cvm_10q.htm

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 March 31, 2026

☐ 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 1-11889

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		8,493,111		May 11, 2026

TABLE OF CONTENTS

PART I FINANCIAL INFORMATION

Item 1.		Page

	Condensed Balance Sheets at March 31, 2026 (unaudited) and September 30, 2025	3

	Condensed Statements of Operations for the six months ended March 31, 2026 and 2025 (unaudited)	4

	Condensed Statements of Operations for the three months ended March 31, 2026 and 2025 (unaudited)	5

	Condensed Statements of Stockholders’ Equity for the six months ended March 31, 2026 and 2025 (unaudited)	6

	Condensed Statements of Cash Flows for the six months ended March 31, 2026 and 2025 (unaudited)	8

	Notes to Condensed Financial Statements(unaudited)	10

Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	22

Item 3.	Quantitative and Qualitative Disclosures about Market Risks	34

Item 4.	Controls and Procedures	34

PART II

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	35

Item 5.	Other Information	35

Item 6.	Exhibits	35

	Signatures	36

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CEL-SCI CORPORATION

CONDENSED BALANCE SHEETS

	March 31, 2026			September 30, 2025
ASSETS	(UNAUDITED)
Current assets:
Cash and cash equivalents	$	1,890,732		$	10,953,460
Prepaid expenses		713,916			332,301
Supplies used for R&D and manufacturing		281,462			303,282
Deposits		7,805			7,085
Total current assets		2,893,915			11,596,128

Finance lease right-of-use assets		4,647,097			5,548,186
Operating lease right-of-use assets		1,491,402			1,274,780
Property and equipment, net		5,070,981			6,079,295
Patent costs, net		73,328			119,856
Deposits		2,319,101			2,319,101
Supplies used for R&D and manufacturing		1,211,450			1,218,402
Total assets	$	17,707,274		$	28,155,748

LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable	$	933,788		$	1,061,351
Accrued expenses		404,220			711,820
Due to employees		857,363			916,588
Finance lease obligation, current portion		2,416,298			2,273,797
Operating lease obligation, current portion		196,340			166,990
Total current liabilities		4,808,009			5,130,546

Finance lease liabilities, net of current portion		4,431,475			5,684,127
Operating lease liabilities, net of current portion		1,468,116			1,258,990
Other liabilities		125,000			125,000
Total liabilities		10,832,600			12,198,663

Commitments and contingencies (Note E)

STOCKHOLDERS' EQUITY
Preferred stock, $0.01 par value; 200,000 shares authorized; 0 shares issued and outstanding		-			-
Common stock, $0.01 par value; 600,000,000 shares authorized; 8,492,777 and 8,015,701 shares issued and outstanding at March 31, 2026 and September 30, 2025, respectively		82,118			80,157
Additional paid-in capital		557,150,669			555,299,844
Accumulated deficit		(550,358,113	)		(539,422,916	)
Total stockholders' equity		6,874,674			15,957,085

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	17,707,274		$	28,155,748

See notes to condensed financial statements.

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CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

SIX MONTHS ENDED MARCH 31, 2026 and 2025

(UNAUDITED)

	2026			2025

Operating expenses:
Research and development	$	7,444,145		$	8,444,328
General & administrative		3,250,670			4,843,193
Total operating expenses		10,694,815			13,287,521

Operating loss		(10,694,815	)		(13,287,521	)

Interest expense, net		(205,274	)		(348,389	)
Other expense		(35,108	)		(9,541	)
Net loss	$	(10,935,197	)	$	(13,645,451	)

Net loss available to common shareholders	$	(10,935,197	)	$	(13,645,451	)

Net loss per common share – basic and diluted	$	(1.35	)	$	(5.47	)
Weighted average common shares outstanding – basic and diluted		8,076,313			2,494,247

See notes to condensed financial statements.

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CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

THREE MONTHS ENDED MARCH 31, 2026 and 2025

(UNAUDITED)

	2026			2025

Operating expenses:
Research and development	$	3,766,915		$	4,014,265
General & administrative		1,559,094			2,379,838
Total operating expenses		5,326,009			6,394,103

Operating loss		(5,326,009	)		(6,394,103	)

Interest expense, net		(117,485	)		(178,286	)
Other expense		(22,257	)		-
Net loss	$	(5,465,751	)	$	(6,572,389	)

Net loss available to common shareholders	$	(5,465,751	)	$	(6,572,389	)

Net loss per common share – basic and diluted	$	(0.67	)	$	(2.33	)
Weighted average common shares outstanding – basic and diluted		8,138,233			2,818,004

See notes to condensed financial statements.

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CEL-SCI CORPORATION

STATEMENT OF STOCKHOLDERS' EQUITY

(UNAUDITED)

	Common Stock				Additional Paid-In			Accumulated
	Shares		Amount		Capital			Deficit			Total

BALANCE, SEPTEMBER 30, 2025		8,015,701	$	80,157	$	555,299,844		$	(539,422,916	)	$	15,957,085

401(k) contributions paid in common stock		10,864		109		57,153			-			57,262
Stock issued to nonemployees for service		9,656		97		57,635			-			57,732
Shares issued for settlement of clinical development costs		10,000		100		48,027			-			48,127
Purchase of stock by officers and directors		8,389		84		49,915			-			49,999
Equity based compensation - employees		-		-		443,275			-			443,275
Share issuance costs		-		-		(5,380	)		-			(5,380	)
Net loss		-		-		-			(5,469,446	)		(5,469,446	)

BALANCE, DECEMBER 31, 2025		8,054,610	$	80,547	$	555,950,469		$	(544,892,362	)	$	11,138,654

401(k) contributions paid in common stock		19,229		192		61,596			-			61,788
Stock issued to nonemployees for service		15,915		159		56,779			-			56,938
Shares issued for settlement of clinical development costs		84,000		840		430,823			-			431,663
Purchase of stock by officers and directors		38,023		380		199,621			-			200,001
Equity based compensation – employees		-		-		451,381			-			451,381
Net loss		-		-		-			(5,465,751	)		(5,465,751	)

BALANCE, MARCH 31, 2026		8,211,777	$	82,118	$	557,150,669		$	(550,358,113	)	$	6,874,674

See notes to condensed financial statements.

