CEL-SCI (CVM) 10-Q 17 May 21 2021 Q2 Quarterly report Financial data

Cover

Cover - shares	6 Months Ended
	Mar. 31, 2021	May 11, 2021
Cover [Abstract]
Entity Registrant Name	CEL-SCI CORPORATION
Entity Central Index Key	0000725363
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--09-30
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Mar. 31, 2021
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2021
Entity Common Stock Shares Outstanding		40,906,593
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Address Address Line 1	8229 Boone Boulevard
Entity Address Address Line 2	Suite 802
Entity Address City Or Town	Vienna
Entity Address State Or Province	VA
Entity Address Postal Zip Code	22182
Local Phone Number	506-9460
City Area Code	703
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSE
Entity Interactive Data Current	Yes

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Mar. 31, 2021	Sep. 30, 2020
Current Assets:
Cash and cash equivalents	$ 6,431,334	$ 15,508,909
U.S. Treasury Bills	11,151,395	0
Receivables	54,922	54,922
Prepaid expenses	722,005	1,313,432
Supplies used for R&D and manufacturing	1,458,823	820,052
Deposits - current portion	48,210	0
Total current assets	19,866,689	17,697,315
Finance lease right of use assets	12,814,612	13,811,849
Operating lease right of use assets	1,121,029	1,198,958
Property and equipment, net	12,599,492	5,843,993
Patent costs, net	292,432	313,422
Deposits	1,670,917	1,670,917
Total Assets	48,365,171	40,536,454
Current Liabilities:
Accounts payable	2,391,316	2,023,067
Accrued expenses	519,071	510,515
Due to employees	457,105	448,022
Derivative instruments, current portion	2,282,609	213,787
Lease liabilities, current portion	172,454	1,070,123
Total current liabilities	5,822,555	4,265,514
Derivative instruments, net of current portion	0	3,551,826
Finance lease obligations, net of current portion	12,054,543	11,753,100
Operating lease obligations, net of current portion	1,031,281	1,114,340
Other liabilities	125,000	125,000
Total liabilities	19,033,379	20,809,780
Commitments and Contingencies	0
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; 40,823,975 and 38,730,150 shares issued and outstanding at March 31, 2021 and September 30, 2020, respectively	408,240	387,302
Additional paid-in capital	429,976,839	401,174,675
Accumulated deficit	(401,053,287)	(381,835,303)
Total stockholders' equity	29,331,792	19,726,674
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 48,365,171	$ 40,536,454

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2021	Sep. 30, 2020
CONDENSED BALANCE SHEETS
Preferred stock, 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, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	40,823,975	38,730,150
Common stock, shares outstanding	40,823,975	38,730,150

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Grant income	$ 0	$ 298,726	$ 0	$ 334,232
Operating Expenses:
Research and development	5,221,514	4,458,547	10,636,274	8,711,360
General and administrative	3,311,484	2,558,522	6,627,640	5,197,418
Total operating expenses	8,532,998	7,017,069	17,263,914	13,908,778
Operating loss	(8,532,998)	(6,718,343)	(17,263,914)	(13,574,546)
Other income	0	18,448	0	36,896
Gain (loss) on derivative instruments	(3,041,017)	(3,049,027)	(2,108,181)	(2,282,518)
Other non-operating gains	553,630	934,511	675,236	1,725,180
Interest expense, net	(260,735)	(253,407)	(521,125)	(504,190)
Net loss	(11,281,120)	(9,067,818)	(19,217,984)	(14,599,178)
Modification of warrants	0	(21,734)	(85,779)	(21,734)
Net loss available to common shareholders	$ (11,281,120)	$ (9,089,552)	$ (19,303,763)	$ (14,620,912)
Net loss per common share - basic and diluted	$ (0.28)	$ (0.25)	$ (0.49)	$ (0.41)
Weighted average common shares outstanding - basic and diluted	40,047,273	36,165,050	39,351,194	35,621,711

