CEL-SCI (CVM) 10-K 21 Dec 21 2021 FY Annual report Financial data

Cover

Cover - USD ($)	12 Months Ended
	Sep. 30, 2021	Dec. 10, 2021	Mar. 31, 2021
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, 2021
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2021
Entity Common Stock Shares Outstanding		43,244,498
Entity Public Float			$ 595,537,907
Document Annual Report	true
Document Transition Report	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
Local Phone Number	506-9460
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSE
Entity Interactive Data Current	Yes

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Current Assets:
Cash and cash equivalents	$ 36,060,148	$ 15,508,909
U.S. Treasury Bills	6,151,385	0
Receivables	54,922	54,922
Prepaid expenses	998,482	1,313,432
Supplies used for R&D and manufacturing	2,006,584	820,052
Total current assets	45,271,521	17,697,315
Finance lease right of use assets	12,691,921	13,811,849
Operating lease right of use assets	2,056,178	1,198,958
Property and equipment, net	13,663,562	5,843,993
Patent costs, net	275,866	313,422
Deposits	1,910,917	1,670,917
Total assets	75,869,965	40,536,454
Current Liabilities:
Accounts payable	1,675,813	2,023,067
Accrued expenses	859,216	510,515
Due to employees	265,993	448,022
Derivative instruments, current portion	437,380	213,787
Lease liabilities, current portion	698,665	1,070,123
Total current liabilities	3,937,067	4,265,514
Derivative instruments, net of current portion	0	3,551,826
Finance lease liabilities, net of current portion	13,252,364	11,753,100
Operating lease liabilities, net of current portion	2,021,308	1,114,340
Other liabilities	125,000	125,000
Total liabilities	19,335,739	20,809,780
STOCKHOLDERS' EQUITY
Common stock, $.01 par value - 600,000,000 shares authorized;43,207,183 and 38,730,150 shares issued and outstanding at September 30, 2021 and 2020, respectively	432,072	387,302
Additional paid-in capital	474,298,566	401,174,675
Accumulated deficit	(418,196,412)	(381,835,303)
Total stockholders' equity	56,534,226	19,726,674
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 75,869,965	$ 40,536,454

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2021	Sep. 30, 2020
CONDENSED BALANCE SHEETS
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	200,000	200,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	43,207,183	38,730,150
Common stock, shares outstanding	43,207,183	38,730,150

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Grant income	$ 0	$ 558,664
Operating expenses:
Research and development	23,108,897	17,840,290
General and administrative	13,085,232	11,703,429
Total operating expenses	36,194,129	29,543,719
Operating loss	(36,194,129)	(28,985,055)
Other (expense) income	(8,213)	38,763
Loss on derivative instruments	(694,858)	(349,078)
Warrant inducement expense	0	(805,753)
Other non-operating gain	1,685,379	887,604
Interest expense, net	(1,149,288)	(1,041,725)
Net loss	(36,361,109)	(30,255,244)
Modification of warrants	(350,861)	(21,734)
Net loss available to common shareholders	$ (36,711,970)	$ (30,276,978)
Net loss per common share - basic	$ (0.90)	$ (0.82)
Weighted average common shares outstanding - basic	40,662,137	36,759,115
Net loss per common share - diluted	$ (0.93)	$ (0.82)
Weighted average common shares outstanding - diluted	40,694,248	36,759,115

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Sep. 30, 2019		35,231,776
Balance, amount at Sep. 30, 2019	$ 5,133,667	$ 352,318	$ 358,507,603	$ (353,726,254)
Adoption of ASC 842, Leases	2,146,195			2,146,195
Proceeds from the sale of common stock, shares		1,422,429
Proceeds from the sale of common stock, amount	13,992,439	$ 14,225	13,978,214	0
Warrant issuances	805,753	$ 0	805,753	0
Warrant exercises, shares		1,711,873
Warrant exercises, amount	15,144,240	$ 17,118	15,127,122	0
Modification of warrants	5,554	$ 0	5,554
401(k) contributions paid in common stock, shares		13,870
401(k) contributions paid in common stock, amount	163,340	$ 139	163,201	0
Stock issued to nonemployees for service, shares		79,950
Stock issued to nonemployees for service, amount	972,667	$ 799	971,868	0
Equity based compensation - employees	10,112,968	$ 0	10,112,968	0
Option exercises, shares		99,740
Option exercises, amount	338,328	$ 998	337,330	0
Purchase of stock by officers and directors, shares		20,512
Purchase of stock by officers and directors, amount	184,990	$ 205	184,785	0
Share issuance costs	(787,723)	$ 0	(787,723)	0
Shares issued for settlement of clinical research costs, shares		150,000
Shares issued for settlement of clinical research costs, amount	1,769,500	$ 1,500	1,768,000	0
Net loss	(30,255,244)	$ 0	0	(30,255,244)
Balance, shares at Sep. 30, 2020		38,730,150
Balance, amount at Sep. 30, 2020	19,726,674	$ 387,302	401,174,675	(381,835,303)
Proceeds from the sale of common stock, shares		2,610,000
Proceeds from the sale of common stock, amount	47,363,426	$ 26,100	47,337,326	0
Warrant exercises, shares		1,597,870
Warrant exercises, amount	10,007,306	$ 15,978	9,991,328	0
Modification of warrants	24,387	$ 0	24,387	0
401(k) contributions paid in common stock, shares		17,990
401(k) contributions paid in common stock, amount	201,099	$ 180	200,919	0
Stock issued to nonemployees for service, shares		75,885
Stock issued to nonemployees for service, amount	1,195,704	$ 759	1,194,945	0
Equity based compensation - employees	13,685,046	$ (20)	13,685,066	0
Option exercises, shares		149,788
Option exercises, amount	746,228	$ 1,498	744,730	0
Purchase of stock by officers and directors, shares		27,500
Purchase of stock by officers and directors, amount	220,000	$ 275	219,725	0
Share issuance costs	(274,535)	0	(274,535)	0
Net loss	(36,361,109)	$ 0	0	(36,361,109)
Equity based compensation - employees, shares		(2,000)
Balance, shares at Sep. 30, 2021		43,207,183
Balance, amount at Sep. 30, 2021	$ 56,534,226	$ 432,072	$ 474,298,566	$ (418,196,412)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (36,361,109)	$ (30,255,244)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,231,108	2,159,729
Share-based payments for services	1,226,690	862,796
Equity based compensation	13,685,046	10,112,968
Common stock contributed to 401(k) plan	201,099	163,340
Shares issued for settlement of clinical research costs	0	1,769,500
Gain on short-term investments	(5,621)	0
Loss on derivative instruments	694,858	349,078
Warrant inducement expense	0	805,753
Modification of warrants	24,387	5,554
(Increase)/decrease in assets:
Receivables	0	7,843
Prepaid expenses	283,964	(623,608)
Supplies used for R&D and manufacturing	(1,186,532)	(37,689)
Deposits	(240,000)	0
Increase/(decrease) in liabilities:
Accounts payable	445,981	(766,073)
Accrued expenses	363,701	406,083
Due to employees	(182,029)	(261,420)
Other liabilities	31,441	25,229
Net cash used in operating activities	(18,787,016)	(15,276,161)
CASH FLOWS FROM INVESTING ACTIVITIES:
Net purchases of U.S. Treasury Bills	(6,145,764)	0
Purchases of property and equipment	(9,016,329)	(2,654,906)
Expenditures for patent costs	(22,641)	(39,975)
Net cash used in investing activities	(15,184,734)	(2,694,881)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	47,363,426	13,992,439
Payments of stock issuance costs	(325,034)	(752,804)
Proceeds from exercise of warrants	5,984,215	12,072,465
Proceeds from exercises of options	746,228	338,328
Proceeds from the purchase of stock by officers and directors	220,000	184,990
Proceeds from landlord funding of leasehold improvements	1,613,546	0
Payments on obligations under finance leases	(1,079,392)	(800,241)
Net cash provided by financing activities	54,522,989	25,035,177
NET INCREASE IN CASH AND CASH EQUIVALENTS	20,551,239	7,064,135
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR	15,508,909	8,444,774
CASH AND CASH EQUIVALENTS, END OF YEAR	36,060,148	15,508,909
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in accrued expenses and accounts payable	435,412	1,184,723
Capitalizable patent costs included in accrued expenses and accounts payable	6,510	15,000
Changes to right of use assets and liabilities	551,444	399,032
Finance lease obligation included in accounts payable	855	790
Prepaid consulting services paid with issuance of common stock	363,911	164,871
Fair value of warrants liabilities on date of exercise	4,023,091	3,071,775
Financing costs included in accounts payable	0	50,499
Accrued consulting services to be paid with common stock	55,000	55,000
Cash paid for interest	$ 1,173,702	$ 1,155,026

ORGANIZATION

ORGANIZATION	12 Months Ended
	Sep. 30, 2021
ORGANIZATION
1. 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 recently announced top line Phase 3 data 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, radiation and/or chemotherapy. The goal is to help the intact immune system kill the micro metastases that usually cause recurrence of the cancer. CEL-SCI is 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.

OPERATIONS AND FINANCING

OPERATIONS AND FINANCING	12 Months Ended
	Sep. 30, 2021
OPERATIONS AND FINANCING
2. OPERATIONS AND FINANCING	2 . OPERATIONS AND FINANCING On June 28, 2021, the Company announced results from its 9.5 year pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection) in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN). The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm that received Multikine treatment followed by surgery and radiation. This survival benefit was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), control arm 48.6%, Multikine arm 62.7% survival. 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 of laboratory facilities and participation in clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company will be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company believes there is a high likelihood that it will continue to receive funds from private and public offerings and warrant exercises similarly to the way it has substantially funded operations in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. To finance the Company through marketing approval, the Company plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until such time as it is able to raise the required funding. Primarily as a result of CEL-SCI's losses incurred to date, CEL-SCI's expected continued future losses, and the uncertainties associated with obtaining regulatory approval and ultimately commercializing its products, management has identified conditions and events that raise substantial doubt about CEL-SCI's ability to continue as a going concern. Management has evaluated the significance of those conditions and has concluded that because there is more than enough cash on hand to meet the Company's budgeted cash requirements, the substantial doubt about the Company's ability to continue as a going concern for more than twelve months from the date of these financial statements has been alleviated. Impact of COVID-19 Pandemic In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. Management follows the Centers for Disease Control and Prevention’s (“CDC”) guidance and the recommendations and restrictions provided by state and local authorities. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude of impact the pandemic will have on the Company’s financial condition, liquidity and future results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on its financial condition, liquidity, operations, suppliers, industry, and workforce.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Sep. 30, 2021
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 . SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash and Cash Equivalents U.S. Treasury Bills – Supplies used for R&D and manufacturing Property and Equipment Patents Leases – Leases The Company accounts for contracts that convey the right to control the use of identified property, plant or equipment over a period of time in exchange for consideration, as leases upon inception. The Company leases certain real estate, machinery, laboratory equipment and office equipment over varying periods. Many of these leases include an option to either renew or terminate the lease. For purposes of calculating lease liabilities, these options are included in the lease term when it is reasonably certain that the Company will exercise such options. The incremental borrowing rate utilized to calculate the lease liabilities is based on the information available at the commencement date, as most of the leases do not provide an implicit borrowing rate. Short-term leases, defined as leases with initial terms of 12 months or less, are not reflected on the balance sheet. Lease expense for such short-term leases is not material. Derivative Instruments Accounting for Derivative Instruments and Hedging Activities In August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. Stock-Based Compensation Compensation – Stock Compensation In June 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-07, Compensation — Stock Compensation (Topic 718 The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the 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 was based on the U.S. Treasury rate at date of the grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant-dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period. Research and Development Costs Grant Income Net Loss Per Common Share Concentration of Credit Risk Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Use of Estimates New Accounting Pronouncements The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

WARRANTS AND NON-EMPLOYEE OPTIO

WARRANTS AND NON-EMPLOYEE OPTIONS	12 Months Ended
	Sep. 30, 2021
WARRANTS AND NON-EMPLOYEE OPTIONS
4. WARRANTS AND NON-EMPLOYEE OPTIONS	4. WARRANTS AND NON-EMPLOYEE OPTIONS The following warrants and non-employee options are outstanding at September 30, 2021: Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 8/18/2022 Series UU 6/11/2018 93,603 $ 2.80 6/30/2022 Series X 1/13/2016 120,000 $ 9.25 7/13/2022 Series Y 2/15/2016 26,000 $ 12.00 8/15/2022 Series Z 5/23/2016 184,800 $ 13.75 11/23/2021 Series CC 12/8/2016 15,845 $ 5.00 12/8/2021 Series HH 2/23/2017 200 $ 3.13 2/16/2022 Series AA 8/26/2016 100,000 $ 13.75 2/22/2022 Series MM 6/22/2017 333,432 $ 1.86 6/22/2022 Series NN 7/24/2017 210,087 $ 2.52 7/24/2022 Series RR 10/30/2017 251,761 $ 1.65 10/30/2022 Series SS 12/19/2017 200,000 $ 2.09 12/18/2022 Series TT 2/5/2018 600 $ 2.24 2/5/2023 Consultants 7/28/2017 – 11/18/2020 15,000 $ 2.18 - $11.61 11/17/2022 - 7/27/2027 The following warrants and non-employee options are outstanding at September 30, 2020: Warrant Issue Date Shares Issuable upon Exercise of Warrants/Options Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 2/18/2021 Series UU 6/11/2018 93,603 $ 2.80 12/31/2020 Series W 10/28/2015 688,930 $ 16.75 10/28/2020 Series X 1/13/2016 120,000 $ 9.25 1/13/2021 Series Y 2/15/2016 26,000 $ 12.00 2/15/2021 Series ZZ 5/23/2016 20,000 $ 13.75 5/18/2021 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 Series Z 5/23/2016 264,000 $ 13.75 11/23/2021 Series CC 12/8/2016 148,643 $ 5.00 12/8/2021 Series HH 2/23/2017 200 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series MM 6/22/2017 797,633 $ 1.86 6/22/2022 Series NN 7/24/2017 348,842 $ 2.52 7/24/2022 Series RR 10/30/2017 417,649 $ 1.65 10/30/2022 Series SS 12/19/2017 326,064 $ 2.09 12/18/2022 Series TT 2/5/2018 371,564 $ 2.24 2/5/2023 Consultants 7/28/17 10,000 $ 2.18 7/27/2027 A. Warrant Liabilities Warrant liabilities outstanding at September 30 are as follows: 2021 2020 Series W warrants $ - $ 73,570 Series Z warrants 64,787 1,207,902 Series ZZ warrants - 75,044 Series AA warrants 276,035 1,082,212 Series BB warrants - 65,173 Series CC warrants 94,961 1,259,712 Series HH warrants 1,597 2,000 Total warrant liabilities $ 437,380 $ 3,765,613 The (losses)/gains on the warrant liabilities for the years ended September 30 are as follows: 2021 2020 Series V Warrants $ - $ 185,652 Series W warrants 73,570 1,119,937 Series Z warrants 252,115 (98,357 ) Series ZZ warrants (98,692 ) 2,594 Series AA warrants (318,823 ) (165,304 ) Series BB warrants 65,173 (1,207 ) Series CC warrants (668,605 ) (875,040 ) Series FF warrants - (319,706 ) Series HH warrants 404 (34,589 ) Series JJ warrants - (64,992 ) Series LL warrants - (98,066 ) Net loss on warrant liabilities $ (694,858 ) $ (349,078 ) The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded. In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting periods is recognized as a gain or loss in the statement of operations. Changes in Warrant Liabilities On August 22, 2021, 16,000 Series BB warrants, with an exercise price of $13.75 expired. On October 28, 2020, 688,930 Series W warrants, with an exercise price of $16.75 expired. On May 26, 2020, the Company lowered the exercise price of 810,127 Series V warrants from $19.75 to $13.75 per share and extended the expiration dates of the Series V warrants from May 28, 2020 to June 25, 2020. The incremental cost of this modification was approximately $664,000, which was included in the net loss on derivatives for the year ended September 30, 2020. On June 25, 2020, 135,963 Series V warrants, with an exercise price of $13.75 expired. The warrants were valued at approximately $211,000 on the date of expiration. Exercise of Warrant Liabilities The following warrants recorded as liabilities were exercised during the year ended September 30, 2021: Warrants Warrants Exercised Exercise Price Proceeds Series Z 79,200 $ 13.75 $ 1,089,000 Series ZZ 20,000 $ 13.75 275,000 Series AA 100,000 $ 13.75 1,375,000 Series CC 132,798 $ 5.00 663,990 331,998 $ 3,402,990 The following warrants recorded as liabilities were exercised during the year ended September 30, 2020: Warrants Warrants Exercised Exercise Price Proceeds Series V 674,164 $ 13.75 $ 9,269,755 Series CC 128,820 $ 5.00 644,100 Series FF 68,048 $ 3.91 265,812 Series HH 6,300 $ 3.13 19,687 Series JJ 9,450 $ 3.13 29,531 Series LL 26,398 $ 3.59 94,867 913,180 $ 10,323,752 B. Equity Warrants Changes in Equity Warrants On December 7, 2020, the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended six months. On June 28, 2021, the expiration dates of these same warrants were extended one year. The incremental costs of both warrant extensions were recorded consistent with the accounting for the initial warrant issuances. The incremental costs of the Series N and Series X warrant extensions were recorded as a deemed dividend and totaled approximately $351,000 for the year ended September 30, 2021. The Series N and Series X warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. The incremental cost of the Series Y warrants extension approximated $103,000 and had no impact on the financial statements for the year ended September 30,2021 due to offsetting entries recorded within additional paid in capital. The incremental cost of the Series UU warrant extension was recorded as interest expense, because these warrants were initially issued as an inducement to convert notes payable into common stock, and totaled approximately $24,000 for the year ended September 30, 2021. The Series UU warrants are held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust. On May 26, 2020, the Company provided that for each Series V liability warrant exercised on or before June 10, 2020, the former holder of the Series V warrant received one Series XX warrant. Each Series XX warrant allowed the holder to purchase one share of the Company's common stock at a price of $18.00 per share at any time on or before September 10, 2020. For each Series V liability warrant exercised after June 10, 2020 but on or before June 25, 2020, the former holder of the Series V warrant received one Series YY warrant. Every two Series YY warrants allowed the holder to purchase one share of the Company's common stock at a price of $20.00 per share at any time on or before September 25, 2020. In June 2020, 461,953 Series XX warrants and 101,839 Series YY warrants were issued to the former holders of the Series V warrants. The Series XX and YY warrants qualified for equity treatment in accordance with ASC 815. The Company recognized a warrant inducement expense equal to the fair value of the Series XX and Series YY warrants issued as of the date the inducement offers were accepted. The fair values of the Series XX and Series YY warrants were calculated to be approximately $629,000 and $177,000, respectively. The total expense of approximately $806,000 is reported as warrant inducement expense in the statement of operations for the year ended September 30, 2020. All Series XX and YY warrants expired in September 2020. On May 8, 2020, the expiration dates of 93,593 Series UU warrants were extended from June 11, 2020 to December 31, 2020. These warrants were previously issued as an inducement to convert notes payable into shares of common stock. The incremental cost of this extension was approximately $6,000 and was recorded as interest expense during the year ended September 30, 2020. The Series 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 January 23, 2020, the expiration date of the Series N warrants was extended to February 18, 2021. The incremental cost of this extension was approximately $22,000, which was recorded as a deemed dividend in the financial statements for the year ended September 30, 2020. The Series N warrants are held by the de Clara Trust. Exercise of Equity Warrants The following equity warrants were exercised during the year ended September 30, 2021. Warrants Warrants Exercised Exercise Price Proceeds Series MM 464,201 $ 1.86 $ 863,414 Series NN 138,755 $ 2.52 349,663 Series RR 165,888 $ 1.65 273,715 Series SS 126,064 $ 2.09 263,474 Series TT 370,964 $ 2.24 830,959 1,265,872 $ 2,581,225 The following equity warrants were exercised during the year ended September 30, 2020. Warrants Warrants Exercised Exercise Price Proceeds Series MM 95,858 $ 1.86 $ 178,296 Series NN 124,956 $ 2.52 314,889 Series OO 50,000 $ 2.52 126,000 Series RR 39,467 $ 1.65 65,121 Series SS 156,580 $ 2.09 327,252 Series TT 188,125 $ 2.24 421,400 Series UU 61,207 $ 2.80 171,380 Series VV 82,500 $ 1.75 144,375 798,693 $ 1,748,713 C. 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, 2021 and 2020 the Company issued 75,885 and 79,950 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 $6.86 to $24.95 per share. The weighted average grant price was $15.46 and $12.01, respectively, for stock issued during the years ended September 30, 2021 and 2020. During the years ended September 30, 2021 and 2020, the Company recorded total expense of approximately $1,227,000 and $863,000, respectively, relating to these consulting agreements. At September 30, 2021 and 2020, costs of approximately $364,000 and $395,000, respectively, are included in prepaid expenses. During the year ended September 30, 2021, the Company issued 5,000 options to a consultant to purchase common stock with an exercise price of $11.61 and an expiration of November 17, 2022. No options were issued to consultants during the year ended September 30, 2020. As of September 30, 2021, 15,000 options issued to consultants as payment for services remained outstanding, all of which were issued from the Non-Qualified Stock Option plan and are fully vested.

