Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (February 2026)
25 slides from Actinogen Medical's investor presentation, Feb 2, 2026
Slide 1: Oral Xanamem Corporate Presentation February 2026
Oral Xanamem® Controlling brain cortisol to slow progression in Alzheimer’s disease and treat depression Corporate Presentation February 2026 ® Xanamem is a registered trademark of Actinogen Medical Limited
Slide 2: Disclaimer
Disclaimer This presentation is dated 2 February 2026 and has been prepared by Actinogen Medical Limited. (“Actinogen” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all
Slide 3: Corporate Summary
Corporate Summary ASX-listed company focussed on oral Xanamem development in Alzheimer’s disease Phase 2b/3 pivotal XanaMIA trial to report topline final results in November 2026 • Positive independent Data Monitoring Committee (DMC) recommendation to continue trial January 2026 • Fully enrolment of
Slide 4: Highly experienced Board and management with strong track record
Highly experienced Board and management with strong track record Board of Directors Dr. Geoff Brooke Dr. Steven Gourlay Mr. Malcolm McComas Dr. George Morstyn Dr. Nicki Vasquez Chairman CEO & MD Non-Executive Director Non-Executive Director Non-Executive Director MBBS; MBA MBBS; FRACP; PhD; MBA BEc,
Slide 5: Interim analysis positive trial recommendation
Interim analysis positive trial recommendation Assessments of safety and efficacy futility January 27, 2026 Recommendation: • Continue the XanaMIA trial without amendment to its final conclusion for the 247 participants Methods: • Independent DMC chaired by Alzheimer’s disease trials expert Dr Hans
Slide 6: Xanamem has a clear path to Alzheimer's approval
Xanamem has a clear path to Alzheimer’s approval Phase 2b/3 trial on track, FDA Sep 2026 agreement streamlines development • Recent FDA agreement confirms development pathway to US marketing approval using one additional pivotal trial of 10 mg vs. placebo and open-label safety studies • Clear guidan
Slide 7: Alzheimer's disease market is large and growing
Alzheimer’s disease market is large and growing Growing Alzheimer’s Disease market – U.S. Large, unsatisfied and growing market Sources: U.S. burden of Alzheimer’s disease, related dementias to double by 2060 | CDC Online Newsroom | CDC, US Alzheimer’s Prevalence Surpasses 7 Million and The Cost of
Slide 8: Xanamem's unique mechanism of action
Xanamem’s unique mechanism of action Click here for animation video Corporate Presentation February 2026 8
Slide 9: Highlights of Alzheimer's treatment landscape
Highlights of Alzheimer’s treatment landscape Oral Xanamem is leading the charge with a potential game-changing new mechanism Mechanistic Admin Comments Older drugs - boosting acetylcholine or Oral • Marketed since '90s/'00s, symptomatic only. Gastrointestinal glutamate side effects. Anti-amyloid pr
Slide 10: Why does the Company have confidence in a positive phase 2b/3 trial outcome?
Why does the Company have confidence in a positive phase 2b/3 trial outcome? 1. Very strong cortisol scientific rationale in Alzheimer’s 2. Human PET study showing high brain target engagement (n = 40) 3. Large clinical benefit in pTau biomarker-positive Alzheimer’s patients (n = 34) 4. Clinically i
Slide 11: 1. Very strong cortisol scientific rationale in Alzheimer's
1. Very strong cortisol scientific rationale in Alzheimer’s • Compelling evidence provided by the Australian Imaging, Biomarker & Lifestyle Study of Ageing (AIBL) study (2017)1 ✓ Higher plasma cortisol leads to a much greater risk of developing AD ✓ Accelerated effect of Αβ+ on decline in global cog
Slide 12: 2. Human PET study shows full target engagement
2. Human PET study shows full target engagement Other 11β-HSD1 enzyme inhibitors have not achieved adequate brain levels Baseline After 7 days of daily dosing 5 mg Xanamem 10 mg Xanamem 20 mg Xanamem SUVRcarotid Xanamem extensively binds to the 11β-HSD1 enzyme throughout the brain, with high post-tr
Slide 13: 3. Large Xanamem benefit in high pTau181 patients
3. Large Xanamem benefit in high pTau181 patients Phase 2a biomarker study: major slowing of CDR-SB decline over 12 weeks (n=34) Xanamem Placebo 0 0.2 0.4 0.36 0.6-point benefit @12 weeks CDR-SB units 0.6 Xanamem vs. Placebo Change from • Mean 0.6 units Baseline (SE) 0.8 • Median 0.8 units • p = 0.0
