CEL-SCI (CVM) 10-K 13 Jan 25 2024 FY Annual report Financial data

Cover

Cover - USD ($)	12 Months Ended
	Sep. 30, 2024	Jan. 06, 2025	Mar. 31, 2024
Cover [Abstract]
Entity Registrant Name	CEL-SCI CORPORATION
Entity Central Index Key	0000725363
Document Type	10-K
Amendment Flag	false
Entity Voluntary Filers	No
Current Fiscal Year End Date	--09-30
Entity Well Known Seasoned Issuer	No
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Sep. 30, 2024
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2024
Entity Common Stock Shares Outstanding		74,107,041
Entity Public Float			$ 100,002,189
Document Annual Report	true
Document Transition Report	false
Document Fin Stmt Error Correction Flag	false
Entity File Number	1-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Address Address Line 1	8229 Boone Blvd.
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
Icfr Auditor Attestation Flag	false
Auditor Name	BDO USA, P.C.
Auditor Location	Potomac, Maryland
Local Phone Number	506-9460
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSE
Entity Interactive Data Current	Yes
Auditor Firm Id	243

BALANCE SHEETS

BALANCE SHEETS - USD ($)	Sep. 30, 2024	Sep. 30, 2023
Current assets:
Cash and cash equivalents	$ 4,738,173	$ 4,145,735
Prepaid expenses	294,097	520,368
Supplies used for R&D and manufacturing	1,019,908	2,248,072
Deposits	3,500	4,245
Total current assets	6,055,678	6,918,420
Finance lease right-of-use assets	7,350,364	9,131,987
Operating lease right-of-use assets	1,495,937	1,698,243
Property and equipment, net	8,129,753	10,188,126
Patent costs, net	165,492	197,704
Deposits	2,319,101	2,319,101
Supplies used for R&D and manufacturing	1,475,441	74,669
Total assets	26,991,766	30,528,250
Current Liabilities:
Accounts payable	1,448,467	2,009,786
Accrued expenses	566,042	1,049,581
Due to employees	363,306	557,244
Finance lease obligation, current portion	2,010,995	1,771,804
Operating lease obligation, current portion	226,969	197,431
Total current liabilities	4,615,779	5,585,846
Finance lease liabilities, net of current portion	7,957,925	9,949,565
Operating lease liabilities, net of current portion	1,425,979	1,652,949
Other liabilities	125,000	125,000
Total liabilities	14,124,683	17,313,360
STOCKHOLDERS' EQUITY
Preferred stock, $0.01 par value; 200,000 shares authorized; 0 shares issued and outstanding	0	0
Common stock, $0.01 par value; 600,000,000 shares authorized; 63,787,104 and 47,422,304 shares issued and outstanding at September 30, 2024 and 2023, respectively	637,870	474,223
Additional paid-in capital	526,241,074	499,832,063
Accumulated deficit	(514,011,861)	(487,091,396)
Total stockholders' equity	12,867,083	13,214,890
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 26,991,766	$ 30,528,250

BALANCE SHEETS (Parenthetical)

BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Sep. 30, 2023
BALANCE SHEETS
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	63,787,104	47,422,304
Common stock, shares outstanding	63,787,104	47,422,304
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

STATEMENTS OF OPERATIONS

STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Operating expenses:
Research and development	$ 18,161,451	$ 22,471,496
General & administrative	8,191,023	9,004,578
Total operating expenses	26,352,474	31,476,074
Operating loss	(26,352,474)	(31,476,074)
Interest expense, net	(745,673)	(675,416)
Other income (expense)	177,682	(42,813)
Net loss	(26,920,465)	(32,194,303)
Modification of warrants	(659,456)	(171,552)
Net loss available to common shareholders	$ (27,579,921)	$ (32,365,855)
Net loss per common share - basic and diluted	$ (0.51)	$ (0.73)
Weighted average common shares outstanding - basic and diluted	54,044,989	44,479,865

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Total	Common Stock	Additional Paid-In Capital	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		97,004
401(k) contributions paid in common stock, amount	207,593	$ 970	206,623	0
Stock issued to nonemployees for service, shares		249,997
Stock issued to nonemployees for service, amount	565,980	$ 2,500	563,480	0
Proceeds from the sale of common stock, shares		3,413,234
Proceeds from the sale of common stock, amount	6,122,497	$ 34,132	6,088,365
2014 Incentive Stock Forfeited, shares		4,000
2014 Incentive Stock Forfeited, amount	22,200	$ 40	22,160	0
Equity based compensation - employees	6,308,431	0	6,308,431	0
Share issuance costs	383,606	0	383,606	0
Net loss	(32,194,303)	$ 0	0	32,194,303
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		136,868
401(k) contributions paid in common stock, amount	218,717	$ 1,368	217,349	0
Stock issued to nonemployees for service, shares		409,932
Stock issued to nonemployees for service, amount	759,901	$ 4,099	755,802	0
Equity based compensation - employees	4,270,180	0	4,270,180	0
Share issuance costs	2,331,760	0	2,331,760	0
Net loss	(26,920,465)	$ 0	0	26,920,465
Proceeds from the sale of common stock and pre-funded warrants, shares		10,080,000
Proceeds from the sale of common stock and pre-funded warrants, amount	23,518,200	$ 100,800	23,417,400	0
Exercise of pre-funded warrants, shares		5,680,000
Exercise of pre-funded warrants, amount	56,800	$ 56,800	0	0
Purchase of stock by officers and directors, shares		58,000
Purchase of stock by officers and directors, amount	80,620	$ 580	80,040	0
Balance, shares at Sep. 30, 2024		63,787,104
Balance, amount at Sep. 30, 2024	$ 12,867,083	$ 637,870	$ 526,241,074	$ 514,011,861

STATEMENTS OF CASH FLOWS

STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (26,920,465)	$ (32,194,303)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	3,969,183	3,958,334
Non-cash lease expense	4,873	15,292
Share-based payments for services	858,498	655,740
Equity based compensation	4,270,180	6,286,231
Common stock contributed to 401(k) plan	218,717	207,593
(Increase)/decrease in assets:
Prepaid expenses	72,674	151,935
Supplies used for R&D and manufacturing	(172,608)	(156,727)
Deposits	745	(2,323,346)
Increase/(decrease) in liabilities:
Accounts payable	(460,576)	257,845
Accrued expenses	(458,489)	207,089
Due to employees	(193,938)	85,756
Net cash used in operating activities	(18,811,206)	(22,848,561)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(94,875)	(361,892)
Expenditures for patent costs	(13,211)	(10,370)
Net cash used in investing activities	(108,086)	(372,262)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and pre-funded warrants	23,575,000	6,552,497
Payments of stock issuance costs	(2,370,513)	(744,913)
Proceeds from the purchase of stock by officers and directors	80,620	0
Proceeds from the exercise of warrants	0	447,291
Payments on obligations under finance leases	(1,773,377)	(1,560,455)
Proceeds from related party loans	450,000	0
Payments of related party loans	(450,000)	0
Net cash provided by financing activities	19,511,730	4,694,420
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	592,438	(18,526,403)
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR	4,145,735	22,672,138
CASH AND CASH EQUIVALENTS, END OF YEAR	4,738,173	4,145,735
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment purchases included in current liabilities	32,954	51,650
Capitalized patent costs included in current liabilities	0	13,211
Assets purchased under finance leases	20,797	0
Finance lease obligation included in accounts payable	1,320	1,451
Consulting services paid with issuance of common stock	759,901	565,980
Financing costs included in current liabilities	38,950	77,703
Accrued consulting services to be paid with common stock	0	55,000
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS:
Cash paid for interest	$ 923,807	$ 1,062,564

ORGANIZATION

ORGANIZATION	12 Months Ended
	Sep. 30, 2024
ORGANIZATION
ORGANIZATION	1. ORGANIZATION CEL-SCI Corporation (the Company) was incorporated on March 22, 1983, in the state of Colorado, to finance research and development in biomedical science and ultimately to engage in marketing and selling products. The Company is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has announced results from its Phase III study for its lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), involving head and neck cancer, for which the Company has received Orphan Drug Status from the United States Food and Drug Administration (FDA). Unlike other immune therapies, Multikine is administered locally at the site of the tumor as a first line treatment right after diagnosis, before surgery and radiation. The goal is to help the intact immune system kill the micro metastases that usually cause recurrence of the cancer to improve outcomes and better overall survival rates for patients suffering from head and neck cancer. CEL-SCI is also investigating a peptide-based immunotherapy (CEL-4000) as a vaccine for rheumatoid arthritis using its LEAPS technology platform. CEL-SCI is in the process of completing pre-IND studies for CEL-4000.