PLANT, PROPERTY AND EQUIPMENT

PLANT, PROPERTY AND EQUIPMENT	12 Months Ended
	Sep. 30, 2021
PLANT, PROPERTY AND EQUIPMENT
5. PLANT, PROPERTY AND EQUIPMENT	5. PROPERTY AND EQUIPMENT Property and equipment consisted of the following at September 30: 2021 2020 Research equipment $ 4,211,124 $ 3,898,242 Furniture and equipment 99,768 99,768 Leasehold improvements 13,465,123 5,519,161 17,776,015 9,517,171 Accumulated depreciation and amortization (4,112,453 ) (3,673,178 ) Net property and equipment $ 13,663,562 $ 5,843,993 Depreciation expense for the years ended September 30, 2021 and 2020 totaled approximately $447,000 and $389,000 respectively.

PATENTS

PATENTS	12 Months Ended
	Sep. 30, 2021
PATENTS
6. PATENTS	6 . PATENTS Patents consist of the following at September 30: 2021 2020 Patents $ 910,523 $ 896,372 Accumulated amortization (634,657 ) (582,950 ) Patents, net $ 275,866 $ 313,422 During the years ended September 30, 2021 and 2020, there was no impairment of patent costs. Amortization expense for the years ended September 30, 2021 and 2020 totaled approximately $52,000 and $53,000, respectively. The total estimated future amortization is as follows: Years ending September 30, 2022 $ 49,000 2023 39,000 2024 31,000 2025 29,000 2026 25,000 Thereafter 103,000 $ 276,000

INCOME TAXES

INCOME TAXES	12 Months Ended
	Sep. 30, 2021
INCOME TAXES
7. INCOME TAXES	7 . INCOME TAXES At September 30, 2021 and 2020, the Company had net deferred tax assets of $44.1 million and $35.5 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 asset 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 for the year ended September 30, 2021 occurred and no such shifts 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 $77.1 million and $51.5 million at September 30, 2021 and 2020, respectively. Approximately $19.2 million of the NOL carryforwards begin to expire during the year ended September 30, 2022 and become fully expired by 2038 and approximately $57.9 million of NOL carryforwards, which were generated post 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 $1.2 million at September 30, 2021 and 2020. The R&D credit expires during the fiscal year ended 2029. Significant components of the Company’s deferred tax assets as of September 30, 2021 and 2020 are listed below: 2021 2020 NOL carryforwards $ 19,789,000 $ 13,407,000 Lease liabilities 4,101,000 3,631,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 7,785,000 5,297,000 Capitalized R&D 15,040,000 15,853,000 Vacation and other 126,000 125,000 Total deferred tax assets 48,062,000 39,534,000 Right of use assets (3,786,000 ) (3,911,000 ) Fixed assets and intangibles (172,000 ) (169,000 ) Total deferred tax liability (3,958,000 ) (4,080,000 ) Net deferred tax asset 44,104,000 35,454,000 Valuation allowance (44,104,000 ) (35,454,000 ) 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 at for the years ended September 30: 2021 2020 Federal Rate 21.00 % 21.00 % State rate change (1.37 ) (1.40 ) State tax rate, net of federal benefit 4.72 5.15 Other adjustments (0.79 ) (3.24 ) Permanent differences 0.23 0.42 Change in valuation allowance (23.79 ) (21.93 ) Effective tax rate 0.00 % 0.00 % The Company applies the provisions of ASC 740, “Accounting for Uncertainty in Income Taxes,”

STOCK COMPENSATION

STOCK COMPENSATION	12 Months Ended
	Sep. 30, 2021
STOCK COMPENSATION
8. STOCK COMPENSATION	8 . STOCK COMPENSATION The Company recognized the following expenses for options issued or vested and restricted stock awarded during the year: Year Ended September 30, 2021 2020 Employees $ 13,685,046 $ 10,112,968 Non-employees $ 1,226,690 $ 862,796 During the years ended September 30, 2021 and 2020 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. 2021 2020 Expected stock price volatility 90.42 – 97.22% 87.36 – 90.26% Risk-free interest rate 0.85 – 1.65% 0.62 – 1.87% Expected life of options 9.68 – 9.69 Years 9.68 – 9.69 Years Expected dividend yield - - Non-Qualified Stock Option Plan s During the year ended September 30, 2021, the Company adopted the 2021 Non-Qualified Stock Option Plan, which provides for the issuance of up to 1,800,000 options to purchase shares of common stock. On May 14, 2021, the Company granted 1,800,000 performance-based stock options from the 2021 Non-Qualified Stock Option Plan and 72,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers and directors. Each option entitles the holder to purchase one share of the Company's common stock at a price of $20.61 per share, the fair value on the date of issuance. The stock options will vest 100% upon the achievement of the following performance goals: (a) the filing of the first marketing application for any pharmaceutical based upon the Company's Multikine technology, in the US, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia or (b) the closing price of the Company's common stock exceeds $42.00. None of the options will be exercisable before May 13, 2022. All options which have not vested as of May 13, 2031, will be canceled and will no longer be exercisable. The options were recorded in permanent equity in accordance with ASC 718, Compensation – Stock Compensation. On the grant date, the options were valued using a Monte Carlo Simulation approach. Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. That valuation resulted in a per share fair value of $0.34 and an aggregate value of approximately $636,000 on the grant date. The aggregate value will be expensed over the requisite service period of the options, which was determined to be 1.3 years. This resulted in compensation expense of approximately $189,000 recorded during the year ended September 30, 2021. The remaining $447,000 will be expensed over the next 11 months. During the year ended September 30, 2020, the Company adopted the 2020 Non-Qualified Stock Option Plan, which provides for the issuance of up to 3,600,000 options to purchase shares of common stock. On April 20, 2020, the Company granted 1,872,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers and directors. Each option entitles the holder to purchase one share of the Company's common stock at a price of $10.93 per share, the fair value on the date of issuance. The stock options vest upon the achievement of the following market conditions: i) 25% of the options will vest when the closing price of the Company's common stock exceeds $20.00 for ten consecutive trading days; ii) 50% of the options will vest when the closing price of the Company's common stock exceeds $25.00 for ten consecutive trading days; and iii) 75% of the options will vest when the closing price of the Company's common stock exceeds $30.00 for ten consecutive trading days. Additionally, 100% of the options will vest when either (a) the first marketing application for any pharmaceutical based upon the Company's Multikine technology, in the US, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia is filed, i.e., the performance condition, or (b) the closing price of the Company's common stock exceeds $40.00 for ten consecutive trading days. All options which have not vested as of April 19, 2030, will be canceled and will no longer be exercisable. The options were recorded as permanent equity in accordance with ASC 718, Compensation – Stock Compensation. On the grant date, the options were valued using a Monte Carlo Simulation approach. That valuation resulted in a per share fair value of $4.21 and an aggregate value of approximately $7.9 million on the grant date. The aggregate value will be expensed over the requisite service period of the options, which was originally determined to be 1.7 years. In May 2021, it became probable that the performance condition would be met approximately 8 months later than originally estimated. Because the valuation and related requisite service period were based on achievement of the performance condition, the Company adjusted the requisite service period when it became probable that the marketing application would be filed within a different period. Compensation expense relating to this Plan was approximately $3.8 million and $2.1 million during the years ended September 30, 2021 and 2020, respectively. The remaining $2.0 million will be expensed over the next 11 months. At September 30, 2021, the Company has collectively authorized the issuance of 11,787,200 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, 2021 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, 2019 6,218,216 $ 5.54 8.88 $ 29,562,594 1,392,241 $ 9.15 7.68 $ 7,869,555 Vested 2,014,501 $ 4.06 Granted 2,563,000 $ 10.93 Exercised 99,740 $ 3.39 99,740 $ 3.39 Forfeited 18,000 $ 10.34 Expired 9,773 $ 132.75 9,773 $ 132.75 Outstanding at September 30, 2020 8,653,703 $ 7.01 8.39 $ 56,193,415 3,297,229 $ 5.85 7.48 $ 29,090,662 Vested 2,401,961 $ 6.26 Granted (a) 2,605,000 $ 20.58 Exercised 149,788 $ 4.98 149,788 $ 4.98 Forfeited 49,832 $ 9.56 Expired 9,374 $ 172.73 9,374 $ 172.73 Outstanding at September 30, 2021 11,049,709 $ 10.08 7.93 $ 54,843,283 5,540,028 $ 5.77 6.96 $ 43,589,598 ______________ (a) Includes 1,872,000 performance based options issued to officers and directors, 728,000 options issued to employees and 5,000 options issued to Consultants. A summary of the status of the Company’s non-vested options for the two years ended September 30, 2021 is presented below: Number of Options Weighted Average Grant Date Fair Value Unvested at September 30, 2019 4,825,975 $ 3.79 Vested (2,014,501 ) Granted 2,563,000 Forfeited (18,000 ) Unvested at September 30, 2020 5,356,474 $ 4.76 Vested (2,401,961 ) Granted 2,605,000 Forfeited (49,832 ) Unvested at September 30, 2021 5,509,681 $ 5.17 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, 2021 is presented below: Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2019 304,500 $ 13.75 Forfeited - Vested - Unvested at September 30, 2020 304,500 $ 13.75 Forfeited (2,000 ) Vested (151,250 ) Unvested at September 30, 2021 151,250 $ 13.75 Stock Bonus Plans Stock Compensation Plan s

