CEL-SCI (CVM) 10-Q 14 Feb 24 2024 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Dec. 31, 2023	Feb. 07, 2024
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	Dec. 31, 2023
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2024
Entity Common Stock Shares Outstanding		50,104,231
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 ($)	Dec. 31, 2023	Sep. 30, 2023
Current assets:
Cash and cash equivalents	$ 3,241,440	$ 4,145,735
Prepaid expenses	549,835	520,368
Supplies used for R&D and manufacturing	2,347,049	2,248,072
Deposits	16,129	4,245
Total current assets	6,154,453	6,918,420
Finance lease right of use assets	8,680,732	9,131,987
Operating lease right of use assets	1,649,020	1,698,243
Property and equipment, net	9,644,158	10,188,126
Patent costs, net	188,294	197,704
Deposits	2,319,101	2,319,101
Supplies used for R&D and manufacturing	74,457	74,669
Total assets	28,710,215	30,528,250
Current liabilities:
Accounts payable	1,144,425	2,009,786
Accrued expenses	985,657	1,049,581
Due to employees	705,698	557,244
Finance lease obligation, current portion	1,827,363	1,771,804
Operating lease obligation, current portion	204,167	197,431
Total current liabilities	4,867,310	5,585,846
Finance lease obligations, net of current portion	9,468,149	9,949,565
Operating lease obligations, net of current portion	1,599,496	1,652,949
Other liabilities	125,000	125,000
Total liabilities	16,059,955	17,313,360
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; 50,018,601 and 47,422,304 shares issued and outstanding at December 31, 2023 and September 30, 2023, respectively	500,186	474,223
Additional paid-in capital	505,950,994	499,832,063
Accumulated deficit	(493,800,920)	(487,091,396)
Total stockholders' equity	12,650,260	13,214,890
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 28,710,215	$ 30,528,250

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2023	Sep. 30, 2023
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	50,018,601	47,422,304
Common stock, shares outstanding	50,018,601	47,422,304

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Operating expenses:
Research and development	$ 4,352,509	$ 5,392,546
General and administrative	2,133,378	2,258,003
Total operating expenses	6,485,887	7,650,549
Operating loss	(6,485,887)	(7,650,549)
Interest expense, net	(197,696)	(152,789)
Other expense	(25,941)	(50,171)
Net loss	(6,709,524)	(7,853,509)
Modification of warrants	0	(171,552)
Net loss available to common shareholders	$ (6,709,524)	$ (8,025,061)
Net loss per common share - basic and diluted	$ (0.14)	$ (0.18)
Weighted average common shares outstanding - basic and diluted	48,470,600	43,440,387

STATEMENTS OF STOCKHOLDERS EQUI

STATEMENTS OF STOCKHOLDERS EQUITY (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Retained Earnings (Accumulated Deficit)
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
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 issued to nonemployees for service, shares		40,236
Stock issued to nonemployees for service, Amount	91,623	$ 402	91,221	0
2014 incentive stock forfeited, Shares		(2,000)
2014 incentive stock forfeited, Amount	(11,100)	$ (20)	(11,080)	0
Equity based compensation - employees	1,703,931	0	1,703,931	0
Net Income (Loss)	(7,853,509)	$ 0	0	(7,853,509)
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, 2023		47,422,304
Balance, amount at Sep. 30, 2023	13,214,890	$ 474,223	499,832,063	(487,091,396)
401(k) contributions paid in common stock, Shares		17,724
401(k) contributions paid in common stock, Amount	48,907	$ 177	48,730	0
Stock issued to nonemployees for service, shares		88,573
Stock issued to nonemployees for service, Amount	202,307	$ 886	201,421	0
Equity based compensation - employees	1,383,909	0	1,383,909	0
Net Income (Loss)	(6,709,524)	$ 0	0	(6,709,524)
Proceeds from the sale of common stock, Shares		2,490,000
Proceeds from the sale of common stock, Amount	4,980,000	$ 24,900	4,955,100	0
Share issuance costs	(470,229)	$ 0	(470,229)	0
Balance, shares at Dec. 31, 2023		50,018,601
Balance, amount at Dec. 31, 2023	$ 12,650,260	$ 500,186	$ 505,950,994	$ (493,800,920)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	3 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (6,709,524)	$ (7,853,509)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1,004,633	988,543
Non-cash lease expense	2,504	5,078
Share-based payments for services	218,386	148,858
Equity-based compensation	1,383,909	1,692,831
Common stock contributed to 401(k) plan	48,907	50,178
(Increase)/decrease in assets:
Prepaid expenses	(100,546)	111,537
Supplies used for R&D and manufacturing	(98,765)	212,687
Deposits	(11,884)	0
Increase/(decrease) in liabilities:
Accounts payable	(765,078)	(115,285)
Accrued expenses	(8,924)	13,346
Due to employees	148,454	79,087
Net cash used in operating activities	(4,887,928)	(4,666,649)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(51,650)	(53,580)
Expenditures for patent costs	(13,211)	0
Net cash used in investing activities	(64,861)	(53,580)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	4,980,000	0
Payments of stock issuance costs	(504,913)	(9,010)
Proceeds from the exercise of warrants	0	447,291
Payments on obligations under finance leases	(426,593)	(372,871)
Net cash provided by financing activities	4,048,494	65,410
NET DECREASE IN CASH AND CASH EQUIVALENTS	(904,295)	(4,654,819)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	4,145,735	22,672,138
CASH AND CASH EQUIVALENTS, END OF PERIOD	3,241,440	18,017,319
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment purchases included in current liabilities	0	105,318
Finance lease obligation included in accounts payable	714	1,853
Prepaid consulting services paid with issuance of common stock	202,307	91,623
Financing costs included in current liabilities	43,019	0
Cash paid for interest	$ 244,659	$ 277,853

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 Months Ended
	Dec. 31, 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, 2023. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments (all of which are of a normal recurring nature) and disclosures necessary for a fair presentation of the Company’s financial position as of December 31, 2023 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2023 is derived from the September 30, 2023 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 Property and Equipment Supplies used for R&D and manufacturing – Patents Leases – Share-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, share-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 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 Earnings Per Share Income Taxes Income Taxes Impairment of long-lived assets Use of Estimates Recently Adopted Accounting Standards In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). New Accounting Pronouncements

LIQUIDITY

LIQUIDITY	3 Months Ended
	Dec. 31, 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 conducting 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, the Company’s lead investigational therapy, 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 any regulatory agency 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	3 Months Ended
	Dec. 31, 2023
STOCKHOLDERS EQUITY
STOCKHOLDERS' EQUITY	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock In November 2023, the Company sold 2,490,000 shares of common stock at a public offering price of $2.00 per share and received aggregate gross proceeds of approximately $5.0 million. Equity Compensation Underlying share information for equity compensation plans as of December 31, 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 Three Months Ended December 31, 2023 2022 Options granted - 2,500 Options exercised - - Options forfeited 11,000 96,832 Options expired - 45,400 Share-Based Compensation Expense Three Months Ended December 31, 2023 2022 Employees $ 1,383,909 $ 1,692,831 Non-employees $ 218,386 $ 148,858 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 December 31, 2023: Warrant/ Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date 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 – 9/2/2023 110,000 $ 1.39 - $2.18 7/27/2027 - 9/1/2028 1. Equity Warrants Changes in Equity Warrants No warrants recorded as equity were exercised during the three months ended December 31, 2023. The following warrants recorded as equity were exercised during the three months ended December 31, 2022. Warrants Warrants Exercised Exercise Price Proceeds Series RR 17,752 $ 1.65 $ 29,291 Series SS 200,000 $ 2.09 418,000 217,752 $ 447,291 No warrants recorded as equity expired or were extended during the three months ended December 31, 2023. 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 in the financial statements for the three months ended December 31, 2022. 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. 2. Options and Shares Issued to Consultants During the three months ended December 31, 2023 and 2022, the Company issued 88,573 and 40,236 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $1.56 and $2.53 during the three months ended December 31, 2023 and 2022, respectively. No options were issued to a consultant during the three months ended December 31, 2023. During the three months ended December 31, 2022, 5,000 options with an exercise price of $11.61 issued to a consultant expired. During the three months ended December 31, 2023 and 2022, the Company recorded total expense of approximately $218,000 and $149,000, respectively, relating to the share-based compensation under various consulting agreements. On December 31, 2023 and September 30, 2023, consulting fees of approximately $134,000 and $205,000, respectively, are included in current assets as prepaid expenses and will be amortized over the remaining service periods.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	3 Months Ended
	Dec. 31, 2023
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS	D. RELATED PARTY TRANSACTIONS During the three months ended December 31, 2023, no restricted shares of the Company’s common stock were purchased by related parties. On October 28, 2022, the expiration date of the Series RR warrants was extended two years from October 30, 2022 to October 30, 2024 (Note C). 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.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	3 Months Ended
	Dec. 31, 2023
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	E. 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 any regulatory agency. 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. The San Tomas lease is classified as a finance lease on the Company’s balance sheet, 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 three months ended December 31, 2023 and 2022 was approximately $0.7 million, of which approximately $0.2 and $0.3 million was for interest, respectively. As of December 31, 2023, the weighted average discount rate of the Company’s finance leases is 8.44% and the weighted average time to maturity is 4.83 years. 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 December 31, 2023 are as follows: Nine months ending September 30, 2024 $ 1,995,000 Year ending September 30, 2025 2,741,000 2026 2,832,000 2027 2,923,000 2028 3,015,000 2029 252,000 Thereafter - Total future minimum lease obligation 13,758,000 Less imputed interest on finance lease obligations (2,463,000 ) Net present value of financing lease obligations 11,295,000 Less net present value of financing lease obligations – current portion (1,827,000 ) Net present value of financing lease obligations - non-current portion $ 9,468,000 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. 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. The Company incurred lease expense for operating leases of approximately $0.1 for both the three months ended December 31, 2023 and 2022. Total cash paid related to operating leases during the three months ended December 31, 2023 and 2022 was approximately $0.1 million for each quarter. The weighted average discount rate of the Company’s operating leases is 10.19% and the weighted average time to maturity is 7.74 years. As of December 31, 2023, future minimum lease payments on operating leases are as follows: Nine months ending September 30, 2024 $ 268,000 Year ending September 30, 2025 366,000 2026 287,000 2027 277,000 2028 285,000 2029 294,000 Thereafter 746,000 Total future minimum lease obligation 2,523,000 Less imputed interest on operating lease obligation (720,000 ) Net present value of operating lease obligations 1,803,000 Less net present value of operating lease obligations - current portion (204,000 ) Net present value of operating lease obligations - non-current portion $ 1,599,000

