Business
Enlivex Announces Full Year 2021 Financial Results, Completion of Development of Frozen Formulation Allocetra™ Ahead of Schedule, and Provides Strategic & Business Updates
Development of frozen formulation Allocetra™, a primary cornerstone of Enlivex’s R&D efforts during the last two years, was successfully completed in Q1 2022,
About this update from Enlivex Ltd.
[{"type":"text","content":"Development of frozen formulation Allocetra™, a primary cornerstone of Enlivex’s R&D efforts during the last two years, was successfully completed in Q1 2022, twelve months ahead of schedule Frozen formulation Allocetra™ is expected to vastly improve the product’s shelf-life, shipping logistics, and manufacturing scalability, which is expected to lower production costs and increase profitability upon potential commercializationThe completion of development of frozen formation Allocetra™ ahead of schedule allows early-than-expected integration of the formulation into the ongoing Phase II sepsis trial. The integration is expected to briefly defer the completion of the trial by approximately six to eight months, yet significantly shorten the overall timeline for a potential regulatory approval of frozen Allocetra™ in sepsis and the associated commercial launchDe-prioritizing Allocetra’s clinical development in COVID-19 due to (a) the emergence of variants that may be associated with less severe disease, (b) a more stringent regulatory environment, and (c) increased volatility of the potential business segment. Re-allocating cash resources to the Company’s primary development priorities, sepsis and oncologyRe-prioritization of resources away from COVID-19 expected to extend cash runway to Q3 2024 On-track to initiate two clinical trials evaluating Allocetra™ in solid tumor patients in 2022 Nes-Ziona, Israel, April 29, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced its full year 2021 financial results, the completion of development of a frozen formulation of Allocetra™ twelve months ahead of schedule, and provided strategic updates on its clinical programs. Frozen Formulation of Allocetra™ Completed Twelve Months Ahead of Schedule: Development of a frozen formulation Allocetra™, a cornerstone of Enlivex’s recent R&D efforts, was completed in Q1 2022, twelve months ahead of Enlivex’s schedule. While the liquid formulation of Allocetra™ has a shelf life of 96 hours, the frozen formulation is expected to have a shelf life spanning multiple years. This is expected to substantially improve the product candidate’s scalability and shipping logistics, lower its production costs, and increase profitability upon potential commerc...