EMPLOYEE BENEFIT PLAN

EMPLOYEE BENEFIT PLAN	12 Months Ended
	Sep. 30, 2021
EMPLOYEE BENEFIT PLAN
9. 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, 2021, 17,990 shares were issued to the Company’s 401(k) plan for a cost of approximately $201,000. During the year ended September 30, 2020, 13,870 shares were issued to the Company’s 401(k) plan for a cost of approximately $163,000.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Sep. 30, 2021
Commitments and Contingencies
10. COMMITMENTS AND CONTINGENCIES	10 . COMMITMENTS AND CONTINGENCIES Clinical Research Agreements In April 2013, the Company entered into a co-development and revenue sharing agreement with Ergomed. Under the agreement, Ergomed will contribute up to $10 million towards the Company’s Phase III clinical study in the form of offering discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. In October 2015, the Company entered into a second co-development and revenue sharing agreement with Ergomed for an additional $2 million, for a total of $12 million. The Company accounted for the co-development and revenue sharing agreement in accordance with ASC 808 “Collaborative Arrangements”. The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the Company entered into the co-development and revenue sharing agreement with Ergomed, it has incurred research and development expenses of approximately $35.1 million related to Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.6 million. During the years ended September 30, 2021 and 2020, the Company recorded approximately $1.6 million and $2.0 million, respectively, as research and development expense related to Ergomed’s services. These amounts were net of Ergomed’s discount of approximately $0.6 million during both the years ended September 30, 2021 and 2020. Lease Agreements The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease, which expires in October 2028. The renewal options are not included in the calculation of the right of use asset and lease liability because exercise of those options is not reasonably certain. Upon adoption of ASC 842 on October 1, 2019, the Company recorded a finance lease right of use asset of approximately $16.5 million and a finance lease liability of approximately $13.5 million. As of September 30, 2021 and 2020, respectively, the net book value of the finance lease right of use asset is approximately $12.7 million and $13.8 million and the balance of the finance lease liability is approximately $13.8 million and $12.7 million, of which approximately $0.6 million and $0.9 million is current. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. The finance right of use assets are being amortized using a straight-line method over the underlying lease terms and totaled approximately $1,732,000 and $1,717,000 in the years ended September 30, 2021 and 2020, respectively. Total cash paid related to finance leases during the years ended September 30, 2021 and 2020, respectively, was approximately $2.2 million and $1.9 million, of which approximately $1.2 million was for interest in both years. The weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 7.1 years. In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The estimated cost of the upgrades is $10.7 million, of which approximately $10.5 million has been incurred as of September 30, 2021. The landlord agreed to finance the final $2.4 million of the costs incurred which will be repaid through increased lease payments over the remaining lease term starting on March 1, 2021. The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the lease liability to account for the modified payments using a 8.45% implicit interest rate. The rate was determined using a synthetic credit rating analysis prepared by an outside valuation specialist. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability as it is realized. Approximately $1.6 million was received from the landlord as of September 30, 2021. The leasehold improvements are recorded in property and equipment and will be amortized over the remaining lease term when the assets are placed in service. During June 2021, the Company determined that it used an incorrect discount rate to calculate the opening ROU asset and lease liability balances upon adoption of ASC 842. Management engaged an outside valuation specialist to perform a synthetic credit rating analysis which resulted in a revised rate to be used upon adoption of ASC 842 of 10.19% compared to the previously used rate of 8.80%. This change resulted in an immaterial difference to the September 30, 2020 financial statements, and was corrected in the quarterly period ended June 30, 2021 as an out of period adjustment. The Company was required to deposit the equivalent of one year of base rent in accordance with the original lease. Under the landlord’s $2.4 million financing arrangement, the Company was required to deposit an additional $0.2 million in March 2021. As September 30, 2021 and 2020, respectively, the approximate $1.9 million and $1.7 million deposit is included in non-current assets. Approximate future minimum lease payments under finance leases as of September 30, 2021 are as follows: Year ending September 30, 2022 $ 1,699,000 2023 2,569,000 2024 2,648,000 2025 2,733,000 2026 2,824,000 Thereafter 6,186,000 Total future minimum lease obligation * 18,659,000 Less imputed interest on finance lease obligations (4,825,000 ) Net present value of lease finance lease obligations $ 13,834,000 * Amount is net of landlord incentive of approximately $0.8 million expected to be realized in quarter ended December 31, 2021. Effective April 30, 2020, the Company terminated a month-to-month arrangement with a sub-lessee as the sub-leased space was needed to prepare the facility to produce Multikine for commercial purposes and before the Company’s Biologics License Application (BLA) can be submitted to the FDA. The sublease rental income for the year ended September 30, 2020 was approximately $39,000. 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 March 29, 2032. The renewal was considered a modification for accounting purposes and the right of use asset and liability were remeasured as of the date of the renewal. This resulted in an increase of approximately $1.1 million to the operating lease right of use asset and liability. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the terms of the leases. Upon adoption of ASC 842 on October 1, 2019, the Company recorded an operating lease right of use asset and an operating lease liability of approximately $1.0 million. As of September 30, 2021, the net book value of the operating lease right of use asset is approximately $2.1 million and the balance of the operating lease liability is approximately $2.1 million, of which approximately $0.1 million is current. As of September 30, 2020, the net book value of the operating lease right of use asset is approximately $1.2 million and the balance of the operating lease liability is approximately $1.2 million, of which approximately $0.1 million is current. The Company incurred lease expense under operating leases of approximately $0.2 million for each of the years ended September 30, 2021 and 2020. Total cash paid related to operating leases during the years ended September 30, 2021 and 2020 was approximately $0.3 million and $0.2 million, respectively. The weighted average discount rate of the Company’s operating leases is 9.12% and the weighted average time to maturity is 9.7 years. As of September 30, 2021, future minimum lease payments on operating leases are as follows: Year ending September 30, 2022 $ 309,000 2023 348,000 2024 357,000 2025 366,000 2026 287,000 Thereafter 1,602,000 Total future minimum lease obligation 3,269,000 Less imputed interest on operating lease obligation (1,130,000 ) Net present value of operating lease obligation $ 2,139,000 Vendor Obligations The Company has contingent obligations with vendors for work that will be completed in relation to the Phase 3 clinical trial. The timing of these obligations cannot be determined at this time. The Company estimates it will incur additional expenses of approximately $1.1 million for the remainder of the Phase 3 clinical trial and the filing of the clinical study report with the FDA. This estimate is based only on the information currently available from the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	12 Months Ended
	Sep. 30, 2021
RELATED PARTY TRANSACTIONS
11. RELATED PARTY TRANSACTIONS	1 1 . RELATED PARTY TRANSACTIONS During the year ended September 30, 2021, the de Clara Trust, of which the Company’s CEO, Geert Kerston, is a beneficiary, and two directors purchased 27,500 restricted shares of the Company’s common stock at an aggregate fair market value of approximately $220,000. During the year ended September 30, 2020, officers and directors of the Company purchased 20,512 shares of restricted common stock at market price at an aggregate fair market value of approximately $185,000. The shares are subject to the conditions of Rule 144 under the Securities Act of 1933. On June 28, 2021, the expiration dates of the Series N and Series X warrants held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary, were extended by twelve months (Note 4). The incremental cost of these modifications was approximately $265,000 and was recorded as a deemed dividend in the financial statements for the year ended September 30, 2021. On June 28, 2021, the expiration date of 93,603 Series UU warrants was extended by twelve months (Note 4). The incremental cost of this extension was $24,000 and was recorded as interest expense for the year ended September 30, 2021. The Series UU warrants are held by certain officers of the Company and the de Clara Trust and were originally issued with convertible debt. On December 7, 2020, the expiration dates of the Series N and Series X warrants held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary, were extended by six months (Note 4). The incremental cost of these modifications was approximately $86,000 and was recorded as a deemed dividend in the financial statements for the year ended September 30, 2021. On December 7, 2020, the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021. The incremental cost of this extension was $192 and was recorded as interest expense for the year ended September 30, 2021. The Series UU warrants are held by certain officers of the Company and were originally issued with convertible debt. On May 8, 2020, the expiration date of 93,593 Series UU warrants were extended from June 11, 2020 to December 31, 2020. The incremental cost of this extension was approximately $6,000 and was recorded as interest expense for the year ended September 30, 2020. The Series UU warrants are held by the Company’s officers and were originally issued with convertible debt. On January 23, 2020, the expiration date of the Series N warrants was extended to February 18, 2021. The incremental cost of this extension was approximately $22,000, which was recorded as a deemed dividend in the financial statements for the year ended September 30, 2020. The Series N warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary.

STOCKHOLDERS EQUITY

STOCKHOLDERS EQUITY	12 Months Ended
	Sep. 30, 2021
STOCKHOLDERS EQUITY
12. STOCKHOLDERS' EQUITY	12. STOCKHOLDERS’ EQUITY Exercise of Warrants During the years ended September 30, 2021 and 2020, the Company received proceeds of approximately $6.0 million and $12.1 million, respectively, from the exercise of warrants, as detailed in Note 4. Upon exercise, 1,597,870 and 1,711,873 shares of common stock were issued during the years ended September 30, 2021 and 2020, respectively. Sales of Securities In June 2021, the Company sold 1,400,000 shares of common stock at a public offering price of $22.62 per share and received aggregate net proceeds of approximately $29.4 million. At that time, the underwriters fully exercised their option to purchase up to 210,000 additional shares of common stock to cover over-allotments, resulting in additional net proceeds to the Company of approximately $4.4 million. In December 2020, the Company sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. In March 2020, the Company sold 630,500 shares of common stock at a public offering price of $12.22 per share and received aggregate net proceeds of approximately $7.1 million. Under the terms of the Underwriting Agreement the Company granted the Underwriters a 45-day option to purchase up to an additional 94,575 shares of common stock solely to cover over-allotments. The underwriter fully exercised this option in May 2020 resulting in additional net proceeds to the Company of approximately $1.1 million. In December 2019, the Company sold 606,395 shares of common stock at a public offering price of $9.07 per share and received aggregate net proceeds of approximately $5.0 million. In January 2020, the underwriters of that offering fully exercised the option to purchase 90,959 additional shares of common stock at the public offering price of $9.07 per share for aggregate net proceeds to the Company of approximately $0.8 million. Other Equity Transactions The Company entered into Securities Purchase Agreements (SPA) with Ergomed plc, one of the Company’s Clinical Research Organizations responsible for managing the Company’s Phase 3 clinical trial, to facilitate payment of amounts due Ergomed. Under the Agreements, the Company issued Ergomed shares of common stock and the net proceeds from the sales of those shares reduces outstanding amounts due Ergomed. Upon issuance, the Company expenses the full value of the shares as Other non-operating gain/loss and subsequently offsets the expense as amounts are realized through the sale by Ergomed and reduces accounts payable to Ergomed. During the year ended September 30, 2020, the Company issued Ergomed 150,000 shares. No shares were issued during the year ended September 30, 2021. All outstanding shares have been resold as of September 30, 2021 and the Company has approximately $500,000 in amounts prepaid to Ergomed. The following table summarizes the Other Non-operating gains (losses) for the years ended September 30 relating to these agreements: 2021 2020 Amount realized through the resale of shares $ 1,685,379 $ 2,652,605 Fair value of shares upon issuance - 1,769,500 Other non-operating gain $ 1,685,379 $ 883,105 As of September 30, 2021, all shares held for resale were sold.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	12 Months Ended
	Sep. 30, 2021
FAIR VALUE MEASUREMENTS
13. FAIR VALUE MEASUREMENTS	1 3 . FAIR VALUE MEASUREMENTS In accordance with the provisions of ASC 820, “ Fair Value Measurements 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: o Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities o 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 inputs other than quoted prices that are observable for the asset or liability o 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 purchased short-term T-bills during the year ended September 30, 2021 that are classified as trading securities. Quoted market prices were applied to determine the fair value of short-term investments, therefore they were categorized as Level 1 on the fair value hierarchy. The T-bills were recorded at fair market value, which includes an unrealized gain of approximately $6,000. The T-bills mature in December 2021 and yield a weighted average interest rate of 0.10%. As of September 30, 2021 and 2020, all of the Company’s derivative liabilities are classified as Level 3. The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3), as of September 30: 2021 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (4,023,091 ) (3,071,775 ) N Net realized and unrealized derivative loss 694,858 349,078 Ending balance $ 437,380 $ 3,765,613 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock. At September 30, 2021, the Company’s Level 3 derivative instruments have a weighted average fair value of $1.45 per share and a weighted average exercise price of $13.28 per share. Fair values were determined using a weighted average risk free interest rate of 0.05% and volatility of 109%. The instruments have a weighted average time to maturity of 0.3 years. At September 30, 2020, the Company’s Level 3 derivative instruments have a weighted average fair value of $2.81 per share and a weighted average exercise price of $14.32 per share. Fair values were determined using a weighted average risk free interest rate of 0.12% and volatility of 95%. The instruments have a weighted average time to maturity of 1.2 years.

