Mesoblast (US:MESO) Newsfilter·2025-01-31 00:11Core Insights - Mesoblast Limited is advancing the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients aged 2 months and older, with a strong focus on ensuring product availability and successful launch this quarter [1][2][6] Company Mission - Mesoblast is dedicated to bringing innovative off-the-shelf allogeneic cellular medicines to market for the treatment of serious and life-threatening inflammatory illnesses [3] Market Opportunity - The annual market potential for steroid-refractory acute GvHD exceeds $1 billion, while heart failure with reduced ejection fraction (HFrEF) and chronic low back pain (CLBP) each have addressable market potentials exceeding $10 billion [5] - Ryoncil® is the only FDA-approved MSC therapy for any indication, specifically targeting pediatric SR-aGvHD, which is a life-threatening condition [5][15] Competitive Advantage - Mesoblast possesses a robust intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to extend through at least 2041 in major markets [17] - The company has demonstrated a proven scientific approach, extensive positive clinical trial results, and the ability to meet regulatory requirements of the FDA [5][14] Financials and Projections - The successful financing of $160 million (A$260 million) has positioned the company with approximately $200 million (A$322 million) in cash on hand, supporting the U.S. launch activities and expansion of clinical indications for Ryoncil® [2][5] Upcoming Milestones - The U.S. launch of Ryoncil® is planned for this quarter, pending receipt of National Drug Codes (NDC) from the FDA [8] - Mesoblast will provide an update on half-year results on February 27, 2025 [2] - The company is also pursuing FDA accelerated approval for Revascor® in end-stage HFrEF and has commenced enrollment for a Phase 3 trial of rexlemestrocel-L for CLBP [10][13]