Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (February 2014)
22 slides from Cynata Therapeutics's investor presentation, Feb 12, 2014
Slide 1: A Next Generation Stem Cell Company
For personal use only A Next Generation Stem Cell Company Dr Ross Macdonald, CEO, Cynata Therapeutics Limited February, 2014 Copyright and Confidential
Slide 2: Important information
Important information For personal use only This presentation has been prepared by Cynata Therapeutics Limited. (“Cynata” 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
Slide 3: Cynata Therapeutics Ltd Key Facts
Cynata Therapeutics Ltd Key Facts For personal use only ASX: CYP (prev ECQ) Market Cap (10 Feb 14): $21.9m Shares on Issue*: 55.0m Options (10 Feb 14, $0.2): 11.11m Cash (31 Dec 13): $6.2m Number of shareholders: ~1121 Business focus: Stem cells + regenerative medicine *includes 10m in escrow until
Slide 4: Cell Replication and Differentiation
Cell Replication and Differentiation For personal use only The extraordinary capacity of cells to multiply and differentiate: 1 fertilized ~100 cells >1013 cells* egg cell “pluripotent” *Ann Hum Biol. 2013 Nov-Dec;40(6):463-71
Slide 5: What is a Stem Cell?
What is a Stem Cell? For personal use only • Stem cells are unspecialised (undifferentiated) cells in the body that give rise to all functional cell types: blood, nerves, bone, muscle…… • Derived from embryos and also certain adult tissues, eg bone marrow • Stem cells may also assist in the body’s o
Slide 6: Cell De-Differentiation & Reprogramming
Cell De-Differentiation & Reprogramming For personal use only • The seminal discovery that cells can be “re-programmed” (leading to a Nobel prize in 2012): MSCs (or other functional “pluripotent” stem 1 x tissue sample cell types) cells (iPSCs) • Eliminates need for embryos or multiple donors • Repr
Slide 7: Cymerus Technology Facilitates Commercial-Scale Manufacture
Cynata’s Cymerus™ Technology Facilitates Commercial-Scale Manufacture For personal use only 1 ~ 1 1022 PSC MCA MSCs Single Donor • Patent-protected • Single donor → unlimited production of uniform, pharmaceutical grade MSCs lacking contaminating immune cells • Easier manufacturing; easier regulatory
Slide 8: Cymerus: Outstanding Pedigree
Cynata’s CymerusTM : Outstanding Pedigree For personal use only • Inventors include James Thomson who derived the first human embryonic stem (ES) cell line in 1998 and human induced pluripotent stem cells (iPSCs) in 2007 • Scientific leadership: Prof Igor Slukvin (UW), co-founder and author of >70 p
Slide 9: Ageing: Major Economic and Medical Challenge
Ageing: Major Economic and Medical Challenge For personal use only • Aging population demographic: 80% of aged Americans have a chronic degenerative disease (eg osteoarthritis, heart disease, diabetes); 50% have two • By 2030, US healthcare costs will increase by 25% with the cost of providing healt
Slide 10: MSC Therapies Are Here and Now
MSC Therapies Are Here and Now For personal use only • Tissue Engineering and Soft Tissue Repair – Reconstruction of tendons, bone, cartilage, bladder, trachea • Cardiovascular Therapies – Pro-angiogenic properties • Inflammatory Diseases, Transplant Rejection – Immunomodulatory properties Translati
Slide 11: Stem Cell Company Market Valuations
Stem Cell Company Market Valuations For personal use only • Analogous to monoclonal antibody enabling technology: hybridoma technology developed in 1975 → therapeutic market value now in excess of US$44.6b1 • Most stem cell companies attractively priced based on forward estimates with many products
Slide 12: Cymerus Product Development Program
For personal use only Cymerus™ Product Development Program
Slide 13: Cymerus Product Development
Cymerus™ Product Development For personal use only • Excellent data so far: – Identification and characterisation of Cymerus™ MCA-derived MSCs – Initial manufacturing process development – Proof-of-concept using Cymerus™ MSCs in model of critical limb ischemia • Recruited VP, Product Development – H
Slide 14: Waisman Biomanufacturing
Waisman Biomanufacturing For personal use only • Specialist biological product manufacturer in Wisconsin, USA • Particular experience in translating discoveries to products: developing scalable manufacturing, validation and quality control processes
Slide 15: Proposed Cymerus Phase Clinical Trial
Proposed Cymerus™ Phase 1 Clinical Trial For personal use only • Acute graft-versus-host disease (aGvHD) – Life threatening complication occurring in ~50% of unrelated-donor bone marrow transplant patients – Approximately 4,500 unrelated-donor bone marrow transplants/year in USA* – Standard-of-care
Slide 16: Commercialisation Roadblock for MSC Therapies
Commercialisation Roadblock for MSC Therapies For personal use only • Commercial-scale manufacture of current MSC products is a major practical & regulatory challenge – Limited expansion potential – Donor-to-donor and intra-population heterogeneity – The difficulties of obtaining pure MSC population
Slide 17: Cynata's Commercial Goal
Cynata’s Commercial Goal For personal use only • Cynata will develop the proprietary Cymerus™ technology into: – a scalable manufacturing process, and – commercial allogeneic stem cell therapeutic products • Cynata’s Cymerus™ MCA- derived MSC’s are outstanding stem cell therapeutic candidates – Prov
Slide 18: Timeline
Timeline For personal use only Complete transaction Regulatory engagement Manufacturing Research Grade cGMP Safety (Animals) Australian human trials Further POC studies Partner engagement and licensing FDA pre IND meetings and filing IND Approval and US trials IP Development 4Q13 2014 2015 2016
Slide 19: Potential revenue from Cymerus Technology
Potential revenue from CymerusTM Technology For personal use only • Two potential revenue sources: – Clinical need: specific “off the shelf” therapeutic products derived from the TM Cymerus technology – Manufacturing scalability: Cymerus proprietary (enabling) method of TM commercial-scale manufactu
Slide 20: Cynata Board and Management
Cynata Board and Management For personal use only Executive Chairman: Dr Stewart Washer Managing Director & CEO: Dr Ross Macdonald VP Product Development: Dr Kilian Kelly (from 3/14) Non-executive Director and Company Secretary: Mr Peter Webse Executive Director: Mr Howard Digby • A tight team with
Slide 21: Why Invest in Cynata Therapeutics?
Why Invest in Cynata Therapeutics? For personal use only • Access to the vibrant and expanding field of stem cell medicine • Innovative technology sourced from established and prestigious centre • Cymerus™ addresses a known shortcoming in the commercial model of existing stem cell companies • Experi
Slide 22: Thank you for your attention
For personal use only Thank you for your attention
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