Mesoblast (NASDAQ:MESO) reported $115 million in net revenue for fiscal 2026 and said it expects a pivotal trial readout for its experimental chronic low back pain treatment around midyear to the third quarter of calendar 2027.
The company also reported $110 million in gross profit on sales for the fiscal year. Its marketed product, RYONCIL, is approved in the United States for children with steroid-refractory acute graft-versus-host disease, or GVHD.
A presenter identified as the Operator in the transcript said Mesoblast had treated all 350 patients enrolled in the confirmatory Phase 3 back pain trial. The company also said it had reached alignment with the Food and Drug Administration on proceeding with an approval filing for its experimental treatment in end-stage heart failure.
Back pain trial and heart failure plans
Mesoblast is developing rexlemestrocel-L for chronic low back pain associated with degenerative disc disease. The confirmatory trial’s primary endpoint is pain reduction at 12 months, with improvement in function as a secondary endpoint.
The presenter said the FDA had agreed that Mesoblast could file for approval if the trial achieves its primary endpoint. The company is scaling up manufacturing in parallel and said approval could potentially come in calendar 2028.
For end-stage heart failure patients supported by a left ventricular assist device, the presenter said the FDA agreed that Mesoblast may proceed with a filing. Mesoblast said the primary outcome achieved in its clinical program was a reduction in life-threatening major gastrointestinal bleeding. The company is also completing manufacturing and related filing work.
Mesoblast highlighted results from a group of patients with elevated pulmonary artery pressure in its 565-patient DREAM-HF trial. The presenter said a single injection of rexlemestrocel-L was associated with improved ventricular diastolic function, reduced pulmonary hypertension and a 53% reduction in mortality in that group. The company said it plans to explore the indication and potential strategic alliances.
RYONCIL expansion and management changes
Mesoblast said it has initiated a randomized registration trial of RYONCIL in adults with severe acute GVHD. The study is designed to enroll up to 180 patients, comparing ruxolitinib alone with ruxolitinib plus RYONCIL. Its primary endpoint is overall response at day 28, and a secondary endpoint is overall survival at day 180.
The company is targeting approximately 40 U.S. centers and expects the trial to last 18 to 24 months, with a potential interim analysis for early success at the end of the following year, according to the presenter.
Mesoblast also said the FDA had approved the start of a pivotal RYONCIL trial in Duchenne’s disease. The presenter said more than 50 U.S. sites had been onboarded for the marketed product and that more than 98% of lives were covered by commercial insurance.
To support potential manufacturing scale-up and launches of rexlemestrocel-L, Mesoblast plans to search for a U.S.-based chief operating officer. Dr. Greg George will serve as interim COO, while Chief Medical Officer Dr. Eric Rose will focus on the cardiopulmonary program and step away from board activities.
The company said Jon Voigtman would join the board subject to shareholder approval, while Bill Burns and Phil Krause would retire. Mesoblast also reported entering a $125 million, five-year non-dilutive credit facility that consolidated and retired two higher-cost facilities.
About Mesoblast (NASDAQ:MESO)
Mesoblast is an Australia-based biotechnology company developing regenerative medicine products made from mesenchymal lineage cells. Its allogeneic cell therapies are designed to address inflammatory and immune-mediated conditions by modulating the body’s immune response and supporting tissue repair. The company’s lead commercial product, Ryoncil (remestemcel-L-rknd), is approved in the United States to treat steroid-refractory acute graft-versus-host disease in pediatric patients. A related product, marketed as Temcell in Japan, is used there to treat acute graft-versus-host disease.
