CEL-SCI (CVM) 10-Q 12 Aug 22 2022 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Jun. 30, 2022	Aug. 03, 2022
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	Jun. 30, 2022
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2022
Entity Common Stock Shares Outstanding		43,367,462
Entity File Number	001-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Interactive Data Current	Yes
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
City Area Code	703
Local Phone Number	506-9460
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSEAMER
Document Quarterly Report	true
Document Transition Report	false

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Jun. 30, 2022	Sep. 30, 2021
Current assets:
Cash and cash equivalents	$ 28,073,673	$ 36,060,148
U.S. Treasury Bills	0	6,151,385
Receivables	0	54,922
Prepaid expenses	708,621	998,482
Supplies used for R&D and manufacturing	2,173,037	2,006,584
Total current assets	30,955,331	45,271,521
Finance lease right of use assets	11,389,249	12,691,921
Operating lease right of use assets	1,928,561	2,056,178
Property and equipment, net	12,394,189	13,663,562
Patent costs, net	222,462	275,866
Deposits	0	1,910,917
Total assets	56,889,792	75,869,965
Current liabilities:
Accounts payable	852,860	1,675,813
Accrued expenses	992,945	859,216
Due to employees	496,005	265,993
Derivative instruments, current portion	0	437,380
Lease liabilities, current portion	1,673,653	698,665
Total current liabilities	4,015,463	3,937,067
Finance lease obligations, net of current portion	12,124,979	13,252,364
Operating lease obligations, net of current portion	1,895,987	2,021,308
Other liabilities	125,000	125,000
Total liabilities	18,161,429	19,335,739
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; 43,355,529 and 43,207,183 shares issued and outstanding at June 30, 2022 and September 30, 2021, respectively	433,555	432,072
Additional paid-in capital	484,729,902	474,298,566
Accumulated deficit	(446,435,094)	(418,196,412)
Total stockholders' equity	38,728,363	56,534,226
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 56,889,792	$ 75,869,965

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2022	Sep. 30, 2021
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	43,355,529	43,207,183
Common Stock, Shares Outstanding	43,355,529	43,207,183

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) 1 - USD ($)	9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Operating expenses:
Research and development	$ 18,893,857	$ 17,818,373
General and administrative	8,220,768	9,902,120
Total operating expenses	27,114,625	27,720,493
Operating loss	(27,114,625)	(27,720,493)
Gain (loss) on derivative instruments	366,791	(991,562)
Other non-operating (loss) gain	(30,793)	1,428,260
Interest expense, net	(1,460,055)	(872,457)
Net loss	(28,238,682)	(28,156,252)
Modification of warrants	(294,409)	(350,861)
Net loss available to common shareholders	$ (28,533,091)	$ (28,507,113)
Net loss per common share - basic	$ (0.66)	$ (0.71)
Weighted average common shares outstanding - basic	43,124,972	39,907,624
Net loss per common share - diluted	$ (0.66)	$ (0.74)
Weighted average common shares outstanding - diluted	43,124,972	40,158,321

CONDENSED STATEMENTS OF OPERA_2

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Operating Expenses:
Research and development	$ 6,286,873	$ 7,182,099
General and administrative	2,432,518	3,274,480
Total operating expenses	8,719,391	10,456,579
Operating loss	(8,719,391)	(10,456,579)
Gain on derivative instruments	0	1,116,619
Other non-operating gains	0	753,024
Interest expense, net	(913,193)	(351,332)
Net loss	(9,632,584)	(8,938,268)
Modification of warrants	(294,409)	(265,082)
Net loss available to common shareholders	$ (9,926,993)	$ (9,203,350)
Net loss per common share - basic	$ (0.23)	$ (0.22)
Weighted average common shares outstanding - basic	43,174,775	41,020,485
Net loss per common share - diluted	$ (0.23)	$ (0.25)
Weighted average common shares outstanding - diluted	43,174,775	41,231,082

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) 1 - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
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
401(k) contributions paid in common stock, shares		3,564
401(k) contributions paid in common stock, amount	41,671	$ 36	41,635	0
Stock and options issued to nonemployees for service, shares		15,044
Stock and options issued to nonemployees for service, amount	152,450	$ 150	152,300	0
Option exercises, shares		5,300
Option exercises, amount	23,511	$ 53	23,458	0
Share issuance costs	(117,021)	0	(117,021)	0
Net loss	(7,936,864)	0	0	(7,936,864)
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	126,954
Net loss	$ (28,156,252)
Balance, shares at Jun. 30, 2021		42,963,391
Balance, amount at Jun. 30, 2021	59,793,744	$ 429,634	469,355,665	(409,991,555)
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
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 and options issued to nonemployees for service, shares		13,486
Stock and options issued to nonemployees for service, amount	379,277	$ 135	379,142	0
Option exercises, shares		48,845
Option exercises, amount	138,788	$ 489	138,299	0
Share issuance costs	(13,828)	0	(13,828)	0
Net loss	(11,281,120)	$ 0	0	(11,281,120)
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)
Warrant exercises, shares		437,312
Warrant exercises, amount	1,379,490	$ 4,373	1,375,117	0
401(k) contributions paid in common stock, shares		6,111
401(k) contributions paid in common stock, amount	53,205	$ 61	53,144	0
Stock and options issued to nonemployees for service, shares		13,184
Stock and options issued to nonemployees for service, amount	$ 267,068	$ 132	266,936	0
Option exercises, shares	72,809	72,809
Option exercises, amount	$ 464,162	$ 728	463,434	0
Share issuance costs	(103,185)	0	(103,185)	0
Net loss	(8,938,268)	0	0	(8,938,268)
Modification of warrants	24,195	$ 0	24,195	0
Balance, shares at Jun. 30, 2021		42,963,391
Balance, amount at Jun. 30, 2021	59,793,744	$ 429,634	469,355,665	(409,991,555)
Balance, shares at Sep. 30, 2021		43,207,183
Balance, amount at Sep. 30, 2021	56,534,226	$ 432,072	474,298,566	(418,196,412)
Warrant exercises, shares		19,705
Warrant exercises, amount	157,954	$ 197	157,757	0
401(k) contributions paid in common stock, shares		7,605
401(k) contributions paid in common stock, amount	52,555	$ 76	52,479	0
Stock and options issued to nonemployees for service, shares		18,020
Stock and options issued to nonemployees for service, amount	143,160	$ 180	142,980	0
Option exercises, shares		6,500
Option exercises, amount	29,835	$ 65	29,770	0
Share issuance costs	(45,965)	0	(45,965)	0
Net loss	(8,782,606)	$ 0	0	(8,782,606)
Balance, shares at Dec. 31, 2021		43,259,013
Balance, amount at Dec. 31, 2021	51,351,455	$ 432,590	477,897,883	(426,979,018)
Balance, shares at Sep. 30, 2021		43,207,183
Balance, amount at Sep. 30, 2021	$ 56,534,226	$ 432,072	474,298,566	(418,196,412)
Option exercises, shares	6,500
Net loss	$ (28,238,682)
Balance, shares at Jun. 30, 2022		43,355,529
Balance, amount at Jun. 30, 2022	38,728,363	$ 433,555	484,729,902	(446,435,094)
Balance, shares at Dec. 31, 2021		43,259,013
Balance, amount at Dec. 31, 2021	51,351,455	$ 432,590	477,897,883	(426,979,018)
Warrant exercises, shares		5,500
Warrant exercises, amount	13,860	$ 55	13,805	0
401(k) contributions paid in common stock, shares		14,614
401(k) contributions paid in common stock, amount	57,517	$ 146	57,371	0
Stock and options issued to nonemployees for service, shares		25,475
Stock and options issued to nonemployees for service, amount	140,052	$ 255	139,797	0
Share issuance costs	(4,550)	0	(4,550)	0
Net loss	(9,823,492)	$ 0	0	(9,823,492)
Balance, shares at Mar. 31, 2022		43,304,602
Balance, amount at Mar. 31, 2022	45,127,548	$ 433,046	481,497,012	(436,802,510)
401(k) contributions paid in common stock, shares		12,640
401(k) contributions paid in common stock, amount	57,208	$ 126	57,082	0
Stock and options issued to nonemployees for service, shares		38,287
Stock and options issued to nonemployees for service, amount	$ 122,266	$ 383	121,883	0
Option exercises, shares	0
Share issuance costs	$ (28,560)	0	(28,560)	0
Net loss	(9,632,584)	0	0	(9,632,584)
Modification of warrants	634,713	$ 0	634,713	0
Balance, shares at Jun. 30, 2022		43,355,529
Balance, amount at Jun. 30, 2022	$ 38,728,363	$ 433,555	$ 484,729,902	$ (446,435,094)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	$ 0	$ 589,400
Assets purchased under finance leases	32,409	0
Capitalizable patent costs included in current liabilities	0	20,000
Changes to right of use assets and liabilities	16,268	551,444
Finance lease obligation included in accounts payable	1,800	1,328
Prepaid consulting services paid with issuance of common stock	221,242	292,792
Accrued consulting services to be paid with issuance of common stock	110,000	110,000
Exercise of derivative liabilities	70,589	3,838,471
Financing costs included in current liabilities	28,560	76,860
Cash paid for interest	$ 872,023	$ 876,779

