Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (April 2023)
41 slides from Cynata Therapeutics's investor presentation, Apr 6, 2023
Slide 1: A Next Generation Stem Cell Therapeutics Company
A Next Generation Stem Cell Therapeutics Company Capital Raising Presentation (April 2023)
Slide 2: Important Information
Important Information This investor presentation (Presentation) has been prepared by Cynata Therapeutics Limited ACN 1104 037 372 Before making an investment decision, prospective investors should consider the appropriateness of the available (Cynata or the Company) and is dated [6 April 2023]. This
Slide 3: Executive Summary
Executive Summary • Cynata is an ASX listed clinical stage biotech advancing innovative cell therapies based on its proprietary CymerusTM platform technology for the scalable manufacture of Company Overview mesenchymal stem cells (MSC) • Cynata currently has a rich clinical pipeline of four key asse
Slide 4: Investment Highlights
Investment Highlights Cynata is a clinical stage biotech developing its proprietary CymerusTM platform technology for the scalable manufacture of mesenchymal stem cell (MSC) therapeutic products to treat serious disorders Unique Strong safety Multiple Significant Market manufacturing and efficacy cl
Slide 5: Why Mesenchymal Stem Cells (MSCs)?
Why Mesenchymal Stem Cells (MSCs)? MSCs play a central co-ordinating role in many of the body’s mechanisms of defence, repair and regeneration: 1 the “sensor and switcher of the immune system” They are able to be used therapeutically without matching the donor and the recipient “MSCs promote an immu
Slide 6: Medical Applications of Mesenchymal Stem Cells
Medical Applications of Mesenchymal Stem Cells MSCs are the subject of intense development worldwide Promising potential as medical treatments Global interest in MSCs continues to grow MSCs are being developed as potential therapeutic products for diseases including: Diabetes (type 1 and type 2) >
Slide 7: Conventional vs. Cynata's Cymerus MSC manufacturing process
Conventional vs. Cynata’s Cymerus MSC manufacturing process Cells donated Conventional process MSCs Cells from Cellular therapies MSC isolation Significant MSC Conventional multiple donors administered culture expansion manufacturing process is sub-optimal Substantial variability Limited quantity of
Slide 8: Cynata's process utilizes induced pluripotent stem cells (iPSCs)
Cynata’s process utilizes induced pluripotent stem cells (iPSCs) • iPSCs are mature cells from adult donors that are reprogrammed to be capable of: − effectively limitless proliferation in cell culture − differentiation into any adult cell type (including MSCs) Thus an ideal starting material for ce
Slide 9: Cynata's technology addresses key area of FDA concern
Cynata’s technology addresses key area of FDA concern Cynata’s Cymerus process actively addresses current inefficiencies of MSC manufacturing from donated tissues, de-risking clinical development Traditional MSC manufacturing is sub-optimal Cynata’s technology is optimal Other MSC therapy (also targ
Slide 10: Strategic Partnership with Fujifilm provides commercial benefits
Strategic Partnership with Fujifilm provides commercial benefits Cynata executed a Strategic Partnership Agreement with Fujifilm, with Fujifilm involved in the path to market1 Strategic benefits for Cynata Fujifilm is one of the largest conglomerates in the world with a significant network and ass
Slide 11: Clinical Trials
Gulplalla therapeutics Clinical Trials
Slide 12: Cynata has an advanced and diverse product pipeline
Cynata has an advanced and diverse product pipeline Cynata is targeting attractive market opportunities across a range of indications Target area Trial phase Estimated market opportunity Osteoarthritis (OA) Phase 3 underway US$11.6bn2 Diabetic Foot Ulcers (DFU) Phase 1 underway US$10bn3 Clinical Acu
Slide 13: aGvHD | Ground-breaking Phase 1 clinical trial results
aGvHD | Ground-breaking Phase 1 clinical trial results Cynata’s Phase 1 aGvHD trial met all safety and efficacy endpoints and broke ground by being the world’s first completed clinical trial of an iPSC-derived product Key results1 demonstrate safety and efficacy of Cymerus MSCs Published in prestigi
Slide 14: Phase 1 Clinical Trial in aGvHD – response by subject
Phase 1 Clinical Trial in aGvHD – response by subject Substantial improvement in aGvHD grades observed with the majority of patients reporting a Complete Response 4 1 2 3 GvHD Grade 2 1 0 Subject # A1 A2 A3 A4 A5 A6 A7 A8 B1 B2 B3 B4 B5 B6 B7 Grade change -1 -2 -1 -3 0 -2 -3 -3 -2 -3 -3 -2 0 -2 -1 B
Slide 15: aGvHD | Phase 2 clinical trial in aGvHD
aGvHD | Phase 2 clinical trial in aGvHD With a cleared IND from the FDA Cynata plans to commence a clinical trial in acute aGvHD in 2Q23 • Acute Graft vs Host Disease (aGvHD) remains a common complication Key Milestones of allogeneic hematopoietic stem cell transplants (e.g., bone marrow aGvHD trans
Slide 16: DFU | Phase 1 clinical trial
DFU | Phase 1 clinical trial Enrolment opened in December 2021 with completion of enrolment expected mid 2023 Diabetic Foot • DFU are sores on the feet of patients with diabetes (also known as Key Milestones Ulcers (DFU) diabetic wounds) Sign licence • >400m diabetics globally, with DFU estimated to
Slide 17: DFU | Initial clinical update from the first 6 patients
DFU | Initial clinical update from the first 6 patients A review has been conducted of the first 6 patients who have completed at least the 28 day follow-up • Three patients were randomised to Group 1 and were treated with CYP-006TK dressings for 4 weeks (dressings changed Patient groups twice a wee
Slide 18: DFU | Largest ulcer at baseline from each group
DFU | Largest ulcer at baseline from each group Day 0 Day 28 CYP-006TK Patient 005 SOC Patient 007
Slide 19: DFU | CYP-006TK treatment data
DFU | CYP-006TK treatment data CYP-006TK has healed more ulcer surface area than standard of care (SoC) at every timepoint of the trial for the first 6 patients Mean % ulcer surface area healed over time (%)1; n=6 The mean extent of ulcer healing 100 in CYP-006TK treated patients is almost double th
Slide 20: Osteoarthritis-SCUlpTOR | Phase 3 clinical trial
Osteoarthritis-SCUlpTOR1 | Phase 3 clinical trial Clinical trial underway, sponsored by the University of Sydney and substantially externally funded • Osteoarthritis (OA) occurs when the cartilage in a joint wears away Key Milestones Osteoarthritis • Causes pain, inflammation, swelling and difficult
Slide 21: Renal | Phase 1 clinical trial
Renal | Phase 1 clinical trial Funding to conduct trial secured from Leiden University Medical Center (LUMC) • MSCs may reduce or eliminate the requirement for aggressive and toxic Key Milestones Renal anti-rejection drugs, leading to a substantial breakthrough in Transplants transplantation medicin
Slide 22: Near term catalysts
Near term catalysts Cynata is in a strong position to advance its proprietary Cymerus platform technology 1H 2023 Commence phase 2 trial in aGvHD Complete recruitment of 30 patients in DFU clinical trial around mid 2023 During 2H 2023 Complete recruitment of up to 440 patients in U Syd phase 3
Slide 23: Portfolio constructed for commercial success
Portfolio constructed for commercial success Cynata has the building blocks in place to execute on its commercial strategy of partnering with pharmaceutical companies across its portfolio Unique Strong patent Unmet medical Preclinical efficacy Clinical safety and Indication manufacturing position ne
Slide 24: Pre-clinical Data
Gulplalla therapeutics Pre-clinical Data
Slide 25: Data supports Cymerus MSCs over conventional MSCs
Data supports Cymerus MSCs over conventional MSCs Key results from a pre-clinical study in rats illustrate that Cymerus MSCs provide better therapeutic effects compared with bone marrow MSCs derived via conventional manufacture • Pre-clinical rat model of myocardial ischemia-reperfusion (heart attac
