Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (July 2024)
29 slides from Actinogen Medical's investor presentation, July 2024
Slide 1: Oral Xanamem: A new class of cognitive enhancer for depression
Oral Xanamem® A new class of cognitive enhancer for depression with disease modifying potential in Alzheimer’s Corporate Presentation July 2024 ® 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 m
Slide 3: Overview
Overview Novel mechanism and attractive oral profile • Xanamem is a unique brain-penetrant tissue cortisol synthesis inhibitor (11β-HSD1 enzyme) • Once-daily oral therapy with potential efficacy, safety and ease of use greater than competitors • More than 350 people treated with promising safety pro
Slide 4: Once-daily oral treatment with a unique mechanism
Once-daily oral treatment with a unique mechanism Xanamem is a small molecule tissue cortisol synthesis inhibitor (11β-HSD1 enzyme) Good safety profile in >350 treated Brain-penetrant at low doses Potentially disease-modifying Pro-cognitive within 2–4 weeks Low drug interaction potential ideal for c
Slide 5: Human PET study shows full target engagement
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-treat
Slide 6: Positive Xanamem effects on cognition in two prior trials
Positive Xanamem effects on cognition in two prior trials Consistent Cogstate improvements in older, cognitively normal people* XanaMIA Phase 1b trial (n=107, 5 and 10mg combined) XanaHES Phase 1b trial (n=42, Xanamem 20 mg)2 0.5 ON-TREATMENT VISITS 0.5 ON-TREATMENT VISITS BETTER 0.4 0.4 Attention c
Slide 7: Xanamem pipeline
Xanamem pipeline Indication Preclinical Phase 1 Phase 2 Phase 3 Alzheimer’s disease Cognitive impairment MDD Open INDs Phase 2 trials Fragile X syndrome Cognitive impairment CIAS Frontotemporal dementia Potential next indications Lewy-body dementia CI and dementia PD MDD: Major depressive disorder;
Slide 8: Experienced board and management team
Experienced board and management team 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; P
Slide 9: Stock price and key shareholders
Stock price and key shareholders* ASX: ACW – YTD CY24 Key Data 52 Week Range $0.015 – $0.099 YTD CY24 change 291% Shares on issue 2.7b Unlisted options 367m Closing price $0.081 Closing market cap* $218m 30 June cash balance $9.45m* Key Shareholders Biotech Value Fund 9.2% CEO Steven Gourlay 3.6% To
Slide 10: Cognitive impairment & depression
Cognitive impairment & depression Corporate Presentation July 2024 10
Slide 11: Cognitive impairment & depression
Cognitive impairment & depression Strong scientific rationale to address the large unmet medical need Scientific rationale U.S. Depression market large unmet need • Elevated cortisol associated with severe, • 21M patients have had ≥ 1 MDD episode melancholic depression • Cortisol levels associated w
Slide 12: XanaCIDD phase 2a trial cognitive impairment & MDD
XanaCIDD phase 2a trial cognitive impairment & MDD Results early Q3 2024, primary endpoint validated in prior trials of Xanamem 10mg Xanamem +/- Existing Antidepressant Follow-up Screening Placebo +/- Existing Antidepressant -4 0 6 Weeks 10 Weeks Double-blind, randomised treatment period (N=167) Pri
Slide 13: XanaCIDD trial data trending positively
XanaCIDD trial data trending positively Pooled blinded data trending in the right direction with final results due early August 2024 Observations • Assessment of data quality found no concerning trends by country or clinical site • Clinical safety profile remains excellent, with no serious adverse e
Slide 14: Alzheimer's disease
Alzheimer’s disease Corporate Presentation July 2024 14
Slide 15: Alzheimer's disease
Alzheimer’s disease Strong scientific rationale to address huge unmet medical need Scientific rationale Alzheimer’s Disease market – U.S. • Cortisol levels are elevated in brain fluid in Large unsatisfied and growing market early AD • Chronic corticosteroid treatment leads to # of patients Cost to t
