• GMP manufacturing of Galidesivir underway to support pivotal Marburg study
• Agreement with PI Health Sciences for manufacturing and analytical validation
• Enhances strategic flexibility for biodefence and outbreak response opportunities
• Existing Galidesivir inventory available for dose optimization studies

Island Pharmaceuticals Ltd. has initiated a GMP manufacturing campaign for Galidesivir with PI Health Sciences, aimed at supporting pivotal studies under the FDA's Animal Rule pathway for Marburg Virus Disease. This campaign includes analytical method validation, reference standard preparation, stability studies, and the manufacture of GMP-grade Galidesivir. The initiative represents a significant milestone in Island's strategy to advance Galidesivir as a countermeasure for high-consequence viral threats, including Ebola and Marburg. The GMP manufacturing is expected to validate and scale production to a level appropriate for late-stage development, transitioning Galidesivir from a development-stage asset to a potential biodefence product. The manufactured product will support the planned pivotal study, while existing Galidesivir supply will be used for pending dose optimization studies.