Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2020)
21 slides from Actinogen Medical's shareholder meeting presentation, Nov 27, 2020
Slide 1: ACW 2020 AGM Chairman's address
27 November 2020 ACW 2020 AGM Chairman’s address For personal use only Good morning, My name is Geoff Brooke, and I am the Chairman of Actinogen. It is my pleasure to welcome you all to Actinogen Medical Ltd’s 2020 Annual General Meeting. With me today I have members of the Actinogen board and manag
Slide 2: Chairman's address (continued)
A detailed and comprehensive review of academic and scientific research supports exploring applications in human disease focusing on cortisol inhibition. Actinogen continues to drive ongoing development of Xanamem across a number of indications and with the strategy to broaden the development pipeli
Slide 3: About Xanamem
About Xanamem™ Xanamem’s novel mechanism of action works by blocking the production of intracellular cortisol – the stress hormone – through the inhibition of the 11β-HSD1 enzyme in the brain. There is a strong association between persistent stress and the production of excess cortisol that leads to
Slide 4: CEO & MD presentation, Dr Bill Ketelbey
For personal use only AGM Presentation Dr. Bill Ketelbey: CEO & MD 27 November 2020 Developing novel therapies for cognitive impairment and behavioural symptoms due to raised cortisol in chronic neurological, psychiatric, developmental and metabolic diseases
Slide 5: Year in review
YEAR IN REVIEW For personal use only October 2019 XanaHES results: breakthrough cognitive efficacy February - April 2020 Target Occupancy data: supports Xanamem works as designed April 2020 Preparation ramps up for XanaMIA and XanaFX studies September 2020 Comprehensive analaysis of dataset complete
Slide 6: Xanamem – lead compound
Xanamem™ – lead compound Novel Mechanism of Action - designed to inhibit cortisol production in the brain (through inhibition of the 11β-HSD1 enzyme) For personal use only Compelling results from various studies underpin further clinical development Pre-clinical long-term toxicology studies Phase II
Slide 7: Significant cognitive efficacy signal achieved
Significant cognitive efficacy signal achieved Breakthrough XanaHES results1 demonstrate robust statistically significant cognitive efficacy improvement in multiple cognition domains – based on Cogstate Cognitive Test Battery For personal use only Working memory (One Back Test) Visual attention (Ide
Slide 8: Target Occupancy study: positive confirmatory data
Target Occupancy study: positive confirmatory data Phase I target occupancy study demonstrates that 5mg to 30mg Xanamem dosed for seven days significantly binds to the neuronal 11β-HSD1 enzyme throughout the brain (32 of 36 patients completed) For personal use only 50% to 85% occupancy, dependent up
Slide 9: Key outcomes from Xanamem studies
Key outcomes from Xanamem studies Xanamem, an oral compound, demonstrated to be an efficacious, safe, brain penetrant, selective and effective 11β –HSD1 inhibitor producing significant pharmacodynamic effects on cortisol For personal use only Xanamem dose Cognitive Breakthrough results demonstrate a
Slide 10: Leveraging clinical development across multiple indications
Leveraging clinical development across multiple indications Two fully funded phase II trials to commence 1H CY21 For personal use only Alzheimer’s disease (AD) FXS selected as next Continued focus on clinical development Alzheimer’s disease Schizophrenia1 ? Fragile X opportunity syndrome XanaMIA: Fu
Slide 11: Mild cognitive impairment due to Alzheimer's disease
For personal use only Mild cognitive impairment due to Alzheimer‘s disease
Slide 12: Alzheimer's disease – Mild Cognitive Impairment due to AD
Alzheimer’s disease – Mild Cognitive Impairment due to AD XanaMIA – evaluating Xanamem in patients with Mild Cognitive Impairment (MCI) due to AD (an early stage of the AD spectrum), linking the compelling XanaHES results with an Alzheimer’s disease patient population For personal use only Healthy
Slide 13: XanaMIA – Phase II clinical trial
XanaMIA – Phase II clinical trial Phase II trial to demonstrate the safety, tolerability and efficacy of Xanamem in patients with MCI due to AD For personal use only Key design learnings incorporated into XanaMIA Key milestones Enriched eligibility criteria including biomarkers Commence recruitmen
Slide 14: Alzheimer's disease remains a focus
Alzheimer’s disease remains a focus Market dynamics of Alzheimer's disease presents a compelling commercial opportunity for Actinogen For personal use only Substantial target market with significant upside1 Underpinned by favourable market dynamics Cognitively Subjective Cognitive and functional dec
Slide 15: Fragile X syndrome
For personal use only Fragile X syndrome
Slide 16: Anxiety, behavioural problems and sleep in Fragile X syndrome
Anxiety, behavioural problems and sleep in Fragile X syndrome FXS is a rare genetic condition representing a significant unmet medical need For personal use only FXS is characterised by a range of developmental problems, including: Cognitive Speech and Anxiety1 impairment language deficits Behaviour
Slide 17: Valuable FXS market opportunity
Valuable FXS market opportunity While FXS is a rare disease, anxiety, sleep, and behavioural symptoms in FXS represent substantial commercial opportunities For personal use only Target population Prevalence Anxiety, sleep, and Approx. 1 in 2500-4000 males behavioural problems and 1 in 7000-8000 fema
Slide 18: XanaFX – Phase II clinical trial
XanaFX – Phase II clinical trial Phase II trial to demonstrate the safety and efficacy of Xanamem on anxiety, sleep, and behavioural problems in patients with Fragile X syndrome For personal use only Proposed clinical trial design Key upcoming milestones Proof-of-concept study Planned to commence
Slide 19: Attractive development pipeline
Attractive development pipeline Targeting a broad portfolio of clinical indications to assess the efficacy of Xanamem For personal use only Studies 2H CY20 1H CY21 2H CY21 Mild cognitive impairment due to XanaMIA Trial planning Alzheimer’s disease Phase II trial Anxiety, sleep & behavioural problems
Slide 20: Next steps and key catalysts
Next steps and key catalysts Plans for key clinical trials to commence in 1H CY21 For personal use only Finalise optimal study parameters and trial protocols (4Q CY20) Receive ethics and regulatory approval and commence next phase of clinical trials – XanaMIA / XanaFX (1H CY21) Completion of T
Slide 21: 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
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