Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2025)
25 slides from Actinogen Medical's shareholder meeting presentation, Nov 19, 2025
Slide 1: Actinogen 2025 AGM – Chair's address and CEO's presentation
ASX ANNOUNCEMENT Actinogen 2025 AGM – Chair’s address and CEO’s presentation Sydney, 19 November 2025. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to release the Chair’s address and CEO’s slide presentation to this morning’s Annual General Meeting commencing at 11am (AEDT) in Sydn
Slide 2: For personal use only
The XanaMIA-OLE Alzheimer’s disease open-label extension is an open-label phase of up to 25 months treatment where all participants will receive active Xanamem 10 mg once daily. The trial will evaluate safety and a limited number of efficacy endpoints such as the CDR-SB. The trial will commence in Q
Slide 3: Actinogen 2025 AGM Chair's Address
19 November 2025 Actinogen 2025 AGM Chair’s Address Good morning, fellow shareholders, my name is Geoff Brooke, and I am the Chair of Actinogen Medical Limited. On behalf of the Board of Directors and staff of the Company it is a pleasure to welcome you to the Actinogen 2025 Annual General Meeting.
Slide 4: For personal use only
instrumental in maintaining a highly effective clinical development program and the corporate operations required of a publicly listed biotechnology company. Turning to governance, our Board remains committed to the highest standards of oversight and strategic leadership. During the year, we underto
Slide 5: CEO's Presentation
For personal use only CEO’s AGM presentation Dr Steven Gourlay MBBS PhD MBA: CEO & MD 19 November 2025 1
Slide 6: Experience matters
Experience matters Board of Directors For personal use only 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
Slide 7: Oral Xanamem: Controlling brain cortisol
For personal use only Oral Xanamem® Controlling brain cortisol to slow progression in Alzheimer’s disease and treat depression ® Xanamem is a registered trademark of Actinogen Medical Limited
Slide 8: Xanamem's unique mechanism of action
Xanamem’s unique mechanism of action For personal use only Click here for animation video ACW AGM 19 November 2025 4
Slide 9: Alzheimer's disease market is large and growing
Alzheimer’s disease market is large and growing For personal use only Growing Alzheimer’s Disease market – U.S. Large, unsatisfied and growing market ACW AGM 19 November 2025 5
Slide 10: Xanamem: Clear pathway to Alzheimer's approval
Xanamem: Clear pathway to Alzheimer’s approval Phase 2b/3 trial on track, FDA agreement streamlines development, EMA meeting 2026 For personal use only • FDA confirms development pathway to US marketing approval using one additional pivotal trial of 10 mg vs. placebo and open-label safety studies •
Slide 11: Previous results that give confidence in a positive phase 2b/3 outcome
For personal use only Previous results that give the company confidence in a positive phase 2b/3 trial outcome in Alzheimer’s 1. Clinical benefit on depression symptoms in phase 2 (n = 165) 2. Large clinical benefit in pTau biomarker-positive Alzheimer’s patients (n = 34) 3. Human PET study showing
Slide 12: Major depressive disorder phase 2a: benefit in patients on background SSRI
Major depressive disorder phase 2a: benefit also seen in patients taking background SSRI anti-depressant (n=76) For personal use only 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)
Slide 13: Large Xanamem benefit in high pTau181 patients
Large Xanamem benefit in high pTau181 patients Phase 2a biomarker study: major slowing of CDR-SB decline over 12 weeks (n=34) For personal use only 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
Slide 14: Human PET study shows full target engagement
3. Human PET study shows full target engagement Other 11β-HSD1 enzyme inhibitors have not achieved adequate brain levels For personal use only 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 br
Slide 15: Very strong cortisol scientific rationale in Alzheimer's
4. Very strong cortisol scientific rationale in Alzheimer’s ✓ Compelling evidence provided by the Australian Imaging, For personal use only 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
Slide 16: Optimal pivotal trial design & patient selection
5. Optimal pivotal trial design & patient selection Interim XanaMIA results in late Jan 2026, topline final results mid Q4 2026 For personal use only 10mg Xanamem Follow-up & open label Screening Placebo -4 0 Double-blind, randomised treatment period (N > 240) 36 Weeks 40 Weeks Key Inclusion Criteri
Slide 17: Strategic insights about commercialization and partnering in AD
For personal use only Strategic insights about commercialization and partnering in AD 1. Anti-amyloid infusions have a borderline risk-benefit profile 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
Slide 18: 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 For personal use only 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 (Ki
Slide 19: Potential for Xanamem to beat existing approved treatments on CDR-SB
2. Potential for Xanamem to beat existing approved treatments on 0.5 CDR-SB primary endpoint For personal use only 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 pe
Slide 20: Opportunity for consistent benefit across safety and key secondary measures
3. Opportunity for consistent benefit across safety and key secondary measures For personal use only Safety1: No serious adverse events related to Xanamem (n ~ 500) Worse Better performance performance Cognition composite Activities of daily living Patient & carer-reported outcomes Quality of life E
Slide 21: XanaMIA catalyst for commercial & partnering events
4. XanaMIA catalyst for commercial & partnering events We know the commercial opportunity is huge: For personal use only ✓ US Neurologists treating AD love the idea of a safe and effective, oral drug and indicate that uptake would be rapid in the first year ✓ Xanamem could easily move to first line
Slide 22: Conclusion
For personal use only Conclusion ACW AGM 19 November 2025 18
Slide 23: Building momentum toward Alzheimer's results
Building momentum toward Alzheimer’s results Numerous value-add near-term milestones For personal use only • On-track with XanaMIA pivotal trial for mild-moderate Alzheimer’s disease ✓ Full enrolment of > 240 participants in XanaMIA pivotal trial Q4 2025 ✓ Interim results late January 2026, topline
Slide 24: Multiple near-term milestones in coming year
Multiple near-term milestones in coming year Milestone Likely Timing For personal use only Screening activities close, XanaMIA AD trial Oct 25 Full enrolment, 220 patients with AD, XanaMIA AD trial Dec 25 XanaCIDD MDD peer-reviewed journal publication Q4 25 / Q1 26 CTAD AD conference in San Diego ad
Slide 25: Q&A
For personal use only Q&A ACW AGM 19 November 2025 21
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