Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2025)
23 slides from Mesoblast's shareholder meeting presentation, Nov 25, 2025
Slide 1: Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases
Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Annual General Meeting 2025 November 2025 ASX: MSB; Nasdaq: MESO
Slide 2: Cautionary Note Regarding Forward Looking Statements
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS This presentation includes forward-looking statements and forecasts that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of
Slide 3: Our Mission
Our Mission To be the world’s leading and most innovative cell therapy company, commercializing off-the-shelf allogeneic cellular medicines to treat serious and life-threatening inflammatory illnesses 3
Slide 4: Execution Strategy
Execution Strategy • Continue strong growth in RYONCIL® sales driven by market adoption • Work towards profitability through strong cash flow, judicious use of funds for operations, optimal capital structure • Culture transition to efficient commercial organization (e.g. new Chief Financial Officer,
Slide 5: 2025: Approval & Successful Launch
2025: Approval & Successful Launch • Received U.S. FDA approval RYONCIL December 2024 • RYONCIL is the first and only FDA-approved allogeneic mesenchymal stromal cell (MSC) product • Launched April 2025, with revenues growing quarter on quarter • Gross revenue from RYONCIL US$22 million in Q1 FY26 •
Slide 6: Strong Financial Position
Strong Financial Position Net operating cash usage for Q1 FY26 was $14.9 million Cash Working towards profitability through strong cash flow and judicious use of funds for operations balance Operating plan includes spend on Phase 3 programs, US$145M manufacturing for BLA filing and commercial invent
Slide 7: Leadership to Deliver Commercial Excellence
Leadership to Deliver Commercial Excellence • Team continues to deliver in a highly resilient and agile manner • Capitalize on embedded culture of efficiency, accountability and growth • Expand executive leadership with commercial operational management skills (e.g. new CFO, CCO) • Complement existi
Slide 8: Growth Pipeline Targeting Multiple Inflammation-Based Indications
Growth Pipeline Targeting Multiple Inflammation-Based Indications RYONCIL Chronic Low Remestemcel-L Inflammatory Adult aGvHD Back Pain with Pivotal trial as part Colitis degenerative disc of second-line Biologic refractory disease; regimen inflammatory colitis confirmatory Phase TAM children & with
Slide 9: Optimizing & diversifying manufacturing
Optimizing & diversifying manufacturing Objectives are to meet projected growth in demand through: • Establishing diversified manufacturing • Focusing on process innovation to increase yield & reduce COGS • Scaling manufacturing operations in U.S. Commercial product for CHF & CLBP to be manufactured
Slide 10: Strategic Partnerships
Strategic Partnerships • Objectives to unlock pipeline value and accelerate market access • FDA approval and know-how provides confidence for partner investment in development and label expansion • Strong revenues and payer engagement demonstrates pipeline value and enhances shareholder return • Co-
Slide 11: RYONCIL Update
RYONCIL Update ® Steroid-Refractory Acute Graft Versus Host Disease (SR-aGvHD)
Slide 12: RYONCIL is the first FDA-approved, off-the-shelf cell therapy for children
RYONCIL® is the first FDA-approved, off- the-shelf cell therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR- aGvHD), a life-threatening condition with high mortality rates.1 Press Release available at www.meso
Slide 13: Success of Commercial Launch
Success of Commercial Launch >40 centers onboarded 45 centers ≈ 80% of pediatric BMTs Expect >US$30M >260 million US lives covered under insurance this quarter gross revenue Specific HCPCS J-Code was assigned by CMS Patient hub established 13 BMT: bone marrow transplant | HCPCS: Healthcare Common Pr
Slide 14: Label Expansion into Adults
Label Expansion into Adults Pivotal study of RYONCIL on top of approved second-line therapy in adults with severe SR-aGvHD RYONCIL in Adult aGvHD Working with NIH-funded BMT-CTN, to initiate next quarter Use of RYONCIL under EAP in patients aged 12 and Primary endpoint is Day 28 response older with
Slide 15: Inflammatory Colitis
Inflammatory Colitis RYONCIL in Colitis Label expansion targeting biologic-refractory Local administration moderate/severe inflammatory colitis improves outcomes in patients with biologic- refractory extensive colitis1 Major unmet need across the adult and pediatric population with high risk of cole
Slide 16: Milestones for RYONCIL
Milestones for RYONCIL Increase revenue growth to fund multiple label expansion opportunities in pediatric and adult inflammatory diseases Commence registrational study in Q1 CY26 in adults with severe aGvHD to gain access to a market 3-4 times larger File an IND for inflammatory colitis in children
Slide 17: Rexlemestrocel-L Update
Rexlemestrocel-L Update Chronic Low Back Pain due to Degenerative Disc Disease (CLBP)
Slide 18: Phase 3 CLBP Program On Track
Phase 3 CLBP Program On Track First 404-patient randomized controlled Phase 3 trial completed Actively recruiting a 300-patient confirmatory Phase 3 trial across 40 sites in the U.S., primary endpoint 12-month reduction in pain Enrollment expected to be completed in the coming quarter Data readout &
Slide 19: Rexlemestrocel + HA Reduces And Eliminates Opioid Use In Phase 3 Trial
Rexlemestrocel + HA Reduces And Eliminates Opioid Use In Phase 3 Trial • Of the 168 patients on opioids in prior Phase 3 trial, a single intra-discal injection of rexlemestrocel-l + HA significantly reduced pain at 12, 24 and 36 months • Pain reduction at 12 months predicted reduction in opioid usag
Slide 20: REVASCOR Update (rexlemestrocel-L)
REVASCOR Update ® (rexlemestrocel-L) Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) and Persistent Inflammation 20
Slide 21: CHF Program Update
CHF Program Update Aligned with FDA on items required for filing BLA for end-stage CHF with LVADs regarding CMC potency assays for commercial product release Commercial manufacturing scale-up in U.S. for capacity, cost efficiencies, and diversification Expect to file BLA for Accelerated Approval Q1
Slide 22: Summary & Upcoming Milestones
Summary & Upcoming Milestones RYONCIL, first & only FDA approved MSC product ✓ On track for gross revenue >US$30 million this quarter ✓ Onboarded >40 centers; 45 centers account for ~80% of U.S. pediatric BMTs ✓ Initiating label expansion to adult aGvHD; 3-4x larger market v. pediatric ✓ Inflammator
Slide 23: Thank You
“Jmesoblast Thank You