Mesoblast Limited files as an Australian foreign private issuer, and its SEC reports document ASX announcements for its ADR-listed securities. Form 6-K reports incorporate Appendix 4C activity reports, press releases and R&D materials covering Ryoncil commercialization, operating cash spend, clinical programs for rexlemestrocel-L and Ryoncil, FDA regulatory updates and the company’s mesenchymal lineage cell therapy platform.
The filing record also documents capital-structure and governance matters through ASX appendices for proposed and quoted securities, unquoted equity securities, cessation of securities and changes in director interests. These disclosures connect Mesoblast’s public reporting to product revenue, pipeline development, equity issuance and foreign-issuer compliance under Form 20-F reporting.
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 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 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.
Mesoblast Limited submitted a foreign issuer report describing an action first disclosed on the Australian Securities Exchange. On December 17, 2025, the company lodged an Appendix 3G with the ASX, which relates to a new issue announcement and the issue, conversion or payment up of unquoted equity securities. This Appendix 3G document is attached to the report as an exhibit and is incorporated by reference for further details.
Mesoblast Limited submitted a Form 6-K to provide U.S. investors with materials it filed with the Australian Securities Exchange. The report states that on November 25, 2025, the company lodged the Chair’s Annual General Meeting address and the CEO’s presentation to the Annual General Meeting, which are included as Exhibits 99.1 and 99.2. It also includes a press release dated the same day as Exhibit 99.3. These documents are incorporated by reference, making the Australian-market communications available to investors following Mesoblast’s U.S. listing.
Mesoblast Limited furnished a Form 6-K to provide investors with Australian Securities Exchange materials. The filing attaches two ASX documents dated October 28, 2025: an Appendix 3Y change of director’s interest notice and an Appendix 3G notification of issue, conversion or payment up of unquoted equity securities, incorporated by reference as Exhibits 99.1 and 99.2.
This update is administrative, making the ASX disclosures available to U.S. investors under the Exchange Act.