10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended December 31, 2022

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______________ to ______________.

Commission File Number 001-11889

CEL-SCI CORPORATION

Colorado	84-0916344
State or other jurisdiction incorporation	(IRS) Employer Identification Number

8229 Boone Boulevard, Suite 802

Vienna, Virginia 22182

 Address of principal executive offices

(703) 506-9460

 Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common Stock	CVM	NYSE American

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) had been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated Filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Exchange Act Rule 12b-2 of the Exchange Act). Yes ☐     No ☒ 

Class of Stock	No. Shares Outstanding	Date
Common	43,738,865	February 10, 2023

TABLE OF CONTENTS

PART I FINANCIAL INFORMATION

Item 1.		Page
	Condensed Balance Sheets at December 31, 2022 (unaudited) and September 30, 2022	3
	Condensed Statements of Operations for the three months ended December 31, 2022 and 2021 (unaudited)	4
	Condensed Statement of Stockholders’ Equity for the three months ended December 31, 2022 and 2021 (unaudited)	5
	Condensed Statements of Cash Flows for the three months ended December 31, 2022 and 2021 (unaudited)	6
	Notes to Condensed Financial Statements (unaudited)	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures about Market Risks	21
Item 4.	Controls and Procedures	21
PART II
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	22
Item 6.	Exhibits	22
	Signatures	23

2

CEL-SCI CORPORATION

CONDENSED BALANCE SHEETS

	DECEMBER 31,			SEPTEMBER 30,
ASSETS	2022			2022
	(UNAUDITED)
Current assets:
Cash and cash equivalents	$	18,017,319		$	22,672,138
Prepaid expenses		538,291			762,063
Supplies used for R&D and manufacturing		1,848,720			2,001,715
Total current assets		20,404,330			25,435,916
Finance lease right of use assets		10,486,344			10,937,797
Operating lease right of use assets		1,839,418			1,884,464
Property and equipment, net		11,520,968			11,889,029
Patent costs, net		202,070			212,201
Supplies used for R&D and manufacturing		104,607			164,299
Total assets	$	44,557,737		$	50,523,706
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,599,812		$	1,618,290
Accrued expenses		800,838			842,492
Due to employees		550,575			471,488
Lease liabilities, current portion		1,790,716			1,731,481
Total current liabilities		4,741,941			4,663,751
Finance lease obligations, net of current portion		11,295,512			11,721,368
Operating lease obligations, net of current portion		1,803,663			1,850,380
Other liabilities		125,000			125,000
Total liabilities		17,966,116			18,360,499
Commitments and contingencies
STOCKHOLDERS’ EQUITY
Preferred stock, $.01 par value-200,000 shares authorized; -0- shares issued and outstanding		-			-
Common stock, $.01 par value - 600,000,000 shares authorized; 43,725,636 and 43,448,317 shares issued and outstanding at December 31, 2022 and September 30, 2022, respectively		437,256			434,484
Additional paid-in capital		488,904,967			486,625,816
Accumulated deficit		(462,750,602	)		(454,897,093	)
Total stockholders’ equity		26,591,621			32,163,207
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	44,557,737		$	50,523,706

See notes to condensed financial statements.

3

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

THREE MONTHS ENDED DECEMBER 31, 2022 and 2021

(UNAUDITED)

	2022			2021
Operating expenses:
Research and development	$	5,392,546		$	6,083,167
General and administrative		2,258,003			2,760,208
Total operating expenses		7,650,549			8,843,375
Operating loss		(7,650,549	)		(8,843,375	)
Other expense		(50,171	)		-
Gain on derivative instruments		-			364,596
Other non-operating gains		-			(30,793	)
Interest expense, net		(152,789	)		(273,034	)
Net loss		(7,853,509	)		(8,782,606	)
Modification of warrants		(171,552	)		-
Net loss available to common shareholders	$	(8,025,061	)	$	(8,782,606	)
Net loss per common share – basic	$	(0.18	)	$	(0.20	)
Weighted average common shares outstanding - basic		43,440,387			43,077,961
Net loss per common share - diluted	$	(0.18	)	$	(0.20	)
Weighted average common shares outstanding - diluted		44,440,387			43,083,420

See notes to condensed financial statements.

4

CEL-SCI CORPORATION

STATEMENTS OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

							Additional
	Common Stock						Paid-In			Accumulated
	Shares			Amount			Capital			Deficit			Total
BALANCES AT SEPTEMBER 30, 2022		43,448,317		$	434,484		$	486,625,816		$	(454,897,093	)	$	32,163,207
Warrant exercises		217,752			2,177			445,114			-			447,291
Equity based compensation - employees		-			-			1,703,931			-			1,703,931
401(k) contributions paid in common stock		21,331			213			49,965			-			50,178
Stock and options issued to nonemployees for service		40,236			402			91,221			-			91,623
2014 Incentive Stock Forfeited		(2,000	)		(20	)		(11,080	)					(11,100	)
Net loss		-			-			-			(7,853,509	)		(7,853,509	)
BALANCES AT DECEMBER 31, 2022		43,725,636		$	437,256		$	488,904,967		$	(462,750,602	)	$	26,591,621

					Additional
	Common Stock				Paid-In			Accumulated
	Shares		Amount		Capital			Deficit			Total
BALANCES AT SEPTEMBER 30, 2021		43,207,183	$	432,072	$	474,298,566		$	(418,196,412	)	$	56,534,226
Warrant exercises		19,705		197		157,757			-			157,954
Equity based compensation - employees		-		-		3,262,296			-			3,262,296
401(k) contributions paid in common stock		7,605		76		52,479			-			52,555
Stock and options issued to nonemployees for service		18,020		180		142,980			-			143,160
Option exercises		6,500		65		29,770			-			29,835
Share issuance costs		-		-		(45,965	)		-			(45,965	)
Net loss		-		-		-			(8,782,606	)		(8,782,606	)
BALANCES AT DECEMBER 31, 2021		43,259,013	$	432,590	$	477,897,883		$	(426,979,018	)	$	51,351,455

See notes to condensed financial statements.

5

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

THREE MONTHS ENDED DECEMBER 31, 2022 and 2021

(UNAUDITED)

	2022			2021
Net loss	$	(7,853,509	)	$	(8,782,606	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		988,543			887,930
Non-cash lease expense		5,078			24,997
Share-based payments for services		148,858			218,318
Equity-based compensation		1,692,831			3,262,296
Common stock contributed to 401(k) plan		50,178			52,555
Gain on short-term investments		-			(615	)
Loss on patent impairment		-			30,793
Gain on derivative instruments		-			(364,596	)
(Increase)/decrease in assets:
Prepaid expenses		111,537			144,542
Supplies used for R&D and manufacturing		212,687			(61,139	)
Increase/(decrease) in liabilities:
Accounts payable		(115,285	)		(523,152	)
Accrued expenses		13,346			95,685
Due to employees		79,087			209,046
Net cash used in operating activities		(4,666,649	)		(4,805,946	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from maturity of US treasury bills		-			6,152,000
Purchases of property and equipment		(53,580	)		(17,036	)
Expenditures for patent costs		-			(22,741	)
Net cash (used in) provided by investing activities		(53,580	)		6,112,223
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments of stock issuance costs		(9,010	)		(32,800	)
Proceeds from exercises of warrants and options		447,291			117,200
Payments on obligations under finance lease		(372,871	)		(340,908	)
Net cash provided by (used in) financing activities		65,410			(256,508	)
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS		(4,654,819	)		1,049,769
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD		22,672,138			36,060,148
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	18,017,319		$	37,109,917

See notes to condensed financial statements.

6

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

THREE MONTHS ENDED DECEMBER 31, 2022 and 2021

	2022		2021
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	$	105,318	$	469,005
Finance lease obligation included in accounts payable	$	1,853	$	771
Prepaid consulting services paid with issuance of common stock	$	91,623	$	233,753
Exercise of derivative liabilities	$	-	$	70,589
Financing costs included in current liabilities	$	-	$	13,165
Cash paid for interest	$	277,853	$	290,212

See notes to condensed financial statements.

7

CEL-SCI CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

THREE MONTHS ENDED DECEMBER 31, 2022 AND 2021 (UNAUDITED)

A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2022.

In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments necessary for a fair presentation of the Company’s financial position as of December 31, 2022 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2022 is derived from the September 30, 2022 audited financial statements.

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:

Cash and Cash Equivalents – Cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months to be cash and cash equivalents.

U.S. Treasury Bills – U.S. Treasury Bills (“T-bills”) are highly liquid short-term investments with maturity dates of greater than 3 months, but less than one year. These investments are recorded at fair value.

Property and Equipment – Property and equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. Property and equipment is reviewed on a quarterly basis to determine if any of the assets are impaired.

Supplies used for R&D and manufacturing – Supplies are consumable items kept on hand to support the Company’s R&D and manufacturing operations. Supplies are recorded at cost and are charged to expense as they are used in operations.

Patents - Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment to the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from disposition, are less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Leases – The Company accounts for contracts that convey the right to control the use of identified property, plant or equipment over a period of time in exchange for consideration as leases upon inception. The Company leases certain real estate, machinery, laboratory equipment and office equipment over varying periods. Many of these leases include an option to either renew or terminate the lease. For purposes of calculating lease liabilities, these options are included in the lease term when it is reasonably certain that the Company will exercise such options. The incremental borrowing rate utilized to calculate the lease liabilities is based on the information available at the commencement date, as most of the leases do not provide an implicit borrowing rate. Short-term leases, defined as leases with initial terms of 12 months or less, are not reflected on the balance sheet. Lease expense for such short-term leases is not material.

