Mesoblast Limited

Mesoblast Ltd is a commercial-stage biotechnology company that develops allogeneic (off-the-shelf) cellular medicines for severe and life-threatening inflammatory conditions. The company's proprietary mesenchymal lineage cell therapy technology platform creates therapies that release anti-inflammatory factors to counter and modulate the immune system, reducing inflammatory processes. In December 2024, Mesoblast received FDA approval for Ryoncil (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older, including adolescents and teenagers. Ryoncil is the first mesenchymal stromal cell ("MSC") product approved by the FDA for any indication. Mesoblast is developing additional late-stage product candidates. Ryoncil, which is the company's first-generation MSC product platform, is also being developed for other systemic inflammatory diseases such as SR-aGvHD in adults, Duchenne Muscular Dystrophy ("DMD"), and biologic-resistant inflammatory bowel disease, including ulcerative colitis and Crohn's disease. Rexlemestrocel-L, the company's second-generation mesenchymal lineage precursor cell product platform, is in late-stage development for chronic low back pain (CLBP) due to degenerative disc disease and chronic heart failure (CHF). Mesoblast's proprietary manufacturing processes produce industrial-scale, cryopreserved, off-the-shelf cellular medicines. These cell therapies, based on mesenchymal precursor cells ("MPCs") and their progeny, MSCs, are intended to be readily available to patients worldwide upon receiving marketing authorizations.