CEL-SCI advances in head and neck cancer treatment study

VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM), whose shares have declined nearly 85% over the past year according to InvestingPro data, today shared an update on its ongoing efforts to gain marketing approval for Multikine, an investigational therapy for head and neck cancer. The company announced it has received feedback from the U.S. Food and Drug Administration (FDA) regarding the Statistical Analysis Plan (SAP) for its confirmatory Registration Study of Multikine as a neoadjuvant treatment in patients with newly diagnosed, previously untreated locally advanced head and neck cancer. The FDA has indicated that no further response is needed from CEL-SCI to their comments on the SAP, and currently, there are no comments on the study protocol.

The company’s 73,000 square foot manufacturing facility has the capacity to produce over 12,000 Multikine treatments annually, with an investment of over $200 million in its development and proprietary biologic manufacturing processes. With a current ratio of 1.07 and operating at an EBITDA loss of $24.6 million over the last twelve months, CEL-SCI is engaging in discussions for potential partnerships to secure non-dilutive funding for the 212-patient confirmatory Registration Study necessary to bring Multikine to market.

Multikine has shown promising results in a completed Phase 3 study, which demonstrated a significant survival benefit over control in patients with locally advanced, resectable head and neck cancer. Analysts tracking the company on InvestingPro have set price targets ranging from $6 to $10, reflecting potential upside if the therapy receives approval. The 5-year survival rate was 73% for those treated with Multikine followed by the standard of care, compared to 45% for control patients who only received the standard treatments. The survival advantage was particularly notable in patients with low to zero PD-L1 tumor expression and no nodal involvement.

CEL-SCI’s CEO Geert Kersten highlighted the recent focus on PD-L1 as a diagnostic biomarker and the potential for Multikine to treat approximately 70% of head and neck cancer patients who have low PD-L1 tumor expression and for whom current PD-L1 inhibitors are ineffective. The company aims to target this patient population in its confirmatory Registration Study.

Multikine is designed to enhance the immune system’s response to cancer before the onset of surgery, radiotherapy, and chemotherapy. The investigational therapy has been administered to over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.

This news is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those projected due to various factors, including the ability to replicate clinical results, receive regulatory approvals, manufacture products, raise necessary capital, and finalize partnership agreements. InvestingPro analysis reveals a weak overall financial health score of 1.41, with additional metrics and insights available to subscribers, including real-time financial data and expert analysis to help evaluate investment opportunities in the biotech sector.

In other recent news, CEL-SCI Corporation has announced the commencement of its Confirmatory Registration Study for Multikine, aimed at treating head and neck cancer. This follows the submission of the final clinical protocol to the FDA, with the study designed to confirm earlier Phase 3 findings that showed a significant increase in 5-year survival rates for patients treated with Multikine. The study will involve 212 patients and is expected to complete enrollment by the second quarter of 2026. Additionally, CEL-SCI has successfully completed a $5 million stock offering, which will support the continued development of Multikine, as well as general corporate purposes and working capital needs. The offering consisted of over 16 million shares of common stock at $0.31 per share, with ThinkEquity acting as the sole placement agent. The funds raised are crucial for advancing the company’s flagship treatment, which has already been administered to over 740 patients. The FDA has granted Orphan Drug designation to Multikine for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. These developments reflect CEL-SCI’s ongoing efforts in cancer immunotherapy treatments.

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