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8-K2026-05-14· grok-4-1-fast-non-reasoning

CVM · CEL-SCI Corporation

0001654954-26-004910

SEC filing

Summary

CEL-SCI Corporation entered a strategic partnership with Amarox for regulatory affairs, marketing, and distribution of Multikine in Saudi Arabia with 50/50 revenue sharing upon SFDA approval.

Key takeaways

Full analysis

CEL-SCI Corporation has signed a strategic partnership agreement with Amarox, a leading Saudi pharmaceutical company, to advance Multikine, its investigational immunotherapy for head and neck cancer, toward commercialization in Saudi Arabia. The agreement covers regulatory affairs, marketing, and distribution, with Amarox leading interactions with the Saudi Food and Drug Authority (SFDA), including pursuit of Breakthrough Medicine Designation. This designation, if granted, would enable rapid patient access, aligning with Saudi Vision 2030's focus on innovative therapies for unmet needs. Key financial terms include a 50/50 split of net revenues from Multikine sales in Saudi Arabia, providing CEL-SCI with a long-term revenue stream without upfront costs or IP transfer. Amarox gains exclusive distribution rights post-approval, with potential expansion to GCC countries, leveraging its top ranking in SFDA applications for shortage medicines over 2022-2024 and oncology expertise. CEL-SCI maintains complete control over global rights and manufacturing. CEO Geert Kersten highlighted this as a transformative milestone, positioning Saudi Arabia as a potential first market for Multikine commercialization and supporting broader international strategy. Amarox CEO Dr. Abdullah Alzomaie emphasized alignment with regional healthcare advancements. First Berlin advised CEL-SCI on the deal structure.