ACW: Early pTau Screening Closure & Extra $1.9m AOF-Enabled RDTI — Helping Alzheimer Patients.
- Noel Ong
- Nov 7
- 6 min read
Announcement
Actinogen Medical Limited (ASX: ACW) released two important updates dated 20 October 2025: (1) accelerated recruitment has enabled early closure of pTau screening for the Phase 2b/3 XanaMIA Alzheimer’s trial; and (2) an Advance Overseas Finding (AOF) approval confirms eligibility for a further RDTI rebate of ~$1.87m, taking the total FY25 RDTI to ~$7.36m if the ATO amendment is favourably assessed. These are operational and funding milestones that speak to trial momentum and balance-sheet support as the program advances toward the January 2026 interim look and mid-Q4 2026 topline.
XanaMIA pTau Screening Closes Early (Operational Momentum) - A Solution for Alzheimer Patients.
Highlight
pTau screening closes to new participants on 31 October 2025 (brought forward from 30 November).
Projected total enrolment ~240 (up from 220); 180 enrolled to date with ~60 more expected by year-end.
Topline final results reaffirmed for mid-Q4 2026; independent DMC interim analysis for safety/futility slated late January 2026.
The added participants increase statistical power for the primary endpoint (CDR-SB) in this 36-week, double-blind, placebo-controlled study across Australia and the US.
Overall, bringing pTau screening forward to 31 October 2025 signals strong site performance and patient flow, with enrolment now targeting ~240 (up from 220) — 180 already in, and ~60 more expected by year-end. This uplift enhances statistical power on the CDR-SB primary endpoint in the 36-week, double-blind, placebo-controlled study across Australia and the US, while key catalysts remain intact: an independent DMC interim for safety/futility in late January 2026 and topline results in mid-Q4 2026.
Highlight
ACW received an Advance Overseas Finding certificate covering eligible overseas R&D in FY25, enabling an ATO return amendment for additional $1,874,143 RDTI rebate (subject to favourable assessment).
Combined with the $5,489,600 RDTI announced 15 Oct 2025, total FY25 RDTI would be ~$7,363,743.
Management flags RDTI as an important ongoing funding source as Alzheimer’s Phase 2b/3 milestones approach.
Trial Snapshot
Design: 36-week, double-blind, placebo-controlled; primary endpoint CDR-SB; biomarker-confirmed AD via pTau181.
Dose: Xanamem® 10 mg once daily vs placebo.
Geography: Australia and the US.
Extension: XanaMIA-OLE (open-label, up to 25 months) to start Q1 2026 for current/former participants.
The Importance
Execution signal: Early screening closure and an uplift in projected enrolment point to site/patient engagement and operational throughput—inputs that typically de-risk timelines.
Statistical power: The ~9% increase from 220 to ~240 enhances the power to detect a treatment effect on CDR-SB.
Funding runway assist: The AOF-enabled RDTI addition improves cash inflows linked to FY25 R&D, complementing capital management ahead of interim (Jan 2026) and topline (mid-Q4 2026) inflection points.
Near-Term Milestones to Watch
31 Oct 2025: pTau screening closure.
By end-2025: Targeting full enrolment (~240).
Late Jan 2026: Independent DMC interim (safety/efficacy futility).
Mid-Q4 2026: Topline primary readout (CDR-SB).
The Science in One Line
Xanamem (emestedastat) aims to reduce elevated brain cortisol by inhibiting 11β-HSD1, a mechanism ACW links to potential benefits in Alzheimer’s and depression, with an overall promising safety profile across ~400 participants to date.
Figure 1: Xanamem - a small molecule tissue cortisol synthesis inhibitor (11β-HSD1 enzyme) (source: ACW)
Clinical Trials
The XanaMIA Phase 2b/3 Alzheimer’s disease trial is a 36-week, double-blind, placebo-controlled trial in ~220 patients with mild–moderate Alzheimer’s, confirmed by elevated blood pTau181. Participants receive Xanamem® 10 mg once daily or placebo; progression is measured across endpoints, with CDR-SB as the primary. Sites are in Australia and the US, with full enrolment due by end-2025, an interim analysis in late Jan 2026, and topline results in mid-Q4 2026.
Samso Concluding Comments
The decision to bring pTau screening forward to 31 October 2025 reads as a signal. Sites are recruiting, processes are working, and the trial appears to be tracking to plan. In my experience, timelines tighten only when the operational engine is running smoothly.
Lifting projected enrolment to ~240 (from 220) improves the study’s statistical footing on CDR-SB without changing the core design. This is important because effect sizes in Alzheimer’s are often modest; a little more power can be the difference between noise and a decision-grade signal.
On funding, the additional ~$1.87m AOF-enabled RDTI (taking FY25 to ~$7.36m if assessed as expected) is practical. It strengthens near-term cash inflows around the late-January 2026 DMC interim and the mid-Q4 2026 topline—precisely when options narrow and choices become consequential.
The path from here is to complete enrolment, pass the interim gates, and deliver the primary readout. For investors, the discipline remains the same—calibrate expectations to the milestones, focus on the quality of data (not headlines), and DYOR.
Figure 2: ACW share price chart as of 29th October 2025 (source: CommSec)
In my opinion, the ACW story is only going to get bigger. Currently, it has a market capitalisation of AUD $104M which is healthy for something that is still at the "early" stage. If everything lines up, I am confident that the market will start to re-rate its business. The share price chart (Figure 2) is moving in the right direction and this is one of the few businesses in the ASX that potential investors should be doing a #SamsoDYOR.
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