NEW YORK, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended December 31, 2025 (H1 FY2026). FINANCIAL HIGHLIGHTS FOR H1 FY20261 Performance driven by successful commercial launch of Ryoncil® Total revenue of US$51.3 million (A$78.3 million),2 up from US$3.2 million.Successful U.S. commercial launch of Ryoncil® (remestemcel-L-rknd) ...

Core Insights - Mesoblast Limited presented data on Ryoncil (remestemcel-L-rknd) at the February 2026 Tandem Meetings, highlighting its effectiveness in treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in both children and adults [1][2]. Group 1: Treatment Efficacy - Ryoncil demonstrated high survival outcomes in SR-aGvHD patients, regardless of age or treatment line, and is the first FDA-approved mesenchymal stromal cell product for this indication [2][6]. - In a study of 53 patients receiving Ryoncil as a third-line treatment, 15% died before completing the treatment, compared to only 2% in the Phase 3 trial for second-line treatment, indicating the importance of early intervention [3]. - Adult patients in the Emergency Investigational New Drug program showed survival rates comparable to children, supporting the rationale for a pivotal trial of Ryoncil in adults [4]. Group 2: Future Developments - A pivotal trial for Ryoncil's use in adults with severe SR-aGvHD is expected to begin enrollment this quarter, pending protocol approval [4]. - If successful, this trial could lead to an extension of Ryoncil's label for adult use, which represents a market approximately three times larger than that of pediatric patients [4]. Group 3: Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [5][7]. - The company has a robust intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 [8]. - Mesoblast is also developing additional therapies for other inflammatory diseases and has established commercial partnerships in Japan, Europe, and China [7].

Core Viewpoint - Mesoblast Limited reported a significant revenue growth of 60% in Q4 2025, driven by Ryoncil sales, and secured a new $125 million financing facility to enhance its financial flexibility and support strategic initiatives [1][3][5]. Financial Performance - The company achieved gross revenue of $35.1 million from Ryoncil sales for the quarter ended December 31, 2025, marking a 60% increase compared to the previous quarter [1]. - The new financing facility of $125 million is a five-year interest-only arrangement that lowers the overall cost of capital and allows for repayment flexibility without penalties [4]. Product Development - Ryoncil is the first FDA-approved mesenchymal stromal cell product for children under 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD) and is set to enter a pivotal trial for adults with SR-aGvHD, a market three times larger than the pediatric segment [2][8]. - The company is also developing additional therapies for other inflammatory diseases and conditions, including biologic-resistant inflammatory bowel disease and heart failure [8]. Strategic Partnerships - The strong balance sheet and revenue growth provide Mesoblast with greater flexibility to pursue strategic partnerships and expand the label for Ryoncil [5]. - The company has established commercial partnerships in key markets including Japan, Europe, and China [8]. Intellectual Property - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2044 in major markets [9].

Core Viewpoint - Mesoblast Limited has secured a new credit facility of up to US$125 million, significantly improving its financial flexibility and reducing its cost of capital while allowing for strategic partnerships and commercialization opportunities [1][4]. Financial Summary - The new credit facility includes an initial drawdown of US$75 million, which is unsecured until the repayment of the NovaQuest debt by July 8, 2026, after which the total facility will be secured by the Temcell royalty [2][3]. - The facility has a fixed interest rate of 8.00% per annum, with a five-year interest-only period, representing a substantial reduction in overall cost compared to existing debt facilities [2][3]. Strategic Implications - The new facility does not encumber any of Mesoblast's material assets or intellectual property, providing total flexibility for the company in terms of additional unsecured debt or licensing activities [3]. - Dr. Gregory George, the provider of the facility, will receive warrants to purchase approximately 323,000 American Depositary Shares (ADSs) at a price of US$21.51 per ADS, which is a 15% premium to the current 30-day volume-weighted average price (VWAP) [3]. Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [4][6]. - The company has established commercial partnerships in Japan, Europe, and China, and is committed to developing additional cell therapies for various indications [6]. Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection extending to at least 2044 in major markets [7]. Manufacturing Capabilities - The company employs proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]. Market Position - Mesoblast is listed on both the Australian Securities Exchange (ASX: MSB) and Nasdaq (NASDAQ: MESO), indicating its significant presence in the global market [9].

Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases and is participating in the Piper Sandler 37th Annual Healthcare Conference in New York from December 2–4, 2025 [1][2] Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3] - The company has a strong intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection extending through at least 2044 in major markets [6] Product Development - Mesoblast's Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] - The company is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [5] Manufacturing Capabilities - Mesoblast employs proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring these therapies are readily available to patients worldwide [7] Global Presence - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8]

Core Viewpoint - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases and is participating in the Piper Sandler 37th Annual Healthcare Conference in New York from December 2–4, 2025 [1][2]. Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection until at least 2044 in major markets [6]. Product Development - Mesoblast's Ryoncil® (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4]. - The company is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [5]. Manufacturing Capabilities - Mesoblast employs proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring these therapies are readily available to patients worldwide [7]. Corporate Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8].

Core Viewpoint - Mesoblast Limited, a leader in allogeneic cellular medicines for inflammatory diseases, provided a trading update and operational overview during the Chief Executive's Annual General Meeting, highlighting significant revenue growth and ongoing development of its therapies [1][2]. Financial Performance - For the quarter ending December 31, 2025, Mesoblast expects gross revenue exceeding US$30.0 million from Ryoncil® sales, marking a more than 37% increase from US$21.9 million in the previous quarter [2]. Product Overview - Ryoncil® (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4]. - The company is also developing Ryoncil® for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while rexlemestrocel-L is being developed for heart failure and chronic low back pain [5]. Intellectual Property - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection extending to at least 2044 in major markets [6]. Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]. Global Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8].

Core Insights - Mesoblast Limited has appointed James M. O'Brien as the new Chief Financial Officer (CFO) to support its transition to a fully integrated commercial organization [1][2] - The company aims to enhance its financial leadership as it commercializes its product Ryoncil and seeks label expansion [2] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [3] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 in major markets [6] Product Development - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] - Mesoblast is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [5] Financial Leadership - James M. O'Brien brings extensive experience in financial management from previous roles at Actavis plc, Cognition Therapeutics, and Faron Pharmaceuticals, among others [2] - His expertise includes overseeing corporate finance, reporting, internal controls, and accounting operations, with a history of managing transactions totaling nearly $10 billion [2]

Company Overview - Mesoblast Limited is a global leader in developing allogeneic cellular medicines for inflammatory diseases [3][5] - The company is focused on treating severe and life-threatening inflammatory conditions using its proprietary mesenchymal lineage cell therapy technology [3][5] Financial Performance - For the quarter ended September 30, 2025, Mesoblast reported gross revenue of US$21.9 million from Ryoncil sales, marking a 66% increase compared to the previous quarter [1] - The gross to net adjustment for Ryoncil sales remained consistent with prior periods [1] Product Information - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell (MSC) product for any indication and is specifically approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD) [2][4] - The company is developing Ryoncil for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease [5] Market and Adoption - The adoption of Ryoncil has been positively influenced by reimbursement from both commercial and government payers [3] - A permanent J-Code assigned by the Centers for Medicare and Medicaid Services (CMS) became active on October 1, which is expected to further enhance adoption [3] Intellectual Property - Mesoblast has a robust global intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection expected to extend through at least 2041 in major markets [6] Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines that are planned to be readily available to patients worldwide [7]

Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases, emphasizing that its products are manufactured from U.S. donors and are not subject to tariffs on imported pharmaceutical products [1][3][6] Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4][6] - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7] Product Information - Ryoncil® (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [2][5] - The company is developing Ryoncil® for additional indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while rexlemestrocel-L is being developed for heart failure and chronic low back pain [6] Manufacturing and Distribution - Mesoblast's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, which are planned to be readily available to patients worldwide [8] - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [9]