• Pivotal XanaMIA phase 2b/3 Alzheimer's disease trial completes enrollment with 247 participants
• Positive interim analysis outcome, trial to continue to completion in November 2026
• Open-label extension trial to commence in Q1 2026

Actinogen Medical Limited has announced the release of its quarterly activity report and Appendix 4C for the three-month period ended 31 December 2025. Key highlights include the completion of enrollment for the pivotal XanaMIA phase 2b/3 Alzheimer's disease trial, with 247 participants randomized, exceeding the original target of 220. The independent Data Monitoring Committee has recommended that the trial continue without amendment after its interim analysis, with topline final results expected in November 2026. The company also plans to commence an open-label extension trial in Q1 2026, providing longer-term safety data and observational data on key efficacy endpoints. Other key activities include manufacturing, commercial planning, partnering, and intellectual property protection. The company has presented at various international and Australian conferences and conducted investment and partnering meetings during the quarter. Financially, the company incurred operating expenditure of $6.5 million during the quarter, with a net cash inflow of $2.3 million after receiving a research and development tax incentive rebate and repaying a loan. The company has further strengthened its balance sheet through additional non-dilutive funding.

The company expects to receive scientific advice from the European Medicines Agency on Xanamem development plans in Alzheimer's in the second quarter of 2026. Positive XanaMIA results will position Xanamem as the first oral therapy to convincingly slow or stabilize Alzheimer's decline.