Mesoblast Reports Ryoncil® Net Revenues of US$36M for the Quarter and US$115M for First Full Year of Product Launch
Rhea-AI Summary
Mesoblast (Nasdaq:MESO; ASX:MSB) reported preliminary Ryoncil® net revenue of US$36 million for the June 2026 quarter and US$115 million for the first full year post-FDA approval, including US$66.5 million in the second half. Net operating cash spend for FY2026 was US$43.8 million, with US$13.4 million in the second half, and cash on hand was US$103 million after drawing US$50 million from a five-year facility to extinguish all maturing debt.
Operationally, Mesoblast is running a registrational trial to extend Ryoncil’s label to adults with steroid-refractory acute GvHD and received FDA IND clearance for a registrational trial in ambulatory children with Duchenne muscular dystrophy. The company also completed enrollment of at least 300 patients in a pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, obtained a BLA filing number and requested modular review for rexlemestrocel-L in LVAD-associated GI bleeding prevention, and licensed a CAR-MSC platform targeting inflammatory bowel disease and B cell autoimmune conditions.
Positive
- Ryoncil® net revenue US$115m first full year post-approval, US$36m Q4
- Operating cash spend limited to US$43.8m for FY2026, US$13.4m H2
- Cash balance US$103m at June 30, 2026 after repaying maturing debt
- Adult SR-aGvHD registrational trial initiated with up to 40 US sites planned
- DMD IND clearance for registrational Ryoncil® trial in ambulatory children aged 5–9
- Rexlemestrocel-L CLBP Phase 3 reached ≥300 treated patients for 12‑month primary endpoint follow-up
- BLA filing number received and modular review requested for rexlemestrocel-L in LVAD patients
- Exclusive CAR-MSC license obtained to enhance MSC products for IBD and B cell autoimmune diseases
Negative
- Net operating cash spend US$43.8m for FY2026 indicates ongoing cash burn
- US$50m facility drawdown required to extinguish all maturing debt obligations
- Revenues provisional, based on initial management analysis and subject to audit and final closing procedures
News Explained
Mesoblast reports that at least 300 patients have been treated in the pivotal chronic-low-back-pain trial, but they still require 12-month follow-up to assess the primary pain endpoint; the release therefore reports a treatment milestone, not a trial result or approval.
News Market Reaction – MESO
In the Jul 30 session, MESO gained 2.97%, reflecting a moderate positive market reaction. Argus tracked a peak move of +18.1% during that session.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 13 | Phase 3 trial update | Positive | +3.2% | Reached 300 treated patients in pivotal Phase 3 chronic low back pain trial |
| Jul 09 | Revenue update | Positive | +4.1% | Reported quarterly and first-full-year Ryoncil net revenues of US$36M and US$115M |
| Jun 30 | BLA filing update | Positive | +4.1% | Received FDA BLA filing number and requested modular review for rexlemestrocel-L |
| Jun 24 | Debt facility draw | Negative | -6.8% | Drew US$50M from five-year non-dilutive facility to retire higher-cost debt |
| Apr 29 | Quarterly revenue report | Positive | +0.8% | Reported Ryoncil revenue and lower quarterly operating cash spend |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
MESO's recent positive operating, regulatory and clinical announcements were followed by gains, while the recent financing announcement was followed by a decline.
Key Terms
investigational new drug (ind) regulatory
biologics license application (bla) regulatory
modular review regulatory
left ventricular assist device (lvad) medical
mesenchymal stromal cell (msc) medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Expanding indications for RYONCIL in children and adults with life-threatening inflammatory diseases
Achieved target of at least 300 Patients treated in Pivotal Phase 3 trial for Chronic Low Back Pain
Activity Report for Quarter Ended June 30, 2026 (Appendix 4C)
NEW YORK, July 29, 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 fourth fiscal quarter ended June 30, 2026.
“We are very pleased with the continued momentum in uptake of Ryoncil® in children with life-threatening steroid-refractory acute GvHD across major U.S. pediatric centers, positioning the treatment well for use next in adults with this life-threatening disease. We will continue to build on the strong first full year of Ryoncil® revenue to ensure our judicious use of capital facilitates achievement of key inflexion points for our blockbuster products, including potential FDA approvals.” said Mesoblast Chief Executive Dr. Silviu Itescu.
FINANCIAL HIGHLIGHTS FOR THE FULL YEAR ENDED JUNE 30, 2026, THE FOURTH QUARTER AND THE SECOND HALF1
- Ryoncil® net revenue for the fourth quarter was US
$36 million . - For the first full year post-FDA approval Ryoncil® net revenue was US
$115 million , with US$66.5 million for the second half. - Net operating cash spend for the full year was US
$43.8 million , with operating cash spend of US$13.4 million for the second half. - Mesoblast had US
$103 million of cash at June 30, 2026, after having drawn down US$50 million from the existing five-year facility to extinguish all maturing debt obligations.
OPERATIONAL HIGHLIGHTS FOR THE FOURTH QUARTER
RYONCIL (remestemcel-L-rknd)
- The Company is executing on its strategy to extend its FDA-approved label for its flagship product Ryoncil® beyond children with steroid-refractory acute graft versus host disease (SR-aGvHD) to adults with SR-aGvHD, a market three times larger, and to both children and adults with other severe, life-threatening inflammatory conditions.
- The registration trial for label extension of Ryoncil® into 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. - Mesoblast received Investigational New Drug (IND) clearance from U.S. Food and Drug Administration (FDA) to proceed directly to a registrational trial evaluating Ryoncil® in ambulatory children aged 5-9 years with Duchenne muscular dystrophy (DMD), which affects approximately 15,000 children in the U.S.
REXLEMESTROCEL L
- Mesoblast achieved its target of at least 300 patients treated in the MSB-DR004 pivotal Phase 3 randomized controlled trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with degenerative disc disease; these patients will be followed through the trial’s twelve-month primary endpoint to assess reduction in pain from baseline between rexlemestrocel-L and placebo-treated groups.
- Received a Biologics License Application (BLA) filing number from FDA and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD).
Other activities
- Held inaugural R&D day on April 8th in New York. A replay of the event is available here and presentation materials here.
- At the R&D day, Mesoblast unveiled next generation mesenchymal stromal cell (MSC) strategies including announcing the acquisition of an exclusive worldwide license to a patented chimeric antigen receptor (CAR) technology platform for precision-enhanced augmentation of therapeutic MSC products.
- This CAR technology provides Mesoblast with an immediate opportunity to generate products with even greater potency for ulcerative colitis or Crohn's disease. In addition, Mesoblast plans to use CAR-MSCs engineered to express CD19 on their surface to induce remission in Lupus Nephritis and other B cell autoimmune diseases where durable, effective and safe immunomodulation is highly desirable.
Corporate
Fees to Non-Executive Directors were US
A copy of the Appendix 4C – Quarterly Cash Flow Report for the fourth 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 fourth quarter and full year ended June 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 |