8

Derivative Instruments – The Company has financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, Accounting for Derivative Instruments and Hedging Activities. In accordance with ASC 815, derivative instruments and hybrid instruments are recognized as either assets or liabilities on the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models considering all the rights and obligations of each instrument. The derivative liabilities are re-measured at fair value at the end of each interim period.

The Company adopted Accounting Standards Update (ASU) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity effective October 1, 2021. The amendments in this Update simplify and clarify the guidance in Subtopic 815-40. There was no financial impact in the period of adoption.

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, Compensation – Stock Compensation. The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized using the straight-line allocation method as expense over the requisite service or vesting period.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. These Plans are collectively referred to as the “Plans”. All Plans have been approved by the Company’s stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. For options issued with service conditions only, the Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

Research and Development Costs - Research and development costs are expensed as incurred. Management accrues Clinical Research Organization (“CRO”) expenses and clinical trial study expenses based on services performed and relies on the CROs to provide estimates of those costs applicable to the completion stage of a study. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. The Company records revisions to estimated expense in the period in which the facts that give rise to the revision become known.

9

Net Loss Per Common Share – The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share (ASC 260). Basic and diluted net loss per common share was determined by dividing net loss applicable to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, unvested restricted stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

Income Taxes – The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized. A full valuation allowance was recorded against the deferred tax assets as of December 31, 2022 and September 30, 2022.

The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes effective October 1, 2021. The new standard includes several provisions that simplify accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and increasing consistency and clarity for the users of financial statements. The adoption of ASU 2019-12 had no impact on the Company’s financial statements.

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying disclosures. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Estimates are used in accounting for, among other items, inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, right of use assets and lease liabilities, deferred tax assets and the related valuation allowance, and the valuation of derivative liabilities. Actual results could differ from estimates, although management does not generally believe such differences would materially affect the financial statements in any given year. However, in regard to the valuation of derivative liabilities determined using the Black-Scholes option pricing model, significant fluctuations may materially affect the financial statements in a given year. Additionally, in calculating the right of use assets and lease liabilities, estimates and assumptions were used to determine the incremental borrowing rates and the expected lease terms. The Company considers the estimates used in valuing the derivative liabilities, stock options and the lease assets and liabilities to be significant.

New Accounting Pronouncements

The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

B. LIQUIDITY

The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge relating to the human immunological defense system, patent applications, research and development, administrative costs, construction and expansion of manufacturing and laboratory facilities and participation in clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company will be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to obtain approval from the U.S. Food and Drug Administration (FDA) 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 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.

10

To finance the Company through marketing approval, the Company plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until such time as it is able to raise the required funding.

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.

Impact of the 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.

C. STOCKHOLDERS’ EQUITY

Equity Compensation

Underlying share information for equity compensation plans as of December 31, 2022 is as follows:

Name of Plan	Total Shares Reserved Under Plans
Incentive Stock Option Plans		138,400
Non-Qualified Stock Option Plans		13,787,200
Stock Bonus Plans		783,760
Stock Compensation Plans		634,000
Incentive Stock Bonus Plan		640,000

 Stock option activity:

	Three Months Ended December 31,
	2022		2021
Options granted		2,500		251,000
Options exercised		-		6,500
Options forfeited		96,832		13,000
Options expired		45,400		-

11

During the quarter ended December 31, 2021, the Company granted 250,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $10.48 per share, the fair value on the date of issuance. The stock options will vest 100% upon approval of the first marketing application for any pharmaceutical based upon the Company’s Multikine technology in any of the USA, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia.  All options which have not vested as of November 18, 2031 will be canceled. On the grant date, the options were valued using a Monte Carlo Simulation approach. A Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. However, because attainment of the performance condition cannot be considered probable, no compensation cost was recognized relating to these options as of December 31, 2022.  Management will re-assess the probability of achieving the performance condition at each reporting date. 

Stock-Based Compensation Expense

	Three months Ended December 31,
	2022		2021
Employees	$	1,692,831	$	3,262,296
Non-employees	$	148,858	$	218,318

Employee compensation expense includes the expense related to options and restricted stock that is expensed over the vesting periods.  Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of the related service contracts.

Warrants and Non-Employee Options

The following chart represents the warrants and non-employee options outstanding at December 31, 2022:

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	8/18/2024	*
Series UU	6/11/2018		93,603	$	2.80	6/30/2024	*
Series X	1/13/2016		120,000	$	9.25	7/13/2024	*
Series Y	2/15/2016		26,000	$	12.00	8/15/2024	*
Series MM	6/22/2017		333,432	$	1.86	6/22/2024	*
Series NN	7/24/2017		200,087	$	2.52	7/24/2024	*
Series RR	10/30/2017		234,009	$	1.65	10/30/2024	2
Series SS	12/19/2017		-	$	2.09	12/18/2022	2
Series TT	2/5/2018		600	$	2.24	2/5/2023	*
Consultant Options	7/28/2017		10,000	$	2.18	7/27/2027	3

* No current period changes for these warrants

1. Derivative Liabilities

The table below presents the gains on the warrant liabilities for the three months ended December 31:

	2022		2021
Series Z warrants	$	-	$	64,787
Series AA warrants		-		274,635
Series CC warrants		-		24,372
Series HH warrants		-		802
Net gain on warrant liabilities	$	-	$	364,596

12

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

During the three months ended December 31, 2022, no warrant liabilities were outstanding.

During the three months ended December 31, 2021, 15,205 Series CC warrants were exercised at an exercise price of $5.00 for gross proceeds of $76,000.

On December 8, 2021, 640 Series CC warrants, with an exercise price of $5.00, expired. On November 23, 2021, 184,800 Series Z warrants, with an exercise price of $13.75, expired.

2. Equity Warrants

Changes in Equity Warrants

The following warrants recorded as equity were exercised during the three months ended December 31, 2022.

Warrants	Warrants Exercised		Exercise Price		Proceeds
Series RR		17,752	$	1.65	$	29,291
Series SS		200,000	$	2.09		418,000
		217,752			$	447,291

The following warrants recorded as equity were exercised during the three months ended December 31, 2021.

Warrants	Warrants Exercised		Exercise Price		Proceeds
Series NN		4,500	$	2.52	$	11,340
Series TT		10,000	$	2.24		22,400
		14,500			$	33,740

On October 28, 2022, the expiration date of the Series RR warrants was extended two years from October 30, 2022 to October 30, 2024.  The incremental cost of this extension was approximately $172,000, which was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2022. The Series RR 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.

3. Options and Shares Issued to Consultants

During the three months ended December 31, 2022 and 2021, the Company issued 40,236 and 18,020 shares of restricted common stock, respectively, to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $2.53 and $9.93 per share, respectively, during the three months ended December 31, 2022 and 2021.

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During the three months ended December 31, 2022, 5,000 options with an exercise price of $11.61 issued to a consultant expired.

As of December 31, 2022, 10,000 options issued to consultants remained outstanding, all of which were issued from the Non-Qualified Stock Option plans. All 10,000 options are vested as of December 31, 2022.

During the three months ended December 31, 2022 and 2021, the Company recorded total expense of approximately $149,000 and $218,000, respectively, relating to the share based compensation under these consulting agreements. At December 31, 2022 and September 30, 2022, approximately $183,000 and $295,000, respectively, are included in prepaid expenses and will be amortized over the remaining service periods.

D. FAIR VALUE MEASUREMENTS

In accordance with ASC 820-10, Fair Value Measurements, the Company determines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations with respect to those future amounts.

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. Assumptions from market participants are used when pricing the asset or liabilities, given there is no readily available market information.

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 U.S. Treasury bills during the year ended September 30, 2021. The Treasury bills matured in December 2021 and yielded a weighted average interest rate of 0.10%.

As of December 31, 2022 and September 30, 2022, the Company does not have any derivative instruments that are classified as Level 3 on the fair value hierarchy.  

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The following sets forth a reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3):

	3 months ended December 31, 2022		3 months ended December 31, 2021
Beginning balance		-	$	437,380
Issuances		-		-
Exercises		-		(70,589	)
Realized and unrealized (gains) and losses		-		(364,596	)
Ending balance	$	-	$	2,195

The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.  At December 31, 2022 and September 30, 2022, the Company did not have any Level 3 derivative instruments.

E. RELATED PARTY TRANSACTIONS

On October 28, 2022, the expiration dates of the Series RR warrants 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 were extended by two years. The incremental cost of these modifications was $172,552 and was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2022.

F. COMMITMENTS AND CONTINGENCIES

Clinical Research Agreement

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 $35.6 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.8 million. During the three months ended December 31, 2022 and 2021, the Company recorded, net of Ergomed’s discount, approximately $0.1 million and $0.2 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. The renewal options are not included in the calculation of the right of use asset and lease liability because exercise of those options is not reasonably certain.

On December 31, 2022 and September 30, 2022, the net book value of the finance lease right of use asset is approximately $10.5 million and $10.9 million, respectively and the balance of the finance lease liability is approximately $12.9 million and $13.3 million, respectively, of which approximately $1.6 million is current in each quarter. 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 the straight-line method over the underlying lease terms. Total cash paid related to finance leases during the three months ended December 31, 2022 and 2021 was approximately $0.6 million for both periods, of which approximately $0.3 million was for interest in each quarter. As of December 31, 2022, the weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 5.08 years.