Slide 16: Anti-amyloid therapy modestly slows AD progression
Anti-amyloid therapy modestly slows AD progression 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 -2 Benefit of donanemab over 18 months -2.5 Worse perf
Slide 17: Xanamem in pTau181-positive patients with mild AD
Xanamem in pTau181-positive patients with mild AD Phase 2a biomarker study: major slowing of CDR-SB decline (n=34) Xanamem Placebo 0 0.2 0.4 0.36 Xanamem vs. Placebo CDR-SB units 0.6 • Mean 0.6 units Change from • Median 0.8 units Baseline (SE) • p = 0.09 0.8 • Cohen’s d = 0.4 1 0.98 1.2 1.4 Worse B
Slide 18: XanaMIA phase 2b trial in Alzheimer's disease
XanaMIA phase 2b trial in Alzheimer’s disease Initial, interim results in mid 2025, final results H1 2026 10mg Xanamem Follow-up & open label Screening from Dec 23 Placebo -4 0 36 Weeks 40 Weeks Double-blind, randomised treatment period (N=220) Interim analysis N=100 @ 24 weeks Key Inclusion Criteri
Slide 19: Recent transactions in neuroscience
Recent transactions in neuroscience Corporate Presentation July 2024 19
Slide 20: Recent neuroscience acquisitions and IPOs
Recent neuroscience acquisitions and IPOs Caraway PIPE-307 Lead Drug(s) TRPML1 KarXT Emraclidine ALTO-100 RAP-219 PIPE-791 Phase Preclinical Phase 3 Phase 2 Phase 2 Phase 2 Phase 1 Epilepsy, BPD, Lead asset PD, other neuro Schizophrenia Schizophrenia MDD MS & MDD other neuro Transaction Acquisition
Slide 21: Active licensing for clinical neuroscience assets
Active licensing for clinical neuroscience assets ulotaront, Drug ACI – 24.060 PRX-005 NBI-1117567 SEP- 378614 AL-001 BIIB-124 Bepranemab and others Phase Phase 1b/2 Phase 1 Phase 2 Phase 3 Phase 3 Phase 3 Phase 1 Alzheimer’s Dementias Alzheimer’s Alzheimer’s Schizophrenia/ Indication (amyloid beta
Slide 22: Milestones & summary
Milestones & summary Corporate Presentation July 2024 22
Slide 23: Upcoming milestones & catalysts
Upcoming milestones & catalysts 2024 2025 2026 H1 H2 H1 H2 H1 H2 Phase 2b Alzheimer’s (AD) Interim data Final results Phase 3 AD Phase 2a Final results Phase 2b Cognition & Depression Cog/Depression Phase 3 Cognition & Depression Ancillary Clinical Pharmacology and Non-clinical Studies PET Trial Pha
Slide 24: Summary
Summary Unique oral treatment for patients with neuropsychiatric diseases and dementia • Rapidly acting oral therapy with potential dual action on cognitive impairment and other depressive symptoms • Cognitively enhancing and potentially disease modifying oral therapy for all stages of Alzheimer’s d
Slide 25: Appendix
Appendix Corporate Presentation July 2024 25
Slide 26: Key references
Key references Other references see also https://actinogen.com.au/xanamem Preclinical 11β-HSD1 inhibition Alzheimer’s disease and cortisol • Cognitive and disease-modifying effects of 11β-hydroxysteroid dehydrogenase type 1 • Plasma Cortisol, Brain Amyloid-β, and Cognitive Decline in Preclinical Alz
Slide 27: Selected Glossary
Selected Glossary 1 • 11β-HSD1 – 11 beta HydroxySteroid Dehydrogenase-1 enzyme. Selectively expressed in brain, liver, adipose. • Aβ – Amyloid beta – a type of amyloid protein associated with Alzheimer’s Disease, 42 and 40 are different forms • ACTH – Adrenocorticotropic hormone that regulates blood
Slide 28: Selected Glossary
Selected Glossary 2 • IQCODE – Informant Questionnaire on Cognitive Decline in the Elderly • MCI – Mild Cognitive Impairment – memory, executive function deterioration with retained functional abilities • MDD – Major Depressive Disorder • MMSE – Mini Mental State Examination – a 30-point scale of si
Slide 29: 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 Corporate Presentation July 2024 29
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