• Positive interim analysis outcome for pivotal XanaMIA Alzheimer's disease trial
• Topline final results expected in November 2026
• Open-label extension phase commenced with 88% rollover of participants

Actinogen Medical announced the release of its quarterly activity report and Appendix 4C for the three-month period ended 31 March 2026. The key highlight was the positive safety and efficacy futility recommendation by the independent Data Monitoring Committee to continue the XanaMIA pivotal Alzheimer's disease trial without amendment. This was a major milestone, with the trial now continuing to treat participants with either Xanamem 10 mg or placebo for a total treatment duration of 36 weeks. Topline final results are expected to be announced in November 2026. The trial is intended to serve as one of two pivotal trials supporting the earliest potential marketing approvals for Xanamem in Alzheimer's disease. Planning has also commenced for a second pivotal Alzheimer's disease trial. The open-label extension (OLE) phase of the XanaMIA Alzheimer's trial commenced on 31 March 2026, with enthusiastic early take-up reflected by an 88% rollover of participants. The OLE enables all current and former participants who have completed the randomized phase to receive active Xanamem 10 mg once daily for up to 25 months. Financially, the company completed a successful $16.8 million capital raising and received a further $1.9 million research and development tax incentive rebate. The company also strengthened its balance sheet through the receipt of $4.3 million in non-dilutive funding. Operating expenditure of $7.4 million was incurred during the quarter, with the majority associated with the XanaMIA trial and its open-label extension. The company ended the quarter with $21.5 million in cash, extending its runway beyond the expected release of XanaMIA topline results.

The company continues to progress commercial planning, regulatory interactions, and partnering engagement as the XanaMIA trial progresses toward topline results in November 2026. The company is also exploring accelerated approval pathways with regulators, including discussions with the FDA regarding its recently announced policy supporting approval based on a single pivotal trial with adequate supporting evidence.