Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (June 2018)
26 slides from Cynata Therapeutics's investor presentation, Jun 26, 2018
Slide 1: Product Development Program Update and New Investor Presentation
ASX ANNOUNCEMENT 26 June 2018 Product Development Program Update and New Investor Presentation Melbourne, Australia, 26 June 2018: Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX: CYP) is pleased to announce an update to its product development activities and
Slide 2: Investor Presentation Investment Highlights
including limb amputation and higher mortality rates. As such, the global commercial opportunity for MSC therapies in CLI, as estimated by ClearView, has the potential to reach US$1.4 billion per year. Cynata will update the market with developments regarding its planned future activities, as approp
Slide 3: A Next Generation Stem Cell Company
A Next Generation Stem Cell Company Investor Presentation: Cynata Therapeutics Limited June 2018
Slide 4: 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 5: Investment Summary
Investment Summary: a Phase II-ready biotech with a highly scalable, proprietary platform for producing commercial quantities of MSCs Scalable, globally CymerusTM platform enables production of high quality Mesenchymal Stem Cells at scale applicable technology Fully patented process overcomes mu
Slide 6: Cynata has the only platform in the world to produce commercial quantities of MSCs
Cynata has the only platform in the world to produce commercial quantities of Mesenchymal Stem Cells from a single source Today’s on-market MSC manufacturing Patented Cymerus Platform solution has a number of shortcomings overcomes shortcomings Sourcing cells from multiple donors leads CONSISTENT
Slide 7: MSCs are a highly potent form of stem cell
MSCs are a highly potent form of stem cell attracting significant clinical interest – and in need of a scalable commercial solution Mesenchymal Stem Cells (MSCs) are believed to Global commercial potential, with multiple target play a vital role in repair and regeneration areas potentially benefitin
Slide 8: Cynata's goal is for its patented Cymerus platform to become the preferred solution
Cynata’s goal is for its patented Cymerus platform to become the preferred solution for Big Pharma to commercially produce MSCs Preclinical data Phase I near completion, Phase II planned Fujifilm licence option Licence available GvHD A ‘hub and spoke’ business model Intention to license Cymerus ac
Slide 9: Trial update: Excellent results in Phase 1 GvHD clinical trial
Trial update | Excellent results in Phase 1 GvHD clinical trial, a clear validation of Cynata’s MSCs and the Cymerus platform Cynata is nearing completion of a successful Phase 1 clinical trial, demonstrating safety and meaningful impact on the patients’ quality of life All endpoints achieved to d
Slide 10: Trial update: Substantial improvement in GvHD grades
Trial update | Substantial improvement in GvHD grades observed with the majority of patients reporting a Complete Response Cohort A, single dose (as at 100-day readout) Cohort B, double dose (as at 28-day readout) Complete Response rate of 50% Complete Response of 57% 4 4 3 3 GvHD grade GvHD grade 2
Slide 11: Trial update: Response rate represents a meaningful improvement
Trial update | Response rate represents a meaningful improvement for a life-threatening, severe disease, in a $300m market opportunity1 Trial results to date2 GvHD grade scale3 Substantial improvement in GvHD grade Overall GvHD grade based on a combination of skin, liver and gut grade scales Skin gr
Slide 12: Trial update: Phase 1 GvHD trial design
Trial update | Phase 1 GvHD trial was designed to demonstrate safety of Cynata’s MSCs and support evaluation of efficacy Graft versus host disease (GVHD) is a condition where following a transplant the donor’s immune cells in the What is transplant (graft) make antibodies against the patient's tissu
Slide 13: Cell therapy is an active market attracting big pharma M&A interest
Cell therapy is an active market attracting big pharma M&A interest USD USD USD 628M 307M 379M Acquired by Acquired by Acquired by March 2015 February 2016 January 20181 • Enables Fujifilm to combine • Enables Astellas to establish a leading • Extends existing partnership between technologies with C
Slide 14: Cynata is executing on a clear scientific and commercial vision
