ASX ANNOUNCEMENT Actinogen updated investor presentation Sydney, 26 November 2018: Actinogen Medical (ASX: ACW, ‘the Company’) is pleased to release an updated Investor Presentation. The presentation will be used to update shareholders, investors and brokers as part of a non-deal roadshow across Australia. The presentation outlines the key investment highlights, progress and outlook of Actinogen, and is available below. Key Investment Highlights • Novel compound: Actinogen’s lead compound Xanamem has a mechanism of action targeting excess cortisol production in the brain. This cortisol hypothesis and its potential role in Alzheimer’s disease has been validated by independent research • Targeted strategic market focus: Alzheimer’s disease addressable market worth >US$7.5bn with unmet needs and potential upside • Advanced clinical stage asset: Fully funded advanced clinical stage program with reported positive safety interim analysis of the XanADu Phase II Alzheimer’s study, which has completed patient enrolment and is on track for results read-out in 2Q CY2019. • Potential value upside: Well positioned to unlock further value in Alzheimer’s and other indications, supported by significant big pharma interest • De-risked opportunity: Initiated nine additional Xanamem-related studies – all studies fully funded and value-adding to Xanamem data-base. Further pipeline development opportunities under evaluation. • Experienced leadership and advisors: Significant drug development and biotech investment experience guided by key opinion leading clinicians and drug discovery teams ENDS Actinogen Medical Investor and Media Enquiries Dr. Bill Ketelbey Ben Walsh CEO & Managing Director WE Buchan P: +61 2 8964 7401 M: +61 411 520 012 E: bill.ketelbey@actinogen.com.au E: bwalsh@we-buchan.com @BillKetelbey About Actinogen Medical Actinogen Medical (ASX: ACW) is an ASX-listed biotech company focused on innovative approaches to treating cognitive decline that occurs in chronic neurodegenerative and metabolic diseases. Actinogen Medical is developing its lead compound Xanamem, as a promising new therapy for Alzheimer’s disease, a condition with a multibillion-dollar market potential. In the US alone, the cost of managing Alzheimer’s disease is estimated to be US$250bn, and is set to increase to US$2tn by 2050, outstripping the treatment costs of all other diseases. Alzheimer’s disease is now the leading cause of death in the UK and second only to ischaemic heart disease in Australia. ACTINOGEN MEDICAL LIMITED TRADING AS ACTINOGEN MEDICAL ACN 086 778 476 ASX | ACW Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 8964 7401 WEB www.actinogen.com.au
About Xanamem™ Xanamem’s novel mechanism of action sets it apart from other Alzheimer’s treatments. It works by blocking the excess production of cortisol - the stress hormone – through the inhibi tion of the 11β -HSD1 enzyme in the brain. This enzyme is highly concentrated in the hippocampus and frontal cortex, the areas of the brain most affected by Alzheimer’s disease. There is a strong association between chronic stress and excess cortisol that leads to changes in the brain affecting memory, and to the development of amyloid plaques and neural death – all hallmarks of Alzheimer’s disease. About XanADu XanADu is a Phase II double-blind, 12-week, randomised, placebo-controlled study to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s disease. XanADu has fully enrolled 186 patients from 25 research sites across Australia, the UK and the USA. Results are expected in Q2 2019. The trial is registered on www.clinicaltrials.gov with the identifier: NCT02727699, where more details on the trial can be found, including the study design, patient eligibility criteria and the locations of the study sites. Actinogen Medical encourages all current investors to go paperless by registering their details with the designated registry service provider, Link Market Services. ACTINOGEN MEDICAL LIMITED TRADING AS ACTINOGEN MEDICAL ACN 086 778 476 ASX | ACW Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 8964 7401 WEB www.actinogen.com.au
Investor Presentation A novel approach to treating cognitive impairment and Alzheimer’s disease Dr. Bill Ketelbey: CEO & MD November 2018
Contents Executive summary Xanamem XanADu Development pipeline Outlook Appendix
Executive summary Key investment highlights What is Xanamem Development pipeline
