CEL-SCI Corporation has announced the pricing of a $5 million public offering to advance its cancer immunotherapy candidate Multikine. The Phase 3 cancer immunotherapy company, listed on the NYSE American under the ticker CVM, will sell 16.13 million shares of common stock (or pre-funded warrants) at $0.31 per share.
The Vienna, Virginia-based company expects to close the offering on December 31, 2024, with ThinkEquity acting as the sole placement agent. CEL-SCI plans to use the proceeds to continue development of Multikine, along with general corporate purposes and working capital needs.
Multikine Development Program
Multikine (Leukocyte Interleukin, Injection) represents a novel approach to cancer treatment as a true first-line therapy. The immunotherapy has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
The company's approach is based on the principle that boosting a patient's immune system while it remains intact should provide the greatest impact on survival. Multikine is designed to help the immune system target tumors at a time when the immune response is still relatively robust and potentially more effective at attacking cancer cells.
FDA-Approved Registration Study
Based on data from a completed randomized controlled Phase 3 study, the FDA has concurred with CEL-SCI's target patient selection criteria and authorized a confirmatory Registration Study. This study will enroll 212 patients with specific characteristics:
- Newly diagnosed locally advanced primary head and neck cancer
- Treatment-naïve resectable cases
- No lymph node involvement (determined via PET scan)
- Low PD-L1 tumor expression (determined via biopsy)
This patient population represents approximately 100,000 patients annually, according to the company.
Strategic Financing
The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC.
"This financing strengthens our ability to advance Multikine through its critical development stages," said Gavin de Windt of CEL-SCI Corporation. "We remain committed to our innovative approach of enhancing the body's natural immune response against cancer."
About Multikine
Multikine is an investigational immunotherapeutic agent that has not yet been licensed or approved for sale by the FDA or any regulatory agency. The proprietary name is subject to FDA review in connection with the company's future anticipated regulatory submission for approval.
The therapy represents a different approach to cancer treatment by focusing on strengthening the immune system before it becomes compromised by other cancer treatments such as surgery, radiation, and chemotherapy. This approach aligns with growing interest in immunotherapy as a cornerstone of cancer treatment strategies.
CEL-SCI maintains operations in Vienna, Virginia, and near Baltimore, Maryland, where it continues its research and development efforts focused on immunotherapy approaches to cancer treatment.
