Actinogen Medical Limited · ASX:ACW
Actinogen Medical — SACHS Neuroscience Forum 2019
38 slides from Actinogen Medical's conference presentation, Jan 6, 2019
Slide 1: Investor Presentation
Investor Presentation A novel approach to treating cognitive impairment and Alzheimer’s disease Dr. Bill Ketelbey: CEO & MD January 2019
Slide 2: Contents
Contents Executive summary Xanamem XanADu Development pipeline Outlook Appendix
Slide 3: Executive summary
Executive summary Key investment highlights What is Xanamem Development pipeline
Slide 4: Key investment highlights
Key investment highlights Actinogen is developing innovative treatments for cognitive impairment associated with neurodegenerative and metabolic diseases with an initial focus on Alzheimer‘s disease Xanamem - lead compound Differentiated with a novel mechanism of action First-in-class, brain penetra
Slide 5: Xanamem
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 d
Slide 6: 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 Studies 4Q CY2018 1Q CY2019 2Q CY2019 Phase II study for Alzheimer‘s disease Key Results expected by mi
Slide 7: Xanamem
Xanamem The cortisol hypothesis Xanamem has been developed in response to 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
Slide 8: The cortisol hypothesis
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
Slide 9: Human pilot studies validate the cortisol hypothesis
Human pilot studies validate the cortisol hypothesis Two pilot studies indicated inhibiting cortisol production in the brain improves cognitive function in healthy elderly men and subjects with Type 2 diabetes (11β-HSD1 inhibition with carbenoxolone – no longer commercially available) 1,2 Verbal flu
Slide 10: Mechanism of action
Mechanism of action Xanamem inhibits the activity of the 11βHSD1 enzyme, reducing the production of cortisol in the brain Overview Xanamem has potential in other diseases with possible cortisol induced cognitive impairment Alzheimer's disease (key focus) Diabetes Depression Schizophrenia P
Slide 11: Xanamem research and development
Xanamem research and development Xanamem is underpinned by significant R&D investment and clinical progress over the last 15 years 11β-HSD1 is Key highly expressed in regions XanADu Results mid-2019: important for Carbenoxolone Interim XanADu, Target XanADu first subject cognition is shown to Analys
Slide 12: XanADu
XanADu Efficacy considerations XanADu is a global Phase II double-blind, randomised, placebo-controlled study asessing the XanADu Phase II clinical trial and milestones efficacy and safety of Xanamem in patients with mild Alzheimer‘s disease Interim analysis Enrolment complete with results expected
Slide 13: 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 Raised cortisol associated with Alzheimer’s disease1 Supported by growing body of medical literature Many studies support the association
Slide 14: Efficacy underpinned by animal model
Efficacy underpinned by animal model Significant and rapid symptomatic and disease modifying effects demonstrated with significant improvement in cognition within one month, continuing out to 41 weeks Cognition: 28 days treatment Amyloid clearance: 28 days treatment Latency to enter dark compartment
Slide 15: 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 Xanamem treatment course 186 patients with mild Alzheimer’s 12 weeks disease (enrolment complete)2 Trial conducted at 25 sites in
Slide 16: XanADu endpoints
XanADu endpoints XanADu’s primary and secondary endpoints are the standard cognitive outcome measures used in Alzheimer’s disease research globally XanADu: primary and secondary endpoints1 Endpoints inform further development ADAS- ADCOMS COG14 XanADu endpoints are standard and validated assessments
Slide 17: 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 First DSMB review Second DSMB review Third DSMB review (23 May 2018) (22 August 2018) Evaluation of 50 Evaluation
Slide 18: Market dynamics of Alzheimer's disease
Market dynamics of Alzheimer’s disease Presents a compelling commercial opportunity for Actinogen to target initially Substantial target market with significant upside1 Underpinned by favourable market dynamics Cortisol-high, Targeting large addressable markets (US, EU5, JP) Subjective Cognitive a
Slide 19: Development pipeline of other cognitive enhancers
Development pipeline of other cognitive enhancers Xanamem is one of the most advanced cognitive enhancers currently in development1 Phase Company Drug candidate Mechanism Primary endpoint(s) Upcoming milestones2 (status) 11βHSD1 II ADAS-Cog14, Results available by mid CY2019 Xanamem inhibitor (ongoi
