Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (January 2026)
23 slides from Actinogen Medical's investor presentation, January 2026
Slide 1: Oral Xanamem (emestedastat)
Oral Xanamem® (emestedastat) Controlling brain cortisol to slow progression in Alzheimer’s disease and treat depression Corporate Presentation January 2026 ® Xanamem is a registered trademark of Actinogen Medical Limited
Slide 2: Disclaimer
Disclaimer This presentation 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 information necessary to mak
Slide 3: Experience & track record matters
Experience & track record matters 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, LLB; FAICD; SF Fin MBBS; PhD;
Slide 4: 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 Corporate Presentation January 2026 4
Slide 5: Xanamem's unique mechanism of action
Xanamem’s unique mechanism of action Click here for animation video Corporate Presentation January 2026 5
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 agreement streamlines development, EMA meeting 2026 • 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 • Cle
Slide 7: 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 side glutamate effects. Anti-amyloid prot
Slide 8: 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 9: 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 10: 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 Xanamem extensively binds SUVRcarotid to the 11β-HSD1 enzyme throughout the brain, with high post-tr
Slide 11: 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 12: 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 13: 5. Evidence-based trial design & patient selection
5. Evidence-based trial design & patient selection Interim XanaMIA phase 2b/3 results in late Jan 2026, topline final results Nov 2026 10mg Xanamem Follow-up & open label Screening Placebo -4 0 Double-blind, randomised treatment period (N = 247) 36 Weeks 40 Weeks Key Inclusion Criteria Primary Endpo
Slide 14: XanaMIA interim analysis and open-label phase detail
XanaMIA interim analysis and open-label phase detail Interim analysis late January 2026, open-label phase commences Q1 2026 Interim analysis of safety and efficacy futility • Independent Data Monitoring Committee made up of experienced clinical and statistics experts • Conducted in a highly confiden
Slide 15: 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 incl
Slide 16: 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 17: 2. Potential for Xanamem to beat existing approved treatments on CDR-SB primary endpoint
2. Potential for Xanamem to beat existing approved treatments on 0.5 CDR-SB primary endpoint Worsening of 0 CDR-SB e.g. Xanamem over 18 months -0.5 approaches full disease -1 stabilization over 18 months -1.5 Modest benefit -2 of donanemab (Kisunla) over -2.5 18 months Worse performance -3 donanemab
Slide 18: 3. Well-established safety and potential to see consistent benefit on key secondary efficacy measures
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 • Activities of daily living related to Xanamem in whole program to date (n ~ 500)1 1. No serious adverse even
Slide 19: 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 20: Conclusion
Conclusion Corporate Presentation January 2026 20
Slide 21: 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 ✓ Interim results late January 2026,
Slide 22: Multiple near-term milestones in coming year
Multiple near-term milestones in coming year Milestone Likely Timing Full enrolment, 247 patients with AD, XanaMIA AD trial Completed XanaCIDD MDD peer-reviewed journal publication Q1 26 Meetings at JP Morgan Healthcare conference week, San Francisco Mid Jan 26 Interim analysis XanaMIA AD trial of a
Slide 23: 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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