CEL-SCI (CVM) 10-Q/A 10 Aug 20 2020 Q3 Quarterly report (amended) Financial data

Cover

Cover - shares	9 Months Ended
	Jun. 30, 2020	Aug. 05, 2020
Cover [Abstract]
Entity Registrant Name	CEL-SCI CORPORATION
Entity Central Index Key	0000725363
Document Type	10-Q/A
Amendment Flag	true
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, 2020
Entity Filer Category	Accelerated Filer
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2020
Entity Common Stock Shares Outstanding		38,624,084
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Address Address Line 1	8229 Boone Boulevard
Entity Address Address Line 2	Suite 802
Entity Address City Or Town	Vienna
Entity Address State Or Province	VA
Entity Address Postal Zip Code	22182
City Area Code	703
Local Phone Number	506-9460
Security 12b Title	Common Stock
Trading Symbol	CVM
Security Exchange Name	NYSE
Entity Interactive Data Current	Yes
Amendment Description	Explanatory Note The purpose of this First Amendment to CEL SCI Corporation’s Quarterly Report on Form 10-Q for the nine months ending June 30, 2020 (the “Form 10-Q”), as filed with the Securities and Exchange Commission on August 10, 2020 is to furnish Exhibits 101 to the Form 10-Q in accordance with Rule 201(c) and Rule 405 of Regulation S-T. Exhibits 101 provide the financial statements and related notes from the Form 10-Q formatted in XBRL (eXtensible Business Reporting Language).  No other changes have been made to the Form 10-Q. This First Amendment to the Form 10-Q continues to speak as of the original filing date of the Form 10-Q, does not reflect events that may have occurred subsequent to the original filing date, and does not modify or update in any way the disclosures made in the original Form 10-Q.

CONDENSED BALANCE SHEETS

CONDENSED BALANCE SHEETS - USD ($)	Jun. 30, 2020	Sep. 30, 2019
Current Assets:
Cash and cash equivalents	$ 20,136,789	$ 8,444,774
Receivables	255,007	62,765
Prepaid expenses	1,505,878	524,953
Supplies used for R&D and manufacturing	787,011	782,363
Total current assets	22,684,685	9,814,855
Finance lease right of use assets	12,367,947	0
Operating lease right of use assets	1,237,339	0
Property and equipment, net	3,762,633	15,825,636
Patent costs, net	311,346	311,586
Deposits	1,670,917	1,670,917
Total Assets	42,034,867	27,622,994
Current Liabilities:
Accounts payable	943,821	1,586,478
Accrued expenses	232,252	34,432
Due to employees	543,132	709,442
Derivative instruments, current portion	1,924,160	674,442
Lease liabilities, current portion	1,007,868	0
Other current liabilities	0	14,956
Total current liabilities	4,651,233	3,019,750
Derivative instruments, net of current portion	5,094,172	5,813,868
Finance lease obligations, net of current portion	11,995,197	13,508,156
Operating lease obligations, net of current portion	1,154,325	0
Other liabilities	125,000	147,553
Total liabilities	23,019,927	22,489,327
STOCKHOLDERS? EQUITY
Preferred stock, $.01 par value-200,000 shares authorized; -0- shares issued and outstanding	0	0
Common stock, $.01 par value - 600,000,000 shares authorized; 38,522,236 and 35,231,776 shares issued and outstanding at June 30, 2020 and September 30, 2019, respectively	385,223	352,318
Additional paid-in capital	396,959,284	358,507,603
Accumulated deficit	(378,329,567)	(353,726,254)
Total stockholders' equity	19,014,940	5,133,667
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 42,034,867	$ 27,622,994

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2020	Sep. 30, 2019
Stockholders Equity
Preferred stock, par value	$ 0.01	$ 0.01
Preferred stock, shares authorized	200,000	200,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	38,522,236	35,231,776
Common stock, shares outstanding	38,522,236	35,231,776

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Grant income	$ 195,874	$ 108,938	$ 530,106	$ 386,121
Operating Expenses:
Research and development	3,912,870	2,965,512	12,511,830	9,269,772
General and administrative	3,192,403	2,353,525	8,389,821	5,667,510
Total operating expenses	7,105,273	5,319,037	20,901,651	14,937,282
Operating loss	(6,909,399)	(5,210,099)	(20,371,545)	(14,551,161)
Other income	1,845	18,448	38,741	54,575
Loss on derivative instruments	(1,282,829)	(7,905,519)	(3,565,347)	(3,316,384)
Warrant inducement expense	(805,753)	0	(805,753)	0
Other non-operating gains	(950,935)	1,455,844	774,245	1,877,197
Interest expense, net	(273,708)	(443,442)	(777,898)	(1,350,774)
Net loss			(24,707,557)	(17,286,547)
Modification of warrants		0	(21,734)	0
Net loss available to common shareholders	$ (10,220,779)	$ (12,084,768)	$ (24,729,291)	$ (17,286,547)
Net loss per common share - basic and diluted	$ (0.27)	$ (0.37)	$ (0.68)	$ (0.58)
Weighted average common shares outstanding - basic and diluted	37,453,539	33,051,888	36,230,092	30,046,241

STATEMENTS OF STOCKHOLDERS' EQU

STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Sep. 30, 2018		28,034,487
Balance, amount at Sep. 30, 2018	$ 916	$ 280,346	$ 331,312,184	$ (331,591,614)
Warrant exercises, shares		298,682
Warrant exercises, amount	649,753	$ 2,987	646,766
401(k) contributions paid in common stock, shares		12,279
401(k) contributions paid in common stock, amount	35,241	$ 123	35,118	0
Stock issued to nonemployees for service, shares		62,784
Stock issued to nonemployees for service, amount	202,380	$ 628	201,752	0
Shares returned for settlement of clinical research costs, shares		(564,905)
Shares returned for settlement of clinical research costs, amount	0	$ (5,649)	5,649	0
Equity based compensation - employees, shares		0
Equity based compensation - employees, amount	573,660	0	573,660	0
Net income	1,245,902	$ 0	0	1,245,902
Balance, shares at Dec. 31, 2018		27,843,327
Balance, amount at Dec. 31, 2018	2,707,852	$ 278,435	332,775,129	(330,345,712)
Balance, shares at Sep. 30, 2018		28,034,487
Balance, amount at Sep. 30, 2018	916	$ 280,346	331,312,184	(331,591,614)
Net income	$ (17,286,547)
Option exercises, shares	42,770
Balance, shares at Jun. 30, 2019		34,066,914
Balance, amount at Jun. 30, 2019	$ 1,146,304	$ 340,669	349,683,796	(348,878,161)
Balance, shares at Dec. 31, 2018		27,843,327
Balance, amount at Dec. 31, 2018	2,707,852	$ 278,435	332,775,129	(330,345,712)
Warrant exercises, shares		1,523,933
Warrant exercises, amount	2,655,634	$ 15,239	2,640,395	0
401(k) contributions paid in common stock, shares		10,419
401(k) contributions paid in common stock, amount	36,883	$ 104	36,779	0
Stock issued to nonemployees for service, shares		77,449
Stock issued to nonemployees for service, amount	225,629	$ 774	224,855	0
Shares returned for settlement of clinical research costs, shares		500,000
Shares returned for settlement of clinical research costs, amount	1,290,000	$ 5,000	1,285,000	0
Equity based compensation - employees, shares		(3,500)
Equity based compensation - employees, amount	530,830	(35)	530,865	0
Net income	(6,447,681)	0	0	(6,447,681)
Share issuance costs	(43,625)	$ 0	(43,625)	0
Balance, shares at Mar. 31, 2019		29,951,628
Balance, amount at Mar. 31, 2019	955,522	$ 299,517	337,449,398	(336,793,393)
Warrant exercises, shares		4,014,109
Warrant exercises, amount	10,252,821	$ 40,141	10,212,680	0
401(k) contributions paid in common stock, shares		4,339
401(k) contributions paid in common stock, amount	36,361	$ 43	36,318	0
Stock issued to nonemployees for service, shares		20,825
Stock issued to nonemployees for service, amount	140,270	$ 208	140,062	0
Equity based compensation - employees, amount	1,521,821	(40)	1,521,861	0
Net income	(12,084,768)	0	0	(12,084,768)
Share issuance costs	(8,010)	$ 0	(8,010)	0
Purchase of stock by officers and directors, shares		37,243
Purchase of stock by officers and directors, amount	$ 234,997	$ 372	234,625	0
Option exercises, shares	42,770	42,770
Option exercises, amount	$ 97,290	$ 428	96,862	0
Balance, shares at Jun. 30, 2019		34,066,914
Balance, amount at Jun. 30, 2019	1,146,304	$ 340,669	349,683,796	(348,878,161)
Balance, shares at Sep. 30, 2019		35,231,776
Balance, amount at Sep. 30, 2019	5,133,667	$ 352,318	358,507,603	(353,726,254)
Warrant exercises, shares		132,900
Warrant exercises, amount	297,101	$ 1,329	295,772	0
401(k) contributions paid in common stock, shares		4,474
401(k) contributions paid in common stock, amount	40,937	$ 45	40,892	0
Stock issued to nonemployees for service, shares		15,819
Stock issued to nonemployees for service, amount	84,447	$ 158	84,289	0
Equity based compensation - employees, shares		0
Net income	(5,475,160)	0	0	(5,475,160)
Share issuance costs	(92,150)	$ 0	(92,150)	0
Adoption of new accounting standard	104,244			104,244
Issuance of common stock, shares		606,395
Issuance of common stock, amount	5,050,003	$ 6,064	5,043,939	0
Equity based compensation - employees, amount	1,800,225	$ 0	1,800,225
Purchase of stock by officer, shares		3,725
Purchase of stock by officer, amount	25,000	$ 37	24,963	0
Balance, shares at Dec. 31, 2019		35,995,089
Balance, amount at Dec. 31, 2019	6,968,314	$ 359,951	365,705,533	(359,097,170)
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 income	$ (24,707,557)
Option exercises, shares	94,199
Balance, shares at Jun. 30, 2020		38,522,236
Balance, amount at Jun. 30, 2020	$ 19,014,940	$ 385,223	396,959,284	(378,329,567)
Balance, shares at Dec. 31, 2019		35,995,089
Balance, amount at Dec. 31, 2019	6,968,314	$ 359,951	365,705,533	(359,097,170)
Warrant exercises, shares		562,100
Warrant exercises, amount	4,318,706	$ 5,621	4,313,085	0
401(k) contributions paid in common stock, shares		3,376
401(k) 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
Equity based compensation - employees, shares		0
Net income	(9,011,618)	0	0	(9,011,618)
Share issuance costs	(199,372)	$ 0	(199,372)	0
Purchase of stock by officers and directors, shares		16,787
Option exercises, shares		20,480
Option exercises, amount	49,898	$ 205	49,693	0
Equity based compensation - employees, amount	1,780,979	$ 0	1,780,979	0
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, amount	159,990	$ 168	159,822	0
Balance, shares at Mar. 31, 2020		37,336,411
Balance, amount at Mar. 31, 2020	12,208,509	$ 373,365	379,943,932	(368,108,788)
Warrant exercises, shares		849,845
Warrant exercises, amount	10,156,275	$ 8,498	10,147,777	0
401(k) contributions paid in common stock, shares		2,875
401(k) 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
Net income	(10,220,779)	0	0	(10,220,779)
Share issuance costs	$ (418,497)	$ 0	(418,497)	0
Option exercises, shares	73,719	73,719
Option exercises, amount	$ 276,415	$ 737	275,678	0
Equity based compensation - employees, amount	3,109,127	$ 0	3,109,127	0
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
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, amount	5,554	0	5,554	0
Warrant issuances, amount	805,753	$ 0	805,753	0
Balance, shares at Jun. 30, 2020		38,522,236
Balance, amount at Jun. 30, 2020	$ 19,014,940	$ 385,223	$ 396,959,284	$ (378,329,567)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (24,707,557)	$ (17,286,547)
net cash used in operating activities:
Depreciation and amortization	1,442,255	513,028
Share-based payments for services	623,146	688,070
Equity based compensation	6,690,331	2,626,311
Common stock contributed to 401(k) plan	122,791	108,485
Shares issued for settlement of clinical research costs	1,769,500	1,290,000
Loss on derivative instruments	3,565,347	3,316,384
Warrants inducement expense	805,753	0
Warrant modification expense	5,554	0
Capitalized lease interest	0	95,742
(Increase)/decrease in assets:
Receivables	(192,242)	393
Prepaid expenses	(969,219)	11,047
Supplies used for R&D and manufacturing	(4,648)	(109,587)
Increase/(decrease) in liabilities:
Accounts payable	(761,675)	(3,567,182)
Accrued expenses	87,820	(113,280)
Due to employees	(166,310)	(3,914)
Other liabilities	(815)	(2,544)
Net cash used in operating activities	(11,689,969)	(12,433,594)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(1,530,327)	(171,321)
Expenditures for patent costs	(39,975)	(115,476)
Net cash used in investing activities	(1,570,302)	(286,797)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock	13,992,439	0
Payments of stock issuance costs	(695,447)	(90,224)
Proceeds from the purchase of stock by officers and directors	184,990	234,997
Proceeds from exercises of warrants	11,736,757	11,657,590
Proceeds from exercises of options	326,313	97,290
Payments on obligations under finance lease	(592,766)	(3,811)
Net cash provided by financing activities	24,952,286	11,895,842
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	11,692,015	(824,549)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	8,444,774	10,310,044
CASH AND CASH EQUIVALENTS, END OF PERIOD	20,136,789	9,485,495
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	121,441	0
Capitalizable patent costs included in current liabilities	0	30,000
Right of use asset acquired and liability incurred	399,032	0
Finance lease obligation included in accounts payable	775	434
Prepaid consulting services paid with issuance of common stock	11,706	(119,791)
Accrued consulting services to be paid with common stock	110,000	0
Fair value of warrant liabilities on date of exercise	3,035,325	1,900,618
Stock issuance costs included in current liabilities	30,152	8,010
Cash paid for interest	$ 872,710	$ 1,355,676

