Core Insights - Enlivex Therapeutics announced positive six-month efficacy data from the Phase IIa stage of its Allocetra™ trial for knee osteoarthritis, reaffirming previous three-month results and identifying an age-related responder population [1][4][6] Summary of Six-Month Data - The six-month follow-up has been completed for all patients, showing substantial and durable reduction in pain and improvement in function for patients aged 60 and above, compared to placebo [1][6] - At six months, Allocetra™ demonstrated a statistically significant improvement of -27.8 points in the treated group versus -15.5 points in the placebo group, corresponding to an 80% improvement over the control group [6] Clinical Development and Future Trials - Enlivex plans to initiate a Phase IIb trial in the first half of 2026 to further evaluate Allocetra™ in age-related primary knee osteoarthritis [4][6] - The trial's design includes an interim statistical evaluation to identify potential responder sub-groups, enhancing future development strategies [7] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [8] - The condition is particularly prevalent among older adults, with significant implications for healthcare systems due to its disabling nature and the lack of approved treatments that address structural damage [8] Company Overview - Enlivex is focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy aimed at rebalancing the immune system [9]

Core Insights - Enlivex Therapeutics Ltd. will present a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025, showcasing clinical data from a Phase IIa trial of Allocetra™ for knee osteoarthritis [1][2]. Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [5]. Clinical Trial Details - The Phase IIa trial (ENX-CL-05-001) demonstrated significant improvements in pain reduction and functional enhancement in patients with moderate-to-severe knee osteoarthritis, particularly in those aged 60 and above, who represent over 50% of the KOA market [2]. - The trial results will be presented by Prof. Philip Conaghan, a leading expert in osteoarthritis, highlighting the credibility of the findings [2]. Presentation Information - The poster presentation is scheduled for October 28, 2025, from 10:30 AM to 12:30 PM CT, under the title "Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial of an Innovative Intra-Articular Apoptotic Cell Therapy in Knee Osteoarthritis" [7]. Conference Participation - Einat Galamidi, MD, the Chief Medical Officer, will attend the ACR conference and is available for meetings with stakeholders and the scientific community [4].

Core Insights - Enlivex Therapeutics Ltd. will participate in a live investor webinar discussing advancements in the treatment of inflammatory diseases, specifically focusing on knee osteoarthritis [1][2][7] Company Overview - Enlivex is a clinical-stage company specializing in macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [8] Webinar Details - The webinar is scheduled for September 30, 2025, at 10:00 AM Eastern Time, featuring key opinion leaders in musculoskeletal disease and Enlivex's Vice Chairman [1][3] - The discussion will highlight positive Phase IIa topline data from the Allocetra™ program, showing significant pain reduction and functional improvement in patients with moderate-to-severe knee osteoarthritis [2][7] Expert Panel - The panel includes notable experts such as Professor Ali Mobasheri, Professor Philip Conaghan, Dr. Roger Pomerantz, and Jason Kolbert, each bringing extensive experience in musculoskeletal health and clinical research [3][4][5][6] Clinical Significance - The Phase IIa data from the Allocetra™ program indicates a strong potential to change the treatment landscape for knee osteoarthritis, a condition currently lacking approved disease-modifying therapies [2][7]

Core Insights - Allocetra™ has shown statistically significant and clinically meaningful improvements in pain and function for patients with knee osteoarthritis (KOA) in a Phase IIa trial [1][3][8] - The company plans to initiate a Phase IIb trial in Q2 2026, with six-month data from the ongoing Phase IIa trial expected in November 2025 [1][13][21] Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy [19] - The company aims to address the unmet medical needs of the aging population suffering from primary idiopathic KOA, which currently has limited treatment options [3][12] Clinical Trial Results - The Phase IIa trial (ENX-CL-05-001) demonstrated a 72% reduction in pain and a 109% improvement in function compared to the placebo group [13] - Allocetra™ achieved substantial improvements in a population of patients aged 60 and above, representing 54% of the study population [8][12] - The treatment was well tolerated, with no serious drug-related adverse events reported [11] Market Significance - KOA affects over 32 million Americans and is projected to impact 78 million by 2040, highlighting the urgent need for effective treatments [12][18] - The prevalence of KOA increases with age, with 30% of individuals over 60 years affected, emphasizing the potential market for Allocetra™ [12][18] Future Development Plans - Enlivex is advancing Allocetra™ toward late-stage development, with key milestones including the expected regulatory approval of the Phase IIb protocol in early 2026 [13][14] - The company is also exploring potential partnerships with larger firms interested in osteoarthritis treatments [15]

Core Insights - Enlivex Therapeutics announced positive topline data from the Phase IIa trial of Allocetra™, showing significant improvements in knee pain and function in patients with moderate-to-severe knee osteoarthritis [1][2][3] Group 1: Clinical Trial Results - In the modified intention-to-treat population, Allocetra™ demonstrated a 24% reduction in knee pain and a 26% improvement in knee function compared to placebo [1] - For age-related primary osteoarthritis patients, Allocetra™ resulted in a 72% reduction in knee pain and a 95% improvement in knee function compared to placebo, indicating a substantial and statistically significant effect [1][2] Group 2: Safety Profile - The trial reported a favorable safety profile for Allocetra™, with no severe adverse events and only mild to moderate, transient, and treatable side effects observed in most patients [2] Group 3: Company Overview - Enlivex Therapeutics is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy aimed at reprogramming macrophages to restore immune balance [8] - The company emphasizes the significant unmet medical need in the knee osteoarthritis market, which affects over 32.5 million Americans and is projected to increase to 78 million by 2040 [6]

