Enlivex Therapeutics Ltd. Announces Six-Month Efficacy Data From Phase IIa Allocetra Trial in Knee Osteoarthritis Patients Aged 60+

Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive six-month efficacy data from the Phase IIa stage of its randomized, multi-country Phase I/II Allocetra™ trial (ENX-CL-05-001) in patients with moderate to severe knee osteoarthritis (OA). The six-month follow-up has now been completed for all patients. The results re-affirm the three-month data reported previously and substantiate the identification of an age-related primary OA responder population.

Summary of the 6-month Topline Data

• On August 18, 2025, Enlivex announced the 3-month topline data, reporting that Allocetra™ demonstrated, in the primary age group (60+), substantial reduction in pain and improvement in function across multiple efficacy endpoints that were evaluated, compared to placebo. The analysis revealed a robust positive correlation between patients' age and the magnitude of the clinical effect and its statistical significance.
  
   
• At 6 months, Allocetra™ continued to demonstrate substantial and durable reduction in pain and improvement in function across multiple efficacy endpoints evaluated in the same primary age group (60+), as compared to placebo. These findings are consistent with the 3-month observations, as well as the robust positive correlation between patients' age and the magnitude of the clinical effect and its statistical significance.
  
   
• Allocetra™ demonstrated a clinically meaningful improvement in pain and function, a composite endpoint which we expect will be a key endpoint in the follow-up pivotal studies, reaching statistical significance at 3-month at age 60+ (-26.8 points in the AllocetraTM treated group versus -13.4 points in the placebo group,  corresponding to 99% improvement over the placebo group (scale 0-100; p=0.008), and at 6-month at age 61+ (-27.8 points in the AllocetraTM treated group versus -15.5 points in the placebo group  corresponding to 80% improvement over the control group (scale 0-100; p=0.02).)
  
   
• Allocetra™ continued to demonstrate a favorable safety profile through the six-month follow-up, consistent with the previously reported three-month data. 

Professor Philip Conaghan, MBBS, PhD, FRACP, FRCP, is an internationally renowned leader in osteoarthritis and musculoskeletal imaging, and the Consultant Rheumatologist and Director of the NIHR Leeds Biomedical Research Centre. Prof. Conaghan has authored more than 700 publications and chaired multiple global guidelines and trial initiatives and is a member of the Clinical Advisory Board of Enlivex.

Prof. Conaghan commented "The toll of knee osteoarthritis continues to grow with the increasing burden of aging and obesity, and subsequently the need for effective therapies is becoming a major need undertaking. With the understanding that inflammatory mediators play a central role in the progression of knee pain and dysfunction, new treatment strategies can be proposed. I am encouraged by the results demonstrated in the study so far and continue to follow the clinical development of Allocetra™ as an immune modulating agent that could potentially pioneer a new therapeutic approach."

Oren Hershkovitz, Ph.D., CEO of Enlivex, stated: "We believe the six-month results provide strong evidence that Allocetra™ delivers a durable and clinically meaningful benefit for patients with age-related primary knee osteoarthritis. A single treatment cycle producing at least six months of sustained efficacy represents not only a potentially transformative therapeutic option for patients but also supports a compelling and scalable commercial opportunity for Enlivex."

Einat Galamidi, M.D., CMO of Enlivex, added: "We are highly encouraged by the durable clinical improvements observed in this patient population. These results pave the way for our upcoming Phase IIb trial evaluating Allocetra™ in age-related primary knee osteoarthritis. We plan to initiate this study in the first half of 2026 and are committed to advancing Allocetra™ as a potential novel treatment to improve the quality of life for millions of patients affected by knee osteoarthritis."

In-depth analysis of the 6-month results is provided in a separate presentation, available as part of the Companiy's SEC filings and can be downloaded from its website.