• XanaMIA phase 2b/3 Alzheimer's trial accelerating patient screening and enrolment
• Successful regulatory meeting with FDA on major depressive disorder program
• New and unique name 'emestedastat' granted to Xanamem by World Health Organization

Actinogen Medical announced the release of its quarterly activity report and Appendix 4C for the three-month period ended 31 March 2025. Key highlights include the acceleration of patient screening and enrolment for the XanaMIA phase 2b/3 Alzheimer's disease (AD) trial, a successful regulatory meeting with the FDA on the major depressive disorder (MDD) program, and the World Health Organization granting the unique name 'emestedastat' for Xanamem. The XanaMIA trial is enrolling 220 participants with elevated blood biomarker pTau181, and over 560 people have been pre-screened. Sixty participants have entered the 36-week treatment phase, with another 35 expected to be enrolled soon. Patient recruitment is accelerating with 15 active sites in Australia and the US, and an additional 5 US sites commencing screening. An interim analysis is anticipated in Q4 2025 when approximately 100 patients reach 24 weeks of treatment, with final results expected in Q4 2026. Actinogen also had a successful Type C meeting with the FDA on the MDD program, reaching a common understanding on the additional clinical trials and studies required for marketing approval. The company continues to advance its commercial planning, strategic team additions, partnering discussions, and intellectual property protection efforts.

The company is confidently engaging in a range of initiatives appropriate to late-stage clinical development, including commercial planning, strategic team additions, partnering discussions, and intellectual property protection efforts.