ANNUAL REPORT 2026 17 The first patient was dosed shortly after the close of the financial year. PROTECT-MI remains on track for completion in the 2027 calendar year with the final patient expected to be dosed in mid-2027 and top-line results anticipated approximately three months after last-patient follow-up. Preclinical Research - Oncology During the year the Company extended investigations of Xolatryp into oncology, an indication in which the TRPC mechanism has a compelling scientific rationale. Two preclinical studies were initiated during the later part of the financial year. In the first study which read out in May 2026, Xolatryp demonstrated clear anti-tumour activity in a preclinical model of liver cancer, both as a monotherapy and in combination with doxorubicin. The combination arm produced the greatest reduction in tumour volume and was well tolerated. The second study, which read out in June 2026, was a pilot conducted in advance of a more comprehensive study to assess Xolatryp as a cardio-protectant against anthracycline induced cardiomyopathy. Doxorubicin, one of the most widely used anthracycline chemotherapies, is regarded as a backbone agent in oncology, but carries a well-recognised risk of cardiac damage at higher cumulative doses which constrains lifetime patient exposure. Preliminary biomarker data from the pilot showed numerically lower mean cardiac troponin I, a clinically relevant marker of cardiac injury, relative to the doxorubicin plus vehicle control group. The study also confirmed the feasibility and tolerability of the intended subcutaneous dosing regimen and informed dose selection for the larger study. That larger cardioprotection study commenced late in June 2026 and is expected to read out in the first quarter of FY2027. Preclinical Research - Neuroprotection In September 2025 the Company reported findings from its collaborative traumatic brain injury study conducted with the Walter Reed Army Institute of Research (WRAIR) and UNSW Sydney. The analysis showed that Xolatryp contributes to the preservation of mitochondrial health by enhancing calcium regulation, shielding the brain's energy centres from damage caused by reactive oxygen species. Beyond their relevance to secondary brain injury, these results reinforce the mechanistic basis for Xolatryp in myocardial ischemia-reperfusion injury, in which TRPC channel activation drives excessive calcium influx, mitochondrial impairment and cardiac cell death. Regulatory Affairs Late in the financial year, the Company commenced preparation of an Investigational New Drug (IND) application for submission to the United States Food and Drug Administration, covering the myocardial ischemia-reperfusion injury program. The Company is targeting submission of the IND application before the end of the 2026 calendar year. Approval would open a regulatory pathway for Xolatryp into the world's largest healthcare market. Intellectual Property Protecting the innovation underpinning Xolatryp remained a priority throughout the year: • the Xolatryp® trademark was granted late in December 2025; • the composition of matter patent application, first filed in September 2024, was published late in the March 2026 quarter; and • formal Notice of Allowance was received from the United States Patent Office in May 2026. Subject to payment of the issue fee, the granted patent will provide protection in the United States over the chemical structure of Xolatryp and associated analogues for a twenty-year term from the September 2024 filing date. Corporate Mr James Bonnar was appointed to the Board of Directors in October 2025, becoming Managing Director and Chief Executive Officer. Dr Gisela Mautner retired from the Board following the November 2025 Annual General Meeting.
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