CEL-SCI Prices $2.5M Offering to Advance Cancer Immunotherapy Development
CEL-SCI Corporation (NYSE American: CVM), a biotechnology company focused on cancer immunotherapy, has announced the pricing of a best-efforts public offering to raise approximately $2.56 million. The offering comprises 16,000,000 shares of common stock or pre-funded warrants in lieu of common stock, and is expected to close on March 18, 2025, subject to customary closing conditions.
The company plans to utilize the net proceeds from this financing to further the development of its lead investigational cancer immunotherapy, Multikine, as well as for general corporate purposes and working capital. ThinkEquity is acting as the sole placement agent for the offering.
This latest capital raise comes as CEL-SCI continues to advance Multikine through the regulatory approval process. The company remains committed to demonstrating its potential to improve survival outcomes in head and neck cancer patients.
Details of the Offering
CEL-SCI’s offering is being conducted under a shelf registration statement filed on Form S-3 (File No. 333-265995), which was submitted to the U.S. Securities and Exchange Commission (SEC) on July 1, 2022, and became effective on July 15, 2022. The offering will be made exclusively through a written prospectus.
A final prospectus supplement outlining the terms of the offering will be filed with the SEC and made available on its website at www.sec.gov. Investors can also obtain copies of the prospectus supplement from ThinkEquity, 17 State Street, 41st Floor, New York, NY 10004, upon availability.
This announcement is for informational purposes only and does not constitute an offer to sell or a solicitation to buy any securities. The sale of these securities is restricted to jurisdictions where such an offering is legally permitted.
Multikine: A Novel Approach to Cancer Immunotherapy
CEL-SCI’s lead candidate, Multikine (Leukocyte Interleukin, Injection), is an investigational cancer immunotherapy designed to activate the immune system before patients undergo traditional treatments such as surgery, radiation, or chemotherapy.
The therapy is administered immediately after diagnosis to leverage the immune system’s natural strength before it becomes weakened by conventional cancer treatments. CEL-SCI believes this approach could significantly enhance survival rates by priming the immune system to attack tumors early in the treatment process.
Multikine has undergone extensive clinical evaluation, including a randomized, controlled Phase 3 study involving over 740 patients with squamous cell carcinoma of the head and neck. The therapy has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for its potential as a neoadjuvant therapy in this patient population.
Next Steps: A Confirmatory Registration Study
Based on findings from the completed Phase 3 trial, the FDA has granted CEL-SCI approval to proceed with a confirmatory Registration Study. This new study will further evaluate Multikine in a targeted patient population, enrolling 212 newly diagnosed, locally advanced head and neck cancer patients who meet the following criteria:
- Primary treatment-naïve (patients who have not yet received any treatment for their cancer)
- Resectable tumors (cancers that can be surgically removed)
- No lymph node involvement, as determined via PET scan
- Low PD-L1 tumor expression, as confirmed through biopsy
These eligibility criteria align with the patient population that demonstrated the strongest response to Multikine in previous studies. Approximately 100,000 patients per year in the U.S. fit this profile, highlighting the significant potential market for the therapy.
Funding to Support Continued Development
The proceeds from this financing will primarily support the continued clinical development of Multikine, ensuring that CEL-SCI remains on track with its regulatory and commercialization plans.
In addition to advancing Multikine, the funds will also be allocated toward general corporate operations and working capital needs, enabling the company to maintain momentum as it works toward securing FDA approval and potential market entry.
CEL-SCI’s Mission and Operational Footprint
CEL-SCI is committed to developing innovative immunotherapies that leverage the body’s natural defense mechanisms to combat cancer. The company operates from Vienna, Virginia, with additional facilities near Baltimore, Maryland.
With over 50 years of experience in immunotherapy research, CEL-SCI continues to push the boundaries of cancer treatment by exploring new strategies to enhance the effectiveness of immune-based therapies.
