Allocetra (HLA-matched donor mononuclear enriched leukocytes) / Enlivex Therap - LARVOL DELTA

Optimal Partitioning for Molecular Phylogenetic Inference and Generic Delimitation in the Cetrarioid Core Group (Parmeliaceae, Ascomycota). (PubMed, J Fungi (Basel)) - "Allocetraria is confirmed to resurrect as a genus separate from Cetraria, with Usnocetraria and Vulpicida treated as its synonyms...Ten new combinations and one new synonym at the species level are made. A dual-band temporal hypothesis for generic delimitation appears taxonomically reasonable for most macrolichens."

Journal

Enlivex Ltd…announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra, the Company's clinical-stage immunotherapy, for the treatment of age-related symptomatic knee osteoarthritis (OA) in patients aged 64 and older. (The Manila Times) - "In connection with the RMAT designation, the FDA has requested a Type B meeting with the Company to conduct a comprehensive, multidisciplinary discussion of the Allocetra development program. The Company intends to schedule this meeting with the FDA to align on key elements of its Phase IIb trial and pivotal development plans."

FDA event • Osteoarthritis

Enlivex…announced the issuance of an Australian patent, numbered 2020340629, titled, 'THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS' (GlobeNewswire) - "The patent will provide Enlivex with added intellectual property protection in Australia through at least 2040 with claims covering methods of using Allocetra to treat subjects with osteoarthritis. With this issuance, the Company has secured patent protection for Allocetra in osteoarthritis in an additional major jurisdiction..."

Patent • Osteoarthritis

DURABLE EFFICACY AT 6 MONTHS USING AN INNOVATIVE INTRA-ARTICULAR APOPTOTIC CELL THERAPY IN KNEE OSTEOARTHRITIS: DATA FROM A PHASE IIA RCT (EULAR 2026) - P1/2 | "Allocetra is a novel allogeneic immune-modulating cell therapy that induces reprogramming of activated macrophages, by harnessing the naturally-occurring activity of apoptotic cells to induce an immuno- modulated pro-homeostatic state...This target population is consistent with an age-linked, macrophage-mediated OA phenotype. Findings support advanced trials targeting an older population with primary, age-related knee OA, demonstrating at least 6 months clinical efficacy and potentially paving the way to a novel therapeutic approach at the intersection of aging, inflammation and tissue damage in knee OA patients."

Clinical • P2a data • Genetic Disorders • Immunology • Musculoskeletal Pain • Obesity • Osteoarthritis • Pain • Rheumatology

Allocetra Shows Durable 6-Month Efficacy in Knee Osteoarthritis Phase IIa Trial; Oral Presentation at EULAR 2026 (GlobeNewswire) - "The presentation will feature extended 3-month and 6-months clinical data, as well as comprehensive mechanistic and pharmacological characterization data, supporting the novel immunomodulating mechanism of action of Allocetra from the Phase IIa (NCT06233474) for Allocetra in patients with moderate-to-severe knee osteoarthritis (KOA). The results demonstrated a 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."

P2a data • Osteoarthritis

Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Enlivex Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: Enlivex Therapeutics Ltd.

New P2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-05-002: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter nStudy of Intra-Articular Allocetra in Participants with Primary Knee nOsteoarthritis. (clinicaltrialsregister.eu) - P1/2 | N=75 | Not yet recruiting | Sponsor: Enlivex Therapeutics Ltd.

New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint (clinicaltrials.gov) - P1/2 | N=46 | Active, not recruiting | Sponsor: Kaplan Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Jan 2027 | Trial primary completion date: Apr 2025 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Amir Oron | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-06-001: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Enlivex Therapeutics Ltd. | Trial completion date: Sep 2026 ➔ Apr 2026 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2026 ➔ Oct 2025; reprioritization

Trial completion date • Trial primary completion date • Trial termination • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

ENX-CL-05-001: A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrialsregister.eu) - P1/2 | N=156 | Completed | Sponsor: Enlivex Therapeutics Ltd. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-05-001: Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: Enlivex Therapeutics Ltd. | Trial completion date: Feb 2026 ➔ May 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-06-001: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Enlivex Therapeutics Ltd. | Trial completion date: Jan 2026 ➔ Sep 2026

