CEL-SCI (CVM) 10-Q 10 Aug 23 2023 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Jun. 30, 2023	Aug. 08, 2023
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, 2023
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2023
Entity Common Stock Shares Outstanding		47,260,097
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
City Area Code	703
Local Phone Number	506-9460
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSEAMER
Entity Interactive Data Current	Yes

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Jun. 30, 2023	Sep. 30, 2022
Current assets:
Cash and cash equivalents	$ 5,135,070	$ 22,672,138
Prepaid expenses	462,848	762,063
Supplies used for R&D and manufacturing	2,109,978	2,001,715
Deposits	23,850	0
Total current assets	7,731,746	25,435,916
Finance lease right of use assets	9,583,440	10,937,797
Operating lease right of use assets	1,746,355	1,884,464
Property and equipment, net	10,674,725	11,889,029
Patent costs, net	183,074	212,201
Deposits	2,319,101	0
Supplies used for R&D and manufacturing	80,527	164,299
Total assets	32,318,968	50,523,706
Current liabilities:
Accounts payable	1,742,651	1,618,290
Accrued expenses	1,141,292	842,492
Due to employees	499,661	471,488
Finance lease obligation, current portion	1,718,038	1,560,553
Operating lease obligation, current portion	190,831	170,928
Total current liabilities	5,292,473	4,663,751
Finance lease obligations, net of current portion	10,406,939	11,721,368
Operating lease obligations, net of current portion	1,705,157	1,850,380
Other liabilities	125,000	125,000
Total liabilities	17,529,569	18,360,499
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; 44,748,437 and 43,448,317 shares issued and outstanding at June 30, 2023 and September 30, 2022, respectively	447,484	434,484
Additional paid-in capital	493,802,607	486,625,816
Accumulated deficit	(479,460,692)	(454,897,093)
Total stockholders' equity	14,789,399	32,163,207
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 32,318,968	$ 50,523,706

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2023	Sep. 30, 2022
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	44,748,437	43,448,317
Common stock, shares outstanding	44,748,437	43,448,317

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating expenses:
Research and development	$ 5,727,789	$ 6,286,873	$ 17,203,823	$ 18,893,857
General and administrative	2,453,968	2,432,518	6,804,729	8,220,768
Total operating expenses	8,181,757	8,719,391	24,008,552	27,114,625
Operating loss	(8,181,757)	(8,719,391)	(24,008,552)	(27,114,625)
Gain on derivative instruments			0	366,791
Other non-operating losses			0	(30,793)
Interest expense, net	(181,670)	(913,193)	(493,522)	(1,460,055)
Other expense	(3,854)	0	(61,525)	0
Net loss	(8,367,281)	(9,632,584)	(24,563,599)	(28,238,682)
Modification of Warrants	0	(294,409)	(171,552)	(294,409)
Net loss available to common shareholders	$ (8,367,281)	$ (9,926,993)	$ (24,735,151)	$ (28,533,091)
Net loss per common share - basic and diluted	$ (0.19)	$ (0.23)	$ (0.57)	$ (0.66)
Weighted average common shares outstanding - basic and diluted	44,254,363	43,174,775	43,761,395	43,124,972

