CVM News & Events

"During the fiscal second quarter, we made significant progress advancing Multikine toward potential commercialization and regulatory approval in multiple markets," stated CEL-SCI CEO Geert Kersten. "Our strategic partnership with Amarox represents an important milestone for CEL-SCI, providing a pathway to potential early commercialization and revenue generation for Multikine in Saudi Arabia through the SFDA's Breakthrough Medicine Designation process as well as potential market access in the GCC countries. At the same time, we are starting efforts to initiate patient enrollment in our pivotal U.S. FDA Confirmatory Registration Study later this summer/fall. We believe the study's design, which allows for rapid assessment of pre-surgical tumor response following a short course of Multikine treatment, may provide an opportunity to pursue accelerated approval in the U.S. With strengthening financial support, continued management investment in the Company, and increasing international interest in Multikine, we believe CEL-SCI is entering an inflection point."

CEL-SCI announced it has signed a strategic partnership, distribution, and revenue sharing agreement with Amarox for regulatory affairs, marketing and potential commercialization of Multikine in the treatment of head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates. Amarox will support and coordinate the local regulatory process with SFDA, including seeking the SFDA's Breakthrough Medicine Designation which, upon granting, would make Multikine rapidly available to patients in Saudia Arabia, representing a pivotal shift in CEL-SCI's commercial trajectory. The companies will share net revenue from sales of Multikine in Saudi Arabia on a 50%/50% basis. Upon SFDA approval, Amarox will receive exclusive rights to distribute Multikine for the treatment of head and neck cancer in Saudi Arabia. CEL-SCI retains full ownership of all Multikine intellectual property, manufacturing know-how and global rights.