CEL-SCI (CVM) 10-K29 Dec 202020 FY Annual reportFinancial data

Company Profile

Cover

Cover - USD ($)	12 Months Ended
Cover - USD ($)	Sep. 30, 2020	Dec. 15, 2020	Mar. 31, 2020
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, 2020
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2020
Entity Common Stock Shares Outstanding		39,756,417
Entity Public Float			$ 411,591,295
Document Annual Report	true
Document Transition Report	false
Entity File Number	001-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Address Address Line 1	8229 Boone 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

BALANCE SHEETS

BALANCE SHEETS - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Current Assets:
Cash and cash equivalents	$ 15,508,909	$ 8,444,774
Receivables	54,922	62,765
Prepaid expenses	1,313,432	524,953
Supplies used for R&D and manufacturing	820,052	782,363
Total current assets	17,697,315	9,814,855
Finance lease right of use assets	13,811,849	0
Operating lease right of use assets	1,198,958	0
Property and equipment, net	5,843,993	15,825,636
Patent costs, net	313,422	311,586
Deposits	1,670,917	1,670,917
Total assets	40,536,454	27,622,994
Current Liabilities:
Accounts payable	2,023,067	1,586,478
Accrued expenses	510,515	34,432
Due to employees	448,022	709,442
Derivative instruments, current portion	213,787	674,442
Lease liabilities, current portion	1,070,123	0
Other current liabilities	0	14,956
Total current liabilities	4,265,514	3,019,750
Derivative instruments, net of current portion	3,551,826	5,813,868
Finance lease liabilities, net of current portion	11,753,100	13,508,156
Operating lease liabilities, net of current portion	1,114,340	0
Other liabilities	125,000	147,553
Total liabilities	20,809,780	22,489,327
STOCKHOLDERS' EQUITY
Preferred stock, $.01 par value- 200,000 shares authorized; -0- shares issued and outstanding	0	0
Common stock, $.01 par value - 600,000,000 shares authorized; 38,730,150 and 35,231,776 shares issued and outstanding at September 30, 2020 and 2019, respectively	387,302	352,318
Additional paid-in capital	401,174,675	358,507,603
Accumulated deficit	(381,835,303)	(353,726,254)
Total stockholders' equity	19,726,674	5,133,667
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 40,536,454	$ 27,622,994

BALANCE SHEETS (Parenthetical)

BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2020	Sep. 30, 2019
Stockholders Equity
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	38,730,150	35,231,776
Common stock, shares outstanding	38,730,150	35,231,776

STATEMENTS OF OPERATIONS

STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
STATEMENTS OF OPERATIONS - USD ($)	Sep. 30, 2020	Sep. 30, 2019
STATEMENTS OF OPERATIONS
Grant income	$ 558,664	$ 462,754
Operating expenses:
Research and development	17,840,290	12,659,287
General and administrative	11,703,429	7,998,573
Total operating expenses	29,543,719	20,657,860
Operating loss	(28,985,055)	(20,195,106)
Other income	38,763	73,022
Loss on derivative instruments	(349,078)	(760,603)
Warrant inducement expense	(805,753)	0
Other non-operating gain	887,604	545,528
Interest expense, net	(1,041,725)	(1,797,481)
Net loss	(30,255,244)	(22,134,640)
Modification of warrants	(21,734)	0
Net loss available to common shareholders	$ (30,276,978)	$ (22,134,640)
Net loss per common share, basic and diluted	$ (0.82)	$ (0.71)
Weighted average common shares outstanding, basic and diluted	36,759,115	31,174,394

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Sep. 30, 2018		28,034,487
Balance, amount at Sep. 30, 2018	$ 916	$ 280,346	$ 331,312,184	$ (331,591,614)
Warrant exercises, shares		6,677,519
Warrant exercises, amount	18,106,617	$ 66,775	18,039,842	0
401(k) contributions paid in common stock, shares		30,996
401(k) contributions paid in common stock, amount	$ 143,878	$ 310	143,568	0
Stock issued to nonemployees for service, shares	199,977	199,977
Stock issued to nonemployees for service, amount	$ 878,588	$ 1,999	876,589	0
Equity based compensation - employees, shares		(7,500)
Equity based compensation - employees, amount	4,428,174	$ (75)	4,428,249	0
Stock option exercises, shares		65,997
Stock option exercises, amount	150,482	$ 660	149,822	0
Purchase of stock by officers and directors, shares		45,205
Purchase of stock by officers and directors, amount	291,997	$ 452	291,545	0
Stock issuance costs	(132,345)	$ 0	(132,345)	0
Shares issued for settlement of clinical research costs, shares		185,095
Shares issued for settlement of clinical research costs, amount	3,400,000	$ 1,851	3,398,149	0
Net loss	(22,134,640)	$ 0	0	(22,134,640)
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)
Warrant exercises, shares		1,711,873
Warrant exercises, amount	15,144,240	$ 17,118	15,127,122	0
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	79,950
Stock issued to nonemployees for service, amount	$ 972,667	$ 799	971,868	0
Equity based compensation - employees, amount	10,112,968	$ 0	10,112,968	0
Stock option exercises, shares		99,740
Stock 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
Stock 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)
Adoption of new accounting principle (ASC 842)	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
Modification of warrants	5,554	$ 0	5,554	0
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)

STATEMENTS OF CASH FLOWS

STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
STATEMENTS OF CASH FLOWS - USD ($)	Sep. 30, 2020	Sep. 30, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (30,255,244)	$ (22,134,640)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,159,729	633,529
Share based payments for services	862,796	856,025
Equity based compensation	10,112,968	4,428,174
Common stock contributed to 401(k) plan	163,340	143,878
Shares issued for settlement of clinical research costs	1,769,500	3,400,000
Loss on derivative instruments	349,078	760,603
Warrant inducement expense	805,753	0
Modification of warrants	5,554	0
Capitalized lease interest	0	128,194
(Increase)/decrease in assets:
Receivables	7,843	55,892
Prepaid expenses	(623,608)	(137,768)
Supplies used for manufacturing	(37,689)	(137,125)
Increase/(decrease) in liabilities:
Accounts payable	(766,073)	(4,084,410)
Accrued expenses	406,083	(170,878)
Due to employees	(261,420)	(55,499)
Other liabilities	25,229	(6,660)
Net cash used in operating activities	(15,276,161)	(16,320,685)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(2,654,906)	(177,779)
Expenditures for patent costs	(39,975)	(158,060)
Net cash used in investing activities	(2,694,881)	(335,839)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	13,992,439	0
Payments of stock issuance costs	(752,804)	(163,364)
Proceeds from exercise of warrants	12,072,465	14,517,260
Proceeds from exercises of options	338,328	150,482
Proceeds from the purchase of stock by officers and directors	184,990	291,997
Payments on obligations under finance leases	(800,241)	(5,121)
Net cash provided by financing activities	25,035,177	14,791,254
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	7,064,135	(1,865,270)
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR	8,444,774	10,310,044
CASH AND CASH EQUIVALENTS, END OF YEAR	15,508,909	8,444,774
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment purchases included in accounts payable	1,184,723	17,329
Prepaid consulting services paid with issuance of common stock	164,871	22,563
Right of use assets acquired and liabilities incurred	399,032	0
Exercise of derivative liabilities	3,071,775	3,589,357
Lease obligation included in accounts payable	790	441
Stock issuance costs included in current liabilities	50,499	15,580
Capitalizable patent costs included in current liabilities	15,000	0
Accrued consulting services to be paid with common stock	55,000	0
Cash paid for interest	$ 1,155,026	$ 1,809,242

ORGANIZATION

ORGANIZATION	12 Months Ended
ORGANIZATION	Sep. 30, 2020
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 reached the end of the pivotal Phase 3 study for its lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), involving head and neck cancer, for which the Company has received Orphan Drug Status from the United States Food and Drug Administration (FDA). The Phase 3 study is in the final statistical analysis phase. 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 and hopes to start human studies with CEL-4000 in 2021. CEL-SCI is also investigating LEAPS COVID-19 conjugates as a potential treatment of COVID-19 in hospitalized and at-high-risk patients at the University of Georgia’s Center for Vaccines and Immunology. Initial animal experiments showed that LEAPS COVID-19 conjugates induced faster and much higher than expected antibody responses against a non-mutating region of the virus that causes COVID-19, after only one injection. These experiments provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID-19. These SARS-CoV-2 challenge studies being conducted at UGA’s Center for Vaccines and Immunology seek to repeat the success of animal challenge studies conducted previously at the National Institutes for Allergies and Infectious Diseases (NIAID) emerging diseases laboratory during the threatened H1N1 flu pandemic.