Cynata is executing on a clear scientific and commercial vision and continually assesses pathways to maximise shareholder value Fujifilm holds a licence option for development and Multiple options to create commercialisation of Cynata’s MSCs for GvHD shareholder value Exercise of Fujifilm option (US
Slide 15: Cynata intends to demonstrate broad global applicability of its Cymerus platform
Cynata intends to demonstrate broad global applicability of its Cymerus platform New enhanced pipeline and clear pathway to commercialisation Direct path to market in Japan following Phase II US$300m1 GvHD Fujifilm holds a licence option for development and commercialisation of Cynata’s MSCs for
Slide 16: ClearView were commissioned to evaluate the full landscape of MSC opportunities
ClearView were commissioned to evaluate the full landscape of MSC opportunities to identify high priority indications Indication prioritisation process ClearView identified Cardiovascular disease selected by ~20 high potential target Cynata as highest priority indication area areas with clear scient
Slide 17: New Phase II programme in Critical Limb Ischemia
New Phase II programme in Critical Limb Ischemia | Opportunity Overview 230,000 ~US$1.4B1 Addressable events per year Forecast annual global market sales Estimated market size MSC therapy for effective treatment of critical limb ischemia patients who are Critical Limb ineligible for revascularizat
Slide 18: Critical Limb Ischemia clinical study follows excellent pre-clinical results
Critical Limb Ischemia clinical study follows excellent results from an earlier pre-clinical study Mice dosed with Cymerus MSCs experienced significantly improved All results published in a peer outcomes when compared with control group reviewed journal DAY TREATED CONTROL Loss of leg Cytotherapy is
Slide 19: Cynata is well funded to progress its enhanced clinical pipeline
Cynata is well funded to progress its enhanced clinical pipeline Pre-clinical Phase I Phase II Overview Excellent results in Phase I GvHD clinical trial: a clear validation of Cynata’s MSCs and the GvHD Phase II ready Cymerus platform Fujifilm responsible for all further development activities a
Slide 20: Key upcoming milestones
Key upcoming milestones Today H1 CY2018 H2 CY2018 H1 CY2019 H2 CY2019 Phase I clinical trials GvHD If Fujifilm do not exercise their option, Cynata intends to progress to Phase 2 independently Cohort B 100 Fujifilm licence or with an alternative partner day read-out option expires Detailed trial pla
Slide 21: Cynata will continue to progress pre-clinical studies
Cynata will continue to progress pre-clinical studies with leading academic and commercial partners Pre-clinical Proof of concept Disease target area trials started completed Key highlights Cymerus MSCs demonstrated significant beneficial effects Monash Asthma on three key components of asthma:
Slide 22: Globally experienced board and management team
Globally experienced board and management team Dr Paul Wotton Dr Ross Macdonald Dr Stewart Washer Dr John Chiplin Mr Peter Webse Dr Kilian Kelly Chairman Managing Director Non-Executive Director Non-Executive Director Non-Executive Director Vice President, Product Chief Executive Officer Company Sec
Slide 23: Investment Highlights
Investment Highlights Scalable, world-first technology: Cymerus platform overcomes inherent challenges of other production methods and enables mass-production of therapeutic MSCs Phase II ready: Excellent Phase I results provide validation of Cynata’s Cymerus platform; Cynata well positioned to
Slide 24: Key recent newsflow
Appendix | Key recent newsflow: last 6 months Release date Announcement GvHD 21-Jun-18 Positive 28-day data from Cohort B 12-Jun-18 Positive 6-month data from Cohort A 24-May-18 Enrolment completed in Cynata’s Phase 1 Clinical Trial 28-Mar-18 FDA Grants Orphan Drug Designation to Cynata for CYP-001
Slide 25: Corporate overview
Appendix | Corporate overview Company profile Share price performance (last 6 months, A$) 1.60 Cynata Therapeutics is an Australian stock exchange +120% listed clinical-stage biotechnology company developing disruptive regenerative medicines. 1.20 Financial information 0.80 +27% Share price (21-June
Slide 26: Thank you for your attention
Thank you for your attention Cynata Therapeutics Limited Contact details: Level 3 62 Lygon Street ross.macdonald@cynata.com Carlton Victoria 3053 +61 (0) 412 119343 Australia www.cynata.com
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