Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (January 2024)
24 slides from Actinogen Medical's investor presentation, Jan 8, 2024
Slide 1: Xanamem: A novel pro-cognitive and potentially disease modifying drug
Xanamem: A novel pro-cognitive and potentially disease modifying drug Two near-term major Phase 2 readouts in Depression and Alzheimer's disease in 2024 & 2025 Corporate Presentation January 8, 2024 Non-confidential ® 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: Xanamem: Oral, once-a-day treatment with a unique, non-amyloid/non-tau mechanism
Xanamem: Oral, once-a-day treatment with a unique, non-amyloid/non-tau mechanism Mouse experimental studies & clinical trials validate cortisol as a target for the treatment of AD1-4 Inflammation and glucose/lipid dysregulation emerging as key mechanisms in AD5 Xanamem is a brain penetrant 11β-HSD1
Slide 4: Two large clinical opportunities: Depression and AD
Two large clinical opportunities: Depression and AD Rapidly acting oral therapy with dual action on cognitive impairment / depression Depression market size ~$17 billion in 2032 Cognitively enhancing and disease modifying oral therapy for all stages of Alzheimer’s disease not just MCI Alzheimer’s ma
Slide 5: Actinogen Xanamem Phase 2 trials underway
Actinogen Xanamem Phase 2 trials underway De-risked by extensive existing clinical data from four previous trials of Xanamem 10mg Phase 2a proof-of-concept trial in Results Q2 2024 Depression/Cognitive Impairment (n=160) Interim results Phase 2b confirmatory trial in mild-moderate H1 2025 Alzheimer’
Slide 6: Targeting brain cortisol with Xanamem is a promising strategy in depression
Targeting brain cortisol with Xanamem is a promising strategy in depression ✓ 80-90% of MDD patients report neurocognitive symptoms1 ✓ Cognitive symptoms often persist during remission1 ✓ Elevated cortisol associated with severe, melancholic depression2 ✓ Cortisol levels associated with treatment ou
Slide 7: XanaCIDD proof-of-concept Phase 2a trial in Depression and Cognitive Impairment
XanaCIDD proof-of-concept Phase 2a trial in Depression and Cognitive Impairment 10mg Xanamem +/- existing antidepressant Follow-up Screening Placebo +/- existing antidepressant -4 0 6 10 Weeks Double-blind, randomised treatment period (N=160) Key inclusion/exclusion criteria Primary Endpoints Key Se
Slide 8: The answers to Alzheimer's Disease are starting to emerge in the clinic
The answers to Alzheimer’s Disease are starting to emerge in the clinic… Alzheimer’s proteins amyloid and tau are the pathology – not the cause… Clearing amyloid produces a very modest benefit Other causal processes are involved like inflammation, lipids and glucose handling… Corporate Presentation
Slide 9: Newer anti-amyloid antibodies shown to slow but not halt progression of AD
Newer anti-amyloid “immunotherapy” antibodies shown to slow but not halt progression of AD1 Ideally patients would not worsen on treatment Worsening of 0 CDR-SB2 over 18 months -0.5 Large area of -1 unmet need requires non- amyloid therapies -1.5 -2 Benefit of donanemab -2.5 donanemab all placebo al
Slide 10: Dr Howard Fillit, Founder Alzheimer's Drug Discovery Foundation
Dr Howard Fillit, Founder Alzheimer’s Drug Discovery Foundation1 “Seventy-eight percent …. of all drugs in clinical development are non- amyloid, non-tau drugs. Multiple targets are being addressed now, which is great for the field because I think the way we're going to have to go is combination the
Slide 11: Rationale: Why targeting brain cortisol with Xanamem is promising in Alzheimer's disease
Rationale: Why targeting brain cortisol with Xanamem is a promising strategy in Alzheimer’s disease Multiple streams of data support the hypothesis Epidemiology, cortisol and animal Clinical trials of Xanamem experiments ✓ Cortisol levels are elevated in brain fluid in early ✓ Inhibits brain 11β-HSD
Slide 12: Xanamem significantly slows the rate of functional decline (CDR-SB) in patients with mild AD
Xanamem significantly slows the rate of functional decline (CDR-SB) in patients with mild AD* Patients with elevated plasma pTau181 indicating progressive, amyloid-positive disease (n=34) Xanamem Placebo 0 0 0.2 0.4 0.36 * CDR-SB units Change from 0.6 * Difference vs. placebo Baseline (SE) • Mean 0.
