Slides
Page 1
A New Standard In Cell Therapy Euroz Hartleys Healthcare Forum Dr Kilian Kelly – Chief Executive Officer and Managing Director 5 February 2026
Page 2
Important Information Summary information This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries (CYP, or Cynata) which is current as at4 February 2026. 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. cynata.com2
Page 3
Cynata Therapeutics Next-generation Mesenchymal Stromal Cells (MSCs) 1 cynata.com Commercialising Cymerus , a novel platform producing MSCs from a single blood donation - once, at scale MSCs are powerful immune-modulating and tissue-repairing cells, but naturally scarce in the human body Traditional manufacturing relies on continuously finding donors and faces inconsistency , potency loss, and scaling limits Cynata solves the MSC production bottleneck, unlocking full therapeutic and commercial potential Four clinical programs underway, including advanced Phase 2 & 3 trials across major indications Front-Runner Status World-first: scalable MSCs from a single blood donation Strong IP moat with early clinical efficacy signals True category pioneers in MSC medicine First mover in a high-barrier , low-competition market 1 - Also known as Mesenchymal Stem Cells3
Page 4
Capital Structure Strong balance sheet. Positioned for upside. cynata.com Backed by institutions: Fidelity, BioScience Managers, and Fujifilm among top holders Funded through milestones: Cash runway secured to mid-2026 - through landmark clinical readouts Attractive valuation: Current market cap does not reflect value of advanced clinical pipeline and near-term catalysts Tightly held register: Top 20 own ~48% Share price (4 February 2026) A$0.35 Shares on issue ~237.5m Market capitalisation ~A$83m Cash1 ~A$3.8m 1 - As of 31 December 2025; based on cash balance at end of quarter of ~$2.6m plus ~$1.2m raised via ATM facility subsequent to quarter end Financial Information Top Holders 9.9% 8.2% 3.4% 4
Page 5
Cynata Is At An cynata.com Tightly focused clinical pipeline Entering the most important chapter in Cynata’s history Two major clinical trial readouts this financial year Advancing with in -human efficacy and safety data already in place Positioned well for global licensing and joint venture deals Inflection Point Phase 1 Market SizePhase 2 Phase 3 Next Catalyst* US$11.6bn3 Osteoarthritis CYP-004 Acute Graft vs Host Disease CYP-001 Kidney Transplantation CYP-001 Results: Q2 CY 2026 Results: Q2 CY 2026 Cohort 1 Results Released: Dec 2025 US$600m1 US$5.9bn4 Ongoing 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 * Timing of events is approximate, based on the Company’s information as at the date of this presentation, and subject to cha nge. Timing refers to calendar years. Diabetic Foot Ulcers CYP-006TK Results Released: Dec 2024 US$9.6bn2 Complete 5 Patient Visits Complete Enrolment Complete
Page 6
MSCs: Nature’s Repair Cells Powerful. Poised for clinical impact. Naturally found in small quantities in the body Regulate and support immune system and reduce inflammation1 Support tissue repair1 What are MSCs? Why They Matter Target root causes of many diseases, not just symptoms Safe and well-tolerated in human trials Immune-privileged – no donor matching needed First human use of MSC- based therapy was in 2004, in a 9-year old boy with graft versus host disease → patient made complete recovery2 1,800+ clinical trials initiated globally Addressing high-burden diseases with limited treatment options Entering a phase of clinical maturity & market readiness Where They’re Going cynata.com 1 - Spees et al. Stem Cell Res Ther 7:125 (2016) | 2 -Le Blanc et al. Lancet. 363: 1439 –41 (2004) 6
Page 7
Conventional MSC Manufacturing MSCs sourced from donor tissue (e.g. bone marrow) MSCs must be separated from other cells Cells grown in lab to reach treatment scale Expanded MSCs used to treat relatively small number of patients 2 Cell Isolation 1 Donor Tissue Collection 3 Culture Expansion 4 Batch Production Challenges Cymerus MSC Manufacturing 2 iPSC Master Cell Bank1 One Donor. One Time 3 Cymerus TM MSC Production This is a representative, high-level summary of a typical process to produce donor -derived MSCs. Some manufacturing processes ma y differ.cynata.com Blood sample from one healthy adult - just once Blood cells reprogrammed into iPSCs* , then stored in a master cell bank iPSCs directed into MSCs via novel Cymerus process *Induced Pluripotent Stem Cells (iPSCs) Benefits of Cymerus TM New donors required on ongoing basis Sourcing new donors → cost & complexity Donor variability → MSC inconsistency MSCs have limited reproduction capacity → scalability constraints MSCs lose function with over-expansion Inconsistent potency and quality • No need for ongoing donor sourcing or variability • Avoids costs & complexity of sourcing new donors • Avoids variability, as starting material is the same for every batch • Highly scalable: iPSCs have effectively limitless reproduction capacity • No need to over-expand MSCs → retains potency • Consistent, potent MSCs every time 7
