Ryoncil® Net Revenues Increase for the Quarter to US$30M
NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the second fiscal quarter ended December 31, 2025.
"This quarter was highlighted by continued strong Ryoncil® sales and the establishment of a new lower-cost non-dilutive financing facility both of which enable greater flexibility for strategic partnerships and pursuit of label expansion for Ryoncil®," said Mesoblast Chief Executive Dr. Silviu Itescu.
FINANCIAL HIGHLIGHTS FOR QUARTER ENDED DECEMBER 31, 20251
- Ryoncil® gross sales for the quarter were US$35 million, a 60% increase on the prior quarter ended September 30, 2025, and net revenues were US$30 million.1
- Mesoblast entered into a new non-dilutive credit-line totaling US$125 million at a fixed interest rate of 8.00% per annum, a substantial reduction from Mesoblast's current debt facilities, with a five-year interest only period. The initial US$75 million drawn is unsecured until the remainder of the secured debt is repaid, no later than July 8, 2026, after which the entire new facility will be secured solely with the Temcell2 royalty.
- Mesoblast had US$130 million of cash at December 31, 2025. Net operating cash spend for the quarter was US$16 million. Mesoblast expects to see reduction in net cash spend over the remainder of the fiscal period based on projected receipts from quarterly revenues and tight control of operating expenses.
OPERATIONAL HIGHLIGHTS FOR QUARTER ENDED DECEMBER 31, 2025
- Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).3
- While many patients are at various stages of treatment with Ryoncil®, the company provided an update on outcomes of the first 25 patients treated with Ryoncil® in a ‘real-world' clinical setting post launch. Of these, 21 were alive (84%) and completed the initial 28-day treatment regimen as per the FDA approval label. The four patients who did not complete the 28-day treatment course had been offered and failed other therapies prior to use of Ryoncil® and died of severe SR-aGvHD within 28 days.
- These early data are consistent with the prior clinical experience with Ryoncil®. The outcomes highlight our focus on getting patients on Ryoncil® therapy as early as possible following steroid resistance to enable completion of an initial 28-day treatment course and maximize survival.
- Given the continued unmet need in adults with severe SR-aGvHD, a pivotal trial of Ryoncil® is expected to commence site enrollment this quarter for label extension of Ryoncil® for use in adults - a population approximately three times the size of the pediatric SR-aGvHD population.
- During the reporting period, Mesoblast received positive feedback from FDA on potential filing of a Biologics License Application (BLA) for its allogeneic cell therapy product rexlemestrocel-L in patients with chronic discogenic low back pain (CLBP). This follows FDA's Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial (MSB-DR003) on pain reduction and relationship to decreased use or elimination of opioids for up to three years following a single rexlemestrocel-L administration.
- FDA acknowledged that the effects on pain intensity appear to favor the active arm. FDA also confirmed that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy and stated that the robust results on opioid reduction from at least one adequate and well controlled trial could be included in the Clinical Studies section of product labeling.
- The confirmatory Phase 3 trial, MSB-DR004, is actively recruiting across 40 sites in the U.S. and is expected to complete the 300-patient enrollment target in the coming three months.
- Commercial manufacturing scale-up work for rexlemestrocel-L is well progressed to support BLA filings for both CLBP and, in the first instance, for end-stage chronic heart failure (CHF) patients with LVADs.
Other
Fees to Non-Executive Directors were US$131,183, consulting payments to Non-Executive Directors were US$223,614, and salary payments to full-time Executive Directors were US$398,753, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.4
A copy of the Appendix 4C – Quarterly Cash Flow Report for the second quarter FY2026 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 lineage 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 Twitter: @Mesoblast
References / Footnotes
- The revenues included in this press release are based on management's initial analysis of operations for the second quarter ended December 31, 2025, and are subject to completion of Mesoblast's financial closing procedures and audit.
- TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd Please see the full Prescribing Information at www.ryoncil.com
- Please see the full Prescribing Information at www.ryoncil.com
- 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.
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