Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2019)
28 slides from Actinogen Medical's shareholder meeting presentation, Nov 25, 2019
Slide 1: Managing Director's AGM Presentation (ASX announcement)
ASX ANNOUNCEMENT Managing Director’s AGM Presentation For personal use only Sydney, 25 November 2019. Actinogen Medical ASX: ACW (‘ACW’ or ‘the Company’) is pleased to release an updated Investor Presentation that will be used in part for the Managing Director’s AGM presentation. Key Highlights • Xa
Slide 2: About Xanamem, XanADu and XanaHES
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 inhibition of the 11β-HSD1 enzyme in the brain. There is a strong association between chronic stress and exces
Slide 3: AGM Presentation
For personal use only AGM Presentation Developing innovative treatments for cognitive impairment associated with a number of medical conditions, including Alzheimer’s disease Dr. Bill Ketelbey: CEO & MD 25 November 2019
Slide 4: 2019 Highlights: Xanamem's efficacy demonstrated!
2019 Highlights: Xanamem’s efficacy demonstrated! Enhancing the Xanamem dataset For personal use only Target Occupancy Additional & Homogenate Toxicology Binding Studies Studies Efficacy shown in Phase 1 Phase 1 Target Occupancy, Phase 2 clinical trial in mild Pre-clinical safety and clinical trial
Slide 5: Xanamem – our lead compound under development
Xanamem – our lead compound under development A novel MoA designed to inhibit cortisol production in the brain, with proof of concept in animals and in humans, a strong safety profile and significant data on dosing For personal use only Novel MoA (cortisol inhibition) POC demonstrated in animal tria
Slide 6: Significant Cognitive Efficacy Signal Achieved
Significant Cognitive Efficacy Signal Achieved Breakthrough XanaHES results demonstrate strong statistically significant cognitive efficacy improvement in multiple cognition domains – based on Cogstate Cognitive Test Battery For personal use only Working memory (One Back Test) Visual attention (Iden
Slide 7: Significant Cognitive Efficacy Signal Achieved
Significant Cognitive Efficacy Signal Achieved Cogstate Cognitive Test Battery evaluated six domains. Statistically significant cognitive improvement in three domains with significant effect size demonstrated For personal use only XanaHES 20mg Cogstate Cognitive Test Battery: p values and Cohen’s d
Slide 8: Target Occupancy Study: Preliminary Results
Target Occupancy Study: Preliminary Results Phase I target occupancy study demonstrates that 10-30mg Xanamem dosed for seven days significantly occupies the neuronal 11β-HSD1 enzyme throughout the brain For personal use only 50% to 85% occupancy, dependent upon brain region, dosage and study subject
Slide 9: Key outcomes from Xanamem studies
Key outcomes from Xanamem studies For personal use only Target Xanamem 10mg-30mg achieves target occupancy (50-85%) of 11B-HSD1 enzyme in Occupancy the brain Cortisol Xanamem 10mg and 20mg inhibits cortisol production and; inhibition Xanamem 20mg achieves statistically significant reduction in serum
Slide 10: Strategic direction and next steps
Strategic direction and next steps The totality of the information from all Xanamem studies are informing Actinogen’s decisions on its future clinical development For personal use only Xanamem - an efficacious, oral, brain penetrant, selective 11β –HSD1 inhibitor with a good safety profile 3 Plan an
Slide 11: Determining the next set of Xanamem studies
Determining the next set of Xanamem studies Actinogen is considering how to best leverage Xanamem development across multiple target indications and determining the optimal study parameters going forward For personal use only Leveraging platform technology Optimising study parameters Alzheimer’s dis
Slide 12: Alzheimer's - the primary development focus
Alzheimer’s - the primary development focus Actinogen plans to target patients with Mild Cognitive Impairment (an early stage of the Alzheimer’s disease spectrum) as part of the next phase of studies, linking the XanaHES results with Alzheimer’s disease For personal use only Healthy Mild Cognitive M
Slide 13: Actinogen - targeting a huge unmet medical need
Actinogen - targeting a huge unmet medical need Alzheimer’s disease - the only top-ten leading fatal illness that cannot be prevented, treated or cured Leading cause of death in Australian women and second only to CV disease in men For personal use only Huge, and growing Limited treatment Unsustaina
Slide 14: Market dynamics of Alzheimer's disease