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In August 2020, the Company entered into an amendment to the San Tomas lease 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 project was finished and the improvements were placed in service in October 2021. Total cost was $11.1 million, of which the landlord agreed to finance $2.4 million. The landlord financing is being repaid through increased lease payments which started in March 2021 and extend over the remaining lease term. The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the lease liability to account for the modified payments using a 8.45% implicit interest rate. The rate was determined using a synthetic credit rating analysis prepared by an outside valuation specialist. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability as it is realized. The entire $2.4 million was received from the landlord as of September 30, 2022. The leasehold improvements are recorded in property and equipment, were deemed to be placed in service in October 2021 and are being amortized over the remaining lease term.

The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. Under the landlord’s $2.4 million financing arrangement, the Company was required to deposit an additional $0.2 million in March 2021. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. During the quarter ended December 31, 2021, it was determined that the Company met the minimum cash requirement and the deposits were returned in January 2022.

Approximate future minimum lease payments under finance leases as of December 31, 2022 are as follows:

Nine months ending September 30, 2023	$	1,937,000
Year ending September 30,
2024		2,655,000
2025		2,741,000
2026		2,832,000
2027		2,923,000
2028		3,015,000
Thereafter		252,000
Total future minimum lease obligation		16,355,000
Less imputed interest on finance lease obligations		(3,446,000	)
Net present value of finance lease obligations	$	12,909,000

The Company leases two facilities under operating leases.  The lease for the Company’s office headquarters will expire on November 30, 2025.  The lease for its research and development laboratory was renewed in September 2021 for an additional ten years and will expire on February 29, 2032.  The renewal was considered a modification for accounting purposes and the right of use asset and liability were remeasured as of the date of the renewal.  This resulted in an increase of approximately $1.1 million to the operating lease right of use asset and liability. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the terms of the leases. As of December 31, 2022 and September 30, 2022, the net book value of the operating lease right of use assets is approximately $1.8 million and $1.9 million, respectively.  As of December 31, 2022 and September 30, 2022, the balance of the operating lease liabilities is approximately $2.0 million, of which approximately $0.2 million, is current in each quarter.  The Company incurred lease expense for operating leases of approximately $91,000 for both the three months ended December 31, 2022 and 2021. Total cash paid related to operating leases during the three months ended December 31, 2022 and 2021 was approximately $85,000 and $66,000, respectively. The weighted average discount rate of the Company’s operating leases is 9.10% and the weighted average time to maturity is 7.6 years.

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As of December 31, 2022, future minimum lease payments on operating leases are as follows:

Nine months ending September 30, 2023		262,000
Year ending September 30,
2024		357,000
2025		366,000
2026		287,000
2027		277,000
2028		285,000
Thereafter		1,040,000
Total future minimum lease obligation		2,874,000
Less imputed interest on operating lease obligation		(893,000	)
Net present value of operating lease obligation	$	1,981,000

G. PATENTS

During the three months ended December 31, 2022 and 2021, the Company recorded approximately $0 and $31,000 in patent impairment charges. During the three months ended December 31, 2022 and 2021, amortization of patent costs totaled approximately $10,000 and $14,000, respectively. Approximate estimated future amortization expense is as follows:

Nine months ending September 30, 2023	$	28,000
Year ending September 30,
2024		30,000
2025		28,000
2026		24,000
2027		21,000
2028		17,000
Thereafter		54,000
Total	$	202,000

H. LOSS PER COMMON SHARE

Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. For the periods presented, the gain on warrant liabilities is excluded from the numerator and the incremental shares, determined using the treasury stock method, are added to the denominator in calculating diluted loss per share.

The following tables provide the details of the basic and diluted loss per-share computations:

	Three months ended December 31,
	2022			2021
Loss per share – basic
Net loss available to common shareholders - basic	$	(8,025,061	)	$	(8,782,606	)
Weighted average shares outstanding - basic		43,440,387			43,077,961
Basic loss per common share	$	(0.18	)	$	(0.20	)
Loss per share – diluted
Net loss available to common shareholders - basic	$	(8,025,061	)	$	(8,782,606	)
Gain on derivatives (1)		-			(25,114	)
Net loss available to common shareholders - diluted	$	(8,025,061	)	$	(8,807,720	)
Weighted average shares outstanding - basic		43,440,387			43,077,961
Incremental shares underlying dilutive - warrants and options (1)		-			5,459
Weighted average shares outstanding – diluted		43,440,387			43,083,420
Diluted loss earnings per common share	$	(0.18	)	$	(0.20	)

(1) Includes Series CC and HH warrants for the three months ended December 31, 2021.

In accordance with the contingently issuable shares guidance of ASC Topic 260, Earnings Per Share, the calculation of diluted net earnings (loss) per share excludes the following securities because their inclusion would have been anti-dilutive as of December 31:

	2022		2021
Options and Warrants		13,917,352		10,477,966
Unvested Restricted Stock		149,250		151,250
Total		14,066,602		10,629,216

J. SUBSEQUENT EVENTS

On January 11, 2023, the Company was required to deposit approximately $2.3 million to its landlord, equivalent to one year’s rent, for falling below the stipulated cash threshold in accordance with the San Tomas lease. The amount will be included in current assets on the balance sheet until the Company meets the minimum cash balance required and the deposit is returned. 

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

The Company has completed 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 results have been posted on www.clinicaltrials.gov. The Phase 3 study results showed a long-term 5-year overall survival (OS) benefit in the treatment arm that received Multikine treatment followed by surgery and radiation. This survival benefit was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5 years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), control arm 48.6%, Multikine arm 62.7% survival.

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 based on pathology from surgery. This meant that there were 2 distinctly different 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.

The analysis of the separate treatment arms (radiation and chemoradiation) was prespecified in the protocol and carried out prior to the Company becoming unblinded. The OS benefit of 14.1% at 5 years for the surgery plus radiation 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, and advanced primary head and neck cancer represents an unmet medical need. The Company believes that these results for one treatment arm in the Phase 3 cancer study of Multikine are very meaningful and is working on the best way to bring Multikine to market in the United States and other countries.

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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 also owns and is developing a pre-clinical technology called LEAPS (Ligand Epitope Antigen Presentation System). The Company is using its LEAPS technology platform to investigate its lead peptide-based immunotherapy (CEL-4000) as a potential therapeutic vaccine treatment of rheumatoid arthritis.

All of the Company’s projects are under development. As a result, the Company cannot predict when it will be able to generate any revenue from the sale of any of its products.

Liquidity and Capital Resources

Since inception, the Company has financed its operations through the issuance of equity securities, convertible notes, loans and certain research grants. The Company will likely continue to generate net operating losses as it continues the development of Multikine and brings other drug candidates into clinical trials. Until such time as the Company becomes profitable, any or all of these financing vehicles or others may be utilized to assist the Company’s capital requirements.

Capital raised by the Company has been expended primarily for patent applications, research and development, administrative costs, and the construction and upgrade of the Company’s manufacturing and laboratory facilities. The Company does not anticipate realizing significant revenues until entering into licensing arrangements for its technology and know-how or until it receives regulatory approval to sell its products (which could take several years). Thus, the Company has been dependent upon the proceeds from the sale of its securities to meet all of the Company’s liquidity and capital requirements and anticipates having to do so in the future.

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. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations.

Since the Company launched its Phase 3 clinical trial for Multikine, the Company has incurred expenses of approximately $64.2 million as of December 31, 2022 on direct costs for the Phase 3 clinical trial and the filing of the clinical study report to the FDA. The Company estimates it will incur additional expenses of approximately $0.6 million for the remainder of the Phase 3 clinical trial and the filing of the clinical study report to the FDA. It should be noted that this estimate is based only on the information currently available from the CROs responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g., the manufacturing of the drug.

The Company uses two CROs to manage the global Phase 3 study; ICON and Ergomed, who are both international leaders in managing oncology trials.

Under a co-development agreement, Ergomed agreed to contribute up to $12 million towards the study where it will perform clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specified maximum amount. Approximately $11.8 million of the committed $12 million contribution has been realized as of December 31, 2022.

During the three months ended December 31, 2022, the Company’s cash decreased by approximately $4.7 million. The significant component of this decrease included cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.7 million.

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During the three months ended December 31, 2021, the Company used approximately $5.1 million in cash, before considering the maturity and transfer to cash of the remaining $6.2 million in U.S. Treasury bills. Significant components of this decrease includes cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.8 million and approximately $0.3 million in lease payments.

Prepaid expenses decreased by approximately $0.2 million, or 29%, at December 31, 2022 as compared to September 30, 2022 primarily due to a decrease in the amounts prepaid in stock compensation to non-employees.

During the three months ended December 31, 2022, 217,752 warrants were exercised at a weighted average exercise price of $2.05 for total proceeds of approximately $447,000. During the three months ended December 31, 2021, 19,705 warrants were exercised at a weighted average exercise price of $4.43 for total proceeds of approximately $87,000.

Results of Operations and Financial Condition

The Company incurred a net operating loss of approximately $7.7 million for the three months ended December 31, 2022. This net operating loss consists of significant non-cash expenses including approximately $1.7 million in stock-based employee compensation, approximately $1.0 million in depreciation and amortization expense and approximately $0.2 million in other non-cash expenses.

During the three months ended December 31, 2022, research and development expenses decreased by approximately $0.7 million, or 11%, compared to the three months ended December 31, 2021. Major components of this decrease include approximately $0.9 million in employee stock compensation expense and $0.4 million in costs related to the Phase 3 clinical study. These decreases are offset by increases in costs incurred to prepare for the potential commercial sale of Multikine of approximately $0.4 million and other research and development costs of approximately $0.2 million.

During the three months ended December 31, 2022, general and administrative expenses decreased by approximately $0.5 million, or 18%, compared to the three months ended December 31, 2021. A major component of the decrease is an approximate $0.7 million decrease in employee stock compensation costs, offset by an approximate $0.2 million increase in other general and administrative costs.

