Welcome to our dedicated page for Mesoblast SEC filings (Ticker: MEOBF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Mesoblast Limited (MEOBF) SEC filings page provides access to the company’s U.S. regulatory disclosures as a foreign private issuer incorporated in Australia. Mesoblast Limited files annual reports under cover of Form 20-F and furnishes current information on Form 6-K pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934.
Mesoblast’s Form 6-K submissions typically attach documents first filed with the Australian Securities Exchange (ASX). These include new issue announcements, notifications of issue, conversion or payment up of unquoted equity securities (Appendix 3G), applications for quotation of securities (Appendix 2A), notifications of cessation of securities (Appendix 3H), proposed issues of securities (Appendix 3B), and change of director’s interest notices (Appendix 3Y), as well as press and news release announcements.
Through this page, users can review how Mesoblast Limited reports on equity securities activity, including issuances, proposed issues, cessations, and applications for quotation, and how it discloses changes in directors’ holdings in its securities. These filings are relevant for investors tracking capital structure developments, director share transactions, and formal corporate announcements.
Stock Titan enhances these filings with AI-powered tools that help explain the structure and contents of lengthy documents. While the original Form 20-F and 6-K texts remain the authoritative sources, AI summaries can highlight key sections, such as equity changes or director interest updates, and make it easier to navigate the exhibits attached from the ASX. Real-time updates from EDGAR ensure that new Mesoblast Limited filings appear promptly, giving users a structured way to follow the company’s regulatory history.
Mesoblast Limited reported that Dr. Teresa Montagut, MD, PhD, has been appointed to the newly created role of Head of Clinical Development and Medical Affairs, reporting to Chief Medical Officer Dr. Eric Rose. She will lead medical affairs, clinical collaborations, investigator-initiated trials, and engagement with healthcare professionals.
Dr. Montagut previously held senior medical and development roles at Regeneron, Novartis, Genentech, and Atara Biotherapeutics, and trained at leading U.S. institutions including Memorial Sloan Kettering Cancer Center. The company highlights her importance in advancing Ryoncil®, its FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft versus host disease, and in expanding Mesoblast’s broader inflammatory disease and cell therapy pipeline.
Mesoblast Ltd Amendment reports that Gregory George beneficially owns 288,522,256 ordinary shares, representing 22.36% of the class as of March 6, 2026, based on 1,290,302,187 ordinary shares outstanding as of March 6, 2025.
The filing breaks down holdings: Gregory George directly holds 138,723,887 shares (including 10,430,602 warrants and 128,293,285 ADRs) and reports shared voting/dispositive power over additional shares held by G to the Fourth Investments, LLC (135,798,292) and by his sons James George (8,000,000) and Grant George (6,000,000). The filing lists James George with 8,000,000 shares (0.62%), Grant George with 6,000,000 shares (0.47%), and G to the Fourth Investments, LLC with 135,798,292 shares (10.52%).
Mesoblast Limited reported a sharp jump in activity for the half-year ended December 31, 2025, as the U.S. launch of Ryoncil drove total revenue to US$51.3 million, up from US$3.2 million a year earlier. Net loss narrowed to US$40.2 million from US$47.9 million, helped by high Ryoncil gross margins and tight cost control.
Ryoncil generated US$48.7 million of revenue and a gross profit of US$44.2 million, funding increased R&D spending of US$46.2 million on late-stage programs in chronic low back pain and heart failure. The company ended the period with cash of US$129.975 million, access to a US$125.0 million five-year credit line, and guided full-year fiscal 2026 Ryoncil net revenue to US$110–120 million.
Mesoblast Limited reported a sharply higher top line for the six months ended December 31, 2025, driven by the U.S. launch of Ryoncil®. Total revenue rose to $51.3 million from $3.2 million a year earlier, including $48.7 million of net product sales and $2.7 million of TEMCELL royalties.
The company still posted a net loss of $40.2 million, improving from a $47.9 million loss, with basic and diluted loss per share of 3.11 cents versus 4.20 cents. Operating cash outflow was $30.3 million, and period-end cash and cash equivalents were $130.0 million.
In December 2025 Mesoblast put in place a new $125.0 million, five-year credit-line facility from its largest shareholder, drawing $75.0 million to fully repay its Oaktree senior loan and partially repay its NovaQuest facility. Net debt, including leases and warrant liabilities, moved from a net cash position of $27.7 million to net debt of $19.3 million, while intangible assets related to Ryoncil® and other pipeline programs remained substantial.
