Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Investor Presentation (November 2021)
34 slides from Actinogen Medical's investor presentation, Nov 25, 2021
Slide 1: Strategic Update & Capital Raising Investor Presentation
Strategic Update & Capital Raising Investor Presentation Dr. Steven Gourlay MBBS PhD MBA: CEO & MD, CMO November 25, 2021
Slide 2: 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
Slide 3: CEO message on the potential of Actinogen
After many years of working in the biopharma industry, I am excited by the huge potential of Actinogen. In my last major role at Principia Biopharma as Chief Medical Officer, I steered two small molecules from a microcap company valuation, through successful Phase II development and into Phase III,
Slide 4: Actinogen is a neurotherapeutics developer
Actinogen is a neurotherapeutics developer realising a revolutionary therapy so neurology patients can live their best lives Strategic Update & Investor Presentation 4
Slide 5: Capital Raising & Strategic Update
Capital Raising & Strategic Update Actinogen announce capital raising of approximately $15m to fund its programs until the end of 2023. Highlights associated with the capital raising: Actinogen will pursue Depression associated with cognitive impairment as a third indication, initiating a Phase 2
Slide 6: Xanamem: oral treatment and novel mechanism
Xanamem: oral treatment and 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 based on human PET evid
Slide 7: Actinogen snapshot
Actinogen snapshot 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 properties Low dose
Slide 8: Strong Leadership and Management
Strong Leadership and Management 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 Drug Dr. Geoff Brooke Mr
Slide 9: Esteemed Advisory Boards
Esteemed Advisory Boards 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 discovery Prof. Craig
Slide 10: ACW stock performance 12 months
ACW stock performance 12 months Share price chart at 24 Nov 2021 Trading Information 52 week high A$0.20 180m 0.20 52 week low A$0.02 160m 0.18 Number of shares 1,660.6M 140m Market capitalisation (24 Nov 2021) A$268.3M 0.15 Pro-forma cash at 30 Sep1,2 A$26.8M 120m 0.13 Share Price 100m Volume 0.10
Slide 11: Xanamem Clinical Development Pipeline
Xanamem Clinical Development Pipeline 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 MCI due to AD: cognit
Slide 12: Alzheimer's Disease
Alzheimer’s Disease Targeting cognitive enhancement and disease- modification in the early stages of disease Strategic Update & Investor Presentation 12
Slide 13: Science Behind the Xanamem AD Program
Science Behind the Xanamem AD Program 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 model6 Xanamem & improv
Slide 14: PET data supports a low Xanamem dose ≤10mg daily
PET data supports a low 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 days at all doses, sli
Slide 15: Cognitive improvement demonstrated
Cognitive improvement demonstrated 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 Large effect sizes seen
Slide 16: Bridging Phase 1 cognition data to patients
Bridging Phase 1 cognition data to patients No functional Impairment XanaMIA XanaMIA XanaMIA Functional Impairment stages in Alzheimer’s disease Trial Part A Part B MCI* patients Mild Moderate Severe v v v v v • Disease biomarkers • 2015 design Healthy elderly • Computerised • Only 12 weeks cognitiv
Slide 17: XanaMIA Phase 1b/2 trial data in 2022 & 2023
XanaMIA Phase 1b/2 trial data in 2022 & 2023 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, • Targeting subjects with mil
Slide 18: Planned retrospective analysis of Phase 2 plasma samples for AD biomarkers
Planned retrospective analysis of Phase 2 plasma samples for Alzheimer’s Disease biomarkers Bringing disease biomarker data readout forward into 2022 XanADu Phase 2 trial 185 patients (n=91 active, n=94 placebo) 10mg daily Mild Alzheimer’s disease without biomarker or imaging confirmation Prel
Slide 19: Fragile X syndrome
Fragile X syndrome An inherited disorder caused by the FMR1 mutation on the X chromosome with no approved treatments Strategic Update & Investor Presentation 19
