Activity Report for Quarter Ended September 30, 2026 (Appendix 4C)
Mesoblast expects up to 40 U.S. sites for its adult RYONCIL registration trial to be activated this year.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Mesoblast (MESO) reported RYONCIL net revenue growth of 44% for its first fiscal quarter ended September 30, 2026. Revenue was US$28 million, subject to financial closing procedures and audit. Operating cash spend fell 86% to US$2.1 million from US$14.9 million a year earlier; quarter-end cash was US$99 million.
The adult RYONCIL registration trial began enrolling patients, and FDA approved an additional potency assay supporting manufacturing scale-up. Treatment of all enrolled patients in the 350-patient Phase 3 rexlemestrocel-L low-back-pain trial was completed, with its 12-month durable pain-reduction endpoint due to read out next year. FDA confirmed a biologics license application for rexlemestrocel-L may proceed for life-threatening major gastrointestinal bleeding in end-stage heart-failure patients supported by a left ventricular assist device. Formal meeting minutes are expected shortly.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointRYONCIL net revenue rose 44% year over year to US$28 million in the first fiscal quarter.
- Moderate pointOperating cash spend improved 86% to US$2.1 million from US$14.9 million in the prior-year quarter.
- Moderate pointFDA confirmed rexlemestrocel-L's license application may proceed for life-threatening major gastrointestinal bleeding in device-supported end-stage heart-failure patients.
- Moderate point. Forward-looking: it has not happened yet and may not happen.All enrolled patients completed treatment in the 350-patient Phase 3 low-back-pain trial; primary endpoint readout is due next year.
- Moderate pointAdult RYONCIL registration trial commenced and is enrolling patients with steroid-refractory acute graft-versus-host disease.
3 minor points
- Minor point. Forward-looking: it has not happened yet and may not happen.Up to 40 U.S. trial sites are expected to activate this year, representing approximately 60% of the ~8,500 annual U.S. allogeneic adult bone marrow transplant population.
- Minor pointFDA approved an additional potency assay as RYONCIL manufacturing scales up.
- Minor pointSeptember recorded the highest monthly new patient starts for RYONCIL.
Negative
- Minor pointRevenue figures remain preliminary, subject to completion of financial closing procedures and audit.
Key Figures
- Net revenue increase
- 44%
- First fiscal quarter versus the prior-year period
- Operating cash spend improvement
- 86%
- First fiscal quarter versus the prior-year period
- Cash
- US$99 million
- At September 30, 2026
- Operating cash spend
- US$2.1 million
- First fiscal quarter
- RYONCIL net revenue
- US$28 million
- First quarter
- Patients treated
- 350 patients
- Phase 3 pivotal trial of rexlemestrocel-L for chronic inflammatory low back pain
- Primary endpoint timing
- 12 months
- Durable pain reduction endpoint in the Phase 3 trial
- Expected activated sites
- Up to 40 sites
- U.S. registration trial for adult SR-aGvHD; expected this year
Historical Context
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FDA had approved TIBA for commercial Ryoncil batch release and stability monitoring.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
allogeneic medical
biologics license application regulatory
regenerative medicine advanced therapy regulatory
left ventricular assist device medical
hfreF medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
“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
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
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
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 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 X: @Mesoblast
References / Footnotes
- 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.
- 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:
| Corporate Communications / Investors | |
| Paul Hughes | |
| T: +61 3 9639 6036 | |
| Media – Global | Media – Australia |
| Rubenstein | BlueDot Media |
| Caroline Nelson | Steve Dabkowski |
| T: +1 703 489 3037 | T: +61 419 880 486 |
| E: cnelson@rubenstein.com | E: steve@bluedot.net.au |
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Mesoblast's RYONCIL revenue and operating cash spend for the quarter ended September 30, 2026?
RYONCIL net revenue was US$28 million, up 44% year over year, while operating cash spend was US$2.1 million, an 86% improvement from US$14.9 million. Revenue remains subject to completion of financial closing procedures and audit.
What did FDA confirm about Mesoblast's rexlemestrocel-L application for gastrointestinal bleeding?
FDA confirmed that a biologics license application may proceed for patients with life-threatening major gastrointestinal bleeding who have end-stage heart failure and are supported by a left ventricular assist device. Formal minutes of the meeting are expected shortly.