CVM 10-K & 10-Q changes, risk factors and insider trading

All of CEL-SCI’s projects are under development. As a result, CEL-SCI cannot predict when it will be able to generate any revenue from the sale of any of its products. In August 2025, CEL-SCI filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority (SFDA) for Multikine in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies, Dallah Pharma.

Results of Operations and Financial Condition

The Company incurred a net operating loss of approximately $26.4$24.8 million for the twelve months ended September 30, 2024.2025. This net operating loss consists of significant non-cash expenses accounting for approximately 30%27% of the operating loss. The non-cash operating expenses include approximately $4.3$2.7 million in stock-based employeecompensation compensationto employees and non-employees and approximately $4.0$3.9 million in depreciation and amortization expense.

CEL-SCI has relied primarily upon capital generated from the public and private offerings of its common stock and convertible notes.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. During fiscal yearyears 20242025 and 2023,2024, CEL-SCI raised net proceeds of approximately $21.2$25.0 million and $6.3$21.2 million, respectively, through a combination of the sale of common stock and the exercise of warrants.

During the yearfiscal years ended September 30, 2025 and 2024, 5,680,000733,834 and 189,335 pre-funded warrants were exercised.exercised, During the year ended September 30, 2023, the following chart lists the warrants that were exercised and the proceeds received.respectively.

Supplies are purchased for use in the Company’s manufacturing and R&D efforts. During the year ended September 30, 2024,2025, the supplies increaseddecreased by approximately $0.2$1.0 million primarily due to supplies used in supportthe manufacturing of the workclinical tolot validate and preparein the manufacturingthird facilityquarter to produce Multikine forof the confirmatorycurrent registrationfiscal study and before the Company’s Biologics License Application (BLA) can be submitted to the FDA.year.

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 fivesix input variables: the strike price of an option, the current stock price, the time to expiration, the risk-free raterate, 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 cost of the confirmatory registration study is currently 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 sixnine months ended MarchJune 31,30, 2025,2026, the Company’s cash decreased by approximately $2.8$4.4 million. SignificantThe significant components of this decrease included net proceeds from the Decemberpurchase 2024of stock by officers and Marchthe 2025June 2026 financing of $6.7$9.3 million offset by cash used to fund the Company’s regular operations of approximately $8.5$12.0 million and approximately $1.0$1.7 million in payments on the Company’s finance lease obligations.

The Company incurred a net operating loss of approximately $10.7$16.3 million for the sixnine months ended MarchJune 31,30, 2026. This net operating loss consists of significant non-cash expenses including approximately $1.0$1.6 million in share-based compensation to employees and non-employees, and approximately $1.9$2.9 million in depreciation and amortization expense.

The following table summarizes our research and development expenses for the sixnine months ended MarchJune 31,30, 2026 and 2025:

The following table summarizes our research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025:

During the sixnine months ended MarchJune 31,30, 2026, the research and development expenses decreased by approximately $1.0$1.1 million, or 12%,9%, compared to the sixnine months ended MarchJune 31,30, 2025. This decrease is primarily due to a $0.4 million decrease in clinical studies costscosts, asand a result of preparing the confirmatory study for enrollment in the prior period, $0.4$0.9 million decrease in costs incurred for supplies and materials usedused, andoffset aby decreasean increase of $0.2 million of employee stock compensation expense compared to the prior period.

During the three months ended MarchJune 31,30, 2026, the research and development expenses decreased by approximately $0.3$0.1 million, or 6%,2%, compared to the three months ended MarchJune 31,30, 2025. This decrease is primarily due to a $0.2$0.6 million decrease in costs incurred for supplies and materials usedused, andoffset by a $0.1$0.5 million decreaseincrease in employee stock compensation expense compared to the prior period.

During the sixnine months ended MarchJune 31,30, 2026, general and administrative expenses decreased by approximately $1.6$1.4 million, or 33%,22%, compared to the sixnine months ended MarchJune 31,30, 2025. This decrease is primarily due to a $1.1 million decrease in costs related to public relations,relations and a $0.3 million decrease in employee stock compensation, and a $0.2 million decrease in other general and administrative expenses.compensation.

During the three months ended MarchJune 31,30, 2026, general and administrative expenses decreasedincreased by approximately $0.8$0.2 million, or 34%,9%, compared to the three months ended MarchJune 31,30, 2025. This decreaseincrease is primarily due to a $0.6$0.4 million decreaseincrease in costs related to publiclegal, relations,consulting and accounting services, offset by a $0.1 million decrease in employee stock compensation, and a $0.1 million decrease in other general and administrative expenses.

During the sixnine months ended MarchJune 31,30, 2026, net interest expense decreased by approximately $0.1$0.2 million, or 42%,40%, compared to the sixnine months ended MarchJune 31,30, 2025. This decrease is primarily due to less interest paid on leases as higher principal balances have been paid over the last period and higher interest and dividend income received in the current period.

During the three months ended MarchJune 31,30, 2026, net interest expense decreased by approximately $0.1 million, or 34%,35%, compared to the three months ended MarchJune 31,30, 2025. This decrease is primarily due to less interest paid on leases as higher principal balances have been paid over the last period and higher interest and dividend income received in the current period.