Page 8
Cell Source Matters Cynata’s iPSC-derived Cymerus MSCs shown to be superior to donor -derived MSCs in multiple important ways Feature Bone marrow/ adipose- derived MSCs Cynata’s Cymerus MSCs Consistency High variability between donors and batches Minimal batch-to-batch variation Protein secretion (secretome) Limited, donor-dependent Many more unique proteins with enhanced immunomodulatory potential Cell “Age” (senescence) More “aged” cellular profile “Younger” phenotype; sustained regenerative capacity Immunomodulatory effects Moderate and variable Superior immune-balancing activity Wound healing (in vitro) Slower wound closure Significantly faster wound closure Independent validation published in Nature’s npj Regenerative Medicine (Feb 2025)1 cynata.com 1 Hodgson-Garms et al. NPJ Regen Med. 2025;10(1):7. 8
Page 9
Osteoarthritis There’s no cure. Only symptom relief or invasive surgery. What is Osteoarthritis? • Chronic joint disease causing pain, stiffness, and reduced mobility • Driven by inflammation and cartilage breakdown over time • Affects ~600 million people globally; major cause of disability2 • Economic burden >US$486 billion annually in U.S. alone1 Osteoarthritis There’s no cure. Only symptom relief and/or invasive surgery. The Challenge • No cure — current drugs only relieve symptoms • Cartilage loss continues despite treatment • Surgery is invasive, costly, and not suitable for all • Urgent need for therapies that change course of disease cynata.com 1 - Total Economic Impact on the US Economy | BMUS: The Burden of Musculoskeletal Diseases in the United States, Table 8.13 2 - European Journal of Public Health - A cross-sectional study unveiling the global impact and future projections through 2060 of osteoarthritis9
Page 10
Our Osteoarthritis Product • Single intra-articular injection – minimally invasive, outpatient procedure • Aims to delay or avoid knee replacement surgery, restore mobility, and improve quality of life • Could reduce long-term healthcare burden if disease-modifying effect confirmed • Early phase 3rd party studies with traditional MSCs have shown; Strong safety Pain relief Improved joint function • Third party MSC data in OA, and CymerusTM MSC track record supported our direct phase 3 entry • World’s largest MSC-based osteoarthritis trial – 321 patients, managed by the University of Sydney, funded by NHMRC • Randomised, double-blind, placebo-controlled design • Primary endpoints*:change in pain and cartilage thickness (disease modification) • Secondary endpoints*: other assessments of pain, function and quality of life • Final results expected Q2 CY26 cynata.com Our Product: CYP - 004 MSC Pilot Trials Phase 3 Trial * Summary only; see https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000870954 for more information NHMRC = (Australian Government) National Health and Medical Research Council 10
Page 11
Acute Graft vs When life-saving transplants become life-threatening. Host Disease (aGvHD) Donor’s bone marrow 1 Donor’s bone marrow or stem cells are transplanted into the patient 2 Donor’s cells view the patient body as foreign Donor’s stem cells 3 Red Blood Cell White Blood Cell (Immune cells) Donor’s Immune cells attack patient cells throughout the body 4 Symptoms can be severe and life threatening • Gastrointestinal damage: Diarrhoea, vomiting, pain, bleeding • Skin damage: Extensive rash, blisters • Liver damage: Jaundice, pain, swelling, liver failure cynata.com11
Page 12
>38,000 Bone Marrow Transplants per year Our aGvHD Product cynata.com Current Standard of Care for aGvHD < 20% 2 year survival rate3 Up to 50% patients develop aGvHD1,2 First Line Treatments = steroids >50% Don’t respond to steroids3 (known as steroid-resistant aGvHD; SR-aGvHD) >9,500 Steroid-resistant cases of aGvHD per year Only Approved Treatment for SR-aGvHD = ruxolitonib • Limited long-term benefits • Severe & life-threatening side effects common • Cost >US$100,000 per patient treated Our Product: CYP -001 • Delivered via intravenous infusionfor systemic immune modulation. • Aims to reduce reliance on steroids, improve survival, and minimise toxicity. • Potential to become a first-line therapy improving long-term transplant outcomes Cynata Phase 1 Success 4,5 60% Alive after two years 87% Improved by at least 1 grade 53% Showed no signs of aGvHD 0% Serious adverse events related to CYP-001 1 - Reshef et al, J Clin Oncol. 39(17):1878 1887 (2021). | 2 - Akahoshi et al. Blood Adv. 7(16):4479 -4491 (2023). | 3 - Westin et al. Adv Hematol. 2011:601953 (2011) | 4 – Bloor et al. Nature Medicine. 26:1720 –1725 (2020) | 5 – Kelly et al. Nature Medicine 30: 1556 –1558 (2024) 12
