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Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2024
Mesoblast Mesoblast (US:MESO) Newsfilter·2025-01-30 23:20

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].