Mesoblast Limited SEC filings document its foreign-issuer reporting through Form 6-K submissions that incorporate Australian Securities Exchange announcements, Appendix 4C activity reports, press releases, and R&D presentation materials. The disclosures cover Ryoncil® commercialization, operating cash activity, and clinical programs built around allogeneic mesenchymal lineage stromal cell products.
The filing record also includes ASX notices for director interests, cessation of securities, unquoted equity securities, and applications for quotation of securities. These materials describe capital-structure changes, governance reporting, product and platform updates, and the company’s Form 20-F foreign private issuer framework.
Mesoblast Limited reported FY2026 revenue of US$120.3 million, compared with US$17.2 million in FY2025. RYONCIL generated US$115.2 million in net product sales in its first full fiscal year of U.S. commercialization, and gross profit was approximately US$104 million.
Net operating cash usage was US$43.8 million, versus US$50.0 million in the prior year, and cash and cash equivalents were US$102.9 million as of June 30, 2026. Mesoblast drew the full US$125.0 million five-year credit facility in two tranches to extinguish existing debt. The facility is secured by TEMCELL royalties, carries a fixed 8.00% annual rate, and has an interest-only period through December 2030.
The adult SR-aGvHD Phase 3 registration trial began enrolling, while the pivotal rexlemestrocel-L Phase 3 chronic low back pain trial completed treatment of 350 patients. Mesoblast said it looks forward to reading out clinical endpoints during the second half of calendar 2027.
Mesoblast Limited (MESO) received FDA approval to implement its T-cell Proliferation Inhibition BioAssay (TIBA) for release and stability monitoring of all new commercial RYONCIL product lots. TIBA will be used in a batch-release matrix alongside the existing IL-2Rα inhibition and Cell Adhesion and Proliferation (CAP) assays. Mesoblast said the assay will provide sensitivity to detect potency shifts that could arise from manufacturing-process changes or production at new facilities.
RYONCIL is approved for steroid-refractory acute graft versus host disease in patients aged 2 months or older. Mesoblast describes it as the first industrially manufactured allogeneic MSC product approved by the FDA for any indication.
Mesoblast Limited (MESO) reported a transformational FY2026 as it transitioned into a commercial-stage company driven by the first full year of U.S. sales of RYONCIL. Total revenue rose to US$120.3 million, up sharply from US$17.2 million, with RYONCIL net product sales contributing US$115.2 million after a 13.4% gross-to-net adjustment.
Reported gross profit was US$103.6 million, and gross profit excluding amortization increased to US$109.7 million versus US$16.0 million a year earlier. Mesoblast continued to invest heavily, with research and development expenses of US$97.5 million and selling, general and administrative costs of US$57.3 million reflecting the RYONCIL launch and Phase 3 programs. The net loss narrowed by 44% to US$57.5 million, and operating cash outflow improved to US$43.8 million.
Cash and cash equivalents at June 30, 2026 were US$102.9 million, and the company entered a US$125 million five-year non-dilutive credit facility that replaced higher-cost debt. Operationally, Mesoblast completed treatment of 350 patients in its Phase 3 chronic low back pain trial of rexlemestrocel-L, advanced a registration trial for adult SR-aGvHD, and gained IND clearance for a Phase 3 trial in pediatric Duchenne muscular dystrophy.
Mesoblast Limited (MESO) files its annual report detailing the first full year of commercialization of Ryoncil®, its FDA‑approved mesenchymal stromal cell therapy for pediatric steroid‑refractory acute graft‑versus‑host disease in the United States. Ryoncil® was launched in March 2025 and generated $115.2 million in net product sales for the year ended June 30, 2026.
The company remains loss‑making, reporting a net loss of $57.5 million and accumulated losses of $1,068.4 million since inception. As of June 30, 2026, Mesoblast held $102.9 million in cash and cash equivalents and used $43.8 million of net cash in operating activities during the year.
In December 2025 Mesoblast refinanced existing borrowings with a $125.0 million five‑year non‑dilutive credit line secured by TEMCELL® royalties, bearing fixed 8.00% interest and interest‑only payments through December 2030. Management expects current cash plus Ryoncil® cash flows to fund forecast operating usage for the next 12 months, but discloses that failure to secure adequate funding or partnerships beyond that period could jeopardize its ability to continue as a going concern.
Mesoblast Limited (MESO) reports that it will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2026. The webcast is scheduled for 6:30 p.m. EDT on August 26, 2026 (8:30 a.m. AEST on August 27, 2026) and will be accessible via the company’s investor relations site.
Mesoblast describes itself as a global leader in developing allogeneic (off‑the‑shelf) cellular medicines for severe inflammatory conditions. Its product Ryoncil (remestemcel-L-rknd) is described as the first FDA‑approved mesenchymal stromal cell therapy, indicated for steroid‑refractory acute graft versus host disease in pediatric patients 2 months and older, with additional indications and pipeline programs under development.
Mesoblast Limited reported preliminary Ryoncil® net revenue of US$36 million for the fourth quarter and US$115 million for the first full year after FDA approval, including US$66.5 million in the second half.
Net operating cash spend for the year was US$43.8 million and US$13.4 million in the second half, leaving US$103 million of cash at June 30, 2026 after drawing US$50 million under a five-year US$125 million credit facility used to extinguish maturing debt obligations. The company advanced its pipeline by enrolling an adult SR-aGvHD registration trial for Ryoncil, receiving IND clearance to proceed directly to a registrational Duchenne muscular dystrophy trial in children, completing treatment of at least 300 patients in a pivotal Phase 3 chronic low back pain study of rexlemestrocel-L, and obtaining an FDA BLA filing number for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding in LVAD patients while requesting modular review. Mesoblast also licensed a CAR-MSC technology platform to enhance future cell therapies. Revenue figures are based on management’s initial analysis and remain subject to closing procedures and audit.
Mesoblast Limited reports that Founder and CEO Dr. Silviu Itescu exercised 1,885,334 options on ordinary shares on 17 July 2026, paying the company A$2,733,734 at an exercise price of A$1.45 per share and retaining all newly issued shares.
Following the transaction he holds 80,844,262 Mesoblast shares (69,642,172 direct and 11,202,090 indirect) and 16,311,253 options. Mesoblast develops allogeneic cellular medicines, including FDA‑approved Ryoncil for pediatric steroid‑refractory acute graft versus host disease.
Mesoblast Ltd reported that Chief Financial Officer James Michael O'Brien received a grant of 650,000 options to acquire Ordinary Shares. The options have an exercise price of A$2.90 per share, expire on December 22, 2032, and vest only if Mr. O'Brien achieves specified milestones.
Mesoblast Limited reported preliminary net revenue from Ryoncil® (remestemcel-L-rknd) of US$36 million for the fourth quarter and US$115 million for the first full year ended June 30, 2026. Management highlights strong uptake since launch and states that revenues have already exceeded initial projections.
The company expects continued revenue growth in the coming fiscal year, citing momentum across major U.S. pediatric centers, and describes its capital position as strong with operational activities well funded through revenue growth and a new five-year facility. Ryoncil® is described as the first FDA-approved mesenchymal stromal cell therapy and the only approved product for children under 12 with steroid-refractory acute graft-versus-host disease. The revenue figures are based on preliminary estimates and remain subject to customary year-end closing and audit procedures.
Mesoblast Limited reports a key regulatory step for its investigational cell therapy rexlemestrocel-L in end-stage heart failure patients supported by left ventricular assist devices (LVADs). The company has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration and has requested a modular review of the BLA for preventing life-threatening gastrointestinal bleeding linked to right ventricular dysfunction.
Rexlemestrocel-L, an allogeneic mesenchymal precursor cell therapy, holds both Regenerative Medicine Advanced Therapy and Orphan Drug designations in this LVAD population, potentially allowing rolling and priority review. Mesoblast highlights recent FDA draft guidance emphasizing regulatory flexibility for serious rare diseases, while positioning rexlemestrocel-L within a broader pipeline that includes the already FDA-approved Ryoncil for pediatric steroid-refractory acute graft versus host disease.