Enlivex Therapeutics to Present Phase IIa 3-month Data of Allocetra in Patients with Moderate-to-Severe Knee Osteoarthritis at the ACR Convergence 2025

Ness-Ziona, Israel, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company")), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will present a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025, taking place October 24–29 at McCormick Place Convention Center in Chicago, Illinois.

The presentation will feature clinical data from the recently announced Phase IIa (ENX-CL-05-001) 3-month topline data readout for Allocetra™ in patients with moderate-to-severe knee osteoarthritis (KOA), including clinically meaningful and statistically significant improvement compared to the control placebo arm in reduction of pain and improvement of function, in idiopathic age-related osteoarthritis patients (≥60 years), representing more than 50% of the total KOA market and 54% of the study population, as well as new supporting biomarker data. The data will be presented by Prof. Philip Conaghan, Consultant Rheumatologist and Director of the NIHR Leeds Biomedical Research Centre. Professor Conaghan is an international leader in osteoarthritis and musculoskeletal imaging, who has authored more than 700 publications and chaired multiple global guidelines and trial initiatives.

Poster Presentation

• Title: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial of an Innovative Intra-Articular Apoptotic Cell Therapy in Knee Osteoarthritis (OA): 3-Month Positive Outcomes and Identification of Responder Population (NCT06233474)
• Abstract ID: 2220562
• Date & Time: October 28, 2025 | 10:30 AM - 12:30 PM CT
  
  

Einat Galamidi, MD, CMO, will attend the conference and will be available for meetings with stakeholders and members of the scientific community.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, 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 and life debilitating conditions. For more information, visit http://www.enlivex.com.

Safe Harbor Statement:  This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "could," "intends," "estimates," "suggests," "has the potential to" and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA ^TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex's business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA ^TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties.  In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex's filings with the Securities and Exchange Commission, including in the Company's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

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