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Sep. 30, 2019		35,231,776
Balance, amount at Sep. 30, 2019	$ 5,133,667	$ 352,318	$ 358,507,603	$ (353,726,254)
Adoption of new accounting standard	2,146,195			2,146,195
Issuance of common stock, shares		606,395
Issuance of common stock, amount	5,050,003	$ 6,064	5,043,939	0
Warrant exercises, shares		132,900
Warrant exercises, amount	297,101	$ 1,329	295,772	0
Equity based compensation - employees	1,800,225	$ 0	1,800,225	0
401(K) Contributions Paid In Common Stock, shares		4,474
401(K) Contributions Paid In Common Stock, amount	40,937	$ 45	40,892	0
Stock issued to nonemployees for service, shares		15,819
Stock issued to nonemployees for service, amount	84,447	$ 158	84,289	0
Purchase of stock by officer, shares		3,725
Purchase of stock by officer, amount	25,000	$ 37	24,963	0
Share issuance costs	(92,150)	0	(92,150)	0
Net loss	(5,531,360)	$ 0	0	(5,531,360)
Balance, shares at Dec. 31, 2019		35,995,089
Balance, amount at Dec. 31, 2019	8,954,065	$ 359,951	365,705,533	(357,111,419)
Balance, shares at Sep. 30, 2019		35,231,776
Balance, amount at Sep. 30, 2019	$ 5,133,667	$ 352,318	358,507,603	(353,726,254)
Option exercises, shares	20,480
Balance, shares at Mar. 31, 2020		37,336,411
Balance, amount at Mar. 31, 2020	$ 14,138,060	$ 373,365	379,943,932	(366,179,237)
Balance, shares at Dec. 31, 2019		35,995,089
Balance, amount at Dec. 31, 2019	8,954,065	$ 359,951	365,705,533	(357,111,419)
Warrant exercises, shares		562,100
Warrant exercises, amount	4,318,706	$ 5,621	4,313,085	0
Equity based compensation - employees	1,780,979	$ 0	1,780,979	0
401(K) Contributions Paid In Common Stock, shares		3,376
401(K) Contributions Paid In Common Stock, amount	38,959	$ 34	38,925	0
Stock issued to nonemployees for service, shares		17,120
Stock issued to nonemployees for service, amount	235,024	$ 171	234,853	0
Share issuance costs	(199,372)	0	(199,372)
Net loss	(9,067,818)	$ 0	0	(9,067,818)
Proceeds from the sale of common stock, shares		721,459
Proceeds from the sale of common stock, amount	7,867,629	$ 7,215	7,860,414	0
Purchase of stock by officers and directors, amount	$ 159,990	$ 168	159,822	0
Purchase of stock by officers and directors, shares		16,787
Option exercises, shares	20,480	20,480
Option exercises, amount	$ 49,898	$ 205	49,693	0
Balance, shares at Mar. 31, 2020		37,336,411
Balance, amount at Mar. 31, 2020	14,138,060	$ 373,365	379,943,932	(366,179,237)
Balance, shares at Sep. 30, 2020		38,730,150
Balance, amount at Sep. 30, 2020	19,726,674	$ 387,302	401,174,675	(381,835,303)
Warrant exercises, shares		15,000
Warrant exercises, amount	89,250	$ 150	89,100	0
Equity based compensation - employees	3,296,309	$ (20)	3,296,329	0
Stock issued to nonemployees for service, shares		15,044
Stock issued to nonemployees for service, amount	152,450	$ 150	152,300	0
Share issuance costs	(117,021)	0	(117,021)	0
Net loss	(7,936,864)	$ 0	0	(7,936,864)
Proceeds from the sale of common stock, shares		1,000,000
Proceeds from the sale of common stock, amount	13,559,500	$ 10,000	13,549,500	0
Option exercises, shares		5,300
Option exercises, amount	23,511	$ 53	23,458	0
Equity based compensation - employees, shares		(2,000)
401(k) contributions paid in common stock, shares		3,564
401(k) contributions paid in common stock, amount	41,671	$ 36	41,635	0
Modification of warrants	192	$ 0	192	0
Balance, shares at Dec. 31, 2020		39,767,058
Balance, amount at Dec. 31, 2020	28,835,672	$ 397,671	418,210,168	(389,772,167)
Balance, shares at Sep. 30, 2020		38,730,150
Balance, amount at Sep. 30, 2020	$ 19,726,674	$ 387,302	401,174,675	(381,835,303)
Option exercises, shares	54,145
Balance, shares at Mar. 31, 2021		40,823,975
Balance, amount at Mar. 31, 2021	$ 29,331,792	$ 408,240	429,976,839	(401,053,287)
Balance, shares at Dec. 31, 2020		39,767,058
Balance, amount at Dec. 31, 2020	28,835,672	$ 397,671	418,210,168	(389,772,167)
Warrant exercises, shares		991,239
Warrant exercises, amount	7,938,841	$ 9,912	7,928,929	0
Equity based compensation - employees	3,282,742	$ 0	3,282,742	0
401(K) Contributions Paid In Common Stock, shares		3,347
401(K) Contributions Paid In Common Stock, amount	51,420	$ 33	51,387	0
Stock issued to nonemployees for service, shares		13,486
Stock issued to nonemployees for service, amount	379,277	$ 135	379,142	0
Share issuance costs	(13,828)	0	(13,828)	0
Net loss	$ (11,281,120)	$ 0	0	(11,281,120)
Option exercises, shares	48,845	48,845
Option exercises, amount	$ 138,788	$ 489	138,299	0
Balance, shares at Mar. 31, 2021		40,823,975
Balance, amount at Mar. 31, 2021	$ 29,331,792	$ 408,240	$ 429,976,839	$ (401,053,287)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (19,217,984)	$ (14,599,178)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1,101,477	1,064,231
Share-based payments for services	552,664	347,227
Equity based compensation	6,579,051	3,581,204
Common stock contributed to 401(k) plan	93,091	79,896
Gain on short-term investments	(5,728)	0
Loss on derivative instruments	2,108,181	2,282,518
Modification of warrants	192	0
(Increase)/decrease in assets:
Receivables	0	476
Prepaid expenses	680,490	96,951
Supplies used for R&D and manufacturing	(638,771)	(67,185)
Short term deposits	(48,210)	0
Increase/(decrease) in liabilities:
Accounts payable	123,920	(765,872)
Accrued expenses	(142,744)	20,110
Due to employees	9,083	(34,034)
Other liabilities	20,793	3,438
Net cash used in operating activities	(8,784,495)	(7,990,218)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of U.S. Treasury Bills	(11,145,667)	0
Purchases of property and equipment	(6,629,050)	(752,797)
Expenditures for patent costs	0	(13,996)
Net cash used in investing activities	(17,774,717)	(766,793)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	13,559,500	12,917,632
Payments of stock issuance costs	(195,295)	(190,553)
Proceeds from the purchase of stock by officer	0	184,990
Proceeds from exercises of warrants and options	4,599,205	2,119,170
Payments on obligations under finance lease	481,773	389,132
Net cash provided by financing activities	17,481,637	14,642,107
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(9,077,575)	5,885,096
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	15,508,909	8,444,774
CASH AND CASH EQUIVALENTS, END OF PERIOD	6,431,334	14,329,870
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	1,529,284	318,894
Capitalizable patent costs included in current liabilities	20,000	13,465
Changes to right of use assets and liabilities	(139,862)	13,712
Finance lease obligation included in accounts payable	1,304	983
Prepaid consulting services paid with issuance of common stock	483,960	137,244
Accrued consulting services to be paid with issuance of common stock	165,000	165,000
Fair value of warrants liabilities on date of exercise	3,591,185	2,546,535
Financing costs included in current liabilities	(13,947)	116,549
Cash paid for interest	$ 561,445	$ 585,748

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	6 Months Ended
	Mar. 31, 2021
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2020. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments necessary for a fair presentation of the Company’s financial position as of March 31, 2021 and the results of its operations for the six and three months then ended. The condensed balance sheet as of September 30, 2020 is derived from the September 30, 2020 audited financial statements. All accounting policies have been consistently applied in the interim financial statements and the annual financial statements. The results of operations for the six and three months ended March 31, 2021 and 2020 are not necessarily indicative of the results to be expected for the entire year. The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B. Summary of Significant Accounting Policies: U.S. Treasury Bills- Property and Equipment Patents Research and Development Costs Leases – Income Taxes Derivative Instruments Stock-Based Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s common stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Vesting of restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period. Newly Adopted Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (Topic ).” New Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 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.

OPERATIONS AND FINANCING

OPERATIONS AND FINANCING	6 Months Ended
	Mar. 31, 2021
OPERATIONS AND FINANCING
B. OPERATIONS AND FINANCING	B. OPERATIONS AND FINANCING On May 4, 2020, the Company announced that the pivotal Phase 3 head and neck cancer study of Multikine immunotherapy had reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation. Database lock has been completed and the Phase 3 study is now in the final statistical analysis phase. The Company will continue to remain blinded to the study results throughout this process. The Company will be advised of the results when the analysis is completed, and the study results will be announced to the public at that time. The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge 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 primarily 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 to continue with its research efforts. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company believes there is a high likelihood that it will continue to receive funds from private and public offerings and warrant exercises similar to the way it has substantially funded operations for the past 12 months. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. To finance the Company, Management plans to raise additional capital in the form of warrant exercises, corporate partnerships, and 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 the Multikine Phase 3 study has ended and is only awaiting final data readout. 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 it is able to raise the required funding. Impact of COVID-19 Pandemic In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. Management follows the Centers for Disease Control and Prevention’s (“CDC”) guidance and the recommendations and restrictions provided by state and local authorities. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude of impact the pandemic will have on the Company’s financial condition, liquidity and future results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on its financial condition, liquidity, operations, suppliers, industry, and workforce. The financial statements have been prepared assuming 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.

STOCKHOLDERS EQUITY

STOCKHOLDERS EQUITY	6 Months Ended
	Mar. 31, 2021
STOCKHOLDERS EQUITY
C. STOCKHOLDERS' EQUITY	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock In December 2020, the Company sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. In March 2020, the Company sold 630,500 shares of common stock at a public offering price of $12.22 per share and received aggregate net proceeds of approximately $7.1 million. Under the terms of the Underwriting Agreement the Company granted the Underwriters a 45-day option to purchase up to an additional 94,575 shares of common stock solely to cover over-allotments. The underwriter fully exercised this option in May 2020 resulting in additional net proceeds to the Company of approximately $1.1 million. In December 2019, the Company sold 606,395 shares of common stock at a public offering price of $9.07 per share and received aggregate net proceeds of approximately $5.0 million. In January 2020, the underwriters of that offering fully exercised the option to purchase 90,959 additional shares of common stock at the public offering price of $9.07 per share for aggregate net proceeds to the Company of approximately $0.8 million. Equity Compensation Underlying share information for equity compensation plans as of March 31, 2021 is as follows: Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Options Plans 138,400 85,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,479,430 N/A 1,200,326 Stock Bonus Plans 783,760 N/A 352,007 431,720 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500 Stock option activity Six Months Ended March 31, 2021 2020 Options granted 8,000 2,500 Options exercised 54,145 20,480 Options forfeited 42,165 1,000 Options expired 67 1,168 Three Months Ended March 31, 2021 2020 Options granted 500 1,500 Options exercised 48,845 20,480 Options forfeited - 1,000 Options expired 12 1,132 Stock-Based Compensation Expense Six months Ended March 31, 2021 2020 Employees $ 6,579,051 $ 3,581,204 Non-employees $ 552,664 $ 347,227 Three months Ended March 31, 2021 2020 Employees $ 3,282,742 $ 1,780,979 Non-employees $ 304,004 $ 191,487 Employee compensation expense includes the expense related to options and restricted stock expensed over their vesting period. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of the related service contracts. Warrants and Non-Employee Options The following chart represents the warrants and non-employee options outstanding at March 31, 2021: Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2021 * Series UU 6/11/2018 93,603 $ 2.80 6/30/2021 * Series X 1/13/2016 120,000 $ 9.25 7/13/2021 * Series Y 2/15/2016 26,000 $ 12.00 8/15/2021 * Series ZZ 5/23/2016 19,200 $ 13.75 5/18/2021 1 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 * Series Z 5/23/2016 184,800 $ 13.75 11/23/2021 1 Series FF 12/8/2016 68,048 $ 3.91 12/1/2021 * Series CC 12/8/2016 46,345 $ 5.00 12/8/2021 1 Series HH 2/23/2017 200 $ 3.13 2/16/2022 * Series AA 8/26/2016 100,000 $ 13.75 2/22/2022 1 Series MM 6/22/2017 481,361 $ 1.86 6/22/2022 2 Series NN 7/24/2017 327,008 $ 2.52 7/24/2022 2 Series RR 10/30/2017 347,560 $ 1.65 10/30/2022 2 Series SS 12/19/2017 220,800 $ 2.09 12/18/2022 2 Series TT 2/5/2018 161,082 $ 2.24 2/5/2023 2 Consultants 7/28/2017 – 11/18/2020 15,000 $ 2.18 - $11.61 11/17/2022 - 7/27/2027 3 * No current period changes to these warrants 1. Derivative Liabilities The table below presents the fair value of the warrant liabilities at the balance sheet dates: March 31, 2021 September 30, 2020 Series W warrants $ - $ 73,570 Series Z warrants 1,013,400 1,207,902 Series ZZ warrants 77,574 75,044 Series AA warrants 619,033 1,082,212 Series BB warrants 81,374 65,173 Series CC warrants 488,784 1,259,712 Series HH warrants 2,444 2,000 Total warrant liabilities $ 2,282,609 $ 3,765,613 The table below presents the losses on the warrant liabilities for the six months ended March 31: 2021 2020 Series V warrants $ - $ 78,461 Series W warrants 73,570 (367,369 ) Series Z warrants (696,498 ) (311,876 ) Series ZZ warrants (11,530 ) (4,585 ) Series AA warrants (661,821 ) (326,623 ) Series BB warrants (16,201 ) (7,028 ) Series CC warrants (795,257 ) (826,277 ) Series FF warrants - (319,706 ) Series HH warrants (444 ) (34,457 ) Series JJ warrants - (64,992 ) Series LL warrants - (98,066 ) Net loss on warrant liabilities $ (2,108,181 ) $ (2,282,518 ) The table below presents the losses on the warrant liabilities for the three months ended March 31: 2021 2020 Series V warrants $ - $ (476,570 ) Series W warrants - (518,743 ) Series Z warrants (974,861 ) (322,425 ) Series ZZ warrants (63,397 ) (19,432 ) Series AA warrants (995,629 ) (391,601 ) Series BB warrants (46,833 ) (6,597 ) Series CC warrants (959,602 ) (803,596 ) Series FF warrants - (312,517 ) Series HH warrants (695 ) (34,375 ) Series JJ warrants - (64,862 ) Series LL warrants - (98,309 ) Net loss on warrant liabilities $ (3,041,017 ) $ (3,049,027 ) The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded. In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss. Changes in Warrant Liabilities On October 28, 2020, 688,930 Series W warrants, with an exercise price of $16.75 expired. Exercise of Warrant Liabilities The following warrants recorded as liabilities were exercised during the periods ended March 31, 2021. Three Months Six Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series Z 79,200 $ 13.75 $ 1,089,000 79,200 $ 13.75 $ 1,089,000 Series ZZ 800 $ 13.75 11,000 800 $ 13.75 11,000 Series AA 100,000 $ 13.75 1,375,000 100,000 $ 13.75 1,375,000 Series CC 97,298 $ 5.00 486,490 102,298 $ 5.00 511,490 277,298 $ 2,961,490 282,298 $ 2,986,490 The following warrants recorded as liabilities were exercised during the periods ended March 31, 2020. Three Months Six Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series CC 123,820 $ 5.00 $ 619,100 123,820 $ 5.00 $ 619,100 Series FF 68,048 $ 3.91 265,812 68,048 $ 3.91 265,812 Series HH 6,300 $ 3.13 19,687 6,300 $ 3.13 19,687 Series JJ 9,450 $ 3.13 29,531 9,450 $ 3.13 29,531 Series LL 26,398 $ 3.59 94,867 26,398 $ 3.59 94,867 234,016 $ 1,028,997 234,016 $ 1,028,997 3. Options and Shares Issued to Consultants During the six months ended March 31, 2021 and 2020, the Company issued 28,530 and 32,939 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $17.66 and $9.44 during the six months ended March 31, 2021 and 2020, respectively. During the three months ended March 31, 2021 and 2020, the Company issued 13,486 and 17,120 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $23.47 and $11.53, respectively, during the three months ended March 31, 2021 and 2020.The aggregate values of the issuances of restricted common stock and common stock options are recorded as prepaid expenses and are charged to general and administrative expenses over the periods of service. Additionally, during the six months ended March 31, 2021, the Company issued to a consultant 5,000 options to purchase common stock with an exercise price of $11.61. The options are exercisable beginning May 18, 2021 and expire on November 17, 2022. The options are being expensed on a straight-line basis over the six-month vesting period at a fair value of approximately $28,000 or $5.65 per option. No options were issued to consultants during the three months ended March 31, 2021. No options were issued to consultants during the six and three months ended March 31, 2020. As of March 31, 2021 and September 30, 2020, respectively, 15,000 and 10,000 options issued to consultants remained outstanding, all of which were issued from the Non-Qualified Stock Option plans and of which 10,000 are vested as of the balance sheet dates. During the six months ended March 31, 2021 and 2020, the Company recorded total expense of approximately $553,000 and $347,000, respectively, relating to these consulting agreements. At March 31, 2021 and September 30, 2020, consulting fees of approximately $484,000 and $395,000, respectively, are included in prepaid expenses. 4. Securities Purchase Agreement The Company entered into a Securities Purchase Agreement (SPA) with Ergomed plc, one of the Company’s Clinical Research Organizations responsible for managing the Company’s Phase 3 clinical trial, to facilitate payment of amounts due to Ergomed. Under the Agreement, the Company issued Ergomed shares of common stock and the net proceeds from the sales of those shares reduces outstanding amounts due 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. No shares were issued during the periods presented. The following amounts were realized through the resale of shares and are included in Other non-operating gains for the periods noted. Six Months Ended Three Months Ended 3/31/2021 3/31/2020 3/31/2021 3/31/2020 Amount realized through the resale of shares $ 675,236 $ 1,720,680 $ 553,630 $ 934,511 As of March 31, 2021, Ergomed held 63,021 shares for resale.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	6 Months Ended
	Mar. 31, 2021
FAIR VALUE MEASUREMENTS
