Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (October 2026)
30 slides from Actinogen Medical's investor presentation, October 2026
Slide 1: Advancing oral Xanamem in Alzheimer's disease
Advancing oral Xanamem® in Alzheimer’s disease XanaMIA Phase 2b/3 pivotal trial final participant visit complete Topline Alzheimer’s data November 2026 Potentially game-changing product profile in CNS diseases Corporate Presentation October 2026 ® Xanamem is a registered trademark of Actinogen Medic
Slide 2: Disclaimer
Disclaimer This presentation is dated October 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 in
Slide 3: Corporate and Xanamem highlights
Corporate and Xanamem highlights Potentially game-changing oral therapy for CNS diseases in late-stage trials Validated mechanism with differentiated oral profile Pivotal Alzheimer’s results • Xanamem is a novel oral therapy targeting elevated brain cortisol, a well- November 2026 established risk f
Slide 4: Experienced leadership
Experienced leadership Proven experience in clinical development, manufacturing, regulatory & commercialization Board of Directors Dr. Geoff Brooke Dr. Steven Gourlay Mr. Malcolm McComas Dr. George Morstyn Dr. Nicki Vasquez Chairman CEO & Managing Director Non-Executive Director Non-Executive Direct
Slide 5: Positioned to meet a huge unmet medical need in Alzheimer's disease
Positioned to meet a huge unmet medical need in Alzheimer’s disease Corporate Presentation October 2026 5
Slide 6: Strong physician interest and demand for Xanamem
Strong physician interest and demand for Xanamem Global Alzheimer’s therapeutic market expected to exceed US$20B by 2030 Quantitative survey of 91 U.S. neurologists treating Alzheimer’s disease (June 2025) Respondents each manage ~250 AD patients on average Rapid adoption expected Significant market
Slide 7: Anti-amyloid therapies only modestly slow decline
Anti-amyloid therapies only modestly slow decline Disease stabilization represents an important therapeutic aspiration 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
Slide 8: Potential for greater magnitude of effect on CDR-SB
Potential for greater magnitude of effect on CDR-SB 0.5 SIMULATED PHASE 2b/3 DATA Xanamem phase 2a 0 Worsening of p-tau–positive CDR-SB patients showed -0.5 over 18 months near-stabilization -1 -1.5 Modest benefit -2 of donanemab (Kisunla) over -2.5 18 months1 Worse -3 donanemab all placebo all perf
Slide 9: Recent milestones
Recent milestones Corporate Presentation October 2026 9
Slide 10: Positive interim safety, efficacy futility reviews
Positive interim safety, efficacy futility reviews Independent Data Monitoring Committee chaired by expert Dr Hans Moebius Recommendation: • Jan 2026 “non-futile” recommendation to continue the XanaMIA trial without modification • Jun 2026 positive safety review without futility assessment Formal in
Slide 11: Open-label extension commenced March 2026
Open-label extension commenced March 2026 Long-term safety and efficacy durability extension to Phase 2b/3 Design • All participants offered active Xanamem 10mg after completion of double-blind phase • Initiated March 2026 with high initial enrolment (>80% continuation from main trial) Data contribu
Slide 12: Clear regulatory pathway to approval in US and EU
Clear regulatory pathway to approval in US and EU Regulatory guidance from FDA & EMA supports streamlined late-stage development Current trial • XanaMIA pivotal trial (n=247) expected to form key part of registrational package • Open-label phase has commenced with high uptake from main trial partici
Slide 13: Commercial and partnering positioning
Commercial and partnering positioning Structural Limitations Differentiated Oral Potential for Meaningful XanaMIA as a Value of Anti-Amyloid Profile Stabilization Catalyst Infusion burden, ARIA Xanamem is positioned Targeting elevated brain Phase 2b/3 readout is risk, and cost limit broad with a fav
Slide 14: Positioned for clinical success
Positioned for clinical success Corporate Presentation October 2026 14
Slide 15: Targeting elevated brain cortisol in Alzheimer's disease
Targeting elevated brain cortisol in Alzheimer’s disease Xanamem selectively inhibits brain 11β-HSD1 while preserving adrenal cortisol function Elevated brain cortisol is associated with cognitive decline and neurodegeneration Watch MOA animation Corporate Presentation October 2026 15
Slide 16: Cortisol and the Alzheimer's brain
Cortisol and the Alzheimer’s brain “Stress” and/or genetic factors may drive multiple AD mechanisms via cortisol Seckl., 2024, J Intern Med 295:20-37 (left panel); Armstrong et al., 2021, Biol Rev 96(5):2209-2228 (right panel). Corporate Presentation October 2026 16
Slide 17: Elevated brain cortisol and Alzheimer's progression
Elevated brain cortisol and Alzheimer’s progression Human observational and biomarker data support cortisol as a disease driver • Higher plasma cortisol associated with increased AD risk (AIBL study) • Cortisol accelerates cognitive decline and interacts with Aβ pathology MEAN CSF CORTISOL LEVELS 0.
