Mesoblast Reports US$30.3M Ryoncil Revenues and Advances Cell Therapy Pipeline

Ryoncil® Sales Approach US$100 Million Since Launch

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net revenues of US$30.3 million from its FDA-approved cell therapy Ryoncil® in the quarter ended March 31, 2026. This brings total sales since the product's launch last year to nearly US$100 million, underscoring steady commercial traction despite seasonal fluctuations. Strong sales in February and March offset a softer January period, reflecting resilient demand for the therapy in steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients.

Ryoncil®'s growing revenue stream supports Mesoblast's broader clinical and commercial ambitions, with the company highlighting its label extension strategy at its inaugural R&D day in New York earlier this month. The event showcased plans to expand Ryoncil®'s indications into adult SR-aGvHD and rare pediatric diseases, alongside pipeline opportunities in inflammatory back pain and heart failure.

Mesoblast also announced it has secured FDA clearance to initiate a pivotal trial for Ryoncil® in adults with SR-aGvHD, with first sites activated this quarter. This regulatory green light represents a significant step towards broadening the therapy's market reach beyond its current pediatric indication.

Clinical Progress in Chronic Low Back Pain and Duchenne Muscular Dystrophy

The company achieved its patient recruitment target in the pivotal Phase 3 trial of rexlemestrocel-L, its second-generation cell therapy candidate for chronic low back pain (CLBP). This milestone is crucial as it sets the stage for upcoming data readouts that could validate the therapy's efficacy in a large, underserved patient population.

Additionally, Mesoblast received Investigational New Drug (IND) clearance from the FDA to proceed directly to a registrational trial evaluating Ryoncil® in Duchenne muscular dystrophy (DMD), a rare genetic disorder affecting approximately 15,000 children in the U.S. The trial aims to address inflammation-driven disease progression in this pediatric cohort, potentially opening a new therapeutic avenue for the company.

Acquisition of CAR Technology to Enhance Cell Therapy Potency

Mesoblast has acquired an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform designed to augment the precision and potency of its mesenchymal stromal cell (MSC) therapies. This strategic move positions the company at the forefront of next-generation cell therapy innovation, enabling the development of enhanced products targeting complex autoimmune and inflammatory diseases such as ulcerative colitis, Crohn's disease, and lupus nephritis.

The CAR technology allows engineered MSCs to express specific receptors that improve their immunomodulatory effects, potentially leading to more durable and effective treatments. Mesoblast plans to use CAR-MSCs expressing CD19 to induce remission in B cell autoimmune diseases, where current therapies often fall short. This acquisition builds on Mesoblast's existing FDA-approved MSC product Ryoncil® and could significantly expand its therapeutic footprint. This development follows the company's recent exclusive CAR technology acquisition that highlighted its commitment to innovation.

Financial Discipline Amid Expanding Operations

Mesoblast reported a net operating cash spend of US$4.1 million for the quarter, a marked improvement driven by US$34.6 million in receipts and stringent expense controls. The company ended the quarter with US$122 million in cash, supported by a US$125 million credit facility secured late last year. This financial position provides a solid runway for ongoing clinical development and commercialization efforts.

Loan repayments also featured prominently, with a US$4.1 million repayment made on the NovaQuest loan facility, reflecting Mesoblast's active debt management following its prior $125 million credit line facility arrangement. The company continues to balance investment in R&D with operational efficiency to sustain its growth trajectory.

Payments to directors and executives amounted to approximately US$705,000 for the quarter, consistent with governance norms for a company at this stage of development.