PATENTS

PATENTS	3 Months Ended
	Dec. 31, 2023
PATENTS
PATENTS	G. PATENTS During the three months ended December 31, 2023 and 2022, there was no impairment of patent costs. The weighted average amortization period for patents is approximately 8 years. Amortization expense for the three months ended December 31, 2023 and 2022 totaled approximately $9,000 and $10,000, respectively. The total estimated future amortization is as follows: Nine months ending September 30, 2024 $ 23,000 Year ending September 30, 2025 29,000 2026 25,000 2027 22,000 2028 19,000 2029 16,000 Thereafter 54,000 Total $ 188,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	3 Months Ended
	Dec. 31, 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 stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants and unveseted restricted stock are not included in the computation of diluted net loss per share if their effect would be anti-dilutive. The following table provides a reconciliation of the numerators and denominators of the basic and diluted loss per-share computations: Three months ended December 31, 2023 2022 Loss per share – basic and diluted Net loss available to common – basic and diluted $ (6,709,524 ) $ (8,025,061 ) Weighted average shares outstanding – basic and diluted 48,470,600 43,440,387 Basic and diluted loss per common share $ (0.14 ) $ (0.18 ) In accordance with the contingently issuable shares guidance of ASC 260, Earnings Per Share 2023 2022 Options and Warrants 15,839,028 13,917,352 Unvested Restricted Stock 147,250 149,250 Total 15,986,278 14,066,602

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	3 Months Ended
	Dec. 31, 2023
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	J. SUBSEQUENT EVENTS On February 9, 2024, the Company sold 3,875,000 shares of common stock at a public offering price of $2.00 per share for gross proceeds of approximately $7.8 million.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	3 Months Ended
	Dec. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
Cash and Cash Equivalents	Cash and Cash Equivalents
Property and Equipment	Property and Equipment
Supplies used for R&D and manufacturing	Supplies used for R&D and manufacturing –
Patents	Patents
Leases	Leases –
Stock-Based Compensation	Share-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, share-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 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 Earnings Per Share
Income Taxes	Income Taxes Income Taxes
Use of Estimates	Use of Estimates
Impairment of long-lived assets	Impairment of long-lived assets
Recently Adopted Accounting Standards	Recently Adopted Accounting Standards In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”).
New Accounting Pronouncements	New Accounting Pronouncements

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	3 Months Ended
	Dec. 31, 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	Three Months Ended December 31, 2023 2022 Options granted - 2,500 Options exercised - - Options forfeited 11,000 96,832 Options expired - 45,400
Schedule of Stock-Based Compensation Expense	Three Months Ended December 31, 2023 2022 Employees $ 1,383,909 $ 1,692,831 Non-employees $ 218,386 $ 148,858
Schedule of warrants and non-employee options outstanding	Warrant/ Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date 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 – 9/2/2023 110,000 $ 1.39 - $2.18 7/27/2027 - 9/1/2028
Schedule of derivative liabilities	Warrants Warrants Exercised Exercise Price Proceeds Series RR 17,752 $ 1.65 $ 29,291 Series SS 200,000 $ 2.09 418,000 217,752 $ 447,291

