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

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Enlivex Therapeutics (Nasdaq: ENLV) will present Phase IIa 3-month topline data for Allocetra in moderate-to-severe knee osteoarthritis (KOA) at ACR Convergence 2025 on October 28, 2025.

The late-breaking poster reports clinically meaningful and statistically significant pain reduction and function improvement versus placebo in idiopathic age-related KOA patients (≥60 years), who represent >50% of the KOA market and 54% of the study population, and includes new supporting biomarker data.

Poster title: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). Presentation by Prof. Philip Conaghan; Einat Galamidi, MD, CMO, available for meetings.

Enlivex Therapeutics (Nasdaq: ENLV) presenterà i dati di fase IIa di 3 mesi topline per Allocetra al ACR Convergence 2025 il 28 ottobre 2025.

Il poster di ultima ora riporta riduzione del dolore clinicamente significativa e statisticamente significativa e miglioramento della funzione rispetto al placebo nei pazienti con KOA idiopatica associata all'età (≥60 anni), che rappresentano >50% del mercato KOA e il 54% della popolazione dello studio, e include nuovi dati di biomarcatori di supporto.

Titolo del poster: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). Presentazione del Prof. Philip Conaghan; Einat Galamidi, MD, CMO, disponibile per incontri.

Enlivex Therapeutics (Nasdaq: ENLV) presentará datos topline de 3 meses de la fase IIa para Allocetra en osteoartritis de rodilla moderada a severa (KOA) en ACR Convergence 2025 el 28 de octubre de 2025.

El póster de última hora reporta reducción del dolor clínicamente significativa y estadísticamente significativa y mejora de la función frente al placebo en pacientes con KOA idiopática relacionada con la edad (≥60 años), que representan >50% del mercado KOA y el 54% de la población del estudio, e incluye nuevos datos de biomarcadores de soporte.

Título del póster: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). Presentación por el Prof. Philip Conaghan; Einat Galamidi, MD, CMO, disponible para reuniones.

Enlivex Therapeutics (Nasdaq: ENLV)Allocetra에 대한 3개월 topline의 Phase IIa 데이터를 2025년 10월 28일 ACR Convergence 2025에서 발표할 예정입니다.

이번 late-breaking 포스터는 임상적으로 의미 있고 통계적으로 유의한 통증 감소와 기능 개선을 위약 대비 idiopathic age-related KOA 환자(≥60세)에서 보고합니다. 이들 환자는 KOA 시장의 50% 이상 및 연구 인구의 54%를 차지하며, 새로운 보조 생물표지자 데이터도 포함합니다.

포스터 제목: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). 발표: Prof. Philip Conaghan; Einat Galamidi, MD, CMO, 미팅 가능.

Enlivex Therapeutics (Nasdaq: ENLV) présentera des données topline de 3 mois de la phase IIa pour Allocetra lors de ACR Convergence 2025 le 28 octobre 2025.

Le poster de dernière minute rapporte une réduction de la douleur cliniquement et statistiquement significative et une amélioration de la fonction par rapport au placebo chez les patients atteints d’arthrose du genou d’origine idiopathique liée à l’âge (≥60 ans), qui représentent >50% du marché KOA et 54% de la population de l’étude, et inclut de nouvelles données de biomarqueurs à l’appui.

Titre du poster: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). Présentation par le Prof. Philip Conaghan; Einat Galamidi, MD, CMO, disponible pour des entretiens.

Enlivex Therapeutics (Nasdaq: ENLV) wird im ACR Convergence 2025 am 28. Oktober 2025 Phase-IIa-Daten zur Allocetra-Behandlung bei mittelschwerer bis schwerer Kniearthrose (KOA) vorstellen.

Der späte Posterbericht zeigt klinisch bedeutsame und statistisch signifikante Schmerzlinderung und Funktionsverbesserung gegenüber Placebo bei idiopathischer altersbedingter KOA-Patienten (≥60 Jahre), die mehr als 50% des KOA-Marktes und 54% der Studienteilnehmer ausmachen, und enthält neue unterstützende Biomarker-Daten.

Poster-Titel: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). Präsentation von Prof. Philip Conaghan; Einat Galamidi, MD, CMO, für Meetings verfügbar.

Enlivex Therapeutics (Nasdaq: ENLV) ستعرض بيانات المرحلة IIa لمدة 3 أشهر لـ Allocetra في KOA، التهاب مفصل الركبة المتوسط إلى الشديد، في ACR Convergence 2025 في 28 أكتوبر 2025.

المُلصَق الذي يعرض معلومات حديثة يتضمن انخفاضاً في الألم ذا دلالة سريرية وإحصائية وتحسناً في الوظيفة مقارنة بالدواء الوهمي لدى مرضى KOA المرتبطة بالعمر بشكل idiopathic (≥60 عامًا)، الذين يمثلون >50% من سوق KOA و54% من عينة الدراسة، ويشمل بيانات جديدة داعمة عن المؤشرات الحيوية.

عنوان الملصق: Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial (NCT06233474). العرض من الأستاذ فِلِيب كونِغان؛ Einat Galamidi، MD، CMO، متاح للاجتماعات.

Enlivex Therapeutics (Nasdaq: ENLV) 将在 ACR Convergence 2025 上于 2025 年 10 月 28 日公布 Allocetra 的阶段 IIa 3 个月 topline 数据,针对中度至重度膝关节炎 KOA。

这份晚间突破型海报报告了在年龄相关的特发性 KOA(≥60 岁)患者中,与安慰剂相比,疼痛降低具有临床意义和统计学意义,以及功能改善,研究样本中这类患者占 KOA 市场的 >50%、占研究人群的 54%,并包含新的生物标志物数据以提供支持。

海报题目:Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial(NCT06233474)。由 Philip Conaghan 教授介绍;Einat Galamidi 医学博士,首席医学官,可安排会面。

Positive
  • Clinically meaningful pain reduction vs placebo at 3 months
  • Statistically significant improvement in function vs placebo at 3 months
  • Biomarker data supports clinical findings
  • Responder population identified in the trial
Negative
  • Data reported at 3 months only (short-term follow-up)
  • Trial focused on idiopathic age-related KOA patients (≥60) comprising 54% of study population

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.

Contact:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
ENLV@redchip.com   


FAQ

What Phase IIa results did Enlivex (ENLV) report for Allocetra at ACR Convergence 2025?

Enlivex reported 3-month Phase IIa topline data showing clinically meaningful and statistically significant pain reduction and function improvement versus placebo.

When and where will Enlivex (ENLV) present Allocetra KOA data at ACR Convergence 2025?

Poster presentation on October 28, 2025 | 10:30 AM - 12:30 PM CT at ACR Convergence, McCormick Place, Chicago.

Which patient subgroup drove the Allocetra Phase IIa KOA results reported by ENLV?

Results include idiopathic age-related KOA patients aged ≥60, who represent 54% of the study population and >50% of the KOA market.

Did the ENLV Phase IIa KOA data include biomarker evidence for Allocetra?

Yes, the presentation included new supporting biomarker data alongside clinical outcomes.

Who will present Enlivex's Allocetra data and who is available for investor meetings?

Prof. Philip Conaghan will present the poster; Einat Galamidi, MD, CMO, will be available for meetings with stakeholders.
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