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Enlivex Therapeutics to Present Clinical Data of Allocetra in Osteoarthritis at EULAR 25 European Congress of Rheumatology

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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) ha annunciato la sua prossima presentazione al Congresso Europeo di Reumatologia EULAR a Barcellona, durante la quale saranno mostrati i dati del loro studio clinico in corso su Allocetra™. La presentazione illustrerà i risultati del loro trial di Fase I/II che valuta questa terapia cellulare di riprogrammazione dei macrofagi pronta all'uso nei pazienti con osteoartrite del ginocchio. Allocetra™ ha mostrato risultati promettenti negli studi di Fase I/II, evidenziando segnali favorevoli di sicurezza ed efficacia, tra cui una significativa riduzione del dolore, un miglioramento della funzionalità articolare e la prevenzione della chirurgia di sostituzione del ginocchio. L'azienda ha completato il reclutamento per la fase II del loro studio randomizzato, controllato e in cieco, con i dati principali attesi entro agosto 2025. La presentazione del poster, intitolata "Studio di Fase I/II della terapia cellulare Allocetra™ per l'osteoartrite del ginocchio: evidenze cliniche della risposta alla modulazione dell'infiammazione", sarà presentata l'11 giugno 2025.
Enlivex Therapeutics (NASDAQ: ENLV) anunció su próxima presentación en el Congreso Europeo de Reumatología EULAR en Barcelona, donde se mostrarán datos de su estudio clínico en curso sobre Allocetra™. La presentación destacará los resultados de su ensayo de Fase I/II que evalúa esta terapia celular de reprogramación de macrófagos lista para usar en pacientes con osteoartritis de rodilla. Allocetra™ ha mostrado resultados prometedores en estudios de Fase I/II, demostrando señales favorables de seguridad y eficacia, incluyendo una reducción significativa del dolor, mejora de la función articular y prevención de la cirugía de reemplazo de rodilla. La compañía ha completado la inscripción para la fase II de su ensayo aleatorizado, controlado y ciego, con datos principales esperados para agosto de 2025. La presentación del póster, titulada "Ensayo de Fase I/II de la terapia celular Allocetra™ para osteoartritis de rodilla: Evidencia clínica de la respuesta a la modulación de la inflamación", se presentará el 11 de junio de 2025.
Enlivex Therapeutics(NASDAQ: ENLV)는 바르셀로나에서 열리는 유럽 류마티스 학회(EULAR)에서 Allocetra™의 진행 중인 임상 연구 데이터를 발표할 예정이라고 발표했습니다. 이번 발표에서는 무릎 골관절염 환자를 대상으로 하는 이 즉시 사용 가능한 대식세포 재프로그래밍 세포 치료제의 1/2상 임상시험 결과를 소개할 예정입니다. Allocetra™는 1/2상 연구에서 유망한 결과를 보였으며, 안전성과 효능 면에서 긍정적인 신호를 나타내어 통증 감소, 관절 기능 개선, 무릎 인공관절 수술 예방 등의 효과를 입증했습니다. 회사는 무작위 배정, 대조, 이중맹검 임상시험의 2상 등록을 완료했으며, 주요 결과 데이터는 2025년 8월까지 발표될 예정입니다. "무릎 골관절염에 대한 Allocetra™ 세포 치료제 1/2상 임상시험: 염증 조절에 대한 임상적 반응 증거"라는 제목의 포스터 발표는 2025년 6월 11일에 진행됩니다.
Enlivex Therapeutics (NASDAQ : ENLV) a annoncé sa prochaine présentation au Congrès européen de rhumatologie EULAR à Barcelone, mettant en avant les données de leur étude clinique en cours sur Allocetra™. La présentation présentera les résultats de leur essai de phase I/II évaluant cette thérapie cellulaire de reprogrammation des macrophages prête à l'emploi chez des patients atteints d'arthrose du genou. Allocetra™ a montré des résultats prometteurs lors des études de phase I/II, démontrant des signaux favorables de sécurité et d'efficacité, notamment une réduction significative de la douleur, une amélioration de la fonction articulaire et la prévention de la chirurgie de remplacement du genou. La société a terminé le recrutement pour la phase II de son essai randomisé, contrôlé et en double aveugle, avec des données principales attendues pour août 2025. La présentation par poster, intitulée « Essai de phase I/II de la thérapie cellulaire AllocetraTM pour l'arthrose du genou : preuves cliniques de la réponse à la modulation de l'inflammation », sera présentée le 11 juin 2025.
Enlivex Therapeutics (NASDAQ: ENLV) kündigte seine bevorstehende Präsentation auf dem EULAR Europäischen Rheumatologie-Kongress in Barcelona an, bei der Daten aus ihrer laufenden klinischen Studie zu Allocetra™ vorgestellt werden. Die Präsentation wird Ergebnisse ihrer Phase-I/II-Studie zeigen, in der diese sofort verfügbare Makrophagen-Umlernzellen-Therapie bei Patienten mit Kniearthrose bewertet wird. Allocetra™ zeigte in Phase-I/II-Studien vielversprechende Ergebnisse mit günstigen Sicherheits- und Wirksamkeitssignalen, einschließlich signifikanter Schmerzlinderung, verbesserter Gelenkfunktion und Verhinderung von Kniegelenkersatzoperationen. Das Unternehmen hat die Einschreibung für die Phase-II-Stufe ihrer randomisierten, kontrollierten, verblindeten Studie abgeschlossen, und die ersten Daten werden bis August 2025 erwartet. Die Posterpräsentation mit dem Titel „Phase-I/II-Studie der AllocetraTM-Zelltherapie bei Kniearthrose: Klinische Evidenz für die Reaktion auf die Modulation von Entzündungen“ findet am 11. Juni 2025 statt.
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Insights