LIQUIDITY

LIQUIDITY	12 Months Ended
	Sep. 30, 2024
LIQUIDITY
LIQUIDITY	2 . 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 III 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.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Sep. 30, 2024
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 . SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation Cash and Cash Equivalents Property and Equipment Supplies used for R&D and manufacturing Patents Leases Share-Based Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. 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 Concentration of Credit Risk 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”). ASU 2016-13 requires a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. The amendments in ASU 2016-13 replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information. ASU 2016-13 was effective for SEC filers, excluding smaller reporting companies, for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. As a smaller reporting company, the Company was permitted to adopt the new standard for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Effective October 1, 2023, the Company adopted ASU 2016-13 using a modified retrospective transition method. The adoption of ASU 2016-13 had no material impact on the Company’s financial position, results of operations, or cash flows. New Accounting Pronouncements In November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which expands disclosures about a public entity’s reportable segments and requires more enhanced information about a reportable segment’s expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit or loss information in assessing segment performance and allocating resources. The update will be effective for annual periods beginning after December 15, 2023 and interim periods beginning after December 15, 2024. The Company is currently evaluating the impact that this change will have on the Company’s disclosures. In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Improvements to Income Tax Disclosures, which require greater disaggregation of income tax disclosures related to the income tax rate reconciliation and income taxes paid. The update will be effective for annual periods beginning after December 15, 2024. The guidance should be applied on a prospective basis with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating the impact that this change will have on the Company's disclosures. In March 2024, the SEC issued its final climate disclosure rules, which require the disclosure of climate-related information in annual reports and registration statements. The rules require disclosure in the audited financial statements of certain effects of severe weather events and other natural conditions above certain financial thresholds, as well as amounts related to carbon offsets and renewable energy credits or certificates, if material. Under the rules as originally issued, disclosure requirements begin phasing in for fiscal years beginning on or after January 1, 2027. However, on April 4, 2024, the SEC determined to voluntarily stay the final rules pending certain legal challenges. We are currently evaluating the impact of the new rules and continue to monitor the status of the related legal challenges. In November 2024, the FASB issued Accounting Standards Update No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures: Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 will require more detailed information about the types of expenses in commonly presented income statement captions such as “Cost of sales” and “Selling, general and administrative expenses”. The new guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted. The Company is currently evaluating the impact that this change will have on the Company's disclosures.

WARRANTS AND NONEMPLOYEE OPTION

WARRANTS AND NONEMPLOYEE OPTIONS	12 Months Ended
	Sep. 30, 2024
WARRANTS AND NONEMPLOYEE OPTIONS
WARRANTS AND NON-EMPLOYEE OPTIONS	4. WARRANTS AND NON-EMPLOYEE OPTIONS The following warrants and non-employee options are outstanding at September 30, 2024: Warrant/ Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 8/18/2026 Series UU 6/11/2018 93,603 $ 2.80 6/30/2026 Series X 1/13/2016 120,000 $ 9.25 7/13/2026 Series Y 2/15/2016 26,000 $ 12.00 8/15/2026 Series MM 6/22/2017 333,432 $ 1.86 6/22/2026 Series NN 7/24/2017 200,087 $ 2.52 7/24/2026 Series RR 10/30/2017 234,009 $ 1.65 10/30/2026 Consultant Options 7/28/2017 – 9/2/2023 110,000 $1.39 - $2.18 7/27/2027 – 9/1/2028 The following warrants and non-employee options are outstanding at September 30, 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 A. Equity Warrants Changes in Equity Warrants During the fiscal year ended September 30, 2024, 5,680,000 pre-funded warrants were exercised. The following equity warrants were exercised during the year ended September 30, 2023: 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 during the fiscal year ended September 30, 2024. On February 5, 2023, 600 Series TT warrants, with an exercise price of $2.24, expired. On May 4, 2024, the Company modified the terms of Series UU, X, Y, N, MM, NN and RR warrants by extending the expiration dates by twenty-four (24) months from their current expiration dates. The incremental cost of this extension was approximately $659,455, which was recorded as a deemed dividend. The Series N, X, MM, NN, RR and UU warrants are held by current Officers of the Company. B. Options and Shares Issued to Consultants The Company typically enters into consulting arrangements in exchange for common stock or stock options. During the years ended September 30, 2024 and 2023, the Company issued 409,932 and 249,997 shares, respectively, of common stock to consultants, all of which were restricted shares. Under these arrangements, during the periods presented, the common stock was issued with stock prices ranging from $1.08 to $3.47 per share. The weighted average grant price was $1.69 and $1.83, respectively, for stock issued during the years ended September 30, 2024 and 2023. During the years ended September 30, 2024 and 2023, the Company recorded total expense of approximately $681,000 and $656,000, respectively, relating to these consulting agreements, which are included in general and administrative expense on the accompanying statements of operations. At September 30, 2024 and 2023, costs of approximately $52,000 and $205,000, respectively, are included in prepaid expenses. No options were issued to consultants during the year ended September 30, 2024. During the year ended September 30, 2023, the Company issued 100,000 options to a consultant to purchase common stock with an exercise price of $1.39. These options vest 50% on September 2, 2024 and 50% on September 2, 2025 and expire on September 1, 2028. As of September 30, 2024, 110,000 options issued to consultants as payment for services remained outstanding, all of which were issued from the Non-Qualified Stock Option Plan.

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT	12 Months Ended
	Sep. 30, 2024
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT	5 . PROPERTY AND EQUIPMENT Property and equipment consisted of the following at September 30: 2024 2023 Research equipment $ 4,167,828 $ 4,109,070 Furniture and equipment 104,593 99,296 Leasehold improvements 13,924,724 13,924,724 18,197,145 18,133,090 Less: Accumulated depreciation (10,067,392 ) (7,944,964 ) Property and equipment, net $ 8,129,753 $ 10,188,126 Depreciation expense for the years ended September 30, 2024 and 2023 totaled approximately $2,135,000 and $2,114,000, respectively, and is included in operating expenses on the accompanying statements of operations.

PATENTS

PATENTS	12 Months Ended
	Sep. 30, 2024
PATENTS
PATENTS	6 . PATENTS Patents consist of the following at September 30: 2024 2023 Patents $ 829,716 $ 853,445 Less: Accumulated amortization (664,224 ) (655,741 ) Patents, net $ 165,492 $ 197,704 During the years ended September 30, 2024 and 2023, there was no impairment of patent costs. The weighted average remaining amortization period for patents is approximately 8 years. For the years ended September 30, 2024 and 2023, amortization of patent costs totaled approximately $32,000 and $38,000, respectively, and is included in general and administrative expense on the accompanying statements of operations. The total estimated future amortization is as follows: Years ending September 30, 2025 $ 29,000 2026 25,000 2027 22,000 2028 19,000 2029 16,000 Thereafter 54,000 $ 165,000