Key investment highlights Actinogen is developing innovative treatments for cognitive impairment associated with neurodegenerative and metobolic diseases with an initial focus on Alzheimer‘s disease Novel compound Differentiated with a novel mechanism of action First-in- class, brain penetrant, orally active, small molecule, inhibitor of 11βHSD1 enzyme Xanamem mechanism of action validated by independent research on the cortisol hypothesis Clinical stage asset Targeted strategic market focus Initially focused on developing a treatment for Alzheimer's disease Advanced clinical stage program assessing Xanamem in Alzheimer’s disease Addressable market worth >US$7.5bn with unmet needs and potential upside XanADu clinical trial fully enrolled, with results expected Q2 CY2019 Target indication underpinned by efficacy results from animal model studies Positive safety interim analysis reported in XanADu Potential value upside De-risked opportunity Experienced leadership Well positioned to unlock further value Fully funded programs Board and Management with significant drug Multiple potential indications Additional Xanamem-related studies initiated development and investment experience, supported by Significant Big Pharma interest Additional pipeline opportunities under evaluation key opinion leaders and Xanamem discovery team │ A novel approach to treating cognitive impairment and Alzheimer's disease 4
Xanamem Actinogen‘s lead compound, Xanamem, is a novel drug designed to inhibit the production of cortisol in the brain with the potential to treat cognitive impairment and Alzheimer‘s disease Well researched In clinical stage development, with over 15 years of R&D completed, and A$40m invested to date Well tolerated Dosed >150 patients with acceptable clinical safety, toxicity and PK / PD 1 profile Differentiated mechanism of action Highly selective inhibitor of the 11βHSD1 enzyme in the brain which reduces excess cortisol production Validated Symptomatic and disease modifying effects (in vivo) and effective demonstration of cortisol hypothesis (in humans) Well protected Composition of matter IP coverage ≥ 2031, patents granted in all major markets Xanamem is a novel, first-in-class, potent, orally bioavailable and brain- penetrant 11βHSD1 inhibitor 1. PK / PD: pharmacokinetic / pharmacodynamic │ A novel approach to treating cognitive impairment and Alzheimer's disease 5
Clinical development and milestones Well progressed Phase II clinical trial (XanADu) underpinned by additional value-adding studies and an exciting Xanamem pipeline for other potential indications Studies 4Q CY2018 1Q CY2019 2Q CY2019 Key Phase II study for Alzheimer‘s disease Results expected by mid CY2019 focus Studies to demonstrate enzyme binding at different doses Target Occupancy studies Results expected by mid CY2019 Enhances Higher doses - safety study Xanamem Results expected by mid CY2019 data set Additional pre-clinical safety and toxicology studies Additional toxicology studies Initial results expected by mid CY2019 Assessment of other indications Upside Evaluating target indications Results expected e.g. diabetes, Parkinson‘s disease, Preliminary decision expected by 2Q CY2019 potential by mid CY2019 depression, schizophrenia, amongst others │ A novel approach to treating cognitive impairment and Alzheimer's disease 6
Xanamem Xanamem has been developed in response to The cortisol hypothesis evidence that there is a strong association Validation of the cortisol hypothesis between chronically raised cortisol levels in the blood and in the brain, and the development and Mechanism of action progression of Alzheimer‘s disease Xanamem research and development Xanamem is underpinned by over 15 years of R&D with A$40m invested in development
The cortisol hypothesis A growing body of literature showing an association between cortisol and cognitive impairment Medical publications: “Cortisol and Cognition” 1 Medical publications: “Cortisol and Alzheimer’s” 1 125 25 No. of publications annually No. of publications annually 100 20 75 15 50 10 25 5 0 0 1960 1975 1990 2005 2020 1980 1990 2000 2010 2020 Actinogen is well positioned to leverage the growing significance of the relationship between cortisol and cognition 1. PubMed keyword search │ A novel approach to treating cognitive impairment and Alzheimer's disease 8
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