Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2023)
24 slides from Actinogen Medical's shareholder meeting presentation, Nov 17, 2023
Slide 1: Actinogen 2023 AGM – Chair's address and CEO's presentation
ASX ANNOUNCEMENT Actinogen 2023 AGM – Chair’s address and CEO’s presentation Sydney, 17 November 2023. 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 10am (AEDT) in Sydn
Slide 2: Current and Upcoming Clinical Trials
Current and Upcoming Clinical Trials The XanaCIDD Phase 2a depression trial is a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 160 patients. Patients are evenly randomized to receive Xanamem 10 mg once daily or placebo, in some cases in addition to their
Slide 3: ACW 2023 AGM Chair's Address
17 November 2023 ACW 2023 AGM Chair’s Address Good morning, ladies and gentlemen. My name is Geoff Brooke, and I am the Chair of Actinogen Medical Limited. On behalf of the Board of Directors and staff of the Company I welcome shareholders to our 2023 Annual General Meeting. For personal use only Ac
Slide 4: Chair's address: executive leadership
The board was delighted when he announced positive results from the Phase 2a clinical biomarker trial in October 2022, which validated Xanamem’s cortisol mechanism of action and the design of the Phase 2 AD program. Following the release of those results, we were able to recruit Dr Dana C. Hilt MD t
Slide 5: Depression & cognition advisory board; capital raising
Hilt at the end of August. Both recordings are posted in the Presentations section of the Investor Centre on our website. You can also register on our website to receive periodic email updates from the Company. Depression & cognition advisory board The Company continues to utilise world-leading advi
Slide 6: Two near-term major Phase readouts in Alzheimer's Disease & Depression
For personal use only Two near-term major Phase 2 readouts in Alzheimer’s Disease & Depression in 2024 and 2025 Xanamem® is a low-dose oral therapy targeting reduced tissue cortisol in the brain CEO’s presentation to Actinogen 2023 AGM Dr. Steven Gourlay MBBS PhD MBA: CEO & MD 17 November 2023 ® Xan
Slide 7: 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 For personal use only and does not contain all inform
Slide 8: Actinogen Phase trials on track for results
Actinogen Phase 2 trials on track for results De-risked by extensive clinical data from 4 trials of Xanamem 10mg For personal use only Phase 2a proof-of-concept trial in Results Q2 2024 Depression/Cognitive Impairment (n=160) Phase 2b confirmatory trial in mild-moderate Initial results H1 2025 Alzhe
Slide 9: A busy year in review
A busy year in review … Month Event Oct 22 Large clinical Xanamem effect shown in biomarker-positive patients Dec First patient enrolled in XanaCIDD trial of cognitive impairment associated with major For personal use only depressive disorder FDA approved XanaMIA Alzheimer’s disease trial design & c
Slide 10: Key elements are now in place
Key elements are now in place …. Three open For personal use only Strengthened executive & US IND Board Two major dossiers leadership phase 2 trials underway Funding Regulatory beyond Extensive toxicology depression business studies results development enable long- Commercial channels term therapy S
Slide 11: Where we are going
Where we are going … For personal use only Rapidly acting oral therapy with dual action on cognitive impairment / depression Depression market size ~$17 billion in 2032 Cognitively enhancing and disease modifying oral therapy for all stages of Alzheimer’s disease Alzheimer’s market ~$14 billion in 2
Slide 12: Xanamem: oral, once-a-day treatment with a unique mechanism
Xanamem: oral, once-a-day treatment with a unique, non-amyloid/non-tau mechanism Mouse experimental studies & clinical trials validate cortisol as a target for the treatment of AD1-4 Inflammation and glucose/lipid dysregulation emerging as causal mechanisms in AD5 For personal use only Brain penetra
Slide 13: Why targeting brain cortisol with Xanamem is promising in depression