INCOME TAXES

INCOME TAXES	12 Months Ended
	Sep. 30, 2024
INCOME TAXES
INCOME TAXES	7 . INCOME TAXES At September 30, 2024 and 2023, the Company had net deferred tax assets of $62.5 million and $60.0 million, respectively. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these assets, a full valuation allowance has been established to offset the net deferred tax assets. In assessing the realization of deferred tax assets, management considered whether it was more likely than not that some, or all, of the deferred tax assets will be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income. Management has considered the history of the Company’s operating losses and believes that the realization of the benefit of the deferred tax assets cannot be reasonably assured. Pursuant to Section 382 of the Internal Revenue Code, or IRC, annual use of the Company’s net operating loss (NOL) carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. Such ownership change could result in annual limitations on the utilization of tax attributes, including NOL carryforwards and tax credits. The Company performed an estimated analysis to determine if any additional ownership changes occurred during the year ended September 30, 2024 and no such changes were identified. If changes in ownership occur after year end, NOL and tax credit carryforwards could be eliminated or restricted. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. The Company had federal NOL carryforwards of approximately $146.4 million and $123.1 million at September 30, 2024 and 2023, respectively. Approximately $19.2 million of the NOL carryforwards begin to expire during the year ended September 30, 2024 and become fully expired by 2038 and approximately $127.2 million of NOL carryforwards, which were generated after the enactment of Tax Cuts and Jobs Act, have an indefinite life. In addition, the Company has a general business credit as a result of the credit for increasing research activities (“R&D credit”) of approximately $0.9 million and $1.2 million at September 30, 2024 and 2023, respectively. The R&D credit expires during the fiscal year ended 2029. Significant components of the Company’s deferred tax assets and liabilities as of September 30, 2024 and 2023 are listed below: 2024 2023 NOL carryforwards $ 34,673,000 $ 30,829,000 Capitalized R&D 14,062,000 15,196,000 Stock-based compensation 11,645,000 11,579,000 Lease liabilities 2,752,000 3,400,000 R&D credit 932,000 1,221,000 Vacation and other 188,000 298,000 Fixed assets and intangibles 347,000 168,000 Total deferred tax assets 64,599,000 62,691,000 Right-of-use assets (2,095,000 ) (2,713,000 ) Fixed assets and intangibles - - Total deferred tax liabilities (2,095,000 ) (2,713,000 ) Net deferred tax asset 62,504,000 59,978,000 Valuation allowance (62,504,000 ) (59,978,000 ) Ending balance $ - $ - The Company has no federal or state current or deferred tax expense or benefit. The Company’s effective tax rate differs from the applicable federal statutory tax rate. The reconciliation of these rates is as follows for the years ended September 30: 2024 2023 Federal rate 21.00 % 21.00 % State rate change (11.97 ) (1.58 ) State tax rate, net of federal benefit 2.68 4.05 Other adjustments (2.32 ) (1.62 ) Permanent differences 0.00 0.00 Change in valuation allowance (9.39 ) (21.85 ) Effective tax rate 0.00 % 0.00 % The Company applies the provisions of ASC 740, Accounting for Uncertainty in Income Taxes,

EQUITY-BASED COMPENSATION

EQUITY-BASED COMPENSATION	12 Months Ended
	Sep. 30, 2024
EQUITY-BASED COMPENSATION
EQUITY-BASED COMPENSATION	8 . EQUITY-BASED COMPENSATION The Company recognized the following expenses for options issued or vested and restricted stock awarded during the year: Year Ended September 30, 2024 2023 Employees $ 4,270,180 $ 6,286,231 Non-employees $ 680,768 $ 655,740 As of September 30, 2024, the total compensation cost related to non-vested options and restricted stock awarded to employees and non-employees not yet recognized was approximately $4.5 million and $0.1 million, respectively, and the weighted-average period over which it is expected to be recognized is 1.9 and 0.54 years, respectively. During the years ended September 30, 2024 and 2023, the fair value of each option grant was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions. 2024 2023 Expected stock price volatility 100.89 – 101.66% 99.18 – 100.18% Risk-free interest rate 3.77 – 4.58% 3.41 – 4.25% Expected life of options 9.61 – 9.64 years 9.63 – 9.66 years Expected dividend yield - - Non-Qualified Stock Option Plan s During the year ended September 30, 2024, the Company adopted the 2024 Non-Qualified Stock Option Plan, which provides for the issuance of up to 2,000,000 options to purchase shares of common stock. On April 19, 2024, the Company granted 1,962,000 options to purchase shares of common stock from the 2024 Non-Qualified Stock Option Plan to officers, directors and employees. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $1.50 per share, vests in three equal annual installments commencing one year after the grant date and expires on April 18, 2034. During the year ended September 30, 2023, the Company adopted the 2023 Non-Qualified Stock Option Plan, which provides for the issuance of up to 2,000,000 options to purchase shares of common stock. On August 8, 2023, the Company granted 1,958,500 options to purchase shares of common stock from the 2023 Non-Qualified Stock Option Plan to officers, directors and employees. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $1.36 per share, vests in three equal annual installments commencing one year after the grant date and expires on August 7, 2033. At September 30, 2024, the Company has collectively authorized the issuance of 17,787,200 options to purchase shares of common stock under its Non-Qualified Stock Option Plans. Options typically vest over a three-year period and expire no later than ten years after the grant date. Terms of the options were determined by the Company’s Compensation Committee which administers the plans. The Company’s employees, directors, officers, and consultants or advisors are eligible to be granted options under the Non-Qualified Stock Option Plans. Incentive Stock Option Plan s Activity in the Company’s Non-Qualified and Incentive Stock Option Plans for the two years ended September 30, 2024 is summarized as follows: Non-Qualified and Incentive Stock Option Plans Outstanding Exercisable Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at September 30, 2022 12,964,014 $ 9.06 7.35 $ 1,866,240 7,067,617 $ 6.21 6.21 $ 1,866,105 Vested 952,256 $ 8.41 Granted (a) 2,065,500 $ 1.37 Exercised - - Forfeited (213,165 ) $ 9.19 Expired (58,791 ) $ 61.05 (58,791 ) $ 61.05 Outstanding at September 30, 2023 14,757,558 $ 7.78 6.81 $ 0 7,961,082 $ 6.07 5.60 $ 0 Vested 1,501,583 $ 4.24 Granted (b) 1,969,000 $ 1.50 Exercised - - - - Forfeited (406,333 ) $ 10.01 - - Expired (62,145 ) $ 27.35 (62,145 ) $ 27.35 Outstanding at September 30, 2024 16,258,080 $ 6.88 6.25 $ 0 9,400,520 $ 5.64 5.19 $ 0 (a) Includes 1,965,500 performance based options issued to officers and directors, 100,000 options issued to consultants. The weighted average grant date fair value was $1.22. (b) The weighted average grant date fair value was $1.36. A summary of the status of the Company’s unvested options for the two years ended September 30, 2024 is presented below: Number of Options Weighted Average Grant Date Fair Value Unvested at September 30, 2022 5,896,397 $ 3.63 Vested (952,256 ) $ 7.30 Granted 2,065,500 $ 1.22 Forfeited (213,165 ) $ 8.02 Unvested at September 30, 2023 6,796,476 $ 2.25 Vested (1,501,583 ) $ 3.73 Granted 1,969,000 $ 1.36 Forfeited (406,333 ) $ 1.94 Unvested at September 30, 2024 6,857,560 $ 1.69 Incentive Stock Bonus Plan A summary of the status of the Company’s restricted common stock issued from the Incentive Stock Bonus Plan for the two years ended September 30, 2024 is presented below: Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2022 151,250 $ 13.75 Forfeited (4,000 ) Vested - Unvested at September 30, 2023 147,250 $ 13.75 Forfeited - Vested - Unvested at September 30, 2024 147,250 $ 13.75 Stock Bonus Plans Stock Compensation Plans

