Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Shareholder Meeting (November 2016)
19 slides from Cynata Therapeutics's shareholder meeting presentation, Nov 16, 2016
Slide 1: Annual General Meeting Address
For personal use only ANNUAL GENERAL MEETING ADDRESS 16 November 2016 Dr Ross Macdonald (CEO) Dr Kilian Kelly (VP, Product Development) 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
About Cynata Cynata Therapeutics Ltd is an Australian stem cell and regenerative medicine company. For personal use only Competitive Strengths Disruptive allogeneic MSC platform technology: CymerusTM Economical production of clinical grade product Strong IP cover Strategic collaborations with commer
Slide 4: Recent Cynata Milestones
Recent Cynata Milestones Partnership term sheet with FUJIFILM For personal use only Executed license option Research coverage by agreement with apceth GmbH Rodman & Renshaw; Shaw & Co & Partners; CPS Capital Collaborations with leading Substantial progress in clinical research centres product develo
Slide 5: Partnership with FUJIFILM
For personal use only Partnership with Non-binding term sheet executed 5 September 2016 Definitive agreement: option to an exclusive, w/w licence to market and sell CYP- 001 for graft-versus-host disease (GvHD) + certain additional rights; on track to complete by end of year Strategic acquisition of
Slide 6: Partnership with apceth
For personal use only Partnership with License Option Agreement with apceth GmbH & Co. KG executed 9 May 2016 Proposes apceth development of Cynata’s Cymerus™ MSCs engineered with apceth’s proprietary genetic modification technology Therapeutic target is cancer as well as several other devastating d
Slide 7: Therapeutic Product Pipeline
Therapeutic Product Pipeline For personal use only www.cynata.com
Slide 8: The Future Is Bright
The Future Is Bright What’s Next? For personal use only FUJIFILM definitive agreement: substantial revenue injection 1st patient in Phase 1 clinical trial; Formal interaction with FDA Licence option agreement with apceth Continued success of MSC-based therapeutics Develop opportunities in engineered
Slide 9: Now is the Right Time to Invest
Now is the Right Time to Invest EXISTING MARKET ISSUES THE FUTURE OF MEDICINE For personal use only • Global demand for stem cell • Traditional production methods therapeutics (ageing population) for MSCs limit their usage as effective therapies • Unique, innovative technology from prestigious centr
Slide 10: Graft Versus Host Disease Program
For personal use only Graft Versus Host Disease Program Kilian Kelly VP, Product Development www.cynata.com
Slide 11: Graft vs Host Disease
Graft vs Host Disease • Bone marrow transplant (BMT) is For personal use only effective for certain blood cancers (e.g. leukaemia, lymphoma, myeloma) • However, graft versus host disease (GvHD) is a potentially fatal complication of BMT • GvHD occurs when immune cells from the donor bone marrow (the
Slide 12: MSCs as a Treatment for GvHD
MSCs as a Treatment for GvHD • MSCs may alleviate or even eliminate GvHD by suppressing immune For personal use only cells from donor bone marrow, and stimulating tissue repair • The first GvHD patient treated with MSCs was a 9 year old boy in Sweden, with a profoundly positive outcome. One year lat
Slide 13: Cynata's Initial Clinical Trial – Why GvHD?
For personal use only Cynata’s Initial Clinical Trial – Why GvHD? • MSCs have shown promise for a huge range of conditions – over 70 different indications • Decision was taken to focus on GvHD initially, because: • Devastating condition with very limited treatment options unmet need; smoother regu
Slide 14: Preclinical Proof of Concept Study
For personal use only Preclinical Proof of Concept Study • Humanised mouse model of severe acute GvHD • Study conducted at University of Massachusetts, Amherst • Initial results – announced April 2016: • Control animals (GvHD, treated with saline): median survival time of just 25.5 days (range 24-31
Slide 15: Preclinical Proof of Concept Study
For personal use only Preclinical Proof of Concept Study • Additional studies still ongoing – survival of treated animals has been unexpectedly long • Latest data: • Survival of additional control animals has been no longer than in initial cohort • CYP-001 treated animals have survived for up to 81
Slide 16: Phase 1 Clinical Trial Overview
Phase 1 Clinical Trial Overview Protocol Number CYP-GVHD-P1-01 For personal use only Patient Population 16 adults with steroid-resistant acute GvHD Locations UK, Australia (+ potentially other countries) Treatment All subjects: 2 infusions of CYP-001 (Day 0 & Day 7) Cohort A: Dose = 1 million cells/
Slide 17: Clinical Trial – Current Status
Clinical Trial – Current Status Product manufacture complete; product has passed QC For personal use only testing and been released for clinical use 7 clinical sites in the UK and Australia selected (All major bone marrow transplant centres) Approved by UK Regulatory Authority (MHRA) Approved
Slide 18: Estimated Timelines
For personal use only Estimated Timelines • Enrolment open – Q4 2016 • Cohort A enrolment complete – Q1-2 2017 • Cohort A results – Q2 2017 • Cohort B enrolment complete – Q3 2017 • Cohort B results – Q4 2017 Notes: • Timelines are heavily dependent on enrolment rates at site • Progress to Cohort B
Slide 19: Thank you for your attention
Thank you for your attention For personal use only 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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