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
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
Equity based compensation - employees	3,262,296	$ 0	3,262,296	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)
Net loss	(28,238,682)
Modification of warrants	634,713
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
Equity based compensation - employees	3,392,706	$ 0	3,392,706	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)
Equity based compensation - employees	2,447,772	$ 0	2,447,772	0
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
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)
Balance, shares at Sep. 30, 2022		43,448,317
Balance, amount at Sep. 30, 2022	32,163,207	$ 434,484	486,625,816	(454,897,093)
Warrant exercises, shares		217,752
Warrant exercises, amount	447,291	$ 2,177	445,114	0
Equity based compensation - employees	1,703,931	$ 0	1,703,931	0
401(k) contributions paid in common stock, shares		21,331
401(k) contributions paid in common stock, amount	50,178	$ 213	49,965	0
Stock and options issued to nonemployees for service, shares		40,236
Stock and options issued to nonemployees for service, amount	91,623	$ 402	91,221	0
Net loss	(7,853,509)	$ 0	0	(7,853,509)
2014 Incentive Stock Forfeited, shares		(2,000)
2014 Incentive Stock Forfeited, amount	(11,100)	$ (20)	(11,080)	0
Balance, shares at Dec. 31, 2022		43,725,636
Balance, amount at Dec. 31, 2022	26,591,621	$ 437,256	488,904,967	(462,750,602)
Balance, shares at Sep. 30, 2022		43,448,317
Balance, amount at Sep. 30, 2022	32,163,207	$ 434,484	486,625,816	(454,897,093)
Net loss	(24,563,599)
Modification of warrants	0
Balance, shares at Jun. 30, 2023		44,748,437
Balance, amount at Jun. 30, 2023	14,789,399	$ 447,484	493,802,607	(479,460,692)
Balance, shares at Dec. 31, 2022		43,725,636
Balance, amount at Dec. 31, 2022	26,591,621	$ 437,256	488,904,967	(462,750,602)
Equity based compensation - employees	1,743,288	$ 0	1,743,288	0
401(k) contributions paid in common stock, shares		23,627
401(k) contributions paid in common stock, amount	54,865	$ 236	54,629	0
Stock and options issued to nonemployees for service, shares		38,562
Stock and options issued to nonemployees for service, amount	100,635	$ 386	100,249	0
Net loss	(8,342,809)	$ 0	0	(8,342,809)
Balance, shares at Mar. 31, 2023		43,787,825
Balance, amount at Mar. 31, 2023	20,147,600	$ 437,878	490,803,133	(471,093,411)
Equity based compensation - employees	1,551,319	$ 0	1,551,319	0
401(k) contributions paid in common stock, shares		12,855
401(k) contributions paid in common stock, amount	52,663	$ 129	52,534	0
Stock and options issued to nonemployees for service, shares		36,523
Stock and options issued to nonemployees for service, amount	135,669	$ 365	135,304	0
Share issuance costs	(111,368)	0	(111,368)	0
Net loss	(8,367,281)	$ 0	0	(8,367,281)
2014 Incentive Stock Forfeited, shares		(2,000)
2014 Incentive Stock Forfeited, amount	(11,100)	$ (20)	(11,080)	0
Proceeds from the sale of common stock, shares		913,234
Proceeds from the sale of common stock, amount	1,391,897	$ 9,132	1,382,765	0
Balance, shares at Jun. 30, 2023		44,748,437
Balance, amount at Jun. 30, 2023	$ 14,789,399	$ 447,484	$ 493,802,607	$ (479,460,692)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (24,563,599)	$ (28,238,682)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,959,681	2,845,978
Non-cash lease expense	12,788	49,390
Share-based payments for services	473,723	603,147
Equity-based compensation	4,976,338	9,102,774
Common stock contributed to 401(k) plan	157,706	167,280
Gain on short-term investments	0	(615)
Loss on patent impairment	0	30,793
Gain on derivative instruments	0	(366,791)
Modification of warrants	0	634,713
Loss on receivables	0	54,922
(Increase)/decrease in assets:
Prepaid expenses	208,419	147,192
Supplies used for R&D and manufacturing	(24,491)	(166,453)
Deposits	(2,342,951)	1,910,917
Increase/(decrease) in liabilities:
Accounts payable	66,616	(410,536)
Accrued expenses	243,800	78,729
Due to employees	28,173	230,012
Net cash used in operating activities	(17,803,797)	(13,327,230)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from maturity of US treasury bills	0	6,152,000
Purchases of property and equipment	(361,892)	(621,826)
Expenditures for patent costs	0	(22,741)
Net cash (used in) provided by investing activities	(361,892)	5,507,433
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	1,391,897	0
Payments of stock issuance costs	(53,196)	(50,515)
Proceeds from exercises of warrants	447,291	101,225
Proceeds from the exercises of stock options	0	29,835
Proceeds from landlord funding of lease improvements	0	786,454
Payments on obligations under finance leases	(1,157,371)	(1,033,677)
Net cash provided by (used in) financing activities	628,621	(166,678)
NET DECREASE IN CASH AND CASH EQUIVALENTS	(17,537,068)	(7,986,475)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	22,672,138	36,060,148
CASH AND CASH EQUIVALENTS, END OF PERIOD	5,135,070	28,073,673
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Changes to right of use assets and liabilities	0	16,268
Finance lease obligation included in accounts payable	927	1,800
Prepaid consulting services paid with issuance of common stock	327,927	221,242
Exercise of derivative liabilities	0	70,589
Assets purchased under finance leases	0	32,409
Financing costs included in current liabilities	58,172	28,560
Accrued consulting services to be paid with common stock	110,000	110,000
Cash paid for interest	$ 809,495	$ 872,023