BASIS OF PRESENTATION AND SUMMA

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Jun. 30, 2020
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (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 notes included in the Company’s annual report on Form 10-K/A for the year ended September 30, 2019. 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, 2020 and the results of its operations for the nine and three months then ended. The condensed balance sheet as of September 30, 2019 is derived from the September 30, 2019 audited financial statements. On October 1, 2019, the Company adopted Accounting Standards Update (ASU) No. 2016-02, “ Leases” The financial statements have been prepared assuming the Company will continue as a going concern, but due to recurring losses from operations and the Company’s necessity to continue to raise capital for future liquidity needs, raises substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B. Summary of Significant Accounting Policies: Property Equipment Patents Research and Development Costs Income Taxes Derivative Instruments Accounting for Derivative Instruments and Hedging Activities Stock-Based Compensation Compensation – Stock 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 Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period. Newly Adopted Accounting Pronouncements Effective October 1, 2019, the Company adopted ASC 842. ASC 842 requires that lessees recognize right-of-use assets and lease liabilities that are measured at the present value of the future lease payments at the lease commencement date. Subsequent measurement, including the presentation of expenses and cash flows, depends on the classification of the lease as either a finance lease or an operating lease. The Company elected the optional transition method that allows for a cumulative-effect adjustment in the period of adoption and did not restate prior periods. The Company also elected the transition package of three practical expedients which eliminates the requirements to reassess prior conclusions about lease identification, lease classification and initial direct costs. Further, the Company elected a short-term lease exception policy permitting the option to not apply the recognition requirements of this standard to short-term leases (i.e., leases with terms of 12 months or less) and an accounting policy to account for lease and non-lease components as a single component. The Company’s lease portfolio includes both finance and operating leases. The impact of adopting ASC 842 was to increase long term assets by approximately $1.0 million, decrease total liabilities by approximately $0.9 million and record a cumulative effect adjustment of approximately $0.1 million to opening accumulated deficit. In June 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-07, Compensation—Stock Compensation (Topic 718 New Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework (Topic )” 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, 2020
OPERATIONS AND FINANCING
B. OPERATIONS AND FINANCING	B. OPERATIONS AND FINANCING On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, because of the rapid increase in exposure globally, the WHO classified the COVID-19 outbreak as a pandemic. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations. Management is actively monitoring the impact of the global situation on its financial condition, liquidity, operations, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for fiscal year 2020. Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak, if the pandemic continues, it may have an adverse effect on the Company’s results of future operations, financial position, and liquidity in fiscal year 2020. On March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (CARES Act). The Cares Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions which are expected to impact the Company’s financial statements include removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. The Company does not expect the enactment of the CARES Act to directly impact its financial position, results of operations or cash flows. The Company did not apply for a PPP loan under the CARES Act because it is able to access funds, if needed, in other ways. On May 4, 2020, the Company announced that the pivotal Phase 3 head and neck cancer study of Multikine (Leukocyte Interleukin, Inj.) immunotherapy had reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation. The Phase 3 study is now in the phase that involves database lock and final analysis of the trial results. Given that the contract research organizations (CROs), not the Company, are running these activities and the uncertainties surrounding COVID-19 and its effect on various countries and their rules regarding travel and hospitals, the Company cannot give a reliable timeline. The Company will continue to remain blinded to the study results throughout this process. The Company will be advised of the results when the analysis is completed, and the study results will be announced to the public at that time. The Company has incurred significant costs since its inception for the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials. The Company has funded such costs with proceeds from loans and the public and private sale of its common stock. The Company will be required to raise additional capital or find additional long-term financing to continue with its research efforts. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company believes there is a high likelihood that it will continue to receive funds from private and public offerings and warrant exercises similarly to the way it has substantially funded operations for the past 12 months. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. The Company is currently in the final stages of its large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. To finance the study beyond the next twelve months, the Company plans to raise additional capital in the form of corporate partnerships, warrant exercises, debt issuances and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because Multikine is a product in the Phase 3 clinical trial stage. 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 can raise the required funding. 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, 2020
STOCKHOLDERS EQUITY
C. STOCKHOLDERS' EQUITY	C. STOCKHOLDERS’ EQUITY Proceeds from the Sale of Common Stock 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, 2020 is as follows: Name of Plan Total Shares Reserved Under Plans Shares Reserved for Outstanding Options Shares Issued Remaining Options/Shares Under Plans Incentive Stock Options Plans 138,400 89,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,593,438 N/A 1,151,666 Stock Bonus Plans 783,760 N/A 341,951 441,776 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 616,500 23,500 Underlying share information for equity compensation plans as of September 30, 2019 is as follows: Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Option Plans 138,400 89,895 N/A 213 Non-Qualified Stock Option Plans 6,387,200 6,128,321 N/A 112,166 Stock Bonus Plans 783,760 N/A 331,226 452,501 Stock Compensation Plans 634,000 N/A 130,183 485,407 Incentive Stock Bonus Plan 640,000 N/A 616,500 23,500 Stock option activity Nine Months Ended June 30, 2020 2019 Granted 2,561,500 3,268,862 Exercised 94,199 42,770 Expired 1,000 29,322 Forfeited 1,180 63,698 Three Months Ended June 30, 2020 2019 Granted 2,559,000 3,268,362 Exercised 73,719 42,770 Expired 16 26,922 Forfeited - 39,505 During the quarter ended June 30, 2020, the Company adopted the 2020 Non-Qualified Stock Option Plan, which provides for the issuance of up to 3,600,000 options to purchase shares of common stock. On April 20, 2020, the Company granted 1,872,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers and directors. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $10.93 per share, the fair value on the date of issuance. The stock options vest upon the achievement of the following performance goals: i) 25% of the options will vest when the closing price of the Company’s common stock exceeds $20.00 for ten consecutive trading days; ii) 50% of the options will vest when the closing price of the Company’s common stock exceeds $25.00 for ten consecutive trading days; iii) 75% of the options will vest when the closing price of the Company’s common stock exceeds $30.00 for ten consecutive trading days; and iv) 100% of the options will vest when either (a) the filing of the first marketing application for any pharmaceutical based upon the Company’s Multikine technology, in the US, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia or (b) the closing price of the Company’s common stock exceeds $40.00 for ten consecutive trading days. All Options which have not vested as of April 19, 2030, will be canceled and will no longer be exercisable. The options were recorded as equity based warrants in accordance with ASC 718, Compensation – Stock Compensation. On the grant date, the options were valued using a Monte Carlo Simulation approach. Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. That valuation resulted in a per share fair value of $4.12 and an aggregate value of $7,881,120 on the grant date, April 20, 2020. The aggregate value will be expensed over the implicit life of the options, which was determined to be 1.7 years. This resulted in compensation expense of approximately $901,000 recorded during the nine and three months ended June 30, 2020. Stock-Based Compensation Expense Nine months Ended June 30, 2020 2019 Employees $ 6,690,331 $ 2,626,311 Non-employees $ 623,146 $ 688,070 Three months Ended June 30, 2020 2019 Employees $ 3,109,127 $ 1,521,821 Non-employees $ 275,919 $ 176,646 Employee compensation expense includes the expense related to options issued or vested and restricted stock granted. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of their service contracts. Warrants and Non-Employee Options The following chart represents the warrants and non-employee options outstanding at June 30, 2020: Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 2/18/2021 2 Series XX 6/11/2020 461,953 $ 18.00 9/10/2020 2 Series YY 6/26/2020 101,839 $ 20.00 9/25/2020 2 Series UU 6/11/2018 93,603 $ 2.80 12/31/2020 2 Series W 10/28/2015 688,930 $ 16.75 10/28/2020 1 Series X 1/13/2016 120,000 $ 9.25 1/13/2021 * Series Y 2/15/2016 26,000 $ 12.00 2/15/2021 * Series ZZ 5/23/2016 20,000 $ 13.75 5/18/2021 1 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 1 Series Z 5/23/2016 264,000 $ 13.75 11/23/2021 1 Series CC 12/8/2016 153,643 $ 5.00 12/8/2021 1 Series HH 2/23/2017 200 $ 3.13 2/16/2022 1 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 1 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 * Series NN 7/24/2017 375,545 $ 2.52 7/24/2022 2 Series OO 7/31/2017 - $ 2.52 7/31/2022 2 Series RR 10/30/2017 457,116 $ 1.65 10/30/2022 2 Series SS 12/19/2017 326,064 $ 2.09 12/18/2022 2 Series TT 2/5/2018 371,564 $ 2.24 2/5/2023 2 Series VV 7/2/2018 - $ 1.75 1/2/2024 2 Consultants 7/28/17 10,000 $ 2.18 7/27/2027 * * No current period changes to these warrants and non-employee options. 1. Warrant Liabilities The table below presents the fair value of the warrant liabilities at the balance sheet dates: June 30, 2020 September 30, 2019 Series V warrants $ - $ 674,442 Series W warrants 1,808,203 1,193,507 Series Z warrants 1,852,040 1,109,545 Series ZZ warrants 115,957 77,638 Series AA warrants 1,464,362 916,908 Series BB warrants 108,586 63,966 Series CC warrants 1,666,749 1,710,898 Series FF warrants - 446,185 Series HH warrants 2,435 45,657 Series JJ warrants - 66,599 Series LL warrants - 182,965 Total warrant liabilities $ 7,018,332 $ 6,488,310 The table below presents the gains/(losses) on the warrant liabilities for the nine months ended June 30: 2020 2019 Series S warrants $ - $ 33 Series V warrants 185,652 (479,399 ) Series W warrants (614,696 ) (1,132,156 ) Series Z warrants (742,495 ) (684,859 ) Series ZZ warrants (38,319 ) (37,970 ) Series AA warrants (547,454 ) (583,516 ) Series BB warrants (44,620 ) (35,800 ) Series CC warrants (1,245,627 ) (2,007,287 ) Series DD warrants - 1,249,287 Series EE warrants - 1,249,287 Series FF warrants (319,706 ) (244,170 ) Series GG warrants - 195,228 Series HH warrants (35,024 ) (22,859 ) Series II warrants - (593,960 ) Series JJ warrants (64,992 ) (32,954 ) Series KK warrants - (55,622 ) Series LL warrants (98,066 ) (99,667 ) Net loss on warrant liabilities $ (3,565,347 ) $ (3,316,384 ) The table below presents the gains/(losses) on the warrant liabilities for the three months ended June 30: 2020 2019 Series V warrants $ 107,191 $ (974,251 ) Series W warrants (247,327 ) (1,748,184 ) Series Z warrants (430,619 ) (799,690 ) Series ZZ warrants (33,734 ) (50,608 ) Series AA warrants (220,831 ) (676,784 ) Series BB warrants (37,592 ) (43,536 ) Series CC warrants (419,350 ) (2,346,985 ) Series FF warrants - (278,773 ) Series GG warrants - 88,478 Series HH warrants (567 ) (33,501 ) Series II warrants - (709,303 ) Series JJ warrants - (48,880 ) Series KK warrants - (169,089 ) Series LL warrants - (114,413 ) Net loss on warrant liabilities $ (1,282,829 ) $ (7,905,519 ) 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 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 was approximately $664,000, which was included within the net loss on derivatives for the nine and three months ended June 30, 2020. Additionally, upon the exercise of 674,164 Series V warrants the Company recognized a final mark-to-market adjustment for a gain of approximately $560,000, which was included within the net loss on derivatives for the nine and three months ended June 30, 2020. On June 25, 2020, 135,963 Series V warrants, with an exercise price of $13.75 expired. The warrants were valued at approximately $211,000 on the date of expiration. On December 10, 2018, 1,360,960 Series DD and 1,360,960 Series EE warrants, with an exercise price of $4.50 expired. On October 11, 2018, 327,729 Series S warrants, with an exercise price of $31.25 expired. Exercise of Warrant Liabilities The following warrants recorded as liabilities were exercised during the 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 The following warrants recorded as liabilities were exercised during the periods ended June 30, 2019. Three Months Nine Months Warrants Exercise Warrants Exercise Warrants Exercised Price Proceeds Exercised Price Proceeds Series CC 69,017 $ 5.00 $ 345,085 69,017 $ 5.00 $ 345,085 Series GG 200,000 $ 3.00 600,000 200,000 $ 3.00 600,000 Series HH 13,500 $ 3.13 42,188 13,500 $ 3.13 42,188 Series II 121,500 $ 3.00 364,500 121,500 $ 3.00 364,500 Series JJ 20,550 $ 3.13 64,219 20,550 $ 3.13 64,219 Series KK 213,870 $ 3.04 649,095 213,870 $ 3.04 649,095 638,437 $ 2,065,087 638,437 $ 2,065,087 2. Equity Warrants Changes in Equity Warrants 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 from June 11, 2020 to December 31, 2020. These warrants were previously issued as an inducement to convert notes payable into shares of common stock. The incremental cost of this extension was approximately $6,000 and was recorded as interest expense for the nine and three months ended June 30, 2020. The Series UU warrants are held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. On January 23, 2020, the expiration date of the Series N warrants was extended to February 18, 2021. The incremental cost of this extension was approximately $22,000, which was recorded as a deemed dividend in the financial statements for the nine and three months ended June 30, 2020. The Series N warrants are held by the de Clara Trust, of which Geert Kersten, is a beneficiary. Exercise of Equity Warrants 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 The following warrants recorded as equity were exercised during the periods ended June 30, 2019. Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series NN 65,502 $ 2.52 $ 165,065 65,502 $ 2.52 $ 165,065 Series PP - - - 60,000 $ 2.30 138,000 Series QQ 3,500 $ 2.50 8,750 3,500 $ 2.50 8,750 Series RR 60,044 $ 1.65 99,073 60,044 $ 1.65 99,073 Series SS 280,264 $ 2.09 585,752 446,054 $ 2.09 932,253 Series TT 450,069 $ 2.24 1,008,155 536,119 $ 2.24 1,200,907 Series UU 24,018 $ 2.80 67,250 24,018 $ 2.80 67,250 Series VV 2,425,000 $ 1.75 4,243,750 3,810,000 $ 1.75 6,667,500 Series WW 67,275 $ 1.63 109,321 193,050 $ 1.63 313,705 3,375,672 $ 6,287,116 5,198,287 $ 9,592,503 3. Options and Shares Issued to Consultants During the nine months ended June 30, 2020 and 2019, the Company issued 47,750 and 161,058 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $11.60 and $3.37, respectively, during the nine months ended June 30, 2020 and 2019, respectively. During the three months ended June 30, 2020 and 2019, the Company issued 14,811 and 20,825, respectively, shares of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $16.41 and $5.62, respectively, during the three months ended June 30, 2020 and 2019. 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 under the consulting arrangements. During the nine months ended June 30, 2020 and 2019, the Company recorded total expense of approximately $623,000 and $688,000, respectively, relating to these consulting agreements. During the three months ended June 30, 2020 and 2019, the Company recorded total expense of approximately $276,000 and $177,000, respectively, relating to these consulting agreements. At June 30, 2020 and September 30, 2019, approximately $242,000 and $230,000, respectively, are included in prepaid expenses. At June 30, 2020, the Company has accrued $110,000 for shares to be issued. As of June 30, 2020, 10,000 options issued to consultants remained outstanding, all of which were issued from the Non-Qualified Stock Option plans and are fully vested. 4. Securities Purchase Agreement The Company has entered into Securities Purchase Agreements (SPA) with Ergomed plc, one of the Company’s Clinical Research Organizations responsible for managing the Company’s Phase 3 clinical trial, to facilitate payment of amounts due Ergomed. Under the Agreements, the Company issued Ergomed shares of common stock and the net proceeds from the sales of those shares reduces outstanding amounts due Ergomed. Upon issuance, the Company expenses the full value of the shares as Other non-operating gain/loss and subsequently offsets the expense as amounts are realized through the sale by Ergomed and reduces accounts payable to Ergomed. On April 6, 2020 and June 29, 2020, the Company entered SPAs under which it issued Ergomed 100,000 and 50,000 restricted shares of the Company’s common stock valued at approximately $1.0 million and $0.8 million, respectively. On January 9, 2019, the Company entered into a SPA under which it issued Ergomed 500,000 restricted shares of the Company’s common stock valued at approximately $1.3 million. As of June 30, 2020, Ergomed held 110,521 shares for resale. The following table summarizes the Other non-operating gain (loss) for the nine and three months ended June 30, 2020 and 2019 relating to these agreements: Nine Months Ended Three Months Ended June 30,2020 June 30, 2019 June 30, 2020 June 30, 2019 Amount realized through the resale of shares $ 2,539,245 $ 3,167,197 $ 818,565 $ 1,455,844 Fair value of shares upon issuance 1,769,500 1,290,000 1,769,500 - Other non-operating gain (loss) $ 769,745 $ 1,877,197 $ (950,935 ) $ 1,455,844

