Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (July 2016)
31 slides from Actinogen Medical's investor presentation, Jul 15, 2016
Slide 1: Developing Xanamem
™ Developing Xanamem For personal use only Presented by, Dr. Bill Ketelbey CEO & Managing Director
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. For personal use only The information in this presentation is provided in summary form and does not contain all inform
Slide 3: Innovative approach through inhibition of cortisol production
For personal use only Focusing on an innovative approach, through the inhibition of cortisol production, for treating cognitive impairment in chronic neurodegenerative and metabolic diseases.
Slide 4: Xanamem: A prime investment opportunity
Xanamem™: A prime investment opportunity For personal use only • Alzheimer's - a significant unmet need in a huge and growing global market • Xanamem™’s innovative, differentiated mechanism of action targeting the stress hormone cortisol • Evidence Xanamem™ is both symptomatic and disease modifying
Slide 5: Actinogen's journey of discovery
Actinogen’s journey of discovery For personal use only Xanamem™ crosses blood 11ẞHSD1 is highly Carbenoxolone is shown brain barrier expressed in regions to enhance cognitive First First important for cognition function in elderly men patent human and type II diabetics filed study (Sandeep et al., 2
Slide 6: Xanamem unique value proposition
Xanamem™ unique value proposition For personal use only • High potency at low oral doses • Highly selective and specific enzyme binding • Safe and well tolerated in humans • Delivered to the brain to target site of action • Established proof of principle in models of Alzheimer’s Disease 6
Slide 7: Leadership Team
Leadership Team For personal use only Dr. Bill Ketelbey CEO & MD Martin Rogers Executive Chairman Dr. Jason Loveridge Non-Executive Director Dr. Anton Uvarov Non-Executive Director 7
Slide 8: Clinical Advisory Board: world renowned neuroscience leaders
Clinical Advisory Board: world renowned neuroscience leaders For personal use only Professor Craig Ritchie Chair, Xanamem™ Clinical Advisory Board Professor Colin Masters Xanamem™ Clinical Advisory Board Professor Jeffrey Cummings Xanamem™ Clinical Advisory Board 8
Slide 9: Xanamem research pipeline
Xanamem™ research pipeline milestone timelines are estimates For personal use only Mild Alzheimer’s Disease (XanADu)1 first subject in: 2H2016 Diabetes Cognitive Impairment2 first subject in: 1Q2017 Parkinson’s Disease Dementia3 first subject in: TBD Preclinical Phase I Phase II Phase III 1 Trial in
Slide 10: Cortisol and Alzheimer's disease
Cortisol and Alzheimer’s disease For personal use only p<0.001 Healthy 0.252 0.251 cognition Neuroendocrine dysfunction leading to elevated cortisol MCI-0 0.239 0.218 precedes disease state in AD dementia MCI-AD 0.493 0.480 Elevated cortisol was associated with progressive AD dementia 0.555 0.387 co
Slide 11: Publications confirm links to cortisol and AD
Publications confirm links to For personal use only cortisol and AD Plasma cortisol, amyloid-β, and cognitive decline in preclinical Alzheimer's disease. Pietrzak et al for the AIBL Research Group, 2016. Under review for publication. 11
Slide 12: Targeting elevated cortisol at the site of action
Targeting elevated cortisol at the site of action For personal use only 12
Slide 13: Xanamem inhibiting action of 11bHSD1
Xanamem™ - inhibiting action of 11bHSD1 For personal use only 11bHSD1 enzyme activates Xanamem™ binds to 11bHSD1, cortisone producing cortisol blocking cortisol production *11β-HSD1 =11β-hydroxysteroid dehydrogenase type 1 13
Slide 14: Symptomatic and disease modifying effects in mouse models
Xanamem™ Symptomatic and disease modifying effects in mouse models For personal use only Test of cognition Amyloid clearance treatment 28 days treatment 28 days Control 43 21 Control 38 3 Treatment** 172 28 Treatment* 22 5 Latency to enter dark compartment (s) # of plaques per brain area Significant
Slide 15: Xanamem development: proposed study design
Xanamem development: proposed study design For personal use only XanADu – Phase II double blind, randomised, placebo-controlled study to assess the efficacy of Xanamem™ in participants with mild AD 200 Co-primary end points Treatment course ADAS-Cog 12 weeks Mild Alzheimer’s patients ADCOMS + Xanam
Slide 16: Xanamem potential for dual mechanism of action