Slide 26: Cymerus MSCs demonstrate significantly higher efficacy than BM MSCs
Cymerus MSCs demonstrate significantly higher efficacy than BM MSCs Preclinical model of Diabetic Wounds demonstrate efficacy of Cymerus MSCs 100 90 80 Percentage re-epithelialisation (%) 70 60 Although gingival fibroblasts and 50 bone chip MSCs produced similar 40 results, there are major challenge
Slide 27: Corporate Summary
CUnate therapeutics Corporate Summary
Slide 28: Board & management
Board & management Highly skilled and experienced senior leadership team with decades of experience Dr Geoff Brooke Dr Ross Macdonald Dr Kilian Kelly Chairman Managing Director / CEO Chief Operating Officer • 30+ years experience and a track record of success in • 15+ years experience in biopharma r
Slide 29: Corporate overview
Corporate overview Cynata is proud to be supported by major institutional investors and the Company remains well funded and debt free Shareholder distribution Major institutional shareholders Bioscience Managers 10.0% 49% Fidelity Fidelity International is a world leading investment and asset manage
Slide 30: Investment summary
Investment summary • Market leader in burgeoning stem cell sector; MSC products already marketed in Japan and Europe Next generation stem cell company • Diverse and highly credentialed leadership team with proven clinical and commercial experience across a range of health sciences at leading institu
Slide 31: Capital Raising Details
CUnate therapeutics Capital Raising Details
Slide 32: Details of the Offer
Details of the Offer Cynata is raising up to ~A$7 million via a Placement of ~A$5 million and a A$2m Share Purchase Plan, to fund the company’s aGvHD Phase 2 trial • A placement to sophisticated and professional investors of ~$5m, comprising: • The issue of approximately 23.3 million new, ordinary f
Slide 33: Use of Funds
Use of Funds1 Capital Raising Use of Funds Sources of Funds Amount Expenditure Item Amount Phase 2 aGvHD Trial $6.0m Cash Position (31 Dec 22) $16.4m Working Capital $0.5m Capital Raise Funds $7m1 Costs of the Offer $0.5m Total $23.4m Total $7.0m 1. Assumes the SPP is fully subscribed. Excludes any
Slide 34: Indicative Timetable
Indicative Timetable Indicative capital raising timetable Trading halt Tuesday, 4 April 2023 Record Date for the SPP 7.00pm Wednesday, 5 April 2023 Capital Raising announced and trading halt lifted Thursday, 6 April 2023 Settlement of the Placement Friday, 14 April 2023 Allotment and trading of Shar
Slide 35: Appendix
Gulplalla therapeutics Appendix
Slide 36: Risks
Risks This section discusses some of the key risks associated with any investment in Cynata together with risks relating to participation in the Capital Raising which may affect the future operating and financial performance of Cynata and the value of Cynata shares. The risks set out below do not co
Slide 37: Risks
Risks Risk Description The Company is pursuing a license partnership model, which typically involves entering into commercial arrangements with other companies by which Cynata licenses its Cymerus technology to the partner in one or more indications and/or geographies and the partner assumes respons
Slide 38: 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 39: Foreign Jurisdiction Selling Restrictions
Foreign Jurisdiction Selling Restrictions This document does not constitute an offer of new ordinary shares (“New Shares”) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sol
Slide 40: Foreign Jurisdiction Selling Restrictions
Foreign Jurisdiction Selling Restrictions UNITED KINGDOM Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Marke
Slide 41: Contact Us
Contact Us Cynata Therapeutics Limited Contact details: Level 3 100 Cubitt Street ross.macdonald@cynata.com Cremorne Victoria 3121 www.cynata.com Australia
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