Record Year for Mesoblast with FDA Approval and Successful Launch of Ryoncil®

Company Overview: Mesoblast Limited, a leader in allogeneic cellular medicines for inflammatory diseases, reported significant financial growth with a 191% increase in revenue to US$17.2 million for the year ending June 30, 2025, driven by the successful launch of its FDA-approved product Ryoncil®.

Product Launch and Market Expansion: Ryoncil®, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children, was commercially launched in March 2025, with plans to expand its indications to adults and other inflammatory conditions.

Financial Performance: Despite a net loss of US$102.1 million for FY2025, Mesoblast maintains a strong balance sheet with US$162 million in cash on hand, supporting ongoing product development and commercialization efforts.

Future Plans and Milestones: The company aims to initiate pivotal trials for Ryoncil® in adults and inflammatory bowel disease, alongside advancing its other therapies, Revascor® and Rexlemestrocel-L, targeting heart failure and chronic low back pain respectively.