CEL-SCI (CVM) 10-Q 13 Aug 21 2021 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Jun. 30, 2021	Aug. 09, 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	--12-31
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Jun. 30, 2021
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2021
Entity Common Stock Shares Outstanding		43,028,150
Document Quarterly Report	true
Document Transition Report	false
Entity Interactive Data Current	Yes
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
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSEAMER
Entity File Number	001-11889
City Area Code	703
Local Phone Number	506-9460

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Jun. 30, 2021	Sep. 30, 2020
Current Assets:
Cash and cash equivalents	$ 35,957,715	$ 15,508,909
U.S. Treasury Bills	11,152,245	0
Receivables	54,922	54,922
Prepaid expenses	978,575	1,313,432
Supplies used for R&D and manufacturing	1,579,245	820,052
Deposits - current portion	8,712	0
Total current assets	49,731,414	17,697,315
Finance lease right of use assets	13,125,302	13,811,849
Operating lease right of use assets	1,046,648	1,198,958
Property and equipment, net	13,548,079	5,843,993
Patent costs, net	279,366	313,422
Deposits	1,910,917	1,670,917
Total Assets	79,641,726	40,536,454
Current Liabilities:
Accounts payable	2,144,455	2,023,067
Accrued expenses	868,443	510,515
Due to employees	532,620	448,022
Derivative instruments, current portion	918,704	213,787
Lease liabilities, current portion	692,478	1,070,123
Total current liabilities	5,156,700	4,265,514
Derivative instruments, net of current portion	0	3,551,826
Finance lease liabilities, net of current portion	13,603,297	11,753,100
Operating lease liabilities, net of current portion	962,985	1,114,340
Other liabilities	125,000	125,000
Total liabilities	19,847,982	20,809,780
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; 42,963,391 and 38,730,150 shares issued and outstanding at June 30, 2021 and September 30, 2020, respectively	429,634	387,302
Additional paid-in capital	469,355,665	401,174,675
Accumulated deficit	(409,991,555)	(381,835,303)
Total stockholders' equity	59,793,744	19,726,674
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 79,641,726	$ 40,536,454

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2021	Sep. 30, 2020
CONDENSED BALANCE SHEETS
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	200,000	200,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	42,963,391	38,730,150
Common stock, shares outstanding	42,963,391	38,730,150

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Grant income	$ 0	$ 195,874	$ 0	$ 530,106
Operating Expenses:
Research and development	7,182,099	3,969,070	17,818,373	12,680,430
General and administrative	3,274,480	3,192,403	9,902,120	8,389,821
Total operating expenses	10,456,579	7,161,473	27,720,493	21,070,251
Operating loss	(10,456,579)	(6,965,599)	(27,720,493)	(20,540,145)
Other (expense) income	(8,213)	(1,845)	(8,213)	(38,741)
Loss on derivative instruments	1,116,619	(1,282,829)	(991,562)	(3,565,347)
Warrant inducement expense	0	(805,753)	0	805,753
Other non-operating gains	761,237	(950,935)	1,436,473	774,245
Interest expense, net	(351,332)	(273,708)	(872,457)	(777,898)
Net loss	(8,938,268)	(10,276,979)	(28,156,252)	(24,876,157)
Modification of warrants	(265,082)	0	(350,861)	(21,734)
Net loss available to common shareholders	$ (9,203,350)	$ (10,276,979)	$ (28,507,113)	$ (24,897,891)
Net loss per common share - basic	$ (0.22)	$ (0.27)	$ (0.71)	$ (0.69)
Weighted average common shares outstanding - basic	41,020,485	37,453,539	39,907,624	36,230,992
Net loss per common share - diluted	$ (0.25)	$ (0.27)	$ (0.74)	$ (0.69)
Weighted average common shares outstanding - diluted	41,231,082	37,453,539	40,158,321	36,230,092

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	1,800,225	$ 0	1,800,225	0
contributions paid in common stock, shares		4,474
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, 2019		35,231,776
Balance, amount at Sep. 30, 2019	5,133,667	$ 352,318	358,507,603	(353,726,254)
Net loss	(24,876,157)
Balance, shares at Jun. 30, 2020		38,522,236
Balance, amount at Jun. 30, 2020	20,888,291	$ 385,223	396,959,284	(376,456,216)
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)
Warrant exercises, shares		562,100
Warrant exercises, amount	4,318,706	$ 5,621	4,313,085	0
Equity based compensation - employees	1,780,979	$ 0	1,780,979	0
contributions paid in common stock, shares		3,376
contributions paid in common stock, amount	38,959	$ 34	38,925	0
Stock issued to nonemployees for service, shares		17,120
Stock issued to nonemployees for service, amount	235,024	$ 171	234,853	0
Share issuance costs	(199,372)	0	(199,372)	0
Net loss	(9,067,818)	$ 0	0	(9,067,818)
Proceeds from the sale of common stock, shares		721,459
Proceeds from the sale of common stock, amount	7,867,629	$ 7,215	7,860,414	0
Purchase of stock by officers and directors, shares		16,787
Purchase of stock by officers and directors, amount	159,990	$ 168	159,822	0
Option exercises, shares		20,480
Option exercises, amount	49,898	$ 205	49,693	0
Balance, shares at Mar. 31, 2020		37,336,411
Balance, amount at Mar. 31, 2020	14,138,060	$ 373,365	379,943,932	(366,179,237)
Warrant exercises, shares		849,845
Warrant exercises, amount	10,156,275	$ 8,498	10,147,777	0
Equity based compensation - employees	3,109,127	$ 0	3,109,127	0
contributions paid in common stock, shares		2,875
contributions paid in common stock, amount	42,895	$ 29	42,866	0
Stock issued to nonemployees for service, shares		14,811
Stock issued to nonemployees for service, amount	205,381	$ 148	205,233	0
Share issuance costs	(418,497)	0	(418,497)	0
Net loss	(10,276,979)	$ 0	0	(10,276,979)
Proceeds from the sale of common stock, shares		94,575
Proceeds from the sale of common stock, amount	1,074,807	$ 946	1,073,861	0
Option exercises, shares		73,719
Option exercises, amount	276,415	$ 737	275,678	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
Modification of warrants	5,554	0	5,554	0
Warrant issuances	805,753	$ 0	805,753	0
Balance, shares at Jun. 30, 2020		38,522,236
Balance, amount at Jun. 30, 2020	20,888,291	$ 385,223	396,959,284	(376,456,216)
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	3,296,309	$ (20)	3,296,329	0
contributions paid in common stock, shares		3,564
contributions paid in common stock, amount	41,671	$ 36	41,635	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
Option exercises, shares		5,300
Option exercises, amount	23,511	$ 53	23,458	0
Modification of warrants	192	$ 0	192	0
Equity based compensation - employees, shares		(2,000)
Stock and options issued to nonemployees for service, shares		15,044
Stock and options issued to nonemployees for service, amount	152,450	$ 150	152,300	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)
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)
Net loss	(28,156,252)
Balance, shares at Jun. 30, 2021		42,963,391
Balance, amount at Jun. 30, 2021	59,793,744	$ 429,634	469,355,665	(409,991,555)
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)
Warrant exercises, shares		991,239
Warrant exercises, amount	7,938,841	$ 9,912	7,928,929	0
Equity based compensation - employees	3,282,742	$ 0	3,282,742	0
contributions paid in common stock, shares		3,347
contributions paid in common stock, amount	51,420	$ 33	51,387	0
Share issuance costs	(13,828)	0	(13,828)	0
Net loss	(11,281,120)	$ 0	0	(11,281,120)
Option exercises, shares		48,845
Option exercises, amount	138,788	$ 489	138,299	0
Stock and options issued to nonemployees for service, shares		13,486
Stock and options issued to nonemployees for service, amount	379,277	$ 135	379,142	0
Balance, shares at Mar. 31, 2021		40,823,975
Balance, amount at Mar. 31, 2021	29,331,792	$ 408,240	429,976,839	(401,053,287)
Warrant exercises, shares		437,312
Warrant exercises, amount	1,379,490	$ 4,373	1,375,117	0
Equity based compensation - employees	3,511,359	$ 0	3,511,359	0
contributions paid in common stock, shares		6,111
contributions paid in common stock, amount	53,205	$ 61	53,144	0
Share issuance costs	(103,185)	0	(103,185)	0
Net loss	(8,938,268)	$ 0	0	(8,938,268)
Proceeds from the sale of common stock, shares		1,610,000
Proceeds from the sale of common stock, amount	33,803,926	$ 16,100	33,787,826	0
Option exercises, shares		72,809
Option exercises, amount	464,162	$ 728	463,434	0
Modification of warrants	24,195	$ 0	24,195	0
Stock and options issued to nonemployees for service, shares		13,184
Stock and options issued to nonemployees for service, amount	267,068	$ 132	266,936	0
Balance, shares at Jun. 30, 2021		42,963,391
Balance, amount at Jun. 30, 2021	$ 59,793,744	$ 429,634	$ 469,355,665	$ (409,991,555)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (28,156,252)	$ (24,876,157)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1,649,699	1,610,855
Share-based payments for services	955,900	623,146
Equity based compensation	10,090,410	6,690,331
Common stock contributed to 401(k) plan	146,296	122,791
Shares issued for settlement of clinical research costs	0	1,769,500
Gain on short-term investments	(6,578)	0
Loss on derivative instruments	991,562	3,565,347
Warrant inducement expense	0	805,753
Modification of warrants	24,387	5,554
(Increase)/decrease in assets:
Receivables	0	(192,242)
Prepaid expenses	232,752	(969,219)
Supplies used for R&D and manufacturing	(759,193)	(4,648)
Deposits	(248,712)	0
Increase/(decrease) in liabilities:
Accounts payable	689,812	(761,675)
Accrued expenses	297,928	87,820
Due to employees	84,598	(166,310)
Other liabilities	22,459	(815)
Net cash used in operating activities	(13,984,932)	(11,689,969)
CASH FLOWS FROM INVESTING ACTIVITIES:
Net purchases of U.S. Treasury Bills	11,145,667	0
Purchases of property and equipment	(8,628,648)	(1,530,327)
Expenditures for patent costs	0	(39,975)
Net cash used in investing activities	(19,774,315)	(1,570,302)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	47,363,426	13,992,439
Payments of stock issuance costs	(207,673)	(695,447)
Proceeds from the purchase of stock by officer	0	184,990
Proceeds from exercises of warrants and options	6,195,571	12,063,070
Proceeds from landlord funding of leasehold improvements	1,613,546	0
Payments on obligations under finance lease	(756,817)	(592,766)
Net cash provided by financing activities	54,208,053	24,952,286
NET INCREASE IN CASH AND CASH EQUIVALENTS	20,448,806	11,692,015
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	15,508,909	8,444,774
CASH AND CASH EQUIVALENTS, END OF PERIOD	35,957,715	20,136,789
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	589,400	121,441
Capitalizable patent costs included in current liabilities	20,000	0
Changes to right of use assets and liabilities	551,444	399,032
Finance lease obligation included in accounts payable	1,328	775
Prepaid consulting services paid with issuance of common stock	292,792	11,706
Accrued consulting services to be paid with issuance of common stock	110,000	110,000
Fair value of warrants liabilities on date of exercise	3,838,471	3,035,325
Financing costs included in current liabilities	76,860	30,152
Cash paid for interest	$ 876,779	$ 872,710