D. FAIR VALUE MEASUREMENTS	D. FAIR VALUE MEASUREMENTS In accordance with ASC 820-10, “Fair Value Measurements,” ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows: · Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities · Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets · Level 3 – Unobservable inputs that reflect management’s assumptions For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of an input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels. The Company purchased short-term T-bills during the quarter ended March 31, 2021 that are classified as trading securities. Quoted market prices were applied to determine the fair value of short-term investments, therefore they were categorized as Level 1 on the fair value hierarchy. The T-bills were recorded at fair market value, which includes an unrealized gain of approximately $7,000. The T-bills have maturity dates ranging from April through December 2021 and yield a weighted average interest rate of 0.09%. The Company measures its warrant liabilities at fair value. At March 31, 2021 and September 30, 2020, all warrant liabilities were measured using unobservable inputs, i.e. Level 3 measurement. The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the six months ended March 31, 2021 and the year ended September 30, 2020: Six months ended Twelve months ended March 31, 2021 September 30, 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (3,591,185 ) (3,071,775 ) Realized and unrealized net loss 2,108,181 349,078 Ending balance $ 2,282,609 $ 3,765,613 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.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	6 Months Ended
	Mar. 31, 2021
RELATED PARTY TRANSACTIONS
E. RELATED PARTY TRANSACTIONS	E. RELATED PARTY TRANSACTIONS On December 7, 2020, the expiration dates of the Series N and Series X warrants held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary, were extended by six months (Note C). The incremental cost of these modifications was approximately $86,000 and was recorded as a deemed dividend in the financial statements for the six months ended March 31, 2021. On December 7, 2020, the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021. The incremental cost of this extension was $192 and was recorded as interest expense for the six months ended March 31, 2021. The Series UU warrants are held by certain officers of the Company and were originally issued with convertible debt. During the six months ended March 31, 2020, officers and directors of the Company purchased 20,512 shares of restricted common stock at an aggregate fair market value of approximately $185,000. This include 16,787 shares purchased during the three months ended March 31, 2020 with an aggregate fair market value of approximately $160,000. On January 23, 2020, the expiration date of the Series N warrants was extended to February 18, 2021. The incremental cost of this extension was approximately $22,000, which was recorded as a deemed dividend in the financial statements for the six and three months ended March 31, 2020. The Series N warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	6 Months Ended
	Mar. 31, 2021
COMMITMENTS AND CONTINGENCIES
F. COMMITMENTS AND CONTINGENCIES	F. COMMITMENTS AND CONTINGENCIES Clinical Research Agreements Under co-development and revenue sharing agreements with Ergomed, Ergomed agreed to contribute up to $12 million towards the Company’s Phase 3 Clinical Trial in the form of discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. The Company accounted for the co-development and revenue sharing agreements in accordance with ASC 808 “Collaborative Arrangements.” The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the inception of the agreement with Ergomed, the Company has incurred research and development expenses of approximately $34.5 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.4 million. During the six months ended March 31, 2021 and 2020, the Company recorded, net of Ergomed’s discount, approximately $1.0 million and $1.6 million, respectively, as research and development expense related to Ergomed’s services. During the three months ended March 31, 2021 and 2020, the Company recorded, net of Ergomed’s discount, approximately $0.4 million and $0.8 million, respectively, as research and development expense related to Ergomed’s services. Lease Agreements The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease, which expires in October 2028. In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The estimated cost of the upgrades is $10.6 million, of which approximately $9.5 million has been incurred as of March 31, 2021. The landlord agreed to finance the final $2.4 million of the costs incurred which will be repaid through increased lease payments over the remaining lease term starting on March 1, 2021. The repayment will include a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the right of use liability to account for the modified payments using a 10% implicit interest rate. This resulted in a decrease of approximately $140,000 to both the right of use asset and liability. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability. The total value of the leasehold improvements will be recorded in property and equipment and will be amortized over the remaining lease term when the assets are placed in service. At March 31, 2021 and September 30, 2020, the net book value of the finance lease right of use asset is approximately $12.8 million and $13.8 million, respectively and the balance of the finance lease liability is approximately $12.1 million and $12.7 million, respectively, most of which is current as of March 31, 2021, and approximately $0.9 million of which is current as of September 30, 2020. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. The finance right of use assets are being depreciated using a straight-line method over the underlying lease terms. Total cash paid related to finance leases during the six months ended March 31, 2021 and 2020 was approximately $1.0 million, of which approximately $0.6 million was for interest. The weighted average discount rate of the Company’s finance leases is 10.0% and the weighted average time to maturity is 7.6 years. The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets at March 31, 2021 and September 30, 2020. Approximate future minimum lease payments under finance leases as of March 31, 2021 are as follows: Six months ending September 30, 2021 (1) $ (1,192,000 ) Years ending September 30, 2022 2,486,000 2023 2,569,000 2024 2,648,000 2025 2,733,000 2026 2,824,000 Thereafter 6,186,000 Total future minimum finance lease obligation 18,254,000 Less: imputed interest on financing lease obligation (6,188,000 ) Net present value of financing lease obligation $ 12,066,000 (1) Amount is net of landlord incentive of $2.4 million to be received in second half of fiscal year 2021 Effective April 30, 2020, the Company terminated a month-to-month arrangement with a sub-lessee as the sub-leased space is needed to prepare the facility to produce Multikine for commercial purposes and before the Company’s Biologics License Application (BLA) can be submitted to the FDA. The sublease rental income for the six and three months ended March 31, 2020 was approximately $37,000 and $18,000, respectively. The Company leases two facilities under 60-month operating leases. The lease for its research and development laboratory expires February 28, 2022 and the lease for its office headquarters was renewed on July 1, 2020 and expires on November 30, 2025. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the full 60-month terms of the leases. As of March 31, 2021 and September 30, 2020, the net book value of the operating lease right of use assets is approximately $1.1 million and $1.2 million, respectively. As of March 31, 2021 and September 30, 2020, the balance of the operating lease liabilities is approximately $1.2 million and $1.3 million, of which approximately $200,000 and $100,000, respectively, is current. The Company incurred lease expense for operating leases of approximately $132,000 and $135,000, respectively, for the six months ended March 31, 2021 and 2020. The Company incurred lease expense for operating leases of approximately $66,000 and $68,000, respectively, for the three months ended March 31, 2021 and 2020. Total cash paid related to operating leases during the six months ended March 31, 2021 and 2020 was approximately $111,000 and $132,000, respectively. Total cash paid related to operating leases during the three months ended March 31, 2021 and 2020 was approximately $63,000 and $66,000, respectively. As of March 31, 2021, future minimum lease payments on operating leases are as follows: Six months ending September 30, 2021 $ 129,000 Year ending September 30, 2022 264,000 2022 272,000 2024 280,000 2025 288,000 2026 207,000 Thereafter 80,000 Total future minimum lease obligation 1,520,000 Less imputed interest on operating lease obligation (327,000 ) Net present value of operating lease obligation $ 1,193,000