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	9 Months Ended
	Jun. 30, 2020
FAIR VALUE MEASUREMENTS
D. FAIR VALUE MEASUREMENTS	D. FAIR VALUE MEASUREMENTS In accordance with ASC 820-10, “Fair Value Measurements,” ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows: · Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities · Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets · Level 3 – Unobservable inputs that reflect management’s assumptions For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of an input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels. The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at June 30, 2020: Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 7,018,332 $ 7,018,332 The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2019: Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 6,488,310 $ 6,488,310 The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the three months ended June 30, 2020 and the year ended September 30, 2019: Nine months ended Twelve months ended June 30, 2020 September 30, 2019 Beginning balance $ 6,488,310 $ 9,317,031 Issuances - - Exercises (3,035,325 ) (3,589,357 ) Realized and unrealized losses 3,565,347 760,636 Ending balance $ 7,018,332 $ 6,488,310 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
	Jun. 30, 2020
RELATED PARTY TRANSACTIONS
E. RELATED PARTY TRANSACTIONS	E. RELATED PARTY TRANSACTIONS During the nine months ended June 30, 2020, 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 May 8, 2020, the expiration date of 93,593 Series UU warrants were extended from June 11, 2020 to December 31, 2020. The incremental cost of this extension was approximately $6,000 and was recorded as interest expense for the nine and 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 and three months ended June 30, 2020. The Series N warrants are held by the de Clara Trust.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Jun. 30, 2020
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 $32.7 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $10.8 million. During the nine months ended June 30, 2020 and 2019, the Company recorded, net of Ergomed’s discount, approximately $1.3 million and $2.2 million, respectively, as research and development expense related to Ergomed’s services. Lease Agreements The Company determines whether a contract contains a lease at the inception of a contract by determining if the contract conveys the right to control the use of identified property, plant or equipment over a period of time in exchange for consideration. The Company leases certain real estate, machinery, equipment and office equipment for varying periods. Many of these leases include an option to either renew or terminate the lease. For purposes of calculating lease liabilities, these options are included in the lease term when it is reasonably certain that the Company will exercise such options. The incremental borrowing rate utilized to calculate the lease liabilities is based on the information available at commencement date, as most of the leases do not provide an implicit borrowing rate. Short-term leases, defined as leases with initial terms of 12 months or less, are not reflected on the balance sheet. Lease expense for such short-term leases is not material. For purposes of calculating lease liabilities, lease and non-lease components are combined. The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease, which expires in October 2028. Upon adoption of ASC 842 on October 1, 2019, the Company recorded a finance lease right of use asset and a finance lease liability of approximately $13.5 million. As of June 30, 2020, the net book value of the finance lease right of use asset is approximately $12.4 million and the balance of the finance lease liability is approximately $12.9 million, of which approximately $0.9 million is current. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. The finance right of use assets are being depreciated using a straight-line method over the underlying lease terms. Total cash paid related to finance leases during the nine months ended June 30, 2020 was approximately $1,414,000, of which approximately $873,000 was for interest. The weighted average discount rate of the Company’s finance leases is 8.8% and the weighted average time to maturity is 8.3 years. The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets at June 30, 2020 and September 30, 2019. Approximate future minimum lease payments under finance leases as of June 30, 2020 are as follows: Three months ending September 30, 2020 $ 473,000 Year ending September 30, 2021 1,953,000 2022 2,014,000 2023 2,083,000 2024 2,148,000 2025 2,218,000 Thereafter 7,322,000 Total future minimum lease obligation 18,211,000 Less imputed interest on finance lease obligations (5,316,000 ) Net present value of lease finance lease obligations $ 12,895,000 Effective April 30, 2020, the Company terminated a month-to-month arrangement with a sub-lessee as the sub-leased space is needed to prepare the facility to produce Multikine for commercial purposes and before the Company’s Biologics License Application (BLA) can be submitted to the FDA. The sublease rental income for the nine and three months ended June 30, 2020 was approximately $39,000 and $2,000, respectively The sublease rental income for the nine and three months ended June 30, 2019 was approximately $55,000 and $18,000, 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 expired on June 30, 2020. The office headquarter lease was renewed on July 1, 2020 and will expire on November 30, 2025. During the nine months ended June 30, 2020, the Company incurred approximately $80,000 in leasehold improvements costs for the research and development lab and is reasonably certain to renew the lease through February 28, 2027. The renewal period is included in the right of use asset and liability calculations. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the full 60-month terms of the leases. Upon adoption of ASC 842 on October 1, 2019, the Company recorded an operating lease right of use asset and an operating lease liability of approximately $1.0 million. As of June 30, 2020, the net book value of the operating lease right of use asset is approximately $1.2 million and the balance of the operating lease liability is approximately $1.3 million, of which approximately $0.1 million is current. The Company incurred lease expense under operating leases of approximately $202,000 and $67,000 for the nine and three months ended June 30, 2020, respectively. Total cash paid related to operating leases during the nine and three months ended June 30, 2020 was approximately $198,000 and $66,000, respectively. As of June 30, 2020, future minimum lease payments on operating leases are as follows: Three months ending September 30, 2020 $ 40,000 Year ending September 30, 2021 241,000 2022 264,000 2023 272,000 2024 280,000 2025 288,000 Thereafter 286,000 Total future minimum lease obligation 1,671,000 Less imputed interest on operating lease obligation (409,000 ) Net present value of operating lease obligation $ 1,262,000