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	3 Months Ended
	Dec. 31, 2023
COMMITMENTS AND CONTINGENCIES
Schedule of future minimum payments under finance leases	Nine months ending September 30, 2024 $ 1,995,000 Year ending September 30, 2025 2,741,000 2026 2,832,000 2027 2,923,000 2028 3,015,000 2029 252,000 Thereafter - Total future minimum lease obligation 13,758,000 Less imputed interest on finance lease obligations (2,463,000 ) Net present value of financing lease obligations 11,295,000 Less net present value of financing lease obligations – current portion (1,827,000 ) Net present value of financing lease obligations - non-current portion $ 9,468,000
Schedule of future minimum payments under operating leases	Nine months ending September 30, 2024 $ 268,000 Year ending September 30, 2025 366,000 2026 287,000 2027 277,000 2028 285,000 2029 294,000 Thereafter 746,000 Total future minimum lease obligation 2,523,000 Less imputed interest on operating lease obligation (720,000 ) Net present value of operating lease obligations 1,803,000 Less net present value of operating lease obligations - current portion (204,000 ) Net present value of operating lease obligations - non-current portion $ 1,599,000

PATENTS (Tables)

PATENTS (Tables)	3 Months Ended
	Dec. 31, 2023
PATENTS
Schedule of total estimated future amortization	Nine months ending September 30, 2024 $ 23,000 Year ending September 30, 2025 29,000 2026 25,000 2027 22,000 2028 19,000 2029 16,000 Thereafter 54,000 Total $ 188,000

LOSS PER COMMON SHARE (Tables)

LOSS PER COMMON SHARE (Tables)	3 Months Ended
	Dec. 31, 2023
LOSS PER COMMON SHARE
Schedule of reconciliation of the numerators and denominators of the basic and diluted per-share computations	Three months ended December 31, 2023 2022 Loss per share – basic and diluted Net loss available to common – basic and diluted $ (6,709,524 ) $ (8,025,061 ) Weighted average shares outstanding – basic and diluted 48,470,600 43,440,387 Basic and diluted loss per common share $ (0.14 ) $ (0.18 )
Schedule of anti-dilutive securities	2023 2022 Options and Warrants 15,839,028 13,917,352 Unvested Restricted Stock 147,250 149,250 Total 15,986,278 14,066,602

STOCKHOLDERS EQUITY (Details)

STOCKHOLDERS EQUITY (Details)	Dec. 31, 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
	Dec. 31, 2023	Dec. 31, 2022
STOCKHOLDERS EQUITY
Options Granted		2,500
Options Forfeited	11,000	96,832
Options Expired		45,400

STOCKHOLDERS EQUITY (Details 2)

STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
STOCKHOLDERS EQUITY
Employees Stock Based Compensation Expense	$ 1,383,909	$ 1,692,831
Non- Employees Stock Based Compensation Expense	$ 218,386	$ 148,858

STOCKHOLDERS EQUITY (Details 3)

STOCKHOLDERS EQUITY (Details 3)	3 Months Ended
	Dec. 31, 2023 $ / shares shares
Consultants Options [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	110,000
Exercise Price	$ 2.18
Consultants [Member] | Minimum [Member]
Issue Date	7/28/2017
Exercise Price	$ 1.39
Expiration Date	7/27/2027
Consultants [Member] | Maximum [Member]
Issue Date	9/2/2023
Expiration Date	9/1/2028
Series N [Member]
Issue Date	8/18/2008
Shares Issuable Upon Exercise Of Warrant/options | shares	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 | shares	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 | shares	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 | shares	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 | shares	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 | shares	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 | shares	234,009
Exercise Price	$ 1.65
Expiration Date	10/30/2024

STOCKHOLDERS EQUITY (Details 4)

STOCKHOLDERS EQUITY (Details 4)	3 Months Ended
	Dec. 31, 2023 USD ($) $ / shares shares
Equity Warrants Exercised | shares	217,752
Equity Warrants Exercise Price | $ / shares	$ 0
Proceeds from Equity Warrants Exercised | $	$ 447,291
Series RR [Member]
Equity Warrants Exercised | shares	17,752
Equity Warrants Exercise Price | $ / shares	$ 1.65
Proceeds from Equity Warrants Exercised | $	$ 29,291
Series SS [Member]
Equity Warrants Exercised | shares	200,000
Equity Warrants Exercise Price | $ / shares	$ 2.09
Proceeds from Equity Warrants Exercised | $	$ 418,000

