CEL-SCI (CVM) 10-Q 12 Feb 21 2021 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Dec. 31, 2020	Feb. 05, 2021
Cover [Abstract]
Entity Registrant Name	CEL-SCI CORPORATION
Entity Central Index Key	0000725363
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--09-30
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Dec. 31, 2020
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2021
Entity Common Stock Shares Outstanding		40,529,278
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Address Address Line 1	8229 Boone Boulevard
Entity Address Address Line 2	Suite 802
Entity Address City Or Town	Vienna
Entity Address State Or Province	VA
Entity Address Postal Zip Code	22182
City Area Code	703
Local Phone Number	506-9460
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSE
Entity Interactive Data Current	Yes

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Dec. 31, 2020	Sep. 30, 2020
Current Assets:
Cash and cash equivalents	$ 21,860,482	$ 15,508,909
Receivables	54,922	54,922
Prepaid expenses	629,894	1,313,432
Supplies used for R&D and manufacturing	1,152,837	820,052
Total current assets	23,698,135	17,697,315
Finance lease right of use assets	13,382,401	13,811,849
Operating lease right of use assets	1,160,305	1,198,958
Property and equipment, net	9,401,891	5,843,993
Patent costs, net	300,356	313,422
Deposits	1,670,917	1,670,917
Total Assets	49,614,005	40,536,454
Current Liabilities:
Accounts payable	3,092,856	2,023,067
Accrued expenses	616,163	510,515
Due to employees	458,740	448,022
Derivative instruments, current portion	2,040,773	213,787
Lease liabilities, current portion	1,125,337	1,070,123
Total current liabilities	7,333,869	4,265,514
Derivative instruments, net of current portion	750,154	3,551,826
Finance lease obligations, net of current portion	11,495,840	11,753,100
Operating lease obligations, net of current portion	1,073,470	1,114,340
Other liabilities	125,000	125,000
Total liabilities	20,778,333	20,809,780
Commitments and Contingencies	0	0
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; 39,767,058 and 38,730,150 shares issued and outstanding at December 31, 2020 and September 30, 2020, respectively	397,671	387,302
Additional paid-in capital	418,210,168	401,174,675
Accumulated deficit	(389,772,167)	(381,835,303)
Total stockholders' equity	28,835,672	19,726,674
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 49,614,005	$ 40,536,454

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2020	Sep. 30, 2020
CONDENSED BALANCE SHEETS
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	200,000	200,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	39,767,058	38,730,150
Common stock, shares outstanding	39,767,058	38,730,150

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Grant income	$ 0	$ 35,506
Operating Expenses:
Research and development	5,414,760	4,252,813
General and administrative	3,316,156	2,638,896
Total operating expenses	8,730,916	6,891,709
Operating loss	(8,730,916)	(6,856,203)
Other income	0	18,448
Gain on derivative instruments	932,836	766,509
Other non-operating gains	121,606	790,669
Interest expense, net	(260,390)	(250,783)
Net loss	(7,936,864)	(5,531,360)
Modification of warrants	(85,779)	0
Net loss available to common shareholders	$ (8,022,643)	$ (5,531,360)
Net loss per common share
BASIC	$ (0.21)	$ (0.16)
DILUTED	$ (0.21)	$ (0.16)
Weighted average common shares outstanding
BASIC	38,670,247	35,084,279
DILUTED	38,767,286	35,098,608

