Actinogen Medical Limited · ASX:ACW
Actinogen Medical — BIO International Convention 2018
24 slides from Actinogen Medical's conference presentation, June 2018
Slide 1: Alzheimer's Treatment Needs a New Approach – Xanamem
Alzheimer’s Treatment Needs a New Approach – Xanamem™ BIO International Convention – June 2018
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) • Developing Xanamem for the treatment of Alzheimer's disease Largest holders (AD) and cortisol-associated Pending completion of the Placement of 300,000,000 shares cognitive impairment (Tranche 1 and 2) and the Share Purchase Plan (SPP) ⃰ • Xanamem, a novel differentiate
Slide 4: Interim analysis – DSMB recommendation to continue trial without modification
Interim analysis – DSMB recommendation to continue trial without modification* • Interim Analysis undertaken by independent Data Safety Monitoring Board (DSMB) • Safety and efficacy data reviewed • Conducted on data from first 50 evaluable XanADu trial patients. Additional 37 patients’ safety data i
Slide 5: 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 6: 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 • Target engagement
Slide 7: Cortisol inhibition improves cognition – key factor in 2014 acquisition
Cortisol inhibition improves cognition – key factor in 2014 acquisition Two 2004 pilot studies concluded that inhibiting cortisol production in the brain with carbenoxolone improves cognitive function in healthy elderly men & type 2 diabetics – established Edinburgh Uni cortisol hypothesis VERBAL FL
Slide 8: Robust animal data with new candidate - key factor in 2014 acquisition
Robust animal data with new candidate - key factor in 2014 acquisition Symptomatic and disease modifying effects in mouse models – AUD $25 million invested pre-acquisition COGNITION: treatment 28 days AMYLOID CLEARANCE: treatment 28 days P=0.004 P=0.01 Control 43 ± 21 Control 38 ±3 Treatment Treatme
Slide 9: Xanamem
Xanamem 9 9 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 10: Xanamem
Xanamem • 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/subjects: acceptable clinica
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: 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
Slide 14: XanADu – Phase II Trial
XanADu – Phase II Trial 14 14 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 15: 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* • 103 patients enrolled (60% of total study cohort) and more than 68 patients already completed study** • On
Slide 16: Investment potential
Investment potential 16 16 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 17: 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 18: Peer comparison
Peer comparison 2000 What big pharma companies are 1800 paying for acquisition 1600 VA L U E U S $ M I L L I O N S of drug developers in 1400 X the Alzheimer’s 1200 space 1000 800 X 600 X 400 200 0 PH I PH II PH III 18 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 19: Xanamem - summary
Xanamem™ - summary 19 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 20: 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 • High quality development plan and regulatory review •
Slide 21: 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 21 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 22: Appendix
Appendix 22 Xanamem™ - novel approach to Alzheimer’s dementia
Slide 23: Xanamem journey of discovery
Xanamem journey of discovery 11β-HSD1 is highly expressed Carbenoxolone is in regions XanADu First Subject In shown to Xanamem data important for enhance cognition cognitive function published in elderly men Webster et al., and type II 2017 diabetics XanADu 11β-HSD1 Sandeep et al., First First Xanam
Slide 24: Recent comparable deals
Recent comparable deals Assets with Alzheimer’s disease as the lead indication or key indication Deal Value Upfront Licensee/acquirer Licensor/acquired Year Candidate(s) Phase (US$M) (US$M) Takeda Denali 2018 ATV platform, three programs Pre-clinical ~$1,000 $150 AbbVie Voyager 2017 AAV anti-tau ant
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