PATENTS

PATENTS	9 Months Ended
	Jun. 30, 2020
PATENTS
G. PATENTS	G. PATENTS During the nine months ended June 30, 2020 and 2019, no patent impairment charges were recorded. For the nine months ended June 30, 2020 and 2019, amortization of patent costs totaled approximately $40,000 and $72,000, respectively. For the three months ended June 30, 2020 and 2019, amortization of patent costs totaled approximately $14,000 and $49,000, respectively. Approximate estimated future amortization expense is as follows: Three months ending September 30, 2020 $ 13,000 Year ending September 30, 2021 51,000 2022 47,000 2023 37,000 2024 29,000 2025 27,000 Thereafter 107,000 Total $ 311,000

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE	9 Months Ended
	Jun. 30, 2020
LOSS PER COMMON SHARE
H. LOSS PER COMMON SHARE	H. LOSS PER COMMON SHARE In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share 2020 2019 Options and Warrants 7,651,718 7,742,857 Unvested Restricted Stock 311,873 552,000 Total 7,963,591 8,294,857

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Jun. 30, 2020
SUBSEQUENT EVENTS
I. SUBSEQUENT EVENTS	J. SUBSEQUENT EVENTS The Company has evaluated subsequent events through the date these financial statements were filed and determined there are no subsequent events that require disclosure.

BASIS OF PRESENTATION AND SUM_2

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)	9 Months Ended
	Jun. 30, 2020
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Property Equipment	Property Equipment
Patents	Patents
Research and Development Costs	Research and Development Costs
Income Taxes	Income Taxes
Derivative Instruments	Derivative Instruments Accounting for Derivative Instruments and Hedging Activities
Stock-Based Compensation	Stock-Based Compensation Compensation – Stock 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 Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.
New Accounting Pronouncements	Newly Adopted Accounting Pronouncements Effective October 1, 2019, the Company adopted ASC 842. ASC 842 requires that lessees recognize right-of-use assets and lease liabilities that are measured at the present value of the future lease payments at the lease commencement date. Subsequent measurement, including the presentation of expenses and cash flows, depends on the classification of the lease as either a finance lease or an operating lease. The Company elected the optional transition method that allows for a cumulative-effect adjustment in the period of adoption and did not restate prior periods. The Company also elected the transition package of three practical expedients which eliminates the requirements to reassess prior conclusions about lease identification, lease classification and initial direct costs. Further, the Company elected a short-term lease exception policy permitting the option to not apply the recognition requirements of this standard to short-term leases (i.e., leases with terms of 12 months or less) and an accounting policy to account for lease and non-lease components as a single component. The Company’s lease portfolio includes both finance and operating leases. The impact of adopting ASC 842 was to increase long term assets by approximately $1.0 million, decrease total liabilities by approximately $0.9 million and record a cumulative effect adjustment of approximately $0.1 million to opening accumulated deficit. In June 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-07, Compensation—Stock Compensation (Topic 718 New Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework (Topic )” 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, 2020
STOCKHOLDERS EQUITY
Stock options, stock bonuses and compensation granted by the Company	Underlying share information for equity compensation plans as of June 30, 2020 is as follows: Name of Plan Total Shares Reserved Under Plans Shares Reserved for Outstanding Options Shares Issued Remaining Options/Shares Under Plans Incentive Stock Options Plans 138,400 89,895 N/A 213 Non-Qualified Stock Option Plans 9,987,200 8,593,438 N/A 1,151,666 Stock Bonus Plans 783,760 N/A 341,951 441,776 Stock Compensation Plans 634,000 N/A 150,695 464,895 Incentive Stock Bonus Plan 640,000 N/A 616,500 23,500 Underlying share information for equity compensation plans as of September 30, 2019 is as follows: Name of Plan Total Shares Reserved Shares Reserved for Outstanding Options Shares Remaining Options/Shares Under Plans Incentive Stock Option Plans 138,400 89,895 N/A 213 Non-Qualified Stock Option Plans 6,387,200 6,128,321 N/A 112,166 Stock Bonus Plans 783,760 N/A 331,226 452,501 Stock Compensation Plans 634,000 N/A 130,183 485,407 Incentive Stock Bonus Plan 640,000 N/A 616,500 23,500
Stock option activity	Nine Months Ended June 30, 2020 2019 Granted 2,561,500 3,268,862 Exercised 94,199 42,770 Expired 1,000 29,322 Forfeited 1,180 63,698 Three Months Ended June 30, 2020 2019 Granted 2,559,000 3,268,362 Exercised 73,719 42,770 Expired 16 26,922 Forfeited - 39,505
Stock-based compensation expense	Nine months Ended June 30, 2020 2019 Employees $ 6,690,331 $ 2,626,311 Non-employees $ 623,146 $ 688,070 Three months Ended June 30, 2020 2019 Employees $ 3,109,127 $ 1,521,821 Non-employees $ 275,919 $ 176,646
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 2/18/2021 2 Series XX 6/11/2020 461,953 $ 18.00 9/10/2020 2 Series YY 6/26/2020 101,839 $ 20.00 9/25/2020 2 Series UU 6/11/2018 93,603 $ 2.80 12/31/2020 2 Series W 10/28/2015 688,930 $ 16.75 10/28/2020 1 Series X 1/13/2016 120,000 $ 9.25 1/13/2021 * Series Y 2/15/2016 26,000 $ 12.00 2/15/2021 * Series ZZ 5/23/2016 20,000 $ 13.75 5/18/2021 1 Series BB 8/26/2016 16,000 $ 13.75 8/22/2021 1 Series Z 5/23/2016 264,000 $ 13.75 11/23/2021 1 Series CC 12/8/2016 153,643 $ 5.00 12/8/2021 1 Series HH 2/23/2017 200 $ 3.13 2/16/2022 1 Series AA 8/26/2016 200,000 $ 13.75 2/22/2022 1 Series MM 6/22/2017 893,491 $ 1.86 6/22/2022 * Series NN 7/24/2017 375,545 $ 2.52 7/24/2022 2 Series OO 7/31/2017 - $ 2.52 7/31/2022 2 Series RR 10/30/2017 457,116 $ 1.65 10/30/2022 2 Series SS 12/19/2017 326,064 $ 2.09 12/18/2022 2 Series TT 2/5/2018 371,564 $ 2.24 2/5/2023 2 Series VV 7/2/2018 - $ 1.75 1/2/2024 2 Consultants 7/28/17 10,000 $ 2.18 7/27/2027 *
Tabular disclosure of derivative liabilities at fair value	June 30, 2020 September 30, 2019 Series V warrants $ - $ 674,442 Series W warrants 1,808,203 1,193,507 Series Z warrants 1,852,040 1,109,545 Series ZZ warrants 115,957 77,638 Series AA warrants 1,464,362 916,908 Series BB warrants 108,586 63,966 Series CC warrants 1,666,749 1,710,898 Series FF warrants - 446,185 Series HH warrants 2,435 45,657 Series JJ warrants - 66,599 Series LL warrants - 182,965 Total warrant liabilities $ 7,018,332 $ 6,488,310
Schedule of gains and (losses) on derivative liabilities	The table below presents the gains/(losses) on the warrant liabilities for the nine months ended June 30: 2020 2019 Series S warrants $ - $ 33 Series V warrants 185,652 (479,399 ) Series W warrants (614,696 ) (1,132,156 ) Series Z warrants (742,495 ) (684,859 ) Series ZZ warrants (38,319 ) (37,970 ) Series AA warrants (547,454 ) (583,516 ) Series BB warrants (44,620 ) (35,800 ) Series CC warrants (1,245,627 ) (2,007,287 ) Series DD warrants - 1,249,287 Series EE warrants - 1,249,287 Series FF warrants (319,706 ) (244,170 ) Series GG warrants - 195,228 Series HH warrants (35,024 ) (22,859 ) Series II warrants - (593,960 ) Series JJ warrants (64,992 ) (32,954 ) Series KK warrants - (55,622 ) Series LL warrants (98,066 ) (99,667 ) Net loss on warrant liabilities $ (3,565,347 ) $ (3,316,384 ) The table below presents the gains/(losses) on the warrant liabilities for the three months ended June 30: 2020 2019 Series V warrants $ 107,191 $ (974,251 ) Series W warrants (247,327 ) (1,748,184 ) Series Z warrants (430,619 ) (799,690 ) Series ZZ warrants (33,734 ) (50,608 ) Series AA warrants (220,831 ) (676,784 ) Series BB warrants (37,592 ) (43,536 ) Series CC warrants (419,350 ) (2,346,985 ) Series FF warrants - (278,773 ) Series GG warrants - 88,478 Series HH warrants (567 ) (33,501 ) Series II warrants - (709,303 ) Series JJ warrants - (48,880 ) Series KK warrants - (169,089 ) Series LL warrants - (114,413 ) Net loss on warrant liabilities $ (1,282,829 ) $ (7,905,519 )
Warrants recorded as liabilities exercised	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 The following warrants recorded as liabilities were exercised during the periods ended June 30, 2019. Three Months Nine Months Warrants Exercise Warrants Exercise Warrants Exercised Price Proceeds Exercised Price Proceeds Series CC 69,017 $ 5.00 $ 345,085 69,017 $ 5.00 $ 345,085 Series GG 200,000 $ 3.00 600,000 200,000 $ 3.00 600,000 Series HH 13,500 $ 3.13 42,188 13,500 $ 3.13 42,188 Series II 121,500 $ 3.00 364,500 121,500 $ 3.00 364,500 Series JJ 20,550 $ 3.13 64,219 20,550 $ 3.13 64,219 Series KK 213,870 $ 3.04 649,095 213,870 $ 3.04 649,095 638,437 $ 2,065,087 638,437 $ 2,065,087
Warrants recorded as equity exercised	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 The following warrants recorded as equity were exercised during the periods ended June 30, 2019. Three Months Nine Months Warrants Warrants Exercised Exercise Price Proceeds Warrants Exercised Exercise Price Proceeds Series NN 65,502 $ 2.52 $ 165,065 65,502 $ 2.52 $ 165,065 Series PP - - - 60,000 $ 2.30 138,000 Series QQ 3,500 $ 2.50 8,750 3,500 $ 2.50 8,750 Series RR 60,044 $ 1.65 99,073 60,044 $ 1.65 99,073 Series SS 280,264 $ 2.09 585,752 446,054 $ 2.09 932,253 Series TT 450,069 $ 2.24 1,008,155 536,119 $ 2.24 1,200,907 Series UU 24,018 $ 2.80 67,250 24,018 $ 2.80 67,250 Series VV 2,425,000 $ 1.75 4,243,750 3,810,000 $ 1.75 6,667,500 Series WW 67,275 $ 1.63 109,321 193,050 $ 1.63 313,705 3,375,672 $ 6,287,116 5,198,287 $ 9,592,503
Other non-operating gains and (losses) on securities purchase agreements	Nine Months Ended Three Months Ended June 30,2020 June 30, 2019 June 30, 2020 June 30, 2019 Amount realized through the resale of shares $ 2,539,245 $ 3,167,197 $ 818,565 $ 1,455,844 Fair value of shares upon issuance 1,769,500 1,290,000 1,769,500 - Other non-operating gain (loss) $ 769,745 $ 1,877,197 $ (950,935 ) $ 1,455,844

