Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (March 2026)
29 slides from Actinogen Medical's investor presentation, March 2026
Slide 1: Advancing Xanamem in Alzheimer's Disease
Advancing Xanamem® in Alzheimer’s Disease Fully enrolled phase 2b/3 study | Topline data November 2026 Independent DMC recommended study continue unchanged (January 2026) Corporate Presentation March 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 and investment highlights
Corporate summary and investment highlights Independent interim validation achieved | Topline phase 2b/3 results November 2026 Validated mechanism with differentiated oral profile NEXT MAJOR VALUE INFLECTION • Xanamem is a novel oral therapy targeting elevated brain cortisol, a well- Phase 2b/3 topl
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: Independent interim review: trial continues unchanged
Independent interim review: trial continues unchanged Interim safety and futility review (January 27, 2026) Recommendation: • Continue the XanaMIA trial without modification Interim review process: • Independent Data Monitoring Committee chaired by Alzheimer’s disease trials expert Dr Hans Moebius •
Slide 6: Xanamem: Well defined path to U.S. approval
Xanamem: Well defined path to U.S. approval FDA alignment confirms streamlined late-stage development pathway Current study • Phase 2b/3 XanaMIA study (n=247) expected to form part of registrational package Remaining clinical requirements • One additional single-dose phase 3 trial (10 mg vs placebo)
Slide 7: Strong physician interest and demand for Xanamem
Strong physician interest and demand for Xanamem Global Alzheimer’s therapeutic market expected to exceed $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 s
Slide 8: Xanamem positioning in Alzheimer's disease
Xanamem positioning in Alzheimer’s disease Oral profile and safety address key limitations of existing therapies Current therapy limitations Xanamem differentiation • Anti-amyloid injectables require infusions • Once-daily oral therapy and extensive MRI monitoring • No ARIA risk observed to date. No
Slide 9: Positioned for phase 2b/3 success
Positioned for phase 2b/3 success Corporate Presentation March 2026 9
Slide 10: 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 March 2026 10
Slide 11: 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 12: Xanamem: CDR-SB slowed in pTau-positive Alzheimer's
Xanamem: CDR-SB slowed in pTau-positive Alzheimer’s Phase 2a study showed slowing of 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 = 0.09 • Cohen’s d =
Slide 13: Durable activity in phase 2 depression study
Durable activity in phase 2 depression study 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 BETTER Cohen’s d = 0.64 EOT 2.6-point difference p = 0.03 -4 Cohen’s d = 0.38 from baseline (± SE) p = 0.1
Slide 14: 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 15: Rigorous phase 2b/3 trial positioned for success
Rigorous phase 2b/3 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
Slide 16: Open-label extension enhances long-term dataset
Open-label extension enhances long-term dataset 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 Q1 2026 Data contribution • ≥12 months additional safety exposure • Longitudinal a
Slide 17: Summary: positioned for phase 2b/3 success
Summary: positioned for phase 2b/3 success Clear Biological Demonstrated Clinical Signal in Consistent CNS Rigorous, Fully Rationale Brain Target Enriched Activity Across Enrolled Phase Engagement Alzheimer’s Indications 2b/3 Trial Population Elevated brain High 11β-HSD1 CDR-SB slowing in Durable se
Slide 18: Strategic implications for commercialization and partnering
Strategic implications for commercialization and partnering Corporate Presentation March 2026 18
Slide 19: 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 20: Anti-amyloid therapies modestly slow decline
Anti-amyloid therapies 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 -2.5 18
Slide 21: 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 p- 0 Worsening of tau–positive patients CDR-SB showed near- -0.5 over 18 months stabilization -1 -1.5 Modest benefit -2 of donanemab (Kisunla) over -2.5 18 months1 Worse -3 donanemab all placebo all pe
Slide 22: Well-established safety and consistent benefit across key secondary measures
Well-established safety and consistent benefit across key secondary measures Safety Key secondary endpoints • Well-tolerated across clinical program • Cognition (validated cognitive measures) • No serious adverse events related to • Activities of daily living (functional Xanamem reported to date (n
Slide 23: XanaMIA as a near-term catalyst for commercial and partnering acceleration
XanaMIA as a near-term catalyst for commercial and partnering acceleration Commercial opportunity drivers include: • U.S. neurologists demonstrate strong interest and demand for a safe, effective oral option • Anti-amyloid injectables face adoption constraints related to administration and monitorin
Slide 24: Summary: commercial and partnering implications
Summary: commercial and partnering implications Structural Limitations Differentiated Oral Potential for Meaningful XanaMIA as a Value of Anti-Amyloid Profile Stabilization Catalyst Infusion burden, ARIA risk, Xanamem is positioned with Targeting elevated brain Phase 2b/3 readout is and cost limit b
Slide 25: Summary
Summary Corporate Presentation March 2026 25
Slide 26: XanaMIA positioned as a registration catalyst
XanaMIA positioned as a registration catalyst Operational execution and regulatory alignment ahead of pivotal Alzheimer’s data • On-track with XanaMIA pivotal trial in patients with mild-to-moderate AD ✓ Full enrolment of 247 participants achieved ✓ Positive interim analysis Jan 2026); topline resul
Slide 27: 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 28: Near-Term Catalysts Through XanaMIA Readout
Near-Term Catalysts Through XanaMIA Readout Milestone Likely Timing Positive interim analysis XanaMIA AD trial of all available data (weeks 12, 24 & 36) Completed XanaCIDD MDD peer-reviewed journal publication Q1/2 2026 XanaMIA AD open-label extension (OLE) commences Q1 2026 ADPD AD conference in Co
Slide 29: 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 March 2026 29
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