Trial completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Enlivex Reaffirms August 18, 2025 As Target Date For Announcement of Phase II Topline Data (GlobeNewswire) - "Enlivex Therapeutics...announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra in patients with moderate to severe knee osteoarthritis, have completed a follow-up period of at least three months, the trial’s primary timepoint for measurement of key endpoints. The data are being analyzed and audited, with a target date of August 18, 2025 for the public release of audited topline results for three-month key endpoints, including safety and change from baseline in knee pain and function."

P2 data • Trial status • Osteoarthritis

Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Amir Oron | N=12 ➔ 18

Enrollment change • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-05-001: Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: Enlivex Therapeutics Ltd. | Trial primary completion date: Jun 2025 ➔ Sep 2025

Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients (clinicaltrials.gov) - P2 | N=148 | Completed | Sponsor: Enlivex Therapeutics Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Dec 2024

Trial completion • Trial completion date • Gastroenterology • Hepatology • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases • Septic Shock

CLINICAL TRIAL OF ALLOCETRATM CELL THERAPY INJECTION FOR END STAGE KNEE OSTEOARTHRITIS: INTERIM RESULTS OF INJECTION THERAPY (EULAR 2025) - "The study results indicate a favorable safety profile following Allocetra TM IA injection in this population of patients with end-stage knee OA indicated for knee replacement surgery. Surprisingly, despite the advanced articular damage many of the patients reported a meaningful improvement in their knee pain, allowing them to preserve their functionality without resorting to extensive knee surgery. This initial study is followed by an ongoing double blind, randomized, multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra TM compared to placebo in patients with symptomatic knee OA."

Clinical • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

Phase I/II Trial of AllocetraTM Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation (EULAR 2025) - "A characterization of safety of Allocetra TM IA injections for knee OA indicates a favorable safety profile with good compliance to repeat injections and initial promising efficacy results. Transient injection reactions were mostly mild, with no observed dose relationship of injection reactions, allowing a recommendation by the independent safety committee to proceed to the randomized phase of the study with the highest Allocetra TM dose tested. Initial indications of efficacy were observed in the majority of the patients, demonstrated as marked reductions in pain reported and an improvement in functionality following treatment, compared to baseline."

Clinical • P1/2 data • Immunology • Inflammation • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Enlivex Therapeutics to Present Clinical Data of Allocetra in Osteoarthritis at EULAR 25 European Congress of Rheumatology (GlobeNewswire) - "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."

P1/2 data • Osteoarthritis

Enlivex Selected to Present at Israeli BioMed 2025 Conference (GlobeNewswire) - "Enlivex Therapeutics Ltd...announced that the Company has been selected to present at the upcoming Israeli BioMed 2025 Conference, taking place May 21–23, 2025 in Tel Aviv, Israel. The Company’s presentation is titled 'Enlivex—Harnessing the Natural Healing Power of Macrophages to Treat Inflammatory Diseases' and will be delivered by the Company’s CEO on May 21st as part of the session 'Personalized Pathways; Genetic and Cellular Based Therapies for Rare and Complex Diseases'...Additional readouts from ongoing trials are expected in 2025."

Clinical data • Immunology • Osteoarthritis • Pain • Psoriatic Arthritis

Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Amir Oron | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Dec 2025 | Trial primary completion date: Jan 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

ENX-CL-05-001: Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: Enlivex Therapeutics Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Enlivex Therapeutics to Showcase Allocetra’s Potential in Osteoarthritis at OARSI 2025 World Congress (GlobeNewswire) - "Enlivex Therapeutics Ltd...today announced that it will present two poster abstracts at the Osteoarthritis Research Society International (OARSI) 2025 World Congress on Osteoarthritis, taking place April 24-27, 2025, in Incheon (Seoul), South Korea....The presentations will feature data from both preclinical and clinical studies evaluating Allocetra...in patients with osteoarthritis."

Clinical data • Preclinical • Osteoarthritis