Slide 18: Xanamem achieves high brain target occupancy
Xanamem achieves high brain target occupancy Human PET imaging confirms brain 11β-HSD1 engagement Baseline After 7 days of daily dosing 5 mg Xanamem 10 mg Xanamem 20 mg Xanamem SUVRcarotid Reduction in tracer signal (loss of color) indicates high 11β-HSD1 occupancy - Strong occupancy observed across
Slide 19: CDR-SB slowed in pTau-positive Alzheimer's
CDR-SB slowed in pTau-positive Alzheimer’s Phase 2a trial showed slowing of decline over 12 weeks (n=34 with elevated pTau181) 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 = 0.09
Slide 20: Durable activity in phase 2 depression trial
Durable activity in phase 2 depression trial 10 mg demonstrated separation from placebo overall and on background SSRI therapy Baseline Week 2 Week 4 Week 6 Week 10 0 -2 PT 4.2-point difference 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 me
Slide 21: Rigorous pivotal trial positioned for success
Rigorous pivotal trial positioned for success Fully enrolled (n=247) across U.S. and Australia; topline results November 2026 10mg Xanamem Follow-up & open label Screening Placebo -4 0 Double-blind, randomized treatment period (N = 247) 40 Weeks 36 Weeks Population Primary Endpoint Key Secondary End
Slide 22: Well-established safety, industry-standard endpoints
Well-established safety, industry-standard endpoints Safety XanaMIA endpoints • Well-tolerated across clinical program • CDR-SB at 36 weeks is primary endpoint • No serious adverse events related to • Cognition (validated cognitive measures) Xanamem reported to date (n ~ 500)1 • “Amsterdam” activiti
Slide 23: Phase 2b/3 summary and rationale for success
Phase 2b/3 summary and rationale for success Clear Biological Demonstrated Clinical Signal in Consistent CNS Rigorous, Fully Rationale Brain Target Enriched Activity Across Enrolled Pivotal Engagement Alzheimer’s Indications Trial Population Elevated brain High 11β-HSD1 CDR-SB slowing in Durable sep
Slide 24: Summary
Summary Corporate Presentation October 2026 24
Slide 25: XanaMIA trial positioned as a game-changer
XanaMIA trial positioned as a game-changer Pivotal Alzheimer’s data from a well-designed 36-week trial due in November • Unique and novel cortisol control mechanism with strong scientific rationale • Biomarker-enriched population with mild-to-moderate AD, CDR-SB primary endpoint ✓ Final participant
Slide 26: Commercial and strategic strength ahead of readout
Commercial and strategic strength ahead of readout Leadership, market validation, lifecycle protection, and financial readiness • Experienced leadership team with proven track records across development, approval, commercialization, and strategic transactions • Strong physician demand across ~100 U.
Slide 27: Appendix
Appendix Corporate Presentation October 2026 27
Slide 28: 2026 catalysts leading to November Alzheimer's results
2026 catalysts leading to November Alzheimer’s results Milestone Likely Timing Positive interim analysis XanaMIA AD trial of all available data (weeks 12, 24 & 36) Completed XanaMIA AD open-label extension (OLE) commences & reports initial enrolment data Completed EMA Scientific Advice meeting for A
Slide 29: AD treatment landscape: meaningful limitations persist
AD treatment landscape: meaningful limitations persist Recent advances have not eliminated meaningful clinical and practical barriers Mechanistic Admin Comments Older drugs - boosting acetylcholine or glutamate Oral • Symptomatic benefit only • Gastrointestinal tolerability limitations Anti-amyloid
Slide 30: Contacts
Contacts Will Souter Steven Gourlay CFO & Investor Relations CEO & Managing Director M: +61 402 035 716 P: +61 2 8964 7401 E. will.souter@actinogen.com.au E. steven.gourlay@actinogen.com.au Join the Actinogen Investor Hub: https://investors.actinogen.com.au/ Corporate Presentation October 2026 30
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