Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Non-Deal Roadshow (August 2022)
34 slides from Actinogen Medical's roadshow presentation, Aug 11, 2022
Slide 1: ASX announcement: CEO presentation for non-deal roadshow
For personal use only ASX ANNOUNCEMENT Actinogen CEO presentation for non-deal roadshow investor meetings Sydney, 11 August 2022. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that the Company’s CEO, Dr Steven Gourlay will be meeting with investors in Singapore on a two-
Slide 2: About Xanamem and disclaimer
Xanamem’s novel mechanism of action is to block the production of cortisol inside cells through the inhibition of the 11β- HSD1 enzyme in the brain. Xanamem is designed to get into the brain after it is absorbed in the intestines upon swallowing its capsule. Chronically elevated cortisol is associat
Slide 3: Clinical-stage company progressing Phase 2 trials for Alzheimer's, Depression
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 Spark Plus investor roadshow 11-12 August 2022
Slide 4: Disclaimer
Disclaimer For personal use only 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 Actinogen Medical (ASX:ACW) is developing a novel oral treatment with rapid onset For personal use only of clinical activity to improve cognition and quality of life ✓ Demonstrated target engagement in brain and HPA axis 1 in human trials Favourable pharmaceutical properties ✓ Low
Slide 6: ACW top stockholders and stock price
ACW top stockholders and stock price For personal use only 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 processes 1,2 Potential to be: • Rapidly cognitive enhancin
Slide 11: The role of cortisol in health
The role of cortisol in health For personal use only • Cortisol is an essential hormone for health in humans • Its key function is to modulate the response to stress: • physical stress such as infection • psychological stress • Outside the brain, cortisol controls the amount of inflammation due to d
Slide 12: Xanamem highly suited to development in brain diseases
Xanamem highly suited to For personal use only development in brain diseases • Well absorbed, small dose (5-10 mg), once-a-day dosing • Penetrates brain well • High binding to target enzyme from 5mg • Safe and very well tolerated • Good candidate for combination therapy due to low potential for drug
Slide 13: High target engagement confirms brain activity at doses of ≤10mg
High target engagement confirms brain activity For personal use only at Xanamem doses of ≤10mg in 2020 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 e
Slide 14: Promising safety profile to date
Promising safety profile in > 300 individuals to date For personal use only Phase 2 trial 10mg daily over 12 weeks in patients with mild AD (MMSE* 20-26) TEAE** term Xanamem (n=91) Placebo (n=94) Total (n=185) Headache 5 (5.5%) 2 (2.1%) 7 (3.8%) Dizziness 4 (4.4%) 3 (3.2%) 7 (3.8%) Diarrhoea 1 (1.1%
Slide 15: Cognitive improvement vs. placebo in XanaHES trial (2019)
Cognitive improvement vs. placebo in healthy, older volunteers in XanaHES trial (2019) For personal use only • 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 eff
Slide 16: Attention composite improved vs. placebo in second trial (2022)
Attention composite improved at weeks 4 and 6 vs. placebo in a second clinical trial (2022) 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 Wee
Slide 17: 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 18: Strategy & Next Trials
For personal use only Strategy & Next Trials Spark Plus investor roadshow 11-12 August 2022 16
Slide 19: Actinogen Strategy
Actinogen Strategy For personal use only 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 • XanaMIA Part B Phase 2 potential partners with new results
Slide 20: Alzheimer's Disease
For personal use only Alzheimer’s Disease Targeting cognitive enhancement and disease- modification in the early stages of disease Spark Plus investor roadshow 11-12 August 2022 18
Slide 21: Characteristics of early Alzheimer's Disease
