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

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

Enlivex Announces Completion of Enrollment In The Phase II stage Of Its Phase I/II Trial Evaluating Allocetra In Patients With Moderate To Severe Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...today announced that the Company completed 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. Overall, 133 patients were randomized and treated in the Phase II stage....The Company expects a topline data readout from the Phase II stage, including full 3-month endpoints, by August 2025."

P2 data • Trial status • Osteoarthritis

SYNERGISTIC IMPACT OF APOPTOTIC CELLS AND CAR T CELL TREATMENTS ON PERITONEAL SOLID TUMORS (EBMT 2025) - "SCID-Bg mice were intraperitoneally (IP) injected with either human HeLa-CD19 or HeLa-CD19-luciferase cells, along with 10×10^6 allocetra-ots or a vehicle control, and 10×10^6 CD19-CAR T cells or mock T cells.Tumors were analyzed for bacterial presence using immunohistochemistry staining with antilipoteichoic acid (LTA) and antilipopolysaccharide (LPS) antibodies... These findings highlight the potential of combining apoptotic cell-based therapy, targeting resident macrophages, with CAR T cell therapy to enhance anti-tumor efficacy."

CAR T-Cell Therapy • IO biomarker • Oncology • Solid Tumor

Enlivex Announces the Dosing of the First Patient in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...today announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis."

Trial status • Osteoarthritis

Enlivex Receives Notice of Allowance for Chinese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra to treat subjects with osteoarthritis. The Company expects that this new patent will be issued in China during the first half of 2025."

Patent • Osteoarthritis

Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra Trial in Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics...is pleased to invite investors to a live investor webinar on March 5, 2025, at 11:00 a.m. ET to discuss the positive interim six-month data from the Phase I stage of its ongoing randomized, multi-country Phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis. The exclusive event, hosted by RedChip Companies, will feature the Company’s Chief Executive Officer, Oren Hershkovitz Ph.D., who will provide a detailed review of the interim results..."

P1 data • Osteoarthritis

Enlivex Announces Positive Interim Data – Statistically Significant 47.0% Durable and Persistent Pain Reduction At Six Months, in Patients with Moderate to Severe Knee Osteoarthritis (GlobeNewswire) - P1 | N=160 | NCT06233474 | Sponsor: Enlivex Therapeutics Ltd. | "Statistically significant 47.0% average reduction of reported pain (P=0.0001) compared to average pain level at baseline; 46% improvement in joint function and 40% improvement in joint stiffness; 83% of the patients were still considered as responders to treatment4 after 6 months; No serious adverse events; Efficacy continues to display strong persistence and durability over time, maintaining the 3-month positive effect...This second stage is progressing along the previously announced timeline, and the Company currently expects a topline data readout from the Phase I/II trial by the third quarter of 2025."

P1 data • P1/2 data • Osteoarthritis

Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ) (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Dr. Amit Druyan

New P1 trial • 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. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis (GlobeNewswire) - "Enlivex Therapeutics...announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating the safety, tolerability and potential therapeutic effect of Allocetra following injection into an affected joint in patients with psoriatic arthritis. No safety concerns were recorded following the dosing of the first patient. The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis."

Trial status • Psoriatic Arthritis

Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics Ltd...announced that the Japanese Patent Office issued a notice of allowance for patent application number 2022-512861 titled 'THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS'. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection through at least 2040. The Company expects that this new patent will be formally issued in Japan by the end of the second quarter of 2025."

Patent • Osteoarthritis

Enlivex Receives Authorization from the Danish Medicines Agency to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis (GlobeNewswire) - "Enlivex Therapeutics...announced that the Danish Medicines Agency authorized the initiation of the Phase II stage of the Company’s multi-country Phase I/II trial in moderate and severe knee osteoarthritis. This approval follows the recently announced recommendation by the independent Data and Safety Monitoring Board (DSMB) that the Company may move forward to the Phase II stage of the trial...The Phase I/II multi-center clinical trial is composed of two stages. The first stage is a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the target knee in order to identify the dose and injection regimen for the subsequent Phase II stage....The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment."

DSMB • Trial status • CNS Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Apoptotic Cell-Based Therapy for the Modification of the Inflammatory Response to Hemorrhagic Shock. (PubMed, Mil Med) - "In a pressure-control hemorrhagic shock model in rats, apoptotic cell infusion showed preliminary signs of a uniform attenuated cytokine response. Apoptotic cell-based therapies might serve as a novel immunomodulatory therapy for hemorrhagic shock."

Journal • Hematological Disorders • Immunology • Inflammation • Mood Disorders • Oncology • IFNG • IL1B • IL6 • TNFA

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Enlivex Therapeutics Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies