Enlivex CEO Issues Letter to Shareholders Outlining Strategic Roadmap Following Positive Phase IIa Allocetra™ Results

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]