EMPLOYEE BENEFIT PLAN

EMPLOYEE BENEFIT PLAN	12 Months Ended
	Sep. 30, 2024
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN	9 . EMPLOYEE BENEFIT PLAN The Company maintains a defined contribution retirement plan, qualifying under Section 401(k) of the Internal Revenue Code, subject to the Employee Retirement Income Security Act of 1974, as amended, and covering substantially all Company employees. Each participant’s contribution is matched by the Company with shares of common stock that have a value equal to 100% of the participant’s contribution, not to exceed the lesser of $10,000 or 6% of the participant’s total compensation. The Company’s contribution of common stock is valued each quarter based upon the closing bid price of the Company’s common stock. During the year ended September 30, 2024, 136,868 shares were issued to the Company’s 401(k) plan for a cost of approximately $219,000. During the year ended September 30, 2023, 97,004 shares were issued to the Company’s 401(k) plan for a cost of approximately $208,000.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Sep. 30, 2024
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	10 . COMMITMENTS AND CONTINGENCIES Clinical Research Agreements In August 2024 the Company entered into an agreement, pursuant to which the Company engaged Ergomed Clinical Research, Inc. to provide clinical development services related to the Company’s upcoming confirmatory registration study in exchange for fees. Since the Company entered into this agreement it has incurred research and development expenses of approximately $0.4 million as of September 30, 2024. 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 III clinical trial and sales of the drug if approved by the FDA or regulators in Canada, the UK or Europe. 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. As of September 30, 2024 and 2023, respectively, the net book value of the finance lease right-of-use asset is approximately $7.4 million and $9.1 million and the balance of the finance lease liability is approximately $10.0 million and $11.7 million, of which approximately $2.0 million and $1.8 million is current. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. During the years ended September 30, 2024 and 2023, the finance right of use assets are being depreciated using a straight-line method over the underlying lease terms and depreciation expense totaled approximately $1.8 million in both periods, which is included in research and development expense on the accompanying statements of operations. Total cash paid related to finance leases during the years ended September 30, 2024 and 2023, respectively, was approximately $2.7 million and $2.6 million, of which approximately $0.9 million and $1.1 million was for interest. The total cash paid related to finance lease principal payments is included in cash flows from financing activities on the accompanying statements of cash flows. The total cash paid related to finance lease interest expense is included in cash flows from operating activities on the accompanying statements of cash flows. The weighted average discount rate of the Company’s finance leases is 8.46% and the weighted average remaining lease term is 4.09 years. During the years ended September 30, 2024 and 2023, total finance lease costs were approximately $2.7 million and $2.9 million, consisting of approximately $1.8 million of lease asset amortization in both periods, and approximately $0.9 million and $1.1 million of interest on the finance lease liabilities, respectively. Variable lease expenses, such as maintenance costs, utilities, and real property taxes are not included in right of use assets or lease liabilities but rather are expensed as incurred. During the year ended September 30, 2024, there were approximately $0.9 million of variable finance lease costs, which are included in research and development expense on the accompanying statements of operations. 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 September 30, 2024 are as follows: Year ending September 30, 2025 $ 2,747,000 2026 2,838,000 2027 2,929,000 2028 3,021,000 2029 255,000 Total future minimum lease obligation 11,790,000 Less imputed interest on finance lease obligations (1,821,000 ) Net present value of finance lease obligations 9,969,000 Net present value of finance lease obligations – current portion 2,011,000 Net present value of finance lease obligations – non-current portion $ 7,958,000 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 and will expire on February 29, 2032. 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 September 30, 2024 and 2023, respectively, the net book value of the operating lease right-of-use asset is approximately $1.5 million and $1.7 million and the balance of the operating lease liability is approximately $1.7 million and $1.9 million, of which approximately $0.2 million is current in both periods. During the years ended September 30, 2024 and 2023, the Company incurred lease expense under operating leases of approximately $0.4 million in both periods, which is included in general and administrative expense on the accompanying statements of operations. Total cash paid related to operating leases during the years ended September 30, 2024 and 2023 was approximately $0.4 million and $0.3 million, respectively. The total cash paid related to operating leases is included in cash flows from operating activities on the accompanying statements of cash flows. The weighted average discount rate of the Company’s operating leases is 9.0% and the weighted average the remaining lease term is 6.98 years. As of September 30, 2024, future minimum lease payments on operating leases are as follows: 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 2,255,000 Less imputed interest on operating lease obligation (602,000 ) Net present value of operating lease obligations 1,653,000 Net present value of operating lease obligations – current portion 227,000 Net present value of operating lease obligations – non-current portion $ 1,426,000

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	12 Months Ended
	Sep. 30, 2024
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS	1 1 . RELATED PARTY TRANSACTIONS During the year ended September 30, 2024, certain officers and directors purchased 58,000 shares of restricted common stock at an aggregated fair market value of approximately $81,000. During the year ended September 30, 2023, no restricted shares of the Company’s common stock were purchased by related parties. On July 11, 2024, Geert Kersten, the Company’s Chief Executive Officer and a director, loaned the Company $200,000. On July 18, 2024, Mr. Kersten loaned the Company an additional $250,000. These amounts were repaid on July 30, 2024. On May 4, 2024, the Company modified the terms of Series UU, X, Y, N, MM, NN and RR warrants by extending the expiration dates by twenty-four (24) months from their current expiration dates. The incremental cost of this extension was approximately $0.7 million, which was recorded as a deemed dividend in the financial statements for the three months ended June 30, 2024. The Series N, X, MM, NN, RR and UU 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 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.

STOCKHOLDERS EQUITY

STOCKHOLDERS EQUITY	12 Months Ended
	Sep. 30, 2024
STOCKHOLDERS EQUITY
STOCKHOLDERS' EQUITY	1 2 . STOCKHOLDERS’ EQUITY Exercise of Warrants During the year ended September 30, 2024, 5,680,000 pre-funded warrants were exercised. During the year ended September 30, 2023, the Company received proceeds of approximately $0.4 million from the exercise of warrants, as detailed in Note 4. Upon exercise, 217,752 shares of common stock were issued during the year ended September 30, 2023. Proceeds from the Sale of Common Stock On July 29, 2024, the Company sold 3,715,000 shares of common stock at an offering price of $1.00 per share, and pre-funded warrants to purchase up to 7,130,000 shares of common stock, at an offering price of $0.99 per pre-funded warrant, for proceeds of approximately $9.7 million, net of issuance costs of approximately $1.1 million. Holders of the pre-funded warrants have exercised 5,680,000 of the pre-funded warrants as of September 30, 2024. The Company determined that the pre-funded warrants sold in the July 26, 2024 offering are freestanding financial instruments because they are both legally detachable and separately exercisable from the common stock sold in the offering. As such, the Company evaluated the pre-funded warrants to determine whether they represent instruments that require liability classification pursuant to the guidance in ASC 480. However, the Company concluded that the pre-funded warrants are not a liability within the scope of ASC 480 due to their characteristics. Further, the Company determined that the pre-funded warrants do not meet the definition of a derivative under ASC 815. Accordingly, the Company assessed the pre-funded warrants relative to the guidance in ASC No. 815-40, Contracts in Entity’s Own Equity, to determine the appropriate treatment. The Company concluded that the pre-funded warrants are both indexed to its own stock and meet all other conditions for equity classification. Accordingly, the Company has classified the pre-funded warrants as permanent equity and recorded them as a component of additional paid-in capital upon the closing of the transaction in July 2024. In February 2024, the Company sold 3,875,000 shares of common stock at a public offering price of $2.00 per share and received proceeds of approximately $7.0 million, net of issuance costs of approximately $0.7 million. 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 proceeds of approximately $4.5 million, net of issuance costs of approximately $0.5 million. In April 2023, the Company sold 794,117 shares of common stock at a public offering price of $1.70 per share and received proceeds of approximately $1.4 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 proceeds to the Company of approximately $200,000. The Company incurred issuance costs of approximately $0.2 million related to this offering.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	12 Months Ended
	Sep. 30, 2024
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS	1 3 . FAIR VALUE MEASUREMENTS In accordance with the provisions of ASC 820, “Fair Value Measurements,” the Company determines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations with respect to the future amounts. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows: · 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 other than quoted prices that are observable for the asset or liability are observable in active markets · Level 3 – Unobservable inputs that reflect management’s assumptions For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels. The Company’s money market funds included in cash equivalents are measured at fair value on a recurring basis. The following tables summarize the Company’s fair value measurements and the level of inputs within the fair value hierarchy utilized to determine such fair value as of September 30: September 30, 2024 Description Level Cost Fair Value Cash and cash equivalents Cash 1 $ - $ 1,258,173 Money market funds included in cash and cash equivalents (Note 2) 1 $ 3,480,000 $ 3,480,000 Total cash and cash equivalents $ 3,480,000 $ 4,738,173 September 30, 2023 Description Level Cost Fair Value Cash and cash equivalents Cash 1 $ - $ 1,895,735 Money market funds included in cash and cash equivalents (Note 2) 1 $ 2,250,000 $ 2,250,000 Total cash and cash equivalents $ 2,250,000 $ 4,145,735