Why targeting brain cortisol with Xanamem is a promising strategy in depression 80-90% of patients report neurocognitive symptoms1 For personal use only Cognitive symptoms often persist during remission1 Elevated cortisol associated with severe, melancholic depression2 Cortisol levels associ
Slide 14: XanaCIDD proof-of-concept Phase 2a trial in Depression
XanaCIDD proof-of-concept Phase 2a trial in Depression Using the Cogstate computerized test system shown to be sensitive to Xanamem beneficial effects For personal use only 10mg Xanamem +/- existing antidepressant Follow-up Screening Placebo +/- existing antidepressant -4 0 6 10 Weeks Double-blind,
Slide 15: The answers to Alzheimer's Disease are starting to emerge in the clinic
The answers to Alzheimer’s Disease For personal use only are starting to emerge in the clinic… Alzheimer’s proteins are the pathology – not the cause… Other causal processes are involved like inflammation, lipids and glucose handling… Annual General Meeting 17 November 2023 10
Slide 16: Why targeting brain cortisol is promising in Alzheimer's disease
Why targeting brain cortisol with Xanamem is a promising strategy in Alzheimer’s disease Many parts of the program have been de-risked For personal use only Epidemiology, cortisol and animal Clinical trials of Xanamem experiments Cortisol levels are elevated in brain fluid in early Inhibits brai
Slide 17: Newer anti-amyloid antibodies slow but not halt progression of AD
Newer anti-amyloid “immunotherapy” antibodies shown to slow but not halt progression of AD1 Ideally patients would not worsen on treatment Worsening of For personal use only 0 CDR-SB2 over 18 months -0.5 Large area of -1 unmet need requires non- amyloid therapies -1.5 -2 Benefit of donanemab -2.5 do
Slide 18: Xanamem dramatically slows the rate of functional decline (CDR-SB)
Xanamem dramatically slows the rate of functional decline (CDR-SB) in patients with mild AD* Patients with elevated plasma pTau181 indicating progressive, amyloid-positive disease (n=34) For personal use only Xanamem Placebo 0 0 0.2 0.4 0.36 * CDR-SB units Change from 0.6 * Difference vs. placebo Ba
Slide 19: Cognitive scores suggest potential clinical benefit across dementia sub-types
Cognitive scores suggest potential clinical benefit across dementia patient sub-types* Positive trends in both high and low plasma pTau biomarker groups For personal use only Higher pTau biomarker (n=34) Lower pTau biomarker (n=34) 0.3 0.3 Composite Units (SE*) Composite Units (SE) 0.2 0.2 0.1 0.1 0
Slide 20: XanaMIA Phase 2b trial in Alzheimer's Disease
XanaMIA Phase 2b trial in Alzheimer’s Disease Matching patients and endpoints used in the positive Phase 2a analysis 10mg Xanamem For personal use only Screening Follow-up & open label Placebo -4 0 36 40 Weeks Double-blind, randomised treatment period (N=220) Interim analysis N=100 @ 24 weeks Key in
Slide 21: Experienced Leadership and Management
Experienced Leadership and Management Extensive drug development and commercial experience Experienced Board of Directors... …with a talented management team in place For personal use only Jeff Carter Chief Financial Officer B. Fin Admin; M. App. Fin; CA Cheryl Townsend VP Clinical Operations RN, M
Slide 22: Dr Howard Fillit on non-amyloid, non-tau drugs
Dr Howard Fillit, Founder Alzheimer’s Drug Discovery Foundation1 For personal use only “Seventy-eight percent … of all drugs in clinical development are non- amyloid, non-tau drugs. Multiple targets are being addressed now, which is great for the field because I think the way we're going to have to
Slide 23: Xanamem AD & Depression programs
Xanamem AD & Depression programs Building on Phase 1 and 2 studies showing safety and procognitive activity For personal use only Prior Phase 1 & 2a studies Safety, cognition, clinical activity demonstrated (n~300 patients) Phase 2a (n=160) Phase 2b (n=220) Cognitive Impairment Alzheimer’s Disease (
Slide 24: Questions
For personal use only Questions
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