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CEL-SCI CORPORATION

STATEMENT OF STOCKHOLDERS' EQUITY

(UNAUDITED)

	Common Stock						Additional Paid-In			Accumulated
	Shares			Amount			Capital			Deficit			Total

BALANCE, SEPTEMBER 30, 2024		2,126,682		$	21,266		$	526,857,678		$	(514,011,861	)	$	12,867,083

Exercise of pre-funded warrants		48,333			483			(483	)		-			-
401(k) contributions paid in common stock		4,761			48			57,086			-			57,134
Stock issued to nonemployees for service		5,154			52			396,035			-			396,087
Proceeds from the sale of common stock and pre-funded warrants		251,750			2,518			4,997,782			-			5,000,300
Equity based compensation - employees		(100	)		(1	)		711,382			-			711,381
Share issuance costs		-			-			(650,291	)		-			(650,291	)
Net loss		-			-			-			(7,073,062	)		(7,073,062	)

BALANCE, DECEMBER 31, 2024		2,436,580		$	24,366		$	532,369,189		$	(521,084,923	)	$	11,308,632

Exercise of pre-funded warrants		199,250			1,993			(1,993	)		-			-
401(k) contributions paid in common stock		7,524			75			53,979			-			54,054
Stock issued to nonemployees for service		1,667			17			60,185			-			60,202
Proceeds from the sale of common stock and pre-funded warrants		133,750			1,338			2,558,662			-			2,560,000
Shares issued for settlement of clinical development costs		33,333			333			350,552			-			350,885
Equity based compensation - employees		-			-			685,668			-			685,668
Share issuance costs		-			-			(449,197	)		-			(449,197	)
Net loss		-			-			-			(6,572,389	)		(6,572,389	)

BALANCE, MARCH 31, 2025		2,812,104		$	28,122		$	535,627,045		$	(527,657,312	)	$	7,997,855

See notes to condensed financial statements.

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CEL-SCI CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

SIX MONTHS ENDED MARCH 31, 2026 and 2025

(UNAUDITED)

	2026			2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(10,935,197	)	$	(13,645,451	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		1,920,823			1,965,294
Non-cash lease expense, net of lease payments		21,854			(911	)
Share-based payments for services		115,424			506,760
Equity based compensation		894,656			1,397,050
Common stock contributed to 401(k) plan		119,050			111,188
Shares issued for settlement of clinical development costs		479,790			350,885
Loss on patent impairment		35,108			9,541
(Increase)/decrease in assets:
Prepaid expenses		(382,369	)		35,163
Supplies used for R&D and manufacturing		28,772			206,182
Deposits		(720	)		(4,000	)
Increase/(decrease) in liabilities:
Accounts payable		(29,860	)		104,209
Accrued expenses		(252,600	)		(39,541	)
Due to employees		(59,225	)		494,079

Net cash used in operating activities		(8,044,494	)		(8,509,552	)

CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment		-			(32,954	)

Net cash used in investing activities		-			(32,954	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and pre-funded warrants		-			7,560,300
Payments of stock issuance costs		(158,115	)		(850,391	)
Proceeds from the purchase of stock by officers and directors		250,000			-
Payments on obligations under finance leases		(1,110,119	)		(981,271	)

Net cash (used in) provided by financing activities		(1,018,234	)		5,728,638

NET DECREASE IN CASH AND CASH EQUIVALENTS		(9,062,728	)		(2,813,868	)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD		10,953,460			4,738,173

CASH AND CASH EQUIVALENTS, END OF PERIOD	$	1,890,732		$	1,924,305

See notes to condensed financial statements.

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CEL-SCI CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

SIX MONTHS ENDED MARCH 31, 2026 and 2025

(UNAUDITED)

SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:	2026		2025
Finance lease obligation included in accounts payable	$	1,165	$	1,649
Changes to operating right of use assets and liabilities	$	312,725	$	-
Obligations paid with issuance of common stock	$	114,670	$	456,289
Financing costs included in current liabilities	$	-	$	288,047

SUPPLEMENTAL DISCLOSURE OF CASH FLOWS:
Cash paid for interest	$	317,391	$	404,557

See notes to condensed financial statements.

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CEL-SCI CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

SIX MONTHS ENDED MARCH 31, 2026 AND 2025 (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, 2025.

In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments (all of which are of a normal recurring nature) and disclosures necessary for a fair presentation of the Company’s financial position as of March 31, 2026 and the results of its operations for the six months then ended. The condensed balance sheet as of September 30, 2025 is derived from the September 30, 2025 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.

On May 19, 2025, the Company’s shareholders approved a reverse split of the Company’s common stock which became effective on the NYSE American on May 20, 2025. On that date, every thirty issued and outstanding shares of the Company’s common stock automatically converted into one outstanding share. As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock decreased from 94,037,256 (pre-split) shares to 3,135,021 (post-split) shares. In addition, by reducing the number of the Company’s outstanding shares, the Company’s loss per share in all prior periods will increase by a factor of thirty. The reverse stock split affected all stockholders of the Company’s common stock uniformly and did not affect any stockholder’s percentage of ownership interest. The par value of the Company’s stock remained unchanged at $0.01 per share and the number of authorized shares of common stock remained the same after the reverse stock split.

As the par value per share of the Company’s common stock remained unchanged at $0.01 per share, a total of $909,021 was reclassified from common stock to additional paid-in capital. In connection with this reverse stock split, the number of shares of common stock reserved for issuance under the Company’s incentive and non-qualified stock option plans, as well as the shares of common stock underlying outstanding stock options and warrants, were also proportionately reduced while the exercise prices of such stock options and warrants were proportionately increased. All references to shares of common stock and per share data for all periods presented in the accompanying financial statements and notes thereto have been adjusted to reflect the reverse stock split on a retroactive basis.

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 equivalents.

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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 the lower of cost or net realizable value and are charged to expense as they are used in operations. The Company regularly reviews the quality and utilization of supplies to determine if future use of these supplies is probable. Due to the generic use of these supplies, they can be used in multiple projects other than those currently being studied. Supplies held less than twelve months are classified as current assets and supplies held longer than twelve months are classified as non-current assets, which is in line with the Company’s expected consumption of the supplies in the future.

Patents costs, net – 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 adjustments to the asset value and period of amortization are made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from its 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. The incremental borrowing rate reflects the rate of interest that the Company would pay on the lease commencement date to borrow an amount equal to the lease payments on a collateralized basis over a similar term in similar economic environments. 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. Operating and finance lease agreements which require payments for lease and non-lease components are accounted for as a single lease component. Variable lease payments that cannot be determined at the commencement of the lease are not included in the calculation of right of use assets or lease liabilities, and are expensed as incurred.

Share-Based Compensation – Compensation cost for all share-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, Compensation – Stock Compensation (“ASC 718”). The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires six input variables: the strike price of an option, the current stock price, the time to expiration, the risk-free rate, the dividend yield and the volatility. The share-based compensation cost is recognized using the straight-line 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, share-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

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Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the Non-Qualified Stock Option Plans are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at 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. 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.