CONDENSED STATEMENTS OF CASH _2

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)1 - USD ($)	9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ 28,238,682	$ 28,156,252
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,845,978	1,649,699
Share-based payments for services	603,147	955,900
Equity based compensation	9,102,774	10,090,410
Common stock contributed to 401(k) plan	(167,280)	(146,296)
Gain on short-term investments	615	6,578
Loss on patent impairment	30,793	0
Gain (loss) on derivative instruments	366,791	(991,562)
Modification of warrants	(634,713)	(24,387)
(Increase)/decrease in assets:
Receivables	(54,922)	0
Prepaid expenses	(147,192)	(232,752)
Supplies used for R&D and manufacturing	(166,453)	(759,193)
Deposits	1,910,917	(248,712)
Increase/(decrease) in liabilities:
Accounts payable	(410,536)	689,812
Accrued expenses	78,729	297,928
Due to employees	230,012	84,598
Other liabilities	49,390	22,459
Net cash used in operating activities	(13,327,230)	(13,984,932)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from maturity (purchases) of US treasury bills	6,152,000	(11,145,667)
Purchases of property and equipment	(621,826)	(8,628,648)
Expenditures for patent costs	(22,741)	0
Net cash provided by (used in) investing activities	5,507,433	(19,774,315)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	0	47,363,426
Share issuance costs	(50,515)	(207,673)
Proceeds from exercises of warrants and options	131,060	6,195,571
Proceeds from landlord funding of leasehold improvements	786,454	1,613,546
Payments on obligations under finance lease	(1,033,677)	(756,817)
Net cash (used in) provided by financing activities	(166,678)	54,208,053
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(7,986,475)	20,448,806
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	36,060,148	15,508,909
CASH AND CASH EQUIVALENTS, END OF PERIOD	$ 28,073,673	$ 35,957,715

STATEMENTS OF STOCKHOLDERS' E_2

STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
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)
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
Warrant exercises, shares		15,000
Warrant exercises, amount	89,250	$ 150	89,100	0
Equity based compensation - employees, shares		(2,000)
Equity based compensation - employees, amount	3,296,309	$ (20)
401(k) contributions paid in common stock, shares		3,564
401(k) contributions paid in common stock, amount	41,671	$ 36	41,635	0
Stock and options issued to nonemployees for service, shares		15,044
Stock and options issued to nonemployees for service, amount	152,450	$ 150	152,300	0
Option exercises, shares		5,300
Option exercises, amount	23,511	$ 53	23,458	0
Modification of warrants	192	0	192	0
Share issuance costs	(117,021)	0	(117,021)	0
Net loss	(7,936,864)	$ 0	0	(7,936,864)
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	126,954
Net loss	$ (28,156,252)
Balance, shares at Jun. 30, 2021		42,963,391
Balance, amount at Jun. 30, 2021	59,793,744	$ 429,634	469,355,665	(409,991,555)
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
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 and options issued to nonemployees for service, shares		13,486
Stock and options issued to nonemployees for service, amount	379,277	$ 135	379,142	0
Option exercises, shares		48,845
Option exercises, amount	138,788	$ 489	138,299	0
Share issuance costs	(13,828)	0	(13,828)	0
Net loss	(11,281,120)	$ 0	0	(11,281,120)
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)
Proceeds from the sale of common stock, shares		1,610,000
Proceeds from the sale of common stock, amount	33,803,926	$ 16,100	33,787,826	0
Warrant exercises, shares		437,312
Warrant exercises, amount	1,379,490	$ 4,373	1,375,117	0
401(k) contributions paid in common stock, shares		6,111
401(k) contributions paid in common stock, amount	53,205	$ 61	53,144	0
Stock and options issued to nonemployees for service, shares		13,184
Stock and options issued to nonemployees for service, amount	$ 267,068	$ 132	266,936	0
Option exercises, shares	72,809	72,809
Option exercises, amount	$ 464,162	$ 728	463,434	0
Modification of warrants	24,195	0	24,195	0
Share issuance costs	(103,185)	0	(103,185)	0
Net loss	(8,938,268)	$ 0	0	(8,938,268)
Balance, shares at Jun. 30, 2021		42,963,391
Balance, amount at Jun. 30, 2021	59,793,744	$ 429,634	469,355,665	(409,991,555)
Balance, shares at Sep. 30, 2021		43,207,183
Balance, amount at Sep. 30, 2021	56,534,226	$ 432,072	474,298,566	(418,196,412)
Warrant exercises, shares		19,705
Warrant exercises, amount	157,954	$ 197	157,757	0
401(k) contributions paid in common stock, shares		7,605
401(k) contributions paid in common stock, amount	52,555	$ 76	52,479	0
Stock and options issued to nonemployees for service, shares		18,020
Stock and options issued to nonemployees for service, amount	143,160	$ 180	142,980	0
Option exercises, shares		6,500
Option exercises, amount	29,835	$ 65	29,770	0
Share issuance costs	(45,965)	0	(45,965)	0
Net loss	(8,782,606)	$ 0	0	(8,782,606)
Balance, shares at Dec. 31, 2021		43,259,013
Balance, amount at Dec. 31, 2021	51,351,455	$ 432,590	477,897,883	(426,979,018)
Balance, shares at Sep. 30, 2021		43,207,183
Balance, amount at Sep. 30, 2021	$ 56,534,226	$ 432,072	474,298,566	(418,196,412)
Option exercises, shares	6,500
Net loss	$ (28,238,682)
Balance, shares at Jun. 30, 2022		43,355,529
Balance, amount at Jun. 30, 2022	38,728,363	$ 433,555	484,729,902	(446,435,094)
Balance, shares at Dec. 31, 2021		43,259,013
Balance, amount at Dec. 31, 2021	51,351,455	$ 432,590	477,897,883	(426,979,018)
Warrant exercises, shares		5,500
Warrant exercises, amount	13,860	$ 55	13,805	0
401(k) contributions paid in common stock, shares		14,614
401(k) contributions paid in common stock, amount	57,517	$ 146	57,371	0
Stock and options issued to nonemployees for service, shares		25,475
Stock and options issued to nonemployees for service, amount	140,052	$ 255	139,797	0
Share issuance costs	(4,550)	0	(4,550)	0
Net loss	(9,823,492)	$ 0	0	(9,823,492)
Balance, shares at Mar. 31, 2022		43,304,602
Balance, amount at Mar. 31, 2022	45,127,548	$ 433,046	481,497,012	(436,802,510)
401(k) contributions paid in common stock, shares		12,640
401(k) contributions paid in common stock, amount	57,208	$ 126	57,082	0
Stock and options issued to nonemployees for service, shares		38,287
Stock and options issued to nonemployees for service, amount	$ 122,266	$ 383	121,883	0
Option exercises, shares	0
Modification of warrants	$ 634,713	0	634,713	0
Share issuance costs	(28,560)	0	(28,560)	0
Net loss	(9,632,584)	$ 0	0	(9,632,584)
Balance, shares at Jun. 30, 2022		43,355,529
Balance, amount at Jun. 30, 2022	$ 38,728,363	$ 433,555	$ 484,729,902	$ (446,435,094)