OPERATIONS AND FINANCING

OPERATIONS AND FINANCING	12 Months Ended
OPERATIONS AND FINANCING	Sep. 30, 2020
OPERATIONS AND FINANCING
2. OPERATIONS AND FINANCING	2. OPERATIONS AND FINANCING On May 4, 2020, the Company announced that the pivotal Phase 3 head and neck cancer study of Multikine immunotherapy had reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation. Database lock is competed and the Phase 3 study is now in the final statistical analysis phase. The Company will continue to remain blinded to the study results throughout this process. The Company will be advised of the results when the analysis is completed, and the study results will be announced to the public at that time. 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 research efforts. 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 for the past 12 months. 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 the Multikine Phase 3 study has ended and is only awaiting final results. 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. On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spread globally beyond its point of origin. In March 2020, because of the rapid increase in exposure globally, the WHO classified the COVID-19 outbreak as a pandemic. 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 that 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. The financial statements have been prepared assuming that the Company will continue as a going concern, but due to the Company’s recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	Sep. 30, 2020
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash and Cash Equivalents Property and Equipment Patents Leases – Leases In connection with the preparation of our financial statements for the year ended September 30, 2020, we identified an error relating to the manufacturing facility lease on the adoption of ASC 842 at October 1, 2019. The error impacted the finance lease right-of-use asset and total stockholders’ equity, both of which were understated by approximately $2.0 million on adoption. We concluded the impact on the interim financial statements during fiscal 2020 was immaterial to the statement of operations but material to the balance sheet and will correct the balances for the quarterly reporting periods at December 31, 2019, March 31, 2020, and June 30, 2020. All adjustments have been reflected in the accompanying financial statements. Additional information has been disclosed in the 8-K filed on December 29, 2020. Derivative Instruments Accounting for Derivative Instruments and Hedging Activities In August 2018, the FASB issued ASU 2018-13, ” Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (Topic ). ” 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. Vesting of restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2020 Non- Qualified Stock Option Plan are subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and 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 Use of Estimates New Accounting Pronouncements In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes The Company has considered all other 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
WARRANTS AND NON-EMPLOYEE OPTIONS	Sep. 30, 2020
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, 2020: Warrant Issue Date Shares Issuable upon Exercise of Warrants 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 The following warrants and non-employee options were outstanding at September 30, 2019: Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 2/18/2020 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 Series UU 6/11/2018 154,810 $ 2.80 6/11/2020 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 FF 12/8/2016 68,048 $ 3.91 12/1/2021 Series CC 12/8/2016 277,463 $ 5.00 12/8/2021 Series HH 2/23/2017 6,500 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series JJ 3/14/2017 9,450 $ 3.13 3/8/2022 Series LL 4/30/2017 26,398 $ 3.59 4/30/2022 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 Series NN 7/24/2017 473,798 $ 2.52 7/24/2022 Series OO 7/31/2017 50,000 $ 2.52 7/31/2022 Series RR 10/30/2017 457,116 $ 1.65 10/30/2022 Series SS 12/19/2017 482,644 $ 2.09 12/18/2022 Series TT 2/5/2018 559,689 $ 2.24 2/5/2023 Series VV 7/2/2018 82,500 $ 1.75 1/2/2024 Consultants 7/28/17 10,000 $ 2.18 7/27/2027 A. Warrant Liabilities Warrant liabilities outstanding at September 30 are as follows: 2020 2019 Series V warrants $ - $ 674,442 Series W warrants 73,570 1,193,507 Series Z warrants 1,207,902 1,109,545 Series ZZ warrants 75,044 77,638 Series AA warrants 1,082,212 916,908 Series BB warrants 65,173 63,966 Series CC warrants 1,259,712 1,710,898 Series FF warrants - 446,185 Series HH warrants 2,000 45,657 Series JJ warrants - 66,599 Series LL warrants - 182,965 Total warrant liabilities $ 3,765,613 $ 6,488,310 The (losses)/gains on the warrant liabilities for the years ended September 30 are as follows: 2020 2019 Series S Warrants $ - $ 33 Series V warrants 185,652 95,994 Series W warrants 1,119,937 (194,426 ) Series Z warrants (98,357 ) (621,778 ) Series ZZ warrants 2,594 (43,423 ) Series AA warrants (165,304 ) (536,434 ) Series BB warrants (1,207 ) (35,510 ) Series CC warrants (875,040 ) (1,198,836 ) Series DD warrants - 1,249,287 Series EE warrants - 1,249,287 Series FF warrants (319,706 ) (257,264 ) Series GG warrants - 195,228 Series HH warrants (34,589 ) (24,465 ) Series II warrants - (442,040 ) Series JJ warrants (64,992 ) (35,301 ) Series KK warrants - (55,622 ) Series LL warrants (98,066 ) (105,333 ) Net loss on warrant liabilities $ (349,078 ) $ (760,603 ) 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 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. On December 10, 2018, 1,360,960 Series DD and 1,360,960 Series EE warrants, with an exercise price of $4.50 expired. On October 11, 2018, 327,729 Series S warrants, with an exercise price of $31.25 expired. Exercise of Warrant Liabilities 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 The following warrants recorded as liabilities were exercised during the year ended September 30, 2019: Warrants Warrants Exercised Exercise Price Proceeds Series CC 403,017 $ 5.00 $ 2,015,085 Series GG 200,000 $ 3.00 600,000 Series HH 13,500 $ 3.13 42,188 Series II 216,500 $ 3.00 649,500 Series JJ 20,550 $ 3.13 64,219 Series KK 213,870 $ 3.04 649,095 1,067,437 $ 4,020,087 B. Equity Warrants Changes in Equity Warrants 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, 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 The following equity warrants were exercised during the year ended September 30, 2019. Warrants Warrants Exercised Exercise Price Proceeds Series NN 65,502 $ 2.52 $ 165,065 Series OO 10,000 $ 2.52 25,200 Series PP 172,500 $ 2.30 396,750 Series QQ 3,500 $ 2.50 8,750 Series RR 98,254 $ 1.65 162,119 Series SS 477,886 $ 2.09 998,782 Series TT 737,188 $ 2.24 1,651,301 Series UU 32,752 $ 2.80 91,706 Series VV 3,817,500 $ 1.75 6,680,625 Series WW 195,000 $ 1.63 316,875 5,610,082 $ 10,497,173 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, 2020 and 2019 the Company issued 79,950 and 199,977 shares, respectively, of common stock to consultants, all of which were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $2.66 and $17.60 per share. The weighted average grant price was $12.01 and $4.25, respectively, for stock issued during the years ended September 30, 2020 and 2019. During the years ended September 30, 2020 and 2019, the Company recorded total expense of approximately $863,000 and $856,000, respectively, relating to these consulting agreements. At September 30, 2020 and 2019, costs of approximately $395,000 and $230,000, respectively, are included in prepaid expenses. No options were issued to consultants during the year ended September 30, 2020. During the year ended September 30, 2019, 10,000 options issued to consultants were exercised and 10,400 options expired. As of September 30, 2020,10,000 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
PLANT, PROPERTY AND EQUIPMENT	Sep. 30, 2020
PLANT, PROPERTY AND EQUIPMENT
5. PLANT, PROPERTY AND EQUIPMENT	5. PLANT, PROPERTY AND EQUIPMENT Plant, property and equipment consisted of the following at September 30: 2020 2019 Leased manufacturing facility $ - $ 21,183,756 Research equipment 3,898,242 3,320,358 Furniture and equipment 99,768 125,872 Leasehold improvements 5,519,161 149,239 9,517,171 24,779,225 Accumulated depreciation and amortization (3,673,178 ) (8,953,589 ) Net plant, property and equipment $ 5,843,993 $ 15,825,636 The Company leases its manufacturing facility under a finance lease. Prior to the adoption of ASC 842 effective October 1, 2019, the Company accounted for the manufacturing facility lease under the build-to-suit provisions of ASC 840. This guidance required the Company to record an asset and liability for construction costs incurred because it was involved in the construction of structural improvements and took construction risk prior to the commencement of the lease. Upon occupancy of the facility, the Company determined that because the lease did not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability would remain on the Company’s balance sheet and is included with property and equipment at September 30, 2019. As of September 30, 2019, accumulated depreciation on the manufacturing facility approximated $5.6 million. On October 1, 2019, the Company adopted ASC 842 and elected the optional transition method that allows for a cumulative-effect adjustment in the period of adoption and no restatement to prior periods. Under ASC 842, the manufacturing facility lease no longer meets the criteria for a build-to-suit lease and is instead is classified as a finance lease. Under the provisions of ASC 842, the Company recognized a right-of-use asset and lease liability for this facility. These balances are classified with other leased assets and liabilities and are no longer included with plant and equipment on the September 30, 2020 balance sheet. Depreciation expense for the year ended September 30, 2020 totaled approximately $2.1 million. Depreciation expense for the year ended September 30, 2019 totaled approximately $588,000 and includes depreciation on the leased manufacturing building of approximately $514,000.

