Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2021)
27 slides from Actinogen Medical's shareholder meeting presentation, Nov 10, 2021
Slide 1: AGM Presentations
ASX ANNOUNCEMENT AGM Presentations For personal use only Sydney, 10 November 2021. Actinogen Medical ASX:ACW (“ACW” or “the Company”) is pleased to attach the Chair’s Address and CEO’s presentation to be presented at today’s Annual General Meeting which will be held virtually commencing at 11.00 am
Slide 2: Forward-looking statements
This announcement and attachments may contain certain forward-looking statements that are based on subjective estimates and assumptions and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements involve known and unknown risks, uncertaint
Slide 3: ACW 2021 AGM Chair's Address
10 November 2021 ACW 2021 AGM Chair’s Address For personal use only On behalf of the Board of Directors and staff of Actinogen Medical Ltd, I welcome you to our 2021 Annual General Meeting. I am pleased to report that Actinogen has managed to do well through the 2021 financial year, despite the COVI
Slide 4: Corporate governance
On corporate governance matters, your Board continually seeks improvement in its governance and management oversight capability. During the past year, we conducted our periodic review of all activities and responsibilities, including the annual Board skills matrix to identify gaps and opportunities
Slide 5: About Actinogen Medical / About Xanamem
About Actinogen Medical Actinogen Medical (ASX:ACW) is an ASX-listed biotechnology company developing novel therapies for neurological diseases associated with dysregulated brain cortisol. The Company is currently developing its lead compound, Xanamem®, as a promising new therapy for Alzheimer’s Dis
Slide 6: CEO's presentation
For personal use only CEO’s presentation Dr. Steven Gourlay MBBS PhD MBA: CEO & MD, CMO 10 November 2021 Annual General Meeting 10 November 2021 1
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 is a neurotherapeutics developer
For personal use only Actinogen is a neurotherapeutics developer realising a revolutionary therapy so neurology patients can live their best lives Annual General Meeting 10 November 2021 3
Slide 9: Xanamem: oral treatment and novel mechanism
Xanamem: oral treatment and For personal use only novel mechanism Brain penetrant 11β-HSD1 small molecule enzyme inhibitor reduces cortisol inside brain cells - modulating signalling pathways and underlying disease processes1,2 1. Xanamem® is a CNS (Central Nervous System) penetrant small molecule b
Slide 10: Actinogen snapshot
Actinogen snapshot For personal use only Actinogen Medical (ASX:ACW) is developing a novel oral treatment with rapid onset of clinical activity to address a range of central nervous system (CNS) diseases Demonstrated target engagement in brain and HPA axis in human trials Favourable pharmaceutical
Slide 11: Strong Leadership and Management
Strong Leadership and Management For personal use only Extensive drug development and commercial experience 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 Dr. George Morstyn Vice President Dr
Slide 12: Esteemed Advisory Boards
Esteemed Advisory Boards For personal use only World-leading, premier academics involved in the development of Xanamem Xanamem Clinical Advisory Board Scientific Advisory Board Deeply experienced in Alzheimer’s Disease drug development Combining deep understanding of endocrinology, 11β-HSD1 and drug
Slide 13: ACW stock performance
ACW stock performance 12 months For personal use only Share price chart at 9 Nov 2021 Trading Information 52 week high A$0.20 52 week low A$0.02 Number of shares 1,660.6M Market capitalisation (9 Nov 2021) A$315M Net cash at 30 Sep1 A$11.8M Major Shareholders BVF Partners 14.9% Steven Gourlay 3.8% E
Slide 14: Xanamem Clinical Development Pipeline
Xanamem Clinical Development Pipeline For personal use only Diseases to be studied in 2021/2022 Phase 2 Pathway Outlook Mild cognitive XanaMIA “Big-to-market” impairment due to Part A: 10mg, 5mg, Placebo Older Volunteers: cognition Multiple Phase 2b/3 trials Alzheimer’s disease Part B: Patients with
