Announcement PDF 1 AdAlta Limited (ASX:1AD) · ABN: 92 120 332 925 · www.adalta.com.au LIMS2 204, La Trobe Institute of Molecular Science, La Trobe University VIC 3086, Australia ASX Announcement | 4 February 2026 AdAlta Limited (ASX:1AD) Increasing patient access to CAR-T cell therapies in Australia and SE Asia: ANZ Biologics Festival presentation AdAlta Limited (ASX:1AD) (“AdAlta” or “the Company”), developer of next generation cell and protein therapeutic products is presenting at ANZ Biologics Festival on 4 February 2026. AdAlta’s CEO and Managing Director, Dr Tim Oldham will present a paper titled “Increasing patient access to CAR-T cell therapies in Australia and SE Asia” in which he will: • Outline the current barriers that exist for patients to maximise access to CAR-T cell therapies • Propose a blueprint to improve that access • Highlight how AdCella’s “East to West” cellular immunotherapy strategy is aligned with this blueprint to bring these ground breaking therapies to more Australian and SE Asian patients Presentation details are: ANZ Biologics Festival 2026 Wednesday, 4 February 2026 3:40 – 4:05 pm AEST Crown Promenade, Melbourne A copy of the presentation is attached and shareholders may comment and ask questions by visiting AdAlta’s InvestorHub here: https://investorhub.adalta.com.au/link/egBBvy This ASX announcement has been authorised for release by the CEO of AdAlta Limited (ASX:1AD). For further information, please contact: AdAlta Limited (ASX:1AD) Tim Oldham CEO & Managing Director P: +61 3 9479 5159 E: t.oldham@adalta.com.au About AdAlta AdAlta (ASX: 1AD) is a clinical stage biotechnology business addressing the need for effective cellular immunotherapies for the treatment of solid cancers. Through its ‘East to West’ strategy, the Company is integrating Asia's prowess in T cell therapy development with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway connecting ‘Eastern’ innovation in cellular immunotherapies with ‘Western’ regulated markets and patients. 2 AdAlta in-licenses products from Asian originators and invests to establish US FDA regulated manufacturing and conduct Phase I clinical studies with potential to position each product for on-licensing to larger biopharmaceutical companies for potential registrational studies and commercialization. AdAlta implements a disciplined approach to asset selection focused on highly differentiated T cell therapy products supported by clinical data in solid cancers. The company adopts a capital efficient business model delivering a rapid return on investment in each project that is replicable and provides opportunities to scale across multiple products. Solid tumours account for 90% of cancers yet remain underserved by current cellular immunotherapies. AdAlta aims to dominate this high-growth segment. The cellular immunotherapy market is projected to grow at a compound annual growth rate of 34% to reach US$20.3 billion by 2028. AdAlta’s first in class fusion protein, AD-214, takes a whole new approach to fibrotic diseases of the lung and kidney, such as the degenerative and fatal Idiopathic Pulmonary Fibrosis. Following demonstration of efficacy in multiple animal models of disease and two successful Phase I clinical studies, AD-214 is available for partnering. To learn more, please visit: www.adalta.com.au For more information Join our InvestorHub Follow us on LinkedIn Follow us on X (formerly Twitter) AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 1 IMPROVING PATIENT ACCESS TO CAR-T CELL THERAPY IN AUSTRALIA AND SE ASIA Tim Oldham CEO and Managing Director, AdAlta Ltd ANZ Biologics Festival 4 Feb 2026 AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 2 ADALTA: NEXT GENERATION CELL & PROTEIN THERAPEUTICS “East to West” cellular immunotherapy strategy for growth Bringing the potential of cellular immunotherapies to solid cancer patients: 90% of cancers, untapped opportunity leveraging existing success in blood cancers and Asian innovation First asset a potential breakthrough treatment addressing US$4b segment of mesothelioma market: BZDS1901 is clinical stage first in class armoured CAR-T product Delivering both clinical and manufacturing proof of concept: Leveraging regional ecosystem and technology partnerships to deliver what larger pharma companies need Capital efficient business model: buying into majority share or short investment horizon projects, leveraging rapid Asian innovation, world class manufacturing partnerships, R&D Tax incentive Two other valuable pipeline assets for monetisation First in class anti-fibrotic protein, AD-214, with strategic partners sought for continued development into Phase II outside the company World first pan-strain inhibitor of malaria parasites, WD-34, with strategic partners sought to advance to proof of concept AdAlta is - a clinical stage biotech: • Growth powered by AdCella “East to West”cellular immunotherapy spin-out • Monetising other valuable assets AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 3 OVERVIEW • CAR-T cell therapies are revolutionizing outcomes in