Mesoblast (US:MESO)2025-11-24 23:00RYONCIL (remestemcel-L-rknd) - RYONCIL received U S FDA approval in December 2024[10] - RYONCIL is the first and only FDA-approved allogeneic mesenchymal stromal cell (MSC) product[10] - Gross revenue from RYONCIL was US$22 million in Q1 FY26 and is expected to be >US$30 million in Q2 FY26[10] - Over 40 centers have been onboarded, with 45 centers accounting for approximately 80% of U S pediatric BMTs[26,41] - A pivotal study of RYONCIL in adults with severe SR-aGvHD is planned, targeting a market 3-4 times larger than the pediatric market[28,41] - An IND filing for inflammatory colitis in children & adults is planned for Q1 CY26[30,41] Rexlemestrocel-L - Enrollment for the confirmatory Phase 3 trial for Chronic Low Back Pain (CLBP) is expected to be completed in Q1 CY26[36,41] - A BLA filing for accelerated approval in end-stage Chronic Heart Failure (CHF) with LVADs is expected[40,41] - By 36 months, 28% of opioid users who received rexlemestrocel-L + HA were able to eliminate all opioids compared with 8% of saline controls (p=0 0083)[38] Financial Status and Manufacturing - The company had a cash balance of US$145 million as of September 30, 2025[11] - The company is optimizing manufacturing and logistics in the U S to support future growth[41]