Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2022)
34 slides from Actinogen Medical's shareholder meeting presentation, Nov 16, 2022
Slide 1: ASX Announcement: Actinogen AGM – Chair's address and CEO's presentation
For personal use only ASX ANNOUNCEMENT Actinogen AGM – Chair’s address and CEO’s presentation Sydney, 16 November 2022. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to release the Chair’s address and CEO’s slide presentation to this morning’s Annual General Meeting commencing at 11
Slide 2: About Xanamem and disclaimer
dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is debilitating for patients, and there is a substantial unmet medical need for new and improved treatments. About Xanamem Xanamem’s novel mechanism of action is to block the production of cortisol
Slide 3: ACW 2022 AGM Chair's Address
16 November 2022 For personal use only ACW 2022 AGM Chair’s Address On behalf of the Board of Directors and staff of Actinogen Medical Ltd, I welcome you to our 2022 Annual General Meeting. I am pleased to report that Actinogen has performed extremely well throughout the past year, with several outs
Slide 4: Chair's Address (continued)
Steve will speak shortly in more detail about the first-class team we are assembling, but shareholders have already seen and heard from several of the executive leadership team in corporate presentations this year, including the very informative Clinical Trials Science Forum held in August. If you h
Slide 5: Chair's Address (continued)
will continue to proactively manage all aspects of business, while working closely with existing and potential new partners to ensure the best possible outcomes for you, our shareholders, while at the same time providing hope for sufferers of conditions like Alzheimer’s Disease and Depression. I wou
Slide 6: Annual General Meeting 2022: De-risked and moving rapidly forward with phase 2 trials
For personal use only Annual General Meeting 2022 De-risked and moving rapidly forward with phase 2 trials Dr. Steven Gourlay MBBS PhD MBA, CEO & MD 16 November 2022 Authorised by the Board of Directors of Actinogen Medical Limited ® Xanamem is a registered trademark of Actinogen Medical Limited
Slide 7: 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 8: Actinogen company snapshot
Actinogen company snapshot Actinogen Medical (ASX:ACW) is developing a novel oral treatment with rapid onset of clinical activity to improve cognition and quality of life For personal use only Demonstrated target engagement in brain and HPA axis1 in human trials Favourable pharmaceutical propertie
Slide 9: Xanamem: Oral, low dose, once-a-day treatment with a unique non-amyloid mechanism
Xanamem: Oral, low dose, once-a-day treatment For personal use only with a unique non-amyloid mechanism Brain penetrant 11β-HSD1 small molecule enzyme inhibitor reduces cortisol inside brain cells - modulating signaling pathways and underlying disease processes1,2 Potential to be: • Rapidly cognitiv
Slide 10: Major price recovery to December 2021 levels
Major price recovery to December 2021 levels For personal use only Share price chart at 15 November 2022 Trading Information 52 week high A$0.20 52 week low A$0.04 25.0m 0.19 Number of issued shares 1,799M 0.17 Market capitalisation (14 Nov 2022) A$216M Positive XanaMIA 20.0m Phase 1b data Positive
Slide 11: Accelerating the right clinical development plans
For personal use only Accelerating the right clinical development plans See also Actinogen Clinical Trials Science Forum 03 August 2022 https://youtu.be/Bm9ATZx1zEk Annual General Meeting 16 November 2022 6
Slide 12: Then and now…
Then and now… For personal use only 2021 2022 XanaHES attention & working memory XanaHES attention & working memory • XanaMIA results pending XanaMIA attention & working memory 5 & 10 mg • Phase 2a stored biomarker samples identified Large CDR-SB effect seen in Phase 2a clinical biomarker st
Slide 13: De-risked and ready…
De-risked and ready… For personal use only 2021 2022 XanaHES attention & working memory XanaHES attention & working memory • XanaMIA results pending XanaMIA attention & working memory 5 & 10 mg • Phase 2a stored biomarker samples identified Large CDR-SB effect seen in Phase 2a clinical bioma
Slide 14: Phase 2b simulation …
Phase 2b simulation … For personal use only 2021 2022 XanaHES attention & working memory XanaHES attention & working memory • XanaMIA results pending XanaMIA attention & working memory 5 & 10 mg • Phase 2a stored biomarker samples identified Large CDR-SB effect seen in Phase 2a clinical biom
Slide 15: Xanamem Phase & program
Xanamem Phase 2 & 3 program Building on four independent Phase 1 and 2 studies showing activity For personal use only Current Phase 1 & 2a, biomarker Safety, cognition activity (n~300) Phase 2b Phase 2a Cognitive Impairment Alzheimer’s Disease (AD) in Depressive Disorder (CIDD) Phase 3 Phase 3 Alzhe
Slide 16: Robust Phase 2b trial design & implementation model
Robust Phase 2b trial design & implementation model: selecting AD patients by blood pTau level For personal use only 10mg Xanamem Screening 5mg Xanamem Follow-up Placebo -4 0 24 28 Weeks Double-blind, randomised treatment period (N=330) Key inclusion/exclusion criteria Primary Endpoints Key Secondar
