CEL-SCI Reports Fiscal First Quarter 2026 Results

Key Terms

pivotal medical

Pivotal describes a test, event, or decision that is decisive for whether a product, idea, or plan moves forward—most often used for a late-stage clinical trial or a regulatory review whose result determines approval or rejection. Investors care because a positive outcome typically unlocks major value (like market access or sales), while a negative one can sharply reduce expected future revenue; think of it as the final exam that decides whether a project passes or fails.

registration study medical

A registration study is a late-stage clinical trial designed to prove a drug or medical device is safe and effective enough for regulatory approval. Think of it as the final exam before a product can be sold: its results directly determine whether authorities will grant market authorization, which in turn can make or break future sales, revenue forecasts and investment decisions. Investors watch these studies for clear go/no-go signals.

Breakthrough Medicine Designation regulatory

A breakthrough medicine designation is a formal status granted by a drug regulator that signals a new treatment shows substantial promise for a serious condition and qualifies for faster, more intensive review. For investors it matters because the designation can shorten development time, reduce some regulatory hurdles and raise the likelihood of eventual approval, similar to giving a promising product a VIP fast‑track through the approval process which can boost a company’s value and investor interest.

accelerated approval regulatory

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

confirmatory study medical

A confirmatory study is a carefully designed medical trial meant to validate earlier positive results by testing whether a drug or device reliably works and is safe in a larger, more rigorous group of people. For investors it is like a final dress rehearsal before regulatory approval: a successful outcome greatly reduces risk and can unlock approvals, partnerships and future sales, while failure can sharply reduce a product’s commercial value.

standard of care medical

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

Phase 3 study medical

A phase 3 study is the large-scale clinical trial that tests whether a new drug or medical treatment actually works and is safe in a broad group of patients, typically after earlier smaller tests. Investors watch these studies like a final dress rehearsal because their successful completion is often required for regulatory approval and market access; positive or negative results can sharply change a company’s future sales prospects and stock value.

Set to Commence Patient Enrollment Summer of 2026 in Pivotal U.S. FDA Head and Neck Cancer Registration Study

Entering Saudi Oncology Market, Potentially Through Key Partnerships to Advance Multikine Approval and Commercialization

VIENNA, Va.--(BUSINESS WIRE)--

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for three months ended December 31, 2025, as well as key recent clinical and corporate developments.

“CEL-SCI is focused on two major value-driving milestones in the near term—starting enrollment in our U.S. FDA confirmatory Registration trial of Multikine in head and neck cancer and advancing Multikine globally in markets including Saudi Arabia. We plan to commence enrollment this summer in our confirmatory study of Multikine in head and neck cancer. Data from this study will be submitted as part of registration applications to allow commercialization and sale of Multikine in the U.S. and other key global markets. Prior studies have shown that pre-surgical tumor responses, such as tumor size reduction and downgrading of the disease by a physician, following Multikine treatment predict substantial survival benefit for the patients. We believe that these pre-surgical tumor responses after the three-week treatment with Multikine, before any other treatment has been administered, could be the basis of an accelerated marketing application for Multikine,” stated CEL-SCI CEO, Geert Kersten. “Concurrently, we have been active in Saudi Arabia, pursuing the potential for Multikine to be available to patients with head and neck cancer following the filing for Breakthrough Medicine Designation there in the second half of 2025.”

Clinical and Corporate Developments:

• CEL-SCI, in conjunction with its CRO Ergomed, expects to start patient enrollment in the summer of 2026 for the 212-patient U.S. Confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection)* in newly diagnosed locally advanced head and neck cancer patients. Pre-surgical tumor responses, following a very short treatment with Multikine, can be assessed within weeks after full enrollment for rapid confirmation of Multikine’s anti-tumor activity, creating the potential for early accelerated approval in the U.S. CEL-SCI plans to seek accelerated approval based on early tumor response data. Ergomed is providing comprehensive global clinical operations support to ensure the timely and efficient execution of the trial. CEL-SCI and Ergomed are building on their previous successful collaboration for the global Phase 3 trial of Multikine, the largest study ever conducted in head and neck cancer. In the Phase 3 study, Multikine treatment, given right after diagnosis and before any other treatment, significantly increased the 5-year overall survival rate of the treated patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
• CEL-SCI is actively engaged with potential partners and investors in Saudi Arabia to advance Multikine to market. A Breakthrough Medicine Designation application for Multikine for the treatment of head and neck cancer was submitted to the Saudi Food and Drug Authority (SFDA). The designation, if granted, will allow patient access to Multikine for the indication, as well as reimbursement/sale in Saudi Arabia.

Financial Results

During the three months ended December 31, 2025, research and development expenses were $3.7 million compared to $4.4 million for the three months ended December 31, 2024. General and administrative expenses for the three months ended December 31, 2025 were $1.7 million compared to $2.5 million for the three months ended December 31, 2024. Net loss was $5.5 million for three months ended December 31, 2025 compared to $7.1 million in the prior year period. Cash used for operating activities during the quarter was $4.0 million. Basic and diluted net loss per common share was $0.68 for the three months ended December 31, 2025, compared to $3.25 for the three months ended December 31, 2024.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line neoadjuvant (pre-surgery) cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and agreed to the conduct of a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2025. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

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COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation