• Completed enrolment in XanaMIA phase 2b/3 Alzheimer's trial
• Received positive interim safety and efficacy analysis from trial's DMC
• Preparing for open-label extension and next pivotal trial

Actinogen Medical has released its interim financial results for the six months ended 31 December 2025, highlighting key progress on its lead Alzheimer's disease program. The company has completed accelerated enrolment in the XanaMIA phase 2b/3 Alzheimer's trial, randomizing the final 247th participant in December 2025. Actinogen also received a positive interim safety and efficacy futility analysis recommendation from the trial's independent Data Monitoring Committee to continue the trial without amendment, following a prior positive safety review in November 2025. The company is now preparing to commence the open-label extension phase of the XanaMIA trial in Q1 2026, allowing all participants access to active Xanamem 10 mg once daily for up to 25 months. Actinogen has also achieved a common understanding with the FDA on the pathway to marketing approval in Alzheimer's disease, including agreement on the design of one further pivotal trial of Xanamem 10 mg vs. placebo commencing in 2027. The company has completed commercial-grade manufacture of 10mg Xanamem tablets and continued other commercial readiness activities. Actinogen remains confident in the prospects for Xanamem as a potential transformative therapy for Alzheimer's disease, with multiple independent trials providing clinical validation of its cortisol-control mechanism.

The company remains confident about its prospects in FY2026 and beyond, with clinical momentum continuing following the positive interim safety and efficacy analysis for the XanaMIA trial. The XanaMIA trial is planned to serve as one of two pivotal trials supporting the earliest possible marketing approvals for Xanamem in Alzheimer's disease. The company will also explore accelerated approval pathways with relevant regulators, including discussions with the FDA on its recently announced policy to approve drugs with a single pivotal trial provided there is adequate supporting evidence.