PATENTS

PATENTS	12 Months Ended
PATENTS	Sep. 30, 2020
PATENTS
6. PATENTS	6. PATENTS Patents consist of the following at September 30: 2020 2019 Patents $ 896,372 $ 841,397 Accumulated amortization (582,950 ) (529,811 ) Patents, net $ 313,422 $ 311,586 During the years ended September 30, 2020 and 2019, there was no impairment of patent costs. Amortization expense for the years ended September 30, 2020 and 2019 totaled approximately $53,000 and $45,000, respectively. The total estimated future amortization is as follows: Years ending September 30, 2021 52,000 2022 48,000 2023 38,000 2024 30,000 2025 28,000 Thereafter 117,000 $ 313,000

INCOME TAXES

INCOME TAXES	12 Months Ended
INCOME TAXES	Sep. 30, 2020
INCOME TAXES
7. INCOME TAXES	7. INCOME TAXES At September 30, 2020 and 2019, the Company had net deferred tax assets of $35.5 million and $28.8 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. The Company determined that because of various stock issuances used to finance its operations, an ownership change as defined in the provisions of Section 382 of the IRC occurred on February 5, 2018. Such ownership change resulted in annual limitations on the utilization of tax attributes, including NOL carryforwards and tax credits. The Company estimates that $188.9 million of its NOL carryforwards were effectively eliminated under Section 382 for federal income tax purposes. A portion of the remaining NOL carryforwards limited by Section 382 will become available each year. No limitations on NOL carryforwards relating to change in ownership were imposed during the year ended September 30, 2020. The Company’s Section 382 estimated analysis was completed through September 30, 2020. If additional changes in ownership occur after year end, additional 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 $51.5 million and $36.7 million at September 30, 2020 and 2019, respectively. Approximately $19.2 million of the NOL carryforwards begin to expire during the year ended September 30, 2021 and become fully expired by 2039 and approximately $32.3 million of NOL carryforwards, which were generated post Tax Cuts and Jobs Act, have an indefinite live. The NOL carryforwards begin to expire during the year ended September 30, 2021 and become fully expired by the end of the fiscal year ended 2039. 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, 2020 and 2019. The R&D credit begins to expire during the year ended September 30, 2021 and becomes fully expired during the fiscal year ended 2029. Significant components of the Company’s deferred tax assets as of September 30, 2020 and 2019 are listed below: 2020 2019 NOL carryforwards $ 13,407,000 $ 9,698,000 Lease liabilities 3,631,000 - R&D credit 1,221,000 1,221,000 Stock-based compensation 5,297,000 3,165,000 Capitalized R&D 15,853,000 14,777,000 Vacation and other 125,000 544,000 Total deferred tax assets 39,534,000 29,405,000 Right of use assets (3,911,000 ) - Fixed assets and intangibles (169,000 ) (586,000 ) Total deferred tax liability (4,080,000 ) (586,000 ) Net deferred tax asset 35,454,000 28,819,000 Valuation allowance (35,454,000 ) (28,819,000 ) 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: 2020 2019 Federal Rate 21.00 % 21.00 % Federal rate change (1.40 ) (2.8 ) State tax rate, net of federal benefit 5.15 5.31 Other adjustments (3.24 ) (4.77 ) Permanent differences 0.42 (0.57 ) Change in valuation allowance (21.93 ) (18.17 ) Effective tax rate 0.00 % 0.00 % The Company applies the provisions of ASC 740, “Accounting for Uncertainty in Income Taxes,” On March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (CARES Act). The Cares Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. The Company does not expect the enactment of the CARES Act to directly impact its financial position, results of operations or cash flows.

STOCK COMPENSATION

STOCK COMPENSATION	12 Months Ended
STOCK COMPENSATION	Sep. 30, 2020
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, 2020 2019 Employees $ 10,112,968 $ 4,428,174 Non-employees $ 862,796 $ 856,025 During the years ended September 30, 2020 and 2019 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. 2020 2019 Expected stock price volatility 87.36 – 90.26% 87.67 – 92.84% Risk-free interest rate 0.62 – 1.87% 1.62 – 2.82% Expected life of options 9.68 – 9.69 Years 9.67 – 9.68 Years Expected dividend yield - - Non-Qualified Stock Option Plans 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 3,600,000options 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 performance goals: 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; 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; and iv) 100% of the options will vest when either (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 $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 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 $4.21 and an aggregate value of $7,881,120 on the grant date. The aggregate value will be expensed over the implicit life of the options, which was determined to be 1.7 years. This resulted in compensation expense of approximately $2.1 million recorded during the year ended September 30, 2020. The remaining $5.8 million will be expensed over the next 1.25 years. At September 30, 2020, the Company has collectively authorized the issuance of 9,987,200 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 Plans Activity in the Company’s Non-Qualified and Incentive Stock Option Plans for the two years ended September 30, 2020 is summarized as follows: Non-Qualified and Incentive Stock Option Plans Outstanding Exercisable Weighted Weighted Weighted Average Ave Remaining Contractual Aggregate Weighted Average Ave Remaining Contractual Aggregate Number of Exercise Term Intrinsic Number of Exercise Term Intrinsic Shares Price (Years) Value Shares Price (Years) Value Outstanding at September 30, 2018 3,160,127 $ 7.30 8.88 $ 4,761,973 577,694 $ 26.18 6.74 $ 604.763 Vested 945,359 $ 2.56 Granted 3,271,362 $ 5.40 Exercised (a) 65,997 $ 2.28 65,997 $ 2.28 Forfeited 82,461 $ 17.89 Expired (b) 64,815 $ 71.86 64,815 $ 71.86 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 (a) Includes 10,000 stock options exercised by consultants (b) Includes 10,400 stock options to consultants A summary of the status of the Company’s non-vested options for the two years ended September 30, 2020 is presented below: Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 2018 2,582,433 $ 2.48 Vested (945,359 ) Granted 3,271,362 Forfeited (82,461 ) 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 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, 2020 is presented below: Number of Shares Weighted Average Grant Date Fair Value Unvested at September 30, 2018 312,000 $ 13.75 Forfeited (7,500 ) Vested - Unvested at September 30, 2019 304,500 $ 13.75 Forfeited - Vested - Unvested at September 30, 2020 304,500 $ 13.75 Stock Bonus Plans Stock Compensation Plans

EMPLOYEE BENEFIT PLAN

EMPLOYEE BENEFIT PLAN	12 Months Ended
EMPLOYEE BENEFIT PLAN	Sep. 30, 2020
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, 2020, 13,870 shares were issued to the Company’s 401(k) plan for a cost of approximately $163,000. During the year ended September 30, 2019, 30,996 shares were issued to the Company’s 401(k) plan for a cost of approximately $144,000.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	12 Months Ended
COMMITMENTS AND CONTINGENCIES	Sep. 30, 2020
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 $33.4 million related to Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.1 million. During the years ended September 30, 2020 and 2019, the Company recorded approximately $2.0 million and $2.8 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 and $1.0 million during the years ended September 30, 2020 and 2019, respectively. Lease Agreements If a contract conveys the right to control the use of identified property, plant or equipment over a period of time in exchange for consideration, the Company accounts for the contract as a lease 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 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. For purposes of calculating lease liabilities, lease and non-lease components are combined. 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. 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, 2020, the net book value of the finance lease right of use asset is approximately $13.8 million and the balance of the finance lease liability is approximately $12.7 million, of which approximately $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 depreciated using a straight-line method over the underlying lease terms. Total cash paid related to finance leases during the year ended September 30, 2020 was approximately $1.9 million, of which approximately $1.2 million was for interest. The weighted average discount rate of the Company’s finance leases is 8.8% and the weighted average time to maturity is 8.1 years. In August 2020, the Company entered into an amendment to the 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 $10.5 million, of which approximately $3.1 million has been incurred to date. Pursuant to the amendment, the landlord agreed to finance the final $2.4 million of the costs incurred, i.e., after the Company has financed the initial $8.1 million. Per the terms of the financing, upon completion of the project, the $2.4 million will be repaid as through increased lease payments over the remaining lease term. The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets at September 30, 2020 and 2019. Approximate future minimum lease payments under finance leases as of September 30, 2020 are as follows: Year ending September 30, 2021 $ 1,953,000 2022 2,014,000 2023 2,083,000 2024 2,148,000 2025 2,218,000 Thereafter 7,322,000 Total future minimum lease obligation 17,738,000 Less imputed interest on finance lease obligations (5,050,000 ) Net present value of lease finance lease obligations $ 12,688,000 Effective April 30, 2020, the Company terminated a month-to-month arrangement with a sub-lessee as the sub-leased space is 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 years ended September 30, 2020 and 2019 was approximately $39,000 and $73,000, respectively. The Company leases two facilities under 60-month operating leases – the lease for its research and development laboratory expires February 28, 2022 and the lease for its office headquarters was renewed on July 1, 2020 and will expire on November 30, 2025. During the year ended September 30, 2020, the Company incurred approximately $80,000 in leasehold improvements costs for the research and development lab and is reasonably certain to renew the lease through February 28, 2027. The renewal period is included in the right of use asset and liability calculations. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the full 60-month 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, 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 $1.3 million, of which approximately $0.1 million is current. The Company incurred lease expense under operating leases of approximately $268,000 for the year ended September 30, 2020. Total cash paid related to operating leases during the year ended September 30, 2020 was approximately $238,000. As of September 30, 2020, future minimum lease payments on operating leases are as follows: Year ending September 30, 2021 $ 241,000 2022 264,000 2023 272,000 2024 280,000 2025 288,000 Thereafter 286,000 Total future minimum lease obligation 1,631,000 Less imputed interest on operating lease obligation (381,000 ) Net present value of operating lease obligation $ 1,250,000 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 $5.9 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
RELATED PARTY TRANSACTIONS	Sep. 30, 2020
RELATED PARTY TRANSACTIONS
11. RELATED PARTY TRANSACTIONS	11. RELATED PARTY TRANSACTIONS 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. During the year ended September 30, 2019, officers and a director of the Company purchased 45,205 restricted shares of the Company’s common stock at market price at an aggregate market value of approximately $292,000. The shares are subject to the conditions of Rule 144 under the Securities Act of 1933. 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.