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Sep. 30, 2019		35,231,776
Balance, amount at Sep. 30, 2019	$ 5,133,667	$ 352,318	$ 358,507,603	$ (353,726,254)
Adoption of new accounting standard	2,146,195			2,146,195
Issuance of common stock, shares		606,395
Issuance of common stock, amount	5,050,003	$ 6,064	5,043,939	0
Warrant exercises, shares		132,900
Warrant exercises, amount	297,101	$ 1,329	295,772	0
Equity based compensation - employees, amount	1,800,225	$ 0	1,800,225	0
401(k) contributions paid in common stock, shares		4,474
401(k) contributions paid in common stock, amount	40,937	$ 45	40,892	0
Stock issued to nonemployees for service, shares		15,819
Stock issued to nonemployees for service, amount	84,447	$ 158	84,289	0
Purchase of stock by officer, shares		3,725
Purchase of stock by officer, amount	25,000	$ 37	24,963	0
Share issuance costs	(92,150)	0	(92,150)	0
Net loss	(5,531,360)	$ 0	0	(5,531,360)
Balance, shares at Dec. 31, 2019		35,995,089
Balance, amount at Dec. 31, 2019	8,954,065	$ 359,951	365,705,533	(357,111,419)
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)
Warrant exercises, shares		15,000
Warrant exercises, amount	89,250	$ 150	89,100	0
Equity based compensation - employees, amount	3,296,309	$ (20)	3,296,329	0
401(k) contributions paid in common stock, shares		3,564
401(k) contributions paid in common stock, amount	41,671	$ 36	41,635	0
Stock issued to nonemployees for service, shares		15,044
Stock issued to nonemployees for service, amount	152,450	$ 150	152,300	0
Share issuance costs	(117,021)	0	(117,021)	0
Net loss	(7,936,864)	$ 0	0	(7,936,864)
Proceeds from the sale of common stock, shares		1,000,000
Proceeds from the sale of common stock, amount	$ 13,559,500	$ 10,000	13,549,500	0
Equity based compensation - employees, shares		(2,000)
Option exercises, shares	5,300	5,300
Option exercises, amount	$ 23,511	$ 53	23,458	0
Modification of warrants	192	$ 0	192	0
Balance, shares at Dec. 31, 2020		39,767,058
Balance, amount at Dec. 31, 2020	$ 28,835,672	$ 397,671	$ 418,210,168	$ (389,772,167)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (7,936,864)	$ (5,531,360)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	550,682	502,540
Share-based payments for services	248,660	155,740
Equity based compensation	3,296,309	1,800,225
Common stock contributed to 401(k) plan	41,671	40,937
Gain on derivative instruments	(932,836)	(766,509)
Modification of warrants	192	0
(Increase)/decrease in assets:
Receivables	532,328	(28,278)
Prepaid expenses	(332,785)	86,567
Supplies used for R&D and manufacturing	0	(123,512)
Increase/(decrease) in liabilities:
Accounts payable	532,679	(393,064)
Accrued expenses	143,028	80,432
Due to employees	10,718	76,520
Other liabilities	18,319	(1,914)
Net cash used in operating activities	(3,827,899)	(4,101,676)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(3,149,820)	(101,820)
Proceeds from the sale of equipment	0	4,500
Expenditures for patent costs	0	(12,390)
Net cash used in investing activities	(3,149,820)	(109,710)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	13,559,500	5,050,003
Payments of stock issuance costs	(79,499)	(31,080)
Proceeds from the purchase of stock by officer	0	25,000
Proceeds from exercises of warrants and options	70,911	297,101
Payments on obligations under finance lease	(221,620)	(191,034)
Net cash provided by financing activities	13,329,292	5,149,990
NET INCREASE IN CASH AND CASH EQUIVALENTS	6,351,573	938,604
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	15,508,909	8,444,774
CASH AND CASH EQUIVALENTS, END OF PERIOD	21,860,482	9,383,378
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	1,700,969	296,941
Capitalizable patent costs included in current liabilities	15,000	0
Finance lease obligation included in accounts payable	1,752	745
Prepaid consulting services paid with issuance of common stock	243,687	(71,293)
Exercise of derivative liabilities	41,850	0
Financing costs included in current liabilities	88,021	76,650
Cash paid for interest	$ 277,618	$ 295,107

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 Months Ended
	Dec. 31, 2020
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2020. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments necessary for a fair presentation of the Company’s financial position as of December 31, 2020 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2020 is derived from the September 30, 2020 audited financial statements. The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B. Summary of Significant Accounting Policies: Property and Equipment Patents Research and Development Costs Leases - Income Taxes Derivative Instruments Stock-Based Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the 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. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s common stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with 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 meet 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. Newly Adopted Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (Topic ).” New Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. 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.

OPERATIONS AND FINANCING

OPERATIONS AND FINANCING	3 Months Ended
	Dec. 31, 2020
OPERATIONS AND FINANCING
B. OPERATIONS AND FINANCING	B. 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 has been completed 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 similar 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 data readout. 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. Impact of COVID-19 Pandemic In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. Management follows the Centers for Disease Control and Prevention’s (“CDC”) guidance and the recommendations and restrictions provided by state and local authorities. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude of impact the pandemic will have on the Company’s financial condition, liquidity and future results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on its financial condition, liquidity, operations, suppliers, industry, and workforce. The financial statements have been prepared assuming 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.