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Jun. 30, 2023
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
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 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, 2022. 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, 2023 and the results of its operations for the nine months then ended. The condensed balance sheet as of September 30, 2022 is derived from the September 30, 2022 audited financial statements. 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: Cash and Cash Equivalents U.S. Treasury Bills – Property and Equipment Supplies used for R&D and manufacturing – 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 an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity 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 Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption 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 Plan 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 Earnings Per Share Income Taxes Income Taxes The Company adopted ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Use of Estimates New Accounting Pronouncements

LIQUIDITY

LIQUIDITY	9 Months Ended
	Jun. 30, 2023
LIQUIDITY
LIQUIDITY	B. 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. To finance the Company through marketing approval, the Company plans to raise additional capital in the form of 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 Multikine 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. 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	9 Months Ended
	Jun. 30, 2023
STOCKHOLDERS EQUITY
STOCKHOLDERS' EQUITY	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock In April 2023, the Company sold 794,117 shares of common stock at a public offering price of $1.70 per share and received aggregate proceeds of approximately $1.2 million. The Company granted the underwriters a 30-day option to purchase up to 119,117 additional shares of common stock to cover over-allotments. The underwriter fully exercised this option in May 2023, resulting in additional aggregate proceeds to the Company of approximately $190,000. Equity Compensation Underlying share information for equity compensation plans as of June 30, 2023 is as follows: Name of Plan Total Shares Reserved Under Plans Incentive Stock Option Plans 138,400 Non-Qualified Stock Option Plans 15,787,200 Stock Bonus Plans 1,283,760 Stock Compensation Plans 634,000 Incentive Stock Bonus Plan 640,000 Stock option activity Nine Months Ended June 30, 2023 2022 Options granted 6,500 1,975,250 Options exercised - 6,500 Options forfeited 179,832 20,166 Options expired 58,787 13,614 Three Months Ended June 30, 2023 2022 Options granted 2,000 1,722,750 Options exercised - - Options forfeited 57,500 - Options expired 13,383 13,614 On November 18, 2021, 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. 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 was recognized relating to these options as of June 30, 2023. Management will re-assess the probability of achieving the performance condition at each reporting date. Stock-Based Compensation Expense Nine Months Ended June 30, 2023 2022 Employees $ 4,976,338 $ 9,102,774 Non-employees $ 473,723 $ 603,147 Three months Ended June 30, 2023 2022 Employees $ 1,540,219 $ 2,447,772 Non-employees $ 188,001 $ 200,877 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 The following chart represents the warrants and non-employee options outstanding at June 30, 2023: 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 8/18/2024 * Series UU 6/11/2018 93,603 $ 2.80 6/30/2024 * Series X 1/13/2016 120,000 $ 9.25 7/13/2024 * Series Y 2/15/2016 26,000 $ 12.00 8/15/2024 * Series MM 6/22/2017 333,432 $ 1.86 6/22/2024 * Series NN 7/24/2017 200,087 $ 2.52 7/24/2024 * Series RR 10/30/2017 234,009 $ 1.65 10/30/2024 * Consultant Options 7/28/2017 10,000 $ 2.18 7/27/2027 * * No current period changes for these warrants 1. Derivative Liabilities The table below presents the gains on the warrant liabilities for the nine months ended June 30: 2023 2022 Series Z warrants $ - $ 64,787 Series AA warrants - 276,035 Series CC warrants - 24,372 Series HH warrants - 1,597 Net gain on warrant liabilities $ - $ 366,791 There were no gains or losses on warrant liabilities during the three months ended June 30, 2023 and 2022. 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 As of June 30, 2023, no warrant liabilities were outstanding. 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 Series CC warrants were exercised during the three months ended June 30, 2022. 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. 2. Equity Warrants Changes in Equity Warrants During the nine months ended June 30, 2023, 600 Series TT warrants, with an exercise price of $2.24, expired. No warrants expired during the three months ended June 30, 2023. During the nine months ended June 30, 2023, 17,752 Series RR warrants with an exercise price of $1.65 and 200,000 Series SS warrants with an exercise price of $2.09 were exercised for gross proceeds of $447,291. No Series RR or SS warrants were exercised during the three months ended June 30, 2023. 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. On October 28, 2022, the expiration date of the Series RR warrants was extended two years from October 30, 2022 to October 30, 2024. The incremental cost of this extension was approximately $172,000, which was recorded as a deemed dividend. The Series RR warrants are held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. 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 Series N, Series X and Series Y warrant extensions were recorded as a deemed dividend and totaled approximately $294,000 for the three and nine months ended June 30, 2022. The Series N and Series X warrants are held by the de Clara Trust. The incremental cost of the Series MM, Series NN and Series UU warrant extensions of approximately $635,000 was recorded as interest expense for the three and nine 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. 