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CEL-SCI (NYSE American: CVM) reported its Q2 fiscal 2024 financial results. Key clinical and corporate developments included FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer, following strong Phase 3 results with a 28% survival benefit at 5 years. The new study will enroll 212 patients.
Financial highlights for the period ending March 31, 2024: R&D expenses decreased by $2.5M to $9M, G&A expenses increased slightly to $4.6M, and net loss narrowed by $2.2M to $14M. CEL-SCI also raised $7.75M through a public stock offering. Other notable developments: completion of a state-of-the-art manufacturing facility and a key waiver from the European Medicines Agency for Multikine's commercialization in Europe.
CEL-SCI has received FDA approval for a confirmatory study of its cancer immunotherapy Multikine for head and neck cancer patients, based on strong Phase 3 data showing a 73% survival rate with Multikine. The study will enroll 212 patients and aims to confirm the results of the Phase 3 trial, paving the way for potential approval. The FDA acknowledged the unmet need for improved therapies in this patient population, supporting approval for Multikine.