NET LOSS PER COMMON SHARE

NET LOSS PER COMMON SHARE	12 Months Ended
	Sep. 30, 2024
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE	1 4 . NET LOSS PER COMMON SHARE Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share is computed using the treasury stock method. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants and restricted stock are not included in the computation of diluted net loss per share if their effect would be anti-dilutive. The calculation of basis and diluted net loss per share includes 1,450,000 of the pre-funded warrants that remain outstanding as of September 30, 2024. The following table provides a reconciliation of the numerators and denominators of the basic and diluted per-share computations: Year ended September 30, 2024 2023 Loss per share – basic and diluted Net loss available to common shareholders – basic and diluted $ (27,579,921 ) $ (32,365,855 ) Weighted average shares outstanding – basic and diluted 54,044,989 44,479,865 Basic and diluted loss per common share $ (0.51 ) $ (0.73 ) In accordance with the contingently issuable shares guidance of ASC 260, Earnings Per Share 2024 2023 Options and warrants 17,350,550 15,850,028 Unvested restricted stock 147,250 147,250 Total 17,497,800 15,997,278

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	12 Months Ended
	Sep. 30, 2024
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	15. SUBSEQUENT EVENTS On October 18, 2024, the Company entered into a Securities Purchase Agreement with Ergomed Group Limited pursuant to which the Company issued 1 million shares of common stock in exchange for services. On December 31, 2024, the Company sold 7,552,500 shares of common stock at an offering price of $0.31 per share, and pre-funded warrants to purchase up to 8,577,500 shares of common stock, at an offering price of $0.3099 per pre-funded warrant, for gross proceeds of approximately $5 million.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Sep. 30, 2024
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation	Basis of Presentation
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
Share-Based Compensation	Share-Based Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. 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
Concentration of Credit Risk	Concentration of Credit Risk
Income Taxes	Income Taxes
Impairment of long-lived assets	Impairment of long-lived assets
Use of Estimates	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”). ASU 2016-13 requires a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. The amendments in ASU 2016-13 replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information. ASU 2016-13 was effective for SEC filers, excluding smaller reporting companies, for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. As a smaller reporting company, the Company was permitted to adopt the new standard for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Effective October 1, 2023, the Company adopted ASU 2016-13 using a modified retrospective transition method. The adoption of ASU 2016-13 had no material impact on the Company’s financial position, results of operations, or cash flows.
New Accounting Pronouncements	In November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which expands disclosures about a public entity’s reportable segments and requires more enhanced information about a reportable segment’s expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit or loss information in assessing segment performance and allocating resources. The update will be effective for annual periods beginning after December 15, 2023 and interim periods beginning after December 15, 2024. The Company is currently evaluating the impact that this change will have on the Company’s disclosures. In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Improvements to Income Tax Disclosures, which require greater disaggregation of income tax disclosures related to the income tax rate reconciliation and income taxes paid. The update will be effective for annual periods beginning after December 15, 2024. The guidance should be applied on a prospective basis with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating the impact that this change will have on the Company's disclosures. In March 2024, the SEC issued its final climate disclosure rules, which require the disclosure of climate-related information in annual reports and registration statements. The rules require disclosure in the audited financial statements of certain effects of severe weather events and other natural conditions above certain financial thresholds, as well as amounts related to carbon offsets and renewable energy credits or certificates, if material. Under the rules as originally issued, disclosure requirements begin phasing in for fiscal years beginning on or after January 1, 2027. However, on April 4, 2024, the SEC determined to voluntarily stay the final rules pending certain legal challenges. We are currently evaluating the impact of the new rules and continue to monitor the status of the related legal challenges. In November 2024, the FASB issued Accounting Standards Update No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures: Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 will require more detailed information about the types of expenses in commonly presented income statement captions such as “Cost of sales” and “Selling, general and administrative expenses”. The new guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted. The Company is currently evaluating the impact that this change will have on the Company's disclosures.

WARRANTS AND NONEMPLOYEE OPTI_2

WARRANTS AND NONEMPLOYEE OPTIONS (Tables)	12 Months Ended
	Sep. 30, 2024
WARRANTS AND NONEMPLOYEE OPTIONS
Schedule of warrants and non-employee options	Warrant/ Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 8/18/2026 Series UU 6/11/2018 93,603 $ 2.80 6/30/2026 Series X 1/13/2016 120,000 $ 9.25 7/13/2026 Series Y 2/15/2016 26,000 $ 12.00 8/15/2026 Series MM 6/22/2017 333,432 $ 1.86 6/22/2026 Series NN 7/24/2017 200,087 $ 2.52 7/24/2026 Series RR 10/30/2017 234,009 $ 1.65 10/30/2026 Consultant Options 7/28/2017 – 9/2/2023 110,000 $1.39 - $2.18 7/27/2027 – 9/1/2028 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 equity warrants were exercised	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

PROPERTY AND EQUIPMENT (Tables)

PROPERTY AND EQUIPMENT (Tables)	12 Months Ended
	Sep. 30, 2024
PROPERTY AND EQUIPMENT
Schedule of property and equipment	2024 2023 Research equipment $ 4,167,828 $ 4,109,070 Furniture and equipment 104,593 99,296 Leasehold improvements 13,924,724 13,924,724 18,197,145 18,133,090 Less: Accumulated depreciation (10,067,392 ) (7,944,964 ) Property and equipment, net $ 8,129,753 $ 10,188,126

PATENTS (Tables)

PATENTS (Tables)	12 Months Ended
	Sep. 30, 2024
PATENTS
Schedule of patents	2024 2023 Patents $ 829,716 $ 853,445 Less: Accumulated amortization (664,224 ) (655,741 ) Patents, net $ 165,492 $ 197,704
Schedule of total estimated future amortization	Years ending September 30, 2025 $ 29,000 2026 25,000 2027 22,000 2028 19,000 2029 16,000 Thereafter 54,000 $ 165,000

INCOME TAXES (Tables)

INCOME TAXES (Tables)	12 Months Ended
	Sep. 30, 2024
INCOME TAXES
Schedule of components of the Company's deferred tax assets	2024 2023 NOL carryforwards $ 34,673,000 $ 30,829,000 Capitalized R&D 14,062,000 15,196,000 Stock-based compensation 11,645,000 11,579,000 Lease liabilities 2,752,000 3,400,000 R&D credit 932,000 1,221,000 Vacation and other 188,000 298,000 Fixed assets and intangibles 347,000 168,000 Total deferred tax assets 64,599,000 62,691,000 Right-of-use assets (2,095,000 ) (2,713,000 ) Fixed assets and intangibles - - Total deferred tax liabilities (2,095,000 ) (2,713,000 ) Net deferred tax asset 62,504,000 59,978,000 Valuation allowance (62,504,000 ) (59,978,000 ) Ending balance $ - $ -
Schedule of federal or state current or deferred tax expense or benefit	2024 2023 Federal rate 21.00 % 21.00 % State rate change (11.97 ) (1.58 ) State tax rate, net of federal benefit 2.68 4.05 Other adjustments (2.32 ) (1.62 ) Permanent differences 0.00 0.00 Change in valuation allowance (9.39 ) (21.85 ) Effective tax rate 0.00 % 0.00 %

