Allogeneic Cellular Medicines

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Mesoblast (MESO) - 2025 H2 - Earnings Call Presentation
2025-08-28 22:30
Financial Performance - Revenue from cell therapy products reached US$172 million, a 191% increase compared to the previous year[30] - Ryoncil's successful launch contributed US$132 million in gross sales and US$113 million in reported net sales after a 146% gross to net adjustment[30] - Net operating cash spend was US$50 million, a 3% increase on prior year[30] - Cash on hand at June 30, 2025, was US$162 million (A$247 million)[30] Ryoncil (remestemcel-L) - Ryoncil became the first FDA-approved MSC product in the US in December 2024 and commercially available on March 28, 2025[24] - The company onboarded 32 US transplant centers, aiming for the top 45 centers (80% of pediatric bone marrow transplants) by the end of the quarter[24] - Ryoncil demonstrated a 70% overall response rate at Day 28 in a Phase 3 trial for SR-aGvHD[41,43] - In children from GVHD001 trial, 49% survival at Year 4, with only 14% (N=7) died due to aGvHD through 4 years[44] Market Opportunities - Steroid-refractory acute GvHD for children & adults represents a ~US$1 billion market[21] - Biologic-refractory inflammatory bowel disease represents a >US$5 billion market[21] - Heart failure with reduced ejection fraction (HFrEF) represents a >US$10 billion market[21] - Chronic low back pain (CLBP) represents a >US$10 billion market[21]
Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board
Globenewswire· 2025-04-28 23:44
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 received FDA approval for RYONCIL (remestemcel-L), the first mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease in pediatric patients [5][6] Recent Developments - Mesoblast appointed Lyn Cobley to its Board of Directors, who brings over 30 years of experience in the financial services industry, including senior roles at major banks [1][3] - Cobley expressed enthusiasm about Mesoblast's recent FDA approval and the company's potential for future growth, including commercialization and new indications for prevalent diseases [3] Strategic Initiatives - The company is focused on developing additional cell therapies for various indications, including adult SR-aGvHD and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [6] - Mesoblast has established commercial partnerships in key markets such as Japan, Europe, and China [6] Intellectual Property and Manufacturing - Mesoblast holds a strong global 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] - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability for patients worldwide [8]