During the three months ended December 31, 2022 and 2021, the Company recorded derivative gains of approximately $0 million and $0.4 million, respectively. This variation was the result of the change in fair value of the derivative liabilities during the period which was caused by fluctuations in the share price of the Company’s common stock.

Net interest expense, which consists primarily of interest paid on lease liabilities, remained relatively constant at approximately $0.2 million and $0.3 million for the three months ended December 31, 2022 and December 31, 2021, respectively.

Research and Development Expenses

The Company’s research and development efforts involve Multikine and LEAPS. The table below shows the research and development expenses associated with each project.

	Three months ended December 31,
	2022		2021
MULTIKINE	$	5,294,377	$	5,791,419
LEAPS		98,169		291,748
TOTAL	$	5,392,546	$	6,083,167

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Clinical and other studies necessary to obtain regulatory approval of a new drug involve significant costs and require several years to complete. The extent of the Company’s clinical trials and research programs are primarily based upon the amount of capital available to the Company and the extent to which the Company has received regulatory approvals for clinical trials. The inability of the Company to conduct clinical trials or research, whether due to a lack of capital or regulatory approval, will prevent the Company from completing the studies and research required to obtain regulatory approval for any products which the Company is developing. Without regulatory approval, the Company will be unable to sell any of its products. Since all of the Company’s projects are under development, the Company cannot predict when it will be able to generate any revenue from the sale of any of its products.

Critical Accounting Estimates and Policies

Management’s discussion and analysis of the Company’s financial condition and results of operations is based on its unaudited condensed financial statements. The preparation of these financial statements is based on the selection of accounting policies and the application of significant accounting estimates, some of which require management to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and notes.

The Company believes some of the more critical estimates and policies that affect its financial condition and results of operations are in the areas of leases and stock-based compensation.

The measurement of the finance and operating lease right-of-use asset and lease liabilities requires the determination of an estimated lease term and an incremental borrowing rate, which involves complex judgment by management. Significant judgment is required by management to develop inputs and assumptions used to determine the incremental borrowing rate for lease contracts.  Share-based compensation cost to employees is measured at fair value as of the grant date in accordance with the provisions of ASC 718. The fair value of the stock options is calculated using the Black-Scholes option pricing model which requires various judgmental assumptions including volatility and expected option life. The compensation cost is recognized as expense over the requisite service or vesting period.  Performance-based options are valued using a Monte-Carlo simulation model, which requires inputs based on estimates, including the likelihood of the occurrence of performance and market conditions, volatility and expected option life.

For more information regarding the Company’s critical accounting estimates and policies, see Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended September 30, 2022. The application of these critical accounting policies and estimates has been discussed with the Audit Committee of the Company’s Board of Directors.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

The Company does not believe that it has any significant exposure to market risk.

Item 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Under the direction and with the participation of the Company’s management, including the Company’s Chief Executive and Chief Financial Officer, the Company carried out an evaluation of the effectiveness of the design and operation of its disclosure controls and procedures as of December 31, 2022. The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in its periodic reports with the Securities and Exchange Commission is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and regulations, and that such information is accumulated and communicated to the Company’s management, including its principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. The Company’s disclosure controls and procedures are designed to provide a reasonable level of assurance of reaching its desired disclosure control objectives.

The Company’s Chief Executive and Chief Financial Officer has concluded that the Company’s disclosure controls and procedures were not effective as of December 31, 2022 due to the material weaknesses described in the Company’s Annual Report on Form 10-K for the year ended September 30, 2022.

Changes in Internal Control over Financial Reporting

There were no changes in the Company’s internal control over financial reporting that occurred during the three months ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

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PART II

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

During the three months ended December 31, 2022, the Company issued 40,236 restricted shares of common stock to consultants for investor relations services.

The Company relied upon the exemption provided by Section 4(a)(2) of the Securities Act of 1933 with respect to the issuance of these shares. The individuals who acquired these shares were sophisticated investors and were provided full information regarding the Company’s business and operations. There was no general solicitation in connection with the offer or sale of these securities. The individuals who acquired these shares acquired them for their own accounts. The certificates representing these shares bear a restricted legend which provides they cannot be sold except pursuant to an effective registration statement or an exemption from registration. No commission or other form of remuneration was given to any person in connection with the issuance of these shares.

Item 6. Exhibits

Number	Exhibit
31	Rule 13a-14(a) Certifications
32	Section 1350 Certifications

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	CEL-SCI CORPORATION
Date: February 14, 2023	By:	/s/  Geert Kersten
		Geert Kersten
		Principal Executive Officer*

* Also signing in the capacity of the Principal Accounting and Financial Officer.

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EX-31

EXHIBIT 31

CERTIFICATIONS

I, Geert Kersten, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of CEL-SCI Corporation;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, considering the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects, the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15 and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	a)	designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b)	designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	c)	evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
	d)	disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
	a)	all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	b)	any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

February 14, 2023	By:	/s/ Geert Kersten
		Geert Kersten
		Principal Executive Officer

CERTIFICATIONS

I, Geert Kersten, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of CEL-SCI Corporation;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, considering the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15 and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	a)	designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b)	designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	c)	evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
	d)	disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
	a)	all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	b)	any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

February 14, 2023	By:	/s/ Geert Kersten
		Geert Kersten
		Principal Financial Officer

EX-32

EXHIBIT 32

In connection with the Quarterly Report of CEL-SCI Corporation (the “Company”) on Form 10-Q for the period ending December 31, 2022 as filed with the Securities and Exchange Commission (the “Report”), Geert Kersten, the Principal Executive and Principal Financial Officer of the Company, certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

(1)	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and results of the Company.

 

	By:	/s/ Geert Kersten
		Geert Kersten
		Principal Executive and
		Principal Financial Officer
February 14, 2023

XML

Cover - shares	3 Months Ended
	Dec. 31, 2022	Feb. 10, 2023
Cover [Abstract]
Entity Registrant Name	CEL-SCI CORPORATION
Entity Central Index Key	0000725363
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--09-30
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Dec. 31, 2022
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2023
Entity Common Stock Shares Outstanding		43,738,865
Entity File Number	001-11889
Entity Incorporation State Country Code	CO
Entity Tax Identification Number	84-0916344
Entity Interactive Data Current	Yes
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 Address Address Line 1	8229 Boone Boulevard
Document Quarterly Report	true
Document Transition Report	false

XML

CONDENSED BALANCE SHEETS - USD ($)	Dec. 31, 2022	Sep. 30, 2022
Current assets:
Cash and cash equivalents	$ 18,017,319	$ 22,672,138
Prepaid expenses	538,291	762,063
Supplies used for R&D and manufacturing	1,848,720	2,001,715
Total current assets	20,404,330	25,435,916
Finance lease right of use assets	10,486,344	10,937,797
Operating lease right of use assets	1,839,418	1,884,464
Property and equipment, net	11,520,968	11,889,029
Patent costs, net	202,070	212,201
Supplies used for R&D and manufacturing	104,607	164,299
Total assets	44,557,737	50,523,706
Current liabilities:
Accounts payable	1,599,812	1,618,290
Accrued expenses	800,838	842,492
Due to employees	550,575	471,488
Lease liabilities, current portion	1,790,716	1,731,481
Total current liabilities	4,741,941	4,663,751
Finance lease obligations, net of current portion	11,295,512	11,721,368
Operating lease obligations, net of current portion	1,803,663	1,850,380
Other liabilities	125,000	125,000
Total liabilities	17,966,116	18,360,499
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; 43,725,636 and 43,448,317 shares issued and outstanding at December 31, 2022 and September 30, 2022, respectively	437,256	434,484
Additional paid-in capital	488,904,967	486,625,816
Accumulated deficit	(462,750,602)	(454,897,093)
Total stockholders' equity	26,591,621	32,163,207
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 44,557,737	$ 50,523,706

XML

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2022	Sep. 30, 2022
CONDENSED BALANCE SHEETS
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	600,000,000	600,000,000
Common stock, shares issued	43,725,636	43,448,317
Common stock, shares outstanding	43,725,636	43,448,317
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

XML

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating expenses:
Research and development	$ 5,392,546	$ 6,083,167
General and administrative	2,258,003	2,760,208
Total operating expenses	7,650,549	8,843,375
Operating loss	(7,650,549)	(8,843,375)
Other expense	(50,171)	0
Gain on derivative instruments	0	364,596
Other non-operating gains	0	(30,793)
Interest expense, net	(152,789)	(273,034)
Net loss	(7,853,509)	(8,782,606)
Modification of warrants	(171,552)	0
Net loss available to common shareholders	$ (8,025,061)	$ (8,782,606)
Net loss per common share - basic	$ (0.18)	$ (0.20)
Weighted average common shares outstanding - basic	43,440,387	43,077,961
Net loss per common share - diluted	$ (0.18)	$ (0.20)
Weighted average common shares outstanding - diluted	44,440,387	43,083,420