PATENTS

PATENTS	6 Months Ended
	Mar. 31, 2021
PATENTS
G. PATENTS	G. PATENTS During the six months ended March 31, 2021 and 2020, no patent impairment charges were recorded. For the six months ended March 31, 2021 and 2020, amortization of patent costs totaled approximately $26,000 and $27,000, respectively. For the three months ended March 31, 2021 and 2020, amortization of patent costs totaled approximately $13,000 and $14,000, respectively. Approximate estimated future amortization expense is as follows: Six months ending September 30, 2021 $ 26,000 Year ending September 30, 2022 48,000 2023 38,000 2024 31,000 2025 28,000 2026 24,000 Thereafter 97,000 Total $ 292,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	6 Months Ended
	Mar. 31, 2021
LOSS PER COMMON SHARE
H. LOSS PER COMMON SHARE	H. LOSS PER COMMON SHARE The following tables provide the details of the basic and diluted loss per-share computations: Six months ended March 31, Three months ended March 31, 2021 2020 2021 2020 Loss per share – basic and diluted Net loss available to common shareholders - basic $ (19,303,763 ) $ (14,620,912 ) $ (11,281,120 ) $ (9,089,552 ) Weighted average shares outstanding - basic 39,351,194 35,621,711 40,047,273 36,165,050 Basic and diluted loss per common share $ (0.49 ) $ (0.41 ) $ (0.28 ) $ (0.25 ) In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2021 2020 Options and Warrants 5,945,064 6,452,645 Unvested Restricted Stock 302,500 318,798 Total 6,247,564 6,771,443

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	6 Months Ended
	Mar. 31, 2021
SUBSEQUENT EVENTS
J. SUBSEQUENT EVENTS	J. SUBSEQUENT EVENTS The Company has evaluated subsequent events through the date these financial statements were filed and determined there are no subsequent events that require disclosure.

BASIS OF PRESENTATION AND SUM_2

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)	6 Months Ended
	Mar. 31, 2021
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
U.S. Treasury Bills	U.S. Treasury Bills-
Property Equipment	Property and Equipment
Patents	Patents
Research and Development Costs	Research and Development Costs
Leases	Leases –
Income Taxes	Income Taxes
Derivative Instruments	Derivative Instruments
Stock-Based Compensation	Stock-Based Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s common stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Vesting of restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.
New Accounting Pronouncements	In August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes 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.
Newly Adopted Accounting Pronouncements	In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (Topic ).”

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	6 Months Ended
	Mar. 31, 2021
Stock options, stock bonuses and compensation granted by the Company	Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Options Plans 138,400 85,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,479,430 N/A 1,200,326 Stock Bonus Plans 783,760 N/A 352,007 431,720 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500
Stock option activity	Six Months Ended March 31, 2021 2020 Options granted 8,000 2,500 Options exercised 54,145 20,480 Options forfeited 42,165 1,000 Options expired 67 1,168 Three Months Ended March 31, 2021 2020 Options granted 500 1,500 Options exercised 48,845 20,480 Options forfeited - 1,000 Options expired 12 1,132
Stock-based compensation expense	Six months Ended March 31, 2021 2020 Employees $ 6,579,051 $ 3,581,204 Non-employees $ 552,664 $ 347,227 Three months Ended March 31, 2021 2020 Employees $ 3,282,742 $ 1,780,979 Non-employees $ 304,004 $ 191,487
Derivative liabilities, warrants and other options	Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2021 * Series UU 6/11/2018 93,603 $ 2.80 6/30/2021 * Series X 1/13/2016 120,000 $ 9.25 7/13/2021 * Series Y 2/15/2016 26,000 $ 12.00 8/15/2021 * Series ZZ 5/23/2016 19,200 $ 13.75 5/18/2021 1 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 * Series Z 5/23/2016 184,800 $ 13.75 11/23/2021 1 Series FF 12/8/2016 68,048 $ 3.91 12/1/2021 * Series CC 12/8/2016 46,345 $ 5.00 12/8/2021 1 Series HH 2/23/2017 200 $ 3.13 2/16/2022 * Series AA 8/26/2016 100,000 $ 13.75 2/22/2022 1 Series MM 6/22/2017 481,361 $ 1.86 6/22/2022 2 Series NN 7/24/2017 327,008 $ 2.52 7/24/2022 2 Series RR 10/30/2017 347,560 $ 1.65 10/30/2022 2 Series SS 12/19/2017 220,800 $ 2.09 12/18/2022 2 Series TT 2/5/2018 161,082 $ 2.24 2/5/2023 2 Consultants 7/28/2017 – 11/18/2020 15,000 $ 2.18 - $11.61 11/17/2022 - 7/27/2027 3
Tabular disclosure of derivative liabilities at fair value	March 31, 2021 September 30, 2020 Series W warrants $ - $ 73,570 Series Z warrants 1,013,400 1,207,902 Series ZZ warrants 77,574 75,044 Series AA warrants 619,033 1,082,212 Series BB warrants 81,374 65,173 Series CC warrants 488,784 1,259,712 Series HH warrants 2,444 2,000 Total warrant liabilities $ 2,282,609 $ 3,765,613
Schedule of gains and (losses) on derivative liabilities	2021 2020 Series V warrants $ - $ 78,461 Series W warrants 73,570 (367,369 ) Series Z warrants (696,498 ) (311,876 ) Series ZZ warrants (11,530 ) (4,585 ) Series AA warrants (661,821 ) (326,623 ) Series BB warrants (16,201 ) (7,028 ) Series CC warrants (795,257 ) (826,277 ) Series FF warrants - (319,706 ) Series HH warrants (444 ) (34,457 ) Series JJ warrants - (64,992 ) Series LL warrants - (98,066 ) Net loss on warrant liabilities $ (2,108,181 ) $ (2,282,518 ) 2021 2020 Series V warrants $ - $ (476,570 ) Series W warrants - (518,743 ) Series Z warrants (974,861 ) (322,425 ) Series ZZ warrants (63,397 ) (19,432 ) Series AA warrants (995,629 ) (391,601 ) Series BB warrants (46,833 ) (6,597 ) Series CC warrants (959,602 ) (803,596 ) Series FF warrants - (312,517 ) Series HH warrants (695 ) (34,375 ) Series JJ warrants - (64,862 ) Series LL warrants - (98,309 ) Net loss on warrant liabilities $ (3,041,017 ) $ (3,049,027 )
Warrants recorded as equity exercised	Three Months Six Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series Z 79,200 $ 13.75 $ 1,089,000 79,200 $ 13.75 $ 1,089,000 Series ZZ 800 $ 13.75 11,000 800 $ 13.75 11,000 Series AA 100,000 $ 13.75 1,375,000 100,000 $ 13.75 1,375,000 Series CC 97,298 $ 5.00 486,490 102,298 $ 5.00 511,490 277,298 $ 2,961,490 282,298 $ 2,986,490 Three Months Six Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series CC 123,820 $ 5.00 $ 619,100 123,820 $ 5.00 $ 619,100 Series FF 68,048 $ 3.91 265,812 68,048 $ 3.91 265,812 Series HH 6,300 $ 3.13 19,687 6,300 $ 3.13 19,687 Series JJ 9,450 $ 3.13 29,531 9,450 $ 3.13 29,531 Series LL 26,398 $ 3.59 94,867 26,398 $ 3.59 94,867 234,016 $ 1,028,997 234,016 $ 1,028,997
Schedule of other non operating gain	Six Months Ended Three Months Ended 3/31/2021 3/31/2020 3/31/2021 3/31/2020 Amount realized through the resale of shares $ 675,236 $ 1,720,680 $ 553,630 $ 934,511
Options and Warrants
Warrants recorded as equity exercised	Three Months Six Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series MM 316,272 $ 1.86 $ 588,265 316,272 $ 1.86 $ 588,265 Series NN 21,834 $ 2.52 55,022 21,834 $ 2.52 55,022 Series RR 70,089 $ 1.65 115,647 70,089 $ 1.65 115,647 Series SS 105,264 $ 2.09 220,002 105,264 $ 2.09 220,002 Series TT 200,482 $ 2.24 449,080 210,482 $ 2.24 471,480 713,941 $ 1,428,016 723,941 $ 1,450,416 Three Months Six Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series NN 98,253 $ 2.52 $ 247,598 98,253 $ 2.52 $ 247,598 Series OO 30,000 $ 2.52 75,600 40,000 $ 2.52 100,800 Series SS 94,474 $ 2.09 197,451 117,106 $ 2.09 244,752 Series TT 77,857 $ 2.24 174,400 178,125 $ 2.24 399,000 Series VV 27,500 $ 1.75 48,125 27,500 $ 1.75 48,125 328,084 $ 743,174 460,984 $ 1,040,275

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	6 Months Ended
	Mar. 31, 2021
FAIR VALUE MEASUREMENTS
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	Six months ended Twelve months ended March 31, 2021 September 30, 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (3,591,185 ) (3,071,775 ) Realized and unrealized net loss 2,108,181 349,078 Ending balance $ 2,282,609 $ 3,765,613

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	6 Months Ended
	Mar. 31, 2021
COMMITMENTS AND CONTINGENCIES
Schedule of future minimum payments under finance leases	Six months ending September 30, 2021 (1) $ (1,192,000 ) Years ending September 30, 2022 2,486,000 2023 2,569,000 2024 2,648,000 2025 2,733,000 2026 2,824,000 Thereafter 6,186,000 Total future minimum finance lease obligation 18,254,000 Less: imputed interest on financing lease obligation (6,188,000 ) Net present value of financing lease obligation $ 12,066,000 (1) Amount is net of landlord incentive of $2.4 million to be received in second half of fiscal year 2021 Six months ending September 30, 2021 $ 129,000 Year ending September 30, 2022 264,000 2022 272,000 2024 280,000 2025 288,000 2026 207,000 Thereafter 80,000 Total future minimum lease obligation 1,520,000 Less imputed interest on operating lease obligation (327,000 ) Net present value of operating lease obligation $ 1,193,000

PATENTS (Tables)

PATENTS (Tables)	6 Months Ended
	Mar. 31, 2021
PATENTS
Schedule of total estimated future amortization	Six months ending September 30, 2021 $ 26,000 Year ending September 30, 2022 48,000 2023 38,000 2024 31,000 2025 28,000 2026 24,000 Thereafter 97,000 Total $ 292,000

LOSS PER COMMON SHARE (Tables)

LOSS PER COMMON SHARE (Tables)	6 Months Ended
	Mar. 31, 2021
LOSS PER COMMON SHARE
Schedule of basic and diluted loss per-share computations	Six months ended March 31, Three months ended March 31, 2021 2020 2021 2020 Loss per share – basic and diluted Net loss available to common shareholders - basic $ (19,303,763 ) $ (14,620,912 ) $ (11,281,120 ) $ (9,089,552 ) Weighted average shares outstanding - basic 39,351,194 35,621,711 40,047,273 36,165,050 Basic and diluted loss per common share $ (0.49 ) $ (0.41 ) $ (0.28 ) $ (0.25 )
Schedule of antidilutive securities	2021 2020 Options and Warrants 5,945,064 6,452,645 Unvested Restricted Stock 302,500 318,798 Total 6,247,564 6,771,443

A BASIS OF PRESENTATION AND SUM

A BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	6 Months Ended
	Mar. 31, 2021
Patents [Member]
Patent useful life	17 years

C STOCKHOLDERS EQUITY (Details)

C STOCKHOLDERS EQUITY (Details)	Mar. 31, 2021shares
Incentive Stock Option Plans [Member]
Total shares reserved under plans	138,400
Shares reserved for outstanding options	85,895
Remaining options/shares under plans	213
Non-Qualified Stock Option Plans [Member]
Total shares reserved under plans	9,987,200
Shares reserved for outstanding options	8,479,430
Remaining options/shares under plans	1,200,326
Stock Bonus Plans [Member]
Total shares reserved under plans	783,760
Remaining options/shares under plans	431,720
Shares issued	352,007
Stock Compensation Plan [Member]
Total shares reserved under plans	634,000
Remaining options/shares under plans	464,895
Shares issued	150,695
Incentive Stock Bonus Plan [Member]
Total shares reserved under plans	640,000
Remaining options/shares under plans	25,500
Shares issued	614,500

C STOCKHOLDERS EQUITY (Details

C STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
STOCKHOLDERS EQUITY
Options granted	500	1,500	8,000	2,500
Options exercised	48,845	20,480	54,145	20,480
Options forfeited		1,000	42,165	1,000
Options expired	12	1,132	67	1,168

C STOCKHOLDERS EQUITY (Detail_2

C STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
STOCKHOLDERS EQUITY
Non- Employees stock based compensation expense	$ 304,004	$ 191,487	$ 552,664	$ 347,227
Employees stock based compensation expense	$ 3,282,742	$ 1,780,979	$ 6,579,051	$ 3,581,204

C STOCKHOLDERS EQUITY (Detail_3

C STOCKHOLDERS EQUITY (Details 3)	6 Months Ended
	Mar. 31, 2021$ / sharesshares
Consultants [Member]
Shares issuable upon exercise of warrant/options | shares	15,000
Expiration date	November 17, 2022
Consultants [Member] | Minimum [Member]
Exercise price	$ 2.18
Issue date	7/28/2017
Expiration date	11/17/2022
Consultants [Member] | Maximum [Member]
Exercise price	$ 11.61
Issue date	11/18/2020
Expiration date	7/27/2027
Series MM [Member]
Shares issuable upon exercise of warrant/options | shares	220,800
Exercise price	$ 2.09
Issue date	12/19/2017
Expiration date	12/18/2022
Series SS [Member]
Shares issuable upon exercise of warrant/options | shares	481,361
Exercise price	$ 1.86
Issue date	6/22/2017
Expiration date	6/22/2022
Series N [Member]
Shares issuable upon exercise of warrant/options | shares	85,339
Exercise price	$ 3
Issue date	8/18/2008
Expiration date	8/18/2021
Series UU [Member]
Shares issuable upon exercise of warrant/options | shares	93,603
Exercise price	$ 2.80
Issue date	6/11/2018
Expiration date	6/30/2021
Series X [Member]
Shares issuable upon exercise of warrant/options | shares	120,000
Exercise price	$ 9.25
Issue date	1/13/2016
Expiration date	7/13/2021
Series Y [Member]
Shares issuable upon exercise of warrant/options | shares	26,000
Exercise price	$ 12
Issue date	2/15/2016
Expiration date	8/15/2021
Series ZZ [Member]
Shares issuable upon exercise of warrant/options | shares	19,200
Exercise price	$ 13.75
Issue date	5/23/2016
Expiration date	5/18/2021
Series BB [Member]
Shares issuable upon exercise of warrant/options | shares	16,000
Exercise price	$ 13.75
Issue date	8/26/2016
Expiration date	8/22/2021
Series Z [Member]
Shares issuable upon exercise of warrant/options | shares	184,800
Exercise price	$ 13.75
Issue date	5/23/2016
Expiration date	11/23/2021
Series FF [Member]
Shares issuable upon exercise of warrant/options | shares	68,048
Exercise price	$ 3.91
Issue date	12/8/2016
Expiration date	12/1/2021
Series CC [Member]
Shares issuable upon exercise of warrant/options | shares	46,345
Exercise price	$ 5
Issue date	12/8/2016
Expiration date	12/8/2021
Series HH [Member]
Shares issuable upon exercise of warrant/options | shares	200
Exercise price	$ 3.13
Issue date	2/23/2017
Expiration date	2/16/2022
Series AA [Member]
Shares issuable upon exercise of warrant/options | shares	100,000
Exercise price	$ 13.75
Issue date	8/26/2016
Expiration date	2/22/2022
Series NN [Member]
Shares issuable upon exercise of warrant/options | shares	327,008
Exercise price	$ 2.52
Issue date	7/24/2017
Expiration date	7/24/2022
Series RR [Member]
Shares issuable upon exercise of warrant/options | shares	347,560
Exercise price	$ 1.65
Issue date	10/30/2017
Expiration date	10/30/2022
Series TT [Member]
Shares issuable upon exercise of warrant/options | shares	161,082
Exercise price	$ 2.24
Issue date	2/5/2018
Expiration date	2/5/2023