STOCKHOLDERS EQUITY

STOCKHOLDERS EQUITY	3 Months Ended
	Dec. 31, 2020
STOCKHOLDERS EQUITY
C. STOCKHOLDERS' EQUITY	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock In December 2020, the Company sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. 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. Equity Compensation Underlying share information for equity compensation plans as of December 31, 2020 is as follows: Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Options Plans 138,400 85,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,527,787 N/A 1,201,832 Stock Bonus Plans 783,760 N/A 348,660 435,067 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500 Underlying share information for equity compensation plans as of September 30, 2020 is as follows: Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Option Plans 138,400 85,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,567,808 N/A 1,167,166 Stock Bonus Plans 783,760 N/A 345,096 438,631 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 616,500 23,500 Stock option activity: Three Months Ended December 31, 2020 2019 Options granted 7,500 1,000 Options exercised 5,300 - Options forfeited 42,166 - Options expired 55 36 Stock-Based Compensation Expense Three months Ended December 31, 2020 2019 Employees $ 3,296,309 $ 1,800,225 Non-employees $ 248,660 $ 155,740 Employee compensation expense includes the expense related to options and restricted stock granted expensed over their vesting periods. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of the related service contracts. Warrants and Non-Employee Options The following chart represents the warrants and non-employee options outstanding at December 31, 2020: Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2021 2 Series UU 6/11/2018 93,603 $ 2.80 6/30/2021 2 Series X 1/13/2016 120,000 $ 9.25 7/13/2021 2 Series Y 2/15/2016 26,000 $ 12.00 8/15/2021 2 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 143,643 $ 5.00 12/8/2021 1 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 361,564 $ 2.24 2/5/2023 2 Consultants 7/28/2017 - 11/18/2020 15,000 $ 2.18-11.61 11/17/2022 - 7/27/2027 3 * No current period changes to these warrants 1. Derivative Liabilities The table below presents the fair value of the warrant liabilities at the balance sheet dates: December 31, 2020 September 30, 2020 Series W warrants $ - $ 73,570 Series Z warrants 929,539 1,207,902 Series ZZ warrants 23,177 75,044 Series AA warrants 748,404 1,082,212 Series BB warrants 34,541 65,173 Series CC warrants 1,053,517 1,259,712 Series HH warrants 1,749 2,000 Total warrant liabilities $ 2,790,927 $ 3,765,613 The table below presents the gains and (losses) on the warrant liabilities for the three months ended December 31: 2020 2019 Series V warrants $ - $ 555,031 Series W warrants 73,570 151,374 Series Z warrants 278,363 10,549 Series ZZ warrants 51,867 14,847 Series AA warrants 333,808 64,978 Series BB warrants 30,632 (431 ) Series CC warrants 164,345 (22,681 ) Series FF warrants - (7,189 ) Series HH warrants 251 (82 ) Series JJ warrants - (130 ) Series LL warrants - 243 Net gain on warrant liabilities $ 932,836 $ 766,509 The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded. In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss. Changes in Warrant Liabilities On October 28, 2020, 688,930 Series W warrants, with an exercise price of $16.75 expired. During the three months ended December 31, 2020, 5,000 Series CC warrants were exercised at an exercise price of $5.00 for gross proceeds of $25,000. No warrants recorded as liabilities were exercised during the three months ended December 31, 2019. 2. Equity Warrants Changes in Equity Warrants On December 7, 2020, the expiration date of the Series N warrants was extended six months from February 18, 2021 to August 18, 2021. The incremental cost of this extension was approximately $1,000, which was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2020. The Series N warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. On December 7, 2020, the expiration date of the Series X warrants was extended six months from January 13, 2021 to July 13, 2021. The incremental cost of this extension was approximately $85,000, which was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2020. The Series X warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. On December 7, 2020, the expiration date of the Series Y warrants, which were issued in connection with a financing, was extended six months from February 15, 2021 to August 15, 2021. The incremental cost of this extension was approximately $41,000 and was recorded as additional paid-in capital. On December 7, 2020, the expiration date of Series UU warrants were extended six months from December 31, 2020 to June 30, 2021. These warrants were previously issued as an inducement to convert notes payable into shares of common stock. The incremental cost of this extension was $192 and was recorded as interest expense for the three months ended December 31, 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. Exercise of Equity Warrants During the three months ended December 31, 2020, 10,000 Series TT warrants were exercised at an exercise price of $2.24 for gross proceeds of $22,400. The following warrants recorded as equity were exercised during the three months ended December 31, 2019. Warrants Warrants Exercised Exercise Price Proceeds Series OO 10,000 $ 2.52 $ 25,200 Series SS 22,632 $ 2.09 47,301 Series TT 100,628 $ 2.24 224,600 132,900 $ 297,101 3. Options and Shares Issued to Consultants During the three months ended December 31, 2020 and 2019, the Company issued 15,044 and 15,819 shares of restricted common stock, respectively, to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $12.45 and $7.18, respectively, during the three months ended December 31, 2020 and 2019. Additionally, during the three months ended December 31, 2020, the Company issued to a consultant 5,000 options to purchase common stock with an exercise price of $11.61. The options are exercisable beginning May 18, 2021 and expire on November 17, 2022. The options are being expensed on a straight-line basis over the six month vesting period at a fair value of approximately $28,000 or $5.65 per option. No options were issued to consultants during the three months ended December 31, 2019. As of December 31, 2020 and September 30, 2020, 15,000 and 10,000 options issued to consultants remained outstanding, respectively, all of which were issued from the Non-Qualified Stock Option plans and of which 10,000 are vested as of the balance sheet dates. During the three months ended December 31, 2020 and 2019, the Company recorded total expense of approximately $249,000 and $156,000, respectively, relating to these consulting agreements. At December 31, 2020 and September 30, 2020, approximately $244,000 and $395,000, respectively, are included in prepaid expenses. 4. Securities Purchase Agreement The Company entered into a Securities Purchase Agreement 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 to Ergomed. Under the Agreement, the Company issued Ergomed shares of common stock that the net proceeds from the sales of those shares would reduce 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 three months ended December 31, 2020 and 2019, the Company realized approximately $0.1 million and $0.8 million, respectively, through the sale by Ergomed of 9,000 and 98,350 shares of the Company’s common stock and the Company reduced the payables to Ergomed, and credited Other Operating Gain by those amounts. No shares were issued to Ergomed during the quarters ended December 31, 2020 and 2019. As of December 31, 2020, Ergomed held 93,521 shares for resale.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	3 Months Ended
	Dec. 31, 2020
FAIR VALUE MEASUREMENTS
D. FAIR VALUE MEASUREMENTS	D. FAIR VALUE MEASUREMENTS In accordance with ASC 820-10, “Fair Value Measurements,” ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows: · Level 1 - Observable inputs such as quoted prices in active markets for identical assets or liabilities · Level 2 - Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets · Level 3 - Unobservable inputs that reflect management’s assumptions For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of an input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels. The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at December 31, 2020: Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 2,790,927 $ 2,790,927 The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2020: Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 3,765,613 $ 3,765,613 The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the three months ended December 31, 2020 and the year ended September 30, 2020: 3 months ended December 31, 2020 12 months ended September 30, 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (41,850 ) (3,071,775 ) Realized and unrealized (gains) and losses (932,836 ) 349,078 Ending balance $ 2,790,927 $ 3,765,613 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	3 Months Ended
	Dec. 31, 2020
RELATED PARTY TRANSACTIONS
E. RELATED PARTY TRANSACTIONS	E. RELATED PARTY TRANSACTIONS On December 7, 2020, the expiration dates of the Series N and Series X warrants held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary, were extended by six months (Note C). The incremental cost of these modifications was approximately $86,000 and was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2020. On December 7, 2020, the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021. The incremental cost of this extension was $192 and was recorded as interest expense for the three months ended December 31, 2020. The Series UU warrants are held by certain officers of the Company and were originally issued with convertible debt.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	3 Months Ended
	Dec. 31, 2020
COMMITMENTS AND CONTINGENCIES
F. COMMITMENTS AND CONTINGENCIES	F. C OMMITMENTS AND CONTINGENCIES Clinical Research Agreements Under co-development and revenue sharing agreements with Ergomed, Ergomed agreed to contribute up to $12 million towards the Company’s Phase 3 Clinical Trial in the form of discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. The Company accounted for the co-development and revenue sharing agreements in accordance with ASC 808 “Collaborative Arrangements”. 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 inception of the agreement with Ergomed, the Company has incurred research and development expenses of approximately $34.0 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.3 million. During the three months ended December 31, 2020 and 2019, the Company recorded, net of Ergomed’s discount, approximately $0.6 million and $0.9 million, respectively, as research and development expense related to Ergomed’s services. Lease Agreements The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease, which expires in October 2028. On December 31, 2020 and September 30, 2020, the net book value of the finance lease right of use asset is approximately $13.4 million and $13.8 million, respectively and the balance of the finance lease liability is approximately $12.5 million and $12.7 million, respectively, of which approximately $1.0 million and $0.9 million, respectively, is current. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. The finance right of use assets are being depreciated using a straight-line method over the underlying lease terms. Total cash paid related to finance leases during the each of the three months ended December 31, 2020 and 2019 was approximately $0.5 million, of which approximately $0.3 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 7.8 years. In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The estimated cost of the upgrades is $10.5 million, of which approximately $6.7 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 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 December 31, 2020 and September 30, 2020. Approximate future minimum lease payments under finance leases as of December 31, 2020 are as follows: Nine months ending September 30, 2021 $ 1,469,000 Year ending September 30, 2022 2,014,000 2023 2,083,000 2024 2,148,000 2025 2,218,000 2026 2,294,000 Thereafter 5,028,000 Total future minimum lease obligation 17,254,000 Less imputed interest on finance lease obligations (4,789,000 ) Net present value of lease finance lease obligations $ 12,465,000 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 three months ended December 31, 2019 was approximately $18,000. 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 expires on November 30, 2025.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. As of December 31, 2020 and September 30, 2020, the net book value of the operating lease right of use assets is approximately $1.2 million. As of December 31, 2020 and September 30, 2020, the balance of the operating lease liabilities is approximately $1.2 million and $1.3 million, respectively, of which approximately $0.2 million and $0.1 million, respectively, is current. The Company incurred lease expense for operating leases of approximately $66,000 and $68,000, respectively, for the three months ended December 31, 2020 and 2019. Total cash paid related to operating leases during the three months ended December 31, 2020 and 2019 was approximately $48,000 and $66,000, respectively. As of December 31, 2020, future minimum lease payments on operating leases are as follows: Nine months ending September 30, 2021 $ 193,000 Year ending September 30, 2022 264,000 2022 272,000 2024 280,000 2025 288,000 2026 207,000 Thereafter 80,000 Total future minimum lease obligation 1,584,000 Less imputed interest on operating lease obligation (354,000 ) Net present value of operating lease obligation $ 1,230,000

PATENTS

PATENTS	3 Months Ended
	Dec. 31, 2020
PATENTS
G. PATENTS	G. PATENTS During the three months ended December 31, 2020 and 2019, no patent impairment charges were recorded. For both the three months ended December 31, 2020 and 2019, amortization of patent costs totaled approximately $13,000. Approximate estimated future amortization expense is as follows: Nine months ending September 30, 2021 $ 39,000 Year ending September 30, 2022 48,000 2023 38,000 2024 30,000 2025 27,000 2026 24,000 Thereafter 94,000 Total $ 300,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	3 Months Ended
	Dec. 31, 2020
LOSS PER COMMON SHARE
H. LOSS PER COMMON SHARE	H. LOSS PER COMMON SHARE The following tables provide the details of the basic and diluted loss per-share computations: Three months ended December 31, 2020 2019 Loss per share - basic Net loss available to common shareholders - basic $ (8,022,643 ) $ (5,531,360 ) Weighted average shares outstanding - basic 38,670,247 35,084,279 Basic loss per common share $ (0.21 ) $ (0.16 ) Loss per share - diluted Net loss available to common shareholders - basic $ (8,022,643 ) $ (5,531,360 ) Gain on derivatives (1) (164,073 ) (243 ) Net loss available to common shareholders - diluted $ (8,186,716 ) $ (5,531,603 ) Weighted average shares outstanding - basic 38,670,247 35,084,279 Incremental shares underlying dilutive - warrants and options (1) 97,039 14,329 Weighted average shares outstanding - diluted 38,767,286 35,098,608 Diluted loss earnings per common share $ (0.21 ) $ (0.16 ) (1) Includes Series CC and HH warrants for the three months ended December 31, 2020 and Series LL warrants for the three months ended December 31, 2019. The gain on derivatives priced lower than the average market price during the period is excluded from the numerator and the related shares are excluded from the denominator in calculating diluted loss per share. In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2020 2019 Options and Warrants 6,517,160 7,009,959 Unvested Restricted Stock 302,500 304,500 Total 6,819,660 7,314,459

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	3 Months Ended
	Dec. 31, 2020
SUBSEQUENT EVENTS
J. SUBSEQUENT EVENTS	J. SUBSEQUENT EVENTS Between January 1, 2021 and February 5, 2021, the Company received approximately $3.9 million through the exercise of options and warrants to purchase shares of the Company’s common stock.

BASIS OF PRESENTATION AND SUM_2

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)	3 Months Ended
	Dec. 31, 2020
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Property Equipment	Property and Equipment
Patents	Patents
Research and Development Costs	Research and Development Costs
Leases	Leases -
Income Taxes	Income Taxes
Derivative Instruments	Derivative Instruments
Stock-Based Compensation	Stock-Based Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the 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. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s common stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with 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 meet 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.
New Accounting Pronouncements	Newly Adopted Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (Topic ).” New Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. 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.

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	3 Months Ended
	Dec. 31, 2020
STOCKHOLDERS EQUITY
Stock options, stock bonuses and compensation granted by the Company	Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Options Plans 138,400 85,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,527,787 N/A 1,201,832 Stock Bonus Plans 783,760 N/A 348,660 435,067 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500 Underlying share information for equity compensation plans as of September 30, 2020 is as follows: Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Option Plans 138,400 85,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,567,808 N/A 1,167,166 Stock Bonus Plans 783,760 N/A 345,096 438,631 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 616,500 23,500
Stock option activity	Three Months Ended December 31, 2020 2019 Options granted 7,500 1,000 Options exercised 5,300 - Options forfeited 42,166 - Options expired 55 36
Stock-based compensation expense	Three months Ended December 31, 2020 2019 Employees $ 3,296,309 $ 1,800,225 Non-employees $ 248,660 $ 155,740
Derivative liabilities, warrants and other options	Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2021 2 Series UU 6/11/2018 93,603 $ 2.80 6/30/2021 2 Series X 1/13/2016 120,000 $ 9.25 7/13/2021 2 Series Y 2/15/2016 26,000 $ 12.00 8/15/2021 2 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 143,643 $ 5.00 12/8/2021 1 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 361,564 $ 2.24 2/5/2023 2 Consultants 7/28/2017 - 11/18/2020 15,000 $ 2.18-11.61 11/17/2022 - 7/27/2027 3
Tabular disclosure of derivative liabilities at fair value	December 31, 2020 September 30, 2020 Series W warrants $ - $ 73,570 Series Z warrants 929,539 1,207,902 Series ZZ warrants 23,177 75,044 Series AA warrants 748,404 1,082,212 Series BB warrants 34,541 65,173 Series CC warrants 1,053,517 1,259,712 Series HH warrants 1,749 2,000 Total warrant liabilities $ 2,790,927 $ 3,765,613
Schedule of gains and (losses) on derivative liabilities	2020 2019 Series V warrants $ - $ 555,031 Series W warrants 73,570 151,374 Series Z warrants 278,363 10,549 Series ZZ warrants 51,867 14,847 Series AA warrants 333,808 64,978 Series BB warrants 30,632 (431 ) Series CC warrants 164,345 (22,681 ) Series FF warrants - (7,189 ) Series HH warrants 251 (82 ) Series JJ warrants - (130 ) Series LL warrants - 243 Net gain on warrant liabilities $ 932,836 $ 766,509
Warrants recorded as equity exercised	Warrants Warrants Exercised Exercise Price Proceeds Series OO 10,000 $ 2.52 $ 25,200 Series SS 22,632 $ 2.09 47,301 Series TT 100,628 $ 2.24 224,600 132,900 $ 297,101

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	3 Months Ended
	Dec. 31, 2020
FAIR VALUE MEASUREMENTS
Measured at fair value on a recurring basis	Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 2,790,927 $ 2,790,927 Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 3,765,613 $ 3,765,613
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	3 months ended December 31, 2020 12 months ended September 30, 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (41,850 ) (3,071,775 ) Realized and unrealized (gains) and losses (932,836 ) 349,078 Ending balance $ 2,790,927 $ 3,765,613

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	3 Months Ended
	Dec. 31, 2020
COMMITMENTS AND CONTINGENCIES
Schedule of future minimum payments under finance leases	Nine months ending September 30, 2021 $ 1,469,000 Year ending September 30, 2022 2,014,000 2023 2,083,000 2024 2,148,000 2025 2,218,000 2026 2,294,000 Thereafter 5,028,000 Total future minimum lease obligation 17,254,000 Less imputed interest on finance lease obligations (4,789,000 ) Net present value of lease finance lease obligations $ 12,465,000 Nine months ending September 30, 2021 $ 193,000 Year ending September 30, 2022 264,000 2022 272,000 2024 280,000 2025 288,000 2026 207,000 Thereafter 80,000 Total future minimum lease obligation 1,584,000 Less imputed interest on operating lease obligation (354,000 ) Net present value of operating lease obligation $ 1,230,000

PATENTS (Tables)

PATENTS (Tables)	3 Months Ended
	Dec. 31, 2020
PATENTS
Schedule of total estimated future amortization	Nine months ending September 30, 2021 $ 39,000 Year ending September 30, 2022 48,000 2023 38,000 2024 30,000 2025 27,000 2026 24,000 Thereafter 94,000 Total $ 300,000

LOSS PER COMMON SHARE (Tables)

