Achieved Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain
Activity Report for Quarter Ended March 31, 2026 (Appendix 4C)
NEW YORK, April 29, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third fiscal quarter ended March 31, 2026.
“We’ve had a busy and exciting March quarter marked by a series of major achievements. Ryoncil® revenues are now approaching US$100 million since last year’s launch, we have substantially improved our net operating cash spend, our pivotal trial in inflammatory back pain has successfully achieved its patient recruitment target, and we have bolstered our long-term leadership in the field by acquiring genetically modified technology for precision-enhanced cell therapy products,” said Dr. Silviu Itescu, Mesoblast Chief Executive.
FINANCIAL HIGHLIGHTS FOR QUARTER ENDED MARCH 31, 20261
- Ryoncil® gross sales for the quarter were US$35.3 million, and net revenues were US$30.3 million.1
- Strong sales in February and March offset holiday seasonality in January.
- Revenue generated during this first year of Ryoncil® launch approaches US$100 million.
- Net operating cash spend for the quarter was US$4.1 million. The reduction in net operating cash spend was driven by receipts of US$34.6 million and tight control of operating expenses.
- Mesoblast had US$122 million of cash at March 31, 2026.
OPERATIONAL HIGHLIGHTS
- Achieved patient recruitment target in pivotal phase 3 trial of second-generation product rexlemestrocel-L for chronic low back pain (CLBP).
- Held inaugural R&D day on April 8th in New York. A replay of the event is available here and presentation materials here.
- At the R&D day Mesoblast highlighted its label extension strategy for Ryoncil® in adult and pediatric rare diseases, provided an update on near- and mid-term blockbuster opportunities in inflammatory back pain and heart failure, showcased leadership in allogeneic cell therapy innovation, and outlined commercial strategies for continued revenue growth.
- The trial for label extension of our flagship product Ryoncil® in adults with SR-aGvHD was cleared to begin by FDA, by data safety monitoring board (DSMB), and by central institutional review board (IRB) with first sites to be activated this quarter.
- FDA granted Investigational New Drug (IND) clearance to proceed directly to a registrational trial evaluating Ryoncil® in Duchenne’s muscular dystrophy (DMD), which affects approximately 15,000 children in the U.S.
- In addition, at the R&D day, Mesoblast unveiled next generation mesenchymal stromal cell (MSC) strategies including announcing the acquisition of an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform for precision-enhanced augmentation of therapeutic MSC products.
- This CAR technology provides Mesoblast with an immediate opportunity to generate products with even greater potency for ulcerative colitis or Crohn’s disease. In addition, Mesoblast plans to use CAR-MSC …