Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today reported that after reviewing previously-reported Phase II trial data, the Israeli Ministry of Health has authorized the initiation of a proposed Company-sponsored, multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating AllocetraTMin severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS).

The Phase IIb trial is expected to recruit up to 152 severe or critical COVID-19 patients in clinical centers in Israel and certain European countries, and is designed to assess the safety and efficacy of AllocetraTM when administered in addition to standard of care treatment.

Enlivex previously reported positive top-line results from Phase Ib and Phase II investigator-initiated clinical trials of AllocetraTM in COVID-19 patients in severe and critical condition. Aggregate data from the two trials demonstrated that AllocetraTMwas safe and well tolerated. Moreover, at the end of the 28-day follow-up period, a 0% (0/21) mortality rate was observed and 90.5% (19/21) of patients recovered from their respective severe/critical condition and were discharged from the hospital after an average of 5.6 days following AllocetraTM administration.

The planned Phase IIb clinical trial will have two primary endpoints: ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical). In addition, the trial will assess several secondary endpoints, including evaluation of long-COVID-19 symptoms.

Oren Hershkovitz, Ph.D., CEO of Enlivex, and Prof. Dror Mevorach, Chief Scientific Officer of Enlivex, stated in a joint comment: "We would like to thank the Israeli Ministry of Health for the expedited review and for authorizing a Phase IIb clinical trial of AllocetraTM in COVID-19 patients in severe and critical condition."

ABOUT ALLOCETRATM

AllocetraTM 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, COVID-19 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, AllocetraTM 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.

ABOUT ENLIVEX

Enlivex is a clinical stage immunotherapy company developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions.