Key points
- Pivotal Alzheimer's trial results expected in November 2026
- Achieved alignment with FDA and EMA on streamlined approval pathways
- Cash runway extends beyond trial results to mid-2027
- Positive anti-depressant activity published in British Journal of Psychiatry
- Received $7.3 million RDTI rebate from Australian Tax Office
Full summary
Actinogen Medical Ltd. (ASX: ACW) reported its FY2026 financial results, emphasizing significant progress in its Alzheimer's disease trial and strategic alignment with regulatory bodies. The company anticipates topline results from its pivotal XanaMIA trial in November 2026. Additionally, Actinogen has secured agreements with the FDA and EMA on streamlined pathways to marketing approvals, positioning Xanamem as a potential breakthrough therapy. The company's financial position remains strong, with a cash balance of $16.7 million, ensuring operational continuity beyond the trial results. Furthermore, Actinogen published positive anti-depressant activity in the British Journal of Psychiatry and received a $7.3 million research and development tax incentive rebate from the Australian Tax Office.
Guidance
Net loss after tax for FY2026 was $15,379,848; R&D costs were $19,027,365.
Outlook
The company aims to complete the XanaMIA trial, prepare for regulatory approvals, and pursue strategic partnerships to maximize the value of Xanamem globally.