STOCKHOLDERS EQUITY

STOCKHOLDERS EQUITY	12 Months Ended
STOCKHOLDERS EQUITY	Sep. 30, 2020
STOCKHOLDERS EQUITY
12. STOCKHOLDERS' EQUITY	12. STOCKHOLDERS’ EQUITY Exercise of Warrants During the years ended September 30, 2020 and 2019, the Company received proceeds of approximately $12.1 million and $14.5 million, respectively, from the exercise of warrants, as detailed in Note 4. Upon exercise, 1,711,873 and 6,677,519 shares of common stock were issued during the years ended September 30, 2020 and 2019, respectively. Sales of Securities 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 $5.0million. 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 and 2019, the Company issued Ergomed 150,000 and 750,000 shares, respectively. On December 31, 2018, the expiration date of a prior agreement, Ergomed returned 564,905 unsold shares for cancellation. The current agreement has no expiration date, but after Ergomed has completed its work and all amounts due are paid any remaining shares will be returned to the Company. The following table summarizes the Other Non-operating gains (losses) for the years ended September 30 relating to these agreements: 2020 2019 Amount realized through the resale of shares $ 2,652,605 $ 3,945,528 Fair value of shares upon issuance 1,769,500 3,400,000 Other non-operating gain (loss) $ 883,105 $ 545,528 As of September 30, 2020, Ergomed held 102,521 shares for resale. As of September 30, 2019, Ergomed held 198,000 shares which were all subsequently sold.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	12 Months Ended
FAIR VALUE MEASUREMENTS	Sep. 30, 2020
FAIR VALUE MEASUREMENTS
13. FAIR VALUE MEASUREMENTS	13. 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 amounts derived from valuation models where all significant inputs are observable in active markets 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. As of September 30, 2020 and 2019, 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: 2020 2019 Beginning balance $ 6,488,310 $ 9,317,031 Issuances - - Exercises (3,071,775 ) (3,589,357 ) Net realized and unrealized derivative loss 349,078 760,636 Ending balance $ 3,765,613 $ 6,488,310 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock as well as U.S. Treasury Bill rates are observable in active markets. 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. At September 30, 2019, the Company’s Level 3 derivative instruments have a weighted average fair value of $2.72 per share and a weighted average exercise price of $15.17 per share. Fair values were determined using a weighted average risk free interest rate of 1.85% and 103% volatility. The instruments have a weighted average time to maturity of 1.86 years.

NET LOSS PER COMMON SHARE

NET LOSS PER COMMON SHARE	12 Months Ended
NET LOSS PER COMMON SHARE	Sep. 30, 2020
NET LOSS PER COMMON SHARE
14. NET LOSS PER COMMON SHARE	14. 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, 2020 2019 Loss per share – basic and diluted Net loss available to common shareholders $ (30,276,978 ) $ (22,134,640 ) Weighted average shares outstanding 36,759,115 31,174,394 Basic and diluted loss per common share $ (0.82 ) $ (0.71 ) In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2020 2019 Options and Warrants 7,221,696 7,164,544 Unvested Restricted Stock 308,814 304,500 Total 7,530,510 7,469,044

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	12 Months Ended
SUBSEQUENT EVENTS	Sep. 30, 2020
SUBSEQUENT EVENTS
15. SUBSEQUENT EVENTS	15. SUBSEQUENT EVENTS 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 net proceeds of approximately $13.6 million. Under the terms of the Underwriting Agreement the Company granted the Underwriters a 30-day option to purchase up to an additional 150,000 shares of common stock at the public offering price to cover over-allotments.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	Sep. 30, 2020
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents	Cash and Cash Equivalents
Property and Equipment	Property and Equipment
Patents	Patents
Leases	Leases – Leases In connection with the preparation of our financial statements for the year ended September 30, 2020, we identified an error relating to the manufacturing facility lease on the adoption of ASC 842 at October 1, 2019. The error impacted the finance lease right-of-use asset and total stockholders’ equity, both of which were understated by approximately $2.0 million on adoption. We concluded the impact on the interim financial statements during fiscal 2020 was immaterial to the statement of operations but material to the balance sheet and will correct the balances for the quarterly reporting periods at December 31, 2019, March 31, 2020, and June 30, 2020. All adjustments have been reflected in the accompanying financial statements. Additional information has been disclosed in the 8-K filed on December 29, 2020.
Derivative Instruments	Derivative Instruments Accounting for Derivative Instruments and Hedging Activities In August 2018, the FASB issued ASU 2018-13, ” Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (Topic ). ”
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. Vesting of restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2020 Non- Qualified Stock Option Plan are subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and 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
Use of Estimates	Use of Estimates
New Accounting Pronouncements	In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes The Company has considered all other 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
WARRANTS AND NON-EMPLOYEE OPTIONS (Tables)	Sep. 30, 2020
WARRANTS AND NON-EMPLOYEE OPTIONS
Schedule of warrants and non-employee options	Warrant Issue Date Shares Issuable upon Exercise of Warrants 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 Warrant Issue Date Shares Issuable upon Exercise of Warrants Exercise Price Expiration Date Series N 8/18/2008 85,339 $ 3.00 2/18/2020 Series V 5/28/2015 810,127 $ 19.75 5/28/2020 Series UU 6/11/2018 154,810 $ 2.80 6/11/2020 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 FF 12/8/2016 68,048 $ 3.91 12/1/2021 Series CC 12/8/2016 277,463 $ 5.00 12/8/2021 Series HH 2/23/2017 6,500 $ 3.13 2/16/2022 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 Series JJ 3/14/2017 9,450 $ 3.13 3/8/2022 Series LL 4/30/2017 26,398 $ 3.59 4/30/2022 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 Series NN 7/24/2017 473,798 $ 2.52 7/24/2022 Series OO 7/31/2017 50,000 $ 2.52 7/31/2022 Series RR 10/30/2017 457,116 $ 1.65 10/30/2022 Series SS 12/19/2017 482,644 $ 2.09 12/18/2022 Series TT 2/5/2018 559,689 $ 2.24 2/5/2023 Series VV 7/2/2018 82,500 $ 1.75 1/2/2024 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 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 Warrants Warrants Exercised Exercise Price Proceeds Series NN 65,502 $ 2.52 $ 165,065 Series OO 10,000 $ 2.52 25,200 Series PP 172,500 $ 2.30 396,750 Series QQ 3,500 $ 2.50 8,750 Series RR 98,254 $ 1.65 162,119 Series SS 477,886 $ 2.09 998,782 Series TT 737,188 $ 2.24 1,651,301 Series UU 32,752 $ 2.80 91,706 Series VV 3,817,500 $ 1.75 6,680,625 Series WW 195,000 $ 1.63 316,875 5,610,082 $ 10,497,173
Schedule of warrant liabilities	2020 2019 Series V warrants $ - $ 674,442 Series W warrants 73,570 1,193,507 Series Z warrants 1,207,902 1,109,545 Series ZZ warrants 75,044 77,638 Series AA warrants 1,082,212 916,908 Series BB warrants 65,173 63,966 Series CC warrants 1,259,712 1,710,898 Series FF warrants - 446,185 Series HH warrants 2,000 45,657 Series JJ warrants - 66,599 Series LL warrants - 182,965 Total warrant liabilities $ 3,765,613 $ 6,488,310
Schedule of (losses)/gains on the warrant liabilities	2020 2019 Series S Warrants $ - $ 33 Series V warrants 185,652 95,994 Series W warrants 1,119,937 (194,426 ) Series Z warrants (98,357 ) (621,778 ) Series ZZ warrants 2,594 (43,423 ) Series AA warrants (165,304 ) (536,434 ) Series BB warrants (1,207 ) (35,510 ) Series CC warrants (875,040 ) (1,198,836 ) Series DD warrants - 1,249,287 Series EE warrants - 1,249,287 Series FF warrants (319,706 ) (257,264 ) Series GG warrants - 195,228 Series HH warrants (34,589 ) (24,465 ) Series II warrants - (442,040 ) Series JJ warrants (64,992 ) (35,301 ) Series KK warrants - (55,622 ) Series LL warrants (98,066 ) (105,333 ) Net loss on warrant liabilities $ (349,078 ) $ (760,603 )
Schedule of warrants recorded as liabilities were exercised	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 Warrants Warrants Exercised Exercise Price Proceeds Series CC 403,017 $ 5.00 $ 2,015,085 Series GG 200,000 $ 3.00 600,000 Series HH 13,500 $ 3.13 42,188 Series II 216,500 $ 3.00 649,500 Series JJ 20,550 $ 3.13 64,219 Series KK 213,870 $ 3.04 649,095 1,067,437 $ 4,020,087

PLANT, PROPERTY AND EQUIPMENT (

PLANT, PROPERTY AND EQUIPMENT (Tables)	12 Months Ended
PLANT, PROPERTY AND EQUIPMENT (Tables)	Sep. 30, 2020
PLANT, PROPERTY AND EQUIPMENT
Schedule of plant, property and equipment	2020 2019 Leased manufacturing facility $ - $ 21,183,756 Research equipment 3,898,242 3,320,358 Furniture and equipment 99,768 125,872 Leasehold improvements 5,519,161 149,239 9,517,171 24,779,225 Accumulated depreciation and amortization (3,673,178 ) (8,953,589 ) Net plant, property and equipment $ 5,843,993 $ 15,825,636

PATENTS (Tables)

PATENTS (Tables)	12 Months Ended
PATENTS (Tables)	Sep. 30, 2020
PATENTS
Schedule of patents	2020 2019 Patents $ 896,372 $ 841,397 Accumulated amortization (582,950 ) (529,811 ) Patents, net $ 313,422 $ 311,586
Schedule of total estimated future amortization	Years ending September 30, 2021 52,000 2022 48,000 2023 38,000 2024 30,000 2025 28,000 Thereafter 117,000 $ 313,000

