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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) reported to U.S. investors that it has issued unquoted options to a director under its employee incentive scheme. On 19 August 2026, key management personnel Philip R. Krause received 875,000 MSBAI options, issued for nil consideration, pursuant to shareholder approval at the 2025 AGM.
Following this grant, Krause holds 3,385,000 options and 28,750 American Depositary Shares. Overall capital now includes 1,298,748,110 ordinary fully paid shares and 89,890,943 MSBAI options on issue, along with several unquoted warrant classes. The options were issued under Listing Rule 7.2 exception 13.
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 completion of patient treatment in its pivotal randomized controlled Phase 3 MSB-DR004 trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease. A total of 350 patients were randomized to receive either an intra-discal injection of rexlemestrocel-L or a sham injection, increased from 300 patients after strong investigator demand.
The primary endpoint is durable pain reduction at 12 months from a single injection, with secondary endpoints including function, quality of life, and reduction or cessation of pain medication, including opioids. The indication is described as having potential peak year revenue of >US$10 billion for Mesoblast at single-digit market penetration. Rexlemestrocel-L holds RMAT designation from the FDA for this indication, allowing eligibility for priority review once a BLA is filed, and top-line trial results are expected in mid-CY2027.
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 Limited furnished a Form 6-K describing several announcements made to the Australian Securities Exchange on July 14, 2026, including new issue notifications, applications for quotation of securities and a change of director’s interests.
The change notice shows Dr Silviu Itescu had 278,571 options lapse on July 7, 2026 due to a previously achieved duplicative milestone. His holdings remain 78,958,928 ordinary shares (67,756,838 direct; 11,202,090 indirect), while option holdings decreased from 18,475,158 to 18,196,587, with nil consideration paid or received.
Mesoblast Limited reported that it has achieved its target of treating at least 300 patients in MSB-DR004, a pivotal Phase 3 randomized controlled trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease. The study is designed to confirm the durable pain reduction from a single intra-discal injection seen in the earlier MSB-DR003 trial, and management states this enrollment level ensures the trial is well powered. Commercial manufacturing is proceeding in parallel so a filing for approval can follow promptly after results.
The primary endpoint measures reduction in low back pain at 12 months versus sham control; secondary endpoints include function, quality of life, and cessation of pain medication, including opioids. The indication is described as a potential blockbuster with potential peak-year revenue of >US$10 billion at single-digit market penetration, addressing over 7 million U.S. patients with chronic low back pain due to inflammatory degenerative disc disease and accounting for approximately 50% of U.S. prescription opioid use. FDA has agreed on the confirmatory trial design and this 12‑month primary endpoint as an approvable indication, and granted Regenerative Medicine Advanced Therapy designation, providing rolling and priority review eligibility for a planned Biologics License Application. Top-line results are expected in mid‑CY2027 after 12‑month follow-up.
Mesoblast highlights broader use of its allogeneic stromal cell platforms, including Ryoncil, described as the first FDA‑approved mesenchymal stromal cell therapy, and reports an intellectual property portfolio of over 1,000 granted patents or applications providing commercial protection through at least 2044 in major markets.
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.