CEL-SCI Corporation develops cancer immunotherapy programs centered on Multikine (Leukocyte Interleukin, Injection), an investigational neoadjuvant therapy for squamous cell carcinoma of the head and neck. Company news commonly covers Multikine regulatory interactions, FDA Orphan Drug designation for neoadjuvant use, confirmatory registration-study preparation, and the company's positioning of the therapy before surgery, radiation, and chemotherapy.
Updates also include financial results, public equity offerings used to fund Multikine development, investor presentations, and regional commercialization or regulatory-affairs agreements, including activity in Saudi Arabia. CEL-SCI's disclosures often connect clinical development with working-capital needs and potential international market access.
CEL-SCI Corporation (NYSE: CVM), a clinical stage cancer immunotherapy company, has announced plans for a proposed underwritten public offering of common stock and/or pre-funded warrants. The company intends to use the proceeds to fund the continued development of their Multikine product, along with general corporate purposes and working capital. ThinkEquity will serve as the sole book-running manager for the offering.
The securities will be offered through a shelf registration statement on Form S-3 filed with the SEC. The offering's completion, size, and terms are subject to market conditions and are not guaranteed. A preliminary prospectus supplement and base prospectus will be available through the SEC website and ThinkEquity's offices.
CEL-SCI Corporation (CVM) has completed its Breakthrough Medicine Designation application for Multikine, an immunotherapy treatment for newly diagnosed head and neck cancer, for submission to the Saudi Food and Drug Authority (SFDA). The application will be submitted by CEL-SCI's prospective Saudi partner in the coming weeks.
Key highlights:
- Multikine increased 5-year survival rates to 73% vs 45% in standard care
- 5-year death risk reduced from 55% to 27%
- SFDA typically responds within 60 days
- If approved, Multikine could be available by Summer 2025
- Head and neck cancers represent 5% of Saudi Arabia's cancer cases
CEL-SCI Corporation (CVM) reported its fiscal Q2 2025 financial results and key developments. The company plans to file for Multikine approval with Breakthrough Therapy Designation in Saudi Arabia based on Phase 3 study data. The study showed significant quality of life improvements, with 95.1% of complete responders reporting improved QoL, and complete responders achieving 100% improvement in 60% of quality of life measures.
The company is preparing to launch a 212-patient Confirmatory Registration Study for Multikine in head and neck cancer patients, concurred by the FDA. CEL-SCI is also in discussions with potential partners. Financial results showed a net loss of $6.6 million for Q2 2025, compared to $7.2 million in the prior year period, with net loss per share improving to $0.08 from $0.14.
CEL-SCI (NYSE: CVM) has announced plans to submit a regulatory filing for Multikine cancer immunotherapy in Saudi Arabia following a successful meeting with the Saudi Food and Drug Authority (SFDA). The company will seek Conditional Approval with Breakthrough Therapy designation for Multikine as a neoadjuvant treatment for newly diagnosed locally advanced head and neck cancer.
The submission will be based on data from CEL-SCI's completed 928-patient randomized controlled Phase 3 study. The SFDA's typical response time for such applications is approximately 60 days after filing. The company is exploring partnerships with local Saudi companies for commercialization, clinical trials, and manufacturing facilities to serve the Middle East and North Africa (MENA) market.
This initiative aligns with Saudi Arabia's Vision 2030 National Biotechnology Strategy, which aims to establish the Kingdom as a regional biotech hub. The MENA region faces a significant health challenge, with head and neck cancer incidence expected to double by 2030, growing at twice the projected worldwide rate.
CEL-SCI (NYSE American: CVM) has received support for its strategy to seek early approval for Multikine in head and neck cancer treatment. A new study in Cancer Cell validates that pre-surgical tumor responses lead to improved survival outcomes.
Key findings from CEL-SCI's Phase 3 trial showed that patients treated with Multikine before surgery achieved a 73% five-year survival rate compared to 45% in the control group. The study demonstrated 45 objective early responders, including 5 complete pathological responders, with a significant 306% overall survival prolongation. Responders showed a notably lower death rate of 22.2% versus 54.1% for non-responders.
The company has received FDA approval for a 212-patient Confirmatory Registration Study to verify these results. Multikine is administered as a neoadjuvant therapy immediately after diagnosis and before surgery.
CEL-SCI (NYSE: CVM) has published new data from its Phase 3 study of Multikine in the Pathology and Oncology Research journal, showing significant quality of life improvements for head and neck cancer patients.
Key findings from the study revealed that 95.1% of complete responders to Multikine reported improved quality of life, with 100% improvement in 60% of measures. Additionally, 89.4% of partial responders reported enhanced quality of life metrics.
The quality of life improvements included:
- Reduction or elimination of head and neck pain
- Enhanced ability to eat, drink, and swallow
- Improved self-care capabilities
- Better emotional wellbeing
The study, which was the largest ever conducted for newly diagnosed locally advanced head and neck cancer, demonstrated 45 objective early responders in the Multikine treated group compared to zero in the control group. Multikine is now proceeding to a final confirmatory Registration Study.
CEL-SCI (NYSE American: CVM) has announced the closing of a $2.5 million best-efforts offering, consisting of 16,000,000 shares of common stock or pre-funded warrants. The offering's gross proceeds, before deducting placement agent fees and expenses, reached approximately $2,560,000.
The company plans to use the net proceeds to fund the continued development of Multikine, their cancer immunotherapy treatment, along with general corporate purposes and working capital. ThinkEquity served as the sole placement agent for this offering, which was conducted under CEL-SCI's effective shelf registration statement.
Multikine, which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients, is currently proceeding with a confirmatory Registration Study. This study will enroll 212 newly diagnosed patients with specific criteria, targeting a potential annual patient pool of about 100,000.
CEL-SCI (NYSE American: CVM) has announced a best-efforts offering of 16,000,000 shares of common stock or pre-funded warrants, expected to raise approximately $2.56 million in gross proceeds. The offering is set to close on March 18, 2025, with ThinkEquity acting as sole placement agent.
The company plans to use the net proceeds to fund the continued development of Multikine, their cancer immunotherapy treatment, along with general corporate purposes and working capital. The securities will be offered through a shelf registration statement on Form S-3.
Multikine, which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients, has been administered to over 740 patients. The FDA has approved a confirmatory Registration Study that will enroll 212 newly diagnosed head and neck cancer patients with specific criteria, targeting a potential annual patient pool of about 100,000.
CEL-SCI (NYSE: CVM) has received FDA clearance for its head and neck cancer Registration Study protocol for Multikine treatment. The FDA required no response to their comments on the Statistical Analysis Plan (SAP) submitted in December 2024.
The company's 73,000 square foot Multikine manufacturing facility can produce over 12,000 treatments annually, representing a $200 million investment in facility and processes. CEL-SCI is currently in discussions with potential partners for non-dilutive funding of the 212-patient confirmatory Registration Study.
The company's previous Phase 3 study involving 928 patients across 23 countries showed significant results: 73% five-year survival rate in the target patient population treated with Multikine before standard care, compared to 45% in the control group. Notably, Multikine shows promise for approximately 70% of head and neck cancer patients with low PD-L1 tumor expression, where current PD-L1 inhibitors are ineffective.