cancer, autoimmune diseases and other fatal diseases • However access to these groundbreaking therapies remains restricted, particularly in small markets like Australia, SE Asia ✗ Financial barriers include reimbursement and margin/cost pressure across the supply chain ✗ Operational barriers include supply chain complexity and delivery system capacity • Actions Australia and SE Asia can take to overcome these barriers include: ✓ Seeking out and developing products with access in mind ✓ Facilitating commercial product licensing ✓ Increasing clinical development, leveraging ”advantage Australia” ✓ Facilitating “home grown”products – carefully ✓ Implementing enablers across the value chain: regulatory, automation, education/models of care and reimbursement/incentives AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 4 CAR-T THERAPIES ARE REVOLUTIONIZING DISEASE OUTCOMES CAR-T cell Turbo-charging patient’s immune cells to “see”and “kill”cancer Living drug, single dose, durable, potentially curative Adapted from:https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy 7 FDA-approved CAR-T therapies for blood cancer 2 FDA-approved T cell therapies for solid cancer in 2024,3 autoimmune coming >US$2.6B earned in 20221 50% of US$20.3B forecast cellular immunotherapy revenue for 20284 Complete response rates:2 83% r/r pALL 51-65% r/r LBCL 78% r/r MM 1.Company websitesand financial filings; 2. Kymriah, Yescarta and Carvytki prescribing information;r/r =relapsed/refractory;pALL– paediatric acutelymphoblasticleukemia, LBCL= largeB celllymphoma, MM= multiplemyeloma; 3.https://www.fda.gov/vaccines-blood-biologics/approved- blood-products/amtagvi; https://www.fda.gov/vaccines-blood-biologics/aucatzyl; 4. Grandview Research, “T-cell Therapy MarketSize,Share & TrendsAnalysis” Feb 2021; PolarisMarket Research, “CAR-T Cell Therapy MarketShare,Size,Trends, Industry AnalysisReport”,June 2021 AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 5 CAR-T ACCESS IS STILL LIMITED, ESPECIALLY OUTSIDE US 12.8 2.2 1.7 0.6 0.1 0 10 USA Europe Japan South Korea China New Zealand Australia CAR-T doses per million population 2023(1) 1. AdAlta analysis of varied market size, value and pricing reports; Australian estimates via industry survey 2. It’s time for CAR-T, CAR-T Vision Report June 2025, https://cartvision.com/ “Despite its curative potential … in the US, as well as in European countries where CAR T-cell therapy is available to treat patients with large B-cell lymphoma (LBCL), only about two out of 10 eligible patients receive access to CAR T-cell therapy” CAR-T Vision2 Product Kymriah (CD19 CAR-T,Novartis) 2017 2018 2021 2018 Yescarta (CD19 CAR-T,Kite) 2017 2018 2020 Tecartus (CD19 CAR-T,Kite) 2020 2020 2021 Breyanzi (CD19 CAR-T,BMS) 2021 2022 Abecma (BCMA CAR-T,BMS) 2021 2021 Carteyva (CD19 CAR-T,JWT) 2021 Yorwida (CD19 CAR-T, HeYuan) 2023 Carvykti (BCMA CAR-T,J&J/Legend) 2022 2022 2024 2023 Fucaso (BCMA CAR-T,IASO) 2023 Zevor-cel (BCMA CAR-T, CARSgen/Nuocheng) 2024 Amtagvi (TIL, Iovance) 2024 Tecelera (MAGE4 TCR-T,USWorld Meds) 2024 Auctazyl (CD19 CAR-T, Autolus) 2024 2025 9 7 6 4 T cell therapies for oncology indications AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 6 BARRIERS TO CAR-T ACCESS • Opacity of system costs • Limited efficacy or durability data • System not geared to "one-and-done" durable treatments Financial - lack of reimbursement/insurance • High COGS limits commercial return to most valuable markets • Ancillary treatment costs, especially AE's, put risk on hospital/payor budgets Financial - margin pressure across value chain • Slow turnaround times/limited capacity in centralised facilities • Complex co-ordination between treatment and manufacturing sites • Onerous conditioning and monitoring requirements Operational - supply chain • High burden to become a qualified treatment centre • Limited capacity in haematology departments – complexity of administration • Lack of awareness, comfort (patients and healthcare professionals) Operational - healthcare system capacity Deep dive topics AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 7 CAR-T CHALLENGES TRADITIONAL REIMBURSEMENT MODELS 2025 Cell and Gene Therapy Report: Advancing the Future of Medicine,InspiroGene by McKesson AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 8 TOTAL COST TO DELIVER CAR-T CELL THERAPY IS SUBSTANTIAL US CAR T-Cell List Prices Carvykti ~$465,000–$500,000+ Kymriah ~$475,000 Yescarta ~$373,000–$400,000+ Tecartus ~$373,000 Abecma ~$400,000+ range Gross margins <50-75% (cf >95% for proteins and small molecules) Source: https://doi.org/10.1016/j.jval.2024.04.004; https://doi.org/10.1007/s40487-023-00228-5 Total cost of CAR-T cell therapy delivery in the US typically ranges from $500,000 to over $1 million per patient $373,000-$475,000 CAR-T product acquisition cost (list) $45,000-$600,000 Comprehensive care (apheresis, infusion, hospitalization, side effect management including ($160,000 average) ICU stays for cytokine release syndrome (CRS), management of neurological events AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 9 INSTITUTIONAL CAPACITY LIMITS ACCESS 2025 Cell and Gene Therapy Report: Advancing the Future of Medicine,InspiroGene by McKesson Up to 25% of eligible, approved patients do not receive therapy • Disease progression prior to product being available • Failedmanufacturing AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 10 ACTIONS TO IMPROVE ACCESS IN ANZ/ASEAN 2025 Cell and Gene Therapy Report: Advancing the Future of Medicine,InspiroGene by McKesson 1. Seeking/designing products for access 2. Facilitate commercial product licensing 3. Increase clinical development: advantage Australia 4. Facilitate "home grown" product development - carefully 5. Implement value chain enablers AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 11 1. DESIGN PRODUCTS FOR ACCESS* What can be done? • Engineer features to enhance efficacy, durability and persistence • Minimize conditioning regimens and adverse event (AE) profile • Shorten manufacturing and QC processes • Establish predictive biomarkers of manufacturing success, clinical response, AE profile • Enable administration in community/out-patient setting eg 50% of Carvykti today • Implement allogeneic/in vivo strategies What are the challenges? • Long term solution implemented product by product • Dependent on new biology • Global, industry objective – cannot be done on a regional basis • Durability comes with experience • Allogeneic and in vivo strategies yet to be proven, especially in solid cancer *This action enhances global access Example: BZDS1901 aPD1-MSLN-CAR-T ✓ Engineered for success First product to secrete PD1 blocking molecules to overcome tumour suppression of CAR-T cells and endogenous T cells ✓ Clinical potential for a step change in care 36 patients in 3 IITs; responses 2-3x better than current 2nd line in r/r mesothelioma – including difficultto achieve complete responses ✓ Faster, cheaper manufacturing Can be manufacturedin less than two days without expensive viral vectors ✓ Well established target Mesothelin (MSLN) is highly expressed on multiple cancers with poor prognosis in advanced mesothelioma ✓ Encouraging safety profile supports lower care/cost Optimised lymphodepletion and predictive markers of adverse immune response AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 12 2. COMMERCIAL PRODUCT LICENSING What can be done? • Fill local product pipeline gaps • License commercial products approved elsewhere for delivery in region • Replicate historical specialty pharma model What are the challenges? • Reimbursement/funding certainty • Managing supply: cost and complexity of technology transfer v long logistics chain competing for scarce capacity in US facilities • Bridging requirements from non-Caucasian, non-Tier 1 regulatory jurisdictions (China, Sth Korea, etc) • Global product or multi-local product: comparability, reproducibility and pharmaco-vigilance *This action enhances global access Example: Selected products approved offshore but not available here (including selected ex vivo gene therapies) AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 13 3. INCREASE CLINICAL DEVELOPMENT: ADVANTAGE AUS What can be done? • Leverage Australia’s excellent cell and gene therapy ecosystem, cost advantages and R&D Tax Incentive to make Australia an early destination for global clinical trials • Brings innovative products to Australian/regional patients early What are the challenges? • CTN not available for ex vivo gene modified cell therapies • Manufacturing/supply chain *This action enhances global access Example: AdCella’s “East to West” cellular immunotherapy strategy AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 14 4. FACILITATE “HOME GROWN”CAR-T PRODUCTS - CAREFULLY What can be done? • Enable academic/not for profit production of CAR-T products at individual hospital centres for administration in that centre • Lowers cost(?) and reduces turnaround time to patient • Enables rapid iteration of product design and development What are the challenges? • Basis for regulatory approval/oversight and funding: hospital exemption, approved product, “generic” or “copy” product, perpetual clinical trial • Standards of quality and efficacy to be met • Basis for differential regulatory treatment cf commercial products • Intellectual property protection; impact on commercial development • Site-to-site quality consistency (production, QC) • True cost of production rarely reflected in costings *This action enhances global access Example: multiple countries experimenting with hospital exemption and“hub and spoke” manufacturing models 2018 National Plan for Advanced Therapies • Hospital exemption pathway for PoC manufacturing • Centralised funding, patient allocation • Hub-and-spoke manufacturing • Centralised patientregistry 2025 Modular manufacturing and point of care amendment UK; CLIC Canada • Allows C&GT to be manufacturedon site/nearby site • Sites must meetlicensing, quality standards • Complements existing hub-and-spoke network of deliveryhospitals for commercialproduct Public-private partnership