Enlivex Therapeutics Ltd. announced positive indication of effect and safety results from its Phase II study of Allocetra? in patients with sepsis, in which 120 patients enrolled. The Phase II trial was a placebo-controlled, randomized, dose-finding, multi-country, multi-center study, evaluating frozen-formulation Allocetra?

in addition to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections. The results contained in this press release represent topline data and are subject to revision based on the ongoing collection of study information and detailed analysis. The Company expects to release further details about the study in a forthcoming presentation.

Allocetra? is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state.

These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra? has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.