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Jun. 30, 2022
Common Stock
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, 2021. 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 June 30, 2022 and the results of its operations for the nine and three months then ended. The condensed balance sheet as of September 30, 2021 is derived from the September 30, 2021 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 nine and three months ended June 30, 2022 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 the discussion in Note B. Summary of Significant Accounting Policies: Cash and Cash Equivalents Property and Equipment Patents Leases – Derivative Instruments Accounting for Derivative Instruments and Hedging Activities The Company adopted Accounting Standards Update (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 The Company adopted ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options Stock-Based Compensation Compensation – Stock 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. 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. For options issued with service conditions only, the assumption for stock price volatility is based on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of 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. Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plans are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured 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. Research and Development Costs Net Loss Per Common Share Income Taxes The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, Use of Estimates New Accounting Pronouncements The Company has considered all 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	9 Months Ended
	Jun. 30, 2022
OPERATIONS AND FINANCING
Operations And Financing	B. OPERATIONS AND FINANCING On June 28, 2021, the Company announced results from its 9.5-year pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection) in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN). The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm that received Multikine treatment followed by surgery and radiation. This survival benefit was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5 years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), control arm 48.6%, Multikine arm 62.7% survival. The study used the standard of care treatment for advanced primary head and neck cancer patients as a comparison. The patients received surgery followed by either radiation or chemoradiation (chemotherapy and radiation at the same time), as determined by the physician. This meant that there were two treatment arms: (1) surgery plus radiation or (2) surgery plus chemoradiation. The arm that received Multikine treatment followed by surgery and radiation showed great survival benefit, but when chemotherapy was added in the second treatment arm, the immunological effect of Multikine was negated. Therefore, when the two treatment arms were combined the study did not achieve its primary endpoint of a 10% improvement in overall survival. Multikine is given for three weeks after cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO, a clear survival advantage for patients treated with Multikine prior to surgery in the surgery-plus-radiation arm of the IT-MATTERS study was described. The survival advantage was driven by objective data derived from patients in the intent-to-treat (ITT) population who had a significant number of early complete and partial tumor responses which occurred prior to surgery. Five patients in the study had their tumors completely disappear (confirmed by pathology) before surgery. In the ITT population as a whole, 8.5% of all Multikine-treated patients had a tumor response before surgery, but not a single tumor response before surgery was seen in the ITT control group before surgery, statistically a highly significant finding (p-value of less than 0.00000000001). This indicates that the likelihood of seeing these results by chance is less than 1 in ten billion. These results confirm findings from the Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity. Liquidity 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 and expansion of manufacturing and laboratory facilities, and participation in 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 efforts to bring Multikine to market. 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 obtain approval from the U.S. Food and Drug Administration (FDA) 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 funded operations in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. To finance the Company through marketing approval, the Company 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 it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. 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. Primarily because of the losses incurred to date, the expected continued future losses, and the uncertainties associated with obtaining regulatory approval and ultimately commercializing its products, management has identified conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern. Management has evaluated the significance of those conditions and has concluded that there is sufficient cash on hand to meet the Company’s budgeted cash requirements. As a result, substantial doubt about the Company’s ability to continue as a going concern for more than twelve months from the date of these financial statements has been alleviated. Impact of the 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 impact the pandemic will have on the Company’s future financial condition, liquidity and results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on the Company’s financial condition, liquidity, operations, suppliers, industry, and workforce.

