Actinogen Medical (ASX: ACW) Advancing Toward Late-Stage Clinical Milestones in Alzheimer’s and Depression.
- Noel Ong
- Aug 19
- 5 min read
Updated: Aug 20
Announcement
Actinogen June 2025 Quarterly Activity Report
Actinogen Medical (ASX: ACW) has released its June 2025 quarterly activities report, highlighting significant progress in its clinical programs and strategic initiatives surrounding Xanamem®, the company’s lead therapeutic compound targeting Alzheimer’s disease (AD) and major depressive disorder (MDD). The June quarter was marked by clinical milestones, manufacturing scale-up, and strengthened financial flexibility through a non-dilutive funding arrangement.
Key Highlights - Targeting Alzheimer and Depression
✅ XanaMIA Phase 2b/3 AD Trial Surpasses 100-Patient Milestone
The pivotal XanaMIA Phase 2b/3 clinical trial in biomarker-positive Alzheimer’s disease reached the key enrolment milestone of 100 participants by 30 June 2025.
As of 29 July, 123 patients were enrolled, with 24 more in advanced screening.
35 sites are open across the US (20) and Australia (15).
A safety and efficacy interim analysis by an independent Data Monitoring Committee is planned for January 2026, with final results expected in Q4 2026.
✅ $13.8 Million Non-Dilutive R&D Tax Funding Facility Secured
Actinogen secured a $13.8 million facility through Endpoints Capital, backed by the FY25 and forecast FY26 R&D Tax Incentives.
$3 million has already been received and is reflected in the June quarter cash balance.
✅ Manufacturing Progress and Commercial Readiness
A 15kg batch of Xanamem drug substance was produced at Asymchem, supporting current and future clinical supply.
This scale-up step is integral to regulatory pathway readiness and future commercialisation discussions.
✅ Clinical Science Engagement and Thought Leadership
Actinogen hosted a Clinical Trials Science Forum (CTSF) on commercialisation readiness featuring its CMO and an external AD expert.
Xanamem’s clinical data were presented at major global scientific meetings, including the American Psychiatric Association (APA), the Alzheimer’s Association International Conference (AAIC), and BIO 2025.
Other Strategic Initiatives
Commercial Planning: Expansion of US engagement with AD key opinion leaders (KOLs) and refinement of investor and partner communications.
Partnering Discussions: Continued active dialogue with multiple potential regional and global pharmaceutical partners across both AD and MDD indications.
Intellectual Property: Ongoing national phase prosecution of new patents to strengthen and extend protection against generics.
Ancillary Trials:
A clinical pharmacokinetic study on food effect and absorption is underway in Adelaide.
An open-label extension trial (XanaMIA-DUR) is set to launch in Q1 2026 for continued Xanamem access post-XanaMIA trial participation.
Financial Position
Actinogen reported a solid financial position at the end of the June 2025 quarter, with $16.5 million in cash on hand. Operating cash outflows totalled $5.2 million for the period, largely directed towards research and development activities. The company maintains a funding runway through to mid-to-late 2026, supported by its recently secured $13.8 million non-dilutive R&D tax incentive facility, of which up to $10.8 million in additional tranches remain conditionally available.
Actinogen CEO, Dr Steven Gourlay, commented:
“The second quarter of 2025 saw accelerated enrolment in the XanaMIA trial as the result of additional clinical sites commencing screening activities. We now have a clear timeline for the planned interim analysis in January 2026 and final results later in the year. As these key clinical milestones approach the team are busy optimizing the many aspects of Xanamem’s development program designed to prepare the Company for partnering and eventual marketing approvals.”
Samso Concluding Comments
We have been following Actinogen Medical for a while, and the consistency of narratives has been shaping itself into a contender in the neuroscience space. The progress made in the June quarter signals a company preparing for commercial relevance. There is a clear clinical development plan, a de-risked funding model, and active partner discussions underway. Actinogen does appear to be executing well.
The 100-patient milestone in the XanaMIA trial was critical—it activates the countdown to the interim readout in January 2026. For investors, that’s the next major value inflection point. As manufacturing capabilities are scaled, IP protections are strengthening, and strategic communication efforts are ramping up across global platforms, the groundwork is being laid for what could be a defining 12 months ahead.
There’s always caution in biotech investing, particularly in neurology. But the Xanamem story has been consistent: a targeted mechanism, robust safety profile, and promising early efficacy signals in both AD and MDD. The company is not trying to do everything at once—it’s doing what matters, and doing it methodically.
This is a business that is aligning itself with milestones that matter—data, partners, and product. That’s where real value gets built, and that’s what makes Actinogen worth watching closely.
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What often looks like a quiet quarter is in fact one built on foundational steps—scale-up manufacturing, open-label trials in motion, and IP fortification. These are signs of a company not only aiming to deliver data but doing so with commercial foresight. For serious investors, this is the kind of progress that merits close attention, not just for what’s been achieved, but for what it enables next.
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