• Island Pharmaceuticals has executed a Statement of Work (SOW) with Texas Biomed to further advance Galidesivir's development
• The SOW establishes the second phase of the Company's dose optimisation program
• The study will evaluate Galidesivir in 12 non-human primates infected with the Angola strain of Marburg virus
• The combined studies are expected to generate data from 32 NHPs for submission to the FDA
• The study aims to optimise dose selection and finalise the design of the planned pivotal Animal Rule efficacy study

Island Pharmaceuticals Limited has executed a Statement of Work (SOW) with the Texas Biomedical Research Institute (Texas Biomed) to further advance Galidesivir's development for the treatment of Marburg Virus Disease. The SOW establishes the second phase of the Company's dose optimisation program, a key component of the regulatory package required to support the design of Galidesivir's planned pivotal Animal Rule efficacy study. The program has been designed in accordance with feedback from the U.S. Food and Drug Administration (FDA), which confirmed Galidesivir's regulatory pathway under the Animal Rule and recommended the completion of dose optimisation studies before finalising the pivotal study design. The Texas Biomed study represents the second phase of Island's FDA-directed dose optimisation program and has been designed to complement the ongoing USAMRIID study. While the USAMRIID program is evaluating the minimally effective dose when treatment is initiated 24 to 48 hours following infection, the Texas Biomed study will assess Galidesivir when treatment commences on days that correlate with first signs of clinical viral disease, typically between 3 and 5 days following infection. Under the terms of the SOW, Texas Biomed will evaluate Galidesivir in 12 non-human primates infected with the Angola strain of Marburg virus, the FDA-preferred challenge strain for Animal Rule development. Animal preparation activities are expected to commence in Q4 2026, with the challenge and treatment phase scheduled to begin in early 2027. Texas Biomed is one of only four BSL-4 facilities in the United States capable of conducting non-human primate infectious disease studies and is the only privately operated BSL-4 laboratory. Its specialised capabilities in high-consequence pathogens, including Marburg virus, make it a globally recognised partner for the development of medical countermeasures against emerging infectious diseases.

The combined USAMRIID and Texas Biomed studies are expected to generate the data required to optimise dose selection and finalise the design of the planned pivotal Animal Rule efficacy study.