drugset / Press release

Sharewise Investor Presentation

2024-06-26 · Cynata Therapeutics Limited · original cynata.com ↗

Cynata Therapeutics Limited ABN – 98 104 037 372 Level 3, 100 Cubitt Street Cremorne VIC 3121 Australia T: +613 7067 6940 E: [email protected] www.cynata.com ASX ANNOUNCEMENT 27 June 2024 Investor Presentation Melbourne, Australia; 2 7 June 2024: Cynata Therapeutics Limited (ASX: “ CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to invite shareholders to attend an investor webinar hosted by Sharewise , to be held today, Thursday 27 June at 2pm AEST. The webinar will commence with a presentation, followed by a live questions and answers session with Cynata’s CEO and MD, Dr Kilian Kelly. Attendees are required to register in advance for the webinar – using the following link: https://zoom.us/webinar/register/3517188549370/WN_1vt2vITETWyLKotFC0-IEg#/registration An updated version of the Company’s Investor Presentation, which will be delivered during the webinar, is attached to this announcement. -ENDS- Authorised for release by Dr Kilian Kelly, CEO & Managing Director CONTACTS: Dr Kilian Kelly, CEO & MD, Cynata Therapeutics, +61 (03) 7067 6940, [email protected] Lauren Nowak, Media Contact, +61 (0)400 434 299, [email protected] About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical -stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblas t (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata’s lead product candidate CYP -001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. A Phase 2 clinical trial in GvHD under a cleared US FDA IND, as well as trials of Cymerus products in osteoarthritis (Phase 3 – patient enrolment completed ) and diabetic foot ulcers (DFU – patient enrolment completed) are currently ongoing, while a trial in renal transplant is expected to commen ce in the near future. In addition, Cynata has also demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registr y service provider, Automic Group. A Clinical Stage Next Generation Stem Cell Therapeutics Company Investor Presentation June 2024 Summary information This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries (CYP) which is current as at 26 June 2024. This Presentation should be read in conjunction with CYP’s other periodic and continuous disclosure information lodged with the Australian Securities Exchange (ASX), which are available at www.asx.com.au. Not an offer This Presentation is not a prospectus, product disclosure statement or other offering document under Australian law (and will not be lodged with the ASIC) or any other law. This Presentation is for information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in any jurisdiction. The release, publication or distribution of this Presentation (including an electronic copy) outside Australia may be restricted by law. If you come into possession of this Presentation, you should observe such restrictions. Any non-compliance with these restrictions may contravene applicable securities laws. Not investment advice This Presentation does not constitute investment or financial product advice (nor tax, accounting or legal advice) or any recommendation by CYP or its advisers to acquire CYP securities. This Presentation has been prepared without taking account of any person’s individual investment objectives, financial situation or particular needs. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own investment objectives, financial situation and needs and seek legal, accounting and taxation advice appropriate to their jurisdiction. CYP is not licensed to provide financial product advice in respect of CYP securities. Investment risk and past performance An investment in CYP securities is subject to known and unknown risks, some of which are beyond the control of CYP and its directors. CYP does not guarantee any particular rate of return or performance of CYP. Past performance cannot be relied upon as an indicator of (and provides no guidance as to) future CYP performance including future share price performance. Financial data All financial information in this Presentation is in Australian currency (A$) unless otherwise stated. This Presentation contains historical financial information based on the Company’s results for the quarter to 31 March 2024. This information is disclosed in the Appendix 4C report lodged with the ASX on 30 April 2024. Any discrepancies between totals and sums of components in