Concentration of Credit Risk – Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and cash equivalents. The Company maintains its cash and cash equivalents with high quality financial institutions. At times, these accounts may exceed federally insured limits. The Company has not experienced any losses in such bank accounts. The Company believes it is not exposed to significant credit risk related to cash and cash equivalents. All non-interest bearing cash balances were fully insured up to $250,000 at March 31, 2026 and September 30, 2025.

Income Taxes – The Company accounts for income taxes in accordance with the provisions of ASC 740, Income Taxes, on a tax jurisdiction basis. 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 March 31, 2026 and September 30, 2025.

Impairment of long-lived assets – CEL-SCI’s fixed assets are made up of leasehold improvements, furniture, and equipment. ASC 360-10 requires that a long-lived asset group be reviewed for impairment only when events or changes in circumstances indicate that the carrying amount of the long-lived asset (group) might not be recoverable. CEL-SCI’s recurring losses are a triggering event that could indicate impairment of long-lived assets such as fixed assets. CEL-SCI reviews these assets to determine if events or changes in circumstances indicate the existence of impairment. If indicators of impairment exist, the Company tests for recoverability, then, if necessary, measures and records the impairment. The amount of the impairment loss would be the amount by which the carrying amount of the asset (group) exceeds its fair value.

Fair Value Measurements - In accordance with the provisions of ASC 820, 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 the future amounts.

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ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows:

	·	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 other than quoted prices that are observable for the asset or liability are observable in active markets

	·	Level 3 – Unobservable inputs that reflect management’s assumptions

For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels.

The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. The Company’s money market funds included in cash equivalents are valued using Level 1 inputs and measured at fair value on a recurring basis. The cost of the Company’s money market funds approximated their fair value at $1,251,000 and $1,000 as of March 31, 2026 and September 30, 2025, respectively.

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, share-based compensation, 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. Actual results could differ from estimates, although management does not generally believe such differences would materially affect the financial statements in any 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 stock options and the lease assets and liabilities to be significant.

Segments – ASC 280, Segment Reporting (“ASC 280”), establishes standards for reporting information about operating segments on a basis consistent with the Company’s internal organizational structure. The Company’s chief operating decision maker (“CODM”) has been identified as the Company’s Chief Executive Officer (“CEO”). The Company’s CODM reviews the operating results for the Company as a whole to make decisions about allocating resources and assessing financial performance. Because the CODM evaluates financial performance as a whole, management determined that the Company operates as a single reportable segment. The CODM does not review segment assets at a different asset level or category than the balance sheets. The CODM utilizes net income (loss) as the sole measure of segment profit or loss. Significant segment expenses include research and development expenses and general & administrative expenses (see Note H).

Recently Adopted Accounting Standards

We have not adopted any new accounting guidance in fiscal year 2026 that has had a material impact on our consolidated financial statements or disclosures.

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New Accounting Pronouncements

In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Improvements to Income Tax Disclosures, which require greater disaggregation of income tax disclosures related to the income tax rate reconciliation and income taxes paid. The update will be effective for annual periods beginning after December 15, 2024. The guidance should be applied on a prospective basis with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating the impact that this change will have on the Company's disclosures.

In November 2024, the FASB issued Accounting Standards Update No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures: Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 will require more detailed information about the types of expenses in commonly presented income statement captions such as “Cost of sales” and “Selling, general and administrative expenses”. The new guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted. The Company is currently evaluating the impact that this change will have on the Company’s disclosures.

In December 2025, the FASB issued (“ASU 2025-11”), Interim Reporting (Topic 270) Narrow-Scope Improvements, which is intended to improve the navigability of the guidance in ASC 270 - Interim Reporting and clarify when it applies. Under the amendments, an entity is subject to ASC 270 if it provides interim financial statements and notes in accordance with GAAP. ASU 2025-11 also addresses the form and content of such financial statements, interim disclosure requirements, and establishes a principle under which an entity must disclose events since the end of the last annual reporting period that have a material impact on the entity. The new guidance will be effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact this standard will have on the Company’s financial statement presentation and disclosures.

In December 2025, the FASB issued (“ASU 2025-12”), Codification Improvements, which includes changes that clarify, correct, or otherwise improve certain components of the Accounting Standards Codification. The standard is effective for the Company’s annual reporting periods beginning July 1, 2027, and interim periods within those annual reporting periods. Early adoption is permitted. The Company is currently evaluating the impact this standard will have on the Company’s financial statement presentation and disclosures.

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 conducting 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, the Company’s lead investigational therapy, to market in the United States. 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 any regulatory agency 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.

To finance the Company through marketing approval, the Company plans to raise additional capital in the form of corporate partnerships, 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 Multikine showed great survival benefit in the Phase III 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 and may be unable to realize its assets and discharge its liabilities in the normal course of business. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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C. STOCKHOLDERS’ EQUITY

Proceeds from the Sale of Common Stock

The Company sold no common stock during the six months ended March 31, 2026. In March 2025, the Company sold 133,750 shares of common stock at an offering price of $4.80 per share and pre-funded warrants to purchase up to 399,585 shares of common stock, at an offering price of $4.797 per pre-funded warrant, for proceeds of approximately $2.1 million, net of issuance costs of approximately $0.5 million. As of March 31, 2026, all of the pre-funded warrants in connection with the March 2025 offering have been exercised.

In December 2024, the Company sold 251,750 shares of common stock at an offering price of $9.30 per share and pre-funded warrants to purchase up to 285,917 shares of common stock, at an offering price of $9.297 per pre-funded warrant, for proceeds of approximately $4.4 million, net of issuance costs of approximately $0.6 million. As of March 31, 2026, all of the pre-funded warrants in connection with the December 2024 offering have been exercised.

The Company determined that the pre-funded warrants sold in the offerings disclosed above are freestanding financial instruments because they are both legally detachable and separately exercisable from the common stock sold in the offering. As such, the Company evaluated the pre-funded warrants to determine whether they represent instruments that require liability classification pursuant to the guidance in ASC 480. However, the Company concluded that the pre-funded warrants are not a liability within the scope of ASC 480 due to their characteristics. Further, the Company determined that the pre-funded warrants do not meet the definition of a derivative under ASC 815. Accordingly, the Company assessed the pre-funded warrants relative to the guidance in ASC No. 815-40, Contracts in Entity’s Own Equity, to determine the appropriate treatment. The Company concluded that the pre-funded warrants are both indexed to its own stock and meet all other conditions for equity classification. Accordingly, the Company has classified the pre-funded warrants as permanent equity and recorded them as a component of additional paid-in capital upon the closing of the financings.

