Cynata Therapeutics Limited · ASX:CYP
Cynata Therapeutics — Investor Presentation (September 2023)
30 slides from Cynata Therapeutics's investor presentation, Sep 18, 2023
Slide 1: Investor Webinar Presentation ASX Announcement
ASX ANNOUNCEMENT 18 September 2023 INVESTOR WEBINAR PRESENTATION Melbourne, Australia; 18 September 2023: Cynata Therapeutics Limited (ASX:CYP) (“CYP”, “Cynata” or “the Company”) is pleased to invite shareholders to attend an investor webinar hosted by The Watchlist, to be held on Tuesday 19 Septemb
Slide 2: A Next Generation Stem Cell Therapeutics Company
For personal use only A Next Generation Stem Cell Therapeutics Company Investor Presentation September 2023
Slide 3: Company highlights
Company highlights Cynata is a clinical stage biotech developing its proprietary Cymerus platform technology for the scalable manufacture of mesenchymal stem cell (MSC) therapeutic products to treat serious disorders For personal use only Unique Strong safety Large Multiple Well funded Manufacturing
Slide 4: Cynata has an advanced and diverse clinical pipeline
Cynata has an advanced and diverse clinical pipeline Target area Trial phase Market opportunity For personal use only Acute Graft vs Host Disease (aGvHD) Cynata Sponsored CYP-001 Phase 2 underway US$0.6bn2 Diabetic Foot Ulcers (DFU) Phase 1 underway US$9.6bn3 CYP-006TK Osteoarthritis (OA) CYP-004 Ph
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 For personal use only
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 For personal use only MSCs are being developed as potential therapeutic products for diseases including: >1,2001 Ap
Slide 7: Manufacturing
For personal use only Manufacturing
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: For personal use only − effectively limitless proliferation in cell culture − differentiation into any adult cell type (including MSCs) Thus an ideal st
Slide 9: Cymerus iPSC-based manufacturing process
Cymerus™ iPSC-based manufacturing process Cells donated Conventional process MSCs Conventional Cells from MSC isolation MSC culture Final product multiple donors process expansion For personal use only Major challenges include inter-donor variability and functional changes Large number of Substantia
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 For personal use only Strategic benefits for Cynata Fujifilm is one of the largest conglomerates in the world with a signi
Slide 11: Preclinical Data
For personal use only Preclinical Data
Slide 12: MSCs from different sources have different properties
MSCs from different sources have different properties For personal use only Key Findings include: • Source is the primary driver of MSC heterogeneity (variability) • Cymerus MSCs differ from tissue-derived MSCs by upregulation of biological processes linked to telomere maintenance and RNA catabolism
Slide 13: Efficacy of Cymerus MSCs vs conventional MSCs in AMI model
Efficacy of Cymerus MSCs vs conventional MSCs in AMI model 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 (he
Slide 14: Efficacy of Cymerus MSCs vs conventional MSCs in DFU model
Efficacy of Cymerus MSCs vs conventional MSCs in DFU model Preclinical model of Diabetic Wounds demonstrate efficacy of Cymerus MSCs Key findings 100 • Primary outcome measure was the For personal use only 90 extent of re-epithelialisation (skin restoration) of the diabetic wound 80 surface after 3
Slide 15: Clinical Trials
For personal use only Clinical Trials
Slide 16: GvHD Phase 1: Primary Evaluation Period (up to Day 100)
GvHD Phase 1: Primary Evaluation Period (up to Day 100) The first completed clinical trial of an iPSC-derived product Published in Nature Medicine3 For personal use only Complete 53% Overall 87% Survival ≥87% response response rate No treatment-related serious adverse events or safety concerns ident
Slide 17: GvHD Phase 1: 2-Year Overall Survival
GvHD Phase 1: 2-Year Overall Survival 2-year overall survival (OS) rate in subjects treated with CYP-001 was 60% (9/15 subjects) For personal use only • Compares very favourably with previously reported outcomes in SR-aGvHD studies: • In the Ph 3 study of ruxolitinib OS at 18 months was just 38% in
Slide 18: aGvHD Phase 2 clinical trial
aGvHD | Phase 2 clinical trial Cynata plans to commence recruitment during the current quarter, with results expected H2 CY 2025 For personal use only • Acute Graft vs Host Disease (aGvHD) is a complication that can occur after Key Milestones aGvHD a bone marrow transplant when the donor’s immune ce
Slide 19: DFU Phase 1 clinical trial
DFU | Phase 1 clinical trial High screening failure rate has resulted in slower than expected recruitment, Cynata has undertaken steps to accelerate recruitment rate with enrolment expected to be completed by the end of CY 2023 For personal use only Diabetic Foot • Diabetic Foot Ulcers (DFU) are sor
Slide 20: DFU | Initial clinical update
DFU | Initial clinical update 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 Patient groups (dressings changed twice a week) and then reverted to st
Slide 21: DFU | Largest ulcer at baseline from each group
DFU | Largest ulcer at baseline from each group Day 0 Day 28 For personal use only CYP-006TK Patient 005 SOC Patient 007
Slide 22: 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 so far Mean % ulcer surface area healed over time (%)1; n=6 For personal use only 100 Mean CYP-006TK Mean SoC 80 60 40 20 0 0 7 14 21 28 Days 1. Mean defined as ave
Slide 23: OA Phase 3 clinical trial
OA | Phase 3 clinical trial1 Recruitment accelerating and expected to be completed by the end of CY 2023, with evaluation results expected to be released in CY 2026 For personal use only • Osteoarthritis (OA) occurs when the cartilage in a joint wears away and Key Milestones Osteoarthritis can cause
Slide 24: Renal Phase 1 clinical trial
Renal | Phase 1 clinical trial Clinical trial start up activities with partner Leiden University Medical Center (LUMC) underway, with outcome from regulatory approval process expected during the current quarter For personal use only Key Milestones Sign contract • MSCs may reduce or eliminate the req
Slide 25: Corporate Information
For personal use only Corporate Information
Slide 26: Board & Senior Management
Board & Senior Management Highly skilled and experienced senior leadership team with decades of experience Dr Kilian Kelly Dr Geoff Brooke Chief Executive Officer & Independent Non-Executive Chairman For personal use only Managing Director • 30+ years' experience in the healthcare • 20+ years' exper
Slide 27: Corporate overview
Corporate overview Cynata has been listed on the Australian Securities Exchange (ASX) since 2013 (Ticker: CYP) Shareholder distribution Substantial shareholders (>5%) For personal use only 52% Bioscience Managers 13.1% Fidelity Remaining Top 20 Bioscience Managers is an international healthcare inve
Slide 28: Investment summary
Investment summary • Market leader in burgeoning stem cell sector 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 institutions For personal use only • Patented Cymerus manu
Slide 29: Important information
Important information Summary information ‘propose’, ‘will’, ‘believe’, ‘forecast’, ‘estimate’, ‘target’, ‘outlook’, ‘guidance’, ‘potential’ and other similar This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries expressions. The forward looking statem
Slide 30: Contact Us
For personal use only Contact Us Cynata Therapeutics Limited Contact details: Level 3 100 Cubitt Street kilian.kelly@cynata.com Cremorne Victoria 3121 www.cynata.com Australia
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