• FDA provides clear alignment on Galidesivir's Animal Rule pathway
• Executed CRADA with USAMRIID and Geneva Foundation to advance clinical development
• Expanded antiviral pipeline through strategic collaboration with Burnet Institute

Island Pharmaceuticals Ltd (ASX: ILA) made considerable progress advancing the clinical development pathway for its Galidesivir antiviral program during the March 2026 quarter. The company received constructive guidance from the US FDA, which confirmed the validity of Island's proposed animal model and outlined the required final steps to progress Galidesivir towards approval under the FDA's Animal Rule. This provided clear regulatory alignment on the use of the Angola strain of Marburg, the cynomolgus macaque model and the viral challenge dose, which are core elements of the Animal Rule development. The FDA also defined a two-stage clinical development pathway for Galidesivir, enabling Island to advance targeted dose-optimisation and pharmacokinetic studies before engaging the FDA on pivotal study design. Animal Rule approval represents a significant opportunity, as it could unlock US Government procurement, including inclusion in the Strategic National Stockpile, as well as eligibility for a Priority Review Voucher. Island also executed a CRADA with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and The Geneva Foundation to design and conduct the non-human primate studies required to advance Galidesivir towards new drug application approval for Marburg under the Animal Rule. USAMRIID has played a central role in Galidesivir's historical development and provides access to world-leading biodefence expertise and infrastructure. Additionally, Island expanded its antiviral pipeline through a strategic research collaboration with the Burnet Institute, evaluating the potential application of ISLA-101 and Galidesivir against additional high-value viral threats. The company also strengthened its intellectual property position with the grant of a new US patent covering the use of Galidesivir across filoviridae viruses, including Marburg and Ebola.

Island remains focused on advancing Galidesivir through the FDA's Animal Rule pathway, leveraging strategic government and research partnerships to progress clinical development and position the program for potential biodefence procurement and non-dilutive revenue opportunities.