Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (May 2019)
47 slides from Actinogen Medical's investor presentation, May 1, 2019
Slide 1: ASX Announcement: Actinogen updated Investor Presentation
ASX ANNOUNCEMENT Actinogen updated Investor Presentation For personal use only Sydney 1 May 2019: Actinogen Medical (ASX: ACW, ‘the Company’) is pleased to release an updated Investor Presentation. This presentation will be used to update investors and potential strategic partners following the rece
Slide 2: About Actinogen, Xanamem, XanADu and XanaHES
Actinogen Medical (ASX: ACW) is an ASX-listed biotechnology company focused on innovative approaches to treating cognitive decline that occurs in chronic neurological and metabolic diseases. Actinogen Medical is developing its lead compound Xanamem, as a promising new therapy for Alzheimer’s disease
Slide 3: Investor Presentation: A novel approach to treating cognitive impairment
For personal use only Investor Presentation A novel approach to treating cognitive impairment Dr. Bill Ketelbey: CEO & MD May 2019
Slide 4: Contents
Contents For personal use only Executive summary Xanamem XanADu Development pipeline Outlook Appendix
Slide 5: Executive summary
For personal use only Executive summary Key investment highlights What is Xanamem Development pipeline
Slide 6: Key investment highlights
Key investment highlights Actinogen is developing innovative treatments for cognitive impairment associated with neurological and metabolic diseases with an initial focus on Alzheimer‘s disease For personal use only Xanamem - lead compound Targeted strategic market focus Clinical stage asset Potenti
Slide 7: 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 For personal use only Well researched In clinical stage development, with over 15 years of R&D completed, and A$40m invested to dat
Slide 8: 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 in mood disorders and schizophrenia For personal use only Studies 1Q CY2019 2Q CY2019 Results expected by mid CY2019 Phase II study for
Slide 9: Xanamem
For personal use only 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 prog
Slide 10: The cortisol hypothesis
The cortisol hypothesis A growing body of literature showing an association between cortisol and cognitive impairment For personal use only Medical publications: “Cortisol and Cognition”1 Medical publications: “Cortisol and Alzheimer’s”1 125 25 No. of publications annually No. of publications annual
Slide 11: 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 For person
Slide 12: Mechanism of action
Mechanism of action Xanamem inhibits the activity of the 11βHSD1 enzyme, reducing the production of cortisol in the brain For personal use only Overview Xanamem has potential in other diseases with possible cortisol induced cognitive impairment Alzheimer's disease (key focus) Mood disorders and
Slide 13: Xanamem research and development
Xanamem research and development Xanamem is underpinned by significant R&D investment and clinical progress over the last 15 years For personal use only 11β-HSD1 is Key highly expressed in regions XanADu Results mid-2019: important for Carbenoxolone Interim XanADu, Target XanADu first subject cognit
Slide 14: XanADu
For personal use only XanADu Efficacy considerations XanADu is a global Phase II double-blind, randomised, placebo-controlled study assessing Phase II clinical trial design and endpoints the efficacy and safety of Xanamem in patients with mild Alzheimer‘s disease Interim analysis Enrolment complete
Slide 15: 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 16: 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 For personal use only Cognition: 28 days treatment Amyloid clearance: 28 days treatment Latency to
Slide 17: 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
Slide 18: XanADu endpoints
XanADu endpoints XanADu’s primary and secondary efficacy endpoints are validated cognitive outcome measures used in Alzheimer’s disease research globally and accepted by all major regulatory bodies globally (including the FDA) For personal use only XanADu: primary and secondary efficacy endpoints1 E
Slide 19: Key takeaways for XanADu efficacy endpoints
Key takeaways for XanADu efficacy endpoints1 For personal use only Results will inform on efficacy, safety and potential utility of Xanamem in Alzheimer’s disease patients Each clinical efficacy endpoint has many domains resulting in numerous potential outcomes No individual endpoint must be achieve
Slide 20: XanADu primary efficacy endpoints
XanADu primary efficacy endpoints A primary endpoint is the endpoint to which a clinical trial is powered for statistical purposes1; XanADu is powered to ADAS-COG14 (ADCOMS is a co-primary endpoint) For personal use only ADAS-COG14 ADCOMS AD Assessment Scale Cognition (version 14) AD Composite Score
Slide 21: XanADu secondary efficacy endpoints
XanADu secondary efficacy endpoints XanADu’s secondary efficacy endpoints complement the primary endpoints and provide additional information about the therapeutic efficacy of the drug candidate to inform further clinical development For personal use only CDR-SOB1 MMSE RAVLT NTB NPI Clinical Dementi
Slide 22: Validity of XanADu's endpoints
