Positive Results from IGNYTE-ESO Trial
The pivotal IGNYTE-ESO trial with lete-cel met its primary endpoint with a 42% response rate overall, including 6 complete responses. This forms the basis of the BLA submission for lete-cel, expected to expand its reach to synovial sarcoma and MRCLS patients.
Successful Tecelra Launch
Tecelra, the first FDA-approved engineered cell therapy for solid tumors, has been embraced by the sarcoma community with 9 treatment centers authorized. Projected to expand to 30 centers by the end of 2025, achieving patient coverage in sarcoma centers of excellence.
Cost Reduction and Strategic Focus
The company plans a 33% headcount reduction and a 25% reduction in operating expenses by next year, leading to a $506 million saving in 2025, aiming for cash flow breakeven by 2027.
Increased Confidence in Sarcoma Franchise Revenue
The company projects $400 million in combined U.S. peak revenue for TCR T-cell and lete-cel, with lete-cel expected to make up over 60% of the revenue.