Successful FDA Approval of RYONCIL
RYONCIL, the first mesenchymal stromal cell therapy, has been approved by the FDA for treating children with severe steroid-refractory acute graft-versus-host disease. The product has demonstrated a 70% overall response rate at day 28 in a Phase 3 trial.
Financial Strength and Fundraising
Mesoblast's cash balance was USD 38 million at the end of 2024, with pro forma cash of approximately USD 200 million after a successful global private placement raising USD 161 million.
Reduction in Operating Cash Spend
Net operating cash spend was USD 20.7 million for the first half of FY 2025, a 22% reduction compared to the first half of FY 2024.
Pipeline Expansion and Strategic Partnerships
Plans to expand RYONCIL for inflammatory bowel disease and adult GVHD. Strategy includes partnerships for distribution in Europe and potential partnerships in the US for chronic low back pain.