• Positive interim analysis outcome from XanaMIA phase 2b/3 Alzheimer's trial
• Topline final results expected in November 2026
• Open-label extension phase commenced for trial 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 (DMC) to continue the XanaMIA pivotal Alzheimer's disease trial without amendment. The DMC reviewed unblinded safety and efficacy data covering approximately 37% of the final dataset and recommended the trial continue. Enrolment of the final 247th participant was completed in December 2025, and 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. The company has also commenced planning for a second pivotal Alzheimer's disease trial, which will be similar in design to XanaMIA but larger in scale. Additionally, the open-label extension (OLE) phase of the XanaMIA trial commenced on 31 March 2026, with enthusiastic early take-up reflected by an 88% rollover of participants from the main trial. The OLE will provide access to active Xanamem therapy for all randomized trial participants and gather extended safety data and observational information on key efficacy endpoints. The company also reported on its strengthened financial position, including a successful $16.8 million capital raising, a further $1.9 million R&D tax incentive rebate, and additional non-dilutive funding, which extends its cash runway beyond the expected release of topline XanaMIA results.

The company is preparing for the earliest possible US marketing approval submission and subsequent global regulatory filings for Xanamem, and will explore accelerated approval pathways with relevant regulators, including the FDA. It will also engage with the European Medicines Agency in Q2 2026 and other regulators regarding its Xanamem development plans in Alzheimer's disease.