Enlivex's conference presentation will showcase promising Phase I/II Allocetra data for osteoarthritis while investors await August 2025 topline results.

Enlivex Therapeutics is gaining visibility for its Allocetra™ cell therapy program with an upcoming presentation at the prestigious EULAR European Congress of Rheumatology. The presentation will highlight clinical data from their ongoing study in knee osteoarthritis, a substantial market opportunity given the prevalence of this degenerative joint condition.

The company has strategically positioned Allocetra™ as a potential breakthrough for osteoarthritis by focusing on macrophage reprogramming. This approach targets the underlying inflammatory processes rather than just symptoms, addressing a root cause of disease progression. The mechanism of action—reprogramming macrophages into a homeostatic state—represents an innovative approach in the osteoarthritis treatment landscape.

What's particularly notable is that Enlivex has already observed favorable safety profiles and promising efficacy signals in their Phase I/II studies. The preliminary results show substantial and durable pain reduction, improved joint function, and even the potential to help patients avoid knee replacement surgery—a significant quality-of-life and economic benefit if confirmed in larger trials.

With enrollment now complete for the Phase II stage of their clinical trial, the company has established a clear timeline for topline data readout by August 2025. This creates a defined catalyst for the stock, giving investors a specific milestone to monitor. The upcoming conference presentation could provide additional insights into the therapy's performance while building awareness within the rheumatology community ahead of these crucial results.

Ness-Ziona, Israel, June 10, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will present a poster at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology, taking place June 11-14, 2025, in Barcelona, Spain.

The Company’s presentation will feature data from the ongoing clinical study evaluating Allocetra™, Enlivex’s proprietary, off-the-shelf macrophage reprogramming cell therapy, in patients with knee osteoarthritis. Allocetra™ is designed to reprogram macrophages into a homeostatic state, thereby promoting immune balance and resolution of chronic inflammation. Allocetra™ has demonstrated favorable safety and promising efficacy signals in Phase I/II studies in patients with moderate and end-stage knee osteoarthritis, including substantial and durable pain reduction, improved joint function, and avoidance of knee replacement surgery. The Company recently announced that it had completed the enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. The Company expects a topline data readout from the Phase II stage by August 2025.

Poster Presentation:

Title: Phase I/II Trial of AllocetraTM Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation

  • Abstract Publication Number: 684
  • Poster View I: Wednesday, June 11  3:30 - 4:30 PM CET

Dr. Oren Hershkovitz, CEO, and Einat Galamidi, MD, CMO, will attend the conference and 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 are the key findings from Enlivex's Allocetra trial in knee osteoarthritis?

In Phase I/II studies, Allocetra demonstrated favorable safety, substantial and durable pain reduction, improved joint function, and helped patients avoid knee replacement surgery.

When will Enlivex (ENLV) release Phase II topline data for Allocetra in osteoarthritis?

Enlivex expects to release topline data from the Phase II stage by August 2025.

What is Allocetra and how does it work in treating osteoarthritis?

Allocetra is an off-the-shelf macrophage reprogramming cell therapy designed to reprogram macrophages into a homeostatic state, promoting immune balance and resolution of chronic inflammation.

What type of clinical trial is Enlivex conducting for Allocetra in osteoarthritis?

Enlivex is conducting a randomized, controlled, blinded Phase I/II trial of Allocetra in patients with moderate to severe knee osteoarthritis.

Where and when will Enlivex present their Allocetra clinical data?

Enlivex will present their data at the EULAR European Congress of Rheumatology in Barcelona, Spain, on June 11, 2025, at 3:30 PM CET.
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