MESOBLAST LTD SEC Filings

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.

Mesoblast Limited has filed a prospectus covering up to 5,000,000 ordinary shares, represented by 500,000 American Depositary Shares (ADSs), for resale by existing warrant holders. These shares are issuable upon exercise of warrants that carry an exercise price of US$16.25 per ADS.

The warrants, issued in December 2025 as part of a commitment fee tied to subscription agreements for up to US$50 million of subordinated unsecured convertible notes, have a four-year term. Two million warrants are immediately exercisable, while three million become exercisable only if Mesoblast elects to issue the convertible notes. Mesoblast will not receive proceeds from any resale of ADSs by the selling shareholders, but will receive cash upon any warrant exercises.

After this offering, Mesoblast states that 1,290,802,187 ordinary shares will be outstanding, including those underlying the ADSs offered by the shareholders. The company highlights that investing in its ADSs involves a high degree of risk and directs investors to detailed risk factors incorporated by reference.

Mesoblast Limited, an Australia-based biotechnology company, submitted a report outlining several equity-related actions first lodged with the Australian Securities Exchange on January 13, 2026. The company attached three ASX appendices to this report for investors’ reference.

One appendix covers a new issue announcement and notification of issue, conversion or payment up of unquoted equity securities (Appendix 3G). A second appendix details a new issue announcement and application for quotation of securities (Appendix 2A). A third appendix reports a new issue announcement and change of a director’s interest (Appendix 3Y). Together, these documents describe recent equity issuances and an update to director holdings, with the full details contained in the attached exhibits.

Mesoblast Limited, an Australia-incorporated company, submitted a Form 6-K as a foreign private issuer for January 2026. On January 12, 2026, the company filed a new issue announcement and a change of director’s interest notice (Appendix 3Y) with the Australian Securities Exchange, and attached this Appendix 3Y as Exhibit 99.1 to the Form 6-K. The filing indicates Mesoblast reports under Form 20-F and is signed on behalf of the company by its Company Secretary, Niva Sivakumar.