INCOME TAXES (Tables)

INCOME TAXES (Tables)	12 Months Ended
INCOME TAXES (Tables)	Sep. 30, 2020
INCOME TAXES
Schedule of components of the Company's deferred tax assets	2020 2019 NOL carryforwards $ 13,407,000 $ 9,698,000 Lease liabilities 3,631,000 - R&D credit 1,221,000 1,221,000 Stock-based compensation 5,297,000 3,165,000 Capitalized R&D 15,853,000 14,777,000 Vacation and other 125,000 544,000 Total deferred tax assets 39,534,000 29,405,000 Right of use assets (3,911,000 ) - Fixed assets and intangibles (169,000 ) (586,000 ) Total deferred tax liability (4,080,000 ) (586,000 ) Net deferred tax asset 35,454,000 28,819,000 Valuation allowance (35,454,000 ) (28,819,000 ) Ending Balance $ - $ -
Schedule of federal or state current or deferred tax expense or benefit	2020 2019 Federal Rate 21.00 % 21.00 % Federal rate change (1.40 ) (2.8 ) State tax rate, net of federal benefit 5.15 5.31 Other adjustments (3.24 ) (4.77 ) Permanent differences 0.42 (0.57 ) Change in valuation allowance (21.93 ) (18.17 ) Effective tax rate 0.00 % 0.00 %

STOCK COMPENSATION (Tables)

STOCK COMPENSATION (Tables)	12 Months Ended
STOCK COMPENSATION (Tables)	Sep. 30, 2020
STOCK COMPENSATION
Schedule of expenses for options issued or vested and restricted stock awarded	Year Ended September 30, 2020 2019 Employees $ 10,112,968 $ 4,428,174 Non-employees $ 862,796 $ 856,025
Schedule of fair value of each option granted	2020 2019 Expected stock price volatility 87.36 – 90.26% 87.67 – 92.84% Risk-free interest rate 0.62 – 1.87% 1.62 – 2.82% Expected life of options 9.68 – 9.69 Years 9.67 – 9.68 Years Expected dividend yield - -
Schedule of non-qualified and incentive stock option plans	Outstanding Exercisable Weighted Weighted Weighted Average Ave Remaining Contractual Aggregate Weighted Average Ave Remaining Contractual Aggregate Number of Exercise Term Intrinsic Number of Exercise Term Intrinsic Shares Price (Years) Value Shares Price (Years) Value Outstanding at September 30, 2018 3,160,127 $ 7.30 8.88 $ 4,761,973 577,694 $ 26.18 6.74 $ 604.763 Vested 945,359 $ 2.56 Granted 3,271,362 $ 5.40 Exercised (a) 65,997 $ 2.28 65,997 $ 2.28 Forfeited 82,461 $ 17.89 Expired (b) 64,815 $ 71.86 64,815 $ 71.86 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
Schedule of non-vested options	Number of Options Weighted Average Grant Date Fair Value Unvested at October 1, 2018 2,582,433 $ 2.48 Vested (945,359 ) Granted 3,271,362 Forfeited (82,461 ) 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
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, 2018 312,000 $ 13.75 Forfeited (7,500 ) Vested - Unvested at September 30, 2019 304,500 $ 13.75 Forfeited - Vested - Unvested at September 30, 2020 304,500 $ 13.75

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
COMMITMENTS AND CONTINGENCIES (Tables)	Sep. 30, 2020
COMMITMENTS AND CONTINGENCIES
Schedule of future minimum payments under finance leases	Year ending September 30, 2021 $ 1,953,000 2022 2,014,000 2023 2,083,000 2024 2,148,000 2025 2,218,000 Thereafter 7,322,000 Total future minimum lease obligation 17,738,000 Less imputed interest on finance lease obligations (5,050,000 ) Net present value of lease finance lease obligations $ 12,688,000
Schedule of future minimum payments under operating leases	Year ending September 30, 2021 $ 241,000 2022 264,000 2023 272,000 2024 280,000 2025 288,000 Thereafter 286,000 Total future minimum lease obligation 1,631,000 Less imputed interest on operating lease obligation (381,000 ) Net present value of operating lease obligation $ 1,250,000

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	12 Months Ended
STOCKHOLDERS EQUITY (Tables)	Sep. 30, 2020
STOCKHOLDERS EQUITY
Schedule of other non-operating gains (losses)	2020 2019 Amount realized through the resale of shares $ 2,652,605 $ 3,945,528 Fair value of shares upon issuance 1,769,500 3,400,000 Other non-operating gain (loss) $ 883,105 $ 545,528

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	12 Months Ended
FAIR VALUE MEASUREMENTS (Tables)	Sep. 30, 2020
FAIR VALUE MEASUREMENTS
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	2020 2019 Beginning balance $ 6,488,310 $ 9,317,031 Issuances - - Exercises (3,071,775 ) (3,589,357 ) Net realized and unrealized derivative loss 349,078 760,636 Ending balance $ 3,765,613 $ 6,488,310

NET LOSS PER COMMON SHARE (Tabl

NET LOSS PER COMMON SHARE (Tables)	12 Months Ended
NET LOSS PER COMMON SHARE (Tables)	Sep. 30, 2020
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, 2020 2019 Loss per share – basic and diluted Net loss available to common shareholders $ (30,276,978 ) $ (22,134,640 ) Weighted average shares outstanding 36,759,115 31,174,394 Basic and diluted loss per common share $ (0.82 ) $ (0.71 )
Schedule of anti-dilutive securities	2020 2019 Options and Warrants 7,221,696 7,164,544 Unvested Restricted Stock 308,814 304,500 Total 7,530,510 7,469,044

SUMMARY OF SIGNIFICANT ACCOUN_3

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	12 Months Ended
	Sep. 30, 2020USD ($)
Patent useful life	17 years
Increase long term assets	$ 3,000,000
Accumulated deficit	2,100,000
Decrease total liabilities	900,000
Fully insured amount of non-interest bearing cash balances	250,000
October 1, 2019 [Member]
Understated value of lease right of use assets and total stockholders equity	$ 2,000,000

WARRANTS AND NONEMPLOYEE OPTION

WARRANTS AND NONEMPLOYEE OPTIONS (Details) - $ / shares	12 Months Ended
WARRANTS AND NONEMPLOYEE OPTIONS (Details) - $ / shares	Sep. 30, 2020	Sep. 30, 2019
Consultants [Member]
STOCKHOLDERS' EQUITY
Issue Date	7/28/17	7/28/17
Shares Issuable upon Exercise of Warrant	10,000	10,000
Exercise Price	$ 2.18	$ 2.18
Expiration Date	7/27/2027	7/27/2027
Series V [Member]
STOCKHOLDERS' EQUITY
Issue Date		5/28/2015
Shares Issuable upon Exercise of Warrant		810,127
Exercise Price		$ 19.75
Expiration Date		5/28/2020
Series W [Member]
STOCKHOLDERS' EQUITY
Issue Date	10/28/2015	10/28/2015
Shares Issuable upon Exercise of Warrant	688,930	688,930
Exercise Price	$ 16.75	$ 16.75
Expiration Date	10/28/2020	10/28/2020
Series ZZ [Member]
STOCKHOLDERS' EQUITY
Issue Date	5/23/2016	5/23/2016
Shares Issuable upon Exercise of Warrant	20,000	20,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	5/18/2021	5/18/2021
Series BB [Member]
STOCKHOLDERS' EQUITY
Issue Date	8/26/2016	8/26/2016
Shares Issuable upon Exercise of Warrant	16,000	16,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	8/22/2021	8/22/2021
Series Z [Member]
STOCKHOLDERS' EQUITY
Issue Date	5/23/2016	5/23/2016
Shares Issuable upon Exercise of Warrant	264,000	264,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	11/23/2021	11/23/2021
Series FF [Member]
STOCKHOLDERS' EQUITY
Issue Date		12/8/2016
Shares Issuable upon Exercise of Warrant		68,048
Exercise Price		$ 3.91
Expiration Date		12/1/2021
Series CC [Member]
STOCKHOLDERS' EQUITY
Issue Date	12/8/2016	12/8/2016
Shares Issuable upon Exercise of Warrant	148,643	277,463
Exercise Price	$ 5	$ 5
Expiration Date	12/8/2021	12/8/2021
Series HH [Member]
STOCKHOLDERS' EQUITY
Issue Date	2/23/2017	2/23/2017
Shares Issuable upon Exercise of Warrant	200	6,500
Exercise Price	$ 3.13	$ 3.13
Expiration Date	2/16/2022	2/16/2022
Series AA [Member]
STOCKHOLDERS' EQUITY
Issue Date	8/26/2016	8/26/2016
Shares Issuable upon Exercise of Warrant	200,000	200,000
Exercise Price	$ 13.75	$ 13.75
Expiration Date	2/22/2022	2/22/2022
Series JJ [Member]
STOCKHOLDERS' EQUITY
Issue Date		3/14/2017
Shares Issuable upon Exercise of Warrant		9,450
Exercise Price		$ 3.13
Expiration Date		3/8/2022
Series LL [Member]
STOCKHOLDERS' EQUITY
Issue Date		4/30/2017
Shares Issuable upon Exercise of Warrant		26,398
Exercise Price		$ 3.59
Expiration Date		4/30/2022
Series N [Member]
STOCKHOLDERS' EQUITY
Issue Date	8/18/2008	8/18/2008
Shares Issuable upon Exercise of Warrant	85,339	85,339
Exercise Price	$ 3	$ 3
Expiration Date	2/18/2021	2/18/2020
Series X [Member]
STOCKHOLDERS' EQUITY
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	1/13/2021	1/13/2021
Series Y [Member]
STOCKHOLDERS' EQUITY
Issue Date	2/15/2016	2/15/2016
Shares Issuable upon Exercise of Warrant	26,000	26,000
Exercise Price	$ 12	$ 12
Expiration Date	2/15/2021	2/15/2021
Series MM [Member]
STOCKHOLDERS' EQUITY
Issue Date	6/22/2017	6/22/2017
Shares Issuable upon Exercise of Warrant	797,633	893,491
Exercise Price	$ 1.86	$ 1.86
Expiration Date	6/22/2022	6/22/2022
Series NN [Member]
STOCKHOLDERS' EQUITY
Issue Date	7/24/2017	7/24/2017
Shares Issuable upon Exercise of Warrant	348,842	473,798
Exercise Price	$ 2.52	$ 2.52
Expiration Date	7/24/2022	7/24/2022
Series OO [Member]
STOCKHOLDERS' EQUITY
Issue Date		7/31/2017
Shares Issuable upon Exercise of Warrant		50,000
Exercise Price		$ 2.52
Expiration Date		7/31/2022
Series RR [Member]
STOCKHOLDERS' EQUITY
Issue Date	10/30/2017	10/30/2017
Shares Issuable upon Exercise of Warrant	417,649	457,116
Exercise Price	$ 1.65	$ 1.65
Expiration Date	10/30/2022	10/30/2022
Series SS [Member]
STOCKHOLDERS' EQUITY
Issue Date	12/19/2017	12/19/2017
Shares Issuable upon Exercise of Warrant	326,064	482,644
Exercise Price	$ 2.09	$ 2.09
Expiration Date	12/18/2022	12/18/2022
Series TT [Member]
STOCKHOLDERS' EQUITY
Issue Date	2/5/2018	2/5/2018
Shares Issuable upon Exercise of Warrant	371,564	559,689
Exercise Price	$ 2.24	$ 2.24
Expiration Date	2/5/2023	2/5/2023
Series VV [Member]
STOCKHOLDERS' EQUITY
Issue Date		7/2/2018
Shares Issuable upon Exercise of Warrant		82,500
Exercise Price		$ 1.75
Expiration Date		1/2/2024
Series UU [Member]
STOCKHOLDERS' EQUITY
Issue Date	6/11/2018	6/11/2018
Shares Issuable upon Exercise of Warrant	93,603	154,810
Exercise Price	$ 2.80	$ 2.80
Expiration Date	12/31/2020	6/11/2020

