Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2024)
25 slides from Actinogen Medical's shareholder meeting presentation, Nov 14, 2024
Slide 1: ASX Announcement: Actinogen 2024 AGM Chair's address and CEO's presentation
ASX ANNOUNCEMENT Actinogen 2024 AGM – Chair’s address and CEO’s presentation Sydney, 14 November 2024. 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 11am (AEDT) in Sydn
Slide 2: Current Clinical Trials
Current Clinical Trials The XanaCIDD Phase 2a depression trial was a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 167 patients with moderate, treatment-resistant depression and a degree of baseline cognitive impairment. Participants were evenly randomiz
Slide 3: Actinogen 2024 AGM Chair's Address
14 November 2024 Actinogen 2024 AGM Chair’s Address Good morning, everyone. 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 2024 Annual General Meeting. We continue to make compelling
Slide 4: Chair's address: executive team, board and governance
Steve leads a small but innovative, high calibre executive leadership team with complementary skills that produces results. We added to the team’s skillset this year with the appointment in February of the Company’s first full-time Chief Financial Officer, Will Souter, and the recent appointment of
Slide 5: Oral Xanamem: AGM CEO Presentation
For personal use only Oral Xanamem® Controlling brain cortisol to treat depression and slow progression in Alzheimer’s disease – increasing clinical validation from phase 2 trials AGM CEO Presentation, Steve Gourlay 14 November 2024 ® Xanamem is a registered trademark of Actinogen Medical Limited
Slide 6: 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 m
Slide 7: Program and 2024's achievements
For personal use only Program and 2024’s achievements ACW AGM 14 November 2024 3
Slide 8: Xanamem is now significantly de-risked
Xanamem is now significantly de-risked Novel 11β-HSD1 cortisol control mechanism, oral, attractive safety profile • Brain cortisol has long been proposed as a pathogenic mechanism in Major Depressive Disorder (MDD) and Alzheimer’s (AD) For personal use only • Unique brain-penetrant tissue cortisol s
Slide 9: Accomplishments since June 2023
Accomplishments since June 30 2023 Actinogen is in a strong position For personal use only Trial & regulatory progress Publications & presentations Commenced enrolment in XanaMIA Two peer-reviewed manuscripts in the Journal phase 2b/3 in patients with pTau-positive of Alzheimer’s Disease AD 1. Xanam
Slide 10: Experienced board and management team
Experienced board and management team Board of Directors For personal use only Dr. Geoff Brooke Dr. Steven Gourlay Mr. Malcolm McComas Dr. George Morstyn Dr. Nicki Vasquez Chairman CEO & MD Non-Executive Director Non-Executive Director Non-Executive Director MBBS; MBA MBBS; FRACP; PhD; MBA BEc, LLB;
Slide 11: Company now in late-stage trials
Company now in late-stage trials ASX-listed company founded in 2014 For personal use only • Market Cap $75 million • Cash runway to mid 2026 • Conducted three phase 1 (Australia) and four phase 2 trials (Australia, US and UK) Key shareholders • Biotech Value Fund (BVF) ~8% • CEO Steve Gourlay ~5% (i
Slide 12: Xanamem - Pipeline
Xanamem - Pipeline For personal use only Indication Preclinical Phase 1 Phase 2 Phase 3 Next Milestone On-going phase 2b/3 Results 25-26 Alzheimer’s disease (AD) FDA Type C MDD Phase 2a complete, Phase 2b/3 in planning Open INDs in Q1 25 Fragile X syndrome Phase 2a on hold On hold Bipolar disorder P
Slide 13: Xanamem – AD and MDD Program Timelines
Xanamem – AD and MDD Program Timelines* 2024 2025 2026 For personal use only H1 H2 H1 H2 H1 H2 Phase 2b/3 Alzheimer’s Interim data Final results Phase 3 Alzheimer’s Phase 2a Depression Final results Phase 2b Depression Expert, partner & Phase 3 Depression FDA discussions Ancillary Clinical Pharmacol
Slide 14: Xanamem is in a class of its own
For personal use only Xanamem is in a class of its own ACW AGM 14 November 2024 10
Slide 15: Xanamem controls cortisol by inhibition of 11β-HSD1
Xanamem controls cortisol by inhibition of 11β-HSD11 Controlling brain cortisol2 has potential durable benefits For personal use only “STRESS” in the brain becomes “CHILL” RAPID changes in kinases, cell function, “Lower stress” shorter term e.g. neurotransmitters over hours to days • Reducing inflam
Slide 16: Human PET study shows full target engagement
Human PET study shows full target engagement Other 11β-HSD1 enzyme inhibitors have not achieved adequate brain levels For personal use only Baseline After 7 days of daily dosing 5 mg Xanamem 10 mg Xanamem 20 mg Xanamem Xanamem extensively binds SUVRcarotid to the 11β-HSD1 enzyme throughout the brain
Slide 17: Conclusions
For personal use only Conclusions ACW AGM 14 November 2024 13
Slide 18: Positive depression data a boost to both AD and MDD
Positive depression data a boost to both AD and MDD For personal use only Evidence of durable benefit on depression from control of brain cortisol validates the Xanamem program in terms of: “Cortisol control” mechanism of action 10 mg daily proof-of-concept dose being used in Alzheimer’s phase 2
Slide 19: What to look forward to in the rest of FY 2025
What to look forward to in the rest of FY 2025 Xanamem has the potential to be a first & best-in-class treatment for MDD and AD For personal use only • Regulatory interactions on both MDD and AD with the FDA • Partnering interactions on new MDD data • Accelerating XanaMIA enrolment towards the inter
Slide 20: Q&A
For personal use only Q&A ACW AGM 14 November 2024 16
Slide 21: Appendix
For personal use only Appendix ACW AGM 14 November 2024 17
Slide 22: Key references
Key references Other references see also https://actinogen.com.au/xanamem 11β-HSD1 inhibition Alzheimer’s disease and cortisol • Seckl J. 11β-Hydroxysteroid dehydrogenase and the brain: Not (yet) lost in translation. J Intern Med. 2024 Jan;295(1):20-37. doi: 10.1111/joim.13741. Epub 2023 Nov 8. • Pl
Slide 23: Selected Glossary
Selected Glossary 1 • 11β-HSD1 – 11 beta HydroxySteroid Dehydrogenase-1 enzyme. Selectively expressed in brain, liver, adipose. • Aβ – Amyloid beta – a type of amyloid protein associated with Alzheimer’s Disease, 42 and 40 are different forms For personal use only • ACTH – Adrenocorticotropic hormon
Slide 24: Selected Glossary
Selected Glossary 2 • IQCODE – Informant Questionnaire on Cognitive Decline in the Elderly • MCI – Mild Cognitive Impairment – memory, executive function deterioration with retained functional abilities For personal use only • MDD – Major Depressive Disorder • MMSE – Mini Mental State Examination –
Slide 25: Contacts
Contacts For personal use only Michael Roberts Steven Gourlay Investor Relations CEO & Managing Director P: +61 2 8964 7401 P: +61 2 8964 7401 M: +61 423 866 231 E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au ACW AGM 14 November 2024 21
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