Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (September 2016)
25 slides from Cynata Therapeutics's investor presentation, Sep 8, 2016
Slide 1: A Next Generation Stem Cell Company
A Next Generation Stem Cell Company Dr. Ross Macdonald, CEO Cynata Therapeutics Limited 7-8 September, 2016 www.cynata.com
Slide 2: Important Information
Important Information 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 all information necess
Slide 3: About Cynata's Technology
About Cynata’s Technology Hyperlink to animation: ..\..\Business Development\Media\Cynata_V04.mp4 www.cynata.com
Slide 4: About Cynata
About Cynata Cynata Therapeutics Ltd is an Australian stem cell and regenerative medicine company. Competitive Strengths Disruptive MSC platform technology: CymerusTM Strong IP cover Economical production of clinical grade product Strategic collaborations with commercial and academic partners Experi
Slide 5: Key Facts
Key Facts ASX CODE CYP COMMENCED OPERATIONS November 2013 MARKET CAP (6 Sep 16) AUD $32m SHARES ON ISSUE 72.7m OPTIONS 10.5m 1 CASH (30 June 2016) AUD $4.9m (~ 8 months) AVERAGE MONTHLY NET CASH BURN AUD $510k (gross) NUMBER OF SHAREHOLDERS ~1900 1 include 3.6m Jul 20 @ AUD $1.00; plus 5m 27 Sep 18
Slide 6: Recent Cynata Milestones
Recent Cynata Milestones Partnership term sheet with FUJIFILM Executed license option Research coverage by agreement (apceth GmbH & Rodman & Renshaw; Shaw Co) & Partners; CPS Capital Substantial progress in product development, e.g. Collaborations with leading GvHD model clinical research centres wo
Slide 7: Partnership with FUJIFILM
Partnership with Non-binding term sheet executed 5 September 2016 Anticipates finalisation of definitive agreement: option to an exclusive, w/w licence to market and sell CYP-001 for prevention and treatment of graft-versus-host disease (GvHD) + option to negotiate a licence for manufacturing CYP-00
Slide 8: Why Are Stem Cells Important?
Why Are Stem Cells Important? Stem cells as therapies for disease: significant media interest. Mesenchymal Stem Cells (MSCs) are specialised stem cells that can be used as therapeutics. MSCs play a key role in modulating inflammation and co-ordinating repair: like an orchestra conductor. www.cynata.
Slide 9: Mesenchymal Stem Cell (MSC) Therapeutics
Mesenchymal Stem Cell (MSC) Therapeutics ~652* open clinical studies using MSCs including: Annual Market Value ($US) • Particular relevance to chronic diseases of ageing • Profound legislative changes to expedite stem cell therapies (Japan) • Massive government investment e.g. California (CIRM): US$
Slide 10: Therapeutic Product Pipeline
Therapeutic Product Pipeline www.cynata.com
Slide 11: Graft vs Host Disease
Graft vs Host Disease What Potentially fatal complication that can occur after a bone marrow transplant in cancer patients. Market Global GvHD market value estimated to increase from US$295m in 2013 to US$544m in 2023 1. Reimbursed cost of MSC treatment (Japan) $US113k-US$170k. Why Cynata has target
Slide 12: Roadblock for MSC Medicines: Manufacture
Roadblock for MSC Medicines:: Manufacture Major practical & regulatory challenges: Issues with production scale-up Inconsistent product quality Reduced product efficacy Donor variability www.cynata.com
Slide 13: Current Manufacture of MSCs
Current Manufacture of MSCs Extraction Expansion Efficacy? • Bone marrow extraction - risky • 20k cells per BM aspirate → • Modest expansion of MSCs in & painful procedure 100m per dose (>12 population culture induces senescence doublings) • Yields too few cells for a • This occurs after as few as 1
Slide 14: Multiple Donors: Multiple Problems
Multiple Donors:: Multiple Problems Major practical & regulatory challenges Recruitment and qualification of donors is costly, time consuming and is associated with logistical challenges Significant intra- and inter- donor variability Regulatory challenges: Comparability studies for each new donatio
Slide 15: Manufacturing Issues Attracting Global Attention
Manufacturing Issues Attracting Global Attention Recent late stage trials are encouraging, e.g. TiGenix, JCR Pharma BUT: initial spectacular successes in Phase 1, 2 not being confirmed Leading many commentators to observe that manufacture is a problem www.cynata.com
Slide 16: The Industry Solution
The Industry Solution New innovative platform technology for the mass production of clinical grade Competitor A MSCs Competitor B Production of Production of MSCs using MSCs using traditional traditional methods methods Industry Needs: Cost effective, commercial production of MSCs, for use as therap
Slide 17: Cynata's Cymerus Breakthrough
Cynata’s Cymerus Breakthrough TM The Solution: Cynata’s Cymerus™ technology enables commercial-scale manufacture of a consistent, robust MSC product: …better, cheaper, faster Cells Induction of Generation Generation Expansion iPSC iPSC from one APLNR+ of MCA of MSCs of MSCs Derivation Expansion Dono
Slide 18: Cynata's Cymerus Breakthrough
Cynata’s Cymerus TM Breakthrough Modern innovative technology Large scale production capacity Efficient production process Premier grade product www.cynata.com
Slide 19: Cymerus MSC Characterization
Cymerus MSC TM Characterization Confirmation of MSC class characteristics / identity Cell surface markers Differentiation Immunopotency Genetic profiling Successful in vivo model: critical limb ischaemia (published) Further in vivo model (GvHD) ongoing www.cynata.com
Slide 20: Cynata's Cymerus: Outstanding Pedigree
Cynata’s Cymerus : TM Outstanding Pedigree Inventors include: Dr James Thomson • In 1998 derived the first human embryonic stem cell line • 2007 derived human induced pluripotent stem cells …and Prof Igor Slukvin, co-founder and author of >70 publications in the stem cell field In-licensed intellect
Slide 21: Academic Partnerships
Academic Partnerships • Cynata has commenced a collaboration with Dr Khalid Shah, of MGH/ Harvard Medical School and Harvard Stem Cell Institute Universities • Pioneers of technology to modify stem • University of Wisconsin cells to secrete cancer-killing toxins • Technology spun out of university •
Slide 22: Business Model: Commercial Partnerships
BUSINESS MODEL: Commercial Partnerships Development and commercialisation of the Cymerus™ technology: • Capital efficient license-driven strategy: partner with leading Companies pharma/big biotech • apceth GmbH (Germany) • Near term revenues through • License option agreement license fees, R&D payme
Slide 23: The Future Is Bright
The Future Is Bright What’s Next? FUJIFILM definitive agreement Green light for Phase 1 clinical trial; Formal interaction with FDA Licence option agreement with apceth & GmBH to bring in additional revenue Continued success of MSC-based therapeutics Develop opportunities in engineered MSCs www.cyna
Slide 24: Now is the Right Time to Invest
Now is the Right Time to Invest EXISTING MARKET ISSUES THE FUTURE OF MEDICINE • Vibrant and expanding field of • Traditional production methods stem cell medicine for MSCs limit their usage as effective therapies • Global demand for stem cell therapeutics (ageing population) • Competitors using exis
Slide 25: Thank you for your attention
Thank you for your attention Cynata Therapeutics Limited Suite 1, 1233 High Street, Armadale, Victoria 3143 Contact details: ross.macdonald@cynata.com +61 (0) 412 119343 www.cynata.com www.cynata.com
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