Other Equity Transactions

In November 2025, the Company entered into a Securities Purchase Agreement with Ergomed Group Limited (“Ergomed”) pursuant to which the Company issued 375,000 shares of common stock in exchange for services. The shares are legally issued and outstanding. The Company determined the issuance of shares to a non-employee for services rendered or to be rendered is within the scope of ASC 718. In accordance with ASC 718, the shares were not issued and outstanding for accounting purposes as they are unvested and forfeitable. The shares will be recognized on the settlement date and measured at fair value when the shares are settled for services rendered by Ergomed. The Company incurred share issuance costs of approximately $32,000 to issue the shares from this agreement which were immediately expensed. During the six months ended March 31, 2026, 94,000 shares were sold by Ergomed and the proceeds were used to settle $144,998 in outstanding payables for services provided to the Company with the remaining proceeds of $334,792 recognized as a prepaid expense on the accompanying condensed balance sheets as of March 31, 2026. During the three months ended March 31, 2026, 84,000 shares were sold by Ergomed and the proceeds were used to settle $96,871 in outstanding payables for services provided to the Company with the remaining proceeds of $334,792 recognized as a prepaid expense on the accompanying condensed balance sheets as of March 31, 2026. As of March 31, 2026, Ergomed held 281,000 shares of CEL-SCI’s common stock.

In October 2024, the Company entered into a Securities Purchase Agreement with Ergomed pursuant to which the Company issued 33,333 shares of common stock in exchange for services. The shares are legally issued and outstanding. The Company incurred share issuance costs of approximately $61,000 to issue the shares from this agreement which were immediately expensed. During the six months ended March 31, 2025, 33,333 shares were sold by Ergomed and the proceeds used to settle $350,885 in outstanding payables for services provided to the Company.

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Equity Compensation

Underlying share information for equity compensation plans as of March 31, 2026 is as follows:

Name of Plan	Total Shares Reserved Under Plans
Incentive Stock Option Plans		4,614
Non-Qualified Stock Option Plans		709,576
Stock Bonus Plans		59,460
Stock Compensation Plans		21,134
Incentive Stock Bonus Plan		21,334

Stock Option Activity:

	Six Months Ended March 31,
	2026		2025
Options granted		2,500		16,784
Options exercised		-		-
Options forfeited		565		922
Options expired		-		2

	Three Months Ended March 31,
	2026		2025
Options granted		1,500		34
Options exercised		-		-
Options forfeited		-		395
Options expired		-		-

Share-Based Compensation Expense:

	Six Months Ended March 31,
	2026		2025
Employees	$	894,656	$	1,397,050
Non-employees	$	115,424	$	506,760

	Three Months Ended March 31,
	2026		2025
Employees	$	451,381	$	685,668
Non-employees	$	57,106	$	109,921

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.

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Warrants and Non-Employee Options

The following chart represents the warrants and non-employee options outstanding at March 31, 2026:

Warrant/ Options	Issue Date	Shares Issuable upon Exercise of Warrants/ Options		Exercise Price		Expiration Date
Series N	8/18/2008		2,845	$	90.00	8/18/2026
Series UU	6/11/2018		3,122	$	84.00	6/30/2026
Series X	1/13/2016		4,000	$	277.50	7/13/2026
Series Y	2/15/2016		867	$	360.00	8/15/2026
Series MM	6/22/2017		11,115	$	55.80	6/22/2026
Series NN	7/24/2017		6,670	$	75.60	7/24/2026
Series RR	10/30/2017		7,802	$	49.50	10/30/2026
Consultant Options	7/28/2017 – 11/19/2024		20,335	$21.00 - $65.40		7/27/2027 – 11/1/2034

1. Equity Warrants

Changes in Equity Warrants

No pre-funded warrants or warrants recorded as equity were issued during the six months ended March 31, 2026. During the six months ended March 31, 2025, 399,585 and 285,917 pre-funded warrants at an offering price of $4.80 and $9.30, respectively, were issued.

No pre-funded warrants or warrants recorded as equity were exercised during the six months ended March 31, 2026. During the six months ended March 31, 2025, 247,583 pre-funded warrants were exercised.

No pre-funded warrants or warrants recorded as equity expired or were extended during the six months ended March 31, 2026 and 2025.

2. Options and Shares Issued to Consultants

During the six months ended March 31, 2026 and 2025, the Company issued 25,571 and 6,821 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $4.48 and $26.13 during the six months ended March 31, 2026 and 2025, respectively. During the three months ended March 31, 2026 and 2025, the Company issued 15,915 and 1,667 shares, respectively, of restricted common stock to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $5.98 and $28.26 during the three months ended March 31, 2026 and 2025, respectively.

No options were issued to a consultant during the six months ended March 31, 2026. During the six months ended March 31, 2025, the Company issued 16,667 options to a consultant with an exercise price of $21.00 and the weighted average grant date fair value was $15.10. The options vest immediately and will expire on November 1, 2034.

During the six months ended March 31, 2026 and 2025, the Company recorded total expense of approximately $115,000 and $507,000, respectively, relating to the share-based compensation under various consulting agreements. During the three months ended March 31, 2026 and 2025, the Company recorded total expense of approximately $57,000 and $110,000, respectively, relating to the share-based compensation under various consulting agreements. On March 31, 2026 and September 30, 2025, consulting fees of approximately $47,000 in both periods, are included in current assets as prepaid expenses and will be amortized over the remaining service periods.

D. RELATED PARTY TRANSACTIONS

During the six months ended March 31, 2026, the Company’s CEO purchased 46,412 shares of restricted common stock at an aggregate fair market value of approximately $250,000. During the three months ended March 31, 2026, the Company’s CEO purchased 38,023 shares of restricted common stock at an aggregate fair market value of approximately $200,000. There were no related party transactions during the six months ended March 31, 2025.

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E. COMMITMENTS AND CONTINGENCIES

Clinical Research Agreements

In August 2024 the Company entered into an agreement, pursuant to which the Company engaged Ergomed Clinical Research, Inc. to provide clinical development services related to the Company’s upcoming confirmatory registration study in exchange for fees. Since the Company entered into this agreement it has incurred research and development expenses of approximately $0.7 million as of March 31, 2026.

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 III clinical trial and sales of the drug if approved by the FDA or regulators in Canada, the UK or Europe. 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.

