Enlivex Therapeutics Ltd Stock Price, News & Analysis

Enlivex Therapeutics (Nasdaq: ENLV) announced a webinar scheduled for August 18, 2025, at 8:00 AM ET to present 3-month topline results from its Phase IIa trial of Allocetra™ for moderate to severe knee osteoarthritis. The study, ENX-CL-05-001, is a double-blind, randomized, placebo-controlled multi-center trial.

The trial has enrolled 134 patients who have completed the 3-month follow-up period. The Phase IIa stage follows a completed Phase I open-label dose-escalation study that evaluated safety, tolerability, and optimal dosing. The trial addresses knee osteoarthritis, which affects over 32.5 million Americans and 300 million people worldwide, with 40% of men and 47% of women developing it in their lifetimes.

Enlivex Therapeutics (NASDAQ:ENLV) has confirmed the target date of August 18, 2025 for announcing topline data from its Phase II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. The trial has completed the three-month follow-up period for all 134 patients, marking a significant milestone in the study.

The Phase I/II trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase, followed by a Phase IIa double-blind, randomized, placebo-controlled multi-centered trial. The study's key endpoints include safety assessment and measurement of changes in knee pain and function at three, six, and twelve months post-treatment.

Enlivex Therapeutics (NASDAQ: ENLV) announced its upcoming presentation at EULAR European Congress of Rheumatology in Barcelona, featuring data from their ongoing clinical study of Allocetra™. The presentation will showcase results from their Phase I/II trial evaluating this off-the-shelf macrophage reprogramming cell therapy in knee osteoarthritis patients. Allocetra™ has shown promising results in Phase I/II studies, demonstrating favorable safety and efficacy signals including significant pain reduction, improved joint function, and prevention of knee replacement surgery. The company has completed enrollment for the Phase II stage of their randomized, controlled, blinded trial, with topline data expected by August 2025. The poster presentation, titled "Phase I/II Trial of AllocetraTM Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation," will be presented on June 11, 2025.

Enlivex Therapeutics (NASDAQ: ENLV) has been selected to present at the Israeli BioMed 2025 Conference in Tel Aviv from May 21-23, 2025. The presentation, titled "Enlivex—Harnessing the Natural Healing Power of Macrophages to Treat Inflammatory Diseases," will focus on their cell therapy product Allocetra™.

Allocetra™ is a universal, off-the-shelf cell therapy designed to reset macrophages to their homeostatic state. The company is currently conducting multiple Phase I/II trials, with promising interim results in moderate knee osteoarthritis showing significant improvements including:

• 47% reduction in pain
• 46% improvement in joint function
• 40% decrease in stiffness

Additional trial readouts are expected in 2025.

Enlivex Therapeutics (Nasdaq: ENLV) announced its participation at the Osteoarthritis Research Society International (OARSI) 2025 World Congress in Incheon, South Korea, scheduled for April 24-27, 2025. The company will present two poster abstracts showcasing their cell therapy product Allocetra™.

The presentations will highlight data from both preclinical and Phase I/II clinical studies of Allocetra™, their proprietary off-the-shelf macrophage reprogramming cell therapy. The therapy has shown promising results in moderate and end-stage osteoarthritis, demonstrating favorable safety profiles, significant pain reduction, improved joint function, and helped patients avoid knee replacement surgery.

Two presentations are scheduled: a Flash Talk & Poster presentation on Phase I/II Clinical Trial results (Abstract #092) and a Poster presentation on Allocetra's biological activity in preclinical models (Abstract #4231304). CEO Dr. Oren Hershkovitz and CMO Dr. Einat Galamidi will be available for meetings during the conference.

Enlivex Therapeutics (Nasdaq: ENLV) has completed patient enrollment in the Phase II stage of its Phase I/II clinical trial evaluating Allocetra™ for moderate to severe knee osteoarthritis treatment. The randomized, controlled, and blinded study successfully enrolled 133 patients. Following promising initial efficacy data from the Phase I stage, the company expects to receive 3-month topline data by August 2025.

Enlivex Therapeutics (Nasdaq: ENLV) has initiated dosing in a Phase I trial evaluating Allocetra™ for temporomandibular joint (TMJ) osteoarthritis patients. The investigator-initiated study, conducted at Sheba Medical Center, aims to assess the safety, tolerability, and initial efficacy of Allocetra™ when injected into the TMJ.

The trial will enroll six patients who have not responded adequately to conventional TMJ osteoarthritis treatments. The study's primary safety endpoint will evaluate adverse events frequency and severity, while efficacy endpoints will measure changes in TMJ pain, joint functionality, and other disease parameters over a 12-month follow-up period.

TMJ osteoarthritis, affecting 5-12% of the global population, is a degenerative and progressive condition causing jaw pain and stiffness, with currently no effective long-term treatments available.

Enlivex Therapeutics (Nasdaq: ENLV) has received a notice of allowance from China's CNIPA for patent application 2020800620493, covering the use of Allocetra™ in treating osteoarthritis patients. The patent, expected to be issued in H1 2025, will provide protection through 2040.

The company recently reported positive interim 6-month efficacy data from its Phase I/II Allocetra™ trial in moderate to severe knee osteoarthritis patients. Key results include:

• 47.0% average reduction in reported pain (P=0.0001) vs baseline
• 46% improvement in joint function
• 40% improvement in joint stiffness
• 83% of patients remained treatment responders after 6 months
• No serious adverse events reported
• Maintained positive effects observed at 3 months

Enlivex Therapeutics (NASDAQ: ENLV) has announced a webinar to discuss positive interim data from its Phase I/II Allocetra™ trial in knee osteoarthritis patients. The six-month data from the Phase I stage showed significant improvements with:

• 47.0% average reduction in reported pain (P=0.0001)
• 46% improvement in joint function
• 83% of patients maintaining response at six months post-treatment

The results demonstrate Allocetra™'s potential as a breakthrough treatment for moderate to severe knee osteoarthritis, with no serious adverse events reported. The investor webinar is scheduled for March 5, 2025, at 11:00 a.m. ET, featuring CEO Oren Hershkovitz Ph.D., who will provide detailed insights into these promising interim results.