STOCKHOLDERS EQUITY

STOCKHOLDERS EQUITY	9 Months Ended
	Jun. 30, 2022
STOCKHOLDERS EQUITY
Stockholders' Equity	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock In June 2021, the Company sold 1,400,000 shares of common stock at a public offering price of $22.62 per share and received aggregate net proceeds of approximately $29.4 million. The Company also granted the underwriters a 30-day option to purchase up to 210,000 additional shares of common stock to cover over-allotments. The underwriters fully exercised this option in June 2021, resulting in additional net proceeds to the Company of approximately $4.4 million. 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. Equity Compensation Underlying share information for equity compensation plans as of June 30, 2022 is as follows: Name of Plan Total Shares Reserved Under Plans Shares Reserved for Outstanding Options Shares Issued Remaining Options/Shares Under Plans Incentive Stock Option Plans 138,400 75,329 N/A 213 Non-Qualified Stock Option Plans 13,787,200 12,909,350 N/A 455,508 Stock Bonus Plans 783,760 N/A 397,945 385,782 Stock Compensation Plans 634,000 N/A 153,195 462,395 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500 Stock option activity Nine Months Ended June 30, 2022 2021 Options granted 1,975,250 2,603,500 Options exercised 6,500 126,954 Options forfeited 20,166 42,166 Options expired 13,614 9,374 Three Months Ended June 30, 2022 2021 Options granted 1,722,750 2,595,500 Options exercised - 72,809 Options forfeited - - Options expired 13,614 9,307 During the three months ended June 30, 2022, the Company adopted the 2022 Non-Qualified Stock Option Plan, which provides for the issuance of up to 2,000,000 options to purchase shares of common stock. During the nine months ended June 30, 2022, the Company granted 250,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $10.48 per share, the fair value on the date of issuance. The stock options will vest 100% upon approval of the first marketing application for any pharmaceutical based upon the Company’s Multikine technology in the USA, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia. None of the options will be exercisable before November 19, 2022. All options which have not vested as of November 18, 2031 will be canceled. On the grant date, the options were valued using a Monte Carlo Simulation approach. A Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. However, because attainment of the performance condition cannot be considered probable, no compensation cost is recognized relating to these options as of June 30, 2022. Management re-assesses the probability of achieving the performance condition at each reporting date. Stock-Based Compensation Expense Nine months Ended June 30, 2022 2021 Employees $ 9,102,774 $ 10,090,410 Non-employees $ 603,147 $ 955,900 Three months Ended June 30, 2022 2021 Employees $ 2,447,772 $ 3,511,359 Non-employees $ 200,877 $ 403,236 Employee compensation expense includes the expense related to options and restricted stock that is expensed over the vesting periods. 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 Warrant/Options Issue Date Underlying Shares Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2024 2 Series UU 6/11/2018 93,603 $ 2.80 6/30/2024 2 Series X 1/13/2016 120,000 $ 9.25 7/13/2024 2 Series Y 2/15/2016 26,000 $ 12.00 8/15/2024 2 Series MM 6/22/2017 333,432 $ 1.86 6/22/2024 2 Series NN 7/24/2017 200,087 $ 2.52 7/24/2024 2 Series RR 10/30/2017 251,761 $ 1.65 10/30/2022 * Series SS 12/19/2017 200,000 $ 2.09 12/18/2022 * Series TT 2/5/2018 600 $ 2.24 2/5/2023 * Consultants 7/28/2017 – 11/18/2020 15,000 $2.18 -$11.61 11/17/2022 - 7/27/2027 * * No current period changes to these warrants 1. Warrant Liabilities The table below presents the fair value of the warrant liabilities as of: June 30, 2022 September 30, 2021 Series Z warrants $ - $ 64,787 Series AA warrants - 276,035 Series CC warrants - 94,961 Series HH warrants - 1,597 Total warrant liabilities $ - $ 437,380 The table below presents the net gains (losses) on the warrant liabilities for the nine months ended June 30: 2022 2021 Series W warrants $ - $ 73,570 Series Z warrants 64,787 (113,094 ) Series ZZ warrants - (98,692 ) Series AA warrants 276,035 (306,606 ) Series BB warrants - 48,477 Series CC warrants 24,372 (596,001 ) Series HH warrants 1,597 784 Net gain (loss) on warrant liabilities $ 366,791 $ (991,562 ) The table below presents the net gains (losses) on the warrant liabilities for the three months ended June 30: 2022 2021 Series Z warrants $ - $ 583,404 Series ZZ warrants - (87,162 ) Series AA warrants - 355,215 Series BB warrants - 64,678 Series CC warrants - 199,256 Series HH warrants - 1,228 Net gain loss on warrant liabilities $ - $ 1,116,619 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. During the nine months ended June 30, 2022, 15,205 Series CC warrants were exercised at an exercise price of $5.00 for gross proceeds of $76,025. No warrants were exercised during the three months ended June 30, 2022. The following warrants recorded as liabilities were exercised during the following periods: Nine Months Ended June 30, 2021 Three Months Ended June 30, 2021 Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series Z 79,200 $ 13.75 $ 1,089,000 - - $ - Series ZZ 20,000 $ 13.75 275,000 19,200 $ 13.75 264,000 Series AA 100,000 $ 13.75 1,375,000 - - - Series CC 107,298 $ 5.00 536,490 5,000 $ 5.00 25,000 306,498 $ 3,275,490 24,200 $ 289,000 In February 2022, 100,000 Series AA warrants with an exercise price of $13.75 and 200 Series HH warrants with an exercise price of $3.13, expired. In December 2021, 640 Series CC warrants, with an exercise price of $5.00, expired. In November 2021, 184,800 Series Z warrants, with an exercise price of $13.75, expired. On October 28, 2020, 688,930 Series W warrants, with an exercise price of $16.75, expired. 2. Equity Warrants During the nine months ended June 30, 2022, 10,000 Series NN warrants were exercised at an exercise price of $2.52 for gross proceeds of $25,200. No warrants were exercised during the three months ended June 30, 2022. The following warrants recorded as equity were exercised during the following periods: Nine Months Ended June 30, 2021 Three Months Ended June 30, 2021 Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series MM 464,201 $ 1.86 $ 863,414 147,929 $ 1.86 $ 275,148 Series NN 131,004 $ 2.52 330,130 109,170 $ 2.52 275,108 Series RR 165,888 $ 1.65 273,715 95,799 $ 1.65 158,068 Series SS 105,264 $ 2.09 220,002 - $ 2.09 - Series TT 270,696 $ 2.24 606,359 60,214 $ 2.24 134,879 1,137,053 $ 2,293,620 413,112 $ 843,204 On June 13, 2022, the expiration dates of the Series N, Series X, Series Y, Series UU, Series MM and Series NN warrants were extended two years. The incremental costs of the warrant extensions were recorded consistent with the accounting for the initial warrant issuances. The incremental costs of the Series N, Series X and Series Y warrant extensions were recorded as a deemed dividend and totaled approximately $294,000 for the nine and three months ended June 30, 2022. The Series N and Series X warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a trustee and beneficiary. The incremental cost of the Series MM, Series NN and Series UU warrant extensions were recorded as interest expense, because these warrants were originally issued with convertible notes payable and totaled approximately $635,000 for the nine and three months ended June 30, 2022. The Series UU warrants and a portion of the Series MM and Series NN warrants are held by Geert Kersten, Patricia Prichep (current officers of the Company) and the de Clara Trust. On June 28, 2021, the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year. On December 7, 2020, the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended six months. The incremental costs of the warrant extensions were recorded consistent with the accounting for the initial warrant issuances. The incremental costs of the Series N and Series X warrant extensions were recorded as a deemed dividend and totaled approximately $351,000 and $265,000 for the nine and three months ended June 30, 2021, respectively. The Series N and Series X warrants are held by the de Clara Trust. The incremental cost of the Series Y warrant extension was recorded as additional paid in capital and totaled approximately $103,000 and $62,000 for the nine and three months ended June 30, 2021. The incremental cost of the Series UU warrant extension was recorded as interest expense because these warrants were initially issued as an inducement to convert notes payable into common stock. The Series UU warrants are held by Geert Kersten, Patricia Prichep and the de Clara Trust. 3. Options and Shares Issued to Consultants During the nine months ended June 30, 2022 and 2021, the Company issued 81,782 and 41,714 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $5.40 and $19.47 during the nine months ended June 30, 2022 and 2021, respectively. During the three months ended June 30, 2022 and 2021, the Company issued 38,287 and 13,184 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $3.52 and $23.39, respectively, during the three months ended June 30, 2022 and 2021. 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. No options were issued to consultants during the nine and three months ended June 30, 2022. During the nine months ended June 30, 2021, the Company issued a consultant 5,000 options to purchase common stock with an exercise price of $11.61, at an aggregate fair value of approximately $28,000 and an expiration date of November 17, 2022. As of June 30, 2022 and September 30, 2021, 15,000 options issued to consultants were outstanding, all of which were issued from the Non-Qualified Stock Option plans and all of which are vested as of the balance sheet dates. During the nine months ended June 30, 2022 and 2021, the Company recorded total expense of approximately $603,000 and $956,000, respectively, relating to the share-based compensation under these consulting agreements. During the three months ended June 30, 2022 and 2021, the Company recorded total expense of approximately $201,000 and $403,000, respectively, relating to the share-based compensation under these consulting agreements. On June 30, 2022 and September 30, 2021, consulting fees of approximately $221,000 and $364,000, respectively, are included in prepaid expenses. 4. Securities Purchase Agreement In prior years, the Company was party to a Securities Purchase Agreement (SPA) with Ergomed plc (Ergomed), 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 reduced outstanding amounts due Ergomed. Upon issuance, the Company expensed the full value of the shares as other non-operating gain/loss and subsequently offset the gain or loss as amounts were realized through the sale of shares by Ergomed and reduced accounts payable to Ergomed. Ergomed resold the final balance of shares issued in the quarter ended September 30, 2021. No shares were issued during the periods presented. No sales were made by Ergomed during the nine and three months ended June 30, 2022. During the nine and three months ended June 30, 2021, respectively, the Company realized approximately $1.4 million and $0.8 million through the sale by Ergomed of 111,500 and 36,000 shares of common stock and the Company reduced the payable to Ergomed and credited other operating gain by those amounts.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	9 Months Ended
	Jun. 30, 2022
FAIR VALUE MEASUREMENTS
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. Assumptions from market participants are used when pricing the assets or liabilities, given there is no readily available market information. 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 U.S. Treasury bills during the year ended September 30, 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 in the fair value hierarchy. The Treasury bills matured in December 2021 and yielded a weighted average interest rate of 0.10%. As of June 30, 2022, there were no outstanding derivative instruments. As of September 30, 2021, all the Company’s derivative instruments are classified as Level 3 of the fair value hierarchy. The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the nine months ended June 30, 2022 and the year ended September 30, 2021: Nine months ended Twelve months ended June 30, 2022 September 30, 2021 Beginning balance $ 437,380 $ 3,765,613 Issuances - - Exercises (70,589 ) (4,023,091 ) Realized and unrealized net (gain) loss (366,791 ) 694,858 Ending balance $ - $ 437,380 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. On September 30, 2021, the Company’s Level 3 derivative instruments had a weighted average fair value of $1.45 per share and a weighted average exercise price of $13.28 per share. Fair values were determined using a weighted average risk-free interest rate of 0.05% and volatility of 109% and the instruments had a weighted average time to maturity of 0.3 years as of September 30, 2021.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
	Jun. 30, 2022
RELATED PARTY TRANSACTIONS
Related Party Transactions	E. RELATED PARTY TRANSACTIONS During the nine months ended June 30, 2022, the Company issued officers 250,000 options that vest upon FDA approval of the marketing application. See Note C for more information about the options. On June 13, 2022, the expiration dates of certain warrants, some of which are held by related parties, were extended by twenty-four months (Note C). The incremental cost of the modification of the Series N and Series X warrants, held by the de Clara Trust, was approximately $264,000 and was recorded as a deemed dividend in the financial statements for the nine and three months ended June 30, 2022. The incremental cost of the modification of the Series MM, Series NN and Series UU warrants, relating to those warrants held by the de Clara Trust and certain officers of the Company, was approximately $457,000 and was recorded as interest expense for the nine and three months ended June 30, 2022. This accounting treatment is consistent with the original recording of these warrants which were issued with convertible debt. All warrants holders were given the same modified terms. In June 2021, the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year. In December 2020, the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended six months. The incremental costs of the warrant extensions were recorded consistent with the accounting for the initial warrant issuances. The incremental costs of the Series N and Series X warrant extensions were recorded as a deemed dividend and totaled approximately $351,000 and $265,000 for the nine and three months ended June 30, 2021, respectively. The incremental cost of the Series UU warrant extension was recorded as interest expense and totaled approximately $24,000 for the nine and three months ended June 30, 2021.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Jun. 30, 2022
Commitments and contingencies
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 $35.5 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.8 million. During the nine months ended June 30, 2022 and 2021, the Company recorded, net of Ergomed’s discount, approximately $0.5 million and $1.4 million, respectively, of research and development expense related to Ergomed’s services. During the three months ended June 30, 2022 and 2021, the Company recorded, net of Ergomed’s discount, approximately $0.1 million and $0.4 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. The renewal options are not included in the calculation of the right of use asset and lease liability because exercise of those options is not probable. On June 30, 2022 and September 30, 2021, the net book value of the finance lease right of use asset is approximately $11.4 million and $12.7 million, respectively, and the balance of the finance lease liability is approximately $13.6 million and $13.8 million, respectively, of which approximately $1.5 million and $0.6 million is current on June 30, 2022 and September 30, 2021, respectively. 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 the straight-line method over the underlying lease terms. Total cash paid related to finance leases during the nine months ended June 30, 2022 and 2021 was approximately $1.9 million and $1.6 million, respectively, of which approximately $0.9 million was for interest in each nine-month period. As of June 30, 2022, the weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 6.3 years. In August 2020, the Company entered an amendment to the San Tomas lease 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 project was completed and the improvements were placed in service in October 2021. The total cost was $11.1 million, of which the landlord financed $2.4 million. The landlord financing is being repaid through increased lease payments which started in March 2021 and extend over the remaining lease term. The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the lease liability to account for the modified payments using an 8.45% implicit interest rate. The rate was determined using a synthetic credit rating analysis prepared by an outside valuation specialist. The financing is accounted for as a lease incentive from the landlord and is included in the calculation of the lease liability as it was realized. The leasehold improvements are recorded in property and equipment and are being amortized over the remaining lease term. The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. Under the landlord’s $2.4 million financing arrangement, the Company deposited an additional $0.2 million in March 2021. Because the Company met the minimum cash balance required by the lease, the full balance of the deposit was returned to the Company in January 2022. If the Company’s cash balance falls below the required balance, the Company will be required to re-deposit these funds with the landlord. The approximate $1.9 million deposit is included in non-current assets on September 30, 2021. Approximate future minimum lease payments under finance leases as of June 30, 2022 are as follows: Three months ending September 30, 2022 $ 625,000 Year ending September 30, 2023 2,576,000 2024 2,655,000 2025 2,741,000 2026 2,832,000 2027 2,923,000 Thereafter 3,267,000 Total future minimum lease obligation 17,619,000 Less imputed interest on finance lease obligations (3,985,000 ) Net present value of finance lease obligations $ 13,634,000 The Company leases two facilities under operating leases. The lease for the Company’s office headquarters will expire on November 30, 2025. The lease for its research and development laboratory was renewed in September 2021 for an additional ten years and will expire on February 29, 2032. The renewal was considered a modification for accounting purposes and the right of use asset and liability were remeasured as of the date of the renewal. This resulted in an increase of approximately $1.1 million to the operating lease right of use asset and liability. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the terms of the leases. As of June 30, 2022 and September 30, 2021, the net book value of the operating lease right of use assets is approximately $1.9 million and $2.1 million, respectively. As of June 30, 2022 and September 30, 2021, the balance of the operating lease liabilities is approximately $2.1 million, of which approximately $0.2 million and $0.1 million is current on June 30, 2022 and September 30, 2021, respectively. The Company incurred lease expense for operating leases of approximately $272,000 and $198,000, respectively, for the nine months ended June 30, 2022 and 2021. The Company incurred lease expense for operating leases of approximately $91,000 and $66,000, respectively, for the three months ended June 30, 2022 and 2021. Total cash paid related to operating leases during the nine months ended June 30, 2022 and 2021 was approximately $199,000 and $176,000, respectively. The weighted average discount rate of the Company’s operating leases is 9.09% and the weighted average time to maturity is 9.0 years. As of June 30, 2022, future minimum lease payments on operating leases are as follows: Three months ending September 30, 2022 $ 86,000 Year ending September 30, 2023 348,000 2024 357,000 2025 366,000 2026 287,000 2027 277,000 Thereafter 1,325,000 Total future minimum lease obligation 3,046,000 Less imputed interest on operating lease obligation (986,000 ) Net present value of operating lease obligation $ 2,060,000