EQUITY-BASED COMPENSATION (Tabl

EQUITY-BASED COMPENSATION (Tables)	12 Months Ended
	Sep. 30, 2024
EQUITY-BASED COMPENSATION
Schedule of expenses for options issued or vested and restricted stock awarded	Year Ended September 30, 2024 2023 Employees $ 4,270,180 $ 6,286,231 Non-employees $ 680,768 $ 655,740
Schedule of assumptions used for fair value of each option granted	2024 2023 Expected stock price volatility 100.89 – 101.66% 99.18 – 100.18% Risk-free interest rate 3.77 – 4.58% 3.41 – 4.25% Expected life of options 9.61 – 9.64 years 9.63 – 9.66 years Expected dividend yield - -
Schedule of non-qualified and incentive stock option plans	Outstanding Exercisable Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at September 30, 2022 12,964,014 $ 9.06 7.35 $ 1,866,240 7,067,617 $ 6.21 6.21 $ 1,866,105 Vested 952,256 $ 8.41 Granted (a) 2,065,500 $ 1.37 Exercised - - Forfeited (213,165 ) $ 9.19 Expired (58,791 ) $ 61.05 (58,791 ) $ 61.05 Outstanding at September 30, 2023 14,757,558 $ 7.78 6.81 $ 0 7,961,082 $ 6.07 5.60 $ 0 Vested 1,501,583 $ 4.24 Granted (b) 1,969,000 $ 1.50 Exercised - - - - Forfeited (406,333 ) $ 10.01 - - Expired (62,145 ) $ 27.35 (62,145 ) $ 27.35 Outstanding at September 30, 2024 16,258,080 $ 6.88 6.25 $ 0 9,400,520 $ 5.64 5.19 $ 0
Schedule of restricted common stock issued from the incentive stock bonus plan	Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2022 151,250 $ 13.75 Forfeited (4,000 ) Vested - Unvested at September 30, 2023 147,250 $ 13.75 Forfeited - Vested - Unvested at September 30, 2024 147,250 $ 13.75
Schedule of non vested options	Number of Options Weighted Average Grant Date Fair Value Unvested at September 30, 2022 5,896,397 $ 3.63 Vested (952,256 ) $ 7.30 Granted 2,065,500 $ 1.22 Forfeited (213,165 ) $ 8.02 Unvested at September 30, 2023 6,796,476 $ 2.25 Vested (1,501,583 ) $ 3.73 Granted 1,969,000 $ 1.36 Forfeited (406,333 ) $ 1.94 Unvested at September 30, 2024 6,857,560 $ 1.69

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Sep. 30, 2024
COMMITMENTS AND CONTINGENCIES
Schedule of future minimum payments under finance leases	Year ending September 30, 2025 $ 2,747,000 2026 2,838,000 2027 2,929,000 2028 3,021,000 2029 255,000 Total future minimum lease obligation 11,790,000 Less imputed interest on finance lease obligations (1,821,000 ) Net present value of finance lease obligations 9,969,000 Net present value of finance lease obligations – current portion 2,011,000 Net present value of finance lease obligations – non-current portion $ 7,958,000
Schedule of future minimum payments under operating leases	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 2,255,000 Less imputed interest on operating lease obligation (602,000 ) Net present value of operating lease obligations 1,653,000 Net present value of operating lease obligations – current portion 227,000 Net present value of operating lease obligations – non-current portion $ 1,426,000

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	12 Months Ended
	Sep. 30, 2024
FAIR VALUE MEASUREMENTS
Schedule of fair value measurements using significant unobservable inputs	September 30, 2024 Description Level Cost Fair Value Cash and cash equivalents Cash 1 $ - $ 1,258,173 Money market funds included in cash and cash equivalents (Note 2) 1 $ 3,480,000 $ 3,480,000 Total cash and cash equivalents $ 3,480,000 $ 4,738,173 September 30, 2023 Description Level Cost Fair Value Cash and cash equivalents Cash 1 $ - $ 1,895,735 Money market funds included in cash and cash equivalents (Note 2) 1 $ 2,250,000 $ 2,250,000 Total cash and cash equivalents $ 2,250,000 $ 4,145,735

NET LOSS PER COMMON SHARE (Tabl

NET LOSS PER COMMON SHARE (Tables)	12 Months Ended
	Sep. 30, 2024
NET LOSS PER COMMON SHARE
Schedule of earnings per share	Year ended September 30, 2024 2023 Loss per share – basic and diluted Net loss available to common shareholders – basic and diluted $ (27,579,921 ) $ (32,365,855 ) Weighted average shares outstanding – basic and diluted 54,044,989 44,479,865 Basic and diluted loss per common share $ (0.51 ) $ (0.73 )
Schedule of anti-dilutive securities	2024 2023 Options and warrants 17,350,550 15,850,028 Unvested restricted stock 147,250 147,250 Total 17,497,800 15,997,278

SUMMARY OF SIGNIFICANT ACCOUN_3

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2022	Sep. 30, 2024	Sep. 30, 2023
Fully insured amount of non-interest bearing cash balances		$ 250,000	$ 250,000
Patents [Member]
Patent Useful Life	17 years

WARRANTS AND NONEMPLOYEE OPTI_3

WARRANTS AND NONEMPLOYEE OPTIONS (Details) - $ / shares	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Consultants [Member]
Shares Issuable upon Exercise of Warrant	110,000
Consultants [Member] | Minimum
Issue Date	7/28/2017	7/28/2017
Exercise Price	$ 1.39	$ 1.39
Expiration Date	7/27/2027	7/27/2027
Consultants 1 [Member]
Shares Issuable upon Exercise of Warrant		110,000
Consultants 1 [Member] | Maximum
Issue Date	9/2/2023	9/2/2023
Exercise Price	$ 2.18	$ 2.18
Expiration Date	9/1/2028	9/1/2028
Series Y [Member]
Issue Date	2/15/2016	2/15/2016
Shares Issuable upon Exercise of Warrant	26,000	26,000
Exercise Price	$ 12	$ 12
Expiration Date	8/15/2026	8/15/2024
Series MM [Member]
Issue Date	6/22/2017	6/22/2017
Shares Issuable upon Exercise of Warrant	333,432	333,432
Exercise Price	$ 1.86	$ 1.86
Expiration Date	6/22/2026	6/22/2024
Series NN [Member]
Issue Date	7/24/2017	7/24/2017
Shares Issuable upon Exercise of Warrant	200,087	200,087
Exercise Price	$ 2.52	$ 2.52
Expiration Date	7/24/2026	7/24/2024
Series RR [Member]
Issue Date	10/30/2017	10/30/2017
Shares Issuable upon Exercise of Warrant	234,009	234,009
Exercise Price	$ 1.65	$ 1.65
Expiration Date	10/30/2026	10/30/2024
Series N [Member]
Issue Date	8/18/2008	8/18/2008
Shares Issuable upon Exercise of Warrant	85,339	85,339
Exercise Price	$ 3	$ 3
Expiration Date	8/18/2026	8/18/2024
Series UU [Member]
Issue Date	6/11/2018	6/11/2018
Shares Issuable upon Exercise of Warrant	93,603	93,603
Exercise Price	$ 2.80	$ 2.80
Expiration Date	6/30/2026	6/30/2024
Series X [Member]
Issue Date	1/13/2016	1/13/2016
Shares Issuable upon Exercise of Warrant	120,000	120,000
Exercise Price	$ 9.25	$ 9.25
Expiration Date	7/13/2026	7/13/2024

WARRANTS AND NONEMPLOYEE OPTI_4

WARRANTS AND NONEMPLOYEE OPTIONS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Equity Warrants Exercised	5,680,000	217,752
Proceeds from Equity Warrants Exercised		$ 447,291
Series RR [Member]
Equity Warrants Exercised		17,752
Proceeds from Equity Warrants Exercised		$ 29,291
Equity Warrants Exercise Price		$ 1.65
Series SS [Member]
Equity Warrants Exercised		200,000
Proceeds from Equity Warrants Exercised		$ 418,000
Equity Warrants Exercise Price		$ 2.09

WARRANTS AND NONEMPLOYEE OPTI_5

WARRANTS AND NONEMPLOYEE OPTIONS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2022
Common stock issued for service, shares	409,932	249,997
Equity Warrants Exercised	5,680,000	217,752
Consultants Member | Restricted Stocks Member
Weighted average grant date fair value	$ 2.24
Non Qualified Stock Options Plans [Member] | Consultant [Member]
Issued options to purchase common stock	100,000
Exercise price	$ 1.39
Options issued to consultants for services	110,000
Non Qualified Stock Options Plans [Member] | Consultant [Member] | September 2, 2024 [Member]
Options vested	50%
Non Qualified Stock Options Plans [Member] | Consultant [Member] | September 2, 2025 [Member]
Options vested	50%
Consulting Agreements [Member]
Total expense	$ 681,000	$ 656,000
Prepaid expenses	$ 52,000		$ 205,000
Minimum
Stock prices per share	$ 1.08
Maximum
Stock prices per share	3.47
Maximum | Consultants Member | Restricted Stocks Member
Weighted average grant date fair value	$ 1.69	$ 1.83
Series RR [Member]
Incremental cost	$ 659,455
Equity Warrants Exercised		17,752