3. Options and Shares Issued to Consultants During the nine months ended June 30, 2023 and 2022, the Company issued 115,321 and 81,782 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $2.45 and $5.40 during the nine months ended June 30, 2023 and 2022, respectively. During the three months ended June 30, 2023 and 2022, the Company issued 36,523 and 38,287 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $2.41 and $3.52, respectively, during the three months ended June 30, 2023 and 2022, respectively. The aggregate values of the issuances of restricted common stock and common stock options are recorded as prepaid expenses and are charged to general and administrative expenses over the periods of service. During the nine months ended June 30, 2023, 5,000 options with an exercise price of $11.61 issued to a consultant expired. As of June 30, 2023, 10,000 options issued to consultants remained outstanding, all of which were issued from the Non-Qualified Stock Option plans. All 10,000 options are vested as of June 30, 2023. During the nine months ended June 30, 2023 and 2022, the Company recorded total expense of approximately $474,000 and $603,000, respectively, relating to the share-based compensation under these consulting agreements. During the three months ended June 30, 2023 and 2022, the Company recorded total expense of approximately $188,000 and $201,000, respectively, relating to the share-based compensation under these consulting agreements. On June 30, 2023 and September 30, 2022, consulting fees of approximately $204,000 and $295,000, respectively, are included in current assets as prepaid expenses and will be amortized over the remaining service periods.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	9 Months Ended
	Jun. 30, 2023
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 asset 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 following sets forth a reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3): Nine months ended June 30, 2023 Nine months ended June 30, 2022 Beginning balance $ - $ 437,380 Issuances - - Exercises - (70,589 ) Realized and unrealized (gains) and losses - (366,791 ) Ending balance $ - $ - The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models which include significant inputs such as the Company’s historical stock price, the volatility of the Company’s stock and U.S. Treasury Bill rates. At June 30, 2023 and September 30, 2022, the Company did not have any Level 3 derivative instruments.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
	Jun. 30, 2023
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS	E. RELATED PARTY TRANSACTIONS On October 28, 2022, the expiration dates of the Series RR warrants held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary were extended by two years. The incremental cost of these modifications was $171,552 and was recorded as a deemed dividend in the financial statements for the nine months ended June 30, 2023.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Jun. 30, 2023
Commitments and contingencies
COMMITMENTS AND CONTINGENCIES	F. COMMITMENTS AND CONTINGENCIES Clinical Research Agreement 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 Research and Development 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 reasonably certain. On June 30, 2023 and September 30, 2022, the net book value of the finance lease right of use asset is approximately $9.6 million and $10.9 million, respectively, and the balance of the finance lease liability is approximately $12.1 million and $13.3 million, respectively, of which approximately $1.7 million and $1.6 million, respectively, is current. 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, 2023 and 2022 was approximately $1.9 million for both periods, respectively, of which approximately $0.8 million was for interest in each nine-month period. As of June 30, 2023, the weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 5.34 years. In August 2020, the Company entered into 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 finished and the improvements were placed in service in October 2021. Total cost was $11.1 million, of which the landlord agreed to finance $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 a 8.45% implicit interest rate. The rate was determined using a synthetic credit rating analysis prepared by an outside valuation specialist. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability as it is realized. The entire $2.4 million was received from the landlord as of September 30, 2022. The leasehold improvements are recorded in property and equipment, were deemed to be placed in service in October 2021 and are being amortized over the remaining lease term. On January 11, 2023, the Company was required to deposit approximately $2.3 million to its landlord, equivalent to one year’s rent, for falling below the stipulated cash threshold in accordance with the San Tomas lease. The amount will be included as an asset on the balance sheet until the Company meets the minimum cash balance required and the deposit is returned. Approximate future minimum lease payments under finance leases as of June 30, 2023 are as follows: Three months ending September 30, 2023 $ 646,000 Year ending September 30, 2024 2,655,000 2025 2,741,000 2026 2,832,000 2027 2,923,000 2028 3,015,000 Thereafter 252,000 Total future minimum lease obligation 15,064,000 Less imputed interest on finance lease obligations (2,939,000 ) Net present value of finance lease obligations $ 12,125,000 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, 2023 and September 30, 2022, the net book value of the operating lease right of use assets is approximately $1.7 million and $1.9 million, respectively. As of June 30, 2023 and September 30, 2022, the balance of the operating lease liabilities is approximately $1.9 million and $2.0 million respectively, of which approximately $0.2 million, is current in each quarter. The Company incurred lease expense for operating leases of approximately $0.3 million for both the nine months ended June 30, 2023 and 2022, respectively. Total cash paid related to operating leases during the nine months ended June 30, 2023 and 2022 was approximately $0.3 and $0.2 million, respectively. The weighted average discount rate of the Company’s operating leases is 10.2% and the weighted average time to maturity is 7.94 years. As of June 30, 2023, future minimum lease payments on operating leases are as follows: Three months ending September 30, 2023 $ 88,000 Year ending September 30, 2024 357,000 2025 366,000 2026 287,000 2027 277,000 2028 285,000 Thereafter 1,040,000 Total future minimum lease obligation 2,700,000 Less imputed interest on operating lease obligation (804,000 ) Net present value of operating lease obligation $ 1,896,000

PATENTS

PATENTS	9 Months Ended
	Jun. 30, 2023
PATENTS
PATENTS	G. PATENTS During the nine months ended June 30, 2023 and 2022, the Company recorded approximately $0 and $31,000 in patent impairment charges. No patent impairment charges were recorded during the three months ended June 30, 2023 and 2022. For the nine months ended June 30, 2023 and 2022, amortization of patent costs totaled approximately $29,000 and $39,000, respectively. For the three months ended June 30, 2023 and 2022, amortization of patent costs totaled approximately $9,000 and $12,000, respectively. Approximate estimated future amortization expense is as follows: Three months ending September 30, 2023 $ 9,000 Year ending September 30, 2024 30,000 2025 28,000 2026 24,000 2027 21,000 2028 17,000 Thereafter 54,000 Total $ 183,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	9 Months Ended
	Jun. 30, 2023
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. 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, 2023 2022 2023 2022 Loss per share – basic and diluted Net loss available to common shareholders – basic and diluted $ (24,735,151 ) $ (28,533,091 ) $ (8,367,281 ) $ (9,926,993 ) Weighted average shares outstanding – basic and diluted 43,761,395 43,124,972 44,254,363 43,174,775 Basic and diluted loss per common share $ (0.57 ) $ (0.66 ) $ (0.19 ) $ (0.23 ) In accordance with the contingently issuable shares guidance of ASC 260, Earnings Per Share 2023 2022 Options and Warrants 13,824,365 14,295,501 Unvested Restricted Stock 147,250 151,250 Total 13,971,615 14,446,751

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Jun. 30, 2023
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	J. SUBSEQUENT EVENTS On July 17, 2023, the Company sold 2,500,000 shares of common stock at a public offering price of $2.00 per share for aggregate net proceeds of approximately $4.6 million.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Jun. 30, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
Cash and Cash Equivalents	Cash and Cash Equivalents
U S Treasury Bills	U.S. Treasury Bills –
Property and Equipment	Property and Equipment
Supplies used for R&D and manufacturing	Supplies used for R&D and manufacturing –
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 an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity
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 Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption 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 Plan 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 Earnings Per Share
Income Taxes	Income Taxes Income Taxes The Company adopted ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
Use of Estimates	Use of Estimates
New Accounting Pronouncements	New Accounting Pronouncements

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	9 Months Ended
	Jun. 30, 2023
STOCKHOLDERS EQUITY
Schedule of equity compensation plans	Name of Plan Total Shares Reserved Under Plans Incentive Stock Option Plans 138,400 Non-Qualified Stock Option Plans 15,787,200 Stock Bonus Plans 1,283,760 Stock Compensation Plans 634,000 Incentive Stock Bonus Plan 640,000
Schedule of Stock option activity	Nine Months Ended June 30, 2023 2022 Options granted 6,500 1,975,250 Options exercised - 6,500 Options forfeited 179,832 20,166 Options expired 58,787 13,614 Three Months Ended June 30, 2023 2022 Options granted 2,000 1,722,750 Options exercised - - Options forfeited 57,500 - Options expired 13,383 13,614
Schedule of Stock-Based Compensation Expense	Nine Months Ended June 30, 2023 2022 Employees $ 4,976,338 $ 9,102,774 Non-employees $ 473,723 $ 603,147 Three months Ended June 30, 2023 2022 Employees $ 1,540,219 $ 2,447,772 Non-employees $ 188,001 $ 200,877
Schedule of warrants and non-employee options outstanding	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 8/18/2024 * Series UU 6/11/2018 93,603 $ 2.80 6/30/2024 * Series X 1/13/2016 120,000 $ 9.25 7/13/2024 * Series Y 2/15/2016 26,000 $ 12.00 8/15/2024 * Series MM 6/22/2017 333,432 $ 1.86 6/22/2024 * Series NN 7/24/2017 200,087 $ 2.52 7/24/2024 * Series RR 10/30/2017 234,009 $ 1.65 10/30/2024 * Consultant Options 7/28/2017 10,000 $ 2.18 7/27/2027 *
Schedule of derivative liabilities	2023 2022 Series Z warrants $ - $ 64,787 Series AA warrants - 276,035 Series CC warrants - 24,372 Series HH warrants - 1,597 Net gain on warrant liabilities $ - $ 366,791