Validity of XanADu’s endpoints XanADu endpoints are validated cognitive outcome measures and results will be highly valued by clinicians and potential strategic partners alike For personal use only Endpoints are validated and accepted by global regulatory bodies, academics and potential strategic pa
Slide 23: Comprehensive assessment process
Comprehensive assessment process The comprehensive review of the data and results from XanADu and the additional studies will underpin the optimal clinical development pathway forward For personal use only Multiple endpoints provides deep insight into Assess safety and tolerability of higher doses,
Slide 24: 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) (26 March
Slide 25: 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 26: Development pipeline of other cognitive enhancers
Development pipeline of other cognitive enhancers Xanamem is one of the most advanced cognitive enhancers currently in development1 For personal use only Phase Company Drug candidate Mechanism Primary endpoint(s) Upcoming milestones2 (status) 11βHSD1 II ADAS-Cog14, Results available by mid CY2019 Xa
Slide 27: 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 28: 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 For personal use only Overview1 Compound (Phase) CSF Aβ Company Population Cognition comments Status
Slide 29: 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 30: Development pipeline
For personal use only Development pipeline Additional Xanamem studies Strategic indications
Slide 31: 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 studies Higher dose safety study Further safety / toxicology s
Slide 32: Assessment of new target indications completed
Assessment of new target indications completed Following extensive scientific, clinical, and commercial review, cognitive impairment in mood disorders and schizophrenia selected as the next indications for development and commercialisation of Xanamem For personal use only 12 indications assessed Sci
Slide 33: Cognitive impairment in mood disorders & schizophrenia
Cognitive impairment in mood disorders & schizophrenia Cognitive impairment can be a debilitating feature of mood disorders and schizophrenia, which exhibit raised cortisol levels For personal use only High cortisol levels are found in severe mood Xanamem’s differentiated mechanism of action may i
Slide 34: Significant opportunity
Significant opportunity Large patient populations and economic costs suggest a high unmet need with significant market opportunity for Xanamem to be used in combination with current therapies in order to address cognitive decline For personal use only Depression Bipolar disorder Schizophrenia Preval
Slide 35: Development pipeline
Development pipeline Multiple studies are currently underway to enhance the Xanamem data set, with results expected in 2Q CY2019, and new indications clinical strategy initiated For personal use only 1Q CY2019 2Q CY2019 9 new studies underway 3 studies including: in-vitro,pre-clinical Target Occupan
Slide 36: Outlook
For personal use only Outlook Upcoming catalysts Key investment highlights
Slide 37: 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 For personal use only Xanamem clinical development License / partnering Progress Xanamem deve
Slide 38: Upcoming catalysts
Upcoming catalysts Significant upcoming milestones across first half 2019 For personal use only Studies 1Q CY2019 2Q CY2019 3Q CY2019 4Q CY2019 Key catalysts Results expected by mid CY2019 Results expected to be available by mid CY2019 Next stage of development will Target occupancy be informed by t
Slide 39: Key investment highlights
Key investment highlights Actinogen is developing innovative treatments for cognitive impairment associated with neurological and metabolic diseases with an initial focus on Alzheimer‘s disease For personal use only Xanamem - lead compound Differentiated with a novel mechanism of action First-in-cla
Slide 40: Appendix
For personal use only Appendix Corporate overview Senior leadership Advisory boards IP protection
Slide 41: Corporate overview
Corporate overview 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 Overview LTM share price performance and trading metrics Actinogen is developing Xanamem, a nove
Slide 42: Substantial Institutional investment in Actinogen
Substantial Institutional investment in Actinogen Recognises potential and endorses strategy For personal use only Positive 2018 interim analysis catalyses significant A$15m investment through Placement1 Leading investors enter register: ‒ USA specialist biotech investor Biotechnology Value Fund L
Slide 43: Board of Directors
Board of Directors Commercially experienced and globally recognised leadership team with decades of experience in drug development and biotech investment For personal use only Dr. Geoff Dr. Bill Dr. George Mr. Malcolm Brooke Ketelbey Morstyn McComas Chairman CEO & MD Non-executive Non-executive dire
Slide 44: 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 45: 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 46: 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 47: 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