Slide 1: Financial Results and Operational Update for Full Year Ended June 30, 2025
mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial Results and Operational Update for the Full Year Ended June 30, 2025 August 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 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 activity, perf
Slide 3: Our Mission
Mesoblast is committed to bringing to market innovative off-the-shelf allogeneic cellular medicines to treat serious and life-threatening inflammatory illnesses Our Mission
Slide 4: Global leader in allogeneic cellular medicines for inflammatory diseases
Global leader in allogeneic cellular medicines for inflammatory diseases Global ✓ World leaderMarkets in developing allogeneic (off-the- shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions ONE ✓ Locations in Australia, the United States and product FDA
Slide 5: Platform technology: shared mechanism of action across our products
Platform technology: shared mechanism of action across our products Our mesenchymal precursor/stromal cells respond to and are activated by multiple inflammatory cytokines through surface receptors, resulting in orchestration of an anti-inflammatory cascade Inflammation IL-10 Breg TH1 Proliferation
Slide 6: Mesoblast allogeneic Mesenchymal Stromal Cell portfolio
Mesoblast allogeneic Mesenchymal Stromal Cell portfolio Product Indication Phase 2 Phase 3 Regulatory Filing Approved Pediatric RYONCIL® SR-aGvHD remestemcel-L Adult SR-aGvHD RYONCIL® IBD / remestemcel-L UC & Crohn’s Adult HFrEF Class II/III REVASCOR® Adult HFrEF rexlemestrocel-L End-stage (STRO3+)
Slide 7: Global Markets
Addressable annual market opportunity for product portfolio First mesenchymal stromal cell (MSC) therapy approved by FDA Global Markets • Steroid-refractory acute GvHD for children & adults ~US$1 billion • Biologic-refractory inflammatory bowel disease >US$5 billion • Heart failure with reduced ejec
Slide 8: Successful commercial launch of Ryoncil
Successful commercial launch of Ryoncil® In December 2024, Ryoncil® became the first and only FDA approved MSC product in the US. Ryoncil® became commercially available for purchase on March 28, 2025, within one quarter of receiving FDA approval for treatment of SR-aGvHD in children. Since launching
Slide 9: Financial Results for the Period Ended June 30, 2025
Financial Results for the Period Ended June 30, 2025 Manufacturing Remestemcel-L 9 © Lonza, reproduced with permission mesoblast
Slide 10: Financial highlights for the year ended June 30, 2025
Financial highlights for the year ended June 30, 2025 Revenue from cell therapy products was US$17.2 million, up 191% on prior year. Revenue growth driven by successful launch of Ryoncil® in the final quarter, with US$13.2m gross sales and US$11.3m in reported net sales after 14.6% gross to net adju
Slide 11: Total Revenues from cell therapy products up 191% on prior year
Total Revenues from cell therapy products up 191% on prior year Cost of Revenues • Related to product sales were $1.2m, 10% of net product sales (gross margin of 90%). • Additionally, $3.9m of expenses related to non-cash amortization of the intangible value of the prior MSC asset acquisition. Selli
Slide 12: First mesenchymal stromal cell (MSC) therapy approved by FDA
First mesenchymal stromal cell (MSC) therapy approved by FDA 12 mesoblast
Slide 13: Opportunity to address critical unmet need in SR-aGvHD
Opportunity to address critical unmet need in children 2 months and older, including adolescents & teenagers with SR-aGVHD >30,000 allogeneic BMTs performed globally ~1,500 Approx. 10,000 allogeneic BMTs performed in the US (>20K US/EU) annually, Children & adolescents annually ~20% pediatric2,3 und
Slide 14: Ryoncil delivered high overall response rates at Day 28
Ryoncil® delivered high overall response rates at Day 28, a measure that predicts survival in aGvHD MSB-GVHD0011,2 Overall Response Rate (n=54) Single-arm, multi-center Phase 3 at Day 28 95% CI 56.4, 82.0 70% SR-GvHD severity3 at baseline in GVHD001: RYONCIL treatment was not discontinued or interru
Slide 15: Only 14% died due to aGvHD through 4 years
Ryoncil® long-term survival free from aGvHD Long-term follow- Year 2 Survival: Children from up of Ryoncil by the Center for International Blood GVHD001 51% and Marrow N=51 Year 4 Survival: Transplant Research (CIBMTR) 88% Grade C/D 49% Only 14% (N=7) died due to aGvHD through 4 years 15 Data on fil
Slide 16: High cost of treating child who dies from SR-aGvHD
High cost of treating child who dies from SR-aGvHD The cost of treating a child who dies of SR-aGVHD within 12 months of transplant is: ➢ Approximately $2.5M ➢ $1.8M higher than for those with SR aGvHD who remain alive1 1. Grabner M et al. Economic burden of acute steroid-refractory graft-versus-hos
Slide 17: Value of Ryoncil in treating pediatric patients with SR-aGvHD
Value of Ryoncil® in treating pediatric patients with SR-aGvHD Total benefits of patient outcomes using Ryoncil® range $3.2m to $4.1m (comprising long-term survival benefit, cost-offset, and cost-savings) Benefits based on health economic models for lifetime ultra rare disease and high- impact short
Slide 18: Label extension strategy for Ryoncil in adult patients with SR-aGvHD
