Mesoblast (US:MESO) Globenewswireยท2025-04-30 00:53Core Insights - Mesoblast Limited has successfully launched Ryoncil (remestemcel-L) for treating children with acute graft versus host disease (GVHD) shortly after receiving FDA approval, marking it as the first approved mesenchymal stromal cell therapy in the US [2][11] - The company is well-positioned financially, with a cash reserve of US$182 million (A$290 million), allowing for the expansion of Ryoncil's indications to other serious pediatric inflammatory diseases and adult acute GVHD [5][12] - Mesoblast is also preparing for a Type B meeting with the FDA to discuss the accelerated approval pathway for Revascor (rexlemestrocel-L) in treating ischemic chronic heart failure with reduced ejection fraction [5][12] Financial Highlights - The net operating cash spend for the quarter was US$12.7 million [5] - Cash on hand at the end of the quarter was US$182 million (A$290 million) [5] - Mesoblast raised A$260 million (US$161 million) through a global private placement primarily to existing major shareholders [12] Operational Highlights - Ryoncil became commercially available in the US on March 28, 2025, with Federal Medicaid coverage, and 15 infusion kits have been purchased for patient treatment [5] - The company has onboarded ten priority transplant centers, with plans to onboard an additional ten in the current quarter [5] - Mesoblast has expanded Ryoncil coverage to over 104 million US lives insured by commercial and government payers [5] Product Development - Ryoncil is being developed for additional indications, including adult SR-aGvHD and biologic-resistant inflammatory bowel disease [13] - Revascor is under development for chronic heart failure and has received RMAT designation from the FDA [12] - The confirmatory Phase 3 trial for rexlemestrocel-L in chronic low back pain is actively enrolling patients, with a focus on opioid cessation [12] Corporate Developments - Mesoblast has strengthened its Board of Directors with the appointment of Dr. Gregory George and Ms. Lyn Cobley [12] - The company was added to the S&P/ASX 200 Index effective March 6, 2025 [12] Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications covering its mesenchymal stromal cell technology [14] Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines [15] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing its proprietary mesenchymal lineage cell therapy technology [10]