XML

STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Sep. 30, 2021		43,207,183
Balance, amount at Sep. 30, 2021	$ 56,534,226	$ 432,072	$ 474,298,566	$ (418,196,412)
Warrant exercises, shares		19,705
Warrant exercises, amount	157,954	$ 197	157,757	0
Equity based compensation - employees	3,262,296	$ 0	3,262,296	0
401(k) contributions paid in common stock, shares		7,605
401(k) contributions paid in common stock, amount	52,555	$ 76	52,479	0
Stock and options issued to nonemployees for service, shares		18,020
Stock and options issued to nonemployees for service, amount	$ 143,160	$ 180	142,980	0
Option exercises, shares	6,500	6,500
Option exercises, amount	$ 29,835	$ 65	29,770	0
Share issuance costs	(45,965)	0	(45,965)	0
Net loss	(8,782,606)	$ 0	0	(8,782,606)
Balance, shares at Dec. 31, 2021		43,259,013
Balance, amount at Dec. 31, 2021	51,351,455	$ 432,590	477,897,883	(426,979,018)
Balance, shares at Sep. 30, 2022		43,448,317
Balance, amount at Sep. 30, 2022	32,163,207	$ 434,484	486,625,816	(454,897,093)
Warrant exercises, shares		217,752
Warrant exercises, amount	447,291	$ 2,177	445,114	0
Equity based compensation - employees	1,703,931	$ 0	1,703,931	0
401(k) contributions paid in common stock, shares		21,331
401(k) contributions paid in common stock, amount	50,178	$ 213	49,965	0
Stock and options issued to nonemployees for service, shares		40,236
Stock and options issued to nonemployees for service, amount	91,623	$ 402	91,221	0
Net loss	(7,853,509)	$ 0	0	(7,853,509)
2014 Incentive Stock Forfeited, shares		(2,000)
Incentive Stock Forfeited, amount	(11,100)	$ (20)	(11,080)
Balance, shares at Dec. 31, 2022		43,725,636
Balance, amount at Dec. 31, 2022	$ 26,591,621	$ 437,256	$ 488,904,967	$ (462,750,602)

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CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
Net loss	$ (7,853,509)	$ (8,782,606)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	988,543	887,930
Non-cash lease expense	5,078	24,997
Share-based payments for services	148,858	218,318
Equity-based compensation	1,692,831	3,262,296
Common stock contributed to 401(k) plan	50,178	52,555
Gain on short-term investments	0	(615)
Loss on patent impairment	0	30,793
Gain on derivative instruments	0	(364,596)
(Increase)/decrease in assets:
Prepaid expenses	111,537	144,542
Supplies used for R&D and manufacturing	212,687	(61,139)
Increase/(decrease) in liabilities:
Accounts payable	(115,285)	(523,152)
Accrued expenses	13,346	95,685
Due to employees	79,087	209,046
Net cash used in operating activities	(4,666,649)	(4,805,946)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from maturity of US treasury bills	0	6,152,000
Purchases of property and equipment	(53,580)	(17,036)
Expenditures for patent costs	0	(22,741)
Net cash (used in) provided by investing activities	(53,580)	6,112,223
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments of stock issuance costs	(9,010)	(32,800)
Proceeds from exercises of warrants and options	447,291	117,200
Payments on obligations under finance lease	(372,871)	(340,908)
Net cash provided by (used in) financing activities	65,410	(256,508)
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(4,654,819)	1,049,769
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	22,672,138	36,060,148
CASH AND CASH EQUIVALENTS, END OF PERIOD	18,017,319	37,109,917
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Property and equipment included in current liabilities	105,318	469,005
Finance lease obligation included in accounts payable	1,853	771
Prepaid consulting services paid with issuance of common stock	91,623	233,753
Exercise of derivative liabilities	0	70,589
Financing costs included in current liabilities	0	13,165
Cash paid for interest	$ 277,853	$ 290,212

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BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Dec. 31, 2022

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2022.

In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments necessary for a fair presentation of the Company’s financial position as of December 31, 2022 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2022 is derived from the September 30, 2022 audited financial statements.

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:

Cash and Cash Equivalents – Cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months to be cash and cash equivalents.

U.S. Treasury Bills – U.S. Treasury Bills (“T-bills”) are highly liquid short-term investments with maturity dates of greater than 3 months, but less than one year. These investments are recorded at fair value.

Property and Equipment – Property and equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. Property and equipment is reviewed on a quarterly basis to determine if any of the assets are impaired.

Supplies used for R&D and manufacturing – Supplies are consumable items kept on hand to support the Company’s R&D and manufacturing operations. Supplies are recorded at cost and are charged to expense as they are used in operations.

Patents - Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment to the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from disposition, are less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Leases – The Company accounts for contracts that convey the right to control the use of identified property, plant or equipment over a period of time in exchange for consideration as leases upon inception. The Company leases certain real estate, machinery, laboratory equipment and office equipment over varying periods. Many of these leases include an option to either renew or terminate the lease. For purposes of calculating lease liabilities, these options are included in the lease term when it is reasonably certain that the Company will exercise such options. The incremental borrowing rate utilized to calculate the lease liabilities is based on the information available at the commencement date, as most of the leases do not provide an implicit borrowing rate. Short-term leases, defined as leases with initial terms of 12 months or less, are not reflected on the balance sheet. Lease expense for such short-term leases is not material.

Derivative Instruments – The Company has financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, Accounting for Derivative Instruments and Hedging Activities. In accordance with ASC 815, derivative instruments and hybrid instruments are recognized as either assets or liabilities on the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models considering all the rights and obligations of each instrument. The derivative liabilities are re-measured at fair value at the end of each interim period.

The Company adopted Accounting Standards Update (ASU) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity effective October 1, 2021. The amendments in this Update simplify and clarify the guidance in Subtopic 815-40. There was no financial impact in the period of adoption.

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, Compensation – Stock Compensation. The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized using the straight-line allocation method as expense over the requisite service or vesting period.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. These Plans are collectively referred to as the “Plans”. All Plans have been approved by the Company’s stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. For options issued with service conditions only, the Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

Research and Development Costs - Research and development costs are expensed as incurred. Management accrues Clinical Research Organization (“CRO”) expenses and clinical trial study expenses based on services performed and relies on the CROs to provide estimates of those costs applicable to the completion stage of a study. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. The Company records revisions to estimated expense in the period in which the facts that give rise to the revision become known.

Net Loss Per Common Share – The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share (ASC 260). Basic and diluted net loss per common share was determined by dividing net loss applicable to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, unvested restricted stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

Income Taxes – The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized. A full valuation allowance was recorded against the deferred tax assets as of December 31, 2022 and September 30, 2022.

The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes effective October 1, 2021. The new standard includes several provisions that simplify accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and increasing consistency and clarity for the users of financial statements. The adoption of ASU 2019-12 had no impact on the Company’s financial statements.

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying disclosures. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Estimates are used in accounting for, among other items, inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, right of use assets and lease liabilities, deferred tax assets and the related valuation allowance, and the valuation of derivative liabilities. Actual results could differ from estimates, although management does not generally believe such differences would materially affect the financial statements in any given year. However, in regard to the valuation of derivative liabilities determined using the Black-Scholes option pricing model, significant fluctuations may materially affect the financial statements in a given year. Additionally, in calculating the right of use assets and lease liabilities, estimates and assumptions were used to determine the incremental borrowing rates and the expected lease terms. The Company considers the estimates used in valuing the derivative liabilities, stock options and the lease assets and liabilities to be significant.

New Accounting Pronouncements

The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

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LIQUIDITY

3 Months Ended

Dec. 31, 2022

LIQUIDITY

LIQUIDITY

B. LIQUIDITY

The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge relating to the human immunological defense system, patent applications, research and development, administrative costs, construction and expansion of manufacturing and laboratory facilities and participation in clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company will be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to obtain approval from the U.S. Food and Drug Administration (FDA) 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 funded operations in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations.

To finance the Company through marketing approval, the Company plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until such time as it is able to raise the required funding.

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.

Impact of the 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.

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STOCKHOLDERS EQUITY

3 Months Ended

Dec. 31, 2022

STOCKHOLDERS EQUITY

STOCKHOLDERS' EQUITY

C. STOCKHOLDERS’ EQUITY

Equity Compensation

Underlying share information for equity compensation plans as of December 31, 2022 is as follows:

Name of Plan	Total Shares Reserved Under Plans
Incentive Stock Option Plans		138,400
Non-Qualified Stock Option Plans		13,787,200
Stock Bonus Plans		783,760
Stock Compensation Plans		634,000
Incentive Stock Bonus Plan		640,000

 Stock option activity:

	Three Months Ended December 31,
	2022		2021
Options granted		2,500		251,000
Options exercised		-		6,500
Options forfeited		96,832		13,000
Options expired		45,400		-

During the quarter ended December 31, 2021, the Company granted 250,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $10.48 per share, the fair value on the date of issuance. The stock options will vest 100% upon approval of the first marketing application for any pharmaceutical based upon the Company’s Multikine technology in any of the USA, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia.  All options which have not vested as of November 18, 2031 will be canceled. On the grant date, the options were valued using a Monte Carlo Simulation approach. A Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. However, because attainment of the performance condition cannot be considered probable, no compensation cost was recognized relating to these options as of December 31, 2022.  Management will re-assess the probability of achieving the performance condition at each reporting date. 

Stock-Based Compensation Expense

	Three months Ended December 31,
	2022		2021
Employees	$	1,692,831	$	3,262,296
Non-employees	$	148,858	$	218,318

Employee compensation expense includes the expense related to options and restricted stock that is expensed over the vesting periods.  Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of the related service contracts.

Warrants and Non-Employee Options

The following chart represents the warrants and non-employee options outstanding at December 31, 2022:

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	8/18/2024	*
Series UU	6/11/2018		93,603	$	2.80	6/30/2024	*
Series X	1/13/2016		120,000	$	9.25	7/13/2024	*
Series Y	2/15/2016		26,000	$	12.00	8/15/2024	*
Series MM	6/22/2017		333,432	$	1.86	6/22/2024	*
Series NN	7/24/2017		200,087	$	2.52	7/24/2024	*
Series RR	10/30/2017		234,009	$	1.65	10/30/2024	2
Series SS	12/19/2017		-	$	2.09	12/18/2022	2
Series TT	2/5/2018		600	$	2.24	2/5/2023	*
Consultant Options	7/28/2017		10,000	$	2.18	7/27/2027	3

* No current period changes for these warrants

1. Derivative Liabilities

The table below presents the gains on the warrant liabilities for the three months ended December 31:

	2022		2021
Series Z warrants	$	-	$	64,787
Series AA warrants		-		274,635
Series CC warrants		-		24,372
Series HH warrants		-		802
Net gain on warrant liabilities	$	-	$	364,596

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

During the three months ended December 31, 2022, no warrant liabilities were outstanding.