C STOCKHOLDERS EQUITY (Detail_4

C STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Sep. 30, 2020
STOCKHOLDERS EQUITY
Series W warrants	$ 0		$ 0		$ 73,570
Series Z warrants	1,013,400		1,013,400		1,207,902
Series ZZ warrants	77,574		77,574		75,044
Series AA warrants	619,033		619,033		1,082,212
Series BB warrants	81,374		81,374		65,173
Series CC warrants	488,784		488,784		1,259,712
Series HH warrants	2,444		2,444		2,000
Total warrant liabilities	2,282,609		2,282,609		$ 3,765,613
Gains (losses) on Series V warrants	0	$ 476,570	0	$ 78,461
Gains (losses) on Series W warrants	0	518,743	73,570	367,369
Gains (losses) on Series Z warrants	974,861	322,425	696,498	311,876
Gains (losses) on Series ZZ warrants	63,397	19,432	11,530	4,585
Gains (losses) on Series AA warrants	995,629	391,601	661,821	326,623
Gains (losses) on Series BB warrants	46,833	6,597	16,201	7,028
Gains (losses) on Series CC warrants	959,602	803,596	795,257	826,277
Gains (losses) on Series FF warrants	0	312,517	0	319,706
Gains (losses) on Series HH warrants	695	34,375	444	34,457
Gains (losses) on Series JJ warrants	0	64,862	0	64,992
Gains (losses) on Series LL warrants	0	98,309	0	98,066
Net loss on warrant liabilities	$ 3,041,017	$ 3,049,027	$ 2,108,181	$ 2,282,518

C STOCKHOLDERS EQUITY (Detail_5

C STOCKHOLDERS EQUITY (Details 5) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Warrants Exercised	277,298	234,016	282,298	234,016
Proceeds	$ 2,961,490	$ 1,028,997	$ 2,986,490	$ 1,028,997
Series FF [Member]
Warrants Exercised		68,048		68,048
Proceeds		$ 265,812		$ 265,812
Exercise Price		$ 3.91		$ 3.91
Series CC [Member]
Warrants Exercised	97,298	123,820	102,298	123,820
Proceeds	$ 486,490	$ 619,100	$ 511,490	$ 619,100
Exercise Price	$ 5	$ 5	$ 5	$ 5
Series HH [Member]
Warrants Exercised		6,300		6,300
Proceeds		$ 19,687		$ 19,687
Exercise Price		$ 3.13		$ 3.13
Series AA [Member]
Warrants Exercised	100,000		100,000
Proceeds	$ 1,375,000		$ 1,375,000
Exercise Price	$ 13.75		$ 13.75
Series Z [Member]
Warrants Exercised	79,200		79,200
Proceeds	$ 1,089,000		$ 1,089,000
Exercise Price	$ 13.75		$ 13.75
Series ZZ [Member]
Warrants Exercised	800		800
Proceeds	$ 11,000		$ 11,000
Exercise Price	$ 13.75		$ 13.75
Series JJ [Member]
Warrants Exercised		9,450		9,450
Proceeds		$ 29,531		$ 29,531
Exercise Price		$ 3.13		$ 3.13
Series LL [Member]
Warrants Exercised		26,398		26,398
Proceeds		$ 94,867		$ 94,867
Exercise Price		$ 3.59		$ 3.59

C STOCKHOLDERS EQUITY (Detail_6

C STOCKHOLDERS EQUITY (Details 6) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Warrants exercised	713,941	328,084	723,941	460,984
Proceeds	$ 1,428,016	$ 743,174	$ 1,450,416	$ 1,040,275
Series NN [Member]
Warrants exercised	21,834	98,253	21,834	98,253
Proceeds	$ 55,022	$ 247,598	$ 55,022	$ 247,598
Exercise price	$ 2.52	$ 2.52	$ 2.52	$ 2.52
Series RR [Member]
Warrants exercised	70,089		70,089
Proceeds	$ 115,647		$ 115,647
Exercise price	$ 1.65		$ 1.65
Series TT [Member]
Warrants exercised	200,482	77,857	210,482	178,125
Proceeds	$ 449,080	$ 174,400	$ 471,480	$ 399,000
Exercise price	$ 2.24	$ 2.24	$ 2.24	$ 2.24
Series Z [Member]
Warrants exercised	316,272		316,272
Proceeds	$ 588,265		$ 588,265
Exercise price	$ 1.86		$ 1.86
Series ZZ [Member]
Warrants exercised	105,264	94,474	105,264	117,106
Proceeds	$ 220,002	$ 197,451	$ 220,002	$ 244,752
Exercise price	$ 2.09	$ 2.09	$ 2.09	$ 2.09
Series OO [Member]
Warrants exercised		30,000		40,000
Proceeds		$ 75,600		$ 100,800
Exercise price		$ 2.52		$ 2.52
Series VV [Member]
Warrants exercised		27,500		27,500
Proceeds				$ 48,125
Exercise price		$ 1.75		$ 1.75

C STOCKHOLDERS EQUITY (Detail_7

C STOCKHOLDERS EQUITY (Details 7) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
STOCKHOLDERS EQUITY
Amount realized through the resale of shares	$ 553,630	$ 934,511	$ 675,236	$ 1,720,680