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	9 Months Ended
	Jun. 30, 2023
FAIR VALUE MEASUREMENTS
Reconciliation of fair value measurements using significant unobservable inputs (Level 3)	Nine months ended June 30, 2023 Nine months ended June 30, 2022 Beginning balance $ - $ 437,380 Issuances - - Exercises - (70,589 ) Realized and unrealized (gains) and losses - (366,791 ) Ending balance $ - $ -

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Jun. 30, 2023
Commitments and contingencies
Schedule of future minimum payments under finance leases	Three months ending September 30, 2023 $ 646,000 Year ending September 30, 2024 2,655,000 2025 2,741,000 2026 2,832,000 2027 2,923,000 2028 3,015,000 Thereafter 252,000 Total future minimum lease obligation 15,064,000 Less imputed interest on finance lease obligations (2,939,000 ) Net present value of finance lease obligations $ 12,125,000
Schedule of future minimum payments under operating leases	Three months ending September 30, 2023 $ 88,000 Year ending September 30, 2024 357,000 2025 366,000 2026 287,000 2027 277,000 2028 285,000 Thereafter 1,040,000 Total future minimum lease obligation 2,700,000 Less imputed interest on operating lease obligation (804,000 ) Net present value of operating lease obligation $ 1,896,000

PATENTS (Tables)

PATENTS (Tables)	9 Months Ended
	Jun. 30, 2023
PATENTS
Schedule of total estimated future amortization	Three months ending September 30, 2023 $ 9,000 Year ending September 30, 2024 30,000 2025 28,000 2026 24,000 2027 21,000 2028 17,000 Thereafter 54,000 Total $ 183,000

LOSS PER COMMON SHARE (Tables)

LOSS PER COMMON SHARE (Tables)	9 Months Ended
	Jun. 30, 2023
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, 2023 2022 2023 2022 Loss per share – basic and diluted Net loss available to common shareholders – basic and diluted $ (24,735,151 ) $ (28,533,091 ) $ (8,367,281 ) $ (9,926,993 ) Weighted average shares outstanding – basic and diluted 43,761,395 43,124,972 44,254,363 43,174,775 Basic and diluted loss per common share $ (0.57 ) $ (0.66 ) $ (0.19 ) $ (0.23 )
Schedule of anti-dilutive securities	2023 2022 Options and Warrants 13,824,365 14,295,501 Unvested Restricted Stock 147,250 151,250 Total 13,971,615 14,446,751

STOCKHOLDERS EQUITY (Details)

STOCKHOLDERS EQUITY (Details)	Jun. 30, 2023 shares
Remaining Options/shares Under Plans	138,400
Non-Qualified Stock Option Plans [Member]
Remaining Options/shares Under Plans	15,787,200
Stock Bonus Plans [Member]
Remaining Options/shares Under Plans	1,283,760
Stock Compensation Plan [Member]
Remaining Options/shares Under Plans	634,000
Incentive Stock Bonus Plan [Member]
Remaining Options/shares Under Plans	640,000

STOCKHOLDERS EQUITY (Details 1)

STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
STOCKHOLDERS EQUITY
Options Granted	2,000	1,722,750	6,500	1,975,250
Options Exercised				6,500
Options Forfeited	57,500		179,832	20,166
Options Expired	13,383	13,614	58,787	13,614

STOCKHOLDERS EQUITY (Details 2)

STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
STOCKHOLDERS EQUITY
Employees Stock Based Compensation Expense	$ 1,540,219	$ 2,447,772	$ 4,976,338	$ 9,102,774
Non- Employees Stock Based Compensation Expense	$ 188,001	$ 200,877	$ 473,723	$ 603,147