During the three months ended December 31, 2021, 15,205 Series CC warrants were exercised at an exercise price of $5.00 for gross proceeds of $76,000.

On December 8, 2021, 640 Series CC warrants, with an exercise price of $5.00, expired. On November 23, 2021, 184,800 Series Z warrants, with an exercise price of $13.75, expired.

2. Equity Warrants

Changes in Equity Warrants

The following warrants recorded as equity were exercised during the three months ended December 31, 2022.

Warrants	Warrants Exercised		Exercise Price		Proceeds
Series RR		17,752	$	1.65	$	29,291
Series SS		200,000	$	2.09		418,000
		217,752			$	447,291

The following warrants recorded as equity were exercised during the three months ended December 31, 2021.

Warrants	Warrants Exercised		Exercise Price		Proceeds
Series NN		4,500	$	2.52	$	11,340
Series TT		10,000	$	2.24		22,400
		14,500			$	33,740

On October 28, 2022, the expiration date of the Series RR warrants was extended two years from October 30, 2022 to October 30, 2024.  The incremental cost of this extension was approximately $172,000, which was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2022. The Series RR 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.

3. Options and Shares Issued to Consultants

During the three months ended December 31, 2022 and 2021, the Company issued 40,236 and 18,020 shares of restricted common stock, respectively, to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $2.53 and $9.93 per share, respectively, during the three months ended December 31, 2022 and 2021.

During the three months ended December 31, 2022, 5,000 options with an exercise price of $11.61 issued to a consultant expired.

As of December 31, 2022, 10,000 options issued to consultants remained outstanding, all of which were issued from the Non-Qualified Stock Option plans. All 10,000 options are vested as of December 31, 2022.

During the three months ended December 31, 2022 and 2021, the Company recorded total expense of approximately $149,000 and $218,000, respectively, relating to the share based compensation under these consulting agreements. At December 31, 2022 and September 30, 2022, approximately $183,000 and $295,000, respectively, are included in prepaid expenses and will be amortized over the remaining service periods.

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FAIR VALUE MEASUREMENTS

3 Months Ended

Dec. 31, 2022

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS

D. FAIR VALUE MEASUREMENTS

In accordance with ASC 820-10, Fair Value Measurements, the Company determines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations with respect to those future amounts.

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. Assumptions from market participants are used when pricing the asset or liabilities, given there is no readily available market information.

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 U.S. Treasury bills during the year ended September 30, 2021. The Treasury bills matured in December 2021 and yielded a weighted average interest rate of 0.10%.

As of December 31, 2022 and September 30, 2022, the Company does not have any derivative instruments that are classified as Level 3 on the fair value hierarchy.  

The following sets forth a reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3):

	3 months ended December 31, 2022		3 months ended December 31, 2021
Beginning balance		-	$	437,380
Issuances		-		-
Exercises		-		(70,589	)
Realized and unrealized (gains) and losses		-		(364,596	)
Ending balance	$	-	$	2,195

The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.  At December 31, 2022 and September 30, 2022, the Company did not have any Level 3 derivative instruments.

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RELATED PARTY TRANSACTIONS

3 Months Ended

Dec. 31, 2022

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS

E. RELATED PARTY TRANSACTIONS

On October 28, 2022, the expiration dates of the Series RR warrants 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 were extended by two years. The incremental cost of these modifications was $172,552 and was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2022.

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COMMITMENTS AND CONTINGENCIES

3 Months Ended

Dec. 31, 2022

Commitments and contingencies

COMMITMENTS AND CONTINGENCIES

F. COMMITMENTS AND CONTINGENCIES

Clinical Research Agreement

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 $35.6 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.8 million. During the three months ended December 31, 2022 and 2021, the Company recorded, net of Ergomed’s discount, approximately $0.1 million and $0.2 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. The renewal options are not included in the calculation of the right of use asset and lease liability because exercise of those options is not reasonably certain.

On December 31, 2022 and September 30, 2022, the net book value of the finance lease right of use asset is approximately $10.5 million and $10.9 million, respectively and the balance of the finance lease liability is approximately $12.9 million and $13.3 million, respectively, of which approximately $1.6 million is current in each quarter. 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 the straight-line method over the underlying lease terms. Total cash paid related to finance leases during the three months ended December 31, 2022 and 2021 was approximately $0.6 million for both periods, of which approximately $0.3 million was for interest in each quarter. As of December 31, 2022, the weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 5.08 years.

In August 2020, the Company entered into an amendment to the San Tomas lease 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 project was finished and the improvements were placed in service in October 2021. Total cost was $11.1 million, of which the landlord agreed to finance $2.4 million. The landlord financing is being repaid through increased lease payments which started in March 2021 and extend over the remaining lease term. The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the lease liability to account for the modified payments using a 8.45% implicit interest rate. The rate was determined using a synthetic credit rating analysis prepared by an outside valuation specialist. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability as it is realized. The entire $2.4 million was received from the landlord as of September 30, 2022. The leasehold improvements are recorded in property and equipment, were deemed to be placed in service in October 2021 and are being amortized over the remaining lease term.

The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. Under the landlord’s $2.4 million financing arrangement, the Company was required to deposit an additional $0.2 million in March 2021. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. During the quarter ended December 31, 2021, it was determined that the Company met the minimum cash requirement and the deposits were returned in January 2022.

Approximate future minimum lease payments under finance leases as of December 31, 2022 are as follows:

Nine months ending September 30, 2023	$	1,937,000
Year ending September 30,
2024		2,655,000
2025		2,741,000
2026		2,832,000
2027		2,923,000
2028		3,015,000
Thereafter		252,000
Total future minimum lease obligation		16,355,000
Less imputed interest on finance lease obligations		(3,446,000	)
Net present value of finance lease obligations	$	12,909,000

The Company leases two facilities under operating leases.  The lease for the Company’s office headquarters will expire on November 30, 2025.  The lease for its research and development laboratory was renewed in September 2021 for an additional ten years and will expire on February 29, 2032.  The renewal was considered a modification for accounting purposes and the right of use asset and liability were remeasured as of the date of the renewal.  This resulted in an increase of approximately $1.1 million to the operating lease right of use asset and liability. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the terms of the leases. As of December 31, 2022 and September 30, 2022, the net book value of the operating lease right of use assets is approximately $1.8 million and $1.9 million, respectively.  As of December 31, 2022 and September 30, 2022, the balance of the operating lease liabilities is approximately $2.0 million, of which approximately $0.2 million, is current in each quarter.  The Company incurred lease expense for operating leases of approximately $91,000 for both the three months ended December 31, 2022 and 2021. Total cash paid related to operating leases during the three months ended December 31, 2022 and 2021 was approximately $85,000 and $66,000, respectively. The weighted average discount rate of the Company’s operating leases is 9.10% and the weighted average time to maturity is 7.6 years.

As of December 31, 2022, future minimum lease payments on operating leases are as follows:

Nine months ending September 30, 2023		262,000
Year ending September 30,
2024		357,000
2025		366,000
2026		287,000
2027		277,000
2028		285,000
Thereafter		1,040,000
Total future minimum lease obligation		2,874,000
Less imputed interest on operating lease obligation		(893,000	)
Net present value of operating lease obligation	$	1,981,000

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PATENTS

3 Months Ended

Dec. 31, 2022

PATENTS

PATENTS

G. PATENTS

During the three months ended December 31, 2022 and 2021, the Company recorded approximately $0 and $31,000 in patent impairment charges. During the three months ended December 31, 2022 and 2021, amortization of patent costs totaled approximately $10,000 and $14,000, respectively. Approximate estimated future amortization expense is as follows:

Nine months ending September 30, 2023	$	28,000
Year ending September 30,
2024		30,000
2025		28,000
2026		24,000
2027		21,000
2028		17,000
Thereafter		54,000
Total	$	202,000

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LOSS PER COMMON SHARE

3 Months Ended

Dec. 31, 2022

LOSS PER COMMON SHARE

LOSS PER COMMON SHARE

H. LOSS PER COMMON SHARE

Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. For the periods presented, the gain on warrant liabilities is excluded from the numerator and the incremental shares, determined using the treasury stock method, are added to the denominator in calculating diluted loss per share.

The following tables provide the details of the basic and diluted loss per-share computations:

	Three months ended December 31,
	2022			2021
Loss per share – basic
Net loss available to common shareholders - basic	$	(8,025,061	)	$	(8,782,606	)
Weighted average shares outstanding - basic		43,440,387			43,077,961
Basic loss per common share	$	(0.18	)	$	(0.20	)
Loss per share – diluted
Net loss available to common shareholders - basic	$	(8,025,061	)	$	(8,782,606	)
Gain on derivatives (1)		-			(25,114	)
Net loss available to common shareholders - diluted	$	(8,025,061	)	$	(8,807,720	)
Weighted average shares outstanding - basic		43,440,387			43,077,961
Incremental shares underlying dilutive - warrants and options (1)		-			5,459
Weighted average shares outstanding – diluted		43,440,387			43,083,420
Diluted loss earnings per common share	$	(0.18	)	$	(0.20	)

(1) Includes Series CC and HH warrants for the three months ended December 31, 2021.

