UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
CEL-SCI Corporation recently reported that a Breakthrough Medicine Designation application was filed with the Saudi Food and Drug Authority (SFDA) for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies.
This pharma company is Dallah Pharma, a subsidiary of Dallah Healthcare Company (Saudi Stock Exchange Tadawul, Symbol: 4004). CEL-SCI has signed a Memorandum of Understanding (MOU) with Dallah Pharma for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3rd quarter of 2025.
Dallah Healthcare Company serves over three million patients annually through an extensive network of hospitals and specialized clinics, in addition to home care services. Relying on a highly experienced team and a distinguished group of specialized physicians, Dallah Healthcare Company operates according to the highest standards of quality and patient safety. Dallah Health remains committed to the humanitarian and professional values that have made it the leading reference for trusted healthcare in the Kingdom.
According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia.
Dallah Pharma is well positioned to procure reimbursement and to accelerate Multikine’s sale and commercial launch.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 22, 2025
CEL-SCI CORPORATION | |||
| By: | /s/ Geert Kersten | ||
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| Geert Kersten | |
Chief Executive Officer | |||
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