Alliance for Regenerative Medicine Meeting Presentation

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 8 October 2024 Cynata to Present at Alliance for Regenerative Medicine Meeting Melbourne, Australia; 8 October 2024: Cynata Therapeutics Limited (ASX: “ CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is participating in the Cell and Gene Meeting on the Mesa in Phoenix, Arizona. This annual conference is run by the Alliance for Regenerative Medicine (ARM) , which represents more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organisations. The conference program features expert -led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by the leading publicly traded and privately held companies in the space . The conference attracts more than 2,000 attendees from over 150 companies. At 10:45am local time today (8 October 2024), Dr Kilian Kelly, Cynata’s Chief Executive Officer and Managing Director, will present on the Company’s Cymerus™ iPSC1-derived MSC2 technology and clinical development programs. Cynata will also be participating in partnering meetings throughout the conference. A copy of the presentation is attached. -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 mesenchymoangioblast (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 commence 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. 1 iPSC = induced pluripotent stem cell 2 MSC = mesenchymal stem (or stromal) cell A Clinical Stage Next Generation Stem Cell Therapeutics Company Phoenix, Arizona, 8 October 2024 Summary information This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries (CYP, or Cynata) which is current as at 4 October 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 financial information that has been disclosed to the ASX. 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. 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 3 Company highlights 1. Also known as mesenchymal stromal cells 2. Zhou J, Shi Y. Cell Mol Immunol 20, 555–557 (2023) 3. CYP-001 granted Orphan Drug Designation for treatment of aGvHD – qualifies Cynata for incentives including extended marketing exclusivity, tax credits and fee waivers Revolutionary Cymerus manufacturing platform • Mesenchymal stem cells (MSCs)1 have shown potential to treat a wide range of illnesses2 • However, standard manufacture requires ongoing supply of donors and extensive MSC culture expansion → challenges with consistency, potency and scale • The induced pluripotent stem cell (iPSC)-based Cymerus platform overcomes these challenges by enabling production of an effectively limitless number of consistent MSC doses from a single blood donation Cynata leads the burgeoning iPSC-derived therapy field • First completed iPSC clinical trial worldwide • US FDA Orphan Drug Designation3 and cleared IND4 • Compelling clinical data in acute graft versus host disease (aGvHD)5 and diabetic foot ulcer (DFU)6 • Four active clinical programs (including ongoing Phase 2 and Phase 3 trials) • Three randomised controlled clinical trial readouts upcoming between late 2024 and early 2026 4. IND = Investigational New Drug application – the clearance required from FDA to conduct clinical trials 5. Completed Phase 1 clinical trial in steroid-resistant aGvHD; 6. Initial data in first 16 patients (n=8 per group) after 10 weeks; final results in all 30 patients expected in Q4 2024/Q1 2025 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 * Timing of events is approximate, based on the Company’s information as at the date of this presentation, and subject to change 4 Advanced and diverse clinical pipeline Indication Market opportunityTrial phase Phase 2 ongoing Phase 1/2 approved Kidney Transplantation CYP-001 (managed and funded by LUMC) Phase 1 ongoing (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 ongoing (enrolment complete) Osteoarthritis (OA) CYP-004 (managed by USYD, funded by NHMRC) Cynata SponsoredPartnered Upcoming catalysts* Enrolment completion – Q4 2024 Results – 2H 2025 Enrolment start – Q4 2024 Cohort 1 results – Q1 2025 Results – Q4 2024/Q1 2025 Results – 1H 2026 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: • MSCs undergo functional changes and loss of potency during extensive culture expansion • Continuously finding and testing new donors is logistically challenging • Inter-donor variability – inconsistent activity in MSCs from different donors 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 culture expansion • High level of potency, consistency and scalability Robust patent protection Compelling Clinical Data CYP-001: Two Nature Medicine publications 10 • CYP-001 has been granted Orphan Drug Designation by the US FDA for the treatment of GvHD • Phase 1 trial of CYP-001 was the first completed clinical trial worldwide with any iPSC-derived product 1. CYP-001 is Cynata’s Cymerus iPSC-derived MSC product candidate for intravenous infusion - 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) 11 87% Day 100 overall response 53%Day 100 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 (SR-aGvHD) 12 Ph1 SR-aGvHD results compared to other therapies Notes: • Ruxolitinib is approved for treatment of SR-aGvHD in most jurisdictions • 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/D56-60 time points used for response rate comparison as D28/D56 were the only response rate time points reported in the ruxolitinib/best available therapy clinical trial (NCT02913261); Overall Response at Day 56-60 refers to Day 56 response for ruxolitinib and best available therapy, and Day 60 response for CYP-001. CYP-001 (Ph 1) Ruxolitinib (Ph 3) “Best available therapy” controls (Ph 3) Day 28 Overall Response 67% 62% 39% Day 56-60* Overall Response 73% 40% 22% Overall Survival 60% after 2 years 38% after 18 months 36% after 18 months Safety No safety concerns related to CYP-001 identified Serious adverse reactions to ruxolitinib are common Several other agents investigated for GvHD have poor safety profiles 13 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 (agreement for Cynata to acquire this IP outright announced 1 July 2024) iPSC-derived MSCs 14 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 Outlook 16 Upcoming catalysts* Results of three randomised controlled clinical trials expected between late 2024 and early 2026 * Timing of events is approximate, and subject to changebased on the Company’s information as at the date of this presentation, Completion of enrolment Results Results Start of enrolment Q4 2024 Q1 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Q2 2026 Phase 1/2 kidney transplant Phase 3 osteo- arthritis Phase 2 aGvHD Phase 1 DFU Results Enrolment complete Results Results First patient enrolled Results (Cohort 1) 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 orphan drug designation & cleared IND for ongoing Phase 2 aGvHD clinical trial • Patient enrolment complete in DFU & OA clinical trials • Commencement of kidney 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 17 Summary 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 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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