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Jun. 30, 2021
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 (U.S. GAAP) 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 footnotes 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 June 30, 2021 and the results of its operations for the nine and three months then ended. The condensed balance sheet as of September 30, 2020 is derived from the September 30, 2020 audited financial statements. All accounting policies have been consistently applied in the interim financial statements and the annual financial statements. The results of operations for the nine and three months ended June 30, 2021 and 2020 are not necessarily indicative of the results to be expected for the entire year. The financial statements have been prepared assuming 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: U.S. Treasury Bills- 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 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 2021 and 2020 Non-Qualified Stock Option Plans are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at 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 or the market condition 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	9 Months Ended
	Jun. 30, 2021
OPERATIONS AND FINANCING
B. OPERATIONS AND FINANCING	B. OPERATIONS AND FINANCING On June 28, 2021, the Company announced results from its 9.5 year pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection) in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN). The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm that received Multikine treatment followed by surgery and radiation. This survival benefit was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), which is about a 29% improvement, control arm 48.6%, Multikine arm 62.7% survival. The study used the standard of care treatment for advanced primary head and neck cancer patients as a comparison. The patients received surgery followed by either radiation or chemoradiation (chemotherapy and radiation at the same time), as determined by the physician. This means that there were 2 treatment arms, 1) surgery plus radiation or 2) surgery plus chemoradiation. The arm that received Multikine treatment followed by surgery and radiation showed great survival benefit, but when chemotherapy was added in the second treatment arm, the immunological effect of Multikine was negated. Therefore when the two treatment arms were combined the study did not achieve its primary endpoint of a 10% improvement in overall survival. However, the analysis of the separate treatment arms was prespecified in the protocol and carried out prior to the Company becoming unblinded. The OS benefit of 14.1% at 5 years for this treatment arm exceeded the 10% OS benefit set out for the study population as a whole. The OS results for this treatment arm are significant (two-sided p=0.0236, HR=0.68) and the effect is robust, durable and increasing over time. The results from the Phase 3 cancer study proved that Multikine met all of the protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies. Based on this the Company will be filing for and seeking FDA approval for the use of Multikine in the treatment of advanced primary head and neck cancer in this patient population of about 210,000 patients annually worldwide. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in this report as Multikine. Multikine is the trademark that the Company has registered for this investigational therapy, and this proprietary name is subject to FDA review under the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved by the FDA or any other regulatory agency. Neither has its safety or efficacy been established for any use. The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge relating to the human immunological defense system, patent applications, research and development, administrative costs, construction and upgrade of laboratory facilities and clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company may be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to 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 in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. If the Company needs to raise capital, Management plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until 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	9 Months Ended
	Jun. 30, 2021
STOCKHOLDERS EQUITY
C. STOCKHOLDERS' EQUITY	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock In June 2021, the Company sold 1,400,000 shares of common stock at a public offering price of $22.62 per share and received aggregate net proceeds of approximately $29.4 million. The Company also granted the underwriters a 30-day option to purchase up to 210,000 additional shares of common stock to cover over-allotments. The underwriters fully exercised this option in June 2021, resulting in additional net proceeds to the Company of approximately $4.4 million. In December 2020, the Company sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. In March 2020, the Company sold 630,500 shares of common stock at a public offering price of $12.22 per share and received aggregate net proceeds of approximately $7.1 million. Under the terms of the Underwriting Agreement the Company granted the Underwriters a 45-day option to purchase up to an additional 94,575 shares of common stock solely to cover over-allotments. The underwriter fully exercised this option in May 2020 resulting in additional net proceeds to the Company of approximately $1.1 million. In December 2019, the Company sold 606,395 shares of common stock at a public offering price of $9.07 per share and received aggregate net proceeds of approximately $5.0 million. In January 2020, the underwriters of that offering fully exercised the option to purchase 90,959 additional shares of common stock at the public offering price of $9.07 per share for aggregate net proceeds to the Company of approximately $0.8 million. Equity Compensation Underlying share information for equity compensation plans as of June 30, 2021 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 76,829 N/A 213 Non-Qualified Stock Option Plans 11,787,200 11,001,880 N/A 404,826 Stock Bonus Plans 783,760 N/A 358,118 425,609 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500 Stock option activity Nine Months Ended June 30, 2021 2020 Options granted 2,603,500 2,561,200 Options exercised 126,954 94,199 Options forfeited 42,166 1,000 Options expired 9,374 1,180 Three Months Ended June 30, 2021 2020 Options granted 2,595,500 2,559,000 Options exercised 72,809 73,719 Options forfeited - 16 Options expired 9,307 - During the quarter ended June 30, 2021, the Company adopted the 2021 Non-Qualified Stock Option Plan, which provides for the issuance of up to 1,800,000 options to purchase shares of common stock. On May 14, 2021, the Company granted 1,800,000 performance-based stock options from the 2021 Non-Qualified Stock Option Plan and 72,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers and directors. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $20.61 per share, the fair value on the date of issuance. The stock options will vest 100% upon the achievement of the following performance goal: (a) the filing of the first marketing application for any pharmaceutical based upon the Company’s Multikine technology, in the US, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia or (b) the closing price of the Company’s common stock exceeds $42.00. None of the options will be exercisable before May 13, 2022. All options which have not vested as of May 13, 2031, will be canceled and will no longer be exercisable. The options were recorded in permanent equity in accordance with ASC 718, Compensation – Stock Compensation. On the grant date, the options were valued using a Monte Carlo Simulation approach. Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. That valuation resulted in a per share fair value of $0.34 and an aggregate value of $636,480 on the grant date. The aggregate value will be expensed over the requisite service period of the options, which was determined to be 1.3 years. This resulted in compensation expense of approximately $64,000 recorded during the nine and three months ended June 30, 2021. Stock-Based Compensation Expense Nine months Ended June 30, 2021 2020 Employees $ 10,090,410 $ 6,690,331 Non-employees $ 955,900 $ 623,146 Three months Ended June 30, 2021 2020 Employees $ 3,511,359 $ 3,109,127 Non-employees $ 403,236 $ 275,919 Employee compensation expense includes the expense related to options and restricted stock expensed over their vesting period. 