Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (December 2020)
26 slides from Cynata Therapeutics's investor presentation, Dec 11, 2020
Slide 1: A Next Generation Stem Cell Therapeutics Company
A Next Generation Stem Cell Therapeutics Company Investor Presentation: Cynata Therapeutics Limited 11 December 2020
Slide 2: Important information
Important information This investor presentation (Presentation) has been prepared by Cynata Therapeutics Limited (ACN 104 037 offered or sold in the United States except in transactions exempt from, or not subject to, registration under 372) (CYP or the Company) and is dated 11 December 2020. This P
Slide 3: Important information
Important information Future performance and forward-looking statements Past performance This Presentation contains certain ‘forward looking statements’, including but not limited to projections, Investors should note that past performance, including past share price performance of CYP is given for
Slide 4: Executive summary
Executive summary • Clinical stage therapeutic mesenchymal stem cell (MSC) pipeline: osteoarthritis, COVID-19 (respiratory Next generation distress) and, via licensee FUJIFILM, graft-versus-host disease (GvHD) stem cell company • Multiple additional value creation pathways through expanding the clin
Slide 5: Company overview
Company overview Cynata Therapeutics is a clinical stage biotech company with a highly scalable, proprietary platform for developing stem cell therapeutics About Cynata Therapeutics Financial information • Our focus: Utilise our proprietary CymerusTM platform technology to develop commercially scala
Slide 6: Conventional vs. Cynata's Cymerus MSC manufacturing process
Conventional vs. Cynata’s Cymerus MSC manufacturing process Cells donated Conventional process MSCs The current Cells from MSC isolation MSC expansion Cellular therapies multiple donors administered conventional manufacturing process is sub optimal Substantial variability Limited quantity of MSCs La
Slide 7: Commercially viable MSC manufacturing process
Commercially viable MSC manufacturing process Cynata has the only clinical-stage platform capable of producing commercial quantities of MSCs from a single source Conventional process Cymerus Significance for Cynata Continuous supply of One donor, one time Donors ✓ Lower cost; simplified logistics; h
Slide 8: FDA focus on manufacturing
FDA focus on manufacturing Cynata’s Cymerus process actively addresses some of the key areas that the FDA is likely to focus on Potential issues raised Key advantages underpinning Cymerus ✓ “The issue of reliable prediction of Product derived from a single donor provides a highly biological activity
Slide 9: Phase 1 clinical trial results
Phase 1 clinical trial results Excellent results in the world-first allogeneic iPSC-derived therapy trial in steroid-resistant acute graft-versus- host disease (GvHD) places Cynata in a strong position to accelerate clinical development Key clinical trial results1 - demonstrating efficacy of our tec
Slide 10: Cymerus platform
Cymerus platform Cynata's Cymerus platform has potential applications across a wide range of diseases Crohn’s Disease Others Osteoarthritis (funded by NHMRC) Fistula Coronary Artery Disease Potential future Phase 3 target areas Underway Heart attack Pre- clinical Brain cancer / Graft vs Host data Gl
Slide 11: Multiple options to create shareholder value
Multiple options to create shareholder value Cynata is executing on a clear scientific and commercial vision and continually assesses pathways to optimise shareholder value Build value in platform License / partner Strategic exit / independently with big Pharma merger Clinical trials – funded by Cyn
Slide 12: Significant market opportunities
Significant market opportunities Cynata is targeting attractive market opportunities across a range of target indications Target area Trial Phase Market opportunity 1 Osteoarthritis (OA) Phase 3 underway US$11.6 bn Graft vs. Host Disease (GvHD) Phase 2 planning US$0.6 bn 2 Acute Respiratory Distress
Slide 13: Expanding clinical development pipeline
Expanding clinical development pipeline Idiopathic pulmonary Renal transplantation Diabetic foot ulcer fibrosis • Incurable disease of unknown cause, • Treatment for end-stage kidney disease, • Sores on the feet of patients with diabetes which results in extensive scarring / where the kidneys are no
Slide 14: Critical Limb Ischaemia (CLI) trial
Critical Limb Ischaemia (CLI) trial Phase 2 ready trial with regulatory and ethics approval received • MSC therapy for critical limb ischemia patients who are ineligible for revascularization, to promote CLI angiogenesis and reduce inflammation • Cymerus preclinical studies were impressive; animals
Slide 15: Osteoarthritis Phase 3 trial underway
Osteoarthritis Phase 3 trial underway Stem Cells as a symptom- and strUcture-modifying Treatment for knee OsteoaRthritis (SCUlpTOR); new Phase 3 program funded by the National Health and Medical Research Council Target • Assess the effect of Cymerus MSCs on clinical outcomes and knee joint structure
Slide 16: COVID-19 Phase 2 trial open for enrolment
COVID-19 Phase 2 trial open for enrolment MEseNchymal coviD-19 Trial (MEND); a Phase 2 Program in COVID-19 and related respiratory diseases Target • 24 adult patients with COVID-19 admitted to intensive care with compromised lung function, which can population ultimately progress to ARDS • Respirato
Slide 17: GvHD Clinical and Commercial Program led by FUJIFILM
GvHD Clinical and Commercial Program led by FUJIFILM Global licensee FUJIFILM responsible for further development & commercialisation of Cymerus MSCs as a treatment for steroid resistant acute GvHD • GvHD is a complication that can occur after bone marrow transplant when the donor’s immune cells (th
Slide 18: Development pipeline
Development pipeline Broad, advanced development pipeline with multiple near-term catalysts Pre-clinical Phase 1 Phase 2 Phase 3 Key catalysts Fujifilm responsible for all updates and ongoing GvHD development via global license agreement US$2m milestone payment on Phase 2 completion Accelerated to P
Slide 19: Investment summary
Investment summary • Patented Cymerus platform technology enables commercial-scale production of mesenchymal stem cells from a single donor, Scalable overcoming multiple issues with today’s on-market solutions technology • Value of platform to a range of diseases demonstrated across clinical and pre
Slide 20: Capital raising details
Capital raising details
Slide 21: Capital raising overview
Capital raising overview Cynata is seeking to raise up to approximately A$20.5m via a Placement and Entitlement Offer • Institutional placement to raise ~A$15.0m through the issue of 21,440,295 New Shares (Placement) • 1 for 15, non-renounceable pro rata entitlement offer to raise up to approximatel
Slide 22: Timetable
Timetable Indicative capital raising timetable1 Date Announcement of the Capital Raising and trading halt lifted – shares recommence trading on ASX Friday, 11 December 2020 Record date for Entitlement Offer Wednesday, 16 December 2020 Settlement of Placement Friday, 18 December 2020 Allotment and co
Slide 23: Risks
Risks This section discusses some of the key risks associated with any investment in Cynata together with risks relating to participation in the Placement and Entitlement Offer which may affect the future operating and financial performance of Cynata and the value of Cynata shares. The risks set out
Slide 24: Risks
Risks Risk Description The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant change. A number of companies, both in Australia and abroad, may be pursuing the development of products that target the same markets and/or diseases that the Company
Slide 25: Risks
Risks Risk Description General economic conditions, movements in interest and inflation rates and currency exchange rates may have an adverse effect on the Company's business and production activities, as Economic well as on its ability to fund those activities. Share market conditions may affect th
Slide 26: Cynata Therapeutics Limited Contact details
Authorised for release by Dr Ross Macdonald, Managing Director & CEO Cynata Therapeutics Limited Contact details: Level 3 62 Lygon Street ross.macdonald@cynata.com Carlton Victoria 3053 www.cynata.com Australia
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