Mesoblast Limited is informing investors that it will host a webcast to discuss operational highlights and financial results for the half year ended December 31, 2025. The webcast is scheduled for 5:00 p.m. EST on Thursday, February 26, and 9:00 a.m. AEDT on Friday, February 27, 2026, and can be accessed online at the provided webcast link.
Mesoblast describes itself as a world leader in developing allogeneic, off-the-shelf cellular medicines for severe inflammatory conditions. Its therapy Ryoncil® (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients is stated to be the first FDA-approved mesenchymal stromal cell therapy, and the company is advancing additional indications and partnerships globally.
Mesoblast reported new real-world and clinical data for its allogeneic cell therapy Ryoncil in steroid-refractory acute graft-versus-host disease (SR-aGvHD). Ryoncil achieved similarly high survival outcomes across children and adults, whether used as second- or third-line therapy and in ruxolitinib-naive or -resistant patients.
In 53 severe SR-aGvHD patients treated under the Emergency IND program as third line or later, 15% died before completing a full Ryoncil course, compared with 2% when used second line in a Phase 3 trial, underscoring the importance of early initiation after steroid resistance. Adult patients in the emergency use setting had at least as favorable day-100 survival as children, supporting Mesoblast’s planned pivotal trial of Ryoncil as part of second-line treatment in adults.
The pivotal adult SR-aGvHD trial is expected to begin enrollment this quarter following central Institutional Review Board approval. If successful, Mesoblast expects it could support extending Ryoncil’s current U.S. label, which now covers pediatric patients, to adults—a group the company says is roughly three times larger than the pediatric SR-aGvHD population.
Mesoblast Limited reported strong commercial and funding progress for the quarter ended December 31, 2025. Ryoncil® gross sales reached US$35 million, up 60% from the prior quarter, with net revenues of US$30 million, reflecting growing uptake in pediatric steroid‑refractory acute graft‑versus‑host disease.
The company entered a new US$125 million non‑dilutive credit line at a fixed 8.00% interest rate and drew US$75 million, which helped refinance higher‑cost debt. Mesoblast held US$130 million in cash at December 31, 2025, after a quarterly net operating cash outflow of US$16 million, and estimates about 11.6 quarters of total funding based on current burn and available facilities.
Operationally, early ‘real‑world’ data from the first 25 Ryoncil® patients post‑launch showed 21 alive after completing the initial 28‑day regimen. A pivotal adult SR‑aGvHD trial is expected to begin site enrollment this quarter. The FDA provided positive feedback on a potential BLA for rexlemestrocel‑L in chronic low back pain, and a confirmatory Phase 3 trial targeting 300 patients is actively recruiting across 40 U.S. sites.
Mesoblast Limited reports early real-world experience and commercial rollout of its FDA-approved cell therapy Ryoncil for children with steroid‑refractory acute graft‑versus‑host disease. Among the first 25 patients treated after launch, 21 were alive after completing the 28‑day course, an 84% survival rate. Access efforts include a MyMesoblast patient hub, onboarding of 45 U.S. transplant centers toward a target of 64 centers covering 94% of transplants, and payer coverage reaching more than 260 million U.S. lives. Mesoblast plans a pivotal adult SR‑aGvHD trial with the NIH‑funded BMT‑CTN expected to begin site enrollment this quarter and is also developing its stromal cell platform for additional inflammatory and cardiovascular indications.
Mesoblast Limited reports that the U.S. FDA has provided feedback supporting a potential Biologics License Application for its allogeneic cell therapy rexlemestrocel-L in chronic discogenic low back pain. After reviewing data from Mesoblast’s first randomized controlled Phase 3 trial, the FDA acknowledged that pain intensity outcomes appear to favor rexlemestrocel-L over placebo, and confirmed that a clinically meaningful reduction in pain at 12 months can support product efficacy. The agency also indicated that robust results on opioid reduction from at least one adequate and well controlled trial could be reflected in the Clinical Studies section of product labeling, meaning the approval label may include opioid reduction. A second 300-patient randomized, placebo-controlled Phase 3 confirmatory trial is over 50% enrolled across about 40 U.S. sites, with enrollment expected to complete in the coming three months.
Mesoblast Limited submitted a Form 6-K as a foreign private issuer, primarily to furnish investors with copies of two equity-related announcements it filed with the Australian Securities Exchange on January 15, 2026. One attached exhibit is an Appendix 3H covering a cessation of securities, and the other is an Appendix 3G relating to the issue, conversion or payment up of unquoted equity securities. These ASX appendices are included as Exhibits 99.1 and 99.2 so U.S. investors can access the same equity capital changes information filed in Australia.