tables and figures in this Presentation are due to rounding. Forward-looking statements This Presentation contains certain ‘forward looking statements’, which can generally be identified by the use of forward looking words such as ‘expect’, ‘anticipate’, ‘likely’, ‘intend’, ‘should’, ‘could’, ‘may’, ‘predict’, ‘plan’, ‘propose’, ‘will’, ‘believe’, ‘forecast’, ‘estimate’, ‘target’, ‘outlook’, ‘guidance’, ‘potential’ and other similar expressions. The forward looking statements contained in this Presentation are not guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of CYP, its directors and management, and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct. There can be no assurance that actual outcomes will not differ materially from these forward looking statements. A number of important factors could cause actual results or performance to differ materially from the forward looking statements. No representation or warranty, express or implied, is made as to the accuracy, likelihood of achievement or reasonableness of any forecasts, prospects, returns or statements in relation to future matters contained in this Presentation. The forward looking statements are based on information available to CYP as at the date of this Presentation. Except as required by law or regulation (including the ASX Listing Rules), CYP and its directors, officers, employees, advisers, agents and intermediaries undertake no obligation to provide any additional or updated information whether as a result of new information, future events or results or otherwise. You are strongly cautioned not to place undue reliance on forward-looking statements, particularly in light of the current economic climate and the significant volatility, uncertainty and disruption caused by the outbreak of COVID-19. Industry and Market data Certain market and industry data used in connection with this Presentation may have been obtained from research, surveys or studies conducted by third parties, including industry or general publications. Neither CYP nor its representatives have independently verified any such market or industry data provided by third parties or industry or general publications. Disclaimer To the maximum extent permitted by law, CYP and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents (Related Persons) exclude and disclaim all liability, including without limitation for negligence, for any expenses, losses, damages or costs arising from this Presentation or reliance on anything contained in or omitted from it. To the maximum extent permitted by law, CYP and its Related Persons make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this Presentation and disclaim any obligation or undertaking to release any update or revision to the information in this Presentation to reflect any change in expectations or assumptions. Statements made in this Presentation are made only as at the date of this Presentation. The information in this Presentation remains subject to change without notice. 2 Important information 1. Also known as mesenchymal stromal cells 2. Zhou, J., Shi, Y. Cell Mol Immunol 20, 555–557 (2023). 3. Initial data in first 16 patients (n=8 per group) after 10 weeks; final results in all 30 patients expected in late 2024/early 2025 3 Company highlights Revolutionary Cymerus manufacturing platform Compelling clinical data Rich clinical pipeline • Mesenchymal stem cells (MSCs)1 have shown potential to treat a wide range of illnesses,2 but standard manufacture requires ongoing supply of new donors → challenges with consistency, potency and scale • The patented Cymerus platform is based on induced pluripotent stem cell (iPSC) technology • Overcomes major obstacle to commercialisation in this highly promising field, by enabling production of an effectively limitless quantity of consistent, high-quality MSC doses from a single blood donation • Acute graft versus host disease (aGvHD) Phase 1: 53% complete response; 87% overall response • Diabetic foot ulcer (DFU) Phase 1: 88% median wound surface area reduction vs 51% in controls3 • Three major randomised controlled clinical trial readouts upcoming: DFU (Ph 1) – late 2024/early 2025; aGvHD (Ph 2) – 2H 2025; and osteoarthritis (Ph 3) – early 2026 • New trial in kidney transplantation to commence in mid 2024 1. Initial data in first 16 patients (n=8 per group) after 10 weeks; final results in all 30 patients expected in late 2024/early 2025 4 FY 2024 – a