Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (June 2024)
26 slides from Actinogen Medical's investor presentation, Jun 19, 2024
Slide 1: Phase 2-stage clinical company with near-term trial results mid 2024 and 2025
Phase 2-stage clinical company with near-term trial results mid 2024 and 2025 Easy-to-use oral therapy for dementia and depression Corporate Presentation 19 June 2024
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: Company Highlights
Company Highlights Positioned to achieve two major phase 2 milestones in next 15 months Clinical-stage, Xanamem® lowers brain cortisol and is in Phase 2 trials to treat patients with cognitive impairment associated with 1 advanced depression and Alzheimer’s disease; to-be-marketed pill formulation c
Slide 4: Experienced Leadership and Management
Experienced Leadership and Management Extensive clinical and commercial experience guides Xanamem development Talented management team… …with an experienced Board Dr. Geoff Brooke Chairman MBBS; MBA Mr. Malcolm McComas Dr. Steven Gourlay Dana Hilt Will Souter Cheryl Townsend Fujun Li Michael Roberts
Slide 5: Market Exclusivity
Market Exclusivity Strong IP portfolio Strong patent position with up to 12 years market exclusivity based on “composition of matter” patents and extensions in all major markets Other patents extend potential patent life protection including ”methods of use” patents, patient selection with biomarker
Slide 6: Attractive product profiles in Depression and Alzheimer's
Attractive product profiles in Depression and Alzheimer’s Rapidly acting oral therapy with dual action on cognitive impairment / depression Cognitively enhancing and disease modifying oral therapy for all stages of Alzheimer’s disease Corporate Presentation 19 June 2024 6
Slide 7: 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 US$14 billion market1 with peak sales potential of US$5 billion3 US$17 billion market2 with peak sales potential of US$2 billion3 Total m
Slide 8: The science and the trials
The science and the trials Corporate Presentation 19 June 2024 8
Slide 9: Xanamem: Oral, once-a-day treatment with a unique mechanism
Xanamem: Oral, once-a-day treatment with a unique mechanism Xanamem is a brain penetrant 11β-HSD1 small molecule enzyme inhibitor which reduces brain tissue cortisol3,4 Potential to be: Rapidly cognitive enhancing Disease-modifying (slowing progression)1,3 Anti-depressant effects Mouse experim
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 Baseline After 7 days of daily dosing PET data2 demonstrates that Xanamem extensively binds 5 mg Xanamem 10 mg Xanamem 20 mg Xanamem to the 11β-HSD1 enzyme SUVR
Slide 11: Actinogen Xanamem Phase 2 trials underway
Actinogen Xanamem Phase 2 trials underway Supported by extensive existing clinical data from four previous trials of Xanamem 10mg Phase 2a proof-of-concept trial in patients with Results Q3 2024 Cognitive Impairment & Depression (n=167) Interim results Phase 2b confirmatory trial in patients with mi
Slide 12: Targeting brain tissue cortisol with Xanamem is a promising strategy
Targeting brain tissue cortisol with Xanamem is a promising strategy in cognitive impairment & depression Elevated cortisol associated with severe, melancholic depression2 Cortisol levels associated with treatment outcomes, relapse, & cognition3 80-90% of MDD patients report neurocognitive sym
Slide 13: XanaCIDD proof-of-concept Phase 2a trial in Cognitive Impairment & Depression
XanaCIDD proof-of-concept Phase 2a trial in Cognitive Impairment & Depression 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 t
Slide 14: XanaCIDD trial blinded data review: methods
XanaCIDD trial blinded data review: methods • Blinded analysis to ensure data quality just prior to end of trial enrolment • Analysis used all available data from up to 148 participants* • Trial data is pooled, meaning that treatment assignment was not unblinded (decoded) • Company and trial personn
Slide 15: Trial is progressing well with pooled data trending in the right direction
Trial is progressing well with pooled data trending in the right direction, results due in early Q3 2024 OBSERVATIONS • Assessment of data quality found no concerning trends by country or clinical site • Clinical safety profile remains excellent, with no serious adverse events related to Xanamem • I
Slide 16: 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 patients with Results Q3 2024 Cognitive Impairment & Depression (n=167) Interim results Phase 2b confirmatory trial in patients with mi
Slide 17: 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 18: Xanamem significantly slows the rate of functional decline (CDR-SB) 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) Xanamem Placebo 0 0 0 0.2 0.4 0.36 * CDR-SB units Change from 0.6 * Difference vs. placebo Baseline (SE) • Mean
Slide 19: 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 20: 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 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 Key inclusion criteri
Slide 21: Recent Milestones & Upcoming Catalysts
Recent Milestones & Upcoming Catalysts1 Q1 2024 Human PET study peer-review publication Q2-4 2024 Various peer-review publications, abstracts Q1 2024 UK Innovation Passport granted Q1 2025 Start cognition & depression Phase 2b Q2 2024 Phase 2b Alzheimer’s trial first patient treated Mid
Slide 22: Appendix
Appendix Corporate Presentation 19 June 2024 22
Slide 23: Strong M&A and licensing activity in the CNS sector
Strong M&A and licensing activity in the CNS sector Target/Partner ulotaront, SEP- Drug KarXT Emraclidine BPN-14770 PRX-005 NBI-1117567 378614 and AL-001 BIIB-124 Bepranemab others Phase Phase 3 Phase 2 Phase 2 Phase 1 Phase 2 Phase 3 Phase 3 Phase 3 Phase 1 Fragile X Dementias Alzheimer’s Schizophr
Slide 24: 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 25: 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 26: 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 19 June 2024 26
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