- Enlivex Therapeutics Ltd. announced **positive Phase IIa topline results** for Allocetra™ in knee osteoarthritis (KOA), demonstrating statistically significant and clinically meaningful improvements in pain and function.  **[1596812_0001213900-25-086674_ea025692801ex99-1_enlivex.htm:0]** 
- In primary idiopathic age-related osteoarthritis patients (≥60 years), Allocetra™ achieved a **72% reduction in pain vs. placebo** and a **109% improvement in function vs. placebo**.  **[1596812_0001213900-25-086674_ea025692801ex99-1_enlivex.htm:1]** 
- The company expects **six-month data from the ongoing Phase IIa trial in November 2025** and plans to initiate a **Phase IIb trial in Q2 2026**.  **[1596812_0001213900-25-086674_ea025692801ex99-1_enlivex.htm:0]** **[1596812_0001213900-25-086674_ea025692801ex99-1_enlivex.htm:2]** 
- Enlivex is pursuing potential partnerships with larger companies and other non-dilutive funding opportunities based on these results.  **[1596812_0001213900-25-086674_ea025692801ex99-1_enlivex.htm:2]**

Enlivex CEO outlines strategic roadmap following positive Phase IIa Allocetra results

- Enlivex Therapeutics announced **positive three-month topline results** from its Phase IIa trial for Allocetra™ in knee osteoarthritis (KOA), demonstrating **72% reduction in pain** and **109% improvement in function** versus placebo in primary idiopathic age-related KOA patients.  **[1596812_3a7b4271d6654b268424e3a952f9d65c_0]** **[1596812_3a7b4271d6654b268424e3a952f9d65c_1]** **[1596812_3a7b4271d6654b268424e3a952f9d65c_2]** 
- The company plans to release **six-month data in November 2025** and initiate a Phase IIb trial in **Q2 2026**, with topline data from the Phase IIb trial expected in **Q2–Q3 2027**.  **[1596812_3a7b4271d6654b268424e3a952f9d65c_0]** **[1596812_3a7b4271d6654b268424e3a952f9d65c_2]** 
- Allocetra™ is being developed to address a significant unmet medical need in KOA, a condition affecting over **32 million Americans** and projected to impact **78 million by 2040**, with no currently approved disease-modifying treatments.  **[1596812_3a7b4271d6654b268424e3a952f9d65c_2]** **[1596812_3a7b4271d6654b268424e3a952f9d65c_4]**

Enlivex Therapeutics Reports Positive Phase IIa Allocetra™ Results and Outlines Clinical Roadmap

- Enlivex Therapeutics Ltd. reported a **net loss of $1,868 thousand** or **$(0.08) per share** for the three months ended June 30, 2025, and a **net loss of $5,320 thousand** or **$(0.22) per share** for the six months ended June 30, 2025.  **[1596812_0001213900-25-082585_ea025461701ex99-1_enlivex.htm:0]** **[1596812_0001213900-25-082585_ea025461701ex99-2_enlivex.htm:5]** 
- As of June 30, 2025, the company had **$1,892 thousand in cash and cash equivalents** and **$17,615 thousand in short-term interest-bearing deposits**, totaling approximately **$19.5 million** in liquid assets.  **[1596812_0001213900-25-082585_ea025461701ex99-1_enlivex.htm:0]** **[1596812_0001213900-25-082585_ea025461701ex99-2_enlivex.htm:1]** **[1596812_0001213900-25-082585_ea025461701ex99-1_enlivex.htm:9]** 
- The company's management anticipates that existing resources will be sufficient to fund planned operations through the **end of 2026**.  **[1596812_0001213900-25-082585_ea025461701ex99-2_enlivex.htm:1]** **[1596812_0001213900-25-082585_ea025461701ex99-2_enlivex.htm:7]** 
- On **August 18, 2025**, Enlivex announced **positive three-month topline data** from its Phase I/II trial evaluating AllocetraTM in patients with moderate-to-severe knee osteoarthritis.  **[1596812_0001213900-25-082585_ea025461701ex99-2_enlivex.htm:1]** **[1596812_0001213900-25-082585_ea025461701ex99-1_enlivex.htm:9]**

Enlivex Therapeutics (ENLV)