Activity Report for Quarter Ended September 30, 2026 (Appendix 4C)

NEW YORK, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided its activity report for the first fiscal quarter ended September 30, 2026.

Financial highlights included 44% increase in net revenues and 86% improvement in net operational cash spend compared with the prior year period. Operational highlights included completion of all patients treated in the MSB-DR004 pivotal randomized controlled Phase 3 trial of rexlemestrocel-L for inflammatory chronic low back pain (CLBP) and a positive meeting with U.S. Food and Drug Administration (FDA) regarding the planned Biologics License Application (BLA) filing for rexlemestrocel-L in prevention of life-threatening gastrointestinal (GI) bleeding in end-stage heart failure patients with a left ventricular assist device (LVAD).

“Our first-quarter results show continued momentum for Ryoncil^® (remestemcel-L-rknd) sales. Importantly, we have shown substantial improvement in our net operating cash spend while continuing to advance our strategic objectives for rexlemestrocel-L in chronic pain and cardiovascular diseases,” said Mesoblast Chief Executive Dr. Silviu Itescu.

Mesoblast had US$99 million of cash at September 30, 2026, US$2.1 million operating cash spend for the first fiscal quarter, an 86% improvement compared with US$14.9 million for the prior year period. RYONCIL net revenue for the first quarter was US$28 million, an increase of 44% compared with the prior year period.¹ September experienced the highest number of new patient starts per month, following the expected seasonality from summer recess-related treatment scheduling that occurs each July and August.

The registration trial for expansion of RYONCIL use for adults with SR-aGvHD has commenced and is currently enrolling patients, with up to 40 sites across the U.S. expected to be activated this year representing approximately 60% of the ~8,500 annual U.S. allogeneic adult bone marrow transplant population. In line with requirement for increased product inventory to meet greater demand in adult indications, Mesoblast implemented and received approval from the FDA for an additional potency assay, T-cell Proliferation Inhibition BioAssay (TIBA), to provide even greater assurance of product potency and consistency as RYONCIL manufacturing scale up proceeds.

After strong demand from trial investigators to enroll their patients in the expanded 350-patient Phase 3 pivotal trial of rexlemestrocel-L for chronic inflammatory low back pain due to degenerative disc disease, Mesoblast completed treatment of all enrolled patients with the trial's primary endpoint of 12 month durable pain reduction to read out next year.

Mesoblast met with FDA to align on the BLA filing for rexlemestrocel-L under its Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for treatment of patients with end-stage heart failure with reduced ejection fraction (HFrEF) being kept alive by a left ventricular assist device. FDA confirmed the BLA filing may proceed for patients with life-threatening major gastrointestinal bleeding, a complication of the severe inflammation and vascular abnormalities in these patients. The vascular inflammation most evident in the gastrointestinal tract in patients with advanced HFrEF is widespread, including in the lungs where it results in pulmonary hypertension, a condition with progressive right heart failure and high mortality. Formal minutes of the meeting are expected shortly.

Corporate
Fees to Non-Executive Directors were US$187,295, salary payments to full-time Executive Directors were US$416,298, and payments to related parties for purchase of services were US$25,000 as detailed in Item 6 of the Appendix 4C cash flow report for the quarter.²

A copy of the Appendix 4C – Quarterly Cash Flow Report for the first quarter FY2027 is available on the investor page of the company’s website www.mesoblast.com.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lieage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast

References / Footnotes

1. The revenues included in this press release are based on management’s initial analysis of operations for the first quarter ended September 30, 2026, and are subject to completion of Mesoblast’s financial closing procedures and audit.
2. As required by ASX listing rule 4.7 and reported in Item 6 of the Appendix 4C, reported are the aggregated total payments to related parties being Executive Directors and Non-Executive Directors.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGvHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

[ Back To TMCnet.com's Homepage ]