Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (September 2018)
27 slides from Actinogen Medical's investor presentation, Sep 12, 2018
Slide 1: Alzheimer's Treatment Needs a New Approach – Xanamem
Alzheimer’s Treatment Needs a New Approach – Xanamem™ Bill Ketelbey – September 2018 Singapore
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: Actinogen Medical (ASX:ACW)
Actinogen Medical (ASX:ACW) • Xanamem, Actinogen’s lead compound, in STOCK METRICS* In May 2018, Actinogen raised development for the treatment of Alzheimer's ASX CODE ACW $16.5m via an institutional disease (AD) and cortisol-associated cognitive placement and SPP that saw Market Capitalisation $63.
Slide 4: Commercially experienced, globally recognised
Commercially experienced, globally recognised Board of Directors Xanamem Clinical Advisory Board Dr. Geoff Brooke Dr. Bill Ketelbey Dr. Jason Loveridge Dr. George Morstyn Prof. Craig Ritchie Prof. Colin Masters Prof. Jeffrey Chairman CEO & MD Non-Executive Director Non-Executive Director Chair Cummi
Slide 5: A foundation of cutting edge research and translation
A foundation of cutting edge research and translation Scientific Advisory Board Prof Jonathan Seckl Prof Brian Walker Prof Scott Webster Vice Principal Pro-Vice-Chancellor Professor of Medicines Discovery University of Edinburgh Research Strategy and University of Edinburgh Resources University of N
Slide 6: Human pilot studies (2004) - Cortisol inhibition improves cognition
Human pilot studies (2004) - Cortisol inhibition improves cognition Inhibiting cortisol production in the brain with carbenoxolone improves cognitive function in healthy elderly men & type 2 diabetics VERBAL FLUENCY – Study 1* VERBAL MEMORY – Study 2** P=0.006 P=0.005 Mean SD Mean SD Placebo 40.6 12
Slide 7: Robust animal data with new candidate
Robust animal data with new candidate Symptomatic and disease modifying effects in mouse models – AUD $25 million invested pre-licensing by ACW COGNITION: treatment 28 days AMYLOID CLEARANCE: treatment 28 days P=0.004 P=0.01 Control 43 ± 21 Control 38 ±3 Treatment Treatment Treatment p=0.004 172 ± 2
Slide 8: Xanamem
Xanamem 8 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 9: Mechanism of action
Mechanism of action Inhibition of 11βHSD1, reducing brain cortisol production 9 Xanamem™ for Alzheimer’s disease CONFIDENTIAL
Slide 10: Xanamem
Xanamem • Actinogen’s lead compound • A novel, first in class, potent, orally bioavailable, brain-penetrant, 11βHSD1 inhibitor1 • Differentiated mechanism of action: blocking cortisol production in the brain • Symptomatic and disease modifying effects in vivo1 • Well-tolerated – dosed >100 patients/
Slide 11: Cortisol: a validated biomarker and target for AD
Cortisol: a validated biomarker and target for AD Cortisol and Alzheimer’s • Recent independent studies support the association between cortisol and AD development and progression1-5 • Cognitive impairment in patients with neuroendocrine dysfunction6-9 • Compelling evidence provided by the Australia
Slide 12: Cortisol, cognitive decline and AD: a growing body of literature
Cortisol, cognitive decline and AD: a growing body of literature Recent relevant reviews: PUBMED:"CORTISOL AND COGNITION" • Cortisol: Mediator of association between Alzheimer's disease and diabetes 140 Number of publications mellitus? (Notarianni, 2017, Psychoneuroendocrinology) 120 100 • Unified t
Slide 13: XanADu – Phase II Trial
XanADu – Phase II Trial 13 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 14: XanADu – Xanamem in Alzheimer's disease
XanADu – Xanamem in Alzheimer's disease Phase II double blind, randomised, placebo-controlled study to assess the efficacy and safety of Xanamem in participants with mild Alzheimer's disease* • 145 patients enrolled (83% of total study cohort) and more than 101 patients already completed study** • O
Slide 15: Interim analysis – DSMB recommendation to continue trial without modification
Interim analysis – DSMB recommendation to continue trial without modification* • Conducted on data from first 50 evaluable XanADu trial patients. Additional 37 patients’ safety data included in the analysis • Safety and efficacy data reviewed • Interim Analysis undertaken by independent Data Safety
Slide 16: Substantial Institutional investment in Actinogen
Substantial Institutional investment in Actinogen⃰ Recognises potential and endorses strategy • Positive interim analysis catalyses significant $15M investment through Placement • Leading investors enter register: • USA specialist biotech investor Biotechnology Value Fund L.P. • Australian instituti
Slide 17: New Xanamem studies – funded through May '18 capital raising
New Xanamem studies – funded through May ‘18 capital raising Enhancing value, broadening scope, strengthening data-set New funding to advance Company's development plan Focus on enhancing the data-set for Xanamem, broadening scope of use and adding substantial value to asset • A Target Occupancy Stu
Slide 18: Market and Investment Opportunity
Market and Investment Opportunity 18 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 19: Large opportunity for Xanamem patient uptake in AD
Large opportunity for Xanamem patient uptake in AD • Huge commercial opportunity • Peak sales potential >US$5bn (base case, mild AD), assuming: • US launch 2024, ex-US (EU5, JP) 2025 • 30% penetration (470,000 in US) of target mild AD in 5 yrs Plus • $19/day gross price in US at launch Plus Prophyla
Slide 20: Peer comparison
Peer comparison What big pharma 2000 companies are paying 1800 for acquisition of drug 1600 developers in the VALUE US$ MILLIONS 1400 X Alzheimer’s space 1200 1000 800 X 600 X 400 200 0 PH I PH II PH III 20 Xanamem™ - novel approach to Alzheimer Dementia
Slide 21: Xanamem - summary
Xanamem™ - summary 21 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 22: Summary
Summary A huge market with a significant unmet medical need Xanamem XanADu • Differentiated, with a novel mechanism of action • Fully funded to completion of XanADu • Small molecule - oral • Additional studies funded with May 2018 capital raise • Numerous studies underway/in planning • Interim Analy
Slide 23: Let's not forget
Let’s not forget Alzheimer’s Remember to wear purple on 21st September World Alzheimer’s Day! % Actinogen Medical
Slide 24: Dr. Bill Ketelbey, CEO & Managing Director
Dr. Bill Ketelbey CEO & Managing Director ☏ Main: +61 2 8964 7401 Email: bill.ketelbey@actinogen.com.au www.actinogen.com.au 24 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 25: Appendix
Appendix 25 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 26: Xanamem journey of discovery
Xanamem journey of discovery 11β-HSD1 is highly expressed Carbenoxolone is in regions Successful XanADu First Subject In shown to Xanamem data important for enhance Interim cognition cognitive function published Analysis in elderly men Webster et al., and type II 2017 diabetics XanADu 11β-HSD1 Sande
Slide 27: Xanamem pipeline of indications, back-up compounds
Xanamem pipeline of indications, back-up compounds* PRE-CLINICAL PHASE I PHASE II Alzheimer’s disease Diabetes Cognitive Impairment & other diseases with possible cortisol induced Cognitive Impairment Post Traumatic Stress Disorder Post Myocardial Infarction * Back-up compounds to Xanamem, licenced
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