Enlivex Therapeutics Ltd. Ordinary Shares - ENLV STOCK NEWS

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the expansion of its Phase II trial of Allocetra^TM to clinical sites in Spain. The trial aims to enroll 120 to 160 patients with pneumonia-associated sepsis. It will assess the safety and efficacy of Allocetra^TM compared to a placebo. Previous positive results from a Phase Ib trial indicate significant improvements in clinical outcomes for sepsis patients treated with Allocetra^TM.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the publication of a significant peer-reviewed paper led by its Chief Scientific Officer, Prof. Dror Mevorach, in The New England Journal of Medicine. This paper examines myocarditis following the BNT162b2 mRNA vaccine against COVID-19 in Israel. The publication reflects the company's research collaboration with prestigious institutions and highlights the growing recognition of their work in immunotherapy. CEO Oren Hershkovitz praised Prof. Mevorach's expertise and its importance in the development of Allocetra, a therapy aimed at treating severe conditions like sepsis and COVID-19.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the Israeli Patent Office has granted a notice of allowance for a patent application covering Allocetra^TM, an immunotherapy product targeting various diseases, including sepsis and COVID-19. This patent will provide intellectual property protection in Israel until at least 2037. Allocetra^TM is designed to reprogram macrophages to restore their homeostatic state, potentially offering new treatment options for life-threatening conditions. The patent issuance is expected in Q1 2022.

Enlivex Therapeutics Ltd. announced peer-reviewed data showing remarkable safety and efficacy of Allocetra in treating severe sepsis. In a Phase Ib trial, patients receiving Allocetra exhibited a 0% mortality rate over 28 days, notably better than the 27% rate in matched controls. Key outcomes included shorter ICU stays and improved organ function. The study validates Allocetra's mechanism in managing cytokine storms. Enlivex is currently progressing into Phase IIb trials for pneumonia-associated sepsis and COVID-19 related acute respiratory distress syndrome.

Enlivex Therapeutics (Nasdaq: ENLV) announced its participation in the Reuters Events' Cell & Gene Therapy USA 2021 event, taking place virtually on September 28-29, 2021. Enlivex will present on September 29 at 11:30 a.m. EDT, discussing Allocetra's large-scale manufacturing process. Allocetra^TM is an innovative cell therapy aimed at reprogramming macrophages, critical in addressing severe diseases like solid cancers and COVID-19. The event will feature various industry leaders sharing insights on gene therapies.

Enlivex Therapeutics (Nasdaq: ENLV) has initiated a Phase IIb clinical trial to evaluate Allocetra^TM in patients with severe COVID-19 experiencing acute respiratory distress syndrome (ARDS). The trial aims to recruit up to 152 patients across Israel and Europe, with the primary endpoints being ventilation-free survival and recovery. Enlivex anticipates top-line results by Q2 2022. Previous trials showed a 0% mortality rate among 21 patients treated with Allocetra^TM, with 90.5% recovering within an average of 5.6 days. This trial represents a crucial step toward addressing severe COVID-19 cases.

Enlivex Therapeutics (Nasdaq: ENLV) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company focuses on macrophage reprogramming immunotherapy aimed at treating sepsis, COVID-19, and solid tumors. An on-demand presentation will be accessible starting 7:00 AM Eastern Time on September 13, 2021, through the provided link. Enlivex is advancing Allocetra™, a novel therapy designed to restore macrophage homeostasis, crucial for immune system balance.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to initiate a Phase IIb clinical trial of Allocetra^TM for severe COVID-19 patients with ARDS. The trial will enroll up to 152 patients across Israel and Europe, focusing on safety and efficacy alongside standard treatment. Previous trials showed Allocetra^TM achieved a 0% mortality rate and 90.5% recovery in severe cases within 28 days. The Phase IIb trial aims to evaluate ventilation-free survival and long-COVID symptoms.

Enlivex Therapeutics (ENLV) announced its Q2 2021 financial results and key clinical updates. The ongoing Phase IIb trial for Allocetra^TM in sepsis is anticipated to report top-line results in Q2 2022, with 120-160 patients expected in the study. A Phase IIb trial for Allocetra^TM in severe COVID-19 patients is set to start in Q3 2021. Enlivex also plans a Phase Ib trial to evaluate Allocetra^TM combined with chemotherapy for solid tumors. Financially, the company posted a net loss of $3.108 million, with cash and marketable securities of $90.6 million to fund operations through 2023.