CEL-SCI to seek Saudi approval for cancer treatment

VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM), currently trading near its 52-week high of $2.39, is poised to apply for Conditional Approval of its cancer immunotherapy, Multikine, in Saudi Arabia following a promising meeting with the Saudi Food and Drug Authority (SFDA). According to InvestingPro data, analysts have set ambitious price targets ranging from $6 to $10 for the stock, despite the company’s current challenges with cash burn. The company’s CEO, Geert Kersten, announced Monday that based on the positive reception of their Phase 3 study data, they are preparing to submit a regulatory filing with the SFDA for Multikine as a pre-surgical treatment for head and neck cancer.

The Phase 3 study involved 928 patients and the submission will seek Conditional Approval with Breakthrough Therapy designation. The SFDA typically responds to such filings within 60 days. With an InvestingPro Financial Health Score of 1.85 (rated as "Fair"), and a moderate debt level with a debt-to-equity ratio of 0.98, the company’s financial position warrants monitoring as it pursues regulatory approvals.

In line with Saudi Arabia’s Vision 2030 and National Biotechnology Strategy, CEL-SCI is exploring partnerships for local Multikine manufacturing and distribution throughout the Middle East and North Africa (MENA) region. While the company’s stock has experienced significant volatility, with a -70% return over the past six months, successful expansion into the MENA region could present growth opportunities. Discover more detailed financial metrics and 8 additional ProTips with InvestingPro. The strategy aims to transform the Kingdom into a biotech hub, enhance self-sufficiency in biologics production, and reduce healthcare costs.

Head and neck cancer incidence in the MENA region is predicted to double by 2030, a rate twice as high as the global projected increase. In the Gulf Cooperation Council countries, the risk is estimated at 1.6%.

Multikine is designed to boost patients’ immune systems before they are compromised by surgery, radiotherapy, or chemotherapy. It has been administered to over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in certain head and neck cancer cases. CEL-SCI is also set to conduct a confirmatory Registration Study as per FDA guidance.

This news is based on a press release statement from CEL-SCI Corporation and does not constitute an endorsement of Multikine, which has not yet been approved for sale or proven safe or effective for any use by the FDA or any other regulatory agency.

In other recent news, CEL-SCI Corporation has shared significant updates on its Multikine therapy for head and neck cancer. The company has received feedback from the U.S. Food and Drug Administration (FDA) regarding the Statistical Analysis Plan for its confirmatory Registration Study of Multikine, indicating no further response is needed from CEL-SCI on the study protocol. This study aims to confirm previous Phase 3 findings, which showed a substantial increase in 5-year survival rates for patients treated with Multikine compared to standard care. CEL-SCI plans to target patients with newly diagnosed resectable stage 3 and 4 head and neck cancer, no lymph node involvement, and low PD-L1 tumor expression. The company has invested over $200 million in its manufacturing facility, capable of producing over 12,000 Multikine treatments annually. Enrollment for the 212-patient trial is anticipated to be completed by Q2 2026, with early tumor response data being used to seek accelerated approval. CEL-SCI is also in discussions to secure non-dilutive funding for the study and has received positive feedback from head and neck cancer physicians. The FDA has agreed with the study’s design, and a biostatistician has advised that the study has over a 95% chance of success.

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