United States — Food and Drug Administration & GT Biopharma

United States — Food and Drug Administration: United States — Food and Drug Administration has engaged with the CannEpil program through the pre-IND process and assigned an Investigational New Drug (IND) number, laying the foundation for future U.S. clinical development.

GT Biopharma: GT Biopharma licensed its CannEpil therapeutic to Splash Beverage Group globally. GT Biopharma will receive a 15% royalty on net revenue from worldwide sales of CannEpil and had approximately $5 million of its indebtedness forgiven by Mercer Street Global Opportunity Fund.

United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for imlifidase in the US, indicating future market potential outside the current deal.

GT Biopharma: GT Biopharma>>> divested the European and MENA rights to Imlifidase for 115 million euros, allowing it to focus on other markets and receive significant payments.