• XanaMIA phase 2b/3 Alzheimer's trial accelerates enrolment, topline results now expected in mid-Q4 2026
• Successful FDA meeting provides clarity on regulatory pathway for Xanamem in Alzheimer's
• Clinical pharmacokinetic trial confirms 10mg once-daily dosing for Xanamem

Actinogen Medical has released its quarterly activity report and Appendix 4C for the three-month period ended 30 September 2025. Key highlights include:- The pivotal XanaMIA phase 2b/3 Alzheimer's disease (AD) trial is projected to enrol up to ~240 participants (original target 220) with elevated levels of the blood biomarker pTau181. As of 22 October 2025, 182 participants are enrolled at 35 sites across the US and Australia, with another ~60 expected to enrol before year-end. A planned safety and efficacy futility interim analysis will occur in late January 2026.- Topline final results for ~240 participants are now expected in mid Q4 2026, an acceleration from the previous timeline of Q4 2026.- Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD, including agreement on regulatory starting materials, the streamlined design of one additional pivotal trial, and the limited number of ancillary studies required.- A successful clinical pharmacokinetic trial confirmed that the intended commercial formulation of Xanamem produces consistent and therapeutic levels in the blood that are similar when given with or without food, allowing flexibility in dosing.- The company continues to progress commercial planning, partnering discussions, and intellectual property protection initiatives to support the Xanamem program.

The company's net cash position as at the date of this report is $10.5m, with an additional $1.9m R&D tax incentive receivable pending, giving a proforma cash position of $12.4m. The company continues to have a cash runway to mid 2026.