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]

NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its participation at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2–4, 2025. Silviu Itescu, Chief Executive of Mesoblast, is scheduled for a fireside chat at 12.00 p.m. ET on Thursday, December 4, 2025. A live webcast of the event will be available using this weblink https://event.webcasts.com/starthere. ...

NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided a trading update, together with a comprehensive operational overview, as part of the Chief Executive’s Annual General Meeting (AGM) address. For the quarter ending December 31, 2025, management expects gross revenue of more than US$30.0 million from sales of Ryoncil® (remestemcel-L-rknd). This represents more than 37% increase on the U ...

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]

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][2]. Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4]. - 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 any indication, specifically for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD) [2][5]. - Ryoncil is also being developed for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while another product, rexlemestrocel-L, targets heart failure and chronic low back pain [6]. Manufacturing and Distribution - Mesoblast's manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability 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].

Core Insights - Mesoblast Limited has successfully launched Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients [1][5] - The company aims to expand Ryoncil's applications to adult SR-aGvHD and inflammatory bowel disease (IBD), alongside advancing its second-generation product, Rexlemestrocel-L [3][6] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines targeting severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [4] - The company has a robust intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2041 in major markets [7] Product Development - Ryoncil is currently being developed for additional indications, including adult SR-aGvHD and biologic-resistant IBD, while Rexlemestrocel-L is focused on heart failure and chronic low back pain [6] - The company is actively working to onboard new sites and increase the usage of Ryoncil [2] Manufacturing and Distribution - Mesoblast's proprietary manufacturing processes allow for industrial-scale production of cryopreserved, off-the-shelf cellular medicines, ensuring availability for patients worldwide [8]

Core Viewpoint - Mesoblast Limited has reported strong initial sales of its FDA-approved product Ryoncil, generating gross revenue of US$13.2 million from March 28 to June 30, 2025, following its launch for treating steroid-refractory acute graft-versus-host disease in pediatric patients [1][6][10]. Financial Highlights - Gross revenue from Ryoncil sales reached US$13.2 million (unaudited) from March 28 to June 30, 2025 [6]. - The company reported US$1.6 million in revenue from royalties on sales of TEMCELL HS Inj. in Japan [6]. - Net operating cash spend for the quarter was US$16.6 million [6]. - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6]. Operational Highlights - More than 25 transplant centers have been onboarded since the product launch, with plans to complete onboarding across all 45 priority centers that account for approximately 80% of U.S. pediatric transplants [6]. - Ryoncil's coverage is expanding, with over 250 million U.S. lives insured by commercial and government payers, and mandatory Medicaid coverage effective July 1 [6]. - A patient access hub, MyMesoblast™, has been established to assist patients with insurance coverage and access to Ryoncil [6]. Regulatory and Exclusivity Status - Ryoncil received seven years of orphan-drug exclusive approval from the FDA for treating SR-aGvHD in pediatric patients aged 2 months and older [6]. - Mesoblast holds biologic exclusivity preventing another sponsor from referencing Ryoncil's biologic license application until December 2036 [6]. - The company has a strong U.S. intellectual property position on MSC technology, providing commercial barriers to entry against competitors through 2044 [6][12]. Future Developments - Mesoblast held a Type B meeting with the FDA to discuss a pivotal trial for Ryoncil in adults with SR-aGvHD, aiming to extend the product's label [6].

Core Insights - Mesoblast is making progress with the FDA regarding the accelerated approval pathway for Revascor and label extension for Ryoncil [1][2][3] Group 1: FDA Interactions and Approvals - A Type B meeting was held with the FDA to discuss the potential filing for a Biologics License Application (BLA) for Revascor, with alignment on key components [2] - An upcoming meeting with the FDA is scheduled to discuss a pivotal trial of Ryoncil in adults with steroid refractory acute graft versus host disease (SR-aGvHD) [3] Group 2: Commercial Launch and Market Coverage - Ryoncil became commercially available in the U.S. on March 28, 2025, with over 20 transplant centers onboarded by the end of the quarter, exceeding expectations [4] - The company has expanded Ryoncil's coverage to over 220 million U.S. lives insured, with 37 of 51 states providing Medicaid coverage [4] Group 3: Company Overview and Future Developments - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [6][8] - The company is committed to developing additional cell therapies for various indications, including inflammatory bowel disease and chronic low back pain [8]