Enlivex CEO Issues Letter to Shareholders – Perspectives on Recent Events

Nes-Ziona, Israel, April 29, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz.

Dear fellow shareholders,

I have been serving as the Chief Executive Officer of Enlivex for the last four and a half years. During that period, we have been working diligently to develop our drug product candidate, Allocetra^TM, as a first-in-kind modulator of a spectrum of negative immune reactions from low, chronic, debilitating inflammation to high-grade, life-threatening cytokine storms.

To-date, we have completed numerous pre-clinical studies across multiple disease models, infused Allocetra^TM in more than 100 patients and witnessed the encouraging safety profile and potential effect of Allocetra^TM. We saw a patient with COVID-19 in critical condition saying goodbye to his loved ones via a video call, as the consensus in the ICU was that he would not last through the night, and that patient received an infusion of Allocetra^TM and within hours had a complete reversal of his condition, resulting in his release from the hospital several days later.  We also saw a patient with an ultra-rare condition, vanishing bone disease in the shoulder joint. In this case, not only was the joint cartilage completely eroded, but the shoulder bone itself had completely disintegrated. After four years of escalation and nine months of continued hospitalization, the patient received a compassionate treatment of injections of matched Allocetra^TM to the shoulder joint. We witnessed the outstanding recovery of the inflammatory condition resulting in hospital discharge after five weeks and no re-hospitalization in the following three years. We have witnessed, first-hand, the potential effect of Allocetra^TM as a life-changer, and all of us at Enlivex are committed to translate that first-hand experience into a global one.

On April 11, 2024, we released the top-line data from a placebo-controlled, randomized, dose-finding, multi-country, multi-center Phase II trial, which evaluated frozen-formulation Allocetra in addition to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections.  

The trial randomization resulted in a higher risk profile of the Allocetra^TM group  as compared to the control group, making some of the data challenging to interpret. In small clinical trials, these things happen from time to time. While we are not happy that this occurred, we are pleased that Allocetra^TM demonstrated (i) a potential indication of effect not only stand-alone but also as compared to the control group in high-risk urinary tract infection (UTI) sepsis patients, and (ii) a favorable safety and tolerability profile.