WARRANTS AND NON-EMPLOYEE OPT_3

WARRANTS AND NON-EMPLOYEE OPTIONS (Details 1) - USD ($)	12 Months Ended
WARRANTS AND NON-EMPLOYEE OPTIONS (Details 1) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Total warrant liabilities	$ 3,765,613	$ 6,488,310
Net (loss) gain on warrant liabilities	(349,078)	(760,603)
Series V [Member]
Total warrant liabilities	0	674,442
Net (loss) gain on warrant liabilities	185,652	95,994
Series W [Member]
Total warrant liabilities	73,570	1,193,507
Net (loss) gain on warrant liabilities	1,119,937	(194,426)
Series ZZ [Member]
Total warrant liabilities	75,044	77,638
Net (loss) gain on warrant liabilities	2,594	(43,423)
Series BB [Member]
Total warrant liabilities	65,173	63,966
Net (loss) gain on warrant liabilities	(1,207)	(35,510)
Series Z [Member]
Total warrant liabilities	1,207,902	1,109,545
Net (loss) gain on warrant liabilities	98,357	(621,778)
Series FF [Member]
Total warrant liabilities	0	446,185
Net (loss) gain on warrant liabilities	(319,706)	(257,264)
Series CC [Member]
Total warrant liabilities	1,259,712	1,710,898
Net (loss) gain on warrant liabilities	(875,040)	(1,198,836)
Series HH [Member]
Total warrant liabilities	2,000	45,657
Net (loss) gain on warrant liabilities	(34,589)	(24,465)
Series AA [Member]
Total warrant liabilities	1,082,212	916,908
Net (loss) gain on warrant liabilities	(165,304)	(536,434)
Series JJ [Member]
Total warrant liabilities	0	66,599
Net (loss) gain on warrant liabilities	(64,992)	(35,301)
Series LL [Member]
Total warrant liabilities	0	182,965
Net (loss) gain on warrant liabilities	(98,066)	(105,333)
Series DD [Member]
Net (loss) gain on warrant liabilities	0	1,249,287
Series EE [Member]
Net (loss) gain on warrant liabilities	0	1,249,287
Series GG [Member]
Net (loss) gain on warrant liabilities	0	195,228
Series II [Member]
Net (loss) gain on warrant liabilities	0	(442,040)
Series KK [Member]
Net (loss) gain on warrant liabilities	0	(55,622)
Series S [Member]
Total warrant liabilities		33
Net (loss) gain on warrant liabilities	$ 0	$ 33

WARRANTS AND NON-EMPLOYEE OPT_4

WARRANTS AND NON-EMPLOYEE OPTIONS (Details 2) - USD ($)	12 Months Ended
WARRANTS AND NON-EMPLOYEE OPTIONS (Details 2) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Proceeds	$ 10,323,752	$ 4,020,087
Warrants Exercised	913,180	1,067,437
Series V [Member]
Proceeds	$ 9,269,755
Warrants Exercised	674,164
Exercise Price	$ 13.75
Series FF [Member]
Proceeds	$ 265,812
Warrants Exercised	68,048
Exercise Price	$ 3.91
Series CC [Member]
Proceeds	$ 644,100	$ 2,015,085
Warrants Exercised	128,820	403,017
Exercise Price	$ 5	$ 5
Series HH [Member]
Proceeds	$ 19,687	$ 42,188
Warrants Exercised	6,300	13,500
Exercise Price	$ 3.13	$ 3.13
Series JJ [Member]
Proceeds	$ 29,531	$ 64,219
Warrants Exercised	9,450	20,550
Exercise Price	$ 3.13	$ 3.13
Series LL [Member]
Proceeds	$ 94,867
Warrants Exercised	26,398
Exercise Price	$ 3.59
Series GG [Member]
Proceeds		$ 600,000
Warrants Exercised		200,000
Exercise Price		$ 3
Series II [Member]
Proceeds		$ 649,500
Warrants Exercised		216,500
Exercise Price		$ 3
Series KK [Member]
Proceeds		$ 649,095
Warrants Exercised		213,870
Exercise Price		$ 3.04

WARRANTS AND NON-EMPLOYEE OPT_5

WARRANTS AND NON-EMPLOYEE OPTIONS (Details 3) - USD ($)	12 Months Ended
WARRANTS AND NON-EMPLOYEE OPTIONS (Details 3) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Equity Warrants Exercised	798,693	5,610,082
Proceeds from Equity Warrants Exercised	$ 1,748,713	$ 10,497,173
Series MM [Member]
Equity Warrants Exercised	95,858
Proceeds from Equity Warrants Exercised	$ 178,296
Equity Warrants Exercise Price	$ 1.86
Series NN [Member]
Equity Warrants Exercised	124,956	65,502
Proceeds from Equity Warrants Exercised	$ 314,889	$ 165,065
Equity Warrants Exercise Price	$ 2.52	$ 2.52
Series OO [Member]
Equity Warrants Exercised	50,000	10,000
Proceeds from Equity Warrants Exercised	$ 126,000	$ 25,200
Equity Warrants Exercise Price	$ 2.52	$ 2.52
Series RR [Member]
Equity Warrants Exercised	39,467	98,254
Proceeds from Equity Warrants Exercised	$ 65,121	$ 162,119
Equity Warrants Exercise Price	$ 1.65	$ 1.65
Series SS [Member]
Equity Warrants Exercised	156,580	477,886
Proceeds from Equity Warrants Exercised	$ 327,252	$ 998,782
Equity Warrants Exercise Price	$ 2.09	$ 2.09
Series TT [Member]
Equity Warrants Exercised	188,125	737,188
Proceeds from Equity Warrants Exercised	$ 421,400	$ 1,651,301
Equity Warrants Exercise Price	$ 2.24	$ 2.24
Series VV [Member]
Equity Warrants Exercised	82,500	3,817,500
Proceeds from Equity Warrants Exercised	$ 144,375	$ 6,680,625
Equity Warrants Exercise Price	$ 1.75	$ 1.75
Series UU [Member]
Equity Warrants Exercised	61,207	32,752
Proceeds from Equity Warrants Exercised	$ 171,380	$ 91,706
Equity Warrants Exercise Price	$ 2.80	$ 2.80
Series QQ [Member]
Equity Warrants Exercised		172,500
Proceeds from Equity Warrants Exercised		$ 396,750
Equity Warrants Exercise Price		$ 2.30
Series PP [Member]
Equity Warrants Exercised		3,500
Proceeds from Equity Warrants Exercised		$ 8,750
Equity Warrants Exercise Price		$ 2.50
Series WW [Member]
Equity Warrants Exercised		195,000
Proceeds from Equity Warrants Exercised		$ 316,875
Equity Warrants Exercise Price		$ 1.63

WARRANTS AND NON-EMPLOYEE OPT_6

WARRANTS AND NON-EMPLOYEE OPTIONS (Details Narrative) - USD ($)	May 08, 2020	Dec. 10, 2018	Oct. 11, 2018	Jun. 25, 2020	May 26, 2020	May 08, 2020	Jan. 23, 2020	Sep. 30, 2020	Sep. 30, 2019
Incremental cost								$ 664,000
Shares to be issued									$ 10,000
Common stock issued for service, shares								79,950	199,977
Fair value of warrant								$ 806,000
Warrants exercised								913,180	1,067,437
Consulting Agreements [Member]
Total expense								$ 863,000	$ 856,000
Prepaid expenses								$ 395,000	$ 230,000
Consultants [Member]
Warrants expired								10,400
Options issued								10,000
Option issued to related party								10,000
Maximum [Member] \| Restricted Stock [Member] \| Consultants [Member]
Weighted average grant date fair value								$ 2.66	$ 17.60
Series V Warrants [Member]
Fair value of warrant				$ 211,000
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 exercised				135,963
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 DD Warrants [Member]
Warrants expired		1,360,960		1,360,960
Series EE Warrants [Member]
Warrants exercised		$ 4.50
Warrants expired		1,360,960		1,360,960
Series S Warrants [Member]
Warrants exercised			$ 31.25
Warrants expired			327,729
Series XX Warrants [Member]
Fair value of warrant								$ 629,000
Common stock price per share								$ 18
Series YY Warrants [Member]
Fair value of warrant								$ 177,000
Warrant issued								101,839
Series UU warrants [Member]
Incremental cost								$ 6,000
Expiration date description	extended from June 11, 2020 to December 31, 2020					extended from June 11, 2020 to December 31, 2020.
Warrants issued	93,593					93,593
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.	expiration date of the Series N warrants was extended to February 18, 2021

PLANT, PROPERTY AND EQUIPMENT_2

PLANT, PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
PLANT, PROPERTY AND EQUIPMENT
Leased manufacturing facility	$ 0	$ 21,183,756
Research equipment	3,898,242	3,320,358
Furniture and equipment	99,768	125,872
Leasehold improvements	5,519,161	149,239
Gross	9,517,171	24,779,225
Accumulated depreciation and amortization	(3,673,178)	(8,953,589)
Net plant, property and equipment	$ 5,843,993	$ 15,825,636

PLANT PROPERTY AND EQUIPMENT (D

PLANT PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	12 Months Ended
PLANT PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
PLANT, PROPERTY AND EQUIPMENT
Depreciation - Building		$ 514,000
Accumulated Depreciation - Facility		5,600,000
Depreciation expense	$ 2,100,000
Depreciation expense, net		$ 588,000

PATENTS (Details)

PATENTS (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Patents	$ 313,422	$ 311,586
Patents [Member]
Patents	896,372	841,397
Accumulated amortization	(582,950)	(529,811)
Patents, net	$ 313,422	$ 311,586

PATENTS (Details 1)

PATENTS (Details 1)	Sep. 30, 2020USD ($)
PATENTS (Details)
2021	$ 52,000
2022	48,000
2023	38,000
2024	30,000
2025	28,000
Thereafter	117,000
Total	$ 313,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	12 Months Ended
PATENTS (Details Narrative) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
PATENTS (Details)
Amortization of patent costs	$ 53,000	$ 45,000

INCOME TAXES (Details)

INCOME TAXES (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
INCOME TAXES
NOL carryforwards	$ 13,407,000	$ 9,698,000
Lease liabilities	3,631,000	0
R&D credit	1,221,000	1,221,000
Stock-based compensation	5,297,000	3,165,000
Capitalized R&D	15,853,000	14,777,000
Vacation and other	125,000	544,000
Total deferred tax assets	39,534,000	29,405,000
Right of use assets	(3,911,000)	0
Fixed assets and intangibles	(169,000)	(586,000)
Total deferred tax liability	(4,080,000)	(586,000)
Net deferred tax asset	(35,454,000)	28,819,000
Valuation allowance	(35,454,000)	(28,819,000)
Ending Balance	$ 0	$ 0

INCOME TAXES (Details 1)

INCOME TAXES (Details 1)	12 Months Ended
INCOME TAXES (Details 1)	Sep. 30, 2020	Sep. 30, 2019
INCOME TAXES
Federal Rate	21.00%	21.00%
Federal rate change	(1.40%)	(28.00%)
State tax rate, net of federal benefit	5.15%	5.31%
Other adjustments	(3.24%)	(4.77%)
Permanent differences	0.42%	(0.57%)
Change in valuation allowance	(21.93%)	(18.17%)
Effective tax rate	0.00%	0.00%

INCOME TAXES (Details Narrative

INCOME TAXES (Details Narrative) - USD ($)	12 Months Ended
INCOME TAXES (Details Narrative) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Federal net operating loss carryforwards	$ 13,407,000	$ 9,698,000
Net deferred tax assets	(35,454,000)	28,819,000
Estimated net operating loss carryforwards	39,534,000	29,405,000
Income Tax [Member]
Research and development credit	$ 1,200,000	1.2
Research and development credit, description	The R&D credit begins to expire during the year ended September 30, 2021 and becomes fully expired during the fiscal year ended 2029.
Federal net operating loss carryforwards	$ 51,500,000	36,700,000
Net deferred tax assets	$ 35,500,000	$ 28,800,000
Net operating loss carryforwards, description	Approximately $19.2 million of the NOL carryforwards begin to expire during the year ended September 30, 2021 and become fully expired by 2039 and approximately $32.3 million of NOL carryforwards, which were generated post Tax Cuts and Jobs Act, have an indefinite live. The NOL carryforwards begin to expire during the year ended September 30, 2021 and become fully expired by the end of the fiscal year ended 2039.
Estimated net operating loss carryforwards	$ 188,900,000

STOCK COMPENSATION (Details)

STOCK COMPENSATION (Details) - USD ($)	12 Months Ended
STOCK COMPENSATION (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
STOCK COMPENSATION
Employees	$ 10,112,968	$ 4,428,174
Non-employees	$ 862,796	$ 856,025

STOCK COMPENSATION (Details 1)

STOCK COMPENSATION (Details 1)	12 Months Ended
STOCK COMPENSATION (Details 1)	Sep. 30, 2020	Sep. 30, 2019
STOCK COMPENSATION
Expected stock price volatility, min	87.36%	87.67%
Expected stock price volatility, max	90.26%	92.84%
Risk-free interest rate, min	0.62%	1.62%
Risk-free interest rate, max	1.87%	2.82%
Expected life of options, min	9 years 8 months 4 days	9 years 8 months 1 day
Expected life of options, max	9 years 8 months 8 days	9 years 8 months 4 days
Expected dividend yield	0.00%	0.00%

STOCK COMPENSATION (Details 2)

STOCK COMPENSATION (Details 2) - USD ($)	12 Months Ended
STOCK COMPENSATION (Details 2) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Outstanding [Member]
Number of Options Outstanding, Beginning	6,218,216	3,160,127
Number of Options Exercised	99,740	65,997
Number of Options Expired	9,773	64,815
Number of Options Outstanding, Ending	8,653,703	6,218,216
Weighted Average Exercise Price Outstanding, Beginning	$ 5.54	$ 7.30
Weighted Average Exercise Price Exercised	3.39	2.28
Weighted Average Exercise Price Expired	132.75	71.86
Weighted Average Exercise Price Outstanding, Ending	$ 7.01	$ 5.54
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Beginning	8 years 10 months 17 days	8 years 10 months 17 days
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Ending	8 years 4 months 20 days	8 years 10 months 17 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 29,562,594	$ 4,761,973
Aggregate Intrinsic Value Outstanding, Ending	$ 56,193,415	$ 29,562,594
Number of Options Granted	2,563,000	3,271,362
Number of Options Forfeited	18,000	82,461
Weighted Average Exercise Price Granted	$ 10.93	$ 5.40
Weighted Average Exercise Price Forfeited	$ 10.34	$ 17.89
Exercisable [Member]
Number of Options Outstanding, Beginning	1,392,241	577,694
Number of Options Vested	2,014,501	945,359
Number of Options Exercised	99,740	65,997
Number of Options Expired	9,773	64,815
Number of Options Outstanding, Ending	3,297,229	1,392,241
Weighted Average Exercise Price Outstanding, Beginning	$ 9.15	$ 26.18
Weighted Average Exercise Price Vested	4.06	2.56
Weighted Average Exercise Price Exercised	3.39	2.28
Weighted Average Exercise Price Expired	132.75	71.86
Weighted Average Exercise Price Outstanding, Ending	$ 5.85	$ 9.15
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Beginning	7 years 8 months 4 days	6 years 8 months 26 days
Weighted Average Remaining Contractual Life Term (Years) Outstanding, Ending	7 years 5 months 23 days	7 years 8 months 5 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 7,869,555	$ 604,763
Aggregate Intrinsic Value Outstanding, Ending	$ 29,090,662	$ 7,869,555

STOCK COMPENSATION (Details 3)