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	9 Months Ended
	Jun. 30, 2020
FAIR VALUE MEASUREMENTS
Measured at fair value on a recurring basis	Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 7,018,332 $ 7,018,332 Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative instruments $ - $ - $ 6,488,310 $ 6,488,310
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, 2020 September 30, 2019 Beginning balance $ 6,488,310 $ 9,317,031 Issuances - - Exercises (3,035,325 ) (3,589,357 ) Realized and unrealized losses 3,565,347 760,636 Ending balance $ 7,018,332 $ 6,488,310

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Jun. 30, 2020
COMMITMENTS AND CONTINGENCIES
Schedule of future minimum payments under finance leases	Three months ending September 30, 2020 $ 473,000 Year ending September 30, 2021 1,953,000 2022 2,014,000 2023 2,083,000 2024 2,148,000 2025 2,218,000 Thereafter 7,322,000 Total future minimum lease obligation 18,211,000 Less imputed interest on finance lease obligations (5,316,000 ) Net present value of lease finance lease obligations $ 12,895,000
Schedule of future minimum payments under operating leases	Three months ending September 30, 2020 $ 40,000 Year ending September 30, 2021 241,000 2022 264,000 2023 272,000 2024 280,000 2025 288,000 Thereafter 286,000 Total future minimum lease obligation 1,671,000 Less imputed interest on operating lease obligation (409,000 ) Net present value of operating lease obligation $ 1,262,000

PATENTS (Tables)

PATENTS (Tables)	9 Months Ended
	Jun. 30, 2020
PATENTS
Schedule of total estimated future amortization	Three months ending September 30, 2020 $ 13,000 Year ending September 30, 2021 51,000 2022 47,000 2023 37,000 2024 29,000 2025 27,000 Thereafter 107,000 Total $ 311,000

LOSS PER COMMON SHARE (Tables)

LOSS PER COMMON SHARE (Tables)	9 Months Ended
	Jun. 30, 2020
LOSS PER COMMON SHARE
Schedule of antidilutive securities	2020 2019 Options and Warrants 7,651,718 7,742,857 Unvested Restricted Stock 311,873 552,000 Total 7,963,591 8,294,857

A BASIS OF PRESENTATION AND SUM

A BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) $ in Millions	9 Months Ended
	Jun. 30, 2020USD ($)
Decrease total liabilities	$ 0.9
Increase long term assets	1
Accumulated deficit	$ 0.1
Patents [Member]
Patent useful life	17 years

C STOCKHOLDERS EQUITY (Details)

C STOCKHOLDERS EQUITY (Details) - shares	Jun. 30, 2020	Sep. 30, 2019
Incentive Stock Option Plans [Member]
Shares reserved for outstanding options	89,895	89,895
Remaining options/shares under plans	213	213
Total shares reserved under plans	138,400	138,400
Non-Qualified Stock Option Plans [Member]
Shares reserved for outstanding options	8,593,438	6,128,321
Remaining options/shares under plans	1,151,666	112,166
Total shares reserved under plans	9,987,200	6,387,200
Stock Bonus Plans [Member]
Shares issued	341,951	331,226
Remaining options/shares under plans	441,776	452,501
Total shares reserved under plans	783,760	783,760
Stock Compensation Plan [Member]
Shares issued	150,695	130,183
Remaining options/shares under plans	464,895	485,407
Total shares reserved under plans	634,000	634,000
Incentive Stock Bonus Plan [Member]
Shares issued	616,500	616,500
Remaining options/shares under plans	23,500	23,500
Total shares reserved under plans	640,000	640,000

C STOCKHOLDERS EQUITY (Details

C STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
STOCKHOLDERS EQUITY
Options granted	2,559,000	3,268,362	2,561,500	3,268,862
Options exercised	73,719	42,770	94,199	42,770
Options expired	16	26,922	1,000	29,322
Options forfeited		39,505	1,180	63,698

C STOCKHOLDERS EQUITY (Detail_2

C STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
Employee [Member]
Stock based compensation expense	$ 3,109,127	$ 1,521,821	$ 6,690,331	$ 2,626,311
Non-Employees [Member]
Stock based compensation expense	$ 275,919	$ 176,646	$ 623,146	$ 688,070

C STOCKHOLDERS EQUITY (Detail_3

C STOCKHOLDERS EQUITY (Details 3)	9 Months Ended
	Jun. 30, 2020$ / sharesshares
Consultants [Meember]
Issue date	7/28/17
Shares issuable upon exercise of warrant | shares	10,000
Exercise price	$ 2.18
Expiration date	7/27/2027
Series YY [Member]
Issue date	6/26/2020
Shares issuable upon exercise of warrant | shares	101,839
Exercise price	$ 20
Expiration date	2/16/2022
Series N [Member]
Issue date	8/18/2008
Shares issuable upon exercise of warrant | shares	85,339
Exercise price	$ 3
Expiration date	2/18/2021
Series XX [Member]
Issue date	6/11/2020
Shares issuable upon exercise of warrant | shares	461,953
Exercise price	$ 18
Expiration date	9/10/2020
Series W [Member]
Issue date	10/28/2015
Shares issuable upon exercise of warrant | shares	688,930
Exercise price	$ 16.75
Expiration date	10/28/2020
Series Y [Member]
Issue date	2/15/2016
Shares issuable upon exercise of warrant | shares	26,000
Exercise price	$ 12
Expiration date	2/15/2021
Series X [Member]
Issue date	1/13/2016
Shares issuable upon exercise of warrant | shares	120,000
Exercise price	$ 9.25
Expiration date	12/31/2020
Series ZZ [Member]
Issue date	5/23/2016
Shares issuable upon exercise of warrant | shares	264,000
Exercise price	$ 13.75
Expiration date	5/18/2021
Series Z [Member]
Issue date	5/23/2016
Shares issuable upon exercise of warrant | shares	20,000
Exercise price	$ 13.75
Expiration date	11/23/2021
Series BB [Member]
Issue date	8/26/2016
Shares issuable upon exercise of warrant | shares	16,000
Exercise price	$ 13.75
Expiration date	8/22/2021
Series CC [Member]
Issue date	12/8/2016
Shares issuable upon exercise of warrant | shares	153,643
Exercise price	$ 5
Expiration date	12/8/2021
Series AA [Member]
Issue date	8/26/2016
Shares issuable upon exercise of warrant | shares	200,000
Exercise price	$ 13.75
Expiration date	2/22/2022
Series HH [Member]
Issue date	2/23/2017
Shares issuable upon exercise of warrant | shares	200
Exercise price	$ 3.13
Expiration date	1/13/2021
Series MM [Member]
Issue date	6/22/2017
Shares issuable upon exercise of warrant | shares	893,491
Exercise price	$ 1.86
Expiration date	6/22/2022
Series NN [Member]
Issue date	7/24/2017
Shares issuable upon exercise of warrant | shares	375,545
Exercise price	$ 2.52
Expiration date	7/24/2022
Series OO [Member]
Issue date	7/31/2017
Exercise price	$ 2.52
Expiration date	7/31/2022
Series RR [Member]
Issue date	10/30/2017
Shares issuable upon exercise of warrant | shares	457,116
Exercise price	$ 1.65
Expiration date	10/30/2022
Series SS [Member]
Issue date	12/19/2017
Shares issuable upon exercise of warrant | shares	326,064
Exercise price	$ 2.09
Expiration date	12/18/2022
Series TT [Member]
Issue date	2/5/2018
Shares issuable upon exercise of warrant | shares	371,564
Exercise price	$ 2.24
Expiration date	2/5/2023
Series UU [Member]
Issue date	6/11/2018
Shares issuable upon exercise of warrant | shares	93,603
Exercise price	$ 2.80
Expiration date	9/25/2020
Series VV [Member]
Issue date	7/2/2018
Exercise price	$ 1.75
Expiration date	1/2/2024

C STOCKHOLDERS EQUITY (Detail_4

C STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019	Sep. 30, 2019
STOCKHOLDERS EQUITY
Series V warrants	$ 0		$ 0		$ 674,442
Series W warrants	1,808,203		1,808,203		1,193,507
Series Z warrants	1,852,040		1,852,040		1,109,545
Series ZZ warrants	115,957		115,957		77,638
Series AA warrants	1,464,362		1,464,362		916,908
Series BB warrants	108,586		108,586		63,966
Series CC warrants	1,666,749		1,666,749		1,710,898
Series FF warrants	0		0		446,185
Series HH warrants	2,435		2,435		45,657
Series JJ warrants	0		0		66,599
Series LL warrants	0		0		182,965
Total warrant liabilities	7,018,332		7,018,332		$ 6,488,310
Gains (losses) on Series S warrants			0	$ 33
Gains (losses) on Series V warrants	107,191	$ (974,251)	185,652	(479,399)
Gains (losses) on Series W warrants	(247,327)	(1,748,184)	(614,696)	(1,132,156)
Gains (losses) on Series Z warrants	(430,619)	(799,690)	(742,495)	(684,859)
Gains (losses) on Series ZZ warrants	(33,734)	(50,608)	(38,319)	(37,970)
Gains (losses) on Series AA warrants	(220,831)	(676,784)	(547,454)	(583,516)
Gains (losses) on Series BB warrants	(37,592)	(43,536)	(44,620)	(35,800)
Gains (losses) on Series CC warrants	(419,350)	(2,346,985)	(1,245,627)	(2,007,287)
Gains (losses) on Series DD warrants			0	1,249,287
Gains (losses) on Series EE warrants			0	1,249,287
Gains (losses) on Series FF warrants	0	(278,773)	(319,706)	(244,170)
Gains (losses) on Series GG warrants	0	88,478	0	195,228
Gains (losses) on Series HH warrants	(567)	(33,501)	(35,024)	(22,859)
Gains (losses) on Series II warrants	0	(709,303)	0	(593,960)
Gains (losses) on Series JJ warrants	0	(48,880)	(64,992)	(32,954)
Gains (losses) on Series KK warrants	0	(169,089)	0	(55,622)
Gains (losses) on Series LL warrants	0	(114,413)	(98,066)	(99,667)
Net loss on warrant liabilities	$ (1,282,829)	$ (7,905,519)	$ (3,565,347)	$ (3,316,384)

C STOCKHOLDERS EQUITY (Detail_5

C STOCKHOLDERS EQUITY (Details 5) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
Warrants exercised	674,164	638,437	908,180	638,437
Proceeds	$ 9,269,755	$ 2,065,087	$ 10,298,752	$ 2,065,087
Series CC [Member]
Warrants exercised		69,017	123,820	69,017
Proceeds	$ 0	$ 345,085	$ 619,100	$ 345,085
Exercise price	$ 0	$ 5	$ 5	$ 5
Series HH [Member]
Warrants exercised		13,500	6,300	13,500
Proceeds	$ 0	$ 42,188	$ 19,687	$ 42,188
Exercise price	$ 0	$ 3.13	$ 3.13	$ 3.13
Series KK [Member]
Warrants exercised		213,870		213,870
Proceeds		$ 649,095		$ 649,095
Exercise price		$ 3.04		$ 3.04
Series II [Member]
Warrants exercised		121,500		121,500
Proceeds		$ 364,500		$ 364,500
Exercise price		$ 3		$ 3
Series GG [Member]
Warrants exercised		200,000		200,000
Proceeds		$ 600,000		$ 600,000
Exercise price		$ 3		$ 3
Series V [Member]
Warrants exercised	674,164		674,164
Proceeds	$ 9,269,755		$ 9,269,755
Exercise price	$ 13.75		$ 13.75
Series FF [Member]
Warrants exercised	0		68,048
Proceeds	$ 0		$ 265,812
Exercise price	$ 0		$ 3.91
Series JJ [Member]
Warrants exercised		20,550	9,450	20,550
Proceeds	$ 0	$ 64,219	$ 29,531	$ 64,219
Exercise price	$ 0	$ 3.13	$ 3.13	$ 3.13
Series LL [Member]
Warrants exercised			26,398
Proceeds	$ 0		$ 94,867
Exercise price	$ 0		$ 3.59

C STOCKHOLDERS EQUITY (Detail_6

C STOCKHOLDERS EQUITY (Details 6) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
Warrants exercised	175,681	3,375,672	636,665	5,198,287
Proceeds	$ 397,730	$ 6,287,116	$ 1,438,005	$ 9,592,503
Series NN [Member]
Warrants exercised	0	65,502	98,253	65,502
Proceeds	$ 0	$ 165,065	$ 247,598	$ 165,065
Exercise price	$ 0	$ 2.52	$ 2.52	$ 2.52
Series OO [Member]
Warrants exercised	10,000		50,000
Proceeds	$ 25,200		$ 126,000
Exercise price	$ 2.52		$ 2.52
Series RR [Member]
Warrants exercised		60,044		60,044
Proceeds		$ 99,073		$ 99,073
Exercise price		$ 1.65		$ 1.65
Series SS [Member]
Warrants exercised	39,474	280,264	156,580	446,054
Proceeds	$ 82,500	$ 585,752	$ 327,252	$ 932,253
Exercise price	$ 2.09	$ 2.09	$ 2.09	$ 2.09
Series TT [Member]
Warrants exercised	10,000	450,069	188,125	536,119
Proceeds	$ 22,400	$ 1,008,155	$ 421,400	$ 1,200,907
Exercise price	$ 2.24	$ 2.24	$ 2.24	$ 2.24
Series UU [Member]
Warrants exercised	61,207	24,018	61,207	24,018
Proceeds	$ 171,380	$ 67,250	$ 171,380	$ 67,250
Exercise price	$ 2.80	$ 2.80	$ 2.80	$ 2.80
Series VV [Member]
Warrants exercised	55,000	2,425,000	82,500	3,810,000
Proceeds	$ 96,250	$ 4,243,750	$ 144,375	$ 6,667,500
Exercise price	$ 1.75	$ 1.75	$ 1.75	$ 1.75
Series QQ [Member]
Warrants exercised		3,500		3,500
Proceeds		$ 8,750		$ 8,750
Exercise price		$ 2.50		$ 2.50
Series PP [Member]
Warrants exercised		0		60,000
Proceeds		$ 0		$ 138,000
Exercise price		$ 0		$ 2.30
Series WW [Member]
Warrants exercised		67,275
Proceeds		$ 109,321		$ 313,705
Exercise price		$ 1.63		$ 1.63

C STOCKHOLDERS EQUITY (Detail_7

C STOCKHOLDERS EQUITY (Details 7) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
STOCKHOLDERS EQUITY
Amount realized through the resale of shares	$ 818,565	$ 1,455,844	$ 2,539,245	$ 3,167,197
Fair value of shares upon issuance	1,769,500	0	1,769,500	1,290,000
Other non-operating gain (loss)	$ (950,935)	$ 1,455,844	$ 769,745	$ 1,877,197

C STOCKHOLDERS EQUITY (Detail_8

C STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	Dec. 10, 2018	Jun. 25, 2020	May 31, 2020	May 26, 2020	May 08, 2020	Apr. 30, 2020	Apr. 20, 2020	Mar. 31, 2020	Jan. 31, 2020	Jan. 23, 2020	Dec. 31, 2019	Oct. 10, 2018	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019	Jun. 29, 2020	Apr. 06, 2020	Sep. 30, 2019	Jan. 09, 2019
Prepaid expenses													$ 242,000		$ 242,000				$ 230,000
Total compensation expense													$ 901,000
Common stock shares issued								630,500			606,395		38,522,236		38,522,236				35,231,776
Public offering price per share								$ 12.22	$ 9.07		$ 9.07
Proceeds from public offering			$ 1,100,000					$ 7,100,000	$ 800,000		$ 5,000,000				$ 184,990	$ 234,997
Additional shares of common stock								94,575	90,959		90,959
Incremental cost													$ 664,000
Interest expense													6,000		6,000
Shares to be issued													$ 110,000		$ 110,000
Performance-based stock options granted													2,559,000	3,268,362	2,561,500	3,268,862
Common stock valued													$ 385,223		$ 385,223				$ 352,318
Fair value of warrant															$ 805,753	$ 0
Warrants expired													16	26,922	1,000	29,322
Series V Warrants [Member]
Common stock price per share		$ 13.75
Expiration date description				extended the expiration date of the Series V warrants from May 28, 2020 to June 25, 2020
Fair value of warrant		$ 211,000
Warrants expired		135,963		810,127
Warrants exercised				674,164
Loss on derivatives				$ 560,000
Series V Warrants [Member] | Maximum [Member]
Common stock price per share				$ 19.75
Series V Warrants [Member] | Minimum [Member]
Common stock price per share				$ 13.75
Series N Warrants [Member]
Incremental cost										$ 22,000
Expiration date description										expiration date of the Series N warrants was extended to February 18, 2021
Series UU warrants [Member]
Incremental cost													$ 6,000		$ 6,000
Expiration date description					extended from June 11, 2020 to December 31, 2020
Warrants issued					93,593
Series YY Warrants [Member]
Warrant issued													101,839		101,839
Fair value of warrant															$ 177,000
Series XX Warrants [Member]
Common stock price per share													$ 18		$ 18
Warrant issued													461,953		461,953
Fair value of warrant															$ 629,000
Series S Warrants [Member]
Common stock price per share												$ 31.25
Warrants expired												327,729
Series DD Warrants [Member]
Common stock price per share	$ 4.50
Warrants expired	1,360,960
Series EE Warrants [Member]
Common stock price per share	$ 4.50
Warrants expired	1,360,960
Consulting Agreements [Meember]
Total expense													$ 276,000	$ 177,000	$ 623,000	$ 688,000
Consultants [Meember]
Options issued															10,000
Consultants [Meember] | Restricted Stock [Member]
Common stock issued for service, shares													14,811	20,825	47,750	161,058
Weighted average grant date fair value													$ 16.41	$ 5.62	$ 11.60	$ 3.37
Ergomed [Member]
Common stock shares held													110,521		110,521
Ergomed [Member] | SPA [Member]
Restricted shares of common stock issued																	100,000	100,000		500,000
Common stock valued																	$ 800,000	$ 1,000,000		$ 1,300,000
Restricted shares																	500,000	50,000
2020 Non-Qualified Stock Option Plans [Member]
Common stock price per share													$ 10.93		$ 10.93
Aggregate fair value							$ 7,881,120
Fair value price per share							$ 4.12
Performance-based stock options granted						1,872,000
Purchase shares of common stock													3,600,000		3,600,000

D FAIR VALUE MEASUREMENTS (Deta

D FAIR VALUE MEASUREMENTS (Details) - USD ($)	Jun. 30, 2020	Sep. 30, 2019
Derivative instruments	$ 7,018,332	$ 6,488,310
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)
Derivative instruments	0	0
Significant Other Observable Inputs (Level 2)
Derivative instruments	0	0
Significant Unobservable Inputs (Level 3)
Derivative instruments	$ 7,018,332	$ 6,488,310

D FAIR VALUE MEASUREMENTS (De_2

D FAIR VALUE MEASUREMENTS (Details 1) - USD ($)	9 Months Ended	12 Months Ended
	Jun. 30, 2020	Sep. 30, 2019
FAIR VALUE MEASUREMENTS
Beginning balance	$ 6,488,310	$ 9,317,031
Issuances	0	0
Exercises	3,035,325	3,589,357
Realized and unrealized losses	3,565,347	760,636
Ending balance	$ 7,018,332	$ 6,488,310

E.RELATED PARTY TRANSACTIONS (D

E.RELATED PARTY TRANSACTIONS (Details Narrative ) - USD ($)	3 Months Ended	9 Months Ended
	Jun. 30, 2020	Jun. 30, 2020
Officer and Director [Member]
Restricted Common shares		20,512
Restricted Common shares, amount		$ 185,000
Series N Warrants [Member]
Deemed dividend	$ 22,000	22,000
Series UU Warrants [Member]
Interest expense	$ 6,000	$ 6,000

F COMMITMENTS AND CONTINGENCIES

F COMMITMENTS AND CONTINGENCIES (Details)	Jun. 30, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
Three months ending September 30, 2020	$ 473,000
2021	1,953,000
2022	2,014,000
2023	2,083,000
2024	2,148,000
2025	2,218,000
Thereafter	7,322,000
Total future minimum lease obligation	18,211,000
Less imputed interest on financing obligation	5,316,000
Net present value of lease financing obligation	$ 12,895,000

F COMMITMENTS AND CONTINGENCI_2

F COMMITMENTS AND CONTINGENCIES (Details 1)	Jun. 30, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
Three months ending September 30, 2020	$ 40,000
2021	241,000
2022	264,000
2023	272,000
2024	280,000
2025	288,000
Thereafter	286,000
Total future minimum lease obligation	1,671,000
Less imputed interest on operating lease obligation	409,000
Total	$ 1,262,000

F COMMITMENTS AND CONTINGENCI_3

F COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019	Sep. 30, 2019
Non current assets	$ 1.7		$ 1.7		$ 1.7
Clinical service trial			12,000,000
Cash paid related to finance leases			$ 1,414,000
Weighted average discount rate	88.00%		88.00%
Maturity years	8 years 3 months 18 days		8 years 3 months 18 days
Interest	$ 6,000		$ 6,000
Research and development expenses			1,300,000	$ 2,200,000
Finance lease right of use assets	12,367,947		12,367,947		0
Rental income	2,000	$ 18,000	39,000	$ 55,000
Operating lease right of use assets	1,237,339		1,237,339		$ 0
Book value of operating lease - liability	1,300,000		1,300,000
Operating lease expense	67,000		202,000
Cash paid related to operating leases	66,000		198,000
Finance lease liability	12,895,000		12,895,000
Finance Leases[Member]
Finance lease liability	$ 12,900,000		$ 12,900,000

G PATENTS (Details)

G PATENTS (Details)	Jun. 30, 2020USD ($)
PATENTS
Three months ending September 30, 2020	$ 13,000
2021	51,000
2022	47,000
2023	37,000
2024	29,000
2025	27,000
Thereafter	107,000
Total	$ 311,000

G PATENTS (Details Narrative)

G PATENTS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
PATENTS
Amortization of patent costs	$ 14,000	$ 49,000	$ 40,000	$ 72,000

H LOSS PER COMMON SHARE (Detail

H LOSS PER COMMON SHARE (Details ) - shares	9 Months Ended
	Jun. 30, 2020	Jun. 30, 2019
Antidilutive securities	7,963,591	8,294,857
Options and Warrants
Antidilutive securities	7,651,718	7,742,857
Unvested Restricted Stock
Antidilutive securities	311,873	552,000