Enlivex Therapeutics Ltd Stock Price, News & Analysis

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the U.S. Patent and Trademark Office granted a notice of allowance for a new patent covering Allocetra^TM, aimed at treating sepsis patients. The patent is expected to be issued in early 2022, extending intellectual property protection until at least 2036. Enlivex is conducting a Phase II trial of Allocetra^TM in pneumonia-associated sepsis, with interim results anticipated mid-2022 and top-line data by year-end 2022. Additional programs target COVID-19 and solid tumors.

Enlivex Therapeutics announced several significant advancements as of November 22, 2021. They have initiated dosing in a Phase IIb trial for Allocetra^TM in severe COVID-19 patients and received authorization to expand trials into Spain. A new cGMP manufacturing facility is currently in the design phase to support future needs. Financially, for Q3 2021, Enlivex reported a net loss of $3.424 million, increasing from $2.125 million year-over-year, while holding $87.6 million in cash and equivalents, sufficient to fund operations through 2023.

Enlivex Therapeutics has received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to expand its Phase IIb trial of Allocetra in treating severe and critical COVID-19 patients with ARDS to Spain. The trial aims to enroll up to 152 patients and assess safety and efficacy against standard treatment. Previous trials reported a 0% mortality rate and 90.5% recovery in treated patients. CEO Oren Hershkovitz highlighted the importance of this expansion for their regulatory strategy, reinforcing the potential of Allocetra across various conditions.

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.