Characteristics of early Alzheimer’s Disease (AD) For personal use only AD is common1 ~55 million people worldwide have dementia, with AD the commonest type AD patients initially suffer memory loss As AD progresses, memory worsens and other problems develop e.g. language, problem solving, ability to
Slide 22: Moving Xanamem trials into AD patients
Moving Xanamem trials into AD patients with a focus on cognitive enhancement & biomarkers 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 • Safe & wel
Slide 23: Planned analysis of Phase 2 plasma samples for AD biomarkers
October 2022: Planned analysis of Phase 2 plasma samples for Alzheimer’s Disease biomarkers For personal use only Biomarker responses to treatment, reanalysis of efficacy in biomarker positive patients XanADu Phase 2 Trial ~70/185 patients 10mg daily Mild Alzheimer’s Disease without available for an
Slide 24: XanaMIA Part B – Patients with early Alzheimer's Disease
XanaMIA Part B – Patients with early Alzheimer’s Disease For personal use only Key design considerations Double-blind randomized parallel-groups design: Patients with: • Placebo, 5 and 10 mg Xanamem once daily • Clinical diagnosis of early-stage AD • Approx. 100 per group • Demonstrated cognitive im
Slide 25: Key outcomes
Key outcomes For personal use only Primary outcome Secondary outcomes • Cogstate attention composite • Amsterdam Activity of Daily Living scale (same as XanaMIA Part A and XanaHES) (more sensitive than ADAS-Cog) • Cogstate • Executive Function Composite • Episodic Memory Function Composite • Individ
Slide 26: Cognitive Impairment associated with Major Depressive Disorder - XanaCIDD
For personal use only Cognitive Impairment associated with Major Depressive Disorder - XanaCIDD Targeting dual cognitive enhancement and anti-depressant activity Spark Plus investor roadshow 11-12 August 2022 24
Slide 27: Science Behind the Xanamem Depression Program
Science Behind the Xanamem Depression Program For personal use only ✓ 80-90% report difficulty with thinking (cognition) 1 ✓ Cognitive symptoms often persist during remission 1 ✓ Elevated cortisol associated with severe, melancholic depression 2 ✓ Cortisol associated with treatment outcomes, relapse
Slide 28: Characteristics of Major Depressive Disorder
Characteristics of Major Depressive Disorder (MDD) For personal use only MDD is common1,2 ~5% prevalence globally, 1 in 7 lifetime risk Neurocognitive symptoms are a typical feature (>80%) 3 Difficulty thinking and concentrating, unable to make decisions Only one anti-depressant has a statement re c
Slide 29: The Xanamem opportunity in depression
The Xanamem opportunity in depression For personal use only Current anti-depressants work slowly (3 weeks) and do not target cognition multiple adverse effects initial suicide risk blood pressure, sexual function, appetite… Xanamem improves cognition quickly Xanamem may improve both depression and c
Slide 30: XanaCIDD trial design & implementation model
XanaCIDD trial design & implementation model For personal use only Double-blind randomized parallel-groups design: Patients with: • Placebo and 10 mg Xanamem once daily • Clinical diagnosis of MDD • Approx. 80 per group • Demonstrated cognitive impairment by coding test • 6 weeks treatment • Persist
Slide 31: Key outcomes
Key outcomes For personal use only Primary outcome Secondary outcomes • Cogstate CTB attentional composite • Montgomery-Åsberg Depression Rating (attention and working memory) Scale (MADRS) • Executive Function Cognitive Composite (One-Back, COWAT, iDSST) • Episodic Memory Cognitive Composite (OCL,
Slide 32: Xanamem Clinical Development Pipeline
Xanamem Clinical Development Pipeline For personal use only 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 33: Timeline for Xanamem data & catalysts
Timeline for Xanamem data & catalysts For personal use only • Ongoing pharma/biotech partnering meetings with new data • Q4 Biomarker data to assess disease-modifying potential 2022 • Q4 CTAD XanaMIA presentation • Q4 New trials commence in Alzheimer’s Disease and Depression • Q4 Key global regulato
Slide 34: Contact
For personal use only Contact For any additional enquiries or questions contact: Michael Roberts Investor Relations E: michael.roberts@actinogen.com.au M: +61 423 866 231