Mesoblast (ASX: MSB) – Files 2026 Quarterly Activities Report

Mesoblast Limited reported first-quarter FY2027 results that show an improving commercial trajectory and increasingly disciplined cash management. The cellular therapy company achieved a 44% increase in net revenues for its approved commercial product Ryoncil to US$28 million, while simultaneously reducing net operating cash spend by 86% compared with the prior year period, falling from US$14.9 million to just US$2.1 million. This combination of topline momentum and operational efficiency reflects the company’s progress in scaling Ryoncil sales while managing development costs for its pipeline programs.

Ryoncil’s growth for the quarter was driven by continued adoption in steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients, the therapy’s FDA-approved indication. September saw the highest number of new patient starts per month to date, following typical seasonal patterns as patient scheduling recovers after summer disruptions in July and August. Mesoblast is advancing Ryoncil expansion into adult SR-aGvHD through a registration trial that commenced this quarter, with up to 40 U.S. sites expected to be activated and serving approximately 60% of the annual U.S. allogeneic adult bone marrow transplant population. This expansion represents a material growth opportunity for the therapy.

On the development front, Mesoblast completed enrollment in the MSB-DR004 Phase 3 key trial evaluating rexlemestrocel-L for chronic inflammatory low back pain due to degenerative disc disease. The trial enrolled 350 patients and is designed to measure 12-month durable pain reduction, with results expected in the coming year. The company reported strong investigator demand for the trial, reflecting confidence in the therapeutic approach. This catalyst positions the company for a potential regulatory filing in this high-prevalence indication if efficacy is demonstrated.

The company also reported a positive interaction with the U.S. Food and Drug Administration regarding a Biologics License Application filing for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding in end-stage heart failure patients supported by a left ventricular assist device. The FDA confirmed that a BLA filing may proceed under Regenerative Medicine Advanced Therapy and Orphan Drug designations, focusing on patients with major gastrointestinal bleeding. This validation from regulators, combined with the company’s designation of rexlemestrocel-L as an RMAT, potentially accelerates the pathway to commercialization in this serious unmet need.

Mesoblast ended the quarter with US$99 million in cash and maintains a US$125 million credit facility, providing substantial runway to fund operations and advance its clinical programs. The company estimates 46.3 quarters of funding available based on current cash burn, providing visibility through 2027 and beyond. Investors should monitor the timing of the chronic low back pain Phase 3 readout next year and progress toward the rexlemestrocel-L BLA filing for the LVAD indication, both of which could be significant value drivers. This announcement is price sensitive and flagged as material by the ASX.

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About Mesoblast Limited (ASX: MSB)

Mesoblast Limited is a biotechnology company headquartered in Melbourne, Australia, specializing in the development of allogeneic cellular medicines derived from adult stem cells. The company focuses on treating severe and life-threatening inflammatory conditions, with a pipeline spanning cardiovascular diseases, spine orthopedic disorders, and immune-mediated conditions. It is a world leader in the development of off-the-shelf cellular medicine therapies for these therapeutic areas.

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