NET LOSS PER COMMON SHARE

NET LOSS PER COMMON SHARE	12 Months Ended
	Sep. 30, 2021
NET LOSS PER COMMON SHARE
14. 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. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants and restricted stock have not been included in the computation of diluted net loss per share for all periods presented, as the result would be anti-dilutive. For the years presented, the gain on derivative instruments is not included in net loss available to common shareholders for purposes of computing dilutive loss per share because its effect is anti-dilutive. The following table provides a reconciliation of the numerators and denominators of the basic and diluted per-share computations: Year ended September 30, 2021 2020 Loss per share – basic Net loss available to common shareholders - basic $ (36,711,970 ) $ (30,276,978 ) Weighted average shares outstanding - basic 40,662,137 36,759,115 Basic loss per common share $ (0.90 ) $ (0.82 ) Loss per share – diluted Net loss available to common shareholders - basic $ (36,711,970 ) $ (30,276,978 ) Unrealized gain on derivatives (1) (1,085,540 ) - Net loss available to common shareholders - diluted $ (37,797,510 ) $ (30,276,978 ) Weighted average shares outstanding - basic 40,662,137 36,759,115 Incremental shares underlying dilutive warrants (1) 32,111 - Weighted average shares outstanding - diluted 40,694,248 36,759,115 Diluted loss per common share $ (0.93 ) $ (0.82 ) (1) Includes Series Z, AA, CC and HH warrants for the year ended September 30, 2021. In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2021 2020 Options and Warrants 10,604,850 7,221,696 Unvested Restricted Stock 151,250 308,814 Total 10,756,100 7,530,510

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	12 Months Ended
	Sep. 30, 2021
SUBSEQUENT EVENTS
15. SUBSEQUENT EVENTS	15. SUBSEQUENT EVENTS The Company has evaluated subsequent events through the date these financial statements were filed and determined there are no subsequent events that require disclosure.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Sep. 30, 2021
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents	Cash and Cash Equivalents
U.S. Treasury Bills	U.S. Treasury Bills –
Supplies used for R&D and manufacturing
Property and Equipment	Property and Equipment
Patents	Patents
Leases	Leases – Leases
Derivative Instruments	Derivative Instruments Accounting for Derivative Instruments and Hedging Activities In August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity.
Stock-Based Compensation	Stock-Based Compensation Compensation – Stock Compensation In June 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-07, Compensation — Stock Compensation (Topic 718 The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the 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 was based on the U.S. Treasury rate at date of the grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant-dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.
Research and Development Costs	Research and Development Costs
Grant Income	Grant Income
Net Loss Per Common Share	Net Loss Per Common Share
Concentration of Credit Risk	Concentration of Credit Risk
Income Taxes	Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
Use of Estimates	Use of Estimates
New Accounting Pronouncements	The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

WARRANTS AND NON-EMPLOYEE OPT_2

WARRANTS AND NON-EMPLOYEE OPTIONS (Tables)	12 Months Ended
	Sep. 30, 2021
WARRANTS AND NON-EMPLOYEE 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 8/18/2022 Series UU 6/11/2018 93,603 $ 2.80 6/30/2022 Series X 1/13/2016 120,000 $ 9.25 7/13/2022 Series Y 2/15/2016 26,000 $ 12.00 8/15/2022 Series Z 5/23/2016 184,800 $ 13.75 11/23/2021 Series CC 12/8/2016 15,845 $ 5.00 12/8/2021 Series HH 2/23/2017 200 $ 3.13 2/16/2022 Series AA 8/26/2016 100,000 $ 13.75 2/22/2022 Series MM 6/22/2017 333,432 $ 1.86 6/22/2022 Series NN 7/24/2017 210,087 $ 2.52 7/24/2022 Series RR 10/30/2017 251,761 $ 1.65 10/30/2022 Series SS 12/19/2017 200,000 $ 2.09 12/18/2022 Series TT 2/5/2018 600 $ 2.24 2/5/2023 Consultants 7/28/2017 – 11/18/2020 15,000 $ 2.18 - $11.61 11/17/2022 - 7/27/2027 Warrant Issue Date Shares Issuable upon Exercise of Warrants/Options Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 2/18/2021 Series UU 6/11/2018 93,603 $ 2.80 12/31/2020 Series W 10/28/2015 688,930 $ 16.75 10/28/2020 Series X 1/13/2016 120,000 $ 9.25 1/13/2021 Series Y 2/15/2016 26,000 $ 12.00 2/15/2021 Series ZZ 5/23/2016 20,000 $ 13.75 5/18/2021 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 Series Z 5/23/2016 264,000 $ 13.75 11/23/2021 Series CC 12/8/2016 148,643 $ 5.00 12/8/2021 Series HH 2/23/2017 200 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series MM 6/22/2017 797,633 $ 1.86 6/22/2022 Series NN 7/24/2017 348,842 $ 2.52 7/24/2022 Series RR 10/30/2017 417,649 $ 1.65 10/30/2022 Series SS 12/19/2017 326,064 $ 2.09 12/18/2022 Series TT 2/5/2018 371,564 $ 2.24 2/5/2023 Consultants 7/28/17 10,000 $ 2.18 7/27/2027
Schedule of equity warrants were exercised	Warrants Warrants Exercised Exercise Price Proceeds Series MM 464,201 $ 1.86 $ 863,414 Series NN 138,755 $ 2.52 349,663 Series RR 165,888 $ 1.65 273,715 Series SS 126,064 $ 2.09 263,474 Series TT 370,964 $ 2.24 830,959 1,265,872 $ 2,581,225 Warrants Warrants Exercised Exercise Price Proceeds Series MM 95,858 $ 1.86 $ 178,296 Series NN 124,956 $ 2.52 314,889 Series OO 50,000 $ 2.52 126,000 Series RR 39,467 $ 1.65 65,121 Series SS 156,580 $ 2.09 327,252 Series TT 188,125 $ 2.24 421,400 Series UU 61,207 $ 2.80 171,380 Series VV 82,500 $ 1.75 144,375 798,693 $ 1,748,713
Schedule of warrants recorded as liabilities were exercised	Warrants Warrants Exercised Exercise Price Proceeds Series Z 79,200 $ 13.75 $ 1,089,000 Series ZZ 20,000 $ 13.75 275,000 Series AA 100,000 $ 13.75 1,375,000 Series CC 132,798 $ 5.00 663,990 331,998 $ 3,402,990 Warrants Warrants Exercised Exercise Price Proceeds Series V 674,164 $ 13.75 $ 9,269,755 Series CC 128,820 $ 5.00 644,100 Series FF 68,048 $ 3.91 265,812 Series HH 6,300 $ 3.13 19,687 Series JJ 9,450 $ 3.13 29,531 Series LL 26,398 $ 3.59 94,867 913,180 $ 10,323,752
Schedule of warrant liabilities	2021 2020 Series W warrants $ - $ 73,570 Series Z warrants 64,787 1,207,902 Series ZZ warrants - 75,044 Series AA warrants 276,035 1,082,212 Series BB warrants - 65,173 Series CC warrants 94,961 1,259,712 Series HH warrants 1,597 2,000 Total warrant liabilities $ 437,380 $ 3,765,613
Schedule of (losses)/gains on the warrant liabilities	2021 2020 Series V Warrants $ - $ 185,652 Series W warrants 73,570 1,119,937 Series Z warrants 252,115 (98,357 ) Series ZZ warrants (98,692 ) 2,594 Series AA warrants (318,823 ) (165,304 ) Series BB warrants 65,173 (1,207 ) Series CC warrants (668,605 ) (875,040 ) Series FF warrants - (319,706 ) Series HH warrants 404 (34,589 ) Series JJ warrants - (64,992 ) Series LL warrants - (98,066 ) Net loss on warrant liabilities $ (694,858 ) $ (349,078 )

PLANT, PROPERTY AND EQUIPMENT (

PLANT, PROPERTY AND EQUIPMENT (Tables)	12 Months Ended
	Sep. 30, 2021
PLANT, PROPERTY AND EQUIPMENT
Schedule of plant, property and equipment	2021 2020 Research equipment $ 4,211,124 $ 3,898,242 Furniture and equipment 99,768 99,768 Leasehold improvements 13,465,123 5,519,161 17,776,015 9,517,171 Accumulated depreciation and amortization (4,112,453 ) (3,673,178 ) Net property and equipment $ 13,663,562 $ 5,843,993

PATENTS (Tables)

PATENTS (Tables)	12 Months Ended
	Sep. 30, 2021
PATENTS
Schedule of patents	2021 2020 Patents $ 910,523 $ 896,372 Accumulated amortization (634,657 ) (582,950 ) Patents, net $ 275,866 $ 313,422
Schedule of total estimated future amortization	Years ending September 30, 2022 $ 49,000 2023 39,000 2024 31,000 2025 29,000 2026 25,000 Thereafter 103,000 $ 276,000

INCOME TAXES (Tables)

INCOME TAXES (Tables)	12 Months Ended
	Sep. 30, 2021
INCOME TAXES
Schedule of components of the Company's deferred tax assets	2021 2020 NOL carryforwards $ 19,789,000 $ 13,407,000 Lease liabilities 4,101,000 3,631,000 R&D credit 1,221,000 1,221,000 Stock-based compensation 7,785,000 5,297,000 Capitalized R&D 15,040,000 15,853,000 Vacation and other 126,000 125,000 Total deferred tax assets 48,062,000 39,534,000 Right of use assets (3,786,000 ) (3,911,000 ) Fixed assets and intangibles (172,000 ) (169,000 ) Total deferred tax liability (3,958,000 ) (4,080,000 ) Net deferred tax asset 44,104,000 35,454,000 Valuation allowance (44,104,000 ) (35,454,000 ) Ending Balance $ - $ -
Schedule of federal or state current or deferred tax expense or benefit	2021 2020 Federal Rate 21.00 % 21.00 % State rate change (1.37 ) (1.40 ) State tax rate, net of federal benefit 4.72 5.15 Other adjustments (0.79 ) (3.24 ) Permanent differences 0.23 0.42 Change in valuation allowance (23.79 ) (21.93 ) Effective tax rate 0.00 % 0.00 %