PATENTS

PATENTS	9 Months Ended
	Jun. 30, 2022
PATENTS
Patents	G. PATENTS During the nine months ended June 30, 2022 and 2021, respectively, patent impairment charges of approximately $31,000 and $0, were recorded. No patent impairment charges were recorded during the three months ended June 30, 2022 and 2021. For the nine months ended June 30, 2022 and 2021, amortization of patent costs totaled approximately $39,000 in each period. For the three months ended June 30, 2022 and 2021, amortization of patent costs totaled approximately $12,000 and $13,000, respectively. Approximate estimated future amortization expense is as follows: Three months ending September 30, 2022 $ 10,000 Year ending September 30, 2023 38,000 2024 30,000 2025 28,000 2026 24,000 2027 21,000 Thereafter 71,000 Total $ 222,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	9 Months Ended
	Jun. 30, 2022
LOSS PER COMMON SHARE
Loss Per Common Share	H. 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. For the years presented, the gain on warrant liabilities priced lower than the average market price during the period is excluded from the numerator and the incremental shares, determined using the treasury stock method, are added to the denominator in calculating diluted loss per share. The following tables provide the details of the basic and diluted loss per-share computations: Nine months ended June 30, Three months ended June 30, 2022 2021 2021 2021 Loss per share - basic Net loss available to common shareholders - basic $ (28,533,091 ) $ (28,507,113 ) $ (9,926,993 ) $ (9,203,350 ) Weighted average shares outstanding - basic 43,124,972 39,907,624 43,174,775 41,020,485 Basic loss per common share $ (0.66 ) $ (0.71 ) $ (0.23 ) $ (0.22 ) Loss per share - diluted Net loss available to common shareholders - basic $ (28,533,091 ) $ (28,507,113 ) $ (9,926,993 ) $ (9,203,350 ) Unrealized gain on derivatives (1) - (1,236,514 ) - (1,233,597 ) Net loss available to common shareholders – diluted $ (28,533,091 ) $ (29,743,627 ) $ (9,926,993 ) $ (10,436,947 ) Weighted average shares outstanding - basic 43,124,972 39,907,624 43,174,775 41,020,485 Incremental shares underlying dilutive “in the money” warrants (1) - 250,697 - 210,597 Weighted average shares outstanding - diluted 43,124,972 40,158,321 43,174,775 41,231,082 Diluted loss per common share $ (0.66 ) $ (0.74 ) $ (0.23 ) $ (0.25 ) (1) Includes shares issuable upon the exercise of the Series Z, AA, BB, CC and HH warrants for the nine and three months ended June 30, 2021. In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2022 2021 Options and Warrants 14,295,501 6,979,170 Unvested Restricted Stock 151,250 166,500 Total 14,446,751 7,145,670