C STOCKHOLDERS EQUITY (Detail_8

C STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	Dec. 07, 2020	Oct. 28, 2020	Sep. 30, 2020	Jan. 23, 2020	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
Fair value of stock option							$ 28,000
Weighted average grant date fair value							$ 5.65
Proceeds from issuance of common stock							$ 13,559,500	$ 12,917,632
Warrants expired					12	1,132	67	1,168
Consulting Agreements [Member]
Total expense					$ 484,000	$ 395,000	$ 553,000	$ 347,000
Non-Qualified Stock Option Plans [Member]
Options issued							10,000
Series W Warrants [Member]
Common stock price per share		$ 16.75
Warrants expired		688,930
Series X [Member]
Incremental cost							$ 85,000
Expiration date description	the expiration date of the Series X warrants was extended six months from January 13, 2021 to July 13, 2021
Expiration date							7/13/2021
Series Y [Member]
Incremental cost	$ 41,000
Expiration date							8/15/2021
Series N Warrants [Member]
Incremental cost				$ 22,000			$ 1,000
Expiration date description	the expiration date of the Series N warrants was extended six months from February 18, 2021 to August 18, 2021
Series UU warrants [Member]
Incremental cost							$ 192
Expiration date description	the expiration date of Series UU warrants were extended six months from December 31, 2020 to June 30, 2021						the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Consultants [Member]
Exercise price							$ 11.61
Options issued							5,000
Expiration date							November 17, 2022
Ergomed [Member]
Common stock shares held					63,021		63,021
Consultants One [Member]
Options issued			10,000				15,000
Restricted Stock [Member] | Consultants [Member]
Weighted average grant date fair value					$ 23.47	$ 11.53	$ 17.66	$ 9.44
Common stock issued for service, shares					13,486	17,120	28,530	32,939
December 2020 [Member]
Common stock sold shares							1,000,000
Public offering price per share					$ 14.65		$ 14.65
Proceeds from issuance of common stock							$ 13,600,000
March 2020 [Member]
Common stock sold shares							630,500
Public offering price per share					12.22		$ 12.22
Proceeds from issuance of common stock							$ 7,100,000
Additional shares of common stock							94,575
May 2020 [Member]
Proceeds from issuance of common stock							$ 1,100,000
January 2020 [Member]
Public offering price per share					9.07		$ 9.07
Proceeds from issuance of common stock							$ 800,000
Additional shares of common stock							90,959
December 2019 [Member]
Common stock sold shares							606,395
Public offering price per share					$ 9.07		$ 9.07
Proceeds from issuance of common stock							$ 5,000,000

D FAIR VALUE MEASUREMENTS (Deta

D FAIR VALUE MEASUREMENTS (Details) - USD ($)	6 Months Ended	12 Months Ended
	Mar. 31, 2021	Sep. 30, 2019
FAIR VALUE MEASUREMENTS
Beginning balance	$ 3,765,613	$ 6,488,310
Issuances	0	0
Exercises	3,591,185	3,071,775
Realized and unrealized net loss	2,108,181	349,078
Ending balance	$ 2,282,609	$ 3,765,613

D FAIR VALUE MEASUREMENTS (De_2

D FAIR VALUE MEASUREMENTS (Details Narrative)	6 Months Ended
	Mar. 31, 2021USD ($)
FAIR VALUE MEASUREMENTS
Weighted average interest rate	0.09%
Unrealized gain	$ 7,000

E RELATED PARTY TRANSACTIONS (D

E RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)	Dec. 07, 2020	Jan. 23, 2020	Mar. 31, 2021	Mar. 31, 2020
Deemed dividend			$ 86,000
Series N Warrants [Member]
Expiration date description	the expiration date of the Series N warrants was extended six months from February 18, 2021 to August 18, 2021
Incremental cost		$ 22,000	$ 1,000
Series UU warrants [Member]
Expiration date description	the expiration date of Series UU warrants were extended six months from December 31, 2020 to June 30, 2021		the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Incremental cost			$ 192
Interest expense			$ 192
Officers And Directors [Member]
Restricted Common shares				20,512
Restricted Common shares, amount				$ 185,000
Restricted Common shares purchased				16,787
Fair market value				$ 160,000

F COMMITMENTS AND CONTINGENCIES

F COMMITMENTS AND CONTINGENCIES (Details)	Mar. 31, 2021USD ($)
COMMITMENTS AND CONTINGENCIES
Six months ending September 30, 2021 (1)	$ (1,192,000)
2022	2,486,000
2023	2,569,000
2024	2,648,000
2025	2,733,000
2026	2,824,000
Thereafter	6,186,000
Total future minimum finance lease obligation	18,254,000
Less: imputed interest on financing lease obligation	(6,188,000)
Net present value of lease finance lease obligations	$ 12,066,000

F COMMITMENTS AND CONTINGENCI_2

F COMMITMENTS AND CONTINGENCIES (Details 1)	Mar. 31, 2021USD ($)
COMMITMENTS AND CONTINGENCIES
Six months ending September 30, 2021	$ 129,000
2022	264,000
2023	272,000
2024	280,000
2025	288,000
2026	207,000
Thereafter	80,000
Total future minimum lease obligation	1,520,000
Less imputed interest on operating lease obligation	(327,000)
Net present value of operating lease obligation	$ 1,193,000

F COMMITMENTS AND CONTINGENCI_3

F COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Sep. 30, 2020
Non current assets	$ 1,700,000		$ 1,700,000		$ 1,700,000
Clinical service trial			12,000,000
Cash paid related to finance leases			1,000,000	$ 1,000,000
Cash paid related to finance leases interest			600,000	600,000
Cash paid related to operating leases	$ 63,000	$ 66,000	$ 111,000	132,000
Weighted average discount rate	10.00%		10.00%
Maturity years			7 years 7 months 6 days
Finance lease right of use assets	$ 12,800,000		$ 12,800,000		13,800,000
Operating lease - liability	1,200,000		1,200,000		1,300,000
Operating lease liabilities current					900,000
Net book value operating lease right of use assets	1,100,000		1,100,000		1,200,000
Operating lease expense	66,000	68,000	132,000	135,000
Finance lease liability	12,100,000		12,100,000		12,700,000
Research and development expenses			34,500,000
Net of discount			11,400,000
Finance lease obligations, net of current portion	200,000		200,000		$ 100,000
Ergomed [Member]
Research and development expenses	400,000	800,000	1,000,000	1,600,000
Landlord [Member]
Finance lease liability	$ 140,000		140,000
Facility improvement costs			2,400,000
Cost incurred, initial			9,500,000
Estimated cost			$ 10,600,000
Interest rate	10.00%		10.00%
Lease description			The repayment will include a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year.
Biologics License Application [Member]
Sublease rental income		$ 18,000		$ 37,000

G PATENTS (Details)

G PATENTS (Details)	Mar. 31, 2021USD ($)
PATENTS
Nine months ending September 30, 2021	$ 26,000
2022	48,000
2023	38,000
2024	31,000
2025	28,000
2026	24,000
Thereafter	97,000
Total	$ 292,000

G PATENTS (Details Narrative)

G PATENTS (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
PATENTS
Amortization of patent costs	$ 13,000	$ 14,000	$ 26,000	$ 27,000

H LOSS PER COMMON SHARE (Detail

H LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended		6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Mar. 31, 2021	Mar. 31, 2020
LOSS PER COMMON SHARE
Net loss available to common shareholders - basic	$ (11,281,120)	$ (9,089,552)	$ (19,303,763)	$ (14,620,912)
Weighted average shares outstanding - basic	40,047,273	36,165,050	39,351,194	35,621,711
Basic and diluted loss per common share	$ (0.28)	$ (0.25)	$ (0.49)	$ (0.41)

H LOSS PER COMMON SHARE (Deta_2

H LOSS PER COMMON SHARE (Details 1) - shares	6 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Antidilutive securities	6,247,564	6,771,443
Options and Warrants
Antidilutive securities	5,945,064	6,452,645
Restricted Stock [Member]
Antidilutive securities	302,500	318,798