PROPERTY AND EQUIPMENT (Details

PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023
PROPERTY AND EQUIPMENT
Research equipment	$ 4,167,828	$ 4,109,070
Furniture and equipment	104,593	99,296
Leasehold improvements	13,924,724	13,924,724
Gross	18,197,145	18,133,090
Accumulated depreciation and amortization	(10,067,392)	(7,944,964)
Net property and equipment	$ 8,129,753	$ 10,188,126

PROPERTY AND EQUIPMENT (Detai_2

PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
PROPERTY AND EQUIPMENT
Depreciation expense	$ 2,135,000	$ 2,114,000

PATENTS (Details)

PATENTS (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023
PATENTS
Patents	$ 829,716	$ 853,445
Accumulated amortization	(664,224)	(655,741)
Patents, net	$ 165,492	$ 197,704

PATENTS (Details 1)

PATENTS (Details 1)	Sep. 30, 2024 USD ($)
PATENTS
2025	$ 29,000
2026	25,000
2027	22,000
2028	19,000
2029	16,000
Thereafter	54,000
Total	$ 165,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
PATENTS
Weighted average amortization period for patents	8 years
Amortization of patent costs	$ 32,000	$ 38,000

INCOME TAXES (Details)

INCOME TAXES (Details) - USD ($)	Sep. 30, 2024	Sep. 30, 2023
INCOME TAXES
NOL carryforwards	$ 34,673,000	$ 30,829,000
Capitalized R&D	14,062,000	15,196,000
Stock-based compensation	11,645,000	11,579,000
Lease liabilities	2,752,000	3,400,000
R&D credit	932,000	1,221,000
Vacation and other	188,000	298,000
Fixed assets and intangibles	347,000	168,000
Total deferred tax assets	64,599,000	62,691,000
Right of use assets	(2,095,000)	(2,713,000)
Fixed assets and intangibles	0	0
Total deferred tax liability	(2,095,000)	(2,713,000)
Net deferred tax asset	62,504,000	59,978,000
Valuation allowance	(62,504,000)	(59,978,000)
Ending Balance	$ 0	$ 0

INCOME TAXES (Details 1)

INCOME TAXES (Details 1)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
INCOME TAXES
Federal Rate	21%	21%
State tax rate change	(11.97%)	(1.58%)
State tax rate, net of federal benefit	2.68%	4.05%
Other adjustments	(2.32%)	(1.62%)
Permanent differences	0%	0%
Change in valuation allowance	(9.39%)	(21.85%)
Effective tax rate	0%	0%

INCOME TAXES (Details Narrative

INCOME TAXES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
NOL carryforwards	$ 34,673,000	$ 30,829,000
Deferred tax asset	62,504,000	59,978,000
Income Tax [Member]
Research and development credit	900,000	1,200,000
NOL carryforwards	$ 146,400,000	123,100,000
Research and development credit, description	The R&D credit expires during the fiscal year ended 2029
Cumulative change in ownership percentage	net operating loss (NOL) carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period
Net operating loss carryforwards, description	Approximately $19.2 million of the NOL carryforwards begin to expire during the year ended September 30, 2024 and become fully expired by 2038 and approximately $127.2 million of NOL carryforwards
Deferred tax asset	$ 62,500,000	$ 60,000,000

EQUITY-BASED COMPENSATION (Deta

EQUITY-BASED COMPENSATION (Details) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Non Employees [Member]
Stock Based Compensation Expense	$ 680,768	$ 655,740
Employees [Member]
Stock Based Compensation Expense	$ 4,270,180	$ 6,286,231

EQUITY-BASED COMPENSATION (De_2

EQUITY-BASED COMPENSATION (Details 1)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
EQUITY-BASED COMPENSATION
Expected stock price volatility, min	100.89%	99.18%
Expected stock price volatility, max	101.66%	100.18%
Risk-free interest rate, min	3.77%	3.41%
Risk-free interest rate, max	4.58%	4.25%
Expected life of options, min	9 years 7 months 9 days	9 years 7 months 17 days
Expected life of options, max	9 years 7 months 28 days	9 years 7 months 20 days
Expected dividend yield	0%	0%

EQUITY-BASED COMPENSATION (De_3

EQUITY-BASED COMPENSATION (Details 2) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Exercisable [Member]
Number of Options Outstanding, Beginning	7,961,082	7,067,617
Number of Options Outstanding, Ending	9,400,520	7,961,082
Weighted Average Exercise Price Outstanding, Beginning	$ 6.07	$ 6.21
Weighted Average Exercise Price Exercised	0
Weighted Average Exercise Price Outstanding, Ending	$ 5.64	$ 6.07
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 1,866,105
Aggregate Intrinsic Value Outstanding, Ending	$ 0	$ 0
Number of Options Vested	1,501,583	952,256
Number of Options Expired	(62,145)	(58,791)
Weighted Average Exercise Price Vested	$ 4.24	$ 8.41
Weighted Average Exercise Price Expired	$ 27.35	$ 61.05
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Beginning		6 years 2 months 15 days
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Ending	5 years 2 months 8 days	5 years 7 months 6 days
Outstanding [Member]
Number of Options Outstanding, Beginning	14,757,558	12,964,014
Number of Options Granted	1,969,000	2,065,500
Number of Options Expired	(62,145)	(58,791)
Number of Options Outstanding, Ending	16,258,080	14,757,558
Weighted Average Exercise Price Outstanding, Beginning	$ 7.78	$ 9.06
Weighted Average Exercise Price Granted	1.50	1.37
Weighted Average Exercise Price Exercised	0
Weighted Average Exercise Price Forfeited	10.01	9.19
Weighted Average Exercise Price Expired	27.35	61.05
Weighted Average Exercise Price Outstanding, Ending	$ 6.88	$ 7.78
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Beginning		7 years 4 months 6 days
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Ending	6 years 3 months	6 years 9 months 21 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 1,866,240
Aggregate Intrinsic Value Outstanding, Ending	$ 0	$ 0

EQUITY-BASED COMPENSATION (De_4

EQUITY-BASED COMPENSATION (Details 3) - $ / shares	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
EQUITY-BASED COMPENSATION
Number of unvested options, Beginning	6,796,476	5,896,397
Vested options	(1,501,583)	(952,256)
Granted options	1,969,000	2,065,500
Forfeited options	(406,333)	(213,165)
Number of unvested options, Ending	6,857,560	6,796,476
Weighted Average Grant Date Fair Value, Beginning	$ 2.25	$ 3.63
Weighted Average Grant Date Fair Value, vested	3.73	7.30
Weighted Average Grant Date Fair Value, Granted	1.36	1.22
Weighted Average Grant Date Fair Value, Forfeited	1.94	8.02
Weighted Average Grant Date Fair Value, Ending	$ 1.69	$ 2.25

EQUITY-BASED COMPENSATION (De_5

EQUITY-BASED COMPENSATION (Details 4) - Restricted Stock Awards [Member] - $ / shares	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Number of unvested shares, Beginning	147,250	151,250
Forfeited		(4,000)
Number of unvested shares, Ending	147,250	147,250
Weighted Average Grant Date Fair Value, Beginning	$ 13.75	$ 13.75
Weighted Average Grant Date Fair Value, Ending	$ 13.75	$ 13.75