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) Overview Therapies / compounds Xanamem Cognitive enh
Slide 21: Significant headwinds for BACE inhibitor development
Significant headwinds for BACE inhibitor development Significant opportunity for Xanamem development, with recent study data indicating that anti-amyloid may not be efficacious as initially expected Overview1 Company Compound (Phase) Population CSF Aβ Cognition comments Status lowering range Resul
Slide 22: 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 3.3 3.5 1.9 Deal value (US$bn) 1.2 Upfront (US$bn) 1.1 1.0 Deal value 0.8 (US$bn) 0.7 0
Slide 23: Development pipeline
Development pipeline Additional Xanamem studies Other potential indications
Slide 24: 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 Target occupancy studies Higher dose safety study Further safety / toxicology studies Aims to accurat
Slide 25: Other potential indications
Other potential indications Actinogen is also focused on developing Xanamem in other indications to optimise shareholder value Overview Possible target indications Multiple potential target indications beyond Alzheimer’s represent significant market Depression Diabetes expansion opportunities Growin
Slide 26: Development pipeline
Development pipeline Multiple studies are currently underway to enhance the Xanamem data set, with results expected in 2Q CY2019, and preliminary decision on assessment of other indications planned for 1Q CY2019 4Q CY2018 1Q CY2019 2Q CY2019 9 new studies underway Target Occupancy 3 studies includin
Slide 27: Outlook
Outlook Upcoming catalysts Key investment highlights
Slide 28: Development and commercialisation strategy
Development and commercialisation strategy Actinogen is focused on progressing Xanamem clinical development, while continually assessing potential value accretive opportunities to optimise shareholder value Xanamem clinical development License / partnering Progress Xanamem development Proactive and
Slide 29: Upcoming catalysts
Upcoming catalysts Significant upcoming milestones across first half 2019 Studies 1Q CY2019 2Q CY2019 3Q CY2019 4Q CY2019 Key catalysts Results expected to be available by mid CY2019 Next stage of development will be informed by these study Target occupancy Results expected to be available results.
Slide 30: Key investment highlights
Key investment highlights Actinogen is developing innovative treatments for cognitive impairment associated with neurodegenerative and metabolic diseases with an initial focus on Alzheimer‘s disease Xanamem - lead compound Differentiated with a novel mechanism of action First-in-class, brain penetra
Slide 31: Appendix
Appendix Corporate overview Senior leadership Advisory boards IP protection
Slide 32: Corporate overview
Corporate overview Actinogen is an ASX-listed biotech company focused on innovative approaches to treating cognitive impairment associated with chronic neurodegenerative and metabolic diseases Overview LTM share price performance and trading metrics • Actinogen is developing Xanamem, a novel therapy
Slide 33: 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 institutions
Slide 34: Board of Directors
Board of Directors Commercially experienced and globally recognised leadership team with decades of experience in drug development and biotech investment Dr. George Dr. Geoff Dr. Bill Morstyn Brooke Ketelbey Non-executive Chairman CEO & MD director 30+ years experience in the healthcare 30+ year
Slide 35: Advisory Boards
Advisory Boards World’s premier academics involved in the development of Xanamem and as a novel treatment for Alzheimer’s disease XanamemTM Clinical Advisory Board Scientific Advisory Board Positions Xanamem at the forefront of Combining deep understanding of cortisol, Alzheimer’s drug development 1
Slide 36: Proactive strategic business development
Proactive strategic business development Continued strategic engagement with prospective development and commercial partners in the lead up to XanADu results Progressing collaboration and commercial discussions with prospective big pharma partners, and presenting to, and educating the scientific com
Slide 37: 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 Geographic patent overview Actinogen’s patent portfolio covers a broad range of neurological and metabolic diseases including Alzh
Slide 38: 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