Mesoblast Limited (ASX:MSB) Announces Q3 2025 Highlights
Operational Highlights
Mesoblast launched Ryoncil® (remestemcel-L) in the United States on March 28, 2025, becoming the first mesenchymal stromal cell therapy approved by the FDA. The treatment received Federal Medicaid coverage, with 15 infusion kits purchased to date. The company has onboarded ten priority transplant centres, enrolling five patients through the MyMesoblast™ hub, and expects to add ten more centres this quarter. Nine key account managers began their roles in April to accelerate the onboarding of 35 additional transplant centres, covering 80% of U.S. pediatric transplants. Coverage for Ryoncil® has expanded to over 104 million U.S. lives, with Medicaid coverage in 37 states and mandatory coverage for all 44 million lives expected by July 1, 2025.
Financial Highlights
For the quarter ended March 31, 2025, Mesoblast reported a net operating cash spend of US$12.7 million and maintained a cash position of US$182 million (A$290 million). The company successfully completed a global private placement, raising A$260 million (US$161 million) primarily from existing major shareholders in the US, UK, and Australia. Additionally, Mesoblast was added to the S&P Dow Jones Indices’ S&P/ASX 200 Index effective March 6, 2025.
Corporate Updates
Mesoblast strengthened its Board of Directors by appointing Dr. Gregory George and Ms Lyn Cobley. The company also advanced its pipeline with plans for accelerated approval of Revascor® (rexlemestrocel-L) for chronic heart failure and initiated a Phase 3 trial for rexlemestrocel-L in chronic low back pain associated with degenerative disc disease.
Executive Comments
Dr. Silviu Itescu, CEO of Mesoblast, stated, “We were very pleased to have made Ryoncil® commercially available to treat children with acute GVHD within one quarter of receiving FDA approval as the first mesenchymal stromal cell (MSC) therapy approved in the US for any indication. With our strong cash position we are well placed to expand Ryoncil® indications to other serious and life-threatening pediatric inflammatory diseases, and to adults with acute GvHD.”
Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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