STOCKHOLDERS EQUITY (Details 3)

STOCKHOLDERS EQUITY (Details 3) - $ / shares	9 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Consultants Options [Member]
Issue Date	7/28/2017
Shares Issuable Upon Exercise Of Warrant/options		10,000
Exercise Price		$ 2.18
Expiration Date	7/27/2027
Series N [Member]
Issue Date	8/18/2008
Shares Issuable Upon Exercise Of Warrant/options		85,339
Exercise Price		$ 3
Expiration Date	8/18/2024
Series UU [Member]
Issue Date	6/11/2018
Shares Issuable Upon Exercise Of Warrant/options		93,603
Exercise Price		$ 2.80
Expiration Date	6/30/2024
Series X [Member]
Issue Date	1/13/2016
Shares Issuable Upon Exercise Of Warrant/options		120,000
Exercise Price		$ 9.25
Expiration Date	7/13/2024
Series Y [Member]
Issue Date	2/15/2016
Shares Issuable Upon Exercise Of Warrant/options		26,000
Exercise Price		$ 12
Expiration Date	8/15/2024
Series MM [Member]
Issue Date	6/22/2017
Shares Issuable Upon Exercise Of Warrant/options		333,432
Exercise Price		$ 1.86
Expiration Date	6/22/2024
Series NN [Member]
Issue Date	7/24/2017
Shares Issuable Upon Exercise Of Warrant/options		200,087
Exercise Price		$ 2.52
Expiration Date	7/24/2024
Series RR [Member]
Issue Date	10/30/2017
Shares Issuable Upon Exercise Of Warrant/options		234,009
Exercise Price		$ 1.65
Expiration Date	10/30/2024

STOCKHOLDERS EQUITY (Details 4)

STOCKHOLDERS EQUITY (Details 4) - USD ($)	9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
STOCKHOLDERS EQUITY
Series Z Warrants	$ 0	$ 64,787
Series AA Warrants	0	276,035
Series CC Warrants	0	24,372
Series HH Warrants	0	1,597
Net Gain On Warrant Liabilities	$ 0	$ 366,791

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	1 Months Ended							3 Months Ended		9 Months Ended
	May 31, 2023	Apr. 30, 2023	Oct. 28, 2022	Feb. 28, 2022	Dec. 31, 2021	Nov. 30, 2021	Nov. 18, 2021	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Sep. 30, 2022
Incremental cost									$ 294,000		$ 294,000
Common stock shares issued		794,117						44,748,437		44,748,437		43,448,317
Public offering price		$ 1.70
Proceeds from the Sale of Common Stock		$ 1,200,000								$ 1,391,897	0
Additional common stock shares issued to underwriters	119,117
Proceeds from additional shares of common stock	$ 190,000
Consulting Agreements [Member]
Total expense								$ 188,000	$ 201,000	474,000	$ 603,000
Consulting fees inclued prepaid expenses								$ 204,000		$ 204,000		$ 295,000
Consultants [Member]
Exercise price										$ 11.61
Options issued										5,000
Restricted Stock [Member] | Consultants [Member]
Weighted average grant date fair value								$ 2.41	$ 3.52	$ 2.45	$ 5.40
Common stock issued for service, shares								36,523	38,287	115,321	81,782
Series AA [Member]
Warrants exercised				100,000
Exercise price per share				$ 13.75
Series NN [Member]
Warrants exercised											10,000
Proceeds from warrants exercised											$ 25,200
Exercise Price											$ 2.52
Interest expense									$ 635,000		$ 635,000
Series RR [Member]
Incremental cost			$ 172,000
Warrants exercised										17,752
Exercise Price										$ 1.65
Series TT [Member]
Warrants exercised										600
Exercise Price										$ 2.24
Series CC [Member]
Warrants exercised					640						15,205
Proceeds from warrants exercised											$ 76,025
Exercise price per share					$ 5						$ 5
Series HH [Member]
Warrants exercised				200
Exercise price per share				$ 3.13
Series Z [Member]
Warrants exercised						184,800
Exercise Price						$ 13.75
Series SS [Member]
Warrants exercised										200,000
Proceeds from warrants exercised										$ 447,291
Exercise Price										$ 2.09
Non-Qualified Stock Option Plans [Member]
Grant performance-based stock options							250,000
Common stock price							$ 10.48
Percentage of vested Stock options							100%
Options vested								10,000		10,000
Options issued to consultants								10,000		10,000

