CEL-SCI plans summer 2026 enrollment in Multikine head and neck cancer registration study

CEL-SCI reported financial results for the three months ended December 31, 2025 and said it expects to start patient enrollment in the summer of 2026 for the 212-patient U.S. confirmatory registration study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The company said data from the 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, and that it plans to seek accelerated approval based on early tumor response data.

The company said 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. 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 said it 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, and the company said the designation, if granted, will allow patient access to Multikine for the indication, as well as reimbursement and sale in Saudi Arabia.

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 were $1.7 million compared to $2.5 million, net loss was $5.5 million compared to $7.1 million, cash used for operating activities during the quarter was $4.0 million, and basic and diluted net loss per common share was $0.68 compared to $3.25.

Multikine has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. Based on data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with the company's target patient selection criteria and agreed to the conduct of a confirmatory registration study which will enroll 212 patients.