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 June 30, 2021: 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 8/18/2022 2 Series UU 6/11/2018 93,603 $ 2.80 6/30/2022 2 Series X 1/13/2016 120,000 $ 9.25 7/13/2022 2 Series Y 2/15/2016 26,000 $ 12.00 8/15/2022 2 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 * Series Z 5/23/2016 184,800 $ 13.75 11/23/2021 * Series CC 12/8/2016 41,345 $ 5.00 12/8/2021 1 Series HH 2/23/2017 200 $ 3.13 2/16/2022 * Series AA 8/26/2016 100,000 $ 13.75 2/22/2022 * Series MM 6/22/2017 333,432 $ 1.86 6/22/2022 2 Series NN 7/24/2017 217,838 $ 2.52 7/24/2022 2 Series RR 10/30/2017 251,761 $ 1.65 10/30/2022 2 Series SS 12/19/2017 220,800 $ 2.09 12/18/2022 * Series TT 2/5/2018 100,868 $ 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: June 30, 2021 September 30, 2020 Series W warrants $ - $ 73,570 Series Z warrants 429,996 1,207,902 Series ZZ warrants - 75,044 Series AA warrants 263,818 1,082,212 Series BB warrants 16,696 65,173 Series CC warrants 206,978 1,259,712 Series HH warrants 1,216 2,000 Total warrant liabilities $ 918,704 $ 3,765,613 The table below presents the gains (losses) on the warrant liabilities for the nine months ended June 30: 2021 2020 Series V warrants $ - $ 185,652 Series W warrants 73,570 (614,696 ) Series Z warrants (113,094 ) (742,495 ) Series ZZ warrants (98,692 ) (38,319 ) Series AA warrants (306,606 ) (547,454 ) Series BB warrants 48,477 (44,620 ) Series CC warrants (596,001 ) (1,245,627 ) Series FF warrants - (319,706 ) Series HH warrants 784 (35,024 ) Series JJ warrants - (64,992 ) Series LL warrants - (98,066 ) Net loss on warrant liabilities $ (991,562 ) $ (3,565,347 ) The table below presents the gains (losses) on the warrant liabilities for the three months ended June 30: 2021 2020 Series V warrants $ - $ 107,191 Series W warrants - (247,327 ) Series Z warrants 583,404 (430,619 ) Series ZZ warrants (87,162 ) (33,734 ) Series AA warrants 355,215 (220,831 ) Series BB warrants 64,678 (37,592 ) Series CC warrants 199,256 (419,350 ) Series HH warrants 1,228 (567 ) Net (gain) loss on warrant liabilities $ 1,116,619 $ (1,282,829 ) 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 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 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 date of the Series V warrants from May 28, 2020 to June 25, 2020. The incremental cost of this modification combined with the mark-to-market gain recorded upon exercise of certain warrants and the expiration of the remaining warrants, resulted in a net gain of approximately $107,000 for the nine and three months ended June 30, 2020. On October 28, 2020, 688,930 Series W warrants, with an exercise price of $16.75 expired. Exercise of Warrant Liabilities The following warrants recorded as liabilities were exercised during the periods ended June 30, 2021. Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series Z - - $ - 79,200 $ 13.75 $ 1,089,000 Series ZZ 19,200 $ 13.75 264,000 20,000 $ 13.75 275,000 Series AA - - - 100,000 $ 13.75 1,375,000 Series CC 5,000 $ 5.00 25,000 107,298 $ 5.00 536,490 24,200 $ 289,000 306,498 $ 3,275,490 The following warrants recorded as liabilities were exercised during the periods ended June 30, 2020. Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series V 674,164 $ 13.75 $ 9,269,755 674,164 $ 13.75 $ 9,269,755 Series CC - - - 123,820 $ 5.00 619,100 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 94,867 674,164 $ 9,269,755 908,180 $ 10,298,752 2. Equity Warrants Changes in Equity Warrants On June 28, 2021, the expiration dates of the Series N, Series X, Series Y and Series UU warrants were extended one year. On December 7, 2020, the expiration dates were extended six months. The incremental costs of the warrant extensions were recorded consistent with the accounting for the initial warrant issuances. The incremental costs of the Series N and Series X warrant extensions were recorded as a deemed dividend and totaled approximately $351,000and $265,000 for the nine and three months ended June 30, 2021, respectively. The Series N and Series X warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. The incremental cost of the Series Y warrants extension was recorded as additional paid in capital and totaled approximately $103,000 and $62,000 for the nine and three months ended June 30,2021. The incremental cost of the Series UU warrant extension was recorded as interest expense, because these warrants were initially issued as an inducement to convert notes payable into common stock, and totaled approximately $24,000for the nine and three months ended June 30,2021. The Series UU warrants are held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust. On May 26, 2020, the Company provided that for each Series V warrant exercised by an accredited investor on or before June 10, 2020 the former holder of the Series V warrant received one Series XX warrant. Every Series XX warrant will allow 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 every two Series V warrant exercised by an accredited investor 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 Series YY warrants will allow 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 Company recognized an 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, and are included as inducement expense in the statements of operations for the nine and three months ended June 30, 2020. The Series XX and YY warrants qualify for equity treatment in accordance with ASC 815. On May 8, 2020, the expiration date of 93,593 Series UU warrants were extended by six months. The incremental cost of this extension was approximately $6,000 and was recorded as interest expense for the nine and three months ended June 30, 2020. As noted above, the Series UU warrants are held by current officers of the Company and the de Clara Trust. On January 23, 2020, the expiration date of the Series N warrants was extended by six months. The incremental cost of this extension was approximately $22,000 and was recorded as a deemed dividend in the financial statements for the nine and three months ended June 30, 2020. The Series N warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. Exercise of Equity Warrants The following warrants recorded as equity were exercised during the periods ended June 30, 2021. Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series MM 147,929 $ 1.86 $ 275,148 464,201 $ 1.86 $ 863,414 Series NN 109,170 $ 2.52 275,108 131,004 $ 2.52 330,130 Series RR 95,799 $ 1.65 158,068 165,888 $ 1.65 273,715 Series SS - - - 105,264 $ 2.09 220,002 Series TT 60,214 $ 2.24 134,879 270,696 $ 2.24 606,359 413,112 $ 843,204 1,137,053 $ 2,293,620 The following warrants recorded as equity were exercised during the periods ended June 30, 2020. Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series NN - - $ - 98,253 $ 2.52 $ 247,598 Series OO 10,000 $ 2.52 25,200 50,000 $ 2.52 126,000 Series SS 39,474 $ 2.09 82,500 156,580 $ 2.09 327,252 Series TT 10,000 $ 2.24 22,400 188,125 $ 2.24 421,400 Series UU 61,207 $ 2.80 171,380 61,207 $ 2.80 171,380 Series VV 55,000 $ 1.75 96,250 82,500 $ 1.75 144,375 175,681 $ 397,730 636,665 $ 1,438,005 3. Options and Shares Issued to Consultants During the nine months ended June 30, 2021 and 2020, the Company issued 41,714 and 47,750 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $19.47 and $11.60 during the nine months ended June 30, 2021 and 2020, respectively. During the three months ended June 30, 2021 and 2020, the Company issued 13,184 and 14,811 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $23.39 and $16.41, respectively, during the three months ended June 30, 2021 and 2020. The aggregate values of the issuances of restricted common stock and common stock options are recorded as prepaid expenses and are charged to general and administrative expenses over the periods of service. Additionally, during the nine months ended June 30, 2021, the Company issued to a consultant 5,000 options to purchase common stock with an exercise price of $11.61. The options were 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 June 30, 2021. No options were issued to consultants during the nine months ended June 30, 2020. As of June 30, 2021 and September 30, 2020, respectively, 15,000 and 10,000 options issued to consultants remained outstanding, 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 nine months ended June 30, 2021 and 2020, the Company recorded total expense of approximately $956,000 and $623,000, respectively, relating to these consulting agreements. At June 30, 2021 and September 30, 2020, consulting fees of approximately $293,000 and $395,000, respectively, are included in prepaid expenses. 4. Securities Purchase Agreement The Company entered into a Securities Purchase Agreement (SPA) with Ergomed plc (“Ergomed”), 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 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. No shares were issued during the periods presented. The following amounts were realized through the resale of shares and are included in Other non-operating gains for the periods noted. Nine Months Ended Three Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 Realized through the resale of shares $ 1,436,473 $ 2,539,245 $ 761,237 $ 818,565 Fair value of shares upon issuance - 1,769,500 - 1,769,500 Other non-operating gain (loss) $ 1,436,473 $ 769,745 $ 761,237 $ (950,935 ) As of June 30, 2021, Ergomed held 27,021 shares for resale.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	9 Months Ended
	Jun. 30, 2021
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 Company purchased short-term T-bills during the nine months ended June 30, 2021 that are classified as trading securities. Quoted market prices were applied to determine the fair value of short-term investments, therefore they were categorized as Level 1 on the fair value hierarchy. The T-bills were recorded at fair market value, which includes an unrealized gain of approximately $2,000. The T-bills have maturity dates ranging from July through December 2021 and yield a weighted average interest rate of 0.09%. The Company measures its warrant liabilities at fair value. At June 30, 2021 and September 30, 2020, all warrant liabilities were measured using unobservable inputs, and therefore were categorized as a Level 3 to the fair value hierarchy. The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the nine months ended June 30, 2021 and the year ended September 30, 2020: Nine months ended Twelve months ended June 30, 2021 September 30, 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (3,838,471 ) 3,071,775 ) Realized and unrealized net loss 991,562 349,078 Ending balance $ 918,704 $ 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	9 Months Ended
	Jun. 30, 2021
RELATED PARTY TRANSACTIONS
E. RELATED PARTY TRANSACTIONS	E. RELATED PARTY TRANSACTIONS On June 28, 2021, the expiration dates of the Series N and Series X warrants held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary, were extended by twelve months (Note C). The incremental cost of these modifications was approximately $265,000 and was recorded as a deemed dividend in the financial statements for the nine and three months ended June 30, 2021. On June 28, 2021, the expiration date of 93,603 Series UU warrants was extended by twelve months (Note C). The incremental cost of this extension was $24,000 and was recorded as interest expense for the nine and three months ended June 30, 2021. The Series UU warrants are held by certain officers of the Company and the de Clara Trust and were originally issued with convertible debt. On December 7, 2020, the expiration dates of the Series N and Series X warrants held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary, were extended by six months (Note C). The incremental cost of these modifications was approximately $86,000 and was recorded as a deemed dividend in the financial statements for the nine months ended June 30, 2021. On December 7, 2020, the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021. The incremental cost of this extension was $192 and was recorded as interest expense for the nine months ended June 30, 2021. The Series UU warrants are held by certain officers of the Company and were originally issued with convertible debt. During the nine months ended June 30, 2020, certain officers and directors of the Company purchased 20,512 shares of restricted common stock at an aggregate fair market value of approximately $185,000. No shares were purchased during the three months ended June 30, 2020. 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 nine months ended June 30, 2020. The Series N warrants are held by the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Jun. 30, 2021
Commitments and Contingencies
F. COMMITMENTS AND CONTINGENCIES	F. COMMITMENTS 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 $34.8 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.7 million. During the nine months ended June 30, 2021 and 2020, the Company recorded, net of Ergomed’s discount, approximately $1.4 million and $1.3 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. In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The estimated cost of the upgrades is $10.7 million, of which approximately $10.5 million has been incurred as of June 30, 2021. The landlord agreed to finance the final $2.4 million of the costs incurred which will be repaid through increased lease payments over the remaining lease term starting on March 1, 2021. The repayment will include a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the right of use liability to account for the modified payments using a 8.45% implicit interest rate. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability as it is realized. Approximately $1.6 million was received as of June 30, 2021. The total value of the leasehold improvements will be recorded in property and equipment and will be amortized over the remaining lease term when the assets are placed in service. During June 2021, CEL-SCI determined that it used an incorrect discount rate to calculate the opening ROU asset and lease liability balances upon adoption of ASC 842. In addition, CEL-SCI determined that the discount rate used to calculate the modification of a finance lease during the quarter ended March 31, 2021 was also incorrect. CEL-SCI engaged an outside valuation specialist to perform a synthetic credit rating analysis to determine an appropriate rate for both the discount rate upon adoption, and the rate used for the lease modification. The revised rate upon adoption of ASC 842 was calculated to be 10.19% compared to the previously used rate of 8.80%, and the revised rate for the lease modification was calculated to be 8.45% compared to the previous rate of 10.00%. CEL-SCI performed an assessment and determined that the impact in the change of interest rates at September 30, 2020 is not material and would have decreased the right of use assets by $712,000 and the related lease liability by $683,000 and increased the net loss by $29,000. As a result, the error was corrected in the quarterly period ended June 30, 2021 as an out of period adjustment. The net impact of correcting these errors resulted in an increase of approximately $0.5 million to the right of use assets and lease liabilities as of June 30, 2021. For the nine months ended June 30, 2021, this resulted in an increase of expense of approximately $27,000, which is recorded as expense in the nine and three months ended June 30, 2021. There is no impact to the Company’s cash flows as a result of the adjustment. At June 30, 2021 and September 30, 2020, the net book value of the finance lease right of use asset is approximately $13.1 million and $13.8 million, respectively and the balance of the finance lease liability is approximately $14.1 million and $12.7 million, respectively, of which approximately $0.5 million and $0.9 million is current as of June 30, 2021, and September 30, 2020, respectively. 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 nine months ended June 30, 2021 and 2020 was approximately $1.6 million, of which approximately $0.9 million was for interest. The weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 7.3 years. The Company was required to deposit the equivalent of one year of base rent in accordance with the original lease. Under the landlord’s $2.4 million financing arrangement, the Company was required to deposit an additional $0.2 million during the quarter ended June 30, 2021. As of June 30, 2021 and September 30, 2020, respectively, the approximate $1.9 million and $1.7 million deposit is included in non-current assets. Approximate future minimum lease payments under finance leases as of June 30, 2021 are as follows: Nine months ending September 30, 2021 (1) $ (182,000 ) Years ending September 30, 2022 2,486,000 2023 2,569,000 2024 2,648,000 2025 2,733,000 2026 2,824,000 Thereafter 6,186,000 Total future minimum finance lease obligation 19,264,000 Less: imputed interest on financing lease obligation (5,126,000 ) Net present value of financing lease obligation $ 14,138,000 (1) Amount is net of landlord incentive of $0.8 million expected to be received in 2021 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 nine and three months ended June 30, 2020 was approximately $39,000 and $2,000, 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 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 June 30, 2021 and September 30, 2020, the net book value of the operating lease right of use assets is approximately $1.0 million and $1.2 million, respectively. As of June 30, 2021 and September 30, 2020, the balance of the operating lease liabilities is approximately $1.1 million and $1.3 million, of which approximately $200,000 and $100,000, respectively, is current. The Company incurred lease expense for operating leases of approximately $0.2 million for the nine months ended June 30, 2021 and 2020. The Company incurred lease expense for operating leases of approximately $66,000 and $67,000, respectively, for the three months ended June 30, 2021 and 2020. Total cash paid related to operating leases during the nine months ended June 30, 2021 and 2020 was approximately $176,000 and $198,000 respectively. Total cash paid related to operating leases during the three months ended June 30, 2021 and 2020 was approximately $64,000 and $66,000 respectively. The weighted average discount rate of the Company’s operating leases is 10.2% and the weighted average time to maturity is 5.9 years. As of June 30, 2021, future minimum lease payments on operating leases are as follows: Three months ending September 30, 2021 $ 66,000 Year ending September 30, 2022 267,000 2022 275,000 2024 281,000 2025 288,000 2026 207,000 Thereafter 80,000 Total future minimum lease obligation 1,464,000 Less imputed interest on operating lease obligation (344,000 ) Net present value of operating lease obligation $ 1,120,000

PATENTS

PATENTS	9 Months Ended
	Jun. 30, 2021
PATENTS
G. PATENTS	G. PATENTS During the nine months ended June 30, 2021 and 2020, no patent impairment charges were recorded. For the nine months ended June 30, 2021 and 2020, amortization of patent costs totaled approximately $39,000 and $40,000, respectively. For the three months ended June 30, 2021 and 2020, amortization of patent costs totaled approximately $13,000 and $14,000, respectively. Approximate estimated future amortization expense is as follows: Three months ending September 30, 2021 $ 13,000 Year ending September 30, 2022 48,000 2023 38,000 2024 31,000 2025 28,000 2026 24,000 Thereafter 97,000 Total $ 279,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	9 Months Ended
	Jun. 30, 2021
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: Nine months ended June 30, Three months ended June 30, 2021 2020 2021 2020 Loss per share - basic Net loss available to common shareholders - basic $ (28,507,113 ) $ (24,897,891 ) $ (9,203,350 ) $ (10,276,979 ) Weighted average shares outstanding - basic 39,907,624 36,230,992 41,020,485 37,453,539 Basic loss per common share $ (0.71 ) $ (0.69 ) $ (0.22 ) $ (0.27 ) Loss per share - diluted Net loss available to common shareholders - basic $ (28,507,113 ) $ (24,897,891 ) $ (9,203,350 ) $ (10,276,979 ) Unrealized gain on derivatives (1) (1,236,514 ) - (1,233,597 ) - Net loss available to common shareholders - diluted $ (29,743,627 ) $ (24,897,891 ) $ (10,436,947 ) $ (10,276,979 ) Weighted average shares outstanding - basic 39,907,624 36,230,992 41,020,485 37,453,539 Incremental shares underlying dilutive “in the money” warrants (1) 250,697 - 210,597 - Weighted average shares outstanding - diluted 40,158,321 36,230,992 41,231,082 37,453,539 Diluted loss per common share $ (0.74 ) $ (0.69 ) $ (0.25 ) $ (0.27 ) (1) Includes shares issuable upon the exercise of the Series Z, AA, BB, CC and HH warrants for the nine and three months ended June 30, 2021. In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2021 2020 Options and Warrants 6,979,170 7,651,718 Unvested Restricted Stock 166,500 311,873 Total 7,145,670 7,963,591

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Jun. 30, 2021
SUBSEQUENT EVENTS
J. SUBSEQUENT EVENTS	J. SUBSEQUENT EVENTS On July 7, 2021, the Company received security purchase agreements for the purchase of 27,500 restricted shares of the Company’s common stock at the closing price on July 6, 2021 of $8.00. The de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary invested $200,000 and two directors of the Company invested $10,000 each.

BASIS OF PRESENTATION AND SUM_2

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)	9 Months Ended
	Jun. 30, 2021
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
U.S. Treasury Bills	U.S. Treasury Bills-
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 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 2021 and 2020 Non-Qualified Stock Option Plans are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at 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 or the market condition 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.

STOCKHOLDERS EQUITY (Tables)

STOCKHOLDERS EQUITY (Tables)	9 Months Ended
	Jun. 30, 2021
Warrants recorded as equity exercised	Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series Z - - $ - 79,200 $ 13.75 $ 1,089,000 Series ZZ 19,200 $ 13.75 264,000 20,000 $ 13.75 275,000 Series AA - - - 100,000 $ 13.75 1,375,000 Series CC 5,000 $ 5.00 25,000 107,298 $ 5.00 536,490 24,200 $ 289,000 306,498 $ 3,275,490 Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series V 674,164 $ 13.75 $ 9,269,755 674,164 $ 13.75 $ 9,269,755 Series CC - - - 123,820 $ 5.00 619,100 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 94,867 674,164 $ 9,269,755 908,180 $ 10,298,752
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 76,829 N/A 213 Non-Qualified Stock Option Plans 11,787,200 11,001,880 N/A 404,826 Stock Bonus Plans 783,760 N/A 358,118 425,609 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 614,500 25,500
Stock option activity	Nine Months Ended June 30, 2021 2020 Options granted 2,603,500 2,561,200 Options exercised 126,954 94,199 Options forfeited 42,166 1,000 Options expired 9,374 1,180 Three Months Ended June 30, 2021 2020 Options granted 2,595,500 2,559,000 Options exercised 72,809 73,719 Options forfeited - 16 Options expired 9,307 -
Stock-based compensation expense	Nine months Ended June 30, 2021 2020 Employees $ 10,090,410 $ 6,690,331 Non-employees $ 955,900 $ 623,146 Three months Ended June 30, 2021 2020 Employees $ 3,511,359 $ 3,109,127 Non-employees $ 403,236 $ 275,919
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 8/18/2022 2 Series UU 6/11/2018 93,603 $ 2.80 6/30/2022 2 Series X 1/13/2016 120,000 $ 9.25 7/13/2022 2 Series Y 2/15/2016 26,000 $ 12.00 8/15/2022 2 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 * Series Z 5/23/2016 184,800 $ 13.75 11/23/2021 * Series CC 12/8/2016 41,345 $ 5.00 12/8/2021 1 Series HH 2/23/2017 200 $ 3.13 2/16/2022 * Series AA 8/26/2016 100,000 $ 13.75 2/22/2022 * Series MM 6/22/2017 333,432 $ 1.86 6/22/2022 2 Series NN 7/24/2017 217,838 $ 2.52 7/24/2022 2 Series RR 10/30/2017 251,761 $ 1.65 10/30/2022 2 Series SS 12/19/2017 220,800 $ 2.09 12/18/2022 * Series TT 2/5/2018 100,868 $ 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
Schedule of fair value of warrant liabilites	June 30, 2021 September 30, 2020 Series W warrants $ - $ 73,570 Series Z warrants 429,996 1,207,902 Series ZZ warrants - 75,044 Series AA warrants 263,818 1,082,212 Series BB warrants 16,696 65,173 Series CC warrants 206,978 1,259,712 Series HH warrants 1,216 2,000 Total warrant liabilities $ 918,704 $ 3,765,613
Schedule of gain and (losses) on derivative liabilities	2021 2020 Series V warrants $ - $ 185,652 Series W warrants 73,570 (614,696 ) Series Z warrants (113,094 ) (742,495 ) Series ZZ warrants (98,692 ) (38,319 ) Series AA warrants (306,606 ) (547,454 ) Series BB warrants 48,477 (44,620 ) Series CC warrants (596,001 ) (1,245,627 ) Series FF warrants - (319,706 ) Series HH warrants 784 (35,024 ) Series JJ warrants - (64,992 ) Series LL warrants - (98,066 ) Net loss on warrant liabilities $ (991,562 ) $ (3,565,347 ) 2021 2020 Series V warrants $ - $ 107,191 Series W warrants - (247,327 ) Series Z warrants 583,404 (430,619 ) Series ZZ warrants (87,162 ) (33,734 ) Series AA warrants 355,215 (220,831 ) Series BB warrants 64,678 (37,592 ) Series CC warrants 199,256 (419,350 ) Series HH warrants 1,228 (567 ) Net (gain) loss on warrant liabilities $ 1,116,619 $ (1,282,829 ) Nine Months Ended Three Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 Realized through the resale of shares $ 1,436,473 $ 2,539,245 $ 761,237 $ 818,565 Fair value of shares upon issuance - 1,769,500 - 1,769,500 Other non-operating gain (loss) $ 1,436,473 $ 769,745 $ 761,237 $ (950,935 )
Options and Warrants [Member]
Warrants recorded as equity exercised	Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series MM 147,929 $ 1.86 $ 275,148 464,201 $ 1.86 $ 863,414 Series NN 109,170 $ 2.52 275,108 131,004 $ 2.52 330,130 Series RR 95,799 $ 1.65 158,068 165,888 $ 1.65 273,715 Series SS - - - 105,264 $ 2.09 220,002 Series TT 60,214 $ 2.24 134,879 270,696 $ 2.24 606,359 413,112 $ 843,204 1,137,053 $ 2,293,620 Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series NN - - $ - 98,253 $ 2.52 $ 247,598 Series OO 10,000 $ 2.52 25,200 50,000 $ 2.52 126,000 Series SS 39,474 $ 2.09 82,500 156,580 $ 2.09 327,252 Series TT 10,000 $ 2.24 22,400 188,125 $ 2.24 421,400 Series UU 61,207 $ 2.80 171,380 61,207 $ 2.80 171,380 Series VV 55,000 $ 1.75 96,250 82,500 $ 1.75 144,375 175,681 $ 397,730 636,665 $ 1,438,005

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	9 Months Ended
	Jun. 30, 2021
FAIR VALUE MEASUREMENTS
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)	Nine months ended Twelve months ended June 30, 2021 September 30, 2020 Beginning balance $ 3,765,613 $ 6,488,310 Issuances - - Exercises (3,838,471 ) 3,071,775 ) Realized and unrealized net loss 991,562 349,078 Ending balance $ 918,704 $ 3,765,613

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Jun. 30, 2021
Commitments and Contingencies
Schedule of future minimum payments under finance leases	Nine months ending September 30, 2021 (1) $ (182,000 ) Years ending September 30, 2022 2,486,000 2023 2,569,000 2024 2,648,000 2025 2,733,000 2026 2,824,000 Thereafter 6,186,000 Total future minimum finance lease obligation 19,264,000 Less: imputed interest on financing lease obligation (5,126,000 ) Net present value of financing lease obligation $ 14,138,000 (1) Amount is net of landlord incentive of $0.8 million expected to be received in 2021 Three months ending September 30, 2021 $ 66,000 Year ending September 30, 2022 267,000 2022 275,000 2024 281,000 2025 288,000 2026 207,000 Thereafter 80,000 Total future minimum lease obligation 1,464,000 Less imputed interest on operating lease obligation (344,000 ) Net present value of operating lease obligation $ 1,120,000

PATENTS (Tables)

PATENTS (Tables)	9 Months Ended
	Jun. 30, 2021
PATENTS
Schedule of total estimated future amortization	Three months ending September 30, 2021 $ 13,000 Year ending September 30, 2022 48,000 2023 38,000 2024 31,000 2025 28,000 2026 24,000 Thereafter 97,000 Total $ 279,000

LOSS PER COMMON SHARE (Tables)

LOSS PER COMMON SHARE (Tables)	9 Months Ended
	Jun. 30, 2021
LOSS PER COMMON SHARE
Schedule of basic and diluted loss per-share computations	Nine months ended June 30, Three months ended June 30, 2021 2020 2021 2020 Loss per share - basic Net loss available to common shareholders - basic $ (28,507,113 ) $ (24,897,891 ) $ (9,203,350 ) $ (10,276,979 ) Weighted average shares outstanding - basic 39,907,624 36,230,992 41,020,485 37,453,539 Basic loss per common share $ (0.71 ) $ (0.69 ) $ (0.22 ) $ (0.27 ) Loss per share - diluted Net loss available to common shareholders - basic $ (28,507,113 ) $ (24,897,891 ) $ (9,203,350 ) $ (10,276,979 ) Unrealized gain on derivatives (1) (1,236,514 ) - (1,233,597 ) - Net loss available to common shareholders - diluted $ (29,743,627 ) $ (24,897,891 ) $ (10,436,947 ) $ (10,276,979 ) Weighted average shares outstanding - basic 39,907,624 36,230,992 41,020,485 37,453,539 Incremental shares underlying dilutive “in the money” warrants (1) 250,697 - 210,597 - Weighted average shares outstanding - diluted 40,158,321 36,230,992 41,231,082 37,453,539 Diluted loss per common share $ (0.74 ) $ (0.69 ) $ (0.25 ) $ (0.27 )
Schedule of antidilutive securities	2021 2020 Options and Warrants 6,979,170 7,651,718 Unvested Restricted Stock 166,500 311,873 Total 7,145,670 7,963,591

BASIS OF PRESENTATION AND SUM_3

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	9 Months Ended
	Jun. 30, 2021
Patent useful life	5 years 10 months 24 days
Patents [Member]
Patent useful life	17 years

STOCKHOLDERS EQUITY (Details)

STOCKHOLDERS EQUITY (Details)	Jun. 30, 2021shares
Incentive Stock Option Plans [Member]
Total shares reserved under plans	138,400
Shares reserved for outstanding options	76,829
Remaining options/shares under plans	213
Non-Qualified Stock Option Plans [Member]
Total shares reserved under plans	11,787,200
Shares reserved for outstanding options	11,001,880
Remaining options/shares under plans	404,826
Stock Bonus Plans [Member]
Total shares reserved under plans	783,760
Remaining options/shares under plans	425,609
Shares issued	358,118
Stock Compensation Plan [Member]
Total shares reserved under plans	634,000
Remaining options/shares under plans	464,895
Shares issued	150,695
Incentive Stock Bonus Plan [Member]
Total shares reserved under plans	640,000
Remaining options/shares under plans	25,500
Shares issued	614,500

STOCKHOLDERS EQUITY (Details 1)

STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
STOCKHOLDERS EQUITY
Options granted	2,595,500	2,559,000	2,603,500	2,561,200
Options exercised	72,809	73,719	126,954	94,199
Options forfeited		16	42,166	1,000
Options expired	9,307		9,374	1,180

STOCKHOLDERS EQUITY (Details 2)

STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
STOCKHOLDERS EQUITY
Employees stock based compensation expense	$ 3,511,359	$ 3,109,127	$ 10,090,410	$ 6,690,331
Non- Employees stock based compensation expense	$ 403,236	$ 275,919	$ 955,900	$ 623,146

STOCKHOLDERS EQUITY (Details 3)

STOCKHOLDERS EQUITY (Details 3)	9 Months Ended
	Jun. 30, 2021$ / sharesshares
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
Series N [Member]
Shares issuable upon exercise of warrant/options | shares	85,339
Exercise price	$ 3
Issue date	8/18/2008
Expiration date	8/18/2022
Series UU [Member]
Shares issuable upon exercise of warrant/options | shares	93,603
Exercise price	$ 2.80
Issue date	6/11/2018
Expiration date	6/30/2022
Series X [Member]
Shares issuable upon exercise of warrant/options | shares	120,000
Exercise price	$ 9.25
Issue date	1/13/2016
Expiration date	12/07/2021
Series Y [Member]
Shares issuable upon exercise of warrant/options | shares	26,000
Exercise price	$ 12
Issue date	2/15/2016
Expiration date	8/15/2022
Series Z [Member]
Shares issuable upon exercise of warrant/options | shares	184,800
Exercise price	$ 13.75
Issue date	5/23/2016
Expiration date	11/23/2021
Series CC [Member]
Shares issuable upon exercise of warrant/options | shares	41,345
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	100,000
Exercise price	$ 13.75
Issue date	8/26/2016
Expiration date	2/22/2022
Series SS [Member]
Shares issuable upon exercise of warrant/options | shares	220,800
Exercise price	$ 2.09
Issue date	12/19/2017
Expiration date	12/18/2022
Series NN [Member]
Shares issuable upon exercise of warrant/options | shares	217,838
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	251,761
Exercise price	$ 1.65
Issue date	10/30/2017
Expiration date	10/30/2022
Series MM [Member]
Shares issuable upon exercise of warrant/options | shares	333,432
Exercise price	$ 1.86
Issue date	6/22/2017
Expiration date	6/22/2022
Series TT [Member]
Shares issuable upon exercise of warrant/options | shares	100,868
Exercise price	$ 2.24
Issue date	2/5/2018
Expiration date	2/5/2023
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

STOCKHOLDERS EQUITY (Details 4)

STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Sep. 30, 2020
STOCKHOLDERS EQUITY
Series W warrants	$ 0		$ 0		$ 73,570
Series Z warrants	429,996		429,996		1,207,902
Series ZZ warrants					75,044
Series AA warrants	263,818		263,818		1,082,212
Series BB warrants	16,696		16,696		65,173
Series CC warrants	206,978		206,978		1,259,712
Series HH warrants	1,216		1,216		2,000
Total warrant liabilities	918,704		918,704		$ 3,765,613
Gains (losses) on Series V warrants	0	$ 107,191	0	$ 185,652
Gains (losses) on Series W warrants	0	(247,327)	73,570	(614,696)
Gains (losses) on Series Z warrants	583,404	(430,619)	(113,094)	(742,495)
Gains (losses) on Series ZZ warrants	(87,612)	(33,734)	(98,692)	(38,319)
Gains (losses) on Series AA warrants	355,215	(220,831)	(306,606)	(547,454)
Gains (losses) on Series BB warrants	64,678	(37,592)	48,477	(44,620)
Gains (losses) on Series CC warrants	199,256	(419,350)	(596,001)	(1,245,627)
Gains (losses) on Series FF warrants	0	0	0	(319,706)
Gains (losses) on Series HH warrants	1,228	(567)	784	(35,024)
Gains (losses) on Series JJ warrants	0	0	0	(64,992)
Gains (losses) on Series LL warrants	0	0	0	(98,066)
Net loss on warrant liabilities	$ 1,116,619	$ (1,282,829)	$ (991,562)	$ (3,565,347)

STOCKHOLDERS EQUITY (Details 5)

STOCKHOLDERS EQUITY (Details 5) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Warrants Exercised	24,200	674,164	306,498	908,180
Proceeds	$ 289,000	$ 9,269,755	$ 3,275,490	$ 10,298,752
Series Z [Member]
Warrants Exercised	0		79,200
Proceeds	$ 0		$ 1,089,000
Exercise Price	$ 0		$ 13.75
Series CC [Member]
Warrants Exercised	5,000		107,298	123,820
Proceeds	$ 25,000		$ 536,490	$ 619,100
Exercise Price	$ 5		$ 5	$ 5
Series HH [Member]
Warrants Exercised				6,300
Proceeds				$ 19,687
Exercise Price				$ 3.13
Series AA [Member]
Warrants Exercised	0		100,000
Proceeds	$ 0		$ 1,375,000
Exercise Price	$ 0		$ 13.75
Series V [Member]
Warrants Exercised		674,164		674,164
Proceeds		$ 9,269,755		$ 9,269,755
Exercise Price		$ 13.75		$ 13.75
Series ZZ [Member]
Warrants Exercised	19,200		20,000
Proceeds	$ 264,000		$ 275,000
Exercise Price	$ 13.75		$ 13.75
Series MM [Member]
Warrants Exercised	19,200		20,000
Proceeds	$ 264,000		$ 275,000
Exercise Price	$ 13.75		$ 13.75
Series FF [Member]
Warrants Exercised				68,048
Proceeds				$ 265,812
Exercise Price				$ 3.91
Series JJ [Member]
Warrants Exercised				9,450
Proceeds				$ 29,531
Exercise Price				$ 3.13
Series LL [Member]
Warrants Exercised				26,398
Proceeds				$ 94,867
Exercise Price				$ 3.59

STOCKHOLDERS EQUITY (Details 6)

STOCKHOLDERS EQUITY (Details 6) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Warrants exercised	413,112	175,681	1,137,053	636,665
Proceeds	$ 843,204	$ 397,730	$ 2,293,620	$ 1,438,005
Series UU [Member]
Warrants exercised		61,207		61,207
Proceeds		$ 171,380		$ 171,380
Exercise price		$ 2.80		$ 2.80
Series SS [Member]
Warrants exercised		39,474	105,264	156,580
Proceeds		$ 82,500	$ 220,002	$ 327,252
Exercise price		$ 2.09	$ 2.09	$ 2.09
Series NN [Member]
Warrants exercised	109,170		131,004	98,253
Proceeds	$ 275,108		$ 330,130	$ 247,598
Exercise price	$ 2.52		$ 2.52	$ 2.52
Series RR [Member]
Warrants exercised	95,799		165,888
Proceeds	$ 158,068		$ 273,715
Exercise price	$ 1.65		$ 1.65
Series TT [Member]
Warrants exercised	60,214	10,000	270,696	188,125
Proceeds	$ 134,879	$ 22,400	$ 606,359	$ 421,400
Exercise price	$ 2.24	$ 2.24	$ 2.24	$ 2.24
Series MM [Member]
Warrants exercised	147,929		464,201
Proceeds	$ 275,148		$ 863,414
Exercise price	$ 1.86		$ 1.86
Series OO [Member]
Warrants exercised		10,000		50,000
Proceeds		$ 25,200		$ 126,000
Exercise price		$ 2.52		$ 2.52
Series VV [Member]
Warrants exercised		55,000		82,500
Proceeds		$ 96,250		$ 144,375
Exercise price		$ 1.75		$ 1.75

STOCKHOLDERS EQUITY (Details 7)

STOCKHOLDERS EQUITY (Details 7) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
STOCKHOLDERS EQUITY
Realized through the resale of shares	$ 761,237	$ 518,565	$ 1,436,473	$ 2,539,245
Fair value of shares upon issuance	0	1,769,500	0	1,769,500
Other non-operating gain (loss)	$ 761,237	$ (950,935)	$ 1,436,473	$ 769,745

STOCKHOLDERS EQUITY (Details Na

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	Dec. 07, 2020	Jun. 25, 2021	Oct. 28, 2020	Sep. 30, 2020	Jan. 23, 2020	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Compensation expense						$ 64,000		$ 64,000
Net gain								$ 107,000
Common stock shares								1,400,000
Offering price						$ 22.62		$ 22.62
Aggregate net proceeds								$ 29,400,000
Additional shares of common stock								210,000
Additional net proceeds								$ 4,400,000
Weighted average grant date fair value		$ 13.75						$ 5.65
Fair value of stock option								$ 28,000
Fair value of warrants		$ 211,000
Warrants expired						9,307		9,374	1,180
Warrants amount								$ 629,000
Warrants shares								461,953
Proceeds from issuance of common stock								$ 47,363,426	$ 13,992,439
Fair value						$ 0	$ (805,753)	0	805,753
Consulting Agreements [Member]
Total expense						$ 293,000	$ 395,000	$ 956,000	$ 395,000
Non-Qualified Stock Option Plans [Member]
Options issued								1,800,000
Grant performance-based stock options								1,800,000
Non-Qualified Stock Option Plan to officers and directors								72,000
Common stock price						$ 20.61		$ 20.61
Stock options vest						100.00%		100.00%
Common stock closing price						$ 42		$ 42
Fair value per share						0.34		$ 0.34
Fair value								$ 636,480
Options period								1 year 3 months 18 days
Series W Warrants [Member]
Warrants expired			688,930
Common stock price per share			$ 16.75
December 2020 [Member]
Common stock shares								1,000,000
Offering price						14.65		$ 14.65
Proceeds from issuance of common stock								$ 13,600,000
March 2020 [Member]
Common stock shares								630,500
Offering price						12.22		$ 12.22
Additional shares of common stock								94,575
Additional net proceeds								$ 1,100,000
Proceeds from issuance of common stock								$ 7,100,000
December 2019 [Member]
Common stock shares								606,395
Offering price						9.07		$ 9.07
Aggregate net proceeds								$ 800,000
Additional shares of common stock								90,959
Proceeds from issuance of common stock								$ 5,000,000
January 2020 [Member]
Offering price						9.07		$ 9.07
Additional shares of common stock								90,959
Proceeds from issuance of common stock								$ 800,000
Consultants [Member]
Exercise price								$ 11.61
Expiration date								November 17, 2022
Options issued								5,000
Consultants [Member] | Minimum [Member]
Expiration date								11/17/2022
Consultants [Member] | Maximum [Member]
Expiration date								7/27/2027
Consultants One [Member]
Options issued				10,000				15,000
Non-Qualified Stock Option shares vest								10,000
Restricted Stock [Member] | Consultants [Member]
Weighted average grant date fair value						$ 23.39	$ 16.41	$ 19.47	$ 11.60
Common stock issued for service, shares						13,184	14,811	41,714	47,750
Series X [Member]
Incremental cost						$ 265,000		$ 351,000
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								12/07/2021
Series Y [Member]
Incremental cost						$ 62,000		$ 103,000
Expiration date								8/15/2022
Series V Warrants [Member]
Warrant shares		$ 135,963
Exercise price		$ 13.75
Warrant value		$ 211,000
Stock price		$ 18
Series XX [Member]
Warrants amount								$ 629,000
Warrants shares								461,953
Series N Warrants [Member]
Incremental cost					$ 22,000			$ 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				expiration date of the Series N warrants was extended to February 18, 2021
Series UU warrants [Member]
Warrants amount								$ 6,000
Warrants shares								93,593
Incremental cost								$ 240,000
Expiration date description	the expiration date of Series UU warrants were extended six months from December 31, 2020 to June 30, 2021							the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Series YY [Member]
Warrants amount								$ 177,000
Warrants shares								101,839
Warrant price								$ 20

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details) - USD ($)	9 Months Ended	12 Months Ended
	Jun. 30, 2021	Sep. 30, 2020
FAIR VALUE MEASUREMENTS
Beginning balance	$ 3,765,613	$ 6,488,310
Issuances	0	0
Exercises	3,838,471	3,071,775
Realized and unrealized net loss	991,562	349,078
Ending balance	$ 918,704	$ 3,765,613

FAIR VALUE MEASUREMENTS (Deta_2

FAIR VALUE MEASUREMENTS (Details Narrative) - Fair Value Inputs Level 3 (Level 3) [Member]	9 Months Ended
	Jun. 30, 2021USD ($)
unrealized gain on short-term T-bills	$ 2,000
Weighted average risk free interest rate	0.09%

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)	Dec. 07, 2020	Jan. 23, 2020	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Jun. 28, 2021
Officer and Director [Member]
Restricted Common shares			0		20,512
Restricted Common shares, amount			$ 0		$ 185,000
Series N Warrants [Member]
Expiration date description	the expiration date of the Series N warrants was extended six months from February 18, 2021 to August 18, 2021	expiration date of the Series N warrants was extended to February 18, 2021
Deemed dividend			265,000	$ 22,000	$ 265,000	$ 22,000
Series UU warrants [Member]
Expiration date description	the expiration date of Series UU warrants were extended six months from December 31, 2020 to June 30, 2021				the expiration date of 93,603 Series UU warrants was extended from December 31, 2020 to June 30, 2021
Warrants issued							93,603
Interest expense	$ 192		24,000		$ 24,000
Series X Warrants [Member]
Deemed dividend			$ 265,000		265,000
Series N and X Warrants [Member]
Deemed dividend					$ 86,000

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES (Details)	Jun. 30, 2021USD ($)
Commitments and Contingencies
Nine months ending September 30, 2021 (1)	$ (182,000)
2022	2,486,000
2023	2,569,000
2024	2,648,000
2025	2,733,000
2026	2,824,000
Thereafter	6,186,000
Total future minimum finance lease obligation	19,264,000
Less: imputed interest on financing lease obligation	(5,126,000)
Net present value of lease finance lease obligations	$ 14,138,000

COMMITMENTS AND CONTINGENCIES_3

COMMITMENTS AND CONTINGENCIES (Details 1)	Jun. 30, 2021USD ($)
Commitments and Contingencies
Three months ending September 30, 2021	$ 66,000
2022	267,000
2023	275,000
2024	281,000
2025	288,000
2026	207,000
Thereafter	80,000
Total future minimum lease obligation	1,464,000
Less imputed interest on operating lease obligation	(344,000)
Net present value of operating lease obligation	$ 1,120,000

COMMITMENTS AND CONTINGENCIES_4

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Sep. 30, 2020
Non current assets	$ 1,900,000		$ 1,900,000		$ 1,700,000
Clinical service trial			12,000,000
Cash paid related to finance leases			1,600,000
Cash paid related to finance leases interest			900,000	$ 600,000
Cash paid related to operating leases	$ 64,000	$ 66,000	$ 176,000	198,000
Weighted average discount rate	8.45%		8.45%
Weighted average discount rate operating lease	10.20%		10.20%
Interest rate	10.19%		10.19%		10.00%
Maturity years			7 years 3 months 18 days
Operating lease maturity years			5 years 10 months 24 days
Total cash paid related to finance leases	$ 1,600,000		$ 1,600,000		$ 900,000
Net book value of the finance lease right of use asset	13,100,000		13,100,000		13,800,000
Balance of the finance lease liability	14,100,000		14,100,000		12,700,000
Current balance	500,000		500,000		900,000
Change in operating lease liability			22,459	(815)
Operating lease - liability	1,100,000		1,100,000		1,300,000
Change in net loss			29,000
Net book value operating lease right of use assets	1,000,000		1,000,000		1,200,000
Change in right of use of assets and liability			500,000
Change in lease expense	27,000		27,000
Change in operating lease right of use of assets			$ 712,000
Balance of the operating lease liabilities					1,300,000
Weighted average time to maturity			5 years 10 months 24 days
Operating lease expense	66,000	67,000	$ 200,000	200,000
Finance lease liability	14,100,000		14,100,000		12,700,000
Research and development expenses			34,800,000
Net of discount			$ 11,700,000
Lease description			The revised rate upon adoption of ASC 842 was calculated to be 10.19% compared to the previously used rate of 8.80%, and the revised rate for the lease modification was calculated to be 8.45% compared to the previous rate of 10.00%.
Finance lease obligations, net of current portion	$ 200,000		$ 200,000		$ 100,000
Biologics License Application [Member]
Sublease rental income		$ 2,000		39,000
Ergomed [Member]
Research and development expenses			$ 1,400,000	$ 1,300,000
Landlord [Member]
Interest rate	8.45%		8.45%
Finance lease liability	$ 1,600,000		$ 1,600,000
Lease description			The repayment will include a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year.
Additional deposit	$ 200,000		$ 200,000
Cost incurred, initial			10,500,000
Estimated cost			10,700,000
Financing arrangement			$ 2,400,000

PATENTS (Details)

PATENTS (Details)	Jun. 30, 2021USD ($)
PATENTS
Three months ending September 30, 2021	$ 13,000
2022	48,000
2023	38,000
2024	31,000
2025	28,000
2026	24,000
Thereafter	97,000
Total	$ 279,000

PATENTS (Details Narrative)

PATENTS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
PATENTS
Amortization of patent costs	$ 13,000	$ 14,000	$ 39,000	$ 40,000

LOSS PER COMMON SHARE (Details)

LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
LOSS PER COMMON SHARE
Net loss available to common shareholders - basic	$ (9,203,350)	$ (10,276,979)	$ (28,507,113)	$ (24,897,891)
Weighted average shares outstanding - basic	41,020,485	37,453,539	39,907,624	36,230,992
Basic loss per common share	$ (0.22)	$ (0.27)	$ (0.71)	$ (0.69)
Loss per share- diluted
Net loss available to common shareholders -basic	$ (9,203,350)	$ (10,276,979)	$ (28,507,113)	$ (24,897,891)
Unrealized gain on derivatives	(1,233,597)	0	(1,236,514)	0
Net loss available to common shareholders - diluted	$ (10,436,947)	$ (10,276,979)	$ (29,743,627)	$ (24,897,891)
Weighted average shares outstanding - basic	41,231,082	37,453,539	40,158,321	36,230,092
Incremental shares underlying dilutive "in the money" warrants	210,597	0	250,697	0
Weighted average shares outstanding - diluted	41,231,082	37,453,539	40,158,321	36,230,992
Diluted loss per common share	$ (0.25)	$ (0.27)	$ (0.74)	$ (0.69)

LOSS PER COMMON SHARE (Details

LOSS PER COMMON SHARE (Details 1) - shares	9 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Antidilutive securities	7,145,670	7,963,591
Restricted Stock [Member]
Antidilutive securities	166,500	311,873
Options and Warrants [Member]
Antidilutive securities	6,979,170	7,651,718

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member]	Jul. 07, 2021USD ($)integer$ / sharesshares
Closing price per share | $ / shares	$ 8
Purchase of restricted shares under security purchase agreements | shares	27,500
Invested beneficiary amount by CEO	$ 200,000
Number of directors | integer	2
Invested amount by each director	$ 10,000