Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (March 2024)
33 slides from Actinogen Medical's investor presentation, Mar 20, 2024
Slide 1: ASX Announcement: Actinogen corporate presentation March 2024
ASX ANNOUNCEMENT Actinogen corporate presentation March 2024 Sydney, 20 March 2024. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to release its latest corporate presentation for March 2024 that includes a number of new and reformatted slides including some related to recent announc
Slide 2: About Xanamem and Disclaimer
The XanaMIA Phase 2b Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in 220 patients with mild to moderate AD and progressive disease, determined by clinical criteria and confirmed by an elevated level of the pTau181 protein biomarker i
Slide 3: Corporate Presentation March 2024
For personal use only Phase 2-stage clinical company with near-term trial results mid 2024 and Q2 2025 De-risked oral therapy for dementia and depression Corporate Presentation March 2024
Slide 4: 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 For personal use only and does not contain all inform
Slide 5: Experienced Leadership and Management
Experienced Leadership and Management Extensive drug development and commercial experience …with an experienced Board For personal use only Talented management team… Dr. Geoff Brooke Chairman MBBS; MBA Mr. Malcolm McComas Dr. Steven Gourlay Dana Hilt Will Souter Cheryl Townsend Fujun Li Michael Robe
Slide 6: Company Highlights
Company Highlights Positioned to leverage the wider biotech market tailwinds For personal use only Xanamem® lowers brain cortisol and is in Phase 2 trials to treat patients with cognitive impairment associated with 1 Clinical-stage depression and Alzheimer’s disease Strong biological Elevated brain
Slide 7: Attractive product profiles in Depression and Alzheimer's
Attractive product profiles in Depression and Alzheimer’s For personal use only Rapidly acting oral therapy with dual action on cognitive Xanamem $2 billion1 impairment / depression Cognitively enhancing and disease modifying oral Xanamem therapy for all stages of Alzheimer’s disease $5 billion1 1.
Slide 8: Opportunity across two key markets
Opportunity across two key markets Significant market opportunity across both Alzheimer’s disease (AD) and Depression Alzheimer’s Disease Market Depression Market For personal use only US$14 billion market1 with peak sales potential of US$5 billion3 US$17 billion market2 with peak sales potential of
Slide 9: Xanamem: Oral, once-a-day treatment with a unique mechanism
Xanamem: Oral, once-a-day treatment with a unique mechanism For personal use only Xanamem is a brain penetrant 11β-HSD1 small molecule enzyme inhibitor which reduces brain cortisol3,4 Potential to be: Rapidly cognitive enhancing Disease-modifying (slowing progression)1,3 Anti-depressant effect
Slide 10: PET data shows full target engagement in the brain at low doses
PET data shows full target engagement in the brain at low doses Previous enzyme inhibitors1 have not achieved adequate brain concentrations For personal use only Baseline After 7 days of daily dosing PET data2 demonstrates that Xanamem extensively binds 5 mg Xanamem 10 mg Xanamem 20 mg Xanamem to th
Slide 11: Market Exclusivity: Strong IP portfolio
Market Exclusivity Strong IP portfolio For personal use only Strong patent position with over 12 years patent protection for composition of matter in all major markets, broad international cover Other patents extend potential patent life protection including ”methods of use” patents and manufacturin
Slide 12: Actinogen Xanamem Phase trials underway
Actinogen Xanamem Phase 2 trials underway De-risked by extensive existing clinical data from four previous trials of Xanamem 10mg For personal use only Phase 2a proof-of-concept trial in patients with Results mid 2024 Depression & Cognitive Impairment (n=160) Interim results Phase 2b confirmatory tr
Slide 13: Targeting brain cortisol with Xanamem in depression
Targeting brain cortisol with Xanamem is a promising strategy in depression For personal use only Elevated cortisol associated with severe, melancholic depression2 Cortisol levels associated with treatment outcomes, relapse, & cognition3 80-90% of MDD patients report neurocognitive symptoms1
Slide 14: XanaCIDD proof-of-concept Phase 2a trial in Depression
XanaCIDD proof-of-concept Phase 2a trial in Depression and Cognitive Impairment Final results mid 2024, primary endpoint validated in prior trials of Xanamem For personal use only 10mg Xanamem +/- existing antidepressant Follow-up Screening Placebo +/- existing antidepressant -4 0 6 Weeks 10 Weeks D
Slide 15: Actinogen Xanamem Phase trials underway
Actinogen Xanamem Phase 2 trials underway De-risked by extensive existing clinical data from four previous trials of Xanamem 10mg For personal use only Phase 2a proof-of-concept trial in patients with Results mid 2024 Depression & Cognitive Impairment (n=160) Interim results Phase 2b confirmatory tr
Slide 16: The answers to Alzheimer's Disease are starting to emerge
The answers to Alzheimer’s Disease are starting to emerge in the clinic… For personal use only 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… C
Slide 17: Quotes: Dr Howard Fillit
Quotes: Dr Howard Fillit Founder & CSO Alzheimer’s Drug Discovery Foundation1 For personal use only “Seventy-eight percent …. of all drugs in clinical development are non- Xanamem is an easy-to-use, oral, amyloid, non-tau drugs” non-amyloid, non-tau tablet “Multiple targets are being addressed now,
Slide 18: Anti-amyloid antibodies 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 For personal use only 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 do
Slide 19: Xanamem significantly slows the rate of functional decline in 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) For personal use only Xanamem Placebo 0 0 0 0.2 0.4 0.36 * CDR-SB units Change from 0.6 * Difference vs. placebo
Slide 20: Cognitive improvements 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 For personal use only 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.
