Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™, a universal, off-the-shelf cell therapy aimed at reprogramming macrophages to their homeostatic state [4]. Clinical Trial Details - The Phase I/II trial of Allocetra™ for moderate to severe knee osteoarthritis has completed follow-up for all 134 patients, with results expected to be publicly released by August 18, 2025 [1]. - The trial consists of two stages: a Phase I safety run-in to assess safety and tolerability, followed by a double-blind, randomized, placebo-controlled Phase IIa stage [2]. - Key efficacy endpoints include evaluating joint pain and function at three, six, and twelve months post-treatment, with an interim evaluation planned to assess the potential addition of up to 50 patients to the study [2]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [3]. - The condition leads to significant disability, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes, resulting in over one million hospitalizations annually in the U.S. [3]. - Currently, there are no FDA or EMA approved medications that can halt or reverse the progression of structural damage in joints affected by osteoarthritis [3].