Slide 20: Fragile X Syndrome has high unmet medical need
Fragile X Syndrome has high unmet medical need • 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 Disease Strategic benefit
Slide 21: Science Behind the Xanamem FXS Program
Science Behind the Xanamem FXS Program 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. 2002; Wisbeck et al. 2
Slide 22: Xanamem may treat multiple symptom domains in FXS
Xanamem may treat multiple symptom domains in FXS 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 Stimulus response (second
Slide 23: Major Depressive Disorder associated with Cognitive Impairment
Major Depressive Disorder associated with Cognitive Impairment Targeting dual cognitive enhancement and anti- depressant activity Strategic Update & Investor Presentation 23
Slide 24: Market characteristics of Major Depressive Disorder (MDD)
Market characteristics of Major Depressive Disorder (MDD) MDD is common1,2 ~5% prevalence globally, 1 in 7 lifetime risk Neurocognitive symptoms are a typical feature (>80%)3 Difficulty thinking and concentrating, unable to make decisions Only one anti-depressant has a cognitive benefit claim Vortio
Slide 25: Science Behind the Xanamem Depression Program
Science Behind the Xanamem Depression Program 80-90% report neurocognitive symptoms1 Cognitive symptoms often persist during remission1 Elevated cortisol associated with severe, melancholic depression2 Cortisol associated with treatment outcomes, relapse, & cognition3 Positive effects with
Slide 26: Clinical/Regulatory – established endpoints & regulatory path
Clinical/Regulatory – established endpoints & regulatory path Initial trial will be placebo-controlled Phase 2 of 6-weeks treatment • MDD endpoints used by other programs o Trintellix endpoints: MADRS1 and HAM-D2 scores o Spravato (esketamine) endpoints: MADRS score o Zulresso endpoints: HAM-D score
Slide 27: Commercial opportunity is large, even at Phase 2
Commercial opportunity is large, even at Phase 2 Global Big Pharma strong M&A interest in acquiring or partnering and licensing assets with novel mechanisms of action where depression is the lead/key indication. Deal value (US$m) 3125 2015 Upfront (US$m) 525 560 575 770 220 385 100 Deal value (US$m,
Slide 28: Summary and Outlook
Summary and Outlook z Strategic Update & Investor Presentation 28
Slide 29: Significant value upside for Actinogen
Significant value upside for Actinogen Value from partnerships, peer companies Accelerate clinical development • Commence Fragile X Syndrome trial Pharma/biotech engagement • Expand pipeline with depression Phase 2 program • Actively engaging with large and mid-size • Create optionality for developm
Slide 30: Next steps and key catalysts
Next steps and key catalysts Clinical trials to read out in 2022 and 2023 Alzheimer’s Disease o XanaMIA Part A cognition results Q2 CY2022 o XanADu retrospective biomarker results H2 CY2022 o XanaMIA Part B patient biomarker/cognition data 2023 Fragile X Syndrome o Commenced in 2021 o XanaFX trial
Slide 31: Offer Summary
Offer Summary z Strategic Update & Investor Presentation 31
Slide 32: Capital Raising Overview
Capital Raising Overview Actinogen is raising approximately A$15m via a Placement and Share Purchase Plan Institutional Placement commitments received for A$12 million Offer Structure Share Purchase Plan (SPP) targeted to raise A$3 million* Placement offer price of A$0.135 per share, which rep
Slide 33: Use of funds
Use of funds* The capital raising will fully fund Actinogen’s clinical development program through end of 2023 Details A$m Expanded Fragile X program to North America 7.0 Depression associated with cognitive impairment (3rd disease 5.0 indication) Early assessment of Alzheimer’s Disease biomarker da
Slide 34: Offer timetable
Offer timetable Indicative capital raising timetable1 Date Trading halt Tuesday, 23 November 2021 Record date for the SPP Wednesday, 24 November 2021 Announcement of the Equity Raising and trading halt lifted – shares recommence trading on ASX Thursday, 25 November 2021 Settlement of Placement Tuesd
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