CEL-SCI partners with Saudi pharmaceutical firm to bring Multikine to market

VIENNA - CEL-SCI Corporation (NYSE American:CVM) has reached an agreement with a leading Saudi Arabian pharmaceutical company to pursue regulatory approval and commercialization of its cancer immunotherapy Multikine in Saudi Arabia, according to a press release statement issued Friday. The company’s stock, which has shown significant volatility with a 53% surge in the past week according to InvestingPro data, currently trades at $3.82 per share.

The Saudi partner will file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA) in the coming weeks. If granted, the designation would allow immediate patient access and reimbursement in Saudi Arabia, with the SFDA expected to respond within approximately 60 days of submission.

Multikine is an immunotherapy administered before surgery for newly diagnosed head and neck cancer patients. In clinical studies spanning 20 countries, the treatment increased the 5-year survival rate to 73% from 45% in the target patient population when compared to standard care alone, reducing the risk of death from 55% to 27%.

"We have been engaging with medical, regulatory and financial experts in Saudi Arabia in preparation for the regulatory filing to the SFDA," said CEL-SCI CEO Geert Kersten.

The company reports that several Saudi investment funds have expressed interest in investing in CEL-SCI, Multikine, or a potential joint venture that would serve the broader Middle East and North Africa market. This potential investment interest comes as InvestingPro analysis shows the company faces financial challenges, with a current ratio of 0.55 indicating short-term obligations exceed liquid assets. Get access to 12 more exclusive InvestingPro Tips about CEL-SCI’s financial health and market position.

Martin Bailey, Managing Director of First Berlin, which represents CEL-SCI in Saudi Arabia, noted that Multikine aligns with Saudi Arabia’s Vision 2030 initiative to become a global biotech hub.

To qualify for Breakthrough Medicine Designation in Saudi Arabia, treatments must target serious conditions with unmet medical needs, offer advantages over current methods, demonstrate positive benefit-risk balance, and not be registered with any regulatory authority at the time of application. With a market capitalization of $19.62 million and significant cash burn rate, InvestingPro’s Fair Value analysis suggests the stock is currently fairly valued, though investors should note the company’s challenging financial metrics, including negative EBITDA of -$23.94 million in the last twelve months.

In other recent news, CEL-SCI Corporation announced a public stock offering to fund the ongoing development of its Multikine therapy. The offering, managed by ThinkEquity, aims to support the cancer immunotherapy treatment, as well as general corporate purposes and working capital needs. CEL-SCI is also seeking approval from the Saudi Food and Drug Authority for Breakthrough Medicine Designation for Multikine, which could expedite patient access in Saudi Arabia. This initiative aligns with Saudi Arabia’s Vision 2030 to become a global biotech hub. Additionally, CEL-SCI’s Board of Directors approved a 1-for-30 stock combination to potentially attract more investor interest by increasing the share price. The company is preparing for a confirmatory Registration Study with the FDA’s concurrence on patient selection criteria. CEL-SCI has received Orphan Drug designation for Multikine, which has shown promising results in extending survival rates in clinical trials. CEO Geert Kersten expressed optimism about the potential for accelerated regulatory approval for Multikine following Merck’s Keytruda approval for similar cancer treatments.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.