Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million
Rhea-AI Summary
Mesoblast (Nasdaq:MESO) reported Ryoncil net revenues of US$30.3m and gross sales US$35.3m for the quarter ended March 31, 2026. Net operating cash spend improved to US$4.1m, cash on hand was US$122m, and first-year Ryoncil sales approach US$100m.
Operationally, Mesoblast achieved patient recruitment for a pivotal Phase 3 CLBP trial, received FDA IND clearance for a registrational Ryoncil trial in DMD, began an SR-aGvHD label-extension trial, and licensed CAR technology for engineered MSCs.
Positive
- Ryoncil net revenues of US$30.3m for the quarter
- Gross sales of US$35.3m for the quarter
- First-year Ryoncil sales approaching US$100m cumulative
- Net operating cash spend reduced to US$4.1m
- Cash balance of US$122m at March 31, 2026
- Patient recruitment target met in pivotal Phase 3 CLBP trial
Negative
- None.
News Market Reaction – MESO
In the Apr 30 session, MESO gained 0.77%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 14 | Platform acquisition | Positive | +7.8% | Acquisition of exclusive CAR-MSC platform license for inflammatory and autoimmune diseases. |
| Apr 10 | Regulatory clearance | Positive | -2.0% | FDA IND clearance to proceed directly to registrational DMD trial for Ryoncil. |
| Apr 08 | R&D day update | Positive | +1.7% | R&D Day outlining plan to double net revenues and multiple late-stage programs. |
| Apr 07 | Regulatory clearance | Positive | +1.7% | Initial announcement of FDA IND clearance for registrational DMD trial of Ryoncil. |
| Apr 06 | Sales update | Positive | -8.0% | Quarterly Ryoncil net sales of US$30.3M as first-year launch progressed. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent Mesoblast news has generally been positive, with three of five events seeing share price gains and two showing negative reactions despite constructive operational or regulatory updates.
Over recent months Mesoblast has advanced both its commercial and R&D profile. A Dec 2024 FDA approval and subsequent Ryoncil® launch led to growing net sales, with a prior March quarter update already citing US$30.3M in net sales as revenue approached US$100M. The company secured FDA IND clearance for a registrational Duchenne muscular dystrophy trial and closed enrollment in a Phase 3 chronic low back pain study. It also acquired a Mayo Clinic‑developed CAR‑MSC platform, reinforcing a strategy of expanding indications and platform innovation alongside rising product revenues.
Key Terms
phase 3 medical
investigational new drug (IND) regulatory
registrational trial medical
mesenchymal stromal cell (MSC) medical
chimeric antigen receptor (CAR) medical
ulcerative colitis medical
Crohn's disease medical
lupus nephritis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Achieved Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain
Activity Report for Quarter Ended March 31, 2026 (Appendix 4C)
NEW YORK, April 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 third fiscal quarter ended March 31, 2026.
“We’ve had a busy and exciting March quarter marked by a series of major achievements. Ryoncil® revenues are now approaching US
FINANCIAL HIGHLIGHTS FOR QUARTER ENDED MARCH 31, 20261
- Ryoncil® gross sales for the quarter were US
$35.3 million , and net revenues were US$30.3 million .1 - Strong sales in February and March offset holiday seasonality in January.
- Revenue generated during this first year of Ryoncil® launch approaches US
$100 million . - Net operating cash spend for the quarter was US
$4.1 million . The reduction in net operating cash spend was driven by receipts of US$34.6 million and tight control of operating expenses. - Mesoblast had US
$122 million of cash at March 31, 2026.
OPERATIONAL HIGHLIGHTS
- Achieved patient recruitment target in pivotal phase 3 trial of second-generation product rexlemestrocel-L for chronic low back pain (CLBP).
- 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 highlighted its label extension strategy for Ryoncil® in adult and pediatric rare diseases, provided an update on near- and mid-term blockbuster opportunities in inflammatory back pain and heart failure, showcased leadership in allogeneic cell therapy innovation, and outlined commercial strategies for continued revenue growth.
- The trial for label extension of our flagship product Ryoncil® in adults with SR-aGvHD was cleared to begin by FDA, by data safety monitoring board (DSMB), and by central institutional review board (IRB) with first sites to be activated this quarter.
- FDA granted Investigational New Drug (IND) clearance to proceed directly to a registrational trial evaluating Ryoncil® in Duchenne’s muscular dystrophy (DMD), which affects approximately 15,000 children in the U.S.
- In addition, 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-MSC 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.
Other
Fees to Non-Executive Directors were US
A copy of the Appendix 4C – Quarterly Cash Flow Report for the third 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 third quarter ended March 31, 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 |