STOCK COMPENSATION (Tables)

STOCK COMPENSATION (Tables)	12 Months Ended
	Sep. 30, 2021
STOCK COMPENSATION
Schedule of expenses for options issued or vested and restricted stock awarded	Year Ended September 30, 2021 2020 Employees $ 13,685,046 $ 10,112,968 Non-employees $ 1,226,690 $ 862,796
Schedule of fair value of each option granted	2021 2020 Expected stock price volatility 90.42 – 97.22% 87.36 – 90.26% Risk-free interest rate 0.85 – 1.65% 0.62 – 1.87% Expected life of options 9.68 – 9.69 Years 9.68 – 9.69 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, 2019 6,218,216 $ 5.54 8.88 $ 29,562,594 1,392,241 $ 9.15 7.68 $ 7,869,555 Vested 2,014,501 $ 4.06 Granted 2,563,000 $ 10.93 Exercised 99,740 $ 3.39 99,740 $ 3.39 Forfeited 18,000 $ 10.34 Expired 9,773 $ 132.75 9,773 $ 132.75 Outstanding at September 30, 2020 8,653,703 $ 7.01 8.39 $ 56,193,415 3,297,229 $ 5.85 7.48 $ 29,090,662 Vested 2,401,961 $ 6.26 Granted (a) 2,605,000 $ 20.58 Exercised 149,788 $ 4.98 149,788 $ 4.98 Forfeited 49,832 $ 9.56 Expired 9,374 $ 172.73 9,374 $ 172.73 Outstanding at September 30, 2021 11,049,709 $ 10.08 7.93 $ 54,843,283 5,540,028 $ 5.77 6.96 $ 43,589,598
Schedule of non-vested options	Number of Options Weighted Average Grant Date Fair Value Unvested at September 30, 2019 4,825,975 $ 3.79 Vested (2,014,501 ) Granted 2,563,000 Forfeited (18,000 ) Unvested at September 30, 2020 5,356,474 $ 4.76 Vested (2,401,961 ) Granted 2,605,000 Forfeited (49,832 ) Unvested at September 30, 2021 5,509,681 $ 5.17
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, 2019 304,500 $ 13.75 Forfeited - Vested - Unvested at September 30, 2020 304,500 $ 13.75 Forfeited (2,000 ) Vested (151,250 ) Unvested at September 30, 2021 151,250 $ 13.75

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Sep. 30, 2021
Commitments and Contingencies
Schedule of future minimum payments under finance leases	Year ending September 30, 2022 $ 1,699,000 2023 2,569,000 2024 2,648,000 2025 2,733,000 2026 2,824,000 Thereafter 6,186,000 Total future minimum lease obligation * 18,659,000 Less imputed interest on finance lease obligations (4,825,000 ) Net present value of lease finance lease obligations $ 13,834,000
Schedule of future minimum payments under operating leases	Year ending September 30, 2022 $ 309,000 2023 348,000 2024 357,000 2025 366,000 2026 287,000 Thereafter 1,602,000 Total future minimum lease obligation 3,269,000 Less imputed interest on operating lease obligation (1,130,000 ) Net present value of operating lease obligation $ 2,139,000

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	12 Months Ended
	Sep. 30, 2021
STOCKHOLDERS EQUITY
Schedule of other non-operating gains (losses)	2021 2020 Amount realized through the resale of shares $ 1,685,379 $ 2,652,605 Fair value of shares upon issuance - 1,769,500 Other non-operating gain $ 1,685,379 $ 883,105

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	12 Months Ended
	Sep. 30, 2021
FAIR VALUE MEASUREMENTS
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	2021 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (4,023,091 ) (3,071,775 ) N Net realized and unrealized derivative loss 694,858 349,078 Ending balance $ 437,380 $ 3,765,613

NET LOSS PER COMMON SHARE (Tabl

NET LOSS PER COMMON SHARE (Tables)	12 Months Ended
	Sep. 30, 2021
NET LOSS PER COMMON SHARE
Schedule of reconciliation of the numerators and denominators of the basic and diluted per-share computations	Year ended September 30, 2021 2020 Loss per share – basic Net loss available to common shareholders - basic $ (36,711,970 ) $ (30,276,978 ) Weighted average shares outstanding - basic 40,662,137 36,759,115 Basic loss per common share $ (0.90 ) $ (0.82 ) Loss per share – diluted Net loss available to common shareholders - basic $ (36,711,970 ) $ (30,276,978 ) Unrealized gain on derivatives (1) (1,085,540 ) - Net loss available to common shareholders - diluted $ (37,797,510 ) $ (30,276,978 ) Weighted average shares outstanding - basic 40,662,137 36,759,115 Incremental shares underlying dilutive warrants (1) 32,111 - Weighted average shares outstanding - diluted 40,694,248 36,759,115 Diluted loss per common share $ (0.93 ) $ (0.82 )
Schedule of anti-dilutive securities	2021 2020 Options and Warrants 10,604,850 7,221,696 Unvested Restricted Stock 151,250 308,814 Total 10,756,100 7,530,510

SUMMARY OF SIGNIFICANT ACCOUN_3

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	12 Months Ended
	Sep. 30, 2021USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Patent useful life	17 years
Fully insured amount of non-interest bearing cash balances	$ 250,000

WARRANTS AND NONEMPLOYEE OPTION

WARRANTS AND NONEMPLOYEE OPTIONS (Details) - $ / shares	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Consultants [Member]
Issue Date	7/28/2017	7/28/17
Shares Issuable upon Exercise of Warrant	15,000	10,000
Exercise Price	$ 2.18	$ 2.18
Expiration Date	7/27/2027	7/27/2027
Series W [Member]
Issue Date		10/28/2015
Shares Issuable upon Exercise of Warrant		688,930
Exercise Price		$ 16.75
Expiration Date		10/28/2020
Series ZZ [Member]
Issue Date		5/23/2016
Shares Issuable upon Exercise of Warrant		20,000
Exercise Price		$ 13.75
Expiration Date		5/18/2021
Series BB [Member]
Issue Date		8/26/2016
Shares Issuable upon Exercise of Warrant		16,000
Exercise Price		$ 13.75
Expiration Date		8/22/2021
Series Z [Member]
Issue Date	5/23/2016	5/23/2016
Shares Issuable upon Exercise of Warrant	184,800	264,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	11/23/2021	11/23/2021
Series CC [Member]
Issue Date	12/8/2016	12/8/2016
Shares Issuable upon Exercise of Warrant	15,845	148,643
Exercise Price	$ 5	$ 5
Expiration Date	12/8/2021	12/8/2021
Series HH [Member]
Issue Date	2/23/2017	2/23/2017
Shares Issuable upon Exercise of Warrant	200	200
Exercise Price	$ 3.13	$ 3.13
Expiration Date	2/16/2022	2/16/2022
Series AA [Member]
Issue Date	8/26/2016	8/26/2016
Shares Issuable upon Exercise of Warrant	100,000	200,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	2/22/2022	2/22/2022
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	8/18/2022	2/18/2021
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	7/13/2022	1/13/2021
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	8/15/2022	2/15/2021
Series MM [Member]
Issue Date	6/22/2017	6/22/2017
Shares Issuable upon Exercise of Warrant	333,432	797,633
Exercise Price	$ 1.86	$ 1.86
Expiration Date	6/22/2022	6/22/2022
Series NN [Member]
Issue Date	7/24/2017	7/24/2017
Shares Issuable upon Exercise of Warrant	210,087	348,842
Exercise Price	$ 2.52	$ 2.52
Expiration Date	7/24/2022	7/24/2022
Series RR [Member]
Issue Date	10/30/2017	10/30/2017
Shares Issuable upon Exercise of Warrant	251,761	417,649
Exercise Price	$ 1.65	$ 1.65
Expiration Date	10/30/2022	10/30/2022
Series SS [Member]
Issue Date	12/19/2017	12/19/2017
Shares Issuable upon Exercise of Warrant	200,000	326,064
Exercise Price	$ 2.09	$ 2.09
Expiration Date	12/18/2022	12/18/2022
Series TT [Member]
Issue Date	2/5/2018	2/5/2018
Shares Issuable upon Exercise of Warrant	600	371,564
Exercise Price	$ 2.24	$ 2.24
Expiration Date	2/5/2023	2/5/2023
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	6/30/2022	12/31/2020

WARRANTS AND NON-EMPLOYEE OPT_3

WARRANTS AND NON-EMPLOYEE OPTIONS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Total warrant liabilities	$ 437,380	$ 3,765,613
Net (loss) gain on warrant liabilities	(694,858)	(349,078)
Series W [Member]
Total warrant liabilities	0	73,570
Net (loss) gain on warrant liabilities	73,570	1,119,937
Series ZZ [Member]
Total warrant liabilities	0	75,044
Net (loss) gain on warrant liabilities	(98,692)	2,594
Series BB [Member]
Total warrant liabilities	0	65,173
Net (loss) gain on warrant liabilities	65,173	(1,207)
Series Z [Member]
Total warrant liabilities	64,787	1,207,902
Net (loss) gain on warrant liabilities	(252,115)	(98,357)
Series CC [Member]
Total warrant liabilities	94,961	1,259,712
Net (loss) gain on warrant liabilities	(668,605)	(875,040)
Series HH [Member]
Total warrant liabilities	1,597	2,000
Net (loss) gain on warrant liabilities	404	(34,589)
Series AA [Member]
Total warrant liabilities	276,035	1,082,212
Net (loss) gain on warrant liabilities	(318,823)	(165,304)
Series FF [Member]
Net (loss) gain on warrant liabilities	0	(319,706)
Series JJ [Member]
Net (loss) gain on warrant liabilities	0	(64,992)
Series LL [Member]
Net (loss) gain on warrant liabilities	0	(98,066)
Series V [Member]
Net (loss) gain on warrant liabilities	$ 0	$ 185,652

WARRANTS AND NON-EMPLOYEE OPT_4

WARRANTS AND NON-EMPLOYEE OPTIONS (Details 2) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Proceeds	$ 3,402,990	$ 10,323,752
Warrants Exercised	331,998	913,180
Series ZZ [Member]
Proceeds	$ 275,000
Warrants Exercised	20,000
Exercise Price	$ 13.75
Series Z [Member]
Proceeds		$ 1,089,000
Warrants Exercised		72,900
Exercise Price		$ 13.75
Series CC [Member]
Proceeds	$ 663,990	$ 644,100
Warrants Exercised	132,798	128,820
Exercise Price	$ 5	$ 5
Series HH [Member]
Proceeds		$ 19,687
Warrants Exercised		6,300
Exercise Price		$ 3.13
Series AA [Member]
Proceeds	$ 1,375,000
Warrants Exercised	100,000
Exercise Price	$ 13.75
Series FF [Member]
Proceeds	$ 265,812
Warrants Exercised	68,048
Exercise Price	$ 3.91
Series JJ [Member]
Proceeds		$ 29,531
Warrants Exercised		9,450
Exercise Price		$ 3.13
Series LL [Member]
Proceeds		$ 94,867
Warrants Exercised		26,398
Exercise Price		$ 3.59
Series V [Member]
Proceeds		$ 9,269,755
Warrants Exercised		674,164
Exercise Price		$ 13.75