STOCK COMPENSATION (Details 3) - $ / shares	12 Months Ended
STOCK COMPENSATION (Details 3) - $ / shares	Sep. 30, 2020	Sep. 30, 2019
STOCK COMPENSATION
Number of unvested options, Beginning	4,825,975	2,582,433
Vested options	(2,014,501)	(945,359)
Granted options	2,563,000	3,271,362
Forfeited options	(18,000)	(82,461)
Number of unvested options, Ending	5,356,474	4,825,975
Weighted Average Grant Date Fair Value, Beginning	$ 3.79	$ 2.48
Weighted Average Grant Date Fair Value, Ending	$ 4.76	$ 3.79

STOCK COMPENSATION (Details 4)

STOCK COMPENSATION (Details 4) - $ / shares	12 Months Ended
STOCK COMPENSATION (Details 4) - $ / shares	Sep. 30, 2020	Sep. 30, 2019
Weighted Average Grant Date Fair Value, Beginning	$ 3.79	$ 2.48
Restricted Stock Awards [Member]
Number of unvested shares, Beginning	304,500	312,000
Forfeited	0	(7,500)
Vested shares	0	0
Number of unvested shares, Ending	304,500	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 ($)	12 Months Ended
STOCK COMPENSATION (Details Narrative) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Apr. 20, 2020	Mar. 31, 2020	Dec. 31, 2019
Common stock, shares issued	38,730,150	35,231,776		630,500	606,395
Common stock, shares authorized	600,000,000	600,000,000
Stock Bonus Plans [Member]
Common stock, shares issued	345,096
Common stock, shares authorized	783,760
Incentive Stock Bonus Plan [Member]
Common stock, shares authorized	640,000
Issuance of restricted stock	$ 300,000	$ 0.3
Unrecognized compensation expense	$ 400,000
Weighted average period	1 year 2 months 12 days
Incentive Stock Option Plans [Member]
Common stock, shares authorized	138,400
Non-Qualified Stock Options Plans [Member]
Common stock, shares authorized	9,987,200
Unrecognized compensation expense	$ 2,100,000
Remaining compensation expense	$ 5,800,000
Issuance of common stock options purchase shares	3,600,000
Performance based stock options shares granted			1,872,000
Stock price	$ 10.93
Stock options vest description	the following performance goals: 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; 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; and iv) 100% of the options will vest when either (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 $40.00 for ten consecutive trading days.
Fair value per share	$ 4.21
Grant date fair value remaining outstanding	$ 7,881,120
Grant date fair value remaining		$ 8.6
Implicit life of options	1 year 8 months 12 days
Expense life over next	1 year 3 months
Stock Compensation Plans [Member]
Common stock, shares issued	150,695	150,695
Common stock, shares authorized	634,000

EMPLOYEE BENEFIT PLAN (Detail N

EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	12 Months Ended
EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
EMPLOYEE BENEFIT PLAN (Detail Narrative)
Expense for Company's contribution to employee benefit plan	$ 163,000	$ 144,000
Total compensation	$ 10,000
Participant compensation	600.00%
Shares issued	13,870	30,996

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
2021	$ 1,953,000
2022	2,014,000
2023	2,083,000
2024	2,148,000
2025	2,218,000
Thereafter	7,322,000
Total future minimum lease obligation	17,738,000
Less imputed interest on financing obligation	(5,050,000)
Net present value of lease financing obligation	$ 12,688,000

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Sep. 30, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
2021	$ 241,000
2022	264,000
2023	272,000
2024	280,000
2025	288,000
Thereafter	286,000
Total future minimum lease obligation	1,631,000
Less imputed interest on operating lease obligation	381,000
Total	$ 1,250,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	Oct. 15, 2015	Aug. 31, 2020	Apr. 30, 2013	Sep. 30, 2020	Sep. 30, 2019
Non current assets				$ 1,700,000
Cash paid related to finance leases				1,900,000
Additional expense				$ 5,900,000
Weighted average discount rate				88.00%
Maturity years				8 years 1 month 6 days
Interest				$ 1,200,000
Research and development expenses				80,000
Rental income				39,000	$ 73,000
Book value of operating lease - liability				$ 1,200,000
Operating lease liability, description				the balance of the operating lease liability is approximately $1.3 million, of which approximately $0.1 million is current.
Operating lease expense				$ 268,000
Cash paid related to operating leases				238,000
Right of use asset				16,500,000
Clinical service				12,000,000
Finance lease liability				13,500,000
Finance Leases[Member]
Finance lease liability				$ 12.7
Finance lease liability, description				the balance of the finance lease liability is approximately $12.7 million, of which approximately $0.9 million is current.
Ergomed [Member]
Research and development expenses				$ 33,400,000
Net of discount				11,100,000
Lease Agreement[Member]
Estimated cost		$ 10,500,000
Cost incurred		$ 3,100,000
Co-Development And Revenue Sharing Agreement [Member]
Research and development expenses				2,000,000	2,800,000
Clinical service	$ 2,000,000		$ 10,000,000
Net of discount				$ 600,000	$ 1,000,000

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)	May 08, 2020	May 08, 2020	Jan. 23, 2020	Sep. 30, 2020	Sep. 30, 2019
Officer and Director [Member]
Restricted Common shares				20,512	45,205
Restricted Common shares, amount				$ 185,000	$ 292,000
Series UU warrants [Member]
Expiration date description	extended from June 11, 2020 to December 31, 2020	extended from June 11, 2020 to December 31, 2020.
Interest expense				6,000
Warrants issued	93,593	93,593
Series N Warrants [Member]
Expiration date description		the expiration date of the Series N warrants was extended to February 18, 2021.	expiration date of the Series N warrants was extended to February 18, 2021
Deemed dividend				$ 22,000

STOCKHOLDERS EQUITY (Details)

STOCKHOLDERS EQUITY (Details) - USD ($)	12 Months Ended
STOCKHOLDERS EQUITY (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
STOCKHOLDERS EQUITY
Amount realized through the resale of shares	$ 2,652,605	$ 3,945,528
Fair value of shares upon issuance	1,769,500	3,400,000
Other non-operating gain (loss)	$ 883,105	$ 545,528

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	1 Months Ended				12 Months Ended
STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	May 31, 2020	Mar. 31, 2020	Jan. 31, 2020	Dec. 31, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2018
Common stock shares issued		630,500		606,395	38,730,150	35,231,776
Public offering price per share		$ 12.22	$ 9.07	$ 9.07
Proceeds from public offering	$ 1,100,000	$ 7,100,000	$ 800,000	$ 5,000,000	$ 184,990	$ 291,997
Additional shares of common stock		94,575	90,959	90,959
Proceeds from issuance of warrant					$ 12,100,000	$ 14,500,000
Warrants exercised					1,711,873	6,677,519
Ergomed [Member]
Common stock shares issued					150,000	750,000
Unsold shares returned							564,905
Shares held, susequently sold						198,000
Common stock shares held					102,521

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details) - USD ($)	12 Months Ended
FAIR VALUE MEASUREMENTS (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
FAIR VALUE MEASUREMENTS
Beginning balance	$ 6,488,310	$ 9,317,031
Issuances	0	0
Exercises	3,071,775	3,589,357
Net realized and unrealized derivative loss	349,078	760,636
Ending balance	$ 3,765,613	$ 6,488,310

FAIR VALUE MEASUREMENTS (Deta_2

FAIR VALUE MEASUREMENTS (Details Narrative) - Fair Value Inputs Level 3 (Level 3) - $ / shares	12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Weighted average fair value, Derivative instruments	$ 2.81	$ 2.72
Weighted average exercise price, Derivative instruments	$ 14.32	$ 15.17
Weighted average risk free interest rate	0.12%	1.85%
Volatility rate	9500.00%	10300.00%
Weighted average time to maturity year	1 year 2 months 12 days	1 year 10 months 9 days

NET LOSS PER COMMON SHARE (Deta

NET LOSS PER COMMON SHARE (Details) - USD ($)	12 Months Ended
NET LOSS PER COMMON SHARE (Details) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
Loss per share - basic and diluted
Net loss available to common shareholders	$ (30,276,978)	$ (22,134,640)
Weighted average shares outstanding	36,759,115	31,174,394
Basic and diluted loss per common share	$ (0.82)	$ (0.71)

NET LOSS PER COMMON SHARE (De_2

NET LOSS PER COMMON SHARE (Details 1) - shares	12 Months Ended
NET LOSS PER COMMON SHARE (Details 1) - shares	Sep. 30, 2020	Sep. 30, 2019
Antidilutive securities	7,530,510	7,469,044
Options and Warrants
Antidilutive securities	7,221,696	7,164,544
Unvested Restricted Stock [Member]
Antidilutive securities	308,814	304,500

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - USD ($)	1 Months Ended	12 Months Ended
SUBSEQUENT EVENTS (Details Narrative) - USD ($)	Dec. 31, 2020	Sep. 30, 2020	Sep. 30, 2019	Mar. 31, 2020	Jan. 31, 2020	Dec. 31, 2019
Common stock shares issued		38,730,150	35,231,776	630,500		606,395
Public offering price per share				$ 12.22	$ 9.07	$ 9.07
Additional shares of common stock				94,575	90,959	90,959
Proceeds from issuance of common stock		$ 13,992,439	$ 0
Subsequent Event [Member]
Common stock shares issued	1,000,000
Public offering price per share	$ 14.65
Additional shares of common stock	150,000
Proceeds from issuance of common stock	$ 13,600,000