Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Spark Plus Australian Equities Day 2022
28 slides from Actinogen Medical's conference presentation, Jul 28, 2022
Slide 1: ASX Announcement: Actinogen CEO presentation to Spark Plus Australian Equities Day
For personal use only ASX ANNOUNCEMENT Actinogen CEO presentation to Spark Plus Australian Equities Day Sydney, 28 July 2022. Actinogen Medical ASX: ACW (“ACW” or “the Company”) announces that the Company’s CEO, Dr Steven Gourlay, will be presenting at the Spark Plus Australian Equities Day webinar
Slide 2: Xanamem background and disclaimer
Chronically elevated cortisol is associated with cognitive decline in Alzheimer’s Disease, and Xanamem has shown the ability to enhance cognition in healthy, older volunteers. Cognitive impairment is also a feature in Depression and many other diseases. Cortisol itself is also associated with depres
Slide 3: A clinical-stage company progressing Phase 2 trials for Alzheimer's Disease, Depression & other diseases
For personal use only A clinical-stage company progressing Phase 2 trials for Alzheimer’s Disease, Depression & other diseases Dr. Steven Gourlay MBBS PhD MBA, CEO & MD 28 July 2022 Presented at Spark Plus Australian Equities Day 28 July 2022
Slide 4: Disclaimer
For personal use only 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 inform
Slide 5: Actinogen snapshot
Actinogen snapshot For personal use only Actinogen Medical (ASX:ACW) is developing a novel oral treatment with rapid onset of clinical activity to improve cognition and quality of life Demonstrated target engagement in brain and HPA axis1 in human trials Favourable pharmaceutical properties Low
Slide 6: ACW top stockholders and stock price
For personal use only ACW top stockholders and stock price Share price chart at 27 July 2022 Trading Information 52 week high A$0.20 52 week low A$0.044 30.m 0.19 Number of issued shares 1,796M 0.17 Market capitalisation (27 July 2022) A$102M 25.m Cash Balance at 30 Jun 2022 A$16.4M 0.15 20.m Share
Slide 7: Leadership and Management
Leadership and Management For personal use only Extensive drug development and commercial experience Experienced Board of Directors... …with a talented management team in place Jeff Carter Chief Financial Officer B. Fin Admin; M. App. Fin; CA Tamara Miller SVP Product Development M.Med Sci; BSc; MSc
Slide 8: International Cognition Clinical Advisory Board
International Cognition Clinical Advisory Board For personal use only Global thought leaders in clinical trials for assessment of cognition Prof. John Harrison Dr Dana C. Hilt Dr Christina Kurre Olsen Prof. Paul Maruff Metis Cognition Ltd • Expert psychologist with a special • 25+ years of drug deve
Slide 9: International Scientific Advisory Boards
International Scientific Advisory Boards For personal use only 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
Slide 10: Xanamem: oral, low dose, once-a-day treatment with a unique mechanism
For personal use only Xanamem®: oral, low dose, once-a-day treatment with a unique mechanism Brain penetrant 11β-HSD1 small molecule enzyme inhibitor reduces cortisol inside brain cells - modulating signaling pathways and underlying disease processes1,2 Potential to be: • Rapidly cognitive enhancing
Slide 11: Previously
For personal use only Previously Presented at Spark Plus Australian Equities Day 28 July 9 2022
Slide 12: Cognitive improvement vs. placebo in healthy, older volunteers in XanaHES trial in 2019
Cognitive improvement vs. placebo in healthy, For personal use only older volunteers in XanaHES trial in 2019 • Cogstate Cognitive Test Battery (CTB) with 20 mg daily, 12-week treatment; effect size (ES) estimated with the same MMRM statistical model as the current trial1 • Clinically significant ef
Slide 13: High target engagement confirms brain activity at Xanamem doses of ≤10mg
For personal use only High target engagement confirms brain activity at Xanamem doses of ≤10mg Baseline After Dose PET data demonstrates that Xanamem extensively binds 5 mg Xanamem 10 mg Xanamem 20 mg Xanamem to the 11β-HSD1 enzyme SUVRcarotid throughout the brain, with high post-treatment effects (
Slide 14: XanaMIA Phase 1b/2 trial design
For personal use only XanaMIA Phase 1b/2 trial design Targeting the earliest stages of Alzheimer’s Disease (AD) XanaMIA - Part A: XanaMIA - Part B: Double-blind Phase 1b Phase 2 H12022: minimally effective dose level 2023-24: robust Phase 2 study design in patients with early stages of Alzheimer’s D
Slide 15: XanaMIA Part A dose-ranging topline results