Slide 17: The Xanamem opportunity in depression
The Xanamem opportunity in depression For personal use only Current anti-depressants work slowly (3 weeks) and do not target cognition multiple adverse effects initial suicide risk blood pressure, sexual function, appetite… Xanamem improves cognition quickly Xanamem may improve both depression and c
Slide 18: XanaCIDD trial design & implementation model
XanaCIDD trial design & implementation model For personal use only 10mg Xanamem Follow-up Screening Placebo -4 0 6 10 Weeks Double-blind, randomised treatment period (N=160) Key inclusion/exclusion criteria Primary Endpoints Key Secondary Endpoints Key Implementation Features • Primary diagnosis of
Slide 19: Involving the right people
For personal use only Involving the right people Annual General Meeting 16 November 2022 14
Slide 20: Leadership strengthened
Leadership strengthened Extensive drug development and commercial experience For personal use only Experienced Board of Directors... …with a talented management team in place Jeff Carter Chief Financial Officer B. Fin Admin; M. App. Fin; CA Tamara Miller SVP Product Development M.Med Sci; BSc; MSc;
Slide 21: International cognition clinical advisors
International cognition clinical advisors Global thought leaders in trials for assessment of cognition in dementia and depression For personal use only Prof. John Harrison Dr Dana C. Hilt Dr Christina Kurre Olsen Prof. Paul Maruff A/Prof Christopher Chen Metis Cognition Ltd • Expert psychologist wit
Slide 22: International Scientific Advisory Boards
International Scientific Advisory Boards Thought-leader academics involved in the development of Xanamem For personal use only Alzheimer’s Disease Clinical Advisory Board Scientific Advisory Board Prof. Craig Ritchie Prof. Colin Masters Prof. Jeffrey Cummings Prof. Jonathan Seckl Prof. Brian Walker
Slide 23: Forward planning for marketing approvals
For personal use only Forward planning for marketing approvals Annual General Meeting 16 November 2022 18
Slide 24: Forward planning for marketing approvals
Forward planning for marketing approvals For personal use only Commercial Regulatory Clinical manufacturing nonclinical studies pharmacology studies Annual General Meeting 16 November 2022 19
Slide 25: Creating value from partnerships
For personal use only Creating value from partnerships Annual General Meeting 16 November 2022 20
Slide 26: Creating value from partnerships
Creating value from partnerships For personal use only Interacting with patient groups Academic collaborations and & granting bodies publications Exploring regional & global Aligning plans with regulators partners like the US FDA Annual General Meeting 16 November 2022 21
Slide 27: Xanamem timeline & catalysts
Xanamem timeline & catalysts For personal use only • Multiple partnering presentations of Phase 2a results 2022 • November CTAD XanaMIA presentation • Enrollment for XanaCIDD trial in Depression • Key global regulatory submissions in AD with FDA, EMA, other • XanaMIA Phase 2b • XanaMIA Phase 2b resu
Slide 28: Questions
For personal use only Questions Annual General Meeting 16 November 2022 23
Slide 29: Thank you
For personal use only Thank you If you have any questions following the AGM please contact: Dr. Steven Gourlay Michael Roberts CEO & Managing Director Investor Relations P. +61 2 8964 7401 M. +61 423 866 231 E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au Annual General Meetin
Slide 30: Appendix
For personal use only Appendix Annual General Meeting 16 November 2022 25
Slide 31: Selected glossary
Selected glossary 1 For personal use only 11β-HSD1 11 beta HydroxySteroid Dehydrogenase-1 enzyme Aβ Amyloid beta – a type of amyloid protein associated with Alzheimer’s Disease, 42 and 40 are different forms ACTH Adrenocorticotropic hormone that regulates blood levels of cortisol ADAS-Cog Alzheimer’
Slide 32: Selected glossary
Selected glossary 2 For personal use only IQCODE Informant Questionnaire on Cognitive Decline in the Elderly MCI Mild Cognitive Impairment – memory, executive function deterioration with retained functional abilities MDD Major Depressive Disorder MMSE Mini Mental State Examination – a 30-point scale
Slide 33: Selected recent announcements and presentations
Selected recent announcements and presentations For personal use only 14 OCT 2022 Annual Report to Shareholders 10 OCT 2022 Large clinical benefit on FDA-approved measurement of cognition and function in patients with Alzheimer’s Disease 10 OCT 2022 ACW clinical biomarker study webcast presentation
Slide 34: Clinical Dementia Rating – Sum of Boxes (CDR-SB)
Clinical Dementia Rating – Sum of Boxes (CDR-SB) endpoint to assess dementia in early-stage AD For personal use only Test domain Impairment None Questionable Mild Moderate Severe 0 0.5 1 2 3 Memory Orientation Judgment & Problem Solving Community Affairs Home & Hobbies Personal Care Score is sum of
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