Label extension strategy for Ryoncil® in adult patients with SR-aGvHD Most of the sites already onboarded for use of Ryoncil® in children with SR-aGvHD also perform adult bone marrow transplants. We have an active compassionate care program to provide Ryoncil® to adults with SR-aGvHD who have failed
Slide 19: Ryoncil: Expanding the Label
Ryoncil® Expanding the Label Expanding the Label 19 mesoblast
Slide 20: Inflammatory Bowel Diseases: Ulcerative Colitis & Crohn's Disease
Inflammatory Bowel Diseases (IBD): Ulcerative Colitis (UC) & Crohn’s Disease (CD) Ulcerative Population Colitis More than 3 million people in the US alone have inflammatory bowel Affects the disease1 colon causing inflammation Approximately 38,000 new cases of ulcerative colitis and 33,000 new of th
Slide 21: Local administration of MSCs improves outcomes in ulcerative proctitis
Local administration of mesenchymal stromal cells is safe and improves outcomes in ulcerative proctitis Ulcerative proctitis (UP) occurs in all patients with ulcerative colitis (UC) and isolated to the rectum in 30%. 13 adult patients with biologic- refractory UP received local administration into t
Slide 22: Local administration of Ryoncil improves outcomes in biologic-refractory extensive colitis
Local administration of Ryoncil® improves outcomes in patients with biologic-refractory extensive colitis In 12 patient pilot study of biologic-refractory inflammatory colitis local administration of Ryoncil® resulted in clinical and endoscopic response and remission by 6 weeks.1,2 In Crohn’s coliti
Slide 23: Rexlemestrocel-L: Chronic Low Back Pain
Rexlemestrocel-L Chronic Low Back Pain due to Degenerative Disc Disease (CLBP) 23 mesoblast
Slide 24: Chronic low back pain due to degenerative disc disease impacts 7M+
Chronic low back pain due to degenerative disc disease (CLBP) impacts 7M+ Burden of Illness Treatment Options Market Opportunity Back pain causes more Minimal treatment options Over 7m patients are disability than any other for patients with chronic low estimated to suffer condition1 back pain (CLBP
Slide 25: Patients with CLBP refractory to standard treatment have minimal options
Patients with CLBP refractory to standard treatment have minimal options Rexlemestrocel-L has potential to be first-line treatment for patients with moderate to severe CLBP, refractory to conservative treatment Rexlemestrocel-L targeting moderate-to-severe CLBP Conservative Opioid Interventional Sur
Slide 26: Phase 3 outcomes showed more than three years of pain reduction
Phase 3 trial outcomes based on a single injection of rexlemestrocel-L + HA showed more than three years of pain reduction Greatest pain reduction was observed in the pre-specified population of subjects with CLBP duration shorter than the baseline study median of 68 months (n=202) with significantl
Slide 27: Rexlemestrocel-L: Heart Failure
Rexlemestrocel-L Heart Failure 27 mesoblast
Slide 28: Adult HFrEF with underlying ischemia is increasing in prevalence
Adult: Heart failure with low ejection fraction (HFrEF) and underlying ischemia is increasing in prevalence and associated with high risk of mortality, heart attacks and strokes Heart failure affects 6.5 million patients in the US alone, with prevalence increasing.1 Chronic heart failure (CHF) is a
Slide 29: REVASCOR has potential to improve endothelial dysfunction in HFrEF patients
REVASCOR has the potential to improve endothelial dysfunction in HFrEF patients across the spectrum of disease from mild-moderate to end-stage patients with a left ventricular assist device (LVAD) Mesoblast’s Programs for REVASCOR (150 million MPCs) DREAM HF-1 Trial LVAD MPC Studies 537 Patients 159
Slide 30: MPCs reduce CV mortality by 60-80% in HFrEF with inflammation
MPCs Compared to Controls Reduce CV Mortality by 60-80% in Patients with HFrEF and Baseline Inflammation (hsCRP >2mg/ml or IL-6 >3.4pg/ml) Perin EC, Borow KM, Henry TD, et al. Mesenchymal precursor cells reduce mortality and major 30 mesoblast morbidity in ischaemic heart failure with inflammation:
Slide 31: Greatest treatment effect on MACE in chronic HFrEF with ischemia plus inflammation
MPCs Compared to Controls had the Greatest Beneficial Treatment Effect on 2-Point MACE and 3-Point MACE in the Sub-group of Chronic HFrEF Patients with Baseline Ischemia plus Inflammation Perin EC, et al Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with
Slide 32: Pathway to accelerated approval for Revascor in adults with HFrEF
Pathway to accelerated approval for Revascor® in adults with HFrEF DREAM-HF Trial over a mean follow-up of 30 months showed significant reduction in 3-Point MACE in ischemic HFrEF patients (n=158). LVAD-MPC Study #2, over 12 months of follow-up, showed significant increase in proportion of LVAD reci
Slide 33: Key Corporate Milestones
Key Corporate Milestones 33 mesoblast
Slide 34: Mesoblast expects to advance its pipeline toward FDA approvals over next six to twelve months
Mesoblast expects to substantially advance its multiple product pipeline toward FDA approvals over the next six to twelve months Program Key Objectives Commence registration trial for label expansion in adults with RYONCIL® 1 severe SR-aGvHD. Pediatric & Adult Inflammatory Diseases Commence registra
Slide 35: Thank You
mesoblast Thank You 35 mesoblast