Slide 13: Cognitive improvements suggest potential clinical benefits across dementia patient sub-types
Cognitive improvements suggest potential clinical benefits across dementia patient sub-types* Positive trends in both high and low plasma pTau biomarker groups Higher pTau biomarker (n=34) Lower pTau biomarker (n=34) 0.3 0.3 Composite Units (SE*) Composite Units (SE) 0.2 0.2 0.1 0.1 0 0 -0.1 -0.1 -0
Slide 14: XanaMIA Phase 2b trial in Alzheimer's Disease
XanaMIA Phase 2b trial in Alzheimer’s Disease Matching patients and endpoints in Phase 2b as in the positive Ph 2a analysis 10mg Xanamem Screening from Dec 23 Follow-up & open label Placebo -4 0 36 40 Weeks Double-blind, randomised treatment period (N=220) Interim analysis N=100 @ 24 weeks Key inclu
Slide 15: Xanamem AD & Depression programs
Xanamem AD & Depression programs Building on multiple Phase 1 and 2 studies showing safety and procognitive activity Prior Phase 1 & 2a studies Safety (n~350), cognition, clinical activity demonstrated in 3 prior trials Phase 2a (n=160) Phase 2b (n=220) Cognitive Impairment Alzheimer’s Disease (AD)
Slide 16: Experienced Leadership and Management
Experienced Leadership and Management Extensive drug development and commercial experience Experienced Board of Directors... …with a talented management team in place Will Souter Chief Financial Officer B. Fin Admin; M. App. Fin; CA Cheryl Townsend VP Clinical Operations RN, M Health Law Dana Hilt D
Slide 17: Actinogen summary
Actinogen summary Actinogen Medical (ASX:ACW) is conducting Phase 2 trials of oral Xanamem in patients with cognitive impairment associated with depression and Alzheimer’s disease. Results due in 2024 and 2025. Attractive disease ✓ Strong cortisol rationale for treatment of multiple diseases: Alzhei
Slide 18: Appendix
Appendix Corporate Presentation January 2024 18
Slide 19: Methods for double-blind, prospective assessment of biomarker-positive mild AD patients in Phase 2a
Methods for double-blind, prospective assessment of biomarker-positive mild AD patients in Phase 2a1 Re-examining the 12-week XanADu Phase 2a trial with biomarkers - a simulation of the 36-week XanaMIA Phase 2b trial Measure disease Assess efficacy trends biomarkers Week 0 & 12 on clinical endpoints
Slide 20: International Cognition Clinical Advisory Board
International Cognition Clinical Advisory Board Preeminent global thought-leaders in clinical trials for assessment of cognition Prof. John Harrison Dr Dana C. Hilt (CMO) Dr Christina Kurre Olsen Prof. Paul Maruff A/Prof Christopher Chen Metis Cognition Ltd • Expert psychologist with a special • 25+
Slide 21: International Scientific Advisory Boards
International Scientific Advisory Boards Preeminent thought-leader academics involved in the development of Xanamem Alzheimer’s Disease Clinical Advisory Board Scientific Advisory Board Prof. Craig Ritchie Prof. Colin Masters Prof. Jeffrey Cummings Prof. Jonathan Seckl Prof. Brian Walker Prof. Scott
Slide 22: 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 levels of c
Slide 23: 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 simple questions t
Slide 24: 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 January 2024 24
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