In accordance with the contingently issuable shares guidance of ASC Topic 260, Earnings Per Share, the calculation of diluted net earnings (loss) per share excludes the following securities because their inclusion would have been anti-dilutive as of December 31:

	2022		2021
Options and Warrants		13,917,352		10,477,966
Unvested Restricted Stock		149,250		151,250
Total		14,066,602		10,629,216

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SUBSEQUENT EVENTS

3 Months Ended

Dec. 31, 2022

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

J. SUBSEQUENT EVENTS

On January 11, 2023, the Company was required to deposit approximately $2.3 million to its landlord, equivalent to one year’s rent, for falling below the stipulated cash threshold in accordance with the San Tomas lease. The amount will be included in current assets on the balance sheet until the Company meets the minimum cash balance required and the deposit is returned. 

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Dec. 31, 2022

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

Cash and Cash Equivalents

Cash and Cash Equivalents – Cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months to be cash and cash equivalents.

U S Treasury Bills

U.S. Treasury Bills – U.S. Treasury Bills (“T-bills”) are highly liquid short-term investments with maturity dates of greater than 3 months, but less than one year. These investments are recorded at fair value.

Supplies used for R&D and manufacturing

Supplies used for R&D and manufacturing – Supplies are consumable items kept on hand to support the Company’s R&D and manufacturing operations. Supplies are recorded at cost and are charged to expense as they are used in operations.

Property and Equipment

Property and Equipment – Property and equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. Property and equipment is reviewed on a quarterly basis to determine if any of the assets are impaired.

Patents

Patents - Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment to the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from disposition, are less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Leases

Leases – The Company accounts for contracts that convey the right to control the use of identified property, plant or equipment over a period of time in exchange for consideration as leases upon inception. The Company leases certain real estate, machinery, laboratory equipment and office equipment over varying periods. Many of these leases include an option to either renew or terminate the lease. For purposes of calculating lease liabilities, these options are included in the lease term when it is reasonably certain that the Company will exercise such options. The incremental borrowing rate utilized to calculate the lease liabilities is based on the information available at the commencement date, as most of the leases do not provide an implicit borrowing rate. Short-term leases, defined as leases with initial terms of 12 months or less, are not reflected on the balance sheet. Lease expense for such short-term leases is not material.

Derivative Instruments

Derivative Instruments – The Company has financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, Accounting for Derivative Instruments and Hedging Activities. In accordance with ASC 815, derivative instruments and hybrid instruments are recognized as either assets or liabilities on the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models considering all the rights and obligations of each instrument. The derivative liabilities are re-measured at fair value at the end of each interim period.

The Company adopted Accounting Standards Update (ASU) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity effective October 1, 2021. The amendments in this Update simplify and clarify the guidance in Subtopic 815-40. There was no financial impact in the period of adoption.

Stock-Based Compensation

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, Compensation – Stock Compensation. The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized using the straight-line allocation method as expense over the requisite service or vesting period.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. These Plans are collectively referred to as the “Plans”. All Plans have been approved by the Company’s stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. For options issued with service conditions only, the Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

Research and Development Costs

Research and Development Costs - Research and development costs are expensed as incurred. Management accrues Clinical Research Organization (“CRO”) expenses and clinical trial study expenses based on services performed and relies on the CROs to provide estimates of those costs applicable to the completion stage of a study. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. The Company records revisions to estimated expense in the period in which the facts that give rise to the revision become known.

Net Loss Per Common Share

Net Loss Per Common Share – The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share (ASC 260). Basic and diluted net loss per common share was determined by dividing net loss applicable to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, unvested restricted stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

Income Taxes

Income Taxes – The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized. A full valuation allowance was recorded against the deferred tax assets as of December 31, 2022 and September 30, 2022.

The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes effective October 1, 2021. The new standard includes several provisions that simplify accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and increasing consistency and clarity for the users of financial statements. The adoption of ASU 2019-12 had no impact on the Company’s financial statements.

Use of Estimates

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying disclosures. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Estimates are used in accounting for, among other items, inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, right of use assets and lease liabilities, deferred tax assets and the related valuation allowance, and the valuation of derivative liabilities. Actual results could differ from estimates, although management does not generally believe such differences would materially affect the financial statements in any given year. However, in regard to the valuation of derivative liabilities determined using the Black-Scholes option pricing model, significant fluctuations may materially affect the financial statements in a given year. Additionally, in calculating the right of use assets and lease liabilities, estimates and assumptions were used to determine the incremental borrowing rates and the expected lease terms. The Company considers the estimates used in valuing the derivative liabilities, stock options and the lease assets and liabilities to be significant.

New Accounting Pronouncements

New Accounting Pronouncements

The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

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STOCKHOLDERS EQUITY (Tables)

3 Months Ended

Dec. 31, 2022

STOCKHOLDERS EQUITY

Schedule of equity compensation plans

Name of Plan	Total Shares Reserved Under Plans
Incentive Stock Option Plans		138,400
Non-Qualified Stock Option Plans		13,787,200
Stock Bonus Plans		783,760
Stock Compensation Plans		634,000
Incentive Stock Bonus Plan		640,000

Schedule of Stock option activity

	Three Months Ended December 31,
	2022		2021
Options granted		2,500		251,000
Options exercised		-		6,500
Options forfeited		96,832		13,000
Options expired		45,400		-

Schedule of Stock-Based Compensation Expense

	Three months Ended December 31,
	2022		2021
Employees	$	1,692,831	$	3,262,296
Non-employees	$	148,858	$	218,318

Schedule of warrants and non-employee options outstanding

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	8/18/2024	*
Series UU	6/11/2018		93,603	$	2.80	6/30/2024	*
Series X	1/13/2016		120,000	$	9.25	7/13/2024	*
Series Y	2/15/2016		26,000	$	12.00	8/15/2024	*
Series MM	6/22/2017		333,432	$	1.86	6/22/2024	*
Series NN	7/24/2017		200,087	$	2.52	7/24/2024	*
Series RR	10/30/2017		234,009	$	1.65	10/30/2024	2
Series SS	12/19/2017		-	$	2.09	12/18/2022	2
Series TT	2/5/2018		600	$	2.24	2/5/2023	*
Consultant Options	7/28/2017		10,000	$	2.18	7/27/2027	3

Schedule of derivative liabilities

	2022		2021
Series Z warrants	$	-	$	64,787
Series AA warrants		-		274,635
Series CC warrants		-		24,372
Series HH warrants		-		802
Net gain on warrant liabilities	$	-	$	364,596

Schedule of equity warrants

Warrants	Warrants Exercised		Exercise Price		Proceeds
Series RR		17,752	$	1.65	$	29,291
Series SS		200,000	$	2.09		418,000
		217,752			$	447,291

Warrants	Warrants Exercised		Exercise Price		Proceeds
Series NN		4,500	$	2.52	$	11,340
Series TT		10,000	$	2.24		22,400
		14,500			$	33,740

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FAIR VALUE MEASUREMENTS (Tables)

3 Months Ended

Dec. 31, 2022

FAIR VALUE MEASUREMENTS

Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)

	3 months ended December 31, 2022		3 months ended December 31, 2021
Beginning balance		-	$	437,380
Issuances		-		-
Exercises		-		(70,589	)
Realized and unrealized (gains) and losses		-		(364,596	)
Ending balance	$	-	$	2,195

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COMMITMENTS AND CONTINGENCIES (Tables)

3 Months Ended

Dec. 31, 2022

Commitments and contingencies

Schedule of future minimum payments under finance leases

Nine months ending September 30, 2023	$	1,937,000
Year ending September 30,
2024		2,655,000
2025		2,741,000
2026		2,832,000
2027		2,923,000
2028		3,015,000
Thereafter		252,000
Total future minimum lease obligation		16,355,000
Less imputed interest on finance lease obligations		(3,446,000	)
Net present value of finance lease obligations	$	12,909,000

Schedule of future minimum payments under operating leases

Nine months ending September 30, 2023		262,000
Year ending September 30,
2024		357,000
2025		366,000
2026		287,000
2027		277,000
2028		285,000
Thereafter		1,040,000
Total future minimum lease obligation		2,874,000
Less imputed interest on operating lease obligation		(893,000	)
Net present value of operating lease obligation	$	1,981,000

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PATENTS (Tables)

3 Months Ended

Dec. 31, 2022

PATENTS

Schedule of total estimated future amortization

Nine months ending September 30, 2023	$	28,000
Year ending September 30,
2024		30,000
2025		28,000
2026		24,000
2027		21,000
2028		17,000
Thereafter		54,000
Total	$	202,000

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LOSS PER COMMON SHARE (Tables)

3 Months Ended

Dec. 31, 2022

LOSS PER COMMON SHARE

Schedule of reconciliation of the numerators and denominators of the basic and diluted per-share computations

	Three months ended December 31,
	2022			2021
Loss per share – basic
Net loss available to common shareholders - basic	$	(8,025,061	)	$	(8,782,606	)
Weighted average shares outstanding - basic		43,440,387			43,077,961
Basic loss per common share	$	(0.18	)	$	(0.20	)
Loss per share – diluted
Net loss available to common shareholders - basic	$	(8,025,061	)	$	(8,782,606	)
Gain on derivatives (1)		-			(25,114	)
Net loss available to common shareholders - diluted	$	(8,025,061	)	$	(8,807,720	)
Weighted average shares outstanding - basic		43,440,387			43,077,961
Incremental shares underlying dilutive - warrants and options (1)		-			5,459
Weighted average shares outstanding – diluted		43,440,387			43,083,420
Diluted loss earnings per common share	$	(0.18	)	$	(0.20	)

