Government approvals secured for the use of Galidesivir as a treatment for

Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to advise that is has secured all regulatory and ethics approvals to enable the compassionate use treatment of patients infected during the current Bundibugyo Ebola virus outbreak in Uganda using Galidesivir under a Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol.

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• All government and regulatory approvals obtained for the compassionate use of Galidesivir as a treatment for infected patients during the ongoing Bundibugyo Ebola epidemic in Uganda
• Island to utilise opportunity to generate human data in an active outbreak setting under the World Health Organization’s (WHO) internationally recognised emergency clinical framework as part of development
• Marks a major opportunity to generate prospective human efficacy, safety and virological data during an active Ebola outbreak – Galidesivir to be deployed within CY26
• Positions Galidesivir as a potential treatment for Bundibugyo Ebola virus disease, where patients currently have no approved therapeutic options
• Bundibugyo Ebola epidemic continues to escalate, with 1,480+ confirmed cases,
• ~450 deaths across multiple densely populated African countries
• Concurrent Ebola and Marburg virus activity in Uganda highlights the growing importance of broad-spectrum antiviral therapies and medical countermeasures such as Galidesivir
• Sponsored by the Uganda Ministry of Health and supported by the World Health Organization (WHO) and leading African infectious disease institutions, validating Galidesivir’s potential as a treatment for Ebola
• Program fully funded by government and supporting institutions, with Island’s contribution limited to the supply of Galidesivir, providing a highly capital-efficient and non-dilutive clinical development opportunity
• Government-sponsored opportunity follows rigorous regulatory and ethics review involving Uganda’s public health, scientific and regulatory authorities
• Clinical opportunity complements demonstrated efficacy in non-human primate (NHP) filovirus models and Island’s FDA Animal Rule approval strategy
• Opportunity advances Galidesivir across two potential complementary development pathways, combining prospective human Ebola clinical data with ongoing pivotal Marburg efficacy studies under the FDA Animal Rule
• Previous NHP studies demonstrated 100% survival in Galidesivir-treated Ebola Zaire-infected primates compared with 0% survival in placebo-treated controls
• Drug deployment to be enabled by recently executed GMP manufacturing campaign, demonstrating readiness to address emerging global viral outbreaks
• Effort further advances Galidesivir towards potential government procurement, biodefence stockpiling and broader commercialisation opportunities as a broad-spectrum antiviral
• Investor webinar to be held on Wednesday, 8 July CY26 at 11:00am AEST

The current Bundibugyo Ebola epidemic continues to accelerate across multiple African…