for indigenous CAR-T • Locally manufactured viral vector, cells at 1<0% of US listprice: IIT Bombay, Tata Memorial, ImmunoACT • Central manufacturing hub, 80 delivery centres • Move towards kits provided by central platform for distributed manufacturing Public supported ”sovereign capability”plan • Pre-approved pricing, abbreviated regulatory path • Academic development (Malaghan), commercial CDMO and delivery centre (bioOra) • Automation (Cocoon), medical tourism for scale AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 15 5. VALUE CHAIN ENABLERS • CTN pathway for ex vivo gene modified cell therapies; conditional approvals • Reduced certification, risk management, monitoring requirements • Manufacturing flexibility: process ≠ product Regulatory • Encourage early adoption of high levels of manufacturing and QC automation • Manufacturing intensity, process development/transfer efficiency, adaptability • Increase digitisation and data … and share across products, patients Automation • Cross-disciplinary care models between haematology and oncology, immunology eg cell therapy fellowships, institutional procedures • Enabling regional/out-patient delivery Education and models of care • Funding pathway clarity • DRGs for CAR-T procedures, AE management • Incentives (pricing, support) for tech transfer and local manufacturing Reimbursement/incentives Deep dive topics AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 16 REGULATORY ENVIRONMENT MOVING IN FAVOUR OF ADAPTIVE MANUFACTURING STRATEGIES Source: Amtagvi Summary Basis of Regulatory Action; https://www.fda.gov/news-events/press-announcements/fda-increases-flexibility-requirements-cell-and-gene-therapies-advance-innovation 11 January 2026 Regulators, industry historical mindset: “product is the process” • Starting material is bigger driver of process outcomes than process itself What is the US FDA allowing? • Faster to clinic: Full cGMP compliance (21 CFR 211) no longer required for Phase 2 trials • Streamlined scale-up: Removal of the rigid "3-lot Process Performance Qualification (PPQ)" requirement • Dynamic specifications: Commercial release criteria can now be "permissive" initially and tightened post-approval • Removed REMS (Risk Evaluation and Management Strategies): reduces hospital certification, compliance burden How does it impact the sector? • Reduces "Manufacturing Death Valley" • Favours automation, continuous improvement approaches” • Enables earlier, more valuable licensing – enhancing confidence for buyers to scale • Increases access: more hospitals able to administer CAR-T with lower monitoring AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 17 CURRENT MANUFACTURING IS THE BOTTLENECK TO SAVING LIVES CURRENT REALITY • Existing CAR-T processes are manual, expensive, and highly variable • High Cost of Goods (COGs): Limits patient access and commercial margins • Scalability issues: Difficult to move from R&D to commercial scale without huge workforce investment • Slow process development and technology transfer: Limited in- process analytical insight,moving production between sites (e.g., Asia to US) is slow, costlyandvariable Prodigy® Cocoon® IRO® Xuri Wave® First generation clinical and commercial manufacturing solutions (Skilled labour intensive, single unit operations, high facility overhead, expensive) G-Rex® Next generation systems (examples) (Closed, compact, multiple unit operations digitally enabled, operated by less skilled labour or robots) FUTURE STATE • Future CAR-T processes are automated, less expensive, and very reproducible • Lower Cost of Goods (COGs): improves commercial viability • Scalable: Limited workforce and facility investment • Faster process development and technology transfer: on board process analytical technology/AI; digital technology transfer ® Xuri Wave, G-Rex, Prodigy, Cocoon and IRO are registered trademarks of Cytiva, Wilson Wolf, Miltenyi, Lonza and Ori Biotech respectively Shuttle® AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 18 A BLUEPRINT FOR CAR-T ACCESS? • CAR-T cell therapies are revolutionizing outcomes in cancer, autoimmune diseases and other fatal diseases • However access to these groundbreaking therapies remains restricted, particularly in small markets like Australia, SE Asia ✗ Financial barriers include reimbursement and margin/cost pressure across the supply chain ✗ Operational barriers include supply chain complexity and delivery system capacity • Actions Australia and SE Asia can take to overcome these barriers include: ✓ Seeking out and developing products with access in mind ✓ Facilitating commercial product licensing ✓ Increasing clinical development, leveraging ”advantage Australia” ✓ Facilitating “home grown”products – carefully ✓ Implementing enablers across the value chain: regulatory, automation, education/models of care and reimbursement/incentives AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 19 FOR MORE INFORMATION PLEASE CONTACT: TIM OLDHAM CEO & MANAGING DIRECTOR +61 403 446 665 T.OLDHAM@ADALTA.COM.AU IR@ADALTA.COM.AU WWW.ADALTA.COM.AU