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	1 Months Ended		3 Months Ended
	Nov. 30, 2023	Oct. 28, 2022	Dec. 31, 2023	Dec. 31, 2022	Sep. 30, 2023
Common stock shares issued	2,490,000		50,018,601		47,422,304
Public offering price	$ 2
Proceeds from the Sale of Common Stock	$ 5,000,000		$ 4,980,000	$ 0
Consulting Agreements [Member]
Consulting fees inclued prepaid expenses			134,000		$ 205,000
Total expense			$ 218,000	$ 149,000
Consultants [Member]
Exercise price				$ 11.61
Options issued				5,000
Restricted Stock [Member] | Consultants [Member]
Weighted average grant date fair value			$ 1.56	$ 2.53
Common stock issued for service, shares			88,573	40,236
Series RR [Member]
Incremental cost		$ 172,000

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative )	1 Months Ended
	Oct. 28, 2022 USD ($)
CEO, Geert Kersten [Member]
Incremental cost	$ 172,000

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2023 USD ($)
COMMITMENTS AND CONTINGENCIES
Three months ending September 30, 2024	$ 1,995,000
2025	2,741,000
2026	2,832,000
2027	2,923,000
2028	3,015,000
2029	252,000
Thereafter	0
Total future minimum lease obligation	13,758,000
Less imputed interest on finance lease obligations	(2,463,000)
Net present value of financing lease obligations	11,295,000
Less net present value of financing lease obligations - current portion	(1,827,000)
Net present value of financing lease obligations - non-current portion	$ 9,468,000

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Dec. 31, 2023 USD ($)
COMMITMENTS AND CONTINGENCIES
Three months ending September 30, 2024	$ 268,000
2025	366,000
2026	287,000
2027	277,000
2028	285,000
2029	294,000
Thereafter	746,000
Total Future Minimum Lease Obligation	2,523,000
Less Imputed Interest On Operating Lease Obligation	(720,000)
Net Present Value Of Operating Lease Obligation	1,803,000
Net present value of lease finance lease obligations - current portion	(204,000)
Net present value of lease finance lease obligations - non-current portion	$ 1,599,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)		3 Months Ended
	Jan. 11, 2023	Dec. 31, 2023	Dec. 31, 2022
Net Of Discount		$ 11,900,000
Total cash payment for financing lease		700,000	$ 700,000
Interest amount		$ 200,000	300,000
Weighted average time of maturity of financing lease		4 years 9 months 29 days
Lease expense for operating leases		$ 100,000	100,000
Total cash payment for oprating lease		$ 100,000	100,000
Weighted average discount rate of financing lease		8.44%
Weighted average time of maturity of operating leases		7 years 8 months 26 days
Research And Development Expenses		$ 35,800,000
Weighted Average Discount Rate Operating Lease		10.19%
Landlord [Member]
Financing arrangement deposit base rent amount	$ 2,300,000
Ergomed [Member]
Research And Development Expenses		$ 100,000	$ 100,000
Clinical Service Trial		$ 12,000,000

PATENTS (Details)

PATENTS (Details)	Dec. 31, 2023 USD ($)
PATENTS
Three months ending September 30, 2024	$ 23,000
2025	29,000
2026	25,000
2027	22,000
2028	19,000
2029	16,000
Thereafter	54,000
Total	$ 188,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	3 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
PATENTS
Patent Impairment Charges	$ 0	$ 0
Amortization expense	$ 9,000	$ 10,000
Weighted average amortization period for patents	8 years

LOSS PER COMMON SHARE (Details)

LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Loss per share- basic and diluted
Net loss available to common shareholders - basic and diluted	$ (6,709,524)	$ (8,025,061)
Weighted average shares outstanding - basic and diluted	48,470,600	43,440,387
Basic and diluted loss per common share	$ (0.14)	$ (0.18)

LOSS PER COMMON SHARE (Details

LOSS PER COMMON SHARE (Details 1) - shares	3 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Antidilutive Securities	15,986,278	14,066,602
Options and Warrants
Antidilutive Securities	15,839,028	13,917,352
Unvested Restricted Stock [Member]
Antidilutive Securities	147,250	149,250

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event $ / shares in Units, $ in Millions	Feb. 09, 2024 USD ($) $ / shares shares
Sale of common stock | shares	3,875,000
Public offering price per share | $ / shares	$ 2
Gross proceeds from sale of stock | $	$ 7.8