Slide 21: XanaMIA Phase 2b trial in Alzheimer's Disease
XanaMIA Phase 2b trial in Alzheimer’s Disease Initial, interim results in H1 2025, final results H2 2025 For personal use only 10mg Xanamem Screening from Dec 23 Follow-up & open label Placebo -4 0 36 weeks 40 Weeks Double-blind, randomised treatment period (N=220) Interim analysis N=100 @ 24 weeks
Slide 22: Strong M&A and licensing activity in the CNS sector
Strong M&A and licensing activity in the CNS sector For personal use only Target/Partner SEP-378614 and Drug KarXT Emraclidine NBI-1117567 AL-001 BIIB-124 Bepranemab others Phase Phase 3 Phase 2 Phase 2 Phase 3 Phase 3 Phase 3 Phase 1 Frontotemporal Indication Alzheimer’s Disease Depression Schizoph
Slide 23: Recent Milestones & Upcoming Catalysts
Recent Milestones & Upcoming Catalysts1 Q1 2024 Human PET study peer-review publication Q2-4 2024 Various peer-review publications, abstracts For personal use only Q1 2024 UK Innovation Passport granted Q1 2025 Start depression Phase 2b Q1 2024 Phase 2b Alzheimer’s trial first patient scre
Slide 24: Appendix
For personal use only Appendix Corporate presentation March 20 2024 22
Slide 25: 11β-HSD1 inhibition and attenuated cognitive decline
11β-HSD1 inhibition and attenuated cognitive decline Xanamem has pleiotropic mechanisms of action to reduce or halt cognitive decline For personal use only Increased synaptic plasticity cortisone Lowers Better working & (inert) X z brain Greater dendritic complexity episodic memory cortisol reduced
Slide 26: Why targeting brain cortisol 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 For personal use only Epidemiology, cortisol and animal Clinical trials of Xanamem experiments Cortisol levels are elevated in brain fluid in early
Slide 27: All major Xanamem development risks mitigated
All major Xanamem development risks mitigated Highly attractive, mid phase 2 profile in dementia and major depression For personal use only Animal tox studies Completed long-term toxicology studies needed for FDA approval Preclinical Neuroprotection in rodent models of Alzheimer’s with chemically
Slide 28: Methods for 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 current 36-week XanaMIA Phase 2b trial For personal use only Assess efficacy trends Measure disease on clinical en
Slide 29: International Cognition Clinical Advisory Board
International Cognition Clinical Advisory Board Preeminent global thought-leaders in clinical trials for assessment of cognition For personal use only Prof. John Harrison Dr Dana C. Hilt (CMO) Dr Christina Kurre Olsen Prof. Paul Maruff A/Prof Christopher Chen Metis Cognition Ltd • Expert psychologis
Slide 30: International Scientific Advisory Boards
International Scientific Advisory Boards Preeminent thought-leader academics involved in the development of Xanamem For personal use only Alzheimer’s Disease Clinical Advisory Board Scientific Advisory Board Prof. Craig Ritchie Prof. Colin Masters Prof. Jeffrey Cummings Prof. Jonathan Seckl Prof. Br
Slide 31: 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 For personal use only ACTH Adrenocorticotropic hormone that regul
Slide 32: 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 For personal use only MDD Major Depressive Disorder MMSE Mini Mental State Examination – a 30-point scale
Slide 33: Contacts
For personal use only 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 March 20 2024 31
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