year of progress Completion of patient enrolment in two randomised controlled trials Further encouraging clinical efficacy data Senior management team strengthened • Phase 3 osteoarthritis – enrolment completed November 2023 • Phase 1 DFU – enrolment completed April 2024 • Promising initial data from ongoing DFU trial released in February 2024 • New Chief Business Officer position created to drive next stage of commercial growth (Dr Mathias Kroll – commenced Apr 2024) New trials adding to rich pipeline • Global Phase 2 aGvHD trial – first patient enrolled in March 2024 • New kidney transplant trial approved and ready to commence Revolutionary iPSC-based Cymerus Manufacturing Platform 1. Also known as mesenchymal stromal cells 2. Kelly and Rasko, Front. Immunol. 12:761616 (2021) 3. Sarsenova et al, Front. Immunol.13:1010399 (2022) 6 Therapeutic potential of MSCs Mesenchymal stem cells1 (MSCs): • Promote an immunomodulatory environment2 • The “sensor and switcher of the immune system”3 • Promote tissue repair and regeneration • Can be used without matching donors to recipients • Can be engineered to express other functional/therapeutic molecules • However, with conventional manufacturing methods, there are consistency, potency and scalability challenges 7 Advantages of iPSC-based platform Induced pluripotent stem cells (iPSCs): • Mature adult cells reprogrammed to become pluripotent, which means: • Effectively limitless proliferation capacity • Potential to differentiate into any adult cell type (including MSCs) • Similar properties to embryonic stem cells … but iPSCs are derived from adult donors, so they avoid ethical controversy associated with embryonic stem cells → iPSCs are ideal starting material for commercial production of cellular products Conventional MSC process 8 Major challenges: • Logistically challenging • Inter-donor variability – inconsistent activity in MSCs from different donors • MSCs undergo functional changes and loss of potency during extensive culture expansion Substantial inter- donor variability Small number of MSCs per donation MSC isolation Culture expansionOngoing need for new donors Extensive MSC culture expansion required Cymerus iPSC-based process Avoids inter-donor variability Effectively limitless expansion potential Minimal MSC culture expansion One donor, one time Reprogramming & iPSC expansion Differentiation into MSCs & culture expansion Advantages of Cymerus platform: • Effectively limitless iPSC expansion potential • Avoids need for new donors • Avoids inter-donor variability • Avoids extensive MSC expansion • High level potency, consistency and scalability Robust patent protection 9 Strategic partnership with Fujifilm • Fujifilm: one of largest healthcare conglomerates globally, with significant assets in biotechnology sector, bolstered by recent multi-billion dollar investments • Fujifilm Cellular Dynamics Inc (FCDI: subsidiary of Fujifilm) developed the original iPSC line used in Cynata’s Cymerus manufacturing process • Cymerus manufacturing process being established at FCDI, with Cynata’s progress showcasing Fujifilm’s iPSC platform • Fujifilm holds a 4.5% shareholding in Cynata Compelling Clinical Data: CYP-001 for aGvHD CYP-001: Two Nature Medicine publications 11 Phase 1 trial of CYP-001 was the first completed clinical trial worldwide with any iPSC-derived product - Subjects received - Eight subjects were enrolled in each cohort, but one subject in Cohort B withdrew prior to infusion of CYP-001 ‡ Subject A3 showed a PR at Days 14 and 21 but died due to pneumonia on Day 28; * Subject B5 withdrew from the trial on Day 22 to commence palliative care 1x106 cells/kg (max 1x108 cells) or 2x106 cells/kg (max 2x108 cells) by IV infusion on D0 and D7 For further information: https://clinicaltrials.gov/study/NCT02923375 aGvHD | Phase 1 clinical trial - results Product: CYP-001 (Cymerus MSCs for intravenous infusion) 12 87% Overall response 53%Complete response 2yr survival 60% • CYP-001 was shown to be safe and well tolerated, with sustained outcomes up to 2 years after the first infusion • No serious adverse events or other safety concerns related to CYP-001 • Very encouraging response rates and overall survival Trial conducted in 15 patients with steroid-resistant aGvHD 1. Note sales figures relate to all approved indications, including myelofibrosis, polycythemia vera, and GvHD • First line treatment for aGvHD is corticosteroids – but up to 50% fail to respond – known as steroid-resistant aGvHD (SR-aGvHD) • Numerous other therapies (e.g. immunosuppressants) have been investigated for SR-aGvHD, but most have limited efficacy and/or problematic safety profiles • Ruxolitinib (a JAK kinase inhibitor): • Approved for treatment of SR-aGvHD in 2019 by the US FDA • Forecast sales of US$4.5b in 20241 • Led to relatively good response rates in SR-aGvHD, but no apparent improvement in overall survival • Associated with a high rate of potentially serious adverse reactions  There remains a significant unmet need for safer and more effective aGvHD treatments 13 aGvHD treatment landscape 14 Efficacy of CYP-001 vs other treatments in SR-aGvHD • Overall response rates for BAT an Rux declined between D28 and D56 • Overall response rate for CYP-001 increased between D28 and D60 • Overall survival rate for CYP-001 was 60% at both 18 and 24 months • Overall survival rates for BAT and Rux were 36% and 38% at 18 months, and not evaluable at 24 months BAT = “best available therapy” in study NCT02913261 - other therapies commonly used in patients with steroid-resistant acute graft versus host disease (SR-aGvHD) Rux = ruxolitinib (now approved for SR-aGvHD) in study NCT02913261 CYP = CYP-001 in study NCT02923375 Note: comparisons are for illustrative purposes only; data taken from different clinical trials with different sample sizes (BAT: n=155; Rux: n=154; CYP-001: n=15). D28/D56 time points used for response rate comparison as D28/D56 were the only response rate time points reported in the BAT/Rux clinical trial (NCT02913261). 1. Overall Response at Day 56-60 refers to Day 56 response for BAT & Rux, and Day 60 response for CYP-001. BAT Rux CYP BAT Rux CYP BAT Rux CYP Overall Response at Day 28 Overall Response at Day 56-601 Overall Survival at 18 months 1. JAKAFI® (ruxolitinib) tablets, for oral use, US FDA approved Prescribing Information, September 2021. Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4 = Life-threatening consequences; urgent intervention indicated. • No safety concerns related to CYP-001 have been identified • Conversely, adverse reactions to ruxolitinib are common • Grade 3-4 (serious/life-threatening) adverse reactions to ruxolitinib in aGvHD patients include:1 15 Safety of CYP-001 vs other treatments in SR-aGvHD Adverse Reaction Grade 3-4 Incidence Infections (type of infection not specified) 41% Bacterial infections 28% Haemorrhage (bleeding) 20% Fatigue 14% Viral infections 14% Hypertension (high blood pressure) 13% Oedema (fluid retention) 13% Thrombosis (blood clots) 11% Blood disorders (thrombocytopenia, anaemia, neutropenia) 61%, 45%, 40% CYP-006TK for DFU 17 CYP-006TK – a novel topical MSC product • CYP-006TK utilises a proprietary surface-coating, optimised for the delivery of MSCs directly to the wound bed • Technology exclusively licenced to Cynata by Tekcyte Limited iPSC-derived MSCs 18 DFU | Phase 1 clinical trial – initial data Product: CYP-006TK (topical Cymerus MSC wound dressing) • Ongoing trial in non-healing diabetic foot ulcer (DFU) • Patients randomised to receive standard of care (SoC) or CYP-006TK for 4 weeks, followed by SoC • In the first 16 patients enrolled in the trial (8 per group), after 10 weeks’ follow-up, the median reduction in wound surface area was: • 87.6% in the active CYP-006TK group • compared to 51.1% in SoC group Day 0 Day 28 Example of ulcer healing in patient treated with CYP-006TK: For further information: https://clinicaltrials.gov/study/NCT05165628 Rich Clinical Pipeline – Multiple Upcoming Data Readouts 1. Global Graft versus Host Disease Market 2019-2029 (Reflects forecast market in 2026); 2. Zion Market Research, 2019 (represents global treatment market in 2025); 3. Persistence Market Research 2018 research report: “Osteoarthritis Treatment Market: Global Industry Analysis (2012-2016) and Forecast (2017-2025) (Reflect OA market by 2025); 4. Organ Transplant Immunosuppressant Drugs Market in 2026, Grand View Research, Inc.,2019 USYD = University of Sydney; NHMRC = National Health and Medical Research Council; LUMC = Leiden University Medical Center 20 Advanced and diverse clinical pipeline Indication Market opportunityTrial phase Phase 2 underway Phase 1 approved Renal Transplantation (Renal) CYP-001 (managed and funded by LUMC) Phase 1 underway (patient enrolment complete) Diabetic Foot Ulcers (DFU) CYP-006TK Acute Graft vs Host Disease (aGvHD) CYP-001 (FDA Orphan