As of March 31, 2026 and September 30, 2025, respectively, the net book value of the finance lease right-of-use asset is approximately $4.6 million and $5.5 million and the balance of the finance lease liability is approximately $6.8 million and $8.0 million, of which approximately $2.4 million and $2.3 million is current. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. During the six months ended March 31, 2026 and 2025, the finance right-of-use assets are being depreciated using a straight-line method over the underlying lease terms and depreciation expense totaled approximately $0.9 million in both periods, which is included in research and development expense on the accompanying condensed statements of operations. Total cash paid related to finance leases during the six months ended March 31, 2026 and 2025, was approximately $1.4 million for both periods, of which approximately $0.3 million and $0.4 million was for interest, respectively. The total cash paid related to finance lease principal payments is included in cash flows from financing activities on the accompanying condensed statements of cash flows. The total cash paid related to finance lease interest expense is included in cash flows from operating activities on the accompanying condensed statements of cash flows. As of March 31, 2026, the weighted average discount rate of the Company’s finance leases is 8.47% and the weighted average remaining lease term is 2.59 years. As of September 30, 2025, the weighted average discount rate of the Company’s finance leases was 8.46% and the weighted average remaining lease term was 3.09 years. During the six months ended March 31, 2026 and 2025, total finance lease costs were approximately $1.2 million and $1.3 million, respectively, consisting of approximately $0.9 million of lease asset amortization for both periods and approximately $0.3 million and $0.4 million of interest on the finance lease liabilities, respectively. Variable lease expenses, such as maintenance costs, utilities, and real property taxes are not included in right-of-use assets or lease liabilities but rather are expensed as incurred. During the six months ended March 31, 2026 and 2025, there were approximately $0.5 million of variable finance lease costs, which are included in research and development expense on the accompanying condensed statements of operations.

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 is shown as a deposit on the Company’s balance sheets until the Company meets the minimum cash balance required and the deposit is returned.

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Approximate future minimum lease payments under finance leases as of March 31, 2026 are as follows:

Six months ending September 30, 2026	$	1,423,000
Year ending September 30,
2027		2,929,000
2028		3,021,000
2029		255,000
Total future minimum lease obligation		7,628,000
Less imputed interest on finance lease obligations		(781,000	)
Net present value of financing lease obligations		6,847,000
Less net present value of financing lease obligations – current portion		(2,416,000	)
Net present value of financing lease obligations - non-current portion	$	4,431,000

The Company leases two facilities under operating leases. On October 2, 2025, the Company entered into an amendment to the lease agreement for its office headquarters. The amendment extends the lease term from its original expiration date through May 31, 2031. This extension is expected to result in additional undiscounted minimum lease payments of approximately $0.4 million over the extended period from December 1, 2025, to May 31, 2031. The lease will continue to be classified as an operating lease. The lease for its research and development laboratory will expire on February 29, 2032. 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 March 31, 2026 and September 30, 2025, respectively, the net book value of the operating lease right-of-use asset is approximately $1.5 million and $1.3 million and the balance of the operating lease liability is approximately $1.7 million and $1.4 million, of which approximately $0.2 million is current in both periods. The lease for the Company’s office headquarters was renewed in October 2025. The renewal was considered a modification for accounting purposes and the right of use asset and liability were remeasured as of the date of renewal. This resulted in an increase of approximately $0.3 million to the operating lease right of use asset and liability. During the six months ended March 31, 2026 and 2025, the Company incurred lease expense under operating leases of approximately $0.1 million in both periods, which is included in general and administrative expense on the accompanying condensed statements of operations. Total cash paid related to operating leases during the six months ended March 31, 2026 and 2025 was approximately $0.2 million for both periods. The total cash paid related to operating leases is included in cash flows from operating activities on the accompanying condensed statements of cash flows. As of March 31, 2026, the weighted average discount rate of the Company’s operating leases is 8.94% and the weighted average remaining lease term is 5.75 years. As of September 30, 2025, the weighted average discount rate of the Company’s operating leases was 8.93% and the weighted average remaining lease term was 6.34 years.

As of March 31, 2026, approximate future minimum lease payments on operating leases are as follows:

Six months ending September 30, 2026	$	162,000
Year ending September 30,
2027		357,000
2028		367,000
2029		378,000
2030		390,000
2031		371,000
Thereafter		131,000
Total future minimum lease obligation		2,156,000
Less imputed interest on operating lease obligation		(492,000	)
Net present value of operating lease obligations		1,664,000
Less net present value of operating lease obligations - current portion		(196,000	)
Net present value of operating lease obligations - non-current portion	$	1,468,000

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F. PATENTS

During the six months ended March 31, 2026 and 2025, the Company abandoned five and three patents, respectively, which resulted in an impairment of $35,108 and $9,541 on patent costs, respectively. The weighted average amortization period for patents is approximately 6 years. For the six months ended March 31, 2026 and 2025, amortization of patent costs totaled approximately $11,000 and $15,000, respectively, and is included in general and administrative expense on the accompanying condensed statements of operations. For the three months ended March 31, 2026 and 2025, amortization of patent costs totaled approximately $6,000 and $7,000, respectively, and is included in general and administrative expense on the accompanying condensed statements of operations. The total estimated future amortization is as follows:

Six months ending September 30, 2026	$	7,000
Year ending September 30,
2027		15,000
2028		14,000
2029		11,000
2030		10,000
2031		5,000
Thereafter		11,000
Total	$	73,000

G. LOSS PER COMMON SHARE

Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share is computed using the treasury stock method. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants, unvested common stock and unvested restricted stock are not included in the computation of diluted net loss per share if their effect would be anti-dilutive.

The calculation of basic and diluted net loss per share for the periods ending March 31, 2025 includes 486,250 of the pre-funded warrants that remained outstanding as of March 31, 2025.

The following table provides a reconciliation of the numerators and denominators of the basic and diluted loss per-share computations:

	Six Months						Three Months
	Ended March 31,						Ended March 31,
	2026			2025			2026			2025
Loss per share – basic and diluted
Net loss available to common – basic and diluted	$	(10,935,197	)	$	(13,645,451	)	$	(5,465,751	)	$	(6,572,389	)
Weighted average shares outstanding – basic and diluted		8,076,313			2,494,247			8,138,233			2,818,004
Basic and diluted loss per common share	$	(1.35	)	$	(5.47	)	$	(0.67	)	$	(2.33	)

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

	2026		2025
Options and Warrants		746,912		594,211
Unvested Common Stock		281,000		-
Unvested Restricted Stock		4,810		4,810
Total		1,032,722		599,021

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H. SEGMENT REPORTING

As the Company operates as one reportable segment, all financial information required by ASC 280 can be found in the accompanying financial statements. The measure of segment assets is total assets as reported on the balance sheets. The Company has not generated any revenue as of the date of these financial statements. In accordance with ASU 2023-07, the Company discloses significant segment expenses that are regularly provided to the CODM and included in the reported measure of segment loss. For the six and three months ended March 31, 2026 and 2025, significant segment expenses include the Company’s operating expenses classified as research & development and general & administrative on the accompanying statements of operations. These significant segment expenses are disaggregated by type in the following tables (rounded to the nearest thousand):

