Core Insights - Mesoblast Limited has reported significant advancements in its operations and financials for the second quarter ended December 31, 2024, including the successful FDA approval of its therapy Ryoncil® for a critical condition in children [1][6]. Financial Summary - The company raised A$260 million (US$161 million) through a global private placement primarily targeting existing major shareholders [3]. - Net operating cash spend for the quarter was US$10.1 million, reflecting an 18% reduction (US$2.2 million) compared to the same quarter in FY2024 [7]. - Cash on hand at the end of the quarter was US$38 million (A$61 million), with pro-forma cash after the recent capital raise estimated at approximately US$200 million (A$322 million) [7]. Operational Highlights - Ryoncil® (remestemcel-L) became the first FDA-approved mesenchymal stromal cell therapy for children aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD) [6][9]. - A distribution network has been established with Cencora to ensure efficient delivery of the therapy to U.S. treatment centers [6]. - The confirmatory Phase 3 trial for rexlemestrocel-L in chronic low back pain patients is actively enrolling, with plans to expand trial sites due to the recent capital raise [6]. - Mesoblast intends to meet with the FDA regarding accelerated approval for its therapy in end-stage heart failure patients under the Regenerative Medicine Advanced Therapy (RMAT) designation [6]. Research and Development - A publication in the European Journal of Heart Failure highlighted the positive outcomes of Revascor® (rexlemestrocel-L) in improving survival rates in high-risk patients with ischemic heart failure [6]. - The company is developing additional therapies for various inflammatory diseases and has established commercial partnerships in Japan, Europe, and China [10]. Intellectual Property and Manufacturing - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2041 in major markets [11]. - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved cellular medicines, ensuring availability for patients worldwide [12].

Core Viewpoint - Mesoblast Limited (MESO) has experienced an 80% increase in share price within one month following FDA approval of remestemcel-L for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and older, marking a significant milestone for the company as it launches its first approved product [1][2]. Company Summary - The FDA approval of remestemcel-L, branded as Ryoncil in the U.S., is expected to provide Mesoblast with a steady income stream as the company prepares for the product launch [2]. - Mesoblast's shares have surged 202.9% over the past six months, contrasting with a 4.8% decline in the industry [3]. - The approval was based on a phase III study where 70% of patients treated with remestemcel-L achieved an overall response by Day 28, indicating a positive prognosis for survival in aGVHD [4]. - No patients discontinued Ryoncil treatment due to laboratory abnormalities, with over 85% completing the full course without interruption [5]. Pipeline and Future Prospects - Mesoblast is exploring the expansion of Ryoncil's label to include adult patients with SR-aGVHD, with a late-stage study currently underway [6]. - The company is also evaluating Ryoncil for inflammatory bowel disease indications, including ulcerative colitis and Crohn's colitis [6]. - Another late-stage candidate, rexlemestrocel-L, is being developed for heart failure and chronic low back pain (CLBP), with FDA support for an accelerated approval pathway in patients with end-stage ischemic heart failure [9]. - Mesoblast initiated patient enrollment for a late-stage study of rexlemestrocel-L in CLBP, focusing on pain reduction and quality of life improvements [10].

Mesoblast Limited (MESO) announced that the FDA has approved Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older, including adolescents and teenagers.Following the FDA nod, Ryoncil became the first and only mesenchymal stromal cell therapy to be approved for any indication in the United States.Ryoncil is also the first FDA-approved therapy for pediatric SR-aGvHD, a life-threatening condition with high mortality rate ...

On Wednesday, the FDA approved Mesoblast Limited’s MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S.Ryoncil is the only MSC therapy approved in the U.S. for any indication and the only therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents.Ryoncil contains MSCs, a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isola ...

RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.In a single-arm, multi-center, Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or Grade D disease, 70% achieved an overall response by Day 28 of treatment wi ...

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (NASDAQ:NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast's inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024. The Nasdaq Biotechnology Index contains securities of Nasdaq-listed companies classified accor ...

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced a key publication in the November 2024 online issue of the prestigious peer-reviewed European Journal of Heart Failure (EJHF), which reports that a single intramyocardial injection of the Company’s allogeneic cell therapy Revascor® (rexlemestrocel-L) results in improved survival in high-risk patients with ischemic heart failure and in ...

NEW YORK, Oct. 30, 2024 (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 first quarter ended September 30, 2024. Mesoblast Chief Executive Silviu Itescu said: "We have had an extremely busy and productive quarter starting right from the outset with the filing of our Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for a ...

Exhibit 99.1 ¶mesoblast ANNUALREPORT 2024 GLOBAL LEADER IN ALLOGENEIC CELLULAR MEDICINES FOR INFLAMMATORY DISEASES CONTENTS CORPORATE GOVERNANCE Mesoblast Limited and its Board of Directors are committed to implementing and achieving an effective corporate governance framework to ensure that the Company is managed effectively and in an honest and ethical way. The Company's Corporate Governance Statement for the financial year ending 30 June 2024 has been approved by the Board and is available on our website ...

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George ("Investor") for issue, at its sole discretion, up to US$50.0 million (A$72.7 million) convertible notes on approval by the United States Food and Drug Administration (FDA) of Mesoblast's lead product candidate Ryoncil® (remestem ...