Page 13
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; Zeiser et al. N Engl J Med 382:1800-1810 [2020]). 1. Overall Response at Day 56 -60 refers to Day 56 response for BAT & Rux, and Day 60 response for CYP -001 36% 38% 60% Overall Response • Between Day 28 and Day 56 -60, the Overall Response Rate (ORR) for both RUX and BAT decreased markedly, while the ORR for CYP -001 marginally increased Overall Survival • CYP also reported 60% survival at 24 months (not shown on graph, as 18 months was the latest timepoint reported in RUX/BAT trial) Safety • No serious adverse events or safety concerns for CYP -001 39% 62% 67% 0% 10% 20% 30% 40% 50% 60% 70% 80% 22% 40% 73% Day 28 Day 56-601 18 months CYP = CYP-001 in Phase 1 trial (NCT02923375). Rux = ruxolitinibin Phase 3 trial (NCT 02913261) (ruxolitinibis now approved for SR-aGvHD). BAT = “best available therapy” control arm in ruxolitinibPhase 3 trial (NCT02913261) Overall Response Overall Survival BAT RUX CYP BAT RUX CYP ▼17% ▼22% ▲6% BAT RUX CYP 13 cynata.com CYP-001 vs other treatments in SR-aGvHD
Page 14
cynata.com Phase 2 Overview Phase 2 Endpoints* Regulatory Milestones Our Phase 2 aGvHD Trial • Randomised, double-blind, placebo- controlled Phase 2 study • CYP-001 + steroids vs steroids + placebo • 65 adults with newly diagnosed high-risk aGvHD • Sites across the US, Europe, and Australia • Patient enrolment completed Dec 2025 • Primary Endpoint: Overall Response Rate (ORR) at Day 28 • Secondary Endpoints: Duration of response, complete response, response at different timepoints, survival, steroid usage, quality of life, safety profile • Readout Timing: results expected June 2026 FDA Orphan Drug Designation FDA Cleared IND EU EMA IMPD Cleared * Summary only; see https://clinicaltrials.gov/study/NCT05643638 for more information14
Page 15
Cynata’s Broader Disease Pipeline cynata.com Respiratory Diseases Strong Pre-Clinical Data Pulmonary Fibrosis Immune-Related Disorders Asthma Cardiovascular Diseases Heart Failure | Heart Attack Artery Disease Critical Limb Ischemia Current Additional Clinical Programs Kidney Transplantation (Phase 1/2 – Ongoing) • Cynata’ s Phase 1/2 trial underway (Netherlands) with Cymerus MSCs • Investigating reduced reliance on immunosuppressants • Results from Cohort 1 expected Q4 CY25 • Phase 1 trial of Cymerus MSCs showed 83.6% wound reduction vs. 47.8% with standard care • Safe, well tolerated • Exploring next development steps Diabetic Foot Ulcers (DFU) (Phase 1 – Successful) 15
Page 16
cynata.com Upcoming Landmark Readouts Market Size Next Catalyst* US$11.6bn2 Osteoarthritis CYP-004 Acute Graft vs Host Disease CYP-001 Kidney Transplantation CYP-001 Phase 3 Results: Q2 CY26 (Efficacy & Safety) Phase 2 Results: Q2 CY26 (Safety + Efficacy) Cohort 2 Phase 1/2 Results: TBC CY26 (Preliminary Safety) US$600m1 US$5.9bn3 Upcoming Preliminary Readouts 2026 Will Define Cynata Later stage results could become a strategic trigger All commercial activities referenced are potential future options only. No agreements have been made. Licensing / Partnering • Positive Phase 2 & 3 results can trigger regional or indication-specific deals • All our indications are attractive licensing targets with clear market needs • Partnership revenue can help fund future trials without equity dilution M&A Potential • Compelling data + scalable platform = highly strategic assets • Strong potential for synergies with other MSC technologies in the market Joint Development / Pharma Alliances • Shared risk models appeal to global pharma with aligned pipelines • Allows Cynata to enter new markets with global reach and local execution 1. Global Graft versus Host Disease Market 2019 -2029 (Reflects forecast market in 2026) 2. Persistence Market Research 2018 research report: “Osteoarthritis Treatment Market: Global Industry Analysis (2012 -2016) and Forecast (2017-2025) (Reflect OA market by 2025); 3. Organ Transplant Immunosuppressant Drugs Market in 2026, Grand View Research, Inc.,201916
Page 17
Thank You. Cynata Therapeutics Limited Level 3, 100 Cubitt Street Cremorne VIC 3121 Australia +61 (03) 7067 6940 investors@cynata.com