Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Bell Potter Healthcare Conference 2022
28 slides from Actinogen Medical's conference presentation, Nov 9, 2022
Slide 1: Actinogen CEO presentation to Bell Potter Healthcare Conference
For personal use only ASX ANNOUNCEMENT Actinogen CEO presentation to Bell Potter Healthcare Conference Sydney, 09 November 2022. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that CEO and Managing Director Dr Steven Gourlay will present to the Bell Potter Healthcare Conf
Slide 2: About Xanamem
Actinogen is currently developing its lead compound, Xanamem, ® as a promising new therapy for Alzheimer’s Disease and Depression and hopes to study Fragile X Syndrome and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive impact in
Slide 3: New Alzheimer's Disease study validates Xanamem activity & program
For personal use only New Alzheimer’s Disease study validates Xanamem® activity & program Positive Phase 2a clinical data with large CDR-SB effect size Dr. Steven Gourlay MBBS PhD MBA, CEO & MD Bell Potter Heathcare Conference, 09 November 2022 Authorised by the Board of Directors of Actinogen Medic
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: Xanamem: Oral, low dose, once-a-day treatment with a 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 7: 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 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 to avoid bias 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
Slide 11: Clinical Dementia Rating – Sum of Boxes (CDR-SB)
Clinical Dementia Rating – Sum of Boxes (CDR-SB) functional endpoint to assess dementia in early-stage AD For personal use only Test domain Impairment None Questionable Mild Moderate Severe 0 0.5 1 2 3 Memory Orientation Judgment & Problem Solving Community Affairs Home & Hobbies Personal Care Score
Slide 12: Xanamem doubled rate of disease stabilization on FDA-approved CDR-SB endpoint
Xanamem doubled rate of disease stabilization on FDA-approved CDR-SB endpoint For personal use only Response analysis in pTau-positive patients with “real AD” likely to progress Twice as many patients in the Xanamem group had stable or improved disease compared with placebo1 56% of patients treated
Slide 13: Bedside cognition test (MMSE) shows Xanamem effect measurable in more severe dementia
Bedside cognition test (MMSE) shows Xanamem effect measurable in more severe dementia For personal use only More clinically impaired subgroup N Change in MMSE score Group Desired Xanamem Placebo Cohen’s p value change d MMSE 20-23 (mean) 46 Up 1.7 -0.3 0.93 0.02 MMSE 20-23 (median) 46 Up 2.0 -1.0 -
Slide 14: Efficacy conclusions
Efficacy conclusions For personal use only This analysis validates and de-risks the AD program by showing: Clinical activity of Xanamem in mild AD patients Large clinical effect size Utility of blood pTau levels to select suitable patients for next Phase 2b trial Utility of CDR-SB to measure
Slide 15: Moving forward rapidly in Cognitive Impairment in AD and Depression
For personal use only Moving forward rapidly in Cognitive Impairment in AD and Depression Biomarker data validate planned Phase 2b protocol in Mild Cognitive Impairment / mild AD with positive blood pTau Bell Potter Healthcare Conference 09 November 2022 13
Slide 16: 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 17: Science Behind the Xanamem Depression Program
Science Behind the Xanamem Depression Program For personal use only 80-90% report neurocognitive symptoms1 Cognitive symptoms often persist during remission1 Elevated cortisol associated with severe, melancholic depression2 Cortisol associated with treatment outcomes, relapse, & cognition3
Slide 18: Market characteristics of Major Depressive Disorder (MDD)
Market 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 cognitiv
Slide 19: 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 20: Xanamem's unique value proposition
For personal use only Xanamem’s unique value proposition Many other opportunities such as other types of dementia and neuropsychiatric conditions Bell Potter Healthcare Conference 09 November 2022 18
Slide 21: Actinogen has the 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 22: The Xanamem opportunity in depression is large
The Xanamem opportunity in depression is large 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 depress
Slide 23: Xanamem Strategy & Timeline
For personal use only Xanamem Strategy & Timeline Bell Potter Healthcare Conference 09 November 2022 21
Slide 24: 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 25: 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 26: Appendix
For personal use only Appendix Bell Potter Healthcare Conference 09 November 2022 24
Slide 27: 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 28: 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
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