Actinogen HY2025 financial report and Appendix 4D
| Stock | Actinogen Medical Ltd (ACW.ASX) |
|---|---|
| Release Time | 26 Feb 2026, 10:26 a.m. |
| Price Sensitive | Yes |
Actinogen reports HY2025 financial results
- Completed enrolment of 247 participants in XanaMIA phase 2b/3 Alzheimer's trial
- Received positive interim safety and efficacy analysis from independent Data Monitoring Committee
- Preparing to commence open-label extension phase of XanaMIA trial in Q1 2026
Actinogen Medical Ltd reported its financial results for the half-year ended 31 December 2025. The company's principal activity during the period was the ongoing clinical development of its lead candidate Xanamem for the treatment of Alzheimer's disease. Key highlights include: Completed accelerated enrolment of 247 participants in the XanaMIA phase 2b/3 Alzheimer's trial, exceeding the original target of 220; Received a positive interim safety and efficacy futility analysis recommendation from the trial's independent Data Monitoring Committee to continue the trial without amendment; 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; Achieved a common understanding with the FDA on the pathway to marketing approval for Xanamem in Alzheimer's disease, including agreement on the design of one further pivotal trial; Successfully completed a pharmacokinetic trial confirming the intended commercial Xanamem formulation achieves consistent and therapeutic blood concentrations; Continued commercial readiness activities and strengthening of intellectual property protection. The company reported a net loss after tax of $11.3 million for the half-year, a 39% increase compared to the prior corresponding period, with the primary expenditure item being Research & Development.
The company has not provided any high-importance, price-sensitive forward-looking financial guidance.
Actinogen is preparing to commence a second pivotal Alzheimer's disease trial for Xanamem in 2027, which will be similar in design to the XanaMIA trial but larger in scale. The company is also planning a limited number of open-label and clinical pharmacology trials to be conducted in parallel.