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Jun. 30, 2022
SUBSEQUENT EVENTS
Subsequent Events	J. SUBSEQUENT EVENTS On August 2 2022, the Company appointed Dr. Gail K. Naughton to the Company's Board of Directors.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Jun. 30, 2022
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash And Cash Equivalents	Cash and Cash Equivalents
Property And Equipment	Property and Equipment
Patents	Patents
Leases	Leases –
Derivative Instruments	Derivative Instruments Accounting for Derivative Instruments and Hedging Activities The Company adopted Accounting Standards Update (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 The Company adopted ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options
Stock-based Compensation	Stock-Based Compensation Compensation – Stock 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. 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. For options issued with service conditions only, the assumption for stock price volatility is based on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of 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. Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plans are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured 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.
Research And Development Costs	Research and Development Costs
Net Loss Per Common Share	Net Loss Per Common Share
Income Taxes	Income Taxes The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,
Use Of Estimates	Use of Estimates
New Accounting Pronouncements	The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

STOCKHOLDERS EQUITY (Table)

STOCKHOLDERS EQUITY (Table)	9 Months Ended
	Jun. 30, 2022
STOCKHOLDERS EQUITY
Schedule options, stock bonuses and compensation granted by the company	Name of Plan Total Shares Reserved Under Plans Shares Reserved for Outstanding Options Shares Issued Remaining Options/Shares Under Plans Incentive Stock Option Plans 138,400 75,329 N/A 213 Non-Qualified Stock Option Plans 13,787,200 12,909,350 N/A 455,508 Stock Bonus Plans 783,760 N/A 397,945 385,782 Stock Compensation Plans 634,000 N/A 153,195 462,395 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500
Schedule of stock option activity	Nine Months Ended June 30, 2022 2021 Options granted 1,975,250 2,603,500 Options exercised 6,500 126,954 Options forfeited 20,166 42,166 Options expired 13,614 9,374 Three Months Ended June 30, 2022 2021 Options granted 1,722,750 2,595,500 Options exercised - 72,809 Options forfeited - - Options expired 13,614 9,307
Schedule of Stock-Based Compensation Expense	Nine months Ended June 30, 2022 2021 Employees $ 9,102,774 $ 10,090,410 Non-employees $ 603,147 $ 955,900 Three months Ended June 30, 2022 2021 Employees $ 2,447,772 $ 3,511,359 Non-employees $ 200,877 $ 403,236
Schedule of Warrants and Non-Employee Options	Warrant/Options Issue Date Underlying Shares Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2024 2 Series UU 6/11/2018 93,603 $ 2.80 6/30/2024 2 Series X 1/13/2016 120,000 $ 9.25 7/13/2024 2 Series Y 2/15/2016 26,000 $ 12.00 8/15/2024 2 Series MM 6/22/2017 333,432 $ 1.86 6/22/2024 2 Series NN 7/24/2017 200,087 $ 2.52 7/24/2024 2 Series RR 10/30/2017 251,761 $ 1.65 10/30/2022 * Series SS 12/19/2017 200,000 $ 2.09 12/18/2022 * Series TT 2/5/2018 600 $ 2.24 2/5/2023 * Consultants 7/28/2017 – 11/18/2020 15,000 $2.18 -$11.61 11/17/2022 - 7/27/2027 *
Schedule of fair value of the warrant liabilities	June 30, 2022 September 30, 2021 Series Z warrants $ - $ 64,787 Series AA warrants - 276,035 Series CC warrants - 94,961 Series HH warrants - 1,597 Total warrant liabilities $ - $ 437,380
Schedule of gains (losses) on the warrant liabilities	2022 2021 Series W warrants $ - $ 73,570 Series Z warrants 64,787 (113,094 ) Series ZZ warrants - (98,692 ) Series AA warrants 276,035 (306,606 ) Series BB warrants - 48,477 Series CC warrants 24,372 (596,001 ) Series HH warrants 1,597 784 Net gain (loss) on warrant liabilities $ 366,791 $ (991,562 ) 2022 2021 Series Z warrants $ - $ 583,404 Series ZZ warrants - (87,162 ) Series AA warrants - 355,215 Series BB warrants - 64,678 Series CC warrants - 199,256 Series HH warrants - 1,228 Net gain loss on warrant liabilities $ - $ 1,116,619
Schedule of warrants recorded as liabilities	Nine Months Ended June 30, 2021 Three Months Ended June 30, 2021 Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series Z 79,200 $ 13.75 $ 1,089,000 - - $ - Series ZZ 20,000 $ 13.75 275,000 19,200 $ 13.75 264,000 Series AA 100,000 $ 13.75 1,375,000 - - - Series CC 107,298 $ 5.00 536,490 5,000 $ 5.00 25,000 306,498 $ 3,275,490 24,200 $ 289,000
Schedule of warrants recorded as equity	Nine Months Ended June 30, 2021 Three Months Ended June 30, 2021 Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series MM 464,201 $ 1.86 $ 863,414 147,929 $ 1.86 $ 275,148 Series NN 131,004 $ 2.52 330,130 109,170 $ 2.52 275,108 Series RR 165,888 $ 1.65 273,715 95,799 $ 1.65 158,068 Series SS 105,264 $ 2.09 220,002 - $ 2.09 - Series TT 270,696 $ 2.24 606,359 60,214 $ 2.24 134,879 1,137,053 $ 2,293,620 413,112 $ 843,204

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	9 Months Ended
	Jun. 30, 2022
FAIR VALUE MEASUREMENTS
Reconciliation Of Beginning And Ending Balances Related To Fair Value Measurements Using Significant Unobservable Inputs (level 3)	Nine months ended Twelve months ended June 30, 2022 September 30, 2021 Beginning balance $ 437,380 $ 3,765,613 Issuances - - Exercises (70,589 ) (4,023,091 ) Realized and unrealized net (gain) loss (366,791 ) 694,858 Ending balance $ - $ 437,380

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Jun. 30, 2022
Commitments and contingencies
Schedule Of Future Minimum Payments Under Operating Leases	Three months ending September 30, 2022 $ 625,000 Year ending September 30, 2023 2,576,000 2024 2,655,000 2025 2,741,000 2026 2,832,000 2027 2,923,000 Thereafter 3,267,000 Total future minimum lease obligation 17,619,000 Less imputed interest on finance lease obligations (3,985,000 ) Net present value of finance lease obligations $ 13,634,000 Three months ending September 30, 2022 $ 86,000 Year ending September 30, 2023 348,000 2024 357,000 2025 366,000 2026 287,000 2027 277,000 Thereafter 1,325,000 Total future minimum lease obligation 3,046,000 Less imputed interest on operating lease obligation (986,000 ) Net present value of operating lease obligation $ 2,060,000

PATENTS (Table)

PATENTS (Table)	9 Months Ended
	Jun. 30, 2022
Commitments and contingencies
Schedule of patents	Three months ending September 30, 2022 $ 10,000 Year ending September 30, 2023 38,000 2024 30,000 2025 28,000 2026 24,000 2027 21,000 Thereafter 71,000 Total $ 222,000

NET LOSS PER COMMON SHARE (Tabl

NET LOSS PER COMMON SHARE (Tables)	9 Months Ended
	Jun. 30, 2022
LOSS PER COMMON SHARE
Schedule Of Reconciliation Of The Numerators And Denominators Of The Basic And Diluted Per-share Computations	Nine months ended June 30, Three months ended June 30, 2022 2021 2021 2021 Loss per share - basic Net loss available to common shareholders - basic $ (28,533,091 ) $ (28,507,113 ) $ (9,926,993 ) $ (9,203,350 ) Weighted average shares outstanding - basic 43,124,972 39,907,624 43,174,775 41,020,485 Basic loss per common share $ (0.66 ) $ (0.71 ) $ (0.23 ) $ (0.22 ) Loss per share - diluted Net loss available to common shareholders - basic $ (28,533,091 ) $ (28,507,113 ) $ (9,926,993 ) $ (9,203,350 ) Unrealized gain on derivatives (1) - (1,236,514 ) - (1,233,597 ) Net loss available to common shareholders – diluted $ (28,533,091 ) $ (29,743,627 ) $ (9,926,993 ) $ (10,436,947 ) Weighted average shares outstanding - basic 43,124,972 39,907,624 43,174,775 41,020,485 Incremental shares underlying dilutive “in the money” warrants (1) - 250,697 - 210,597 Weighted average shares outstanding - diluted 43,124,972 40,158,321 43,174,775 41,231,082 Diluted loss per common share $ (0.66 ) $ (0.74 ) $ (0.23 ) $ (0.25 )
Schedule Of Anti-dilutive Securities	2022 2021 Options and Warrants 14,295,501 6,979,170 Unvested Restricted Stock 151,250 166,500 Total 14,446,751 7,145,670