EQUITY-BASED COMPENSATION (De_6

EQUITY-BASED COMPENSATION (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Jul. 29, 2024	Feb. 29, 2024	Nov. 30, 2023
Common stock, shares issued	63,787,104	47,422,304	3,715,000	3,875,000	2,490,000
Common stock, shares authorized	600,000,000	600,000,000
Stock Compensation Plans [Member]
Common stock, shares issued	153,195
Common stock, shares authorized	634,000
Stock Bonus Plans [Member]
Common stock, shares issued	649,840
Common stock, shares authorized	1,283,760
Non-Qualified Stock Options Plans [Member]
Common stock, shares authorized	17,787,200
Issuance of common stock options authorized shares	2,000,000	2,000,000
Performance based stock options shares granted	1,962,000	1,958,500
Stock price	$ 1.50	$ 1.36
Incentive Stock Option Plans [Member]
Common stock, shares authorized	138,400
Incentive Stock Bonus Plan [Member]
Forfeited	0	(4,000)
Common stock, shares authorized	610,500
Grant date fair value remaining outstanding	$ 8,600
Vested shares	463,250
Unrecognized compensation expense	$ 0
Restricted Stock Awards [Member]
Total compensation cost	$ 100
Weighted-average period	6 months 14 days
Forfeited		(4,000)
Non Vested Options [Member]
Total compensation cost	$ 4,500
Weighted-average period	1 year 10 months 24 days

EMPLOYEE BENEFIT PLAN (Detail N

EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
EMPLOYEE BENEFIT PLAN
Expense for Company's contribution to employee benefit plan	$ 219,000	$ 208,000
Employee Contributions to Defined Contribution Plans	$ 10,000	$ 10,000
Percentage of employee Contributions to Defined Contribution Plans	6%
Shares issued	136,868	97,004

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2024 USD ($)
COMMITMENTS AND CONTINGENCIES
2025	$ 2,747,000
2026	2,838,000
2027	2,929,000
2028	3,021,000
2029	255,000
Total Future Minimum Lease Obligation	11,790,000
Less: Imputed Interest On Financing Lease Obligation	(1,821,000)
Net present value of finance lease obligations	9,969,000
Net present value of lease finance lease obligations - current portion	2,011,000
Net present value of lease finance lease obligations - non-current portion	$ 7,958,000

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Sep. 30, 2024 USD ($)
COMMITMENTS AND CONTINGENCIES
2025	$ 366,000
2026	287,000
2027	277,000
2028	285,000
2029	294,000
Thereafter	746,000
Total Future Minimum Lease Obligation	2,255,000
Less Imputed Interest On Operating Lease Obligation	(602,000)
Net present value of operating lease obligations	1,653,000
Net present value of operating lease obligation - current portion	227,000
Net present value of operating lease obligation - non-current portion	$ 1,426,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)		12 Months Ended
	Jan. 11, 2023	Sep. 30, 2024	Sep. 30, 2023
Interest payment to lease liability		$ 900,000	$ 1,100,000
Finance lease right of use assets		7,350,364	9,131,987
Finance lease liability		9,969,000
Finance lease liability, current		2,010,995	1,771,804
Operating lease liability, current		226,969	197,431
Operating lease liability		1,653,000
Operating lease right of use assets		1,495,937	1,698,243
Operating Expense [Member]
cash paid related to operating leases		$ 400,000	300,000
Weighted average operating lease discount rate		9%
Operating lease liability, current		$ 200,000	200,000
Operating lease liability		1,700,000	1,900,000
Operating lease right of use assets		$ 1,500,000	1,700,000
Weighted average operating lease maturity year		6 years 11 months 23 days
Lease expenses		$ 400,000	400,000
Lease Agreement [Member]
Research and development expenses		900,000
Total Finance lease costs		2,700,000	2,900,000
Finance Lease, Amortization		1,800,000	1,800,000
Interest payment to lease liability		$ 900,000	1,100,000
Weighted average maturity year		4 years 1 month 2 days
Finance lease right of use assets		$ 7,400,000	9,100,000
Finance lease liability		10,000,000	11,700,000
Finance lease liability, current		2,000,000	1,800,000
Depreciation expenses		1,800,000	1,800,000
Cash paid related to finance leases		$ 2,700,000	$ 2,600,000
Weighted average discount rate		8.46%
Landlord [Member]
Payments Made to Landlord	$ 2,300,000
Ergomed [Member]
Research and development expenses		$ 400,000

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)			1 Months Ended				12 Months Ended
	Jul. 11, 2024	May 04, 2024	Jul. 29, 2024	Jul. 18, 2024	Feb. 29, 2024	Nov. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Proceeds from issuance of restricted common stock			$ 9,700,000		$ 7,000,000	$ 4,500,000	$ 23,575,000	$ 6,552,497
Proceeds from loan from CEO							450,000	0
Description of modification of warrants		the Company modified the terms of Series UU, X, Y, N, MM, NN and RR warrants by extending the expiration dates by twenty-four (24) months from their current expiration dates. The incremental cost of this extension was approximately $0.7 million, which was recorded as a deemed dividend
Series RR Warrant [Member]
Incremental cost of warrants extension							172,000
Officer and Director [Member]
Issuance of restricted common stock							58,000	0
Proceeds from issuance of restricted common stock							$ 81,000	$ 0
CEO [Member]
Additional debt from CEO				$ 250,000
Maturity date of debt	Jul. 30, 2024
Proceeds from loan from CEO	$ 200,000

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	1 Months Ended			12 Months Ended
	Jul. 29, 2024	Feb. 29, 2024	Nov. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Common stock shares issued	3,715,000	3,875,000	2,490,000	63,787,104	47,422,304
Proceeds from issuance of warrant					$ 400,000
Proceeds from issuance of common stock	$ 9,700,000	$ 7,000,000	$ 4,500,000	$ 23,575,000	$ 6,552,497
Net of issuance costs		$ 700,000	$ 500,000	$ 1,100,000
Purchase shares of common stock				7,130,000
Equity Warrants Exercised				5,680,000	217,752
Public offering price per share	$ 1	$ 2	$ 2	$ 0.99
Warrants exercised					217,752
Equity Proceeds From Sale Common Stock Member
Proceeds from issuance of warrant				$ 1,400,000
Proceeds from issuance of common stock				200,000
Issuance cost of common stock				$ 200,000
Additional purchase of common stock				119,117
Public offering price per share				$ 1.70
Sale of common stock at a public offering price				794,117

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cost [Member]
Cash	$ 0	$ 0
Money market funds included in cash and cash equivalents (Note 2)	3,480,000	2,250,000
Total cash and cash equivalents	3,480,000	2,250,000
Fair Value
Cash	1,258,173	1,895,735
Money market funds included in cash and cash equivalents (Note 2)	3,480,000	2,250,000
Total cash and cash equivalents	$ 4,738,173	$ 4,145,735

NET LOSS PER COMMON SHARE (Deta

NET LOSS PER COMMON SHARE (Details) - USD ($)	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Loss per share - basic and diluted
Net loss available to common shareholders - basic and diluted	$ (27,579,921)	$ (32,365,855)
Weighted average shares outstanding - basic and diluted	54,044,989	44,479,865
Basic and diluted loss per common share	$ (0.51)	$ (0.73)

NET LOSS PER COMMON SHARE (De_2

NET LOSS PER COMMON SHARE (Details 1) - shares	12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Antidilutive securities	17,497,800	15,997,278
Options and Warrants
Antidilutive securities	17,350,550	15,850,028
Unvested Restricted Stock [Member]
Antidilutive securities	147,250	147,250

NET LOSS PER COMMON SHARE (De_3

NET LOSS PER COMMON SHARE (Details Narrative)	12 Months Ended
	Sep. 30, 2024 shares
NET LOSS PER COMMON SHARE
Prefunded warrants	1,450,000

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - USD ($)	1 Months Ended		12 Months Ended
	Dec. 31, 2024	Oct. 18, 2024	Sep. 30, 2023
Proceeds from newly issued shares			$ 6,122,497
Subsequent Event Member
Public offering price	$ 0.31
Pre funded warrants offering price	$ 0.3099
Sale of common stock at a public offering price	7,552,500
Proceeds from newly issued shares	$ 5,000,000
Pre-funded warrants to purchase common stock	8,577,500
Subsequent Event Member | Ergomed Group [Member]
Stock issued for services		1,000,000