Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Shareholder Meeting (November 2015)
20 slides from Actinogen Medical's shareholder meeting presentation, Nov 12, 2015
Slide 1: Developing Xanamem for Alzheimer's Dementia
Developing Xanamem™ For personal use only for Alzheimer’s Dementia Dr. Bill Ketelbey CEO and Managing Director, Actinogen Medical Actinogen AGM November 2015
Slide 2: Forward Statements
Forward Statements For personal use only This presentation has been prepared by Actinogen 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 3: Actinogen Board
Actinogen Board For personal use only A highly experienced Board and Management team with a wealth of drug development, commercialisation and clinical research expertise. Martin Rogers • Biotechnology entrepreneur and executive. Executive • Non-Executive Director of OncoSil (ASX:OSL), Chair of Rhino
Slide 4: Senior Management
Senior Management For personal use only • MD with 30 years’ experience in pharmaceuticals. Dr. Bill Ketelbey • Senior roles at Pfizer, including development of Aricept™, the CEO & MD current leading AD treatment. Vince Ruffles • Extensive drug development experience over 20 years. VP Clinical • Resp
Slide 5: Alzheimer's: A significant unmet need
Alzheimer's: A significant unmet need For personal use only Alzheimer’s disease is emerging as one of the most significant health challenges of our time. • A person develops AD almost every minute in the US¹. • AD is the second leading cause of death in Australia behind ischaemic heart disease. • 1:
Slide 6: Disease progression and diagnosis
Disease progression and diagnosis For personal use only 6
Slide 7: Cortisol and Alzheimer's disease
For personal use only Cortisol and Alzheimer’s disease Elevated cortisol associated with cognitive decline. Evening Cortisol with Cognitive Functioning Memory Speed Executive Function 0 -0.05 0.8 Mean CSF Cortisol Levels -0.1 * * -0.15 * 0.6 CSF Cortisol (μg/dl) -0.2 * * 0.4 -0.25 * <1.7 nmoL/L (n=1
Slide 8: 11β-HSD1, Cortisol and Cognition
11β-HSD1, Cortisol and Cognition For personal use only Extensive human and animal proof of concept: • 11β-HSD1 generates cortisol in brain regions important for cognition (Seckl et al., 2004). • 11β-HSD1 inhibition (with non-selective inhibitor, carbenoxolone) improves cognition in humans (Sandeep e
Slide 9: Inhibiting 11β-HSD1
Inhibiting 11β-HSD1 For personal use only Xanamem™’s mechanism of action – a novel pathway supressing cortisol production HSD1 enzyme activates cortisone producing cortisol. Xanamem™ binds to HSD1, blocking cortisol production. 9
Slide 10: Cognitive efficacy of UE2316
For personal use only Cognitive efficacy of UE2316* *precursor to Xanamem™ Cognitive Enhancement in AD with UE Performance in Passive Avoidance Test – Treatment for 28 days 250 Latency to enter dark compartment(s) ** 200 150 Cognitive Enhancement in AD with UE Performance in Passive Avoidance Test –
Slide 11: Disease modification of UE2316
For personal use only Disease modification of UE2316* 60 Number of Aβ Plaques in AD Brain *precursor to Xanamem™ Treatment for 28 days ** # of Plaques per Brain Area 50 40 IDE Expression in AD Brain 0.02 * 30 IDE/β-tubulin 20 0.015 10 0.01 0 ** p = 0.01 Vehicle Total UE Total Xanamem™ 0.005 Tg 2576
Slide 12: Xanamem development milestones
Xanamem™ development milestones For personal use only 2015 Completed second Phase I trial (MAD, fed/fasted, CNS PK). Completed second species pre-clinical toxicology study. Established the Xanamem Clinical Advisory Board. Designed Alzheimer's Phase II trial - “Xanadu”. Selected service pro
Slide 13: Xanamem Clinical Advisory Board
TM Xanamem Clinical Advisory Board For personal use only Powerhouse Advisory Board of world expert to drive Xanamem™’s clinical development in early Alzheimer’s disease. Prof. Craig Ritchie Prof. Colin Masters Prof. Jeffrey Cummings • Professor of Psychiatry of Aging, • Professor, University of • Pr
Slide 14: "Xanadu" Development Meeting
“Xanadu” Development Meeting For personal use only Left-right: Prof Craig Ritchie, Prof Brian Walker, Prof Colin Masters, Martin Rogers, Dr Bill Ketelbey, Vincent Ruffles, Dr Scott Webster, Prof Jonathan Seckl. Absent: Prof Jeff Cummings. The Alzheimer's Phase II trial design meeting, held in Edinbu
Slide 15: Phase II trial design – XANADU
Phase II trial design – “XANADU” For personal use only “XANADU” - A Phase II double-blind, randomised, placebo controlled study to assess the safety, tolerability and efficacy of Xanamem in participants with mild AD. Design Feature Description Patient Number 200 - US, UK, AUS Treatment Course 12 wee
Slide 16: Investment Highlights
Investment Highlights For personal use only • Alzheimer's - a significant unmet need in a huge and growing global market. • Xanamem’s™ novel mechanism of action targeting the stress hormone cortisol – a key differentiator. • Cortisol inhibition hypothesis supported by good pre-clinical and clinical
Slide 17: Xanamem Pipeline
Xanamem™ Pipeline For personal use only Xanamem™’s novel mechanism of action – blocking excess cortisol production – offers a number of additional potential indications in the central nervous and endocrine/metabolic systems. Development opportunities: • Cognitive dysfunction in Parkinson's disease.
Slide 18: Financials
Financials For personal use only Key Corporate Data: Market Cap.⃰⃰ ~$33m Share Price⃰ $0.055 Cash** $8.88m Shares on issue^ 606.16m ⃰ Market cap and share price data as of 11th November, 2015. **Includes the proceeds from the Placement and SPP. Doesn’t include R&D tax rebates. As at 30th September,
Slide 19: Contact Details
Contact Details For personal use only Head Office Level 9, Suite 1 68 Pitt Street. Sydney NSW 2000. Telephone: +61 (02) 8964 7401 Facsimile: +61 (02) 8964 7588 Email: bill.ketelbey@actinogen.com.au Twitter: @billketelbey 19
Slide 20: Thank You
For personal use only Thank You
Actinogen Medical — Shareholder Meeting (November 2015) on 6ix