Slide 14: 4. Durable activity of Xanamem on depression in phase 2
4. Durable activity of Xanamem 10 mg daily on depression in phase 2 Baseline Week 2 Week 4 Week 6 Week 10 0 -2 PT 4.2-point difference BETTER Cohen’s d = 0.64 EOT 2.6-point difference p = 0.03 -4 Cohen’s d = 0.38 from baseline (± SE) p = 0.15 LS mean change MADRS -6 -8 -10 -12 ON TREATMENT AND BACKG
Slide 15: 5. Evidence-based trial design & patient selection
5. Evidence-based trial design & patient selection Positive XanaMIA phase 2b/3 interim analysis outcome achieved, topline final results Nov 2026 10mg Xanamem Follow-up & open label Screening Placebo -4 0 Double-blind, randomized treatment period (N = 247) 36 Weeks 40 Weeks Key Inclusion Criteria Pri
Slide 16: XanaMIA trial open-label phase
XanaMIA trial open-label phase Open-label phase commences Q1 2026 • Active Xanamem 10 mg offered to all current and prior XanaMIA phase 2b/3 trial participants irrespective of any gaps between completing the main trial and OLE availability • No placebo control group • Provides longer term safety dat
Slide 17: Strategic insights about commercialization and partnering in AD
Strategic insights about commercialization and partnering in AD 1. Anti-amyloid infusions have a borderline risk- benefit profile and are expensive 2. Xanamem is being developed with a better risk- benefit and ease-of-use profile aimed at stabilizing the disease safely 3. Desired Xanamem benefits in
Slide 18: 1. Anti-amyloid drugs only modestly slow disease
1. Anti-amyloid drugs only modestly slow disease Ideally patients with AD would not worsen on treatment at all 0.5 Ideal trajectory Worsening of 0 with disease CDR-SB stabilization over 18 months -0.5 Unmet need -1 despite amyloid therapy -1.5 Modest benefit -2 of donanemab (Kisunla) over -2.5 18 mo
Slide 19: 2. Potential for Xanamem to beat existing approved treatments on CDR-SB
2. Potential for Xanamem to beat existing approved treatments on CDR-SB primary endpoint 0.5 Worsening of 0 e.g. Xanamem CDR-SB approaches full over 18 months -0.5 disease -1 stabilization -1.5 Modest benefit -2 of donanemab (Kisunla) over -2.5 18 months1 Worse donanemab all placebo all performance
Slide 20: 3. Well-established safety and potential for consistent secondary benefit
3. Well-established safety and potential to see consistent benefit on key secondary efficacy measures Safety Key secondary endpoints • Well-tolerated • Cognition • No serious adverse events related • Activities of daily living to Xanamem in whole program to date (n ~ 500)1 1. No serious adverse even
Slide 21: 4. XanaMIA catalyst for commercial & partnering events
4. XanaMIA catalyst for commercial & partnering events We know the commercial opportunity is huge: • US Neurologists treating AD embrace the idea of a safe and effective, oral drug and indicate that uptake would be rapid in the first year – anti-amyloid injectables have low market appeal • Xanamem c
Slide 22: Summary
Summary Corporate Presentation February 2026 22
Slide 23: Building momentum toward Alzheimer's results
Building momentum toward Alzheimer’s results Numerous value-add near-term milestones • Experienced team with proven track records • On-track with XanaMIA pivotal trial for mild-moderate Alzheimer’s disease ✓ Full enrolment of 247 participants in XanaMIA achieved ✓ Positive interim analysis results J
Slide 24: Multiple near-term milestones in coming year
Multiple near-term milestones in coming year Milestone Likely Timing Positive interim analysis XanaMIA AD trial of all available data (weeks 12, 24 & 36) Achieved XanaCIDD MDD peer-reviewed journal publication Q1/2 26 XanaMIA AD open-label extension (OLE) commences Q1 26 ADPD AD conference in Copenh
Slide 25: Contacts
Contacts Michael Roberts Steven Gourlay Investor Relations CEO & Managing Director P: +61 2 8964 7401 P: +61 2 8964 7401 M: +61 423 866 231 E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au Join the Actinogen Investor Hub: https://investors.actinogen.com.au/ Corporate Presentati
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