Core Insights - Enlivex Therapeutics Ltd. will host a webinar on August 18, 2025, to present 3-month topline results from the Phase IIa stage of its ENX-CL-05-001 trial evaluating Allocetra™ in patients with moderate to severe knee osteoarthritis [1][2] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [5] Clinical Trial Details - The ongoing Phase IIa trial is a double-blind, randomized, placebo-controlled study assessing safety and efficacy, with endpoints measuring joint pain and function at 3, 6, and 12 months post-injection [4] - An interim analysis has been conducted to evaluate the potential benefits of expanding patient enrollment from 130 to 180, with 134 patients having completed the 3-month follow-up period [4][3] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million people globally, with symptomatic knee osteoarthritis being particularly prevalent, impacting 40% of men and 47% of women in their lifetimes [3]

Core Insights - Enlivex Therapeutics Ltd. will present data on its macrophage reprogramming therapy, Allocetra™, at the EULAR European Congress of Rheumatology in Barcelona from June 11-14, 2025 [1][2] - Allocetra™ aims to treat knee osteoarthritis by reprogramming macrophages to promote immune balance and reduce chronic inflammation, showing promising results in Phase I/II trials [2][4] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, with Allocetra™ being a universal, off-the-shelf cell therapy [4] - The therapy is designed to reset non-homeostatic macrophages to a homeostatic state, which is essential for immune system rebalancing [4] Clinical Study Details - The ongoing clinical study of Allocetra™ involves patients with moderate to severe knee osteoarthritis, with all patients enrolled in the Phase II stage of the trial [2] - The company anticipates topline data from the Phase II stage to be available by August 2025 [2] Presentation Information - The poster presentation titled "Phase I/II Trial of Allocetra™ Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation" will be presented by Dr. Oren Hershkovitz and Einat Galamidi at the conference [3][6]

Core Insights - Enlivex Therapeutics is presenting two poster abstracts at the OARSI 2025 World Congress, focusing on Allocetra™ as a novel therapeutic approach for osteoarthritis [1][2] - The company emphasizes the potential of Allocetra™ to restore macrophage homeostasis, addressing chronic joint inflammation and cartilage degradation [2] Company Overview - Enlivex Therapeutics is a clinical-stage company specializing in macrophage reprogramming immunotherapy, developing Allocetra™, an off-the-shelf cell therapy aimed at reprogramming macrophages to a homeostatic state [7] - The company believes that resetting non-homeostatic macrophages is crucial for immune system rebalancing and resolving debilitating conditions [7] Clinical Data - Allocetra™ has shown favorable safety and promising efficacy in Phase I/II studies for moderate and end-stage osteoarthritis, including significant pain reduction and improved joint function [3] - The therapy has demonstrated the potential to avoid knee replacement surgery, supported by preclinical studies on its mechanism of action in modulating macrophage-driven inflammation [3] Conference Details - The presentations at OARSI 2025 will include data from both preclinical and clinical studies evaluating Allocetra™ in osteoarthritis patients [2] - Specific sessions include a Flash Talk on April 26, 2025, and poster sessions on April 25 and 26, 2025, showcasing the biological activity of Allocetra™ [8]

Core Insights - Enlivex Therapeutics has completed patient enrollment for the Phase II stage of its clinical trial for Allocetra™ in treating moderate to severe knee osteoarthritis, involving a total of 133 patients [1][2][3] - The company aims to release topline data by August 2025, following promising initial efficacy results from the Phase I stage [2][3] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, which is designed to restore macrophages to their homeostatic state [5] - The company emphasizes the potential of Allocetra™ to transform osteoarthritis treatment, addressing a significant unmet medical need [2][4] Clinical Trial Details - The Phase I/II trial consists of a safety run-in and a double-blind, randomized, placebo-controlled Phase II stage, with an independent data safety and monitoring board overseeing safety evaluations [3] - Positive interim results from the Phase I stage showed significant improvements in key efficacy endpoints without safety issues [3] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have the condition by 2040 [4] - The disease leads to significant healthcare burdens, including over one million hospitalizations annually in the U.S. for joint replacements, highlighting the critical need for effective treatments [4]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [5]. Clinical Trial Progress - The company has completed patient enrollment for the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, involving a total of 133 patients [1][3]. - The Phase I stage provided promising initial efficacy data, with significant improvements in key efficacy endpoints and no safety issues reported for the first 12 patients treated [2][3]. Future Expectations - Enlivex aims to release topline data from the Phase II trial, including full 3-month endpoints, by August 2025 [2][3]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [4]. - The condition leads to significant healthcare burdens, with over one million hospitalizations annually in the U.S. primarily for total joint replacement, highlighting the critical need for effective treatments [4].