Schedule of anti-dilutive securities

	2022		2021
Options and Warrants		13,917,352		10,477,966
Unvested Restricted Stock		149,250		151,250
Total		14,066,602		10,629,216

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BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	3 Months Ended
	Dec. 31, 2022
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Patent Useful Life	17 years

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STOCKHOLDERS EQUITY (Details)	Dec. 31, 2022 shares
Remaining Options/shares Under Plans	138,400
Non-Qualified Stock Option Plans [Member]
Remaining Options/shares Under Plans	13,787,200
Stock Bonus Plans [Member]
Remaining Options/shares Under Plans	783,760
Stock Compensation Plan [Member]
Remaining Options/shares Under Plans	634,000
Incentive Stock Bonus Plan [Member]
Remaining Options/shares Under Plans	640,000

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STOCKHOLDERS EQUITY (Details 1) - shares	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
STOCKHOLDERS EQUITY
Options Granted	2,500	251,000
Options Exercised		6,500
Options Forfeited	96,832	13,000
Options Expired	45,400

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STOCKHOLDERS EQUITY (Details 2) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
STOCKHOLDERS EQUITY
Employees Stock Based Compensation Expense	$ 1,692,831	$ 3,262,296
Non- Employees Stock Based Compensation Expense	$ 148,858	$ 218,318

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STOCKHOLDERS EQUITY (Details 3)	3 Months Ended
	Dec. 31, 2022 $ / shares shares
Consultants [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	10,000
Exercise Price	$ 2.18
Expiration Date	7/27/2027
Issue Date	7/28/2017
Series N [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	85,339
Exercise Price	$ 3.00
Expiration Date	8/18/2024
Issue Date	8/18/2008
Series UU [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	93,603
Exercise Price	$ 2.80
Expiration Date	6/30/2024
Issue Date	6/11/2018
Series X [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	120,000
Exercise Price	$ 9.25
Expiration Date	7/13/2024
Issue Date	1/13/2016
Series Y [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	26,000
Exercise Price	$ 12.00
Expiration Date	8/15/2024
Issue Date	2/15/2016
Series MM [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	333,432
Exercise Price	$ 1.86
Expiration Date	6/22/2024
Issue Date	6/22/2017
Series NN [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	200,087
Exercise Price	$ 2.52
Expiration Date	7/24/2024
Issue Date	7/24/2017
Series RR [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	234,009
Exercise Price	$ 1.65
Expiration Date	10/30/2024
Issue Date	10/30/2017
Series SS [Member]
Exercise Price	$ 2.09
Expiration Date	12/18/2022
Issue Date	12/19/2017
Series TT [Member]
Shares Issuable Upon Exercise Of Warrant/options | shares	600
Exercise Price	$ 2.24
Expiration Date	2/5/2023
Issue Date	2/5/2018

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STOCKHOLDERS EQUITY (Details 4) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
STOCKHOLDERS EQUITY
Series Z Warrants	$ 0	$ 64,787
Series AA Warrants	0	274,635
Series CC Warrants	0	24,372
Series HH Warrants	0	802
Net Gain On Warrant Liabilities	$ 0	$ 364,596

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STOCKHOLDERS EQUITY (Details 5) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Warrants Exercised	217,752	14,500
Proceeds	$ 447,291	$ 33,740
Series NN [Member]
Warrants Exercised		4,500
Proceeds		$ 11,340
Exercise Price		$ 2.52
Series RR [Member]
Warrants Exercised	17,752
Proceeds	$ 29,291
Exercise Price	$ 1.65
Series SS [Member]
Warrants Exercised	200,000
Proceeds	$ 418,000
Exercise Price	$ 2.09
Series TT [Member]
Warrants Exercised		10,000
Proceeds		$ 22,400
Exercise Price		$ 2.24

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STOCKHOLDERS EQUITY (Details Narrative) - USD ($)		1 Months Ended	3 Months Ended
	Dec. 08, 2021	Nov. 23, 2021	Dec. 31, 2022	Dec. 31, 2021
Incremental cost			$ 172,000
Consulting Agreements [Member]
Total expense			149,000	$ 218,000
Consulting fees inclued prepaid expenses			$ 183,000	$ 295,000
Series CC [Member]
Warrants exercised	640			15,205
Proceeds from warrants exercised				$ 76,000
Exercise price per share	$ 5.00			$ 5.00
Series Z [Member]
Warrants exercised		184,800
Exercise Price		$ 13.75
Consultants [Member]
Exercise price			$ 11.61
Options issued			5,000
Consultants [Member] | Restricted Stock [Member]
Weighted average grant date fair value			$ 2.53	$ 9.93
Common stock issued for service, shares			40,236	18,020
Non-Qualified Stock Option Plans [Member]
Grant performance-based stock options				250,000
Common stock price				$ 10.48
Stock options vest				100.00%

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FAIR VALUE MEASUREMENTS (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
FAIR VALUE MEASUREMENTS
Beginning Balance	$ 0	$ 437,380
Issuances	0	0
Exercises	0	(70,589)
Realized And Unrealized (gains) And Losses	0	(364,596)
Ending Balance	$ 0	$ 2,195

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FAIR VALUE MEASUREMENTS (Details Narrative)	3 Months Ended
	Dec. 31, 2022
Fair Value Inputs Level 1 (Level 1)
Weighted Average Interest Rate	0.10%

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RELATED PARTY TRANSACTIONS (Details Narrative )	3 Months Ended
	Dec. 31, 2022 USD ($)
CEO, Geert Kersten [Member]
Modifications cost	$ 172,552

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COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2022 USD ($)
Commitments and contingencies
Nine months ending September 30, 2023	$ 1,937,000
2024	2,655,000
2025	2,741,000
2026	2,832,000
2027	2,923,000
2028	3,015,000
Thereafter	252,000
Total Future Minimum Lease Obligation	16,355,000
Less: Imputed Interest On Financing Lease Obligation	(3,446,000)
Net Present Value Of Finance Lease Obligations	$ 12,909,000

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COMMITMENTS AND CONTINGENCIES (Details 1)	Dec. 31, 2022 USD ($)
Commitments and contingencies
Nine months ending September 30, 2023	$ 262,000
2024	357,000
2025	366,000
2026	287,000
2027	277,000
2028	285,000
Thereafter	1,040,000
Total Future Minimum Lease Obligation	2,874,000
Less Imputed Interest On Operating Lease Obligation	(893,000)
Net Present Value Of Operating Lease Obligation	$ 1,981,000

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COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Sep. 30, 2022	Mar. 31, 2021
Weighted Average Discount Rate Operating Lease	9.10%
Current portion of the operating lease obligation				$ 200,000
Increase In Right Of Use Asset And Liability	$ 1,100,000
Operating Lease Liabilities	2,000,000.0
Research And Development Expenses	35,600,000
Operating Lease Right Of Use Assets	1,800,000		$ 1,900,000
Current Balance	200,000
Net Of Discount	11,800,000
Operating Lease Expense	91,000	$ 91,000
Operating Lease Payment	$ 85,000	66,000
Weighted Average Time To Maturity	5 years 29 days
Landlord [Member]
Interest Rate	8.45%
Financing arrangement deposit base rent amount	$ 2,400,000
Financing arrangement deposit base rent percentage description	The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year.
Financing Arrangement	$ 11,100,000
Payments Made By Landlord	$ 2,400,000
Transaction One [Member]
Weighted average maturity date of operating leases	7 years 7 months 6 days
Weighted Average Discount Rate	8.45%
Net Book Value Of The Finance Lease Right Of Use Asset	$ 10,500,000		$ 1,090,000
Balance Of The Finance Lease Liability	12,900,000
Cash Paid Related To Finance Leases	600,000
Cash Paid Related To Finance Leases Interest	300,000
Ergomed [Member]
Research And Development Expenses	10,000	$ 200,000
Clinical Service Trial	$ 12,000,000

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PATENTS (Details)	Dec. 31, 2022 USD ($)
PATENTS
Nine months ending September 30, 2023	$ 28,000
2024	30,000
2025	28,000
2026	24,000
2027	21,000
2028	17,000
Thereafter	54,000
Total	$ 202,000

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PATENTS (Details Narrative) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Patent Impairment Charges	$ 0	$ 31,000
Amortization Of Patent Costs	0	30,793
Amortization Of Patent Costs
Amortization Of Patent Costs	$ 10,000	$ 14,000

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LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
LOSS PER COMMON SHARE
Net loss available to common shareholders - basic	$ (8,025,061)	$ (8,782,606)
Weighted average shares outstanding - basic	43,440,387	43,077,961
Basic loss per common share	$ (0.18)	$ (0.20)
Loss per share- diluted
Net loss available to common shareholders -basic	$ (8,025,061)	$ (8,782,606)
Gain on derivatives (1)	0	(25,114)
Net loss available to common shareholders - diluted	$ (8,025,061)	$ (8,807,720)
Weighted average shares outstanding - basic	43,440,387	43,077,961
Incremental shares underlying dilutive - warrants and options (1)		5,459
Weighted average shares outstanding - diluted	43,440,387	43,083,420
Diluted loss earnings per common share	$ (0.18)	$ (0.20)

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LOSS PER COMMON SHARE (Details 1) - shares	3 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Antidilutive Securities	14,066,602	10,629,216
Options and Warrants
Antidilutive Securities	13,917,352	10,477,966
Unvested Restricted Stock [Member]
Antidilutive Securities	149,250	151,250

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SUBSEQUENT EVENTS (Details Narrative) $ in Millions	Jan. 11, 2023 USD ($)
Subsequent Events [Member]
Deposit to landlord	$ 2.3