CEL-SCI Corporation, a clinical-stage cancer immunotherapy company, has successfully priced an underwritten public offering of 2 million shares of its common stock at $2.50 per share. The offering, announced on May 22, 2025, is expected to generate $5 million in gross proceeds before deducting underwriting discounts and other expenses.
The Vienna, Virginia-based company has also granted underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price. ThinkEquity is serving as the sole book-running manager for the transaction, which is expected to close on May 23, 2025, subject to customary closing conditions.
Advancing Multikine Immunotherapy
CEL-SCI intends to use the net proceeds to fund the continued development of its flagship product, Multikine (Leukocyte Interleukin, Injection), along with general corporate purposes and working capital. Multikine represents a novel approach to cancer treatment, designed to be administered immediately after diagnosis and before conventional treatments like surgery, radiotherapy, and chemotherapy.
The company's therapeutic strategy is based on the premise that boosting a patient's immune system while it remains relatively intact—before it becomes compromised by conventional cancer treatments—may provide the greatest impact on survival. Multikine is specifically designed to help the immune system target tumors during this critical window.
FDA-Approved Registration Study
Based on data from a completed randomized controlled Phase 3 study, the FDA has given CEL-SCI approval to conduct a confirmatory Registration Study for Multikine. The immunotherapy has already received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
The upcoming study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients. The carefully defined patient population will include those with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). According to CEL-SCI, this specific patient group represents approximately 100,000 patients annually.
Dr. Geert Kersten, CEO of CEL-SCI, commented on the significance of the funding: "This capital raise strengthens our financial position as we prepare to launch our Registration Study for Multikine. We believe our approach of activating the immune system before it's compromised by conventional treatments represents a paradigm shift in cancer therapy."
Clinical Experience and Development Status
To date, Multikine has been administered to over 740 patients in clinical trials. The immunotherapy is still investigational and has not been licensed or approved for sale by the FDA or any other regulatory agency. Its safety and efficacy have not been established for any use, and the proprietary name remains subject to FDA review in connection with the company's future anticipated regulatory submission for approval.
The securities for this offering are being sold pursuant to a shelf registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission on July 1, 2022, and declared effective on July 15, 2022.
Market Impact and Future Outlook
The financing comes at a critical juncture for CEL-SCI as it prepares to advance Multikine through its final stages of clinical development. The company's stock, traded on the NYSE American under the symbol CVM, has attracted investor interest due to the potential of its immunotherapy approach.
Industry analysts note that successful immunotherapies for head and neck cancer could address significant unmet needs in a market projected to grow substantially in the coming years. Head and neck cancers represent the sixth most common cancer type globally, with limited treatment options for patients with advanced disease.
With operations in Vienna, Virginia, and near Baltimore, Maryland, CEL-SCI is positioned to continue its clinical development program with the additional funding secured through this public offering.