	Six Months Ended March 31,
	2026		2025
Research and development:
Salaries, wages & employee benefits	$	3,100,000	$	3,078,000
Stock-based compensation		527,000		769,000
Depreciation and amortization expense		1,904,000		1,945,000
Clinical trial expense		47,000		471,000
Supplies & materials		579,000		1,011,000
Other operating expenses		1,287,000		1,170,000
General & administrative:
Salaries, wages & employee benefits		759,000		746,000
Stock-based compensation		368,000		628,000
Legal & accounting fees		387,000		500,000
Public & investor relation costs		718,000		1,832,000
Other operating expenses		1,019,000		1,137,000
Interest expense, net		205,000		348,000
Other income, net		35,000		10,000
Net loss	$	10,935,000	$	13,645,000

	Three Months Ended March 31,
	2026		2025
Research and development:
Salaries, wages & employee benefits	$	1,557,000	$	1,534,000
Stock-based compensation		270,000		375,000
Depreciation and amortization expense		948,000		959,000
Clinical trial expense		6,000		71,000
Supplies & materials		337,000		491,000
Other operating expenses		649,000		584,000
General & administrative:
Salaries, wages & employee benefits		382,000		383,000
Stock-based compensation		182,000		311,000
Legal & accounting fees		102,000		144,000
Public & investor relation costs		401,000		970,000
Other operating expenses		493,000		572,000
Interest expense, net		117,000		178,000
Other income, net		22,000		-
Net loss	$	5,466,000	$	6,572,000

I. SUBSEQUENT EVENTS

On May 13, 2026, the Company sold 6,000,000 shares of common stock at an offering price of $1.20 per share for gross proceeds of approximately $7.2 million.

On May 13, 2026, the CEO purchased 100,000 shares of restricted common stock at an aggregate fair market value of approximately $119,000. On May 14, 2026, the de Clara Trust, of which the Company’s CEO is a trustee, purchased 300,000 shares of restricted common stock at an aggregate fair market value of approximately $360,000.

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

Company Overview

CEL-SCI Corporation is a late clinical-stage biotechnology company dedicated to research and development directed at improving the treatment of cancer and other diseases by using the immune system, the body’s natural defense system. CEL-SCI is currently focused on the development of the following product candidates and technologies with emphasis on Multikine:

	1)	Multikine, an investigational Phase 3 immunotherapy under development for the potential treatment of certain head and neck cancers; and

	2)	L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology, or LEAPS, with several product candidates under development for the potential treatment of rheumatoid arthritis.

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. None of the Company’s product candidates have been approved for sale, barter or exchange by the Food and Drug Administration (FDA) or any other regulatory agency for any use to treat disease in humans nor has the safety or efficacy of these products been established for any use. There can be no assurance that obtaining marketing approval from the FDA in the United States and by comparable agencies in most foreign countries will be granted.

MULTIKINE, THE PHASE III CLINICAL TRIAL RESULTS, AND PATH FORWARD

Immunotherapy is a large, high growth market. Immunotherapies use the patient’s own immune system to fight disease. These “targeted therapies” are at the forefront of modern cancer research. A Bloomberg report from January 2023 asserted that:

The global cancer immunotherapy market is expected to reach USD $196.45 billion by 2030, registering CAGR of 7.2% during the forecast period, according to a new report by Grand View Research, Inc. The rising adoption of immunotherapy over other therapy options for cancer owing to its targeted action is anticipated to increase the adoption during the forecast period. Moreover, increasing regulatory approvals from authoritarian establishments for novel immunotherapy used for oncology is also expected to further fuel the market growth. (https://www.bloomberg.com/press-releases/2023-01-18/cancer-immunotherapy-market-worth-196-45-billion-by-2030-grand-view-research-inc)

CEL-SCI hopes to participate in this growing market with its lead investigational therapy Multikine® (Leukocyte Interleukin, Injection). Multikine is unique among approved cancer immunotherapies because it is given first, right after diagnosis, before any other treatment including surgery.

Multikine has been tested in approximately 740 patients in Phase 1, 2 and 3 clinical studies conducted in the U.S., Canada, Europe, Israel and Asia. In these studies, it has been administered in multiple doses by various routes and various frequencies to determine its safety and efficacy. The data from these studies allowed CEL-SCI to determine the patient population most responsive to Multikine and most likely to benefit from it. The target population is newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET imaging), and with low PD-L1 tumor expression (determined via biopsy), two features that physicians routinely assess at baseline as part of standard practice.

CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for a confirmatory registration study. The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms. Therefore, no bias was found, which supports confidence in Multikine’s efficacy results.

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In the target patient population CEL-SCI believes Multikine significantly extended life. In the Phase III study, CEL-SCI observed a 73% survival rate with Multikine vs. only 45% without Multikine at 5 years after treatment, and a Hazard ratio of 0.35 (95% CIs [0.19, 0.66]).

CEL-SCI applied to the FDA for a 212-patient randomized controlled confirmatory registration study focusing only on those patients in the target population, which accounts for approximately 100,000 patients worldwide per year. In May 2024, CEL-SCI announced that the FDA indicated CEL-SCI may move forward with a confirmatory registration study of Multikine in the target population.

What is Multikine and who is it for? Multikine is a biological medicinal immunotherapy comprised of a mixture of natural cytokines and small biological molecules. Multikine is injected around the tumor and adjacent lymph nodes for three weeks as a first-line treatment before the standard of care (SOC), which is surgery followed by either radiotherapy or chemoradiotherapy. Multikine’s rationale for use is to incite a locoregional immune response against the tumor before the local immune system has been compromised by the standard of care and/or disease progression.

The Multikine target population is not yet treated adult patients with resectable locally advanced primary squamous cell carcinoma of the head and neck (SCCHN) in the oral cavity and who have:

	·	No lymph node involvement (via PET imaging)
	·	Low PD-L1 tumor expression (TPS<10) (via biopsy)

PD-L1 is a protein receptor on the tumor surface that helps the tumor repel cells of the immune system. CEL-SCI believes that patients with tumors having low PD-L1 would be more likely to respond to Multikine because their tumors have lower defenses against the patient’s immune system. CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary patients with squamous cell carcinoma of the head and neck, or SCCHN (hereafter also referred to as advanced primary head and neck cancer).

Targeting low PD-L1 also differentiates Multikine from other immunotherapies. For example, checkpoint inhibitors like Keytruda and Opdivo appear to best serve patients having high PD-L1, because these drugs work by blocking PD1/PD-L1 receptors interaction; when this interaction (PD1/PD-L1) happens it leads to inactivation/death of the immune cells attacking the tumor. These checkpoint inhibitors appear to act best when tumors express high levels of PD-L1 receptors (usually TPS >20 to TPS >50).

Keytruda was approved by FDA in June 2025 as a perioperative (before and after surgery) treatment for respectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.