Slide 15: Alzheimer's Disease
For personal use only Alzheimer’s Disease Targeting cognitive enhancement and disease- modification in the early stages of disease Annual General Meeting 10 November 2021 10
Slide 16: Science Behind the Xanamem AD Program
Science Behind the Xanamem AD Program For personal use only Cortisol is toxic to monkey brain cells1 Cortisol impairs animal cognition2 Cortisol & hippocampal volume/memory3 Higher blood cortisol & cognitive decline4 Higher CSF cortisol & cognitive decline5 11β-HSD1 Alzheimer’s mouse mod
Slide 17: PET data supports a low Xanamem dose ≤10mg daily
PET data supports a low For personal use only Xanamem dose ≤10mg daily Baseline After Dose PET data demonstrates that Xanamem extensively binds 5mg Xanamem 10mg Xanamem 20mg Xanamem to the 11β-HSD1 enzyme SUVRcarotid throughout the brain, with high post-treatment effects (absence of colour) after 7
Slide 18: Cognitive improvement demonstrated
Cognitive improvement demonstrated For personal use only Phase 1 XanaHES study demonstrated statistically significant cognitive efficacy signal in multiple cognition domains based on Cogstate Cognitive Test Battery as early as 2 weeks1 Treatment Group Xanamem 30pts Placebo 12 pts Score Score Score L
Slide 19: Bridging Phase cognition data to patients
Bridging Phase 1 cognition data to patients For personal use only XanaMIA XanaMIA XanaMIA Functional Impairment in later Alzheimer’s disease Trial Part A Part B MCI patients Mild Moderate Severe v v v v • Disease biomarkers • 2015 design Healthy elderly • Computerised • Only 12 weeks cognitive testi
Slide 20: XanaMIA Phase 1b/2 trial data in 2022 & 2023
XanaMIA Phase 1b/2 trial data in 2022 & 2023 For personal use only Targeting the first stages of Alzheimer’s Disease XanaMIA - Part A XanaMIA - Part B H12022: minimum effective dose on cognition 2023: disease-modifying potential on biomarkers • Healthy older subjects - with normal cognition, • Targe
Slide 21: Fragile X Syndrome
For personal use only Fragile X Syndrome An inherited disorder caused by the FMR1 mutation on the X chromosome with no approved treatments Annual General Meeting 10 November 2021 16
Slide 22: Fragile X Syndrome has high unmet medical need
Fragile X Syndrome has high unmet medical need For personal use only • Commonest genetic cause of intellectual disability, predominantly males Unmet medical need • Management of FXS is often complex, with life-long treatment required for patients • Xanamem in FXS has been awarded Rare Paediatric Dis
Slide 23: Science Behind the Xanamem FXS Program
Science Behind the Xanamem FXS Program For personal use only Elevated blood cortisol in patients1 Elevated cortisol & human symptoms2 Glutamate linked to cortisol response3 FMR1 KO mice show raised cortisol4 Elevated 11β-HSD1 in FXS mouse5 11β-HSD1 Fragile X mouse model6 1. Hessl et al.
Slide 24: Xanamem may treat multiple symptom domains in FXS
Xanamem may treat multiple symptom domains in FXS For personal use only Normalisation of anxiety in the FXS KO mouse1 Symptoms of Fragile X Syndrome are all potentially amenable to Xanamem therapy XanaFX trial target symptoms FXS anxiety reduced by 250 cortisol inhibition to almost normal levels Sti
Slide 25: Summary and Outlook
For personal use only Summary and Outlook z Annual General Meeting 10 November 2021 20
Slide 26: Significant value upside for Actinogen
Significant value upside for Actinogen For personal use only Value from partnerships, peer companies Accelerate clinical development • Commence Fragile X Syndrome trial Pharma/biotech engagement • Expand pipeline with third Phase 2 program • Actively engaging with large and mid-size • Create optiona
Slide 27: Next steps and key catalysts
Next steps and key catalysts For personal use only Clinical trials to read out in 2022 and 2023 XanaMIA o Part A cognition data H1 2022 o First disease biomarker data possible H2 2022 o Part B patient biomarker/cognition data 2023 XanaFX o Commencing in 2021, results 2023 Pursue other high prior
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