LOSS PER COMMON SHARE (Tables)	3 Months Ended
	Dec. 31, 2020
LOSS PER COMMON SHARE
Schedule of basic and diluted loss per-share computations	Three months ended December 31, 2020 2019 Loss per share - basic Net loss available to common shareholders - basic $ (8,022,643 ) $ (5,531,360 ) Weighted average shares outstanding - basic 38,670,247 35,084,279 Basic loss per common share $ (0.21 ) $ (0.16 ) Loss per share - diluted Net loss available to common shareholders - basic $ (8,022,643 ) $ (5,531,360 ) Gain on derivatives (1) (164,073 ) (243 ) Net loss available to common shareholders - diluted $ (8,186,716 ) $ (5,531,603 ) Weighted average shares outstanding - basic 38,670,247 35,084,279 Incremental shares underlying dilutive - warrants and options (1) 97,039 14,329 Weighted average shares outstanding - diluted 38,767,286 35,098,608 Diluted loss earnings per common share $ (0.21 ) $ (0.16 )
Schedule of antidilutive securities	2020 2019 Options and Warrants 6,517,160 7,009,959 Unvested Restricted Stock 302,500 304,500 Total 6,819,660 7,314,459

A BASIS OF PRESENTATION AND SUM

A BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	3 Months Ended
	Dec. 31, 2020
Patents [Member]
Patent useful life	17 years

C STOCKHOLDERS EQUITY (Details)

C STOCKHOLDERS EQUITY (Details) - shares	Dec. 31, 2020	Sep. 30, 2020
Incentive Stock Option Plans [Member]
Shares reserved for outstanding options	85,895	85,895
Remaining options/shares under plans	213	213
Total shares reserved under plans	138,400	138,400
Non-Qualified Stock Option Plans [Member]
Shares reserved for outstanding options	8,527,787	8,567,808
Remaining options/shares under plans	1,201,832	1,167,166
Total shares reserved under plans	9,987,200	9,987,200
Stock Bonus Plans [Member]
Remaining options/shares under plans	435,067	438,631
Total shares reserved under plans	783,760	783,760
Shares issued	348,660	345,096
Stock Compensation Plan [Member]
Remaining options/shares under plans	464,895	464,895
Total shares reserved under plans	634,000	634,000
Shares issued	150,695	150,695
Incentive Stock Bonus Plan [Member]
Remaining options/shares under plans	25,500	23,500
Total shares reserved under plans	640,000	640,000
Shares issued	614,500	616,500

C STOCKHOLDERS EQUITY (Details

C STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
STOCKHOLDERS EQUITY
Options granted	7,500	1,000
Options exercised	5,300
Options forfeited	42,166
Options expired	55	36

C STOCKHOLDERS EQUITY (Detail_2

C STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
STOCKHOLDERS EQUITY
Employees stock based compensation expense	$ 3,296,309	$ 1,800,225
Non- Employees stock based compensation expense	$ 248,660	$ 155,740

C STOCKHOLDERS EQUITY (Detail_3

C STOCKHOLDERS EQUITY (Details 3)	3 Months Ended
	Dec. 31, 2020$ / sharesshares
Series N [Member]
Shares issuable upon exercise of warrant/options | shares	85,339
Exercise price	$ 3
Issue date	8/18/2008
Expiration date	8/18/2021
Series UU [Member]
Shares issuable upon exercise of warrant/options | shares	93,603
Exercise price	$ 2.80
Issue date	6/11/2018
Expiration date	6/30/2021
Series X [Member]
Shares issuable upon exercise of warrant/options | shares	120,000
Exercise price	$ 9.25
Issue date	1/13/2016
Expiration date	7/13/2021
Series Y [Member]
Shares issuable upon exercise of warrant/options | shares	26,000
Exercise price	$ 12
Issue date	2/15/2016
Expiration date	8/15/2021
Series ZZ [Member]
Shares issuable upon exercise of warrant/options | shares	20,000
Exercise price	$ 13.75
Issue date	5/23/2016
Expiration date	5/18/2021
Series BB [Member]
Shares issuable upon exercise of warrant/options | shares	16,000
Exercise price	$ 13.75
Issue date	8/26/2016
Expiration date	8/22/2021
Series Z [Member]
Shares issuable upon exercise of warrant/options | shares	264,000
Exercise price	$ 13.75
Issue date	5/23/2016
Expiration date	11/23/2021
Series FF [Member]
Shares issuable upon exercise of warrant/options | shares	68,048
Exercise price	$ 3.91
Issue date	12/8/2016
Expiration date	12/1/2021
Series CC [Member]
Shares issuable upon exercise of warrant/options | shares	143,643
Exercise price	$ 5
Issue date	12/8/2016
Expiration date	12/8/2021
Series HH [Member]
Shares issuable upon exercise of warrant/options | shares	200
Exercise price	$ 3.13
Issue date	2/23/2017
Expiration date	2/16/2022
Series AA [Member]
Shares issuable upon exercise of warrant/options | shares	200,000
Exercise price	$ 13.75
Issue date	8/26/2016
Expiration date	2/22/2022
Series MM [Member]
Shares issuable upon exercise of warrant/options | shares	797,633
Exercise price	$ 1.86
Issue date	6/22/2017
Expiration date	6/22/2022
Series NN [Member]
Shares issuable upon exercise of warrant/options | shares	348,842
Exercise price	$ 2.52
Issue date	7/24/2017
Expiration date	7/24/2022
Series RR [Member]
Shares issuable upon exercise of warrant/options | shares	417,649
Exercise price	$ 1.65
Issue date	10/30/2017
Expiration date	10/30/2022
Series SS [Member]
Shares issuable upon exercise of warrant/options | shares	326,064
Exercise price	$ 2.09
Issue date	12/19/2017
Expiration date	12/18/2022
Series TT [Member]
Shares issuable upon exercise of warrant/options | shares	361,564
Exercise price	$ 2.24
Issue date	2/5/2018
Expiration date	2/5/2023
Consultants [Member]
Shares issuable upon exercise of warrant/options | shares	15,000
Expiration date	November 17, 2022
Consultants [Member] | Minimum [Member]
Exercise price	$ 2.18
Issue date	7/28/2017
Expiration date	11/17/2022
Consultants [Member] | Maximum [Member]
Exercise price	$ 11.61
Issue date	11/18/2020
Expiration date	7/27/2027

C STOCKHOLDERS EQUITY (Detail_4

C STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Sep. 30, 2019
STOCKHOLDERS EQUITY
Series W warrants	$ 0		$ 73,570
Series Z warrants	929,539		1,207,902
Series ZZ warrants	23,177		75,044
Series AA warrants	748,404		1,082,212
Series BB warrants	34,541		65,173
Series CC warrants	1,053,517		1,259,712
Series HH warrants	1,749		2,000
Total warrant liabilities	2,790,927		$ 3,765,613
Gains (losses) on Series V warrants	0	$ 555,031
Gains (losses) on Series W warrants	73,570	151,374
Gains (losses) on Series Z warrants	278,363	10,549
Gains (losses) on Series ZZ warrants	51,867	14,847
Gains (losses) on Series AA warrants	333,808	64,978
Gains (losses) on Series BB warrants	30,632	(431)
Gains (losses) on Series CC warrants	164,345	(22,681)
Gains (losses) on Series FF warrants	0	(7,189)
Gains (losses) on Series HH warrants	251	(82)
Gains (losses) on Series JJ warrants	0	(130)
Gains (losses) on Series LL warrants	0	243
Net loss on warrant liabilities	$ 932,836	$ 766,509

C STOCKHOLDERS EQUITY (Detail_5

C STOCKHOLDERS EQUITY (Details 5)	3 Months Ended
	Dec. 31, 2019USD ($)$ / sharesshares
Warrants exercised | shares	132,900
Proceeds | $	$ 297,101
Series SS [Member]
Warrants exercised | shares	22,632
Proceeds | $	$ 47,301
Exercise price | $ / shares	$ 2.09
Series TT [Member]
Warrants exercised | shares	100,628
Proceeds | $	$ 224,600
Exercise price | $ / shares	$ 2.24
Series OO [Member]
Warrants exercised | shares	10,000
Proceeds | $	$ 25,200
Exercise price | $ / shares	$ 2.52

C STOCKHOLDERS EQUITY (Detail_6

C STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	Dec. 07, 2020	Sep. 30, 2020	Jun. 25, 2020	Dec. 31, 2020	Dec. 31, 2019	Sep. 30, 2019
Prepaid expenses				$ 244,000		$ 395,000
Proceeds from the sale of common stock				1,000,000
Public offering price per share				$ 14.65
Proceeds from public offering				$ 13,600,000
Additional shares of common stock				150,000
Fair value of stock option				$ 28,000
Weighted average grant date fair value				$ 5.65
Proceeds from warrants exercised				$ 70,911	$ 297,101
Stock options granted				7,500	1,000
Warrants expired				55	36
Common stock shares issued		38,730,150		39,767,058
Common stock valued		$ 387,302		$ 397,671
Consulting Agreements [Member]
Total expense				$ 249,000	$ 156,000
Series W Warrants [Member]
Common stock price per share			$ 16.75
Warrants expired			688,930
Non-Qualified Stock Option Plans [Member]
Stock options granted				10,000
Series X [Member]
Incremental cost				$ 85,000
Expiration date description	the expiration date of the Series X warrants was extended six months from January 13, 2021 to July 13, 2021
Expiration date				7/13/2021
Series Y [Member]
Incremental cost	$ 41,000
Expiration date				8/15/2021
Series CC [Member]
Warrants exercised				5,000
Warrant exercise price				$ 5
Proceeds from warrants exercised				$ 25,000
Expiration date				12/8/2021
Series TT [Member]
Warrants exercised				10,000
Warrant exercise price				$ 2.24
Proceeds from warrants exercised				$ 22,400
Expiration date				2/5/2023
Series UU warrants [Member]
Incremental cost				$ 192
Expiration date description	the expiration date of Series UU warrants were extended six months from December 31, 2020 to June 30, 2021
Series N Warrants [Member]
Incremental cost				$ 1,000
Expiration date description	the expiration date of the Series N warrants was extended six months from February 18, 2021 to August 18, 2021
Consultants One [Member]
Options issued		10,000		15,000
Ergomed [Member]
Common stock shares held				93,521
Common stock shares issued				9,000	98,350
Ergomed [Member] | SPA [Member]
Common stock valued				$ 100,000	$ 800,000
Consultants [Member]
Exercise price				$ 11.61
Options issued				5,000
Expiration date				November 17, 2022
Consultants [Member] | Restricted Stock [Member]
Weighted average grant date fair value				$ 12.45	$ 7.18
Common stock issued for service, shares				15,044	15,819

D FAIR VALUE MEASUREMENTS (Deta

D FAIR VALUE MEASUREMENTS (Details) - USD ($)	Dec. 31, 2020	Sep. 30, 2020
Derivative instruments	$ 2,790,927	$ 3,765,613
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)
Derivative instruments	0	0
Significant Unobservable Inputs (Level 3)
Derivative instruments	2,790,927	3,765,613
Significant Other Observable Inputs (Level 2)
Derivative instruments	$ 0	$ 0

D FAIR VALUE MEASUREMENTS (De_2

D FAIR VALUE MEASUREMENTS (Details 1) - USD ($)	3 Months Ended	12 Months Ended
	Dec. 31, 2020	Sep. 30, 2019
FAIR VALUE MEASUREMENTS
Beginning balance	$ 3,765,613	$ 6,488,310
Issuances	0	0
Exercises	41,850	3,071,775
Realized and unrealized (gains) and losses	(932,836)	349,078
Ending balance	$ 2,790,927	$ 3,765,613

ERELATED PARTY TRANSACTIONS (De

ERELATED PARTY TRANSACTIONS (Details Narrative )	3 Months Ended
	Dec. 31, 2020USD ($)
Deemed dividend	$ 86,000
Series UU warrants [Member]
Expiration date description	the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Interest expense	$ 192

F COMMITMENTS AND CONTINGENCIES

F COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
Nine months ending September 30, 2021	$ 1,469,000
2022	2,014,000
2023	2,083,000
2024	2,148,000
2025	2,218,000
2026	2,294,000
Thereafter	5,028,000
Total future minimum lease obligation	17,254,000
Less imputed interest on finance lease obligations	(4,789,000)
Net present value of lease finance lease obligations	$ 12,465,000

F COMMITMENTS AND CONTINGENCI_2

F COMMITMENTS AND CONTINGENCIES (Details 1)	Dec. 31, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
Nine months ending September 30, 2021	$ 193,000
2022	264,000
2023	272,000
2024	280,000
2025	288,000
2026	207,000
Thereafter	80,000
Total future minimum lease obligation	1,584,000
Less imputed interest on operating lease obligation	354,000
Net present value of operating lease obligation	$ 1,230,000

F COMMITMENTS AND CONTINGENCI_3

F COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	1 Months Ended	3 Months Ended
	Aug. 31, 2020	Dec. 31, 2020	Dec. 31, 2019	Sep. 30, 2019
Lease description		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
Non current assets		$ 1,700,000		$ 1,700,000
Clinical service trial		12,000,000
Cash paid related to finance leases		500,000	$ 500,000
Cash paid related to finance leases interest		300,000	300,000
Cash paid related to operating leases		$ 48,000	66,000
Weighted average discount rate		8.80%
Maturity years		7 years 9 months 18 days
Finance lease right of use assets		$ 13,400,000		13,800,000
Operating lease - liability		1,200,000		1,300,000
Operating lease liabilities current		200,000		100,000
Net book value operating lease right of use assets		1,200,000		1,200,000
Operating lease expense		66,000	68,000
Finance lease liability		12,500,000		12,700,000
Research and development expenses		34,000,000
Sublease rental income			18,000
Finance lease obligations, net of current portion		1,000,000		$ 900,000
Lease Agreement [Member]
Estimated cost	$ 10,500,000
Cost to improve the maufacturing facility	6,700,000
Increased lease payments	2,400,000
Ergomed [Member]
Research and development expenses		600,000	$ 900,000
Net of discount		$ 11,300,000
Landlord [Member]
Facility improvement costs	2,400,000
Cost incurred, initial	$ 8,100,000

G PATENTS (Details)

G PATENTS (Details)	Dec. 31, 2020USD ($)
PATENTS
Nine months ending September 30, 2021	$ 39,000
2022	48,000
2023	38,000
2024	30,000
2025	27,000
2026	24,000
Thereafter	94,000
Total	$ 300,000

G PATENTS (Details Narrative)

G PATENTS (Details Narrative) - USD ($)	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
PATENTS
Amortization of patent costs	$ 13,000	$ 13,000

H LOSS PER COMMON SHARE (Detail

H LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Loss per share - basic
Net loss available to common shareholders - basic	$ (8,022,643)	$ (5,531,360)
Weighted average shares outstanding - basic	38,670,247	35,084,279
Basic loss per common share	$ (0.21)	$ (0.16)
Loss per share - diluted
Net loss available to common shareholders - basic	$ (8,022,643)	$ (5,531,360)
Gain on derivatives (1)	(164,073)	(243)
Net loss available to common shareholders - diluted	(8,186,716)	(5,531,603)
Weighted average shares outstanding - basic	$ 38,670,247	$ 35,084,279
Incremental shares underlying dilutive "in the money" warrants	97,039	14,329
Weighted average shares outstanding - diluted	38,767,286	35,098,608
Diluted loss earnings per common share	$ (0.21)	$ (0.16)

H LOSS PER COMMON SHARE (Deta_2

H LOSS PER COMMON SHARE (Details 1) - shares	3 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Antidilutive securities	6,819,660	7,314,459
Options and Warrants
Antidilutive securities	6,517,160	7,009,959
Unvested Restricted Stock
Antidilutive securities	302,500	304,500

J SUBSEQUENT EVENTS (Details Na

J SUBSEQUENT EVENTS (Details Narrative) - USD ($)	1 Months Ended	3 Months Ended
	Feb. 05, 2021	Dec. 31, 2020	Dec. 31, 2019
Proceeds from exercise of options and warrants		$ 70,911	$ 297,101
Subsequent Event [Member]
Proceeds from exercise of options and warrants	$ 3,900,000