Designation) US$5.9bn4 US$600m1 US$11.6bn3 US$9.6bn2 Phase 3 underway (patient enrolment complete) Osteoarthritis (OA) CYP-004 (managed by USYD, funded by NHMRC) Cynata SponsoredPartnered 21 aGvHD | Phase 2 clinical trial Product CYP-001 (Cymerus iPSC-derived MSCs for intravenous infusion) Indication High risk acute graft versus host disease (aGvHD)1 Study Design • Randomised controlled trial in ~60 adults (steroids + CYP-001 vs steroids + placebo) • Primary objective is to assess efficacy of CYP-001 based on Overall Response Rate at Day 28 Study Conduct • Clinical sites in USA, Europe and Australia • Regulatory/ethics clearance secured in all participating jurisdictions – including IND from US FDA • First patient enrolled – March 2024 • Aiming to complete patient enrolment by end of calendar year 2024 Results Primary evaluation results anticipated in 2H CY 2025 1. aGvHD may occur after bone marrow transplantation/similar procedures, due to donor immune cells (from the “graft”) attacking the transplant recipient (the “host”) For further information: https://clinicaltrials.gov/study/NCT05643638 22 DFU | Phase 1 clinical trial Product CYP-006TK (Novel silicone dressing seeded with Cymerus iPSC-derived MSCs) Indication Non-healing diabetic foot ulcers (DFU) Study Design • Randomised controlled trial in ~30 adults • Patients randomised to receive either standard of care or CYP-006TK for 4 weeks, followed by standard of care • Primary objective is safety; efficacy measures include wound healing, pain and quality of life Study Conduct • Clinical sites in Australia (Adelaide and Perth) • Patient enrolment complete (April 2024) • Last patient visit expected ~September 2024 Results • Positive initial results from first 16 patients – median reduction in wound surface area after 10 weeks was 87.6% in CYP-006TK group compared to 51.1% in controls (n=8 per group) • Final results anticipated in Q4 2024 or Q1 2025 For further information: https://clinicaltrials.gov/study/NCT05165628 23 OA | Phase 3 clinical trial1 Product CYP-004 (Cymerus iPSC-derived MSCs for intra-articular injection) Indication Osteoarthritis (OA) of the knee (Kellgren-Lawrence Grade 2-3) Study Design • Randomised, double-blind placebo-controlled trial in ~320 adults • Each participant receives 3 injections over 12 months; follow-up of 24 months from first dose • Co-primary endpoints are reduction of knee symptoms and measure of cartilage loss Study Conduct • Trial conducted by University of Sydney, funded by Australian Government NHMRC grant • Clinical centres in Australia (Sydney and Hobart) • Patient enrolment complete (November 2023) • Last patient last visit expected ~November 2025 Results • Results anticipated in H1 CY 2026 1. Clinical trial entitled Stem Cells as a symptom – and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis: a randomised placebo-controlled trial (SCUlpTOR). NHMRC: National Health and Medical Research Council For further information: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379726&isReview=true 24 Renal transplant | Phase 1 clinical trial Product CYP-001 (Cymerus iPSC-derived MSCs for intravenous infusion) Indication Prevention of kidney transplant rejection Study Design • ~16 patients to receive CYP-001 after kidney transplantation: cohort 1 (n=3); cohort 2 (n=3); cohort 3 (n=10) • Trial will evaluate safety (all cohorts) and efficacy of MSCs in facilitating reduction of calcineurin inhibitors (anti-rejection medication; Cohort 3) Study Conduct • Trial to be conducted and funded by Leiden University Medical Center (LUMC), Netherlands • Regulatory and ethics approvals in place; final trial start-up activities ongoing • Aiming to commence patient enrolment in mid 2024 Results Results of Cohort 1 anticipated in late 2024 Strategy, Outlook and Corporate Overview 26 Research partnerships Large body of positive preclinical data generated via R&D partnerships: • GvHD • Diabetic wounds • Critical limb ischaemia • Organ transplant rejection • Osteoarthritis • Respiratory disorders (including asthma, pulmonary fibrosis, acute respiratory distress syndrome) • Sepsis • Cardiovascular disorders (including coronary artery disease, myocardial infarction) • Cytokine release syndrome • Glioblastoma Several of these studies have been published in peer- reviewed journals – see cynata.com/science_publications Studies conducted in partnership with leading research groups worldwide 27 Several distinct products in