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details) - USD ($)	9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
FAIR VALUE MEASUREMENTS
Beginning Balance	$ 0	$ 437,380
Issuances	0	0
Exercises	0	(70,589)
Realized And Unrealized (gains) And Losses	0	(366,791)
Ending Balance	$ 0	$ 0

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative )	1 Months Ended
	Oct. 28, 2022 USD ($)
CEO, Geert Kersten [Member]
Modifications cost	$ 171,552

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Jun. 30, 2023 USD ($)
Commitments and contingencies
Three months ending September 30, 2023	$ 646,000
2024	2,655,000
2025	2,741,000
2026	2,832,000
2027	2,923,000
2028	3,015,000
Thereafter	252,000
Total Future Minimum Lease Obligation	15,064,000
Less: Imputed Interest On Financing Lease Obligation	(2,939,000)
Net Present Value Of Finance Lease Obligations	$ 12,125,000

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Jun. 30, 2023 USD ($)
Commitments and contingencies
Three months ending September 30, 2023	$ 88,000
2024	357,000
2025	366,000
2026	287,000
2027	277,000
2028	285,000
Thereafter	1,040,000
Total Future Minimum Lease Obligation	2,700,000
Less Imputed Interest On Operating Lease Obligation	(804,000)
Net Present Value Of Operating Lease Obligation	$ 1,896,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Sep. 30, 2022
Net Of Discount			$ 11,800,000
Research And Development Expenses			35,700,000
Increase In Right Of Use Asset And Liability			1,100,000
Operating Lease Right Of Use Assets	$ 1,700,000		1,700,000		$ 1,900,000
Operating Lease Liabilities	$ 1,900,000		$ 1,900,000		2,000,000
Weighted Average Discount Rate Operating Lease	10.20%		10.20%
Current portion of the operating lease obligation	$ 200,000		$ 200,000
Operating Lease Expense			300,000	$ 300,000
Operating Lease Payment			$ 300,000	200,000
Weighted Average Time To Maturity			7 years 11 months 8 days
Landlord [Member]
Interest Rate	8.45%		8.45%
Financing arrangement deposit base rent amount			$ 2,300,000
Financing arrangement deposit base rent percentage 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
Transaction One [Member]
Weighted average maturity date of operating leases			5 years 4 months 2 days
Weighted Average Discount Rate	8.45%		8.45%
Net Book Value Of The Finance Lease Right Of Use Asset	$ 9,600,000		$ 9,600,000		10,900,000
Balance Of The Finance Lease Liability	12,100,000		12,100,000		$ 13,300,000
Cash Paid Related To Finance Leases			1,900,000	1,900,000
Cash Paid Related To Finance Leases Interest			800,000
Ergomed [Member]
Research And Development Expenses	$ 100,000	$ 100,000	100,000	$ 400,000
Clinical Service Trial			$ 12,000,000

PATENTS (Details)

PATENTS (Details)	Jun. 30, 2023 USD ($)
PATENTS
Three months ending September 30, 2023	$ 9,000
2024	30,000
2025	28,000
2026	24,000
2027	21,000
2028	17,000
Thereafter	54,000
Total	$ 183,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
PATENTS
Patent Impairment Charges			$ 0	$ 31,000
Amortization Of Patent Costs	$ 9,000	$ 12,000	$ 29,000	$ 39,000

LOSS PER COMMON SHARE (Details)

LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Loss per share- basic and diluted
Net loss available to common shareholders - basic and diluted	$ (8,367,281)	$ (9,926,993)	$ (24,735,151)	$ (28,533,091)
Weighted average shares outstanding - basic and diluted	44,254,363	43,174,775	43,761,395	43,124,972
Basic and diluted loss per common share	$ (0.19)	$ (0.23)	$ (0.57)	$ (0.66)

LOSS PER COMMON SHARE (Details

LOSS PER COMMON SHARE (Details 1) - shares	9 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Antidilutive Securities	13,971,615	14,446,751
Options and Warrants
Antidilutive Securities	13,824,365	14,295,501
Unvested Restricted Stock [Member]
Antidilutive Securities	147,250	151,250

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event $ / shares in Units, $ in Millions	1 Months Ended
	Jul. 17, 2023 USD ($) $ / shares shares
Common stock sold | shares	2,500,000
Public offering price | $ / shares	$ 2
Net proceed | $	$ 4.6