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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 For personal use only
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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 For personal use only
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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 For personal use only
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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. Compan y web sites and financial filings; 2. Kymriah, Yescarta an d Carvytki prescribing information; r/r = relapsed/refractory; pALL – paediatric acute lymphoblastic leukemia, LBCL = large B cell lympho ma, MM = multiple myelo ma; 3. https://www.fda.gov/vaccines-blo od-biologics/approved- blo od-products/amtagvi; https://www.fda.gov/vaccines-blood-biologics/au catzyl; 4. Gran dview Research, “T-cell Th erapy Market Size, Share & Trends Analysis” Feb 2021; Polaris Market Research, “CAR-T Cell Th erapy Market Share, Size, Tren ds, Ind ustry Analysis Report”, Ju ne 2021 For personal use only
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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 Vision 2 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, US World Meds) 2024 Auctazyl (CD19 CAR-T, Autolus) 2024 2025 9 7 6 4 T cell therapies for oncology indications For personal use only
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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 For personal use only
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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 For personal use only
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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 For personal use only
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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 • Failed manufacturing For personal use only
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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 For personal use only
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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 difficult to achieve complete responses ✓ Faster, cheaper manufacturing Can be manufactured in 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 For personal use only
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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) For personal use only
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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 For personal use only
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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 patient registry 2025 Modular manufacturing and point of care amendment UK; CLIC Canada • Allows C> to be manufactured on site/nearby site • Sites must meet licensing, quality standards • Complements existing hub-and-spoke network of delivery hospitals for commercial product Public-private partnership for indigenous CAR-T • Locally manufactured viral vector , cells at 1<0% of US list price: 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 For personal use only
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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 For personal use only
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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 l icensing – enhancing confidence for buyers to scale • Increases access: more hospitals able to administer CAR -T with lower monitoring For personal use only
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AdAlta Limited (ASX:1AD) | ANZ Festival of Biologics | February 2026 | 17 CURRENT MANUFACTURING IS THE BOTTLENECK TO SAVING LIVES CURRENT REALITY • Existing CAR-T processesare manual, expensive, andhighly variable • High Cost of Goods (COGs):Limits patient access and commercial margins • Scalability issues: Difficult to move from R&D tocommercial scale withouthuge workforce investment • Slow process development and technology transfer: Limited in- process analytical insight, moving production between sites(e.g., Asia to US) is slow, costly and variable 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 processesare 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® For personal use only
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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 For personal use only
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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 For personal use only