Enlivex Stock Plunges 50% Following Mixed Phase II Sepsis Results for Allocetra Cell Therapy

1. Enlivex Therapeutics Ltd. (Nasdaq: ENLV) experienced a significant stock decline of 50% due to mixed results from a mid-stage study evaluating its lead drug, Allocetra, as a potential treatment for sepsis.
2. Allocetra is an off-the-shelf cell therapy designed to restore macrophages to their homeostatic state and is currently being assessed for organ failure linked to sepsis.
3. The study data demonstrated a 90% reduction in sequential organ failure assessment (SOFA) scores for patients with urinary tract infections (UTIs) compared to 68% for pneumonia-associated sepsis patients and 36% for patients with other infections.
4. The overall mortality rate for patients treated with Allocetra was reduced by 65% compared to the placebo group.
5. Despite these positive findings, the relative analysis presented challenges due to imbalances between the Allocetra and placebo groups, such as a 20% higher frequency of septic shock and a 35% higher frequency of invasive ventilation in the Allocetra-treated group, making it challenging to deduce the relative effect in other patient subgroups.
6. Year to date, ENLV's shares have plummeted 41.5% compared to the industry's 9.9% growth.
7. Enlivex is considering a potential follow-on study focusing exclusively on high-risk UTI patients, as up to 31% of sepsis cases originate as UTIs and contribute to approximately 1.6 million deaths in Europe.
8. Enlivex is also investigating Allocetra in two separate phase I/II studies for moderate and end-stage knee osteoarthritis.