BASIS OF PRESENTATION AND SUM_2

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	9 Months Ended
	Jun. 30, 2022
Patent Useful Life	9 years
Patents [Member]
Patent Useful Life	17 years
Minimum [Member]
Property And Equipment Useful Life	5 years
Maximum [Member]
Property And Equipment Useful Life	7 years

STOCKHOLDERS EQUITY (Details)

STOCKHOLDERS EQUITY (Details)	Jun. 30, 2022 shares
Incentive Stock Option Plans [Member]
Total Shares Reserved Under Plans	138,400
Shares Reserved For Outstanding Options	75,329
Remaining Options/shares Under Plans	213
Non-Qualified Stock Option Plans [Member]
Total Shares Reserved Under Plans	13,787,200
Shares Reserved For Outstanding Options	12,909,350
Remaining Options/shares Under Plans	455,508
Stock Bonus Plans [Member]
Total Shares Reserved Under Plans	783,760
Remaining Options/shares Under Plans	385,782
Shares Issued	397,945
Stock Compensation Plan [Member]
Total Shares Reserved Under Plans	634,000
Remaining Options/shares Under Plans	462,395
Shares Issued	153,195
Incentive Stock Bonus Plan [Member]
Total Shares Reserved Under Plans	640,000
Remaining Options/shares Under Plans	25,500
Shares Issued	614,500

STOCKHOLDERS EQUITY (Details 1)

STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
STOCKHOLDERS EQUITY
Options Granted	1,722,750	2,595,500	1,975,250	2,603,500
Options Exercised	0	72,809	6,500	126,954
Options Forfeited	0	0	20,166	42,166
Options Expired	13,614	9,307	13,614	9,374

STOCKHOLDERS EQUITY (Details 2)

STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
STOCKHOLDERS EQUITY
Employees Stock Based Compensation Expense	$ 2,447,772	$ 3,511,359	$ 9,102,774	$ 10,090,410
Non- Employees Stock Based Compensation Expense	$ 200,877	$ 403,236	$ 603,147	$ 955,900

STOCKHOLDERS EQUITY (Details 3)

STOCKHOLDERS EQUITY (Details 3)	9 Months Ended
	Jun. 30, 2022 $ / shares shares
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 N [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	85,339
Exercise Price	$ 3
Issue Date	8/18/2008
Expiration Date	8/18/2024
Series UU [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	93,603
Exercise Price	$ 2.80
Issue Date	6/11/2018
Expiration Date	6/30/2024
Series X [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	120,000
Exercise Price	$ 9.25
Issue Date	1/13/2016
Expiration Date	7/13/2024
Series Y [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	26,000
Exercise Price	$ 12
Issue Date	2/15/2016
Expiration Date	8/15/2024
Series MM [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	333,432
Exercise Price	$ 1.86
Issue Date	6/22/2017
Expiration Date	6/22/2024
Series NN [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	200,087
Exercise Price	$ 2.52
Issue Date	7/24/2017
Expiration Date	7/24/2024
Series RR [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	251,761
Exercise Price	$ 1.65
Issue Date	10/30/2017
Expiration Date	10/30/2022
Series SS [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	200,000
Exercise Price	$ 2.09
Issue Date	12/19/2017
Expiration Date	12/18/2022
Series TT [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	600
Exercise Price	$ 2.24
Issue Date	2/5/2018
Expiration Date	2/5/2023

STOCKHOLDERS EQUITY (Details 4)

STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Sep. 30, 2021
STOCKHOLDERS EQUITY
Series Z Warrants	$ 0		$ 0		$ 64,787
Series Aa Warrants	0		0		276,035
Series Cc Warrants	0		0		94,961
Series Hh Warrants	0		0		1,597
Total Warrant Liabilities	0		0		$ 437,380
Gains On Series W Warrants			0	$ 73,570
Gains On Series Z Warrants	0	$ 583,404	64,787	(113,094)
Gains On Series Zz Warrants	0	(87,162)	0	(98,692)
Gains On Series Aa Warrants	0	355,215	276,035	(306,606)
Gains On Series Bb Warrants	0	64,678	0	48,477
Gains On Series Cc Warrants	0	199,256	24,372	(596,001)
Gains On Series Hh Warrants	0	1,228	1,597	784
Net Gain On Warrant Liabilities	$ 0	$ 1,116,619	$ 366,791	$ (991,562)

STOCKHOLDERS EQUITY (Details 5)

STOCKHOLDERS EQUITY (Details 5) - USD ($)	1 Months Ended		3 Months Ended	9 Months Ended
	Feb. 28, 2022	Nov. 30, 2021	Jun. 30, 2021	Jun. 30, 2021
Proceeds			$ 289,000	$ 3,275,490
Warrants Exercised			24,200	306,498
Proceeds			$ 843,204	$ 2,293,620
Series Z [Member]
Warrants Exercised			0	79,200
Proceeds			$ 0	$ 1,089,000
Exercise Price		$ 13.75	$ 0	$ 13.75
Series ZZ [Member]
Warrants Exercised			19,200	20,000
Proceeds			$ 264,000	$ 275,000
Exercise Price			$ 13.75	$ 13.75
Series AA [Member]
Warrants Exercised			0	100,000
Proceeds			$ 0	$ 1,375,000
Exercise Price	$ 13.75		$ 0	$ 13.75
Series CC [Member]
Warrants Exercised			5,000	107,298
Proceeds			$ 25,000	$ 536,490
Exercise Price			$ 5	$ 5

STOCKHOLDERS EQUITY (Details 6)

STOCKHOLDERS EQUITY (Details 6) - USD ($)	3 Months Ended	9 Months Ended
	Jun. 30, 2021	Jun. 30, 2021
Proceeds	$ 843,204	$ 2,293,620
Warrants Exercised	413,112	1,137,053
Warrants Exercised	24,200	306,498
Series MM [Member]
Proceeds	$ 275,148	$ 863,414
Warrants Exercised	147,929	464,201
Exercise Price	$ 1.86	$ 1.86
Series NN [Member]
Proceeds	$ 275,108	$ 330,130
Warrants Exercised	109,170	131,004
Exercise Price	$ 2.52	$ 2.52
Series RR [Member]
Proceeds	$ 158,068	$ 273,715
Warrants Exercised	95,799	165,888
Exercise Price	$ 1.65	$ 1.65
Series SS [Member]
Proceeds	$ 0	$ 220,002
Warrants Exercised	0	105,264
Exercise Price	$ 2.09	$ 2.09
Series TT [Member]
Proceeds	$ 134,879	$ 606,359
Warrants Exercised	60,214	270,696
Exercise Price	$ 2.24	$ 2.24

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)		1 Months Ended				3 Months Ended		9 Months Ended
	Dec. 07, 2020	Feb. 28, 2022	Dec. 31, 2021	Nov. 30, 2021	Oct. 28, 2020	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Sep. 30, 2021
Common stock shares									1,400,000
Offering price							$ 22.62		$ 22.62
Aggregate net proceeds									$ 29,400,000
Additional net proceeds									$ 4,400,000
Additional shares of common stock									210,000
Fair value of common stock							$ 36,000		$ 111,500
Proceeds from issuance of common stock							800,000		1,400,000
Proceeds from issuance of common stock								$ 0	47,363,426
Series HH [Member]
Warrants exercised		200
Exercise Price		$ 3.13
Consulting Agreements [Member]
Total expense						$ 201,000	$ 403,000	603,000	$ 956,000
Consulting fees inclued prepaid expenses						$ 221,000		$ 221,000		$ 364,000
December 2020 [Member]
Common stock shares									1,000,000
Offering price							$ 14.65		$ 14.65
Proceeds from issuance of common stock									$ 13,600,000
Consultants [Member]
Exercise price								$ 11.61
Expiration date								November 17, 2022
Aggregate Option Fair Value								$ 28,000
Options issued								5,000
Consultants [Member] | Restricted Stock [Member]
Weighted average grant date fair value						$ 3.52	$ 23.39	$ 5.40	$ 19.47
Common stock issued for service, shares						38,287	13,184	81,782	41,714
Consultants One [Member]
Options issued								15,000
Series X [Member]
Expiration date								7/13/2024
Incremental cost						$ 294,000	$ 351,000	$ 294,000	$ 265,000
Expiration date description	the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year
Series Y [Member]
Expiration date								8/15/2024
Incremental cost						$ 635,000	$ 103,000	$ 635,000	$ 62,000
Expiration date description	the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year
Series NN [Member]
Warrants exercised								10,000
Exercise Price Of Warrants Exercised								$ 2.52
Proceeds from warrants exercised								$ 25,200
Exercise Price							$ 2.52		$ 2.52
Expiration date								7/24/2024
Series Z [Member]
Warrants exercised				184,800
Exercise Price				$ 13.75			0		13.75
Series AA [Member]
Warrants exercised		100,000
Exercise Price		$ 13.75					0		13.75
Series CC [Member]
Warrants exercised			640					15,205
Proceeds from warrants exercised								$ 76,025
Exercise price per share			$ 5					$ 5
Exercise Price							$ 5		$ 5
Series UU warrants [Member]
Expiration date description	the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year
Series N Warrants [Member]
Incremental cost							$ 351,000		$ 265,000
Expiration date description	the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year
Non-Qualified Stock Option Plans [Member]
Total Shares Reserved Under Plans						2,000,000
Grant performance-based stock options								250,000
Common stock price							$ 10.48		$ 10.48
Stock options vest							100%		100%
Series W Warrants [Member]
Warrants exercised					688,930
Exercise Price					$ 16.75

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details) - USD ($)	9 Months Ended	12 Months Ended
	Jun. 30, 2022	Sep. 30, 2021
FAIR VALUE MEASUREMENTS
Beginning Balance	$ 437,380	$ 3,765,613
Issuances	0	0
Exercises	(70,589)	(4,023,091)
Realized And Unrealized (gains) And Losses	(366,791)	694,858
Ending balance	$ 0	$ 437,380

FAIR VALUE MEASUREMENTS (Deta_2

FAIR VALUE MEASUREMENTS (Details Narrative) - $ / shares	9 Months Ended	12 Months Ended
	Jun. 30, 2022	Sep. 30, 2021
Fair Value Inputs Level 1 (Level 1)
Weighted Average Interest Rate	0.10%
Fair Value, Inputs, Level 3 [Member]
Weighted Average Risk Free Interest Rate		0.05%
Weighted Average Fair Value, Derivative Instruments		$ 1.45
Weighted Average Exercise Price, Derivative Instruments		$ 13.28
Volatility Rate		109%
Weighted Average Time To Maturity Year		3 months 18 days

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Officer [Member]
Options Issued			250,000
De Clara Trust [Member]
Deemed Dividend After Net Loss To Arrive At Net Loss Available Common Shareholders	$ 264,000	$ 265,000	$ 264,000	$ 351,000
Interest expense	$ 457,000	$ 24,000	$ 457,000	$ 24,000

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Jun. 30, 2022 USD ($)
Commitments and contingencies
Three months ending September 30, 2022	$ 625,000
2023	2,576,000
2024	2,655,000
2025	2,741,000
2026	2,832,000
2027	2,923,000
Thereafter	3,267,000
Total Future Minimum Lease Obligation	17,619,000
Less: Imputed Interest On Financing Lease Obligation	(3,985,000)
Net Present Value Of Finance Lease Obligations	$ 13,634,000

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Jun. 30, 2022 USD ($)
Commitments and contingencies
Three months ending September 30, 2022	$ 86,000
2023	348,000
2024	357,000
2025	366,000
2026	287,000
2027	277,000
Thereafter	1,325,000
Total Future Minimum Lease Obligation	3,046,000
Less Imputed Interest On Operating Lease Obligation	(986,000)
Net Present Value Of Operating Lease Obligation	$ 2,060,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Sep. 30, 2021	Mar. 31, 2021
Weighted Average Discount Rate Operating Lease	9.09%		9.09%
Additional Deposit Amount					$ 1,900,000	$ 200,000
Increase In Right Of Use Asset And Liability			$ 1,100,000
Operating Lease Liabilities	$ 2,100,000		2,100,000
Research And Development Expenses			35,500,000
Operating Lease Right Of Use Assets	1,900,000		1,900,000		2,100,000
Current Balance	200,000		200,000		100,000
Net Of Discount			11,800,000
Operating Lease Expense	$ 91,000	$ 66,000	272,000	$ 198,000
Operating Lease Payment			$ 199,000	176,000
Weighted Average Time To Maturity			9 years
Landlord [Member]
Interest Rate	8.45%		8.45%
Lease Description			The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year
Financing Arrangement			$ 11,100,000
Payments Made By Landlord			$ 2,400,000
October 1, 2019 [Member] | Transaction One [Member]
Weighted Average Time To Maturity			6 years 3 months 18 days
Weighted Average Discount Rate	8.45%		8.45%
Net Book Value Of The Finance Lease Right Of Use Asset	$ 11,400,000		$ 11,400,000		12,700,000
Balance Of The Finance Lease Liability	13,600,000		13,600,000		$ 13,800,000
Cash Paid Related To Finance Leases			1,900,000	1,600,000
Cash Paid Related To Finance Leases Interest			900,000
Ergomed [Member]
Research And Development Expenses	$ 100,000	$ 400,000	500,000	$ 1,400,000
Clinical Service Trial			$ 12,000,000

PATENTS (Details)

PATENTS (Details)	Jun. 30, 2022 USD ($)
PATENTS
Three months ending September 30, 2022	$ 10,000
2023	38,000
2024	30,000
2025	28,000
2026	24,000
2027	21,000
Thereafter	71,000
Total	$ 222,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
PATENTS
Patent Impairment Charges	$ 0	$ 0	$ 31,000	$ 0
Amortization Of Patent Costs	$ 12,000	$ 13,000	$ 39,000	$ 39,000

LOSS PER COMMON SHARE (Details)

LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
LOSS PER COMMON SHARE
Net loss available to common shareholders - basic	$ (9,926,993)	$ (9,203,350)	$ (28,533,091)	$ (28,507,113)
Weighted average shares outstanding - basic	43,174,775	41,020,485	43,124,972	39,907,624
Basic loss per common share	$ (0.23)	$ (0.22)	$ (0.66)	$ (0.71)
Loss per share- diluted
Net loss available to common shareholders -basic	$ (9,926,993)	$ (9,203,350)	$ (28,533,091)	$ (28,507,113)
Unrealized gain on derivatives	0	(1,233,597)	0	(1,236,514)
Net loss available to common shareholders - diluted	$ (9,926,993)	$ (10,436,947)	$ (28,533,091)	$ (29,743,627)
Weighted average shares outstanding - basic	43,174,775	41,020,485	43,124,972	39,907,624
Incremental shares underlying dilutive "in the money" warrants	0	210,597	0	250,697
Weighted average shares outstanding - diluted	43,174,775	41,231,082	43,124,972	40,158,321
Diluted loss per common share	$ (0.23)	$ (0.25)	$ (0.66)	$ (0.74)

LOSS PER COMMON SHARE (Details

LOSS PER COMMON SHARE (Details 1) - shares	9 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Antidilutive Securities	14,446,751	7,145,670
Options and Warrants
Antidilutive Securities	14,295,501	6,979,170
Unvested Restricted Stock [Member]
Antidilutive Securities	151,250	166,500