development → potential for multiple partnerships Reinvestment of proceeds to maximise potential of the platform Platform also available to partners pursuing other indications and/or engineered MSC applications Commercial partnering Source: IRESS 1. As at 31 March 2024 Corporate overview Cynata has been listed on the Australian Securities Exchange (ASX) since 2013 (Ticker: CYP) Financial information Share price (26 June 2024) A$0.28 Shares on issue 179m Market capitalisation ~A$50m Cash1 ~A$9.0m 28 Substantial shareholders (>5%)Shareholder distribution 52% 25% 10% 13% Fidelity Bioscience Managers Other Remaining Top 20 10.0% Fidelity International is a world leading investment and asset management firm, responsible for total client assets of >US$750 billion, from clients across Asia Pacific, Europe, the Middle East, South America and Canada. 13.1% Bioscience Managers is an international healthcare investment firm headquarter in Melbourne that finances and enables innovative science and technology with the potential to transform healthcare. Highly skilled and experienced senior leadership team with decades of experience 29 Board & senior management Dr Darryl Maher Independent Non-Executive Director • Former Vice President, R&D and Medical Affairs at CSL Behring • Former President of Australian Pharmaceutical Physicians Association and Director of Vaccine Solutions Dr Paul Wotton Independent Non-Executive Director • 30+ years' experience • Previously CEO of Ocata Therapeutics (acquired by Astellas) and Obsidian Therapeutics • EY Entrepreneur of the Year (NJ, 2014) Ms Janine Rolfe Independent Non-Executive Director • 20+ years legal, governance and management experience across multiple sectors • Founder of Company Matters Dr Mathias Kroll Chief Business Officer • 25+ years' experience in biopharmaceutical industry • Previously held leadership positions at various institutions, including Bayer, Sanofi-Aventis and GlaxoSmithKline Dr Geoff Brooke Independent Non-Executive Chair • 30+ years' experience in the healthcare investment industry • Founder and MD of Medvest Inc and GBS Venture Partners Dr Kilian Kelly Chief Executive Officer & Managing Director • 20+ years' experience in biopharma R&D • Previous roles at Biota Pharmaceuticals, Mesoblast, Amgen & AstraZeneca Dr Jolanta Airey Chief Medical Officer • 25+ years' experience in respiratory, rheumatology, dermatology, biologicals and listed companies • Previously Director, Translational Development at CSL Mr Peter Webse Company Secretary • 25+ years company secretarial experience • Director of Governance Corporate Pty Ltd 30 Upcoming catalysts* Results of three randomised controlled clinical trials expected between early 2025 and early 2026 * Timing of events is approximate, and subject to change Results Completion of enrolment Results Results Start of enrolment Mid 2024 • Renal trial – start of enrolment 2H 2024 • Renal trial – results (Cohort A) • aGvHD trial – completion of enrolment 1H 2025 • DFU trial – results (potentially late 2024) 2H 2025 • aGvHD trial – results 1H 2026 • OA trial - results Next generation stem cell company • Leading platform technology in burgeoning stem cell sector • Diverse and highly credentialed leadership team with proven experience Scalable manufacturing • Cymerus manufacturing technology protected by robust patent portfolio • Enables scalable production of consistent MSCs from a single donation from a single donor, overcoming major challenges with conventional approaches Compelling clinical data • Very encouraging safety and efficacy results from aGvHD clinical trial (CYP-001) • Promising initial data from ongoing DFU clinical trial (CYP-006TK) Rich clinical pipeline • Broad pipeline with four active clinical programs • FDA cleared IND for Phase 2 aGvHD clinical trial; study underway • Patient enrolment complete in DFU & OA clinical trials • Commencement of renal transplantation clinical trial imminent Significant growth potential • Global estimated market opportunity across targeted indications of ~US$28bn1 • Focus on indications with significant unmet need • Proactive B-2-B outreach to drive partnering strategy 31 Summary 1. Refer to slide #20 for breakdown/sources Contact Us Cynata Therapeutics Limited Level 3, 100 Cubitt Street Cremorne Victoria 3121 Australia [email protected] www.cynata.com cynatatherapeutics @cynatastemcells cynata-therapeutics

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