Xanamem™ potential for dual mechanism of action For personal use only Disease Modifying Symptomatic Anti- Tau inflammatory BACEI Xanamem™ Amyloid plaque therapeutics Xanamem™ Cholinesterase inhibitors γ-secretase 5HTr inhibitors Amyloid NMDAr Aẞ antibodies antagonists clearance 16
Slide 17: Target clinical positioning
Target clinical positioning For personal use only An oral agent that provides durable symptomatic and disease modifying benefits in mild Alzheimer’s disease by direct inhibition of excess cortisol production. Xanamem™ is a novel agent likely to be used in combination with other AD therapies. 17
Slide 18: Xanamem's estimated market share
Xanamem’s™ estimated market share Global peak sales in 2031 For personal use only Prodromal and mild Diabetes Parkinson’s Alzheimer’s Cognitive Impairment Disease Dementia US$4.3 BILLION1 + US$1.5 + US$495 BILLION2 MILLION3 1 Reference Baker Young Initiation Coverage, August 2015. 2 Price comparator
Slide 19: ACW financials
ACW financials For personal use only Key Corporate Data Market Cap* ~AU$43 million Public company listed on the Entity Australia Stock Exchange (ACW) Share Price* AU$0.071 Shares on issue^ ~606 million Cash position** AU$7.87 million Ownership by top 20 55% *market cap and share price data as at 24
Slide 20: Xanamem: A prime investment opportunity
Xanamem™: A prime investment opportunity For personal use only • Alzheimer's - a significant unmet need in a huge and growing global market • Xanamem™’s innovative, differentiated mechanism of action targeting the stress hormone cortisol • Evidence Xanamem™ is both symptomatic and disease modifying
Slide 21: Contact Details
For personal use only Contact Details Office: Level 9, Suite 1, 68 Pitt Street Sydney NSW 2000 Australia Tel: +61 (02) 8964 7401 Fax: +61 (02) 8964 7588 Email: [email protected] Twitter: @billketelbey Web: www.actinogen.com.au 21
Slide 22: Thank you
For personal use only THANK YOU 22
Slide 23: Supplemental Slides
For personal use only Supplemental Slides
Slide 24: Alzheimer's disease is emerging as the most significant health challenge
Alzheimer’s disease is emerging as the most significant health challenge of our time For personal use only One person Total cost rise every 3 seconds 47M 75M 132M to US$2 trillion Globally there by 2030 were ~10M new Numbers will Dementia will become cases of dementia double every a trillion dollar
Slide 25: Alzheimer's cannot currently be prevented, cured, or even slowed
Alzheimer’s cannot currently be prevented, cured, or even slowed For personal use only 50% of 85 year olds have Alzheimer’s Disease 1 in 3 seniors will die with Alzheimer’s disease or other dementia The Alzheimer’s Association Facts and Figures, 2014. 25
Slide 26: Hallmarks of Alzheimer's Disease
Hallmarks of Alzheimer’s Disease For personal use only Normal brain Neural death and brain Abnormal β-amyloid (volumetric MRI) shrinkage plaque build up (red) Alzheimer’s research aspiration - earlier detection and treatment to slow disease progression 26
Slide 27: Disease progression and diagnosis
Disease progression and diagnosis For personal use only Diagnosis Functional impairment Cognitive impairment Brain structural changes (Aβ, Tau, volumetric) Sub-clinical MCI Dementia Mild Cognitive normal Impairment 20+ brain 15+ years years function Source: adapted from http://ww.re-cognitionhealth.
Slide 28: Clinical goal for Xanamem
Clinical goal for Xanamem™ Filling an unmet need in the market For personal use only diagnosis/ treatment Progression with best available therapy, Xanamem™ plus other treatments time normal brain function Untreated Progression Progression with progression with best best available therapy available p
Slide 29: Focusing on markets with high risk of progressive cognitive decline
Focusing on markets with high risk of progressive cognitive decline For personal use only Alzheimer’s Diabetes Parkinson’s 29
Slide 30: Unmet need in Diabetes Cognitive Impairment
Unmet need in Diabetes Cognitive Impairment For personal use only 1 Twice the risk Treatment 422M of dementia inertia Suffer from 14.77M2 suffer No-one is looking Diabetes globally from dementia for a solution 1 WHO Diabetes Fact Sheet March, 2016. 2 Biessels et al., 2006. 30
Slide 31: Unmet need in Parkinson's Disease Dementia
Unmet need in Parkinson’s Disease Dementia For personal use only 1 symptomatic 7-10M 31% relief Living with Progress from MCI to Treatments are Parkinson’s dementia short term Disease 100% penetrance after 10 years 1 Parkinson’s Disease Foundation http://www.pdf.org/en/parkinson_statistics. Medtrack
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