Actinogen Medical has raised approximately $17 million through a share placement and purchase plan to fund the completion of its pivotal XanaMIA Alzheimer’s trial following encouraging interim results.
- Raised $12 million via share placement at $0.042 per share
- Additional $5 million targeted through share purchase plan
- Funding supports completion of XanaMIA Phase 2b/3 trial and open-label extension
- Positive interim analysis materially de-risks trial ahead of November 2026 topline results
- Directors, including CEO Dr Steven Gourlay, to participate subject to shareholder approval
Funding Boost Following Positive Interim Analysis
Actinogen Medical Limited (ASX – ACW) has successfully secured approximately $17 million in new capital to advance its lead Alzheimer’s disease therapy, Xanamem, through the critical stages of clinical development. The funding comprises a $12 million share placement to sophisticated investors and directors, alongside a $5 million share purchase plan (SPP) open to eligible shareholders.
This capital raise follows the announcement of a positive interim analysis from the company’s XanaMIA Phase 2b/3 trial, which assesses Xanamem’s efficacy in slowing the progression of mild to moderate Alzheimer’s disease. The independent Data Monitoring Committee reviewed unblinded safety and efficacy data and recommended continuation without amendment, a significant milestone that materially de-risks the program as it moves toward final topline results expected in November 2026.
Strategic Use of Funds and Director Support
Proceeds from the placement and SPP will primarily fund the completion of the XanaMIA pivotal trial and the initiation of its open-label extension phase, which will provide longer-term safety and efficacy data. Additional funds will support ongoing research and development, manufacturing, and general corporate purposes.
Notably, Actinogen’s CEO and Managing Director, Dr Steven Gourlay, has committed $500,000 to the placement, with other directors collectively subscribing for $167,000. Their participation is contingent on shareholder approval at an upcoming Extraordinary General Meeting, reflecting strong internal confidence in the trial’s prospects.
Xanamem’s Unique Position in Alzheimer’s Treatment
Xanamem targets elevated brain cortisol levels, a novel mechanism distinct from existing Alzheimer’s therapies that focus on amyloid or tau proteins. Elevated cortisol is implicated in cognitive decline and brain cell damage, making Xanamem’s approach potentially transformative. The drug is administered orally once daily and has demonstrated a promising safety profile across approximately 500 trial participants to date.
The XanaMIA trial enrolled 247 patients across Australia and the United States, all confirmed to have biomarker-positive Alzheimer’s disease. The trial’s primary endpoint is the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB), a widely accepted measure of cognitive and functional decline. The positive interim data suggest the trial is on track to meet its objectives, with the open-label extension set to begin in early 2026.
Looking Ahead – Regulatory and Commercial Prospects
Actinogen is preparing for a pivotal Phase 3 trial following the completion of XanaMIA, supported by recent FDA guidance that streamlines the development pathway. The company is also engaging with global biopharmaceutical partners to explore potential collaborations or licensing deals, aiming to leverage Xanamem’s differentiated profile in a competitive Alzheimer’s market.
With a strong cash position projected beyond the trial’s final results, Actinogen is well-positioned to maintain momentum in clinical development and commercial discussions. The company’s strategy includes targeting a large and growing Alzheimer’s patient population, particularly in the United States, where demand for effective and safe oral therapies remains high.
Bottom Line?
Actinogen’s successful capital raise and positive interim data set the stage for a pivotal year ahead as it advances Xanamem toward potential regulatory approval and market entry.
Questions in the middle?
- Will the final XanaMIA trial results confirm the early promise shown in the interim analysis?
- How will Actinogen’s planned Phase 3 trial be structured, and what partnerships might emerge?
- What market reception can Xanamem expect given the competitive landscape of Alzheimer’s treatments?