Allocetra - (ENX-CL-05-001)

July 13, 2026: Enlivex Ltd. (NASDAQ: ENLV) announced the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra™ for treatment of age-related symptomatic primary knee osteoarthritis in patients aged 64 and older. The RMAT was supported by a completed Phase I/IIa trial in which Allocetra-treated patients showed statistically significant and clinically meaningful improvements in knee pain and physical function versus placebo, with durability through at least six months. Enlivex has initiated a randomized, controlled Phase IIb trial in the U.S. and EU, planning to enroll 182 patients aged 64+, and expects top-line data by the end of Q2 2027. The FDA also requested a Type B meeting for a comprehensive discussion of the Allocetra development program; Enlivex plans to schedule it to align on Phase IIb elements and pivotal development plans.