WARRANTS AND NON-EMPLOYEE OPT_5

WARRANTS AND NON-EMPLOYEE OPTIONS (Details 3) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Equity Warrants Exercised	1,265,872	798,693
Proceeds from Equity Warrants Exercised	$ 2,581,225	$ 1,748,713
Series MM [Member]
Equity Warrants Exercised	863,414	95,858
Proceeds from Equity Warrants Exercised	$ 464,201	$ 178,296
Equity Warrants Exercise Price	$ 1.86	$ 1.86
Series NN [Member]
Equity Warrants Exercised	138,755	124,956
Proceeds from Equity Warrants Exercised	$ 349,663	$ 314,889
Equity Warrants Exercise Price	$ 2.52	$ 2.52
Series RR [Member]
Equity Warrants Exercised	165,888	39,467
Proceeds from Equity Warrants Exercised	$ 273,715	$ 65,121
Equity Warrants Exercise Price	$ 1.65	$ 1.65
Series SS [Member]
Equity Warrants Exercised	126,064	156,580
Proceeds from Equity Warrants Exercised	$ 263,474	$ 327,252
Equity Warrants Exercise Price	$ 2.09	$ 2.09
Series TT [Member]
Equity Warrants Exercised	370,964	188,125
Proceeds from Equity Warrants Exercised	$ 830,959	$ 421,400
Equity Warrants Exercise Price	$ 2.24	$ 2.24
Series UU [Member]
Equity Warrants Exercised		61,207
Proceeds from Equity Warrants Exercised		$ 171,380
Equity Warrants Exercise Price		$ 2.80
Series OO [Member]
Equity Warrants Exercised		50,000
Proceeds from Equity Warrants Exercised		$ 126,000
Equity Warrants Exercise Price		$ 2.52
Series VV [Member]
Equity Warrants Exercised		82,500
Proceeds from Equity Warrants Exercised		$ 144,375
Equity Warrants Exercise Price		$ 1.75

WARRANTS AND NON-EMPLOYEE OPT_6

WARRANTS AND NON-EMPLOYEE OPTIONS (Details Narrative) - USD ($)	Dec. 07, 2020	May 08, 2020	Aug. 22, 2021	Oct. 28, 2020	Jun. 25, 2020	Jun. 20, 2020	May 26, 2020	Jan. 23, 2020	Sep. 30, 2021	Sep. 30, 2020
Incremental cost									$ 664,000	$ 664,000
Common stock issued for service, shares									75,885	79,950
Warrant inducement expense										$ 806,000
Fair value of warrant									$ 0	805,753
Consulting Agreements [Member]
Total expense									1,227,000	863,000
Prepaid expenses									$ 364,000	$ 395,000
Consultants [Member]
Options issued									5,000
Option issued to related party									15,000
Option expiration date									Nov. 17, 2022
Stock prices per share									$ 6.86	$ 24.95
Series Y [Member]
Incremental cost								$ 22,000	$ 103,000
Maximum [Member] | Restricted Stock [Member] | Consultants [Member]
Weighted average grant date fair value									$ 15.46	12.01
Series W [Member]
Warrants exercised				$ 16.75
Warrants expired				688,930
Series BB [Member]
Warrants exercised			$ 13.75
Warrants expired			16,000
Series V Warrants [Member]
Warrants exercised shares							810,127
Warrants exercised					$ 13.75
Expiration date description							extended the expiration dates of the Series V warrants from May 28, 2020 to June 25, 2020
Warrants expired					135,963
Fair value of warrant					$ 211,000
Series V Warrants [Member] | Maximum [Member]
Common stock price per share							$ 19.75
Series V Warrants [Member] | Minimum [Member]
Common stock price per share							$ 13.75
Series XX Warrants [Member]
Fair value of warrant						$ 629,000
Common stock price per share										18
Warrants issued during period						461,963
Series YY Warrants [Member]
Fair value of warrant						$ 177,000
Common stock price per share										$ 20
Warrants issued during period						101,839
Series UU warrants [Member]
Incremental cost									$ 24,000	$ 6,000
Expiration date description	from December 31, 2020 to June 30, 2021	extended from June 11, 2020 to December 31, 2020							the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Warrants issued during period		93,593				101,839
Series N and Series X [Member]
Incremental cost									$ 351,000
Series N Warrants [Member]
Incremental cost								$ 22,000
Expiration date description	the expiration date of the Series N warrants was extended to February 18, 2021							the expiration date of the Series N warrants was extended to February 18, 2021

PROPERTY AND EQUIPMENT (Details

PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
PLANT, PROPERTY AND EQUIPMENT
Research equipment	$ 4,211,124	$ 3,898,242
Furniture and equipment	99,768	99,768
Leasehold improvements	13,456,123	5,519,161
Gross	17,776,015	9,517,171
Accumulated depreciation and amortization	(4,112,453)	(3,673,178)
Net property and equipment	$ 13,663,562	$ 5,843,993

PROPERTY AND EQUIPMENT (Detai_2

PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
PLANT, PROPERTY AND EQUIPMENT
Depreciation expense	$ 447,000	$ 389,000

PATENTS (Details)

PATENTS (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
Patents	$ 275,866	$ 313,422
Patents [Member]
Patents	910,523	896,372
Accumulated amortization	(634,657)	(582,950)
Patents, net	$ 275,866	$ 313,422

PATENTS (Details 1)

PATENTS (Details 1)	Sep. 30, 2021USD ($)
PATENTS (Details)
2022	$ 49,000
2023	39,000
2024	31,000
2025	29,000
2026	25,000
Thereafter	103,000
Total	$ 276,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
PATENTS (Details)
Amortization of patent costs	$ 52,000	$ 53,000

INCOME TAXES (Details)

INCOME TAXES (Details) - USD ($)	Sep. 30, 2021	Sep. 30, 2020
INCOME TAXES
NOL carryforwards	$ 19,789,000	$ 13,407,000
Lease liabilities	4,101,000	3,631,000
R&D credit	1,221,000	1,221,000
Stock-based compensation	7,785,000	5,297,000
Capitalized R&D	15,040,000	15,853,000
Vacation and other	126,000	125,000
Total deferred tax assets	48,062,000	39,534,000
Right of use assets	(3,786,000)	(3,911,000)
Fixed assets and intangibles	(172,000)	(169,000)
Total deferred tax liability	(3,958,000)	(4,080,000)
Net deferred tax asset	44,104,000	(35,454,000)
Valuation allowance	(44,104,000)	(35,454,000)
Ending Balance	$ 0	$ 0

INCOME TAXES (Details 1)

INCOME TAXES (Details 1)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
INCOME TAXES
Federal Rate	21.00%	21.00%
Federal rate change	(1.37%)	(1.40%)
State tax rate, net of federal benefit	4.72%	5.15%
Other adjustments	(0.79%)	(3.24%)
Permanent differences	0.23%	0.42%
Change in valuation allowance	(23.79%)	(21.93%)
Effective tax rate	0.00%	0.00%

INCOME TAXES (Details Narrative

INCOME TAXES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Federal net operating loss carryforwards	$ 19,789,000	$ 13,407,000
Estimated net operating loss carryforwards	48,062,000	39,534,000
Income Tax [Member]
Research and development credit	$ 1,200,000	1,200,000
Research and development credit, description	The R&D credit expires during the fiscal year ended 2029.
Federal net operating loss carryforwards	$ 77,100,000	51,500,000
Cumulative change in ownership percentage	(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, 2022 and become fully expired by 2038 and approximately $57.9 million of NOL carryforwards
Estimated net operating loss carryforwards		$ 188,900,000

STOCK COMPENSATION (Details)

STOCK COMPENSATION (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
STOCK COMPENSATION
Employees	$ 13,685,046	$ 10,112,968
Non-employees	$ 1,226,690	$ 862,796

STOCK COMPENSATION (Details 1)

STOCK COMPENSATION (Details 1)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
STOCK COMPENSATION
Expected stock price volatility, min	90.42%	87.36%
Expected stock price volatility, max	97.22%	90.26%
Risk-free interest rate, min	0.85%	0.62%
Risk-free interest rate, max	1.65%	1.87%
Expected life of options, min	9 years 8 months 4 days	9 years 8 months 4 days
Expected life of options, max	9 years 8 months 8 days	9 years 8 months 8 days
Expected dividend yield	0.00%	0.00%

STOCK COMPENSATION (Details 2)

STOCK COMPENSATION (Details 2) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Outstanding [Member]
Number of Options Outstanding, Beginning	8,653,703	6,218,216
Number of Options Exercised	149,788	99,740
Number of Options Expired	9,374	9,773
Number of Options Outstanding, Ending	11,049,709	8,653,703
Weighted Average Exercise Price Outstanding, Beginning	$ 7.01	$ 5.54
Weighted Average Exercise Price Exercised	4.98	3.39
Weighted Average Exercise Price Expired	172.73	132.75
Weighted Average Exercise Price Outstanding, Ending	$ 10.08	$ 7.01
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Beginning	7 years 11 months 4 days	8 years 10 months 17 days
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Ending	8 years 10 months 17 days	8 years 4 months 20 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 56,193,415	$ 29,562,594
Aggregate Intrinsic Value Outstanding, Ending	$ 54,843,283	$ 56,193,415
Number of Options Granted	2,605,000	2,563,000
Number of Options Forfeited	49,832	18,000
Weighted Average Exercise Price Granted	$ 20.58	$ 10.93
Weighted Average Exercise Price Forfeited	$ 9.56	$ 10.34
Exercisable [Member]
Number of Options Outstanding, Beginning	3,297,229	1,392,241
Number of Options Vested	2,401,961	2,014,501
Number of Options Exercised	149,788	99,740
Number of Options Expired	9,374	9,773
Number of Options Outstanding, Ending	5,540,028	3,297,229
Weighted Average Exercise Price Outstanding, Beginning	$ 5.85	$ 9.15
Weighted Average Exercise Price Vested	6.26	4.06
Weighted Average Exercise Price Exercised	4.98	3.39
Weighted Average Exercise Price Expired	172.73	132.75
Weighted Average Exercise Price Outstanding, Ending	$ 5.77	$ 5.85
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Beginning	6 years 11 months 15 days	7 years 8 months 4 days
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Ending	7 years 8 months 5 days	7 years 5 months 23 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 29,090,662	$ 7,869,555
Aggregate Intrinsic Value Outstanding, Ending	$ 43,589,598	$ 29,090,662

