Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2018)
23 slides from Actinogen Medical's shareholder meeting presentation, Nov 28, 2018
Slide 1: Actinogen Medical AGM Business Overview
For personal use only Actinogen Medical AGM Business Overview Dr. Bill Ketelbey: CEO & MD 28th November 2018
Slide 2: 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 3: 2018 Highlights
For personal use only 2018 Highlights
Slide 4: Actinogen's journey
Actinogen‘s journey Xanamem is underpinned by significant R&D investment and clinical progress over the last 15 years For personal use only 11β-HSD1 is highly expressed in regions XanADu important for Carbenoxolone Interim XanADu first subject cognition is shown to Analysis enhance Xanamem cognitive
Slide 5: 2018 Highlights
2018 Highlights For personal use only XanADu Building beyond XanADu Partnering Enrolment completed Fully funded to complete XanADu ACW “Partner Ready” and ongoing and other Xanamem studies partner outreach Primary and secondary endpoints inform further development Xanamem Clinical Advisory
Slide 6: Phase II clinical trial
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 conducted
Slide 7: Endpoints
Endpoints XanADu’s primary and secondary endpoints are the standard cognitive outcome measures used in Alzheimer’s disease research globally For personal use only XanADu: primary and secondary endpoints1 Endpoints inform further development ADAS- ADCOMS COG14 XanADu endpoints are standard and valida
Slide 8: Interim analysis
Interim analysis Positive recommendations from the DSMB1 reflect confidence in the safety of the drug and the design of the XanADu study. Supports the broader development of Xanamem For personal use only First DSMB review Second DSMB review Third DSMB review (23 May 2018) (22 August 2018) Evaluati
Slide 9: 2018 Highlights
2018 Highlights For personal use only XanADu Building beyond XanADu Partnering Enrolment completed Fully funded to complete XanADu ACW “Partner Ready” and ongoing and other Xanamem studies partner outreach Primary and secondary endpoints inform further development Xanamem Clinical Advisory
Slide 10: Substantial Institutional investment in Actinogen
Substantial Institutional investment in Actinogen⃰ Recognises potential and endorses strategy For personal use only Positive interim analysis catalyses significant $15M investment through Placement Leading investors enter register: USA specialist biotech investor Biotechnology Value Fund L.P. Au
Slide 11: Additional value-adding Xanamem studies
Additional value-adding Xanamem studies Actinogen is focused on completing nine key additional studies to enhance the Xanamem data set, which can also be potentially leveraged into other indications For personal use only Target occupancy study Higher dose safety study Further safety / toxicology stu
Slide 12: Advisory Boards
Advisory Boards World’s premier academics involved in the development of Xanamem and as a novel treatment for Alzheimer’s disease For personal use only Xanamem Clinical Advisory Board Scientific Advisory Board Positions Xanamem at the forefront of Combining deep understanding of cortisol, Alzheimer’
Slide 13: 2018 Highlights
2018 Highlights For personal use only XanADu Building beyond XanADu Partnering Enrolment completed Fully funded to complete XanADu Ongoing outreach program and and other Xanamem studies business development Primary and secondary endpoints inform further development Xanamem Clinical Advisor
Slide 14: Big Pharma interest
Big Pharma interest Global Big Pharma demonstrating strong M&A interest in acquiring or partnering with companies and licensing novel mechanism of action assets with Alzheimer’s disease as the lead/key indication For personal use only 3,340 3,500 Deal value (US$m) 1,200 Upfront (US$m) 1,119 1,000 82
Slide 15: IP protection
IP protection Actinogen maintains a broad granted composition of matter patent estate, extending to at least 2031, 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 d
Slide 16: 2019 Outlook
For personal use only 2019 Outlook
Slide 17: Clinical development and milestones
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 For personal use only Studies 4Q CY2018 1Q CY2019 2Q CY2019 Phase II study for Alzheimer‘s disease Key
Slide 18: Proactive strategic business development
Proactive strategic business development Continued strategic engagement with prospective development and commercial partners in the lead up to XanADu results For personal use only Progressing collaboration and commercial discussions with prospective big pharma partners, and presenting to, and educat
Slide 19: 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 20: Comparison of Alzheimer's disease treatments
Comparison of Alzheimer’s disease treatments Actinogen’s novel treatment for Alzheimer’s disease is clearly differentiated and may be used in combination with existing cognitive enhancers and potential anti-amyloid drugs (currently in development) For personal use only Overview Therapies / compounds
Slide 21: Significant headwinds for BACE inhibitor development
Significant headwinds for BACE inhibitor development Significant opportunity for Xanamen development, with recent study data indicating that anti-amyloid may not be efficacious as initially expected For personal use only Overview1 Company Compound (Phase) Population CSF Aβ Cognition comments Status
Slide 22: XanADu, Xanamem and Cortisol
XanADu, Xanamem and Cortisol Video featuring the Xanamem Clinical Advisory Board - October 2018, Barcelona For personal use only https://actinogen.com.au/video │ A novel approach to treating cognitive impairment and Alzheimer's disease 22
Slide 23: Dr. Bill Ketelbey contact details
Dr. Bill Ketelbey For personal use only CEO & Managing Director ☏ Main: +61 2 8964 7401 Email: bill.ketelbey@actinogen.com.au www.actinogen.com.au
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