Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Spark Plus Healthcare Day 2022
27 slides from Actinogen Medical's conference presentation, Nov 3, 2022
Slide 1: Actinogen CEO presentation to Spark Plus Healthcare Day
For personal use only ASX ANNOUNCEMENT Actinogen CEO presentation to Spark Plus Healthcare Day Sydney, 03 November 2022. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce its participation in the Spark Plus Healthcare Day webinar to be held today from 4:00pm AEDT / 1:00pm AW
Slide 2: About Xanamem
Cognitive function means how a person understands, remembers and thinks clearly. Cognitive functions include memory, attention, reasoning, awareness and decision-making. Actinogen is currently developing its lead compound, Xanamem, ® as a promising new therapy for Alzheimer’s Disease and Depression
Slide 3: Alzheimer's Disease biomarker study validates Xanamem program
For personal use only Alzheimer’s Disease biomarker study validates Xanamem® program Positive Phase 2a clinical data with large CDR-SB effect size Dr. Steven Gourlay MBBS PhD MBA, CEO & MD SparkPlus Healthcare Day, 3 November 2022 Authorised by the Board of Directors of Actinogen Medical Limited ® X
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: ACW top stockholders and stock price
ACW top stockholders and stock price For personal use only Share price chart at 01 November 2022 Trading Information 52 week high A$0.20 25m 52 week low A$0.04 0.19 Number of issued shares 1,796M 0.17 Market capitalisation (01 Nov 2022) A$242M 20m Cash Balance at 30 Sep 2022 A$17M1 0.15 Share Pirce
Slide 6: Leadership and Management
Leadership and Management Extensive drug development and commercial experience For personal use only 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 7: Xanamem: Oral, low dose, once-a-day treatment with unique non-amyloid mechanism
Xanamem: Oral, low dose, once-a-day treatment For personal use only with a unique non-amyloid 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 cognitiv
Slide 8: Xanamem Phase & program
Xanamem Phase 2 & 3 program Building on four independent Phase 1 and 2 studies showing activity For personal use only Current Phase 1 & 2a, biomarker Safety, cognition activity (n~300) Phase 2b Phase 2a Cognitive Impairment Alzheimer’s Disease (AD) in Depressive Disorder (CIDD) Phase 3 Phase 3 Alzhe
Slide 9: Previously: evidence of Xanamem activity in cognition from multiple sources
Previously: evidence of Xanamem activity in cognition from multiple sources For personal use only In animals Protection against cognitive decline in animal model of AD using a Xanamem analogue independent of amyloid plaque In humans PET scan study showing high levels of target binding at dos
Slide 10: Phase 2a blood biomarker study design & methods
Phase 2 blood biomarker study design & methods Uses a pre-specified protocol and analysis plan For personal use only Assess efficacy trends on clinical endpoints Measure disease biomarkers Week 0 & 12 • Prespecified analysis to avoid bias • Select by baseline pTau181, MMSE 72 patients with • pTau181
Slide 11: New Alzheimer's Disease key clinical findings
New Alzheimer’s Disease (AD) key clinical findings For personal use only Design • Phase 2a placebo-controlled trial of Xanamem 10 mg vs. placebo over 12 weeks was re-run in 72 patients with mild AD who had biomarker samples available • Used a pre-specified protocol & analysis plan to avoid bias Majo
Slide 12: Expert commentary on positive CDR-SB data
Eminent world-leading authority on dementia, Associate For personal use only Professor Michael Woodward, commented: “The positive data for CDR-SB and other endpoints are encouraging and indicate a likely therapeutic effect of Xanamem in patients with the early stages of Alzheimer’s Disease. The use
Slide 13: Focus on speed to market as a cognitive enhancing treatment
Focus on speed to market as a cognitive enhancing treatment For personal use only No functional impairment XanaMIA XanaMIA Functional impairment & loss of independence Phase 1b Phase 2b Healthy 50-80 MCI/early AD1 patients years Mild • N=330, placebo-controlled • pTau patient selection • 10 mg vs. p
Slide 14: Only non-amyloid mechanism drug in development with credible cognitive data
Actinogen has the only non-amyloid mechanism drug in development with credible cognitive data For personal use only It is one of only three worldwide AD clinical trial programs for an oral medication with credible cognitive activity data Mechanism Stage Cognitive endpoint Company market cap. ($AU)1
Slide 15: 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 16: XanaCIDD trial design & implementation model
XanaCIDD trial design & implementation model For personal use only 10mg Xanamem Follow-up Screening Placebo -4 0 6 10 Weeks Double-blind, randomised treatment period (N=160) Key inclusion/exclusion criteria Primary Endpoints Key Secondary Endpoints Key Implementation Features • Primary diagnosis of
Slide 17: Actinogen strategy validated by new results
Actinogen strategy validated by new results Backed by strong balance sheet and intellectual property For personal use only Accelerate clinical development Create value from partnerships • Focus on cognitive enhancement: Pharma/biotech engagement • Patients with early Alzheimer’s Disease • Actively e
Slide 18: Xanamem timeline & catalysts
Xanamem timeline & catalysts For personal use only • October multiple partnering presentations of new results • November CTAD XanaMIA presentation • Trial enrollment starts for XanaCIDD trial in Depression 2022 • Key global regulatory submissions in AD with FDA, EMA, other • Phase 2b XanaMIA AD tria
Slide 19: Questions
For personal use only Questions SparkPlus Healthcare Day 17
Slide 20: Thank you
For personal use only Thank you If you have any questions following the webinar please contact: Dr. Steven Gourlay Michael Roberts CEO & Managing Director Investor Relations P. +61 2 8964 7401 M. +61 423 866 231 E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au SparkPlus Healthc
Slide 21: Appendix
For personal use only Appendix SparkPlus Healthcare Day 19
Slide 22: Actinogen company snapshot
Actinogen company snapshot Actinogen Medical (ASX:ACW) is developing a novel oral treatment with rapid onset of clinical activity to improve cognition and quality of life For personal use only Demonstrated target engagement in brain and HPA axis1 in human trials Favourable pharmaceutical propertie
Slide 23: International Cognition Clinical Advisory Board
International Cognition Clinical Advisory Board Global thought leaders in clinical trials for assessment of cognition For personal use only Prof. John Harrison Dr Dana C. Hilt Dr Christina Kurre Olsen Prof. Paul Maruff A/Prof Christopher Chen Metis Cognition Ltd • Expert psychologist with a special
Slide 24: International Scientific Advisory Boards
International Scientific Advisory Boards 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. Brian Walker
Slide 25: Xanamem Clinical Development Pipeline
Xanamem Clinical Development Pipeline For personal use only Phase 2 Pathway Outlook Biomarker/efficacy analysis in patients with mild AD Cognitive impairment in - Phase 2 dataset of 10mg vs. placebo over 12 weeks, October 2022 “Big-to-market” early Alzheimer’s disease Cognitive benefit in patients w
Slide 26: Selected glossary
Selected glossary 1 For personal use only 11β-HSD1 11 beta HydroxySteroid Dehydrogenase-1 enzyme 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 cortisol ADAS-Cog Alzheimer’
Slide 27: Selected glossary
Selected glossary 2 For personal use only 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