Market dynamics of Alzheimer’s disease Presents a compelling commercial opportunity for Actinogen to target initially For personal use only Substantial target market with significant upside1 Underpinned by favourable market dynamics Cortisol-high, Targeting large addressable markets (US, EU5, JP)
Slide 15: Investment summary
Investment summary Actinogen - developing innovative treatments for cognitive impairment associated with neurological and metabolic diseases, with a primary focus on Alzheimer’s disease For personal use only Xanamem – our differentiated lead compound (efficacious, oral, brain penetrant, selective
Slide 16: 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 17: Appendix: Background information
Appendix: For personal use only Background information
Slide 18: Corporate overview
Corporate overview ASX:ACW Actinogen is an ASX-listed biotech company focused on innovative approaches to treating cognitive impairment associated with neurological and metabolic diseases For personal use only LTM share price performance Board of Directors Price (A$) Volume (m) 0.080 600 Dr. Geoff B
Slide 19: Advisory Boards
Advisory Boards World’s premier academics involved in the development of Xanamem and as a novel treatment for Alzheimer’s disease For personal use only Clinical Advisory Board (Alzheimer’s disease) Scientific Advisory Board Positions Xanamem at the forefront of Combining deep understanding of cortis
Slide 20: IP protection
IP protection Actinogen maintains a broad granted composition of matter patent estate, with key patents granted in all major target markets For personal use only Geographic patent overview Actinogen’s patent portfolio covers a broad range of neurological and metabolic diseases including Alzheimer’
Slide 21: Xanamem
Xanamem A novel drug designed to inhibit cortisol production in the brain, with the potential to treat cognitive impairment For personal use only Well researched Differentiated mechanism of action: >15 years of R&D completed Highly selective 11βHSD1 inhibitor in the brain which reduces excess cortis
Slide 22: Alzheimer's strategic focus underpinned by medical research
Alzheimer‘s strategic focus underpinned by medical research A growing body of medical literature supports the association between cortisol and Alzheimer‘s disease For personal use only Raised cortisol associated with Alzheimer’s disease1 Supported by growing body of medical literature Many studies s
Slide 23: Big Pharma interest
Big Pharma interest Global Big Pharma demonstrating strong M&A interest in acquiring or partnering with companies and licensing novel mechanism of action assets with Alzheimer’s disease as the lead/key indication For personal use only 3.3 3.5 1.9 Deal value (US$bn) 1.2 Upfront (US$bn) 1.1 1.0 Deal v
Slide 24: Phase I clinical trial
Phase I clinical trial Single blind placebo-controlled, dose escalation study to assess safety, tolerability and efficacy of Xanamem in healthy elderly subjects – full results expected in 4Q CY2019 For personal use only 12 weeks 42 Xanamem treatment course Healthy elderly subjects Trial conducted at
Slide 25: Cortisol Levels Reduced with Acceptable Safety
Cortisol Levels Reduced with Acceptable Safety Efficacy results complemented by a statistically significant reduction in serum cortisol observed in the trial For personal use only Significant reduction in cortisol levels (all patients) Score: Efficacy Measure – Cortisol (nmol/L) P<0.001 Xanamem achi
Slide 26: Xanamem: Phase I Target Occupancy Study & Homogenate Binding Studies
Xanamem: Phase I Target Occupancy Study & Homogenate Binding Studies To assist with confirming and optimising Xanamem dosing For personal use only To accurately demonstrate the effects different doses of Xanamem have on inhibiting the Aim 11β-HSD1 enzyme in the human brain. Phase I Target Occupancy
Slide 27: Long-Term Safety and Toxicology Studies
Long-Term Safety and Toxicology Studies For personal use only Evaluate safety and toxicology in rodent (six months) and dog (nine months) studies Aim in preparation for longer term clinical studies Studies required by all regulators - FDA Will allow future clinical studies beyond 12 weeks Stud
Slide 28: XanADu Phase II clinical trial
XanADu Phase II clinical trial Double-blind, randomised, placebo-controlled study to assess the efficacy and safety of Xanamem in subjects with mild Alzheimer's disease1 For personal use only Xanamem treatment course 186 patients with mild Alzheimer’s 12 weeks disease (enrolment complete)2 Trial con
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