In contrast to the results of the KEYNOTE-689, CEL-SCI’s Phase 3 study showed that Multikine treated patients whose tumors expressed low (Tumor Proportion Score [TPS <10]) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65], p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI’s Phase 3 study had low to zero levels of PD-L1.

CEL-SCI believes Multikine leads to longer survival with no safety issues. Clinical investigations of Multikine, presented at ESMO (Europe Society for Medical Oncology) in October 2023, have demonstrated in the randomized controlled Phase III trial (RCT) the following in the target population:

	·	*risk of death cut in half at five years* versus the control;
	·	28.6% absolute 5-year overall survival benefit versus control (p=0.0015);
	·	0.349 hazard ratio vs control (95% CIs [0.18, 0.66], Wald p=0.0012);
	·	>35% rate of pre-surgery reductions and/or downstages (p<0.01); and
	·	low PD-L1 tumor expression (vs high PD-L1 where Keytruda and Opdivo work best).

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There were no demonstrable safety signals or toxicities observed in approximately 740 Multikine-treated subjects across multiple clinical trials. Adverse event (AE) and serious adverse event (SAE) incidences were not significantly different among treatment and control groups. There were no Multikine-related deaths, no Multikine-related delays of surgery, no Multikine-related interference with post-surgical treatment, and only two discontinuations. Multikine-related AEs before surgery were local and resolved after surgery. Although the literature reports that some of Multikine’s components may be toxic when administered systemically (e.g., TNFα, IFN γ, IL-1β), these toxicities did not emerge with Multikine, even at doses many times higher than those administered in the Phase III trial, primarily due to Multikine’s delivery by local injection and dosage.

CEL-SCI published its data as abstracts and posters at the annual conferences for the 2022 American Society of Clinical Oncology (ASCO), 2022 and 2023 European Society for Medical Oncology (ESMO), the 2023 European Head and Neck Society’s (EHNS’s) annual European Conference on Head and Neck Oncology (ECHNO), the 2023 European Society for Therapeutic Radiology and Oncology (ESTRO), the 2023 American Head and Neck Society (AHNS), 2024 ESMO Congress and in the peer reviewed journal Pathology Oncology Research (POR) 2025.

In March 2025, CEL-SCI published a comprehensive presentation of results from the Phase 3 trial in the peer reviewed journal Pathology and Oncology Research (POR). The article is titled “Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study” and included new data on quality of life, in addition to improved overall survival (OS) in the Multikine-treated low-risk patients with a 46.5 months median OS advantage over low-risk control (treated with standard of care only, SOC).

	·	As a neoadjuvant therapy, patients were treated with Multikine before surgery. Pre-surgery objective early response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders (which included 5 complete responders following 3-weeks of Multikine treatment) in the Multikine treated + standard of care group and zero responders (none reported by investigators) in the control group, which received the standard of care treatments only (i.e., surgery plus radiotherapy or surgery plus chemoradiotherapy; with cisplatin as the chemotherapeutic agent per the study protocol and NCCN Guidelines).
	·	Quality of life improvements included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing.
	·	Complete responders to Multikine treatment reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) quality of life measures.
	·	89.4% of partial responders to Multikine reported improved quality of life measures.

These Quality of Life (QoL) improvements were self-reported by study participants and were sustained throughout the 3-years follow-up post SOC administration in which data on quality of life was systematically measured by EORTC validated QoL instruments specifically designed to measure QoL in Head and Neck Cancer patients.

Multikine works by inducing pre-surgical responses. CEL-SCI observed statistically significant pre-surgical responses after Multikine treatment, and therefore CEL-SCI believes in the following:

	➢	Multikine causes pre-surgical responses;
	➢	Pre-surgical responses lead to longer life;
	➢	Therefore, selecting more patients predicted to have a pre-surgical response should lead to much better survival in the target population.

A “pre-surgical response” is a significant change in disease before surgery. CEL-SCI saw two kinds of responses in the Phase III trial. First, there were “reductions” in the size of the tumor—a reduction of 30% or more qualified as a “pre-surgical reduction” or “PSR” for short. Second, there were disease “downstages” (e.g., the disease improved from Stage IV to Stage III) pre-surgery. CEL-SCI calls this a “pre-surgical downstaging” or “PSD” for short. CEL-SCI’s 2022 ESMO cancer conference presentation reported on PSR, and CEL-SCI’s new 2023 ESMO presentation reported on PSD and POR 2025.

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Across the whole Phase III trial, PSRs were seen in 8.5% of Multikine patients compared to none in the control group. PSDs were seen in 22% of Multikine patients as compared to 13% in the control group. Because Multikine was the only therapy given to these patients before surgery, it is CEL-SCI’s strong belief that Multikine had to be the cause of the higher rates of PSR and PSD. These data are presented visually below. The taller blue columns show PSR and PSD rates in all 529 Multikine-treated patients in the Phase III trial, and the gray columns show PSR and PSD rates for all 394 control patients.

It was not enough for CEL-SCI to show that Multikine likely leads to PSRs and PSDs as compared to a control group, CEL-SCI also had to test if PSRs and PSDs lead to improved survival. CEL-SCI’s Phase III trial demonstrated that PSR patients were 72% likely to be alive after five years, whereas control patients were only about 49% likely to be alive after five years. Patients with PSD saw similar improvement in CEL-SCI’s Phase III trial. Their five-year chance of survival was approximately 68%. Therefore, CEL-SCI believes that the Phase III trial demonstrated that those patients who had PSR or PSD resulting from Multikine lived longer than those who were not treated with Multikine. It is important to note that these results are from the entire Phase III study population, not from a subgroup. The likelihood of living at least five years is shown in the graphic below for patients with PSR (blue), patients with PSD (orange) and control patients who did not receive Multikine (gray).

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Multikine cut the 5-year risk of death in half in the target population. CEL-SCI’s results show that Multikine can cut the risk of death in half at five years versus the control group in the target population. Survival increased from 45% in the control group to 73% in the Multikine group at five years. This means the risk of death fell to 27% in the Multikine group from 55% in the control, shown below.

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Another way to see the survival benefit of Multikine in the target population is the Kaplan-Meier curve from our ESMO ’23 poster, shown below. On the vertical axis is the probability of survival and the horizontal axis is time in months. The blue Multikine line is far above the green control line, meaning the chance of survival is much higher in the Multikine group at every point in time compared to the control. These results had a low (log rank) p-value of 0.0015, which is very significant as a statistical matter.

CEL-SCI’s physician consultants have informed CEL-SCI that the early separation of these two survival curves (e.g., at 12 months) adds validation to the potential positive effects of Multikine.

