On February 18, 2026 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended December 31, 2025, as well as key recent clinical and corporate developments.
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"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.
(Press release, Cel-Sci, FEB 18, 2026, View Source [SID1234662767])