For personal use only XanaMIA Part A dose-ranging topline results Presented at Spark Plus Australian Equities Day 28 July 2022 13
Slide 16: The XanaMIA Part A trial met its objectives
The XanaMIA Part A trial met its objectives For personal use only • Clinically significant improvements were seen in the attentional domains, including working memory, of the Cogstate CTB with both doses, including visual attention with 5 mg at the end of treatment achieving the a priori primary end
Slide 17: Attention Composite improved at Week 6 and 10 vs. placebo
Attention Composite improved at Week 4 and 6 vs. placebo For personal use only Pooled working memory/visual attention/psychomotor speed (mean, SE) 0.35 ON-TREATMENT VISITS 0.3 BETTER 0.25 Mean change from baseline 0.2 (Units) 0.15 0.1 0.05 0 Baseline Week 2 Week 4 Week 6 Week 10 Xanamem pooled doses
Slide 18: Xanamem was safe and well-tolerated
For personal use only Xanamem was safe and well-tolerated • No treatment-related serious adverse events • Other predominantly mild events were generally equally distributed across the three groups including placebo • No adverse events of concern, consistent with program safety database of over 300 p
Slide 19: Summary
For personal use only Summary • There is a strong unmet need for new and safer treatments for many diseases where dysregulated cortisol is a target - Xanamem is designed to reduce cortisol inside brain cells • Xanamem is potentially a rapidly-acting cognitive enhancer and, in the longer term, a dise
Slide 20: Strategy & Next Trials
For personal use only Strategy & Next Trials Presented at Spark Plus Australian Equities Day 28 July 2022 18
Slide 21: Actinogen Strategy
For personal use only Actinogen Strategy Accelerate clinical development Create value from partnerships • Focus on cognitive enhancement: Pharma/biotech engagement • Early stages of Alzheimer’s Disease • Actively engage large and mid-size • Implement XanaMIA Part B Phase 2 potential partners with ne
Slide 22: Moving Xanamem trials into AD patients with a focus on cognitive enhancement & biomarkers
Moving Xanamem trials into AD patients with a For personal use only focus on cognitive enhancement & biomarkers No functional impairment XanaMIA Functional impairment & loss of independence XanaMIA Part A Part B Healthy 50-80 MCI/early AD* patients years Mild • N~300, placebo-controlled • Safe & wel
Slide 23: Regulatory consultations and pivotal studies
Regulatory consultations and pivotal studies For personal use only No functional impairment XanaMIA Functional impairment & loss of independence XanaMIA Part A Part B Healthy 50-80 MCI/early AD* patients years Mild • N~300, placebo-controlled • 10 mg vs. placebo • Safe & well-tolerated • 5 mg & 10 m
Slide 24: XanaMIA Part B trial design: 6-month treatment, parallel groups
For personal use only XanaMIA Part B trial design: 6-month treatment, parallel groups 10mg Xanamem Screening 5mg Xanamem Follow-up Placebo -4 0 24 28 Weeks Double-blind, randomised treatment period N~300 (~100 per group) Key inclusion/exclusion criteria Primary Endpoints Key Secondary Endpoints Key
Slide 25: Science Behind the Xanamem Depression Program
Science Behind the Xanamem For personal use only Depression Program Unmet medical need for rapid, safe treatment 80-90% report difficulty with thinking (cognition)1 Cognitive symptoms often persist during remission1 Elevated cortisol associated with severe, melancholic depression2 Cortisol a
Slide 26: XanaCIDD trial design: 6-week treatment, parallel groups
XanaCIDD trial design: 6-week treatment, parallel groups For personal use only 10mg Xanamem Follow-up Screening Placebo -4 0 6 10 Weeks Double-blind, randomised treatment period N~120 (~60 per group) Key inclusion/exclusion criteria Primary Endpoints Key Secondary Endpoints Key Implementation Featur
Slide 27: Xanamem Clinical Development Pipeline
For personal use only Xanamem Clinical Development Pipeline Phase 2 Pathway Outlook Biomarker analysis in patients with mild AD Cognitive impairment in - Phase 2 dataset of 10mg vs. placebo over 12 weeks, H2 2022 “Big-to-market” early Alzheimer’s disease Cognitive benefit in patients with early stag
Slide 28: Timeline for Xanamem data & catalysts
Timeline for Xanamem data & catalysts For personal use only 2022 • Q2 XanaMIA Part A confirmed cognitive enhancement • Q2 BIO in-person pharma/biotech meetings with new data • Q3/4 Biomarker data to assess disease-modifying potential • Q4 CTAD XanaMIA presentation • Q4 New trials commence in Alzheim
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