Another measure of survival benefit is called the “hazard ratio,” which compares the rate of an event (chances) of dying between two different groups. Here, in the Multikine target population, the hazard ratio was 0.35, which means that deaths occurred in the Multikine group about one-third as frequently as in the control group. It is also important to note that the hazard ratio’s 95% confidence interval remained far below 1.0 (which would mean parity between the compared groups). In the case of Multikine, statistically speaking, there is a 95% chance that the hazard ratio would fall between 0.18 and 0.66 if Multikine were tested in the target population in another study. A hazard ratio of 0.66 as the “so called worst case scenario” (the upper limit of the 95% confidence interval – for the hazard ratio – in this case) is still below (better) than the hazard ratio required for most drug approvals.

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These positive survival outcomes—increased overall survival, reduced risk of death, widely separated Kaplan-Meier curves with early separation, low hazard ratio, low p-values, low confidence intervals—CEL-SCI believes were driven by high PSR/PSD rates in the target population, as shown in the graphic below:

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CEL-SCI relies on all of these data together to support its plan to request accelerated/conditional approval in the new target population without waiting until the completion of another clinical trial. CEL-SCI’s regulatory strategy going forward is to seek approval of Multikine following full enrollment of its confirmatory study wherever possible.

CEL-SCI applied to the FDA for a 212-patient randomized controlled confirmatory registration study focusing only on those patients in the target population, which accounts for approximately 100,000 patients worldwide per year. CEL-SCI is moving forward with a Phase 3 confirmatory registration study of Multikine in the target population.

	·	The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone.

	·	If approved as a pre-surgical treatment, CEL-SCI believes Multikine should be added to the standard of care for the target population in this unmet medical need.

	·	CEL-SCI believes that the confirmatory study has a high likelihood of success based on the large survival benefit that has already been observed in the target population from the completed Phase III study. The planned confirmatory study will be much smaller—less than a quarter the size of the prior study— and will focus on the patients who saw the greatest survival benefit when treated with Multikine.

Why Do We Believe Our Confirmatory Study Will Be Successful?

An “unmet need” is a factor for approval considered by all major regulatory bodies worldwide. In the Multikine target population, there is also a great unmet need for improved survival. The current standard of care provides only about a 50/50 chance of surviving five years, whereas Multikine could increase that survival rate to over 70% in the target population based on the Phase III data. Chemotherapy (in addition to radiotherapy following surgery) has improved survival outcome for some head and neck patients, but chemotherapy is only indicated for high-risk patients, who are not likely to fall within the Multikine target population. Currently available immunotherapies are given after surgery or where surgery is not indicated, in contrast to Multikine, which is given before surgery to patients with resectable tumors. Available checkpoint inhibitors work best on tumors with high PD-L1 expression, whereas Multikine works best in tumors with low PD-L1 expression. Therefore, Multikine’s target population is underserved, and will continue to be underserved, by current therapies.

The major regulatory bodies with whom we are working, U.S. FDA, Health Canada, European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) all have conditional approval pathways designed for situations where the target population has not been fully tested prospectively and there is strong data supporting clinical benefit for patients. The reason is that regulators understand that in many cases patients should not have to wait for additional data before being offered the chance to benefit from a new drug, especially if the drug has been shown to be safe. Every situation is different and depends on the specific facts.

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IN CONCLUSION

	·	Strong survival data: Multikine-treated patients in the target population had a 73% 5-year survival vs a 45% 5-year survival in the control group who did not receive Multikine in the Phase III study. In addition, no safety signals or toxicities versus standard of care. The Hazard ratio is 0.35 with an upper limit (95% Confidence interval) of 0.66.

	·	Addressing an unmet medical need: Multikine focuses on the 70% of patients (based on our 928 patient Phase III study) not well served by Keytruda or by other immune checkpoint inhibitors, at present.

	·	Multikine’s Target Population: The confirmatory registration study will focus on newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).

	·	FDA pathway: CEL-SCI’s goal is to begin the 212-patient confirmatory registration study as soon as the needed capital has been raised, with full enrollment about 18-24 months later with the potential to seek early approval after full enrollment.

Liquidity and Capital Resources

CEL-SCI has relied primarily upon capital generated from the public and private offerings of its common stock. In addition, CEL-SCI has utilized short-term loans to meet its capital requirements. Capital raised by CEL-SCI has been used to acquire an exclusive worldwide license to use, and later purchase, certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system and for clinical trials. Capital has also been used for patent applications, debt repayment, research and development, administrative costs, and for CEL-SCI’s laboratory and manufacturing facilities. CEL-SCI does not anticipate realizing significant revenues until it enters into licensing arrangements regarding its technology and know-how or until it receives regulatory approval to sell its products (which could take a number of years). As a result, CEL-SCI has been dependent primarily upon the proceeds from the sale of its securities to meet all of its liquidity and capital requirements and anticipates having to do so in the future.

The cost of the confirmatory registration study is estimated to be about $30-$35 million. 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. 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.

During the six months ended March 31, 2025, 247,583 pre-funded warrants were exercised. No warrants were exercised during the six months ended March 31, 2026.

During the six months ended March 31, 2026, the Company’s cash decreased by approximately $9.1 million. The significant components of this decrease included cash used to fund the Company’s regular operations of approximately $8.0 million and approximately $1.1 million in payments on the Company’s finance lease obligations.

During the six months ended March 31, 2025, the Company’s cash decreased by approximately $2.8 million. Significant components of this decrease included net proceeds from the December 2024 and March 2025 financing of $6.7 million offset by cash used to fund the Company’s regular operations of approximately $8.5 million and approximately $1.0 million in payments on the Company’s finance lease obligations.

Primarily as a result of CEL-SCI’s losses incurred to date, its expected continued future losses, and limited cash balances, CEL-SCI has included a disclosure in its financial statements expressing substantial doubt about its ability to continue as a going concern.

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Results of Operations and Financial Condition

The Company incurred a net operating loss of approximately $10.7 million for the six months ended March 31, 2026. This net operating loss consists of significant non-cash expenses including approximately $1.0 million in share-based compensation to employees and non-employees, and approximately $1.9 million in depreciation and amortization expense.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including the development of our products, and include:

	·	employee‑related expenses, including salaries, related benefits and stock‑based compensation expense for employees engaged in research and development functions;
	·	fees paid to consultants for services directly related to our product development and regulatory efforts;
	·	expenses incurred under agreements with Clinical Research Organizations, or CROs, and consultants that conduct and provide supplies for our clinical studies and clinical trials;
	·	costs associated with clinical activities and development activities; and
	·	costs related to compliance with regulatory requirements.

The following table summarizes our research and development expenses for the six months ended March 31, 2026 and 2025:

SEC Form 10-Q filed by Cel-Sci Corporation