ACW FY2025 results - accelerating Alzheimers pivotal trial

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Stock Actinogen Medical Ltd (ACW.ASX)
Release Time 25 Aug 2025, 6:46 p.m.
Price Sensitive Yes
 ACW FY2025 results - accelerating Alzheimer's pivotal trial
Key Points
  • Advanced two major clinical trial programs: XanaMIA phase 2b/3 Alzheimer's disease trial passed 100th participant milestone, XanaCIDD phase 2a major depressive disorder trial completed
  • Received new and unique International Nonproprietary Name (INN) 'emestedastat' for Xanamem®
  • Secured funding to mid-late CY2026 through capital raising, R&D tax incentive rebate and R&D tax incentive funding facility
Full Summary

Actinogen Medical has reported its financial results and annual report for the year ended 30 June 2025, highlighting a highly productive year of value-add activities. The company advanced two major clinical trial programs - the XanaMIA phase 2b/3 Alzheimer's disease (AD) trial passed the 100th participant milestone, with an interim analysis scheduled for January 2026 and final results expected in Q4 2026, and the XanaCIDD phase 2a major depressive disorder (MDD) trial was completed, with the data to be used to support development in Alzheimer's disease pending independent funding for additional MDD trials. Actinogen also received a new and unique International Nonproprietary Name (INN) 'emestedastat' for Xanamem®, conducted a successful regulatory meeting with the FDA on MDD, and completed commercial readiness planning including appointing a Chief Commercial Officer. The company secured funding to mid-late CY2026 through a $11.1m capital raising, a $9.0 million R&D tax incentive rebate, and a $13.8m non-dilutive R&D tax incentive funding facility. Actinogen remains confident about its prospects in FY2026 and beyond as it continues the transformational clinical development of Xanamem, with the XanaMIA phase 2b/3 AD trial expected to reach final results in late 2026.

Guidance

The company expects to receive a $5,489,600 R&D tax rebate in Q2 FY2026, and potentially a further $1,874,143 in R&D tax incentive in Q4 2025 subject to ATO approval.

Outlook

Actinogen is focused on optimizing its current clinical trials program and forward planning for marketing approvals while balancing partnering efforts and building optimal shareholder returns. Key upcoming news events include a new peer-reviewed publication, academic presentations, regulatory interactions, and clinical trial updates, including interim data from the XanaMIA phase 2b/3 AD trial in January 2026 and final results in late 2026.