STOCK COMPENSATION (Details 3)

STOCK COMPENSATION (Details 3) - $ / shares	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
STOCK COMPENSATION
Number of unvested options, Beginning	5,356,474	4,825,975
Vested options	(2,401,961)	(2,014,501)
Granted options	2,605,000	2,563,000
Forfeited options	(49,832)	(18,000)
Number of unvested options, Ending	5,509,681	5,356,474
Weighted Average Grant Date Fair Value, Beginning	$ 4.76	$ 3.79
Weighted Average Grant Date Fair Value, Ending	$ 5.17	$ 4.76

STOCK COMPENSATION (Details 4)

STOCK COMPENSATION (Details 4) - $ / shares	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Weighted Average Grant Date Fair Value, Beginning	$ 4.76	$ 3.79
Restricted Stock Awards [Member]
Number of unvested shares, Beginning	304,500	304,500
Forfeited	(2,000)	0
Vested shares	(151,250)	0
Number of unvested shares, Ending	151,250	304,500
Weighted Average Grant Date Fair Value, Beginning	$ 13.75	$ 13.75
Weighted Average Grant Date Fair Value, Ending	$ 13.75	$ 13.75

STOCK COMPENSATION (Details Nar

STOCK COMPENSATION (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Jun. 30, 2021	May 14, 2021	Dec. 31, 2020	Apr. 20, 2020	Mar. 31, 2020	Dec. 31, 2019
Common stock, shares issued	43,207,183	38,730,150	1,400,000		1,000,000		630,500	606,395
Common stock, shares authorized	600,000,000	600,000,000
Stock Compensation Plans [Member]
Common stock, shares issued	154,195
Common stock, shares authorized	634,000
Stock Bonus Plans [Member]
Common stock, shares issued	363,086
Common stock, shares authorized	783,760
Non-Qualified Stock Options Plans [Member]
Common stock, shares authorized	11,787,200
Unrecognized compensation expense	$ 3,800,000	$ 2,100,000
Remaining compensation expense	$ 189,000	$ 3,800,000
Issuance of common stock options purchase shares	1,800,000	3,600,000
Performance based stock options shares granted		72,000		1,800,000		1,872,000
Stock price	$ 20.61	$ 10.93
Stock options vest description		The stock options vest upon the achievement of the following market conditions: i) 25% of the options will vest when the closing price of the Company's common stock exceeds $20.00 for ten consecutive trading days; ii) 50% of the options will vest when the closing price of the Company's common stock exceeds $25.00 for ten consecutive trading days; and iii) 75% of the options will vest when the closing price of the Company's common stock exceeds $30.00 for ten consecutive trading days.
Fair value per share	$ 0.34	$ 4.21
Grant date fair value remaining outstanding		$ 7,900,000
Grant date fair value remaining	$ 447,000	$ 2,000,000
Implicit life of options	1 year 3 months 18 days	1 year 8 months 12 days
Expense life over next	11 years	11 years
Incentive Stock Option Plans [Member]
Common stock, shares authorized	138,400
Incentive Stock Bonus Plan [Member]
Common stock, shares authorized	614,500
Grant date fair value remaining outstanding	$ 8,600,000
Vested shares	463,250
Issuance of restricted stock	$ 300,000
Unrecognized compensation expense	$ 45,000

EMPLOYEE BENEFIT PLAN (Detail N

EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
EMPLOYEE BENEFIT PLAN (Detail Narrative)
Expense for Company's contribution to employee benefit plan	$ 163,000	$ 201,000
Total compensation	$ 10,000
Participant compensation	6.00%
Shares issued	13,870	17,990

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2021USD ($)
Commitments and Contingencies
2022	$ 1,699,000
2023	2,569,000
2024	2,648,000
2025	2,733,000
2026	2,824,000
Thereafter	6,186,000
Total future minimum lease obligation	18,659,000
Less imputed interest on financing obligation	4,825,000
Net present value of lease financing obligation	$ (13,834,000)

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Sep. 30, 2021USD ($)
Commitments and Contingencies
2022	$ 309,000
2023	348,000
2024	357,000
2025	366,000
2026	287,000
Thereafter	1,602,000
Total future minimum lease obligation	3,269,000
Less imputed interest on operating lease obligation	(1,130,000)
Total	$ 2,139,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Weighted average discount rate	8.45%
Weighted average discount rate operating lease	9.12%
Interest rate	0.1019%	0.10%
Maturity years	7 years 1 month 6 days
Operating lease maturity years	9 years 8 months 12 days
Research and development expenses	$ 35,100,000
Net of discount	$ 11,600,000
Lease description	revised rate to be used upon adoption of ASC 842 of 10.19% compared to the previously used rate of 8.80%
Finance lease obligations, net of current portion	$ 200,000	$ 100,000
Weighted average time to maturity	17 years
Biologics License Application [Member]
Sublease rental income		39,000
Ergomed [Member]
Research and development expenses	$ 1,600,000	1,400,000
Net of discount	600,000	600,000
Clinical service trial	10,000,000
Additional clinical trial	$ 2,000,000
Weighted average time to maturity	7 years 1 month 6 days
TransactionTwoMember [Member] | October 1, 2019 [Member]
Change in right of use of assets and liability	$ 1,000,000
Cash paid related to operating leases	300,000	200,000
Net book value operating lease right of use assets	2,100,000	1,200,000
Current balance	100,000	100,000
Operating lease - liability	2,100,000	1,200,000
Operating lease expense	$ 200,000	200,000
Transaction One [Member] | October 1, 2019 [Member]
Weighted average discount rate	0.0845%
Change in right of use of assets and liability	$ 16,500,000
Current balance	600,000	900,000
Operating lease - liability	1,732,000	1,717,000
Finance lease liability	13,500,000
Net book value of the finance lease right of use asset	12,700,000	13,800,000
Balance of the finance lease liability	13,800,000	12,700,000
Cash paid related to finance leases	2,200,000	1,900,000
Cash paid related to finance leases interest	$ 1,200,000	1,200,000
Landlord [Member]
Interest rate	8.45%
Lease description	The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year.
Lease incentive payable current	$ 1,600,000
Additional deposit	200,000
Cost incurred, initial	10,500,000
Estimated cost	10,700,000
Non current assets	1,900,000	$ 1,700,000
Financing arrangement	2,400,000
Vendor Obligations [Member]
Additional expenses	$ 1,100,000

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)	Dec. 07, 2020	May 08, 2020	Jan. 23, 2020	Jun. 30, 2021	Sep. 30, 2021	Sep. 30, 2020	Jun. 28, 2021
Officer and Director [Member]
Restricted Common shares					27,500	20,512
Restricted Common shares, amount					$ 220,000	$ 185,000
Series N Warrants [Member]
Expiration date description	the expiration date of the Series N warrants was extended to February 18, 2021		the expiration date of the Series N warrants was extended to February 18, 2021
Incremental cost				$ 265,000	$ 265,000	$ 22,000
Series UU warrants [Member]
Expiration date description	from December 31, 2020 to June 30, 2021	extended from June 11, 2020 to December 31, 2020			the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Warrants issued	93,603	93,593					93,603
Interest expense	$ 192	$ 6,000		24,000	$ 24,000
Series X Warrants [Member]
Incremental cost				$ 265,000	265,000
Series N and X Warrants [Member]
Incremental cost					$ 86,000

STOCKHOLDERS EQUITY (Details)

STOCKHOLDERS EQUITY (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
STOCKHOLDERS EQUITY
Amount realized through the resale of shares	$ 1,685,379	$ 2,652,605
Fair value of shares upon issuance	0	1,769,500
Other non-operating gain (loss)	$ 1,685,379	$ 883,105

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	1 Months Ended						12 Months Ended
	Jun. 30, 2021	Dec. 31, 2020	May 31, 2020	Mar. 31, 2020	Jan. 31, 2020	Dec. 31, 2019	Sep. 30, 2021	Sep. 30, 2020
Common stock shares issued	1,400,000	1,000,000		630,500		606,395	43,207,183	38,730,150
Proceeds from public offering	$ 210,000			$ 94,575	$ 90,959	$ 90,959
Proceeds from initial public offering	$ 29,400,000	$ 13,600,000	$ 1,100,000	$ 7,100,000	$ 800,000	$ 5,000,000
Public offering price per share	$ 22.62	$ 14.65		$ 12.22	$ 9.07	$ 9.07
Proceeds from issuance of warrant	$ 4,400,000						$ 6,000,000	$ 12,100,000
Warrants exercised							1,597,870	1,711,873
Ergomed [Member]
Common stock shares issued								150,000
Prepaid of resold amount							$ 500,000

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
FAIR VALUE MEASUREMENTS
Beginning balance	$ 3,765,613	$ 6,488,310
Issuances	0	0
Exercises	4,023,091	3,071,775
Net realized and unrealized derivative loss	694,858	349,078
Ending balance	$ 437,380	$ 3,765,613

FAIR VALUE MEASUREMENTS (Deta_2

FAIR VALUE MEASUREMENTS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
unrealized gain on short-term T-bills	$ 6,000
Weighted average risk free interest rate	0.10%
Fair Value Inputs Level 3 (Level 3)
Weighted average risk free interest rate	0.05%	0.12%
Weighted average fair value, Derivative instruments	$ 1.45	$ 2.81
Weighted average exercise price, Derivative instruments	$ 13.28	$ 14.32
Volatility rate	109.00%	95.00%
Weighted average time to maturity year	3 months 18 days	1 year 2 months 12 days

NET LOSS PER COMMON SHARE (Deta

NET LOSS PER COMMON SHARE (Details) - USD ($)	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
NET LOSS PER COMMON SHARE
Net loss available to common shareholders - basic	$ (36,711,970)	$ (30,276,978)
Weighted average shares outstanding - basic	40,662,137	36,759,115
Basic loss per common share	$ (0.90)	$ (0.82)
Loss per share- diluted
Net loss available to common shareholders -basic	$ (36,711,970)	$ (30,276,978)
Unrealized gain on derivatives	(1,085,540)	0
Net loss available to common shareholders - diluted	$ (37,797,510)	$ (30,276,978)
Weighted average shares outstanding - basic	40,694,248	36,759,115
Incremental shares underlying dilutive "in the money" warrants	32,111	0
Weighted average shares outstanding - diluted	40,694,248	36,759,115
Diluted loss per common share	$ (0.93)	$ (0.82)

NET LOSS PER COMMON SHARE (De_2

NET LOSS PER COMMON SHARE (Details 1) - shares	12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Antidilutive securities	10,756,100	7,530,510
Options and Warrants
Antidilutive securities	10,604,850	7,221,696
Unvested Restricted Stock [Member]
Antidilutive securities	151,250	308,814