments	$ 6,488,310	$ 9,317,031

15. FAIR VALUE MEASUREMENTS (_2

15. FAIR VALUE MEASUREMENTS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Fair Value Disclosures [Abstract]
Beginning balance	$ 9,317,031	$ 2,029,629
Issuances	0	0
Exercises	(3,589,357)	(595,780)
Net realized and unrealized derivative (gain)/loss	760,636	7,892,182
Ending balance	$ 6,488,310	$ 9,317,031

16. NET LOSS PER COMMON SHARE_2

16. NET LOSS PER COMMON SHARE (Details) - USD ($)	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
NET LOSS PER COMMON SHARE
Net loss - available to common shareholders	$ (22,134,640)	$ (31,851,573)
Weighted average number of shares - basic	31,174,394	17,004,722
Weighted average number of shares - diluted	31,174,394	17,004,722
Loss per share - basic	$ (0.71)	$ (1.87)
Loss per share - diluted	(0.71)	(1.87)
LPS - Basic and Diluted	$ (0.71)	$ (1.87)

16. NET LOSS PER COMMON SHARE_3

16. NET LOSS PER COMMON SHARE (Details 1) - shares	12 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
NET LOSS PER COMMON SHARE
Options and Warrants	7,164,544	11,794,603
Unvested Restricted Stock	304,500	312,000
Total	7,469,044	12,106,603