Enlivex Therapeutics .(US:ENLV)2022-04-28 16:00Product Development - Enlivex completed the development of the frozen formulation Allocetra™ twelve months ahead of schedule in Q1 2022, significantly improving shelf-life and scalability[2] - The frozen formulation is expected to lower production costs and increase profitability upon potential commercialization, with a shelf life spanning multiple years compared to the liquid formulation's 96 hours[3] - Enlivex plans to integrate the frozen formulation into its ongoing Phase II sepsis trial, which may defer trial completion by approximately six to eight months but shorten the overall timeline for regulatory approval[4] - Enlivex plans to initiate two clinical trials for Allocetra™ in solid tumor patients in 2022, including a Phase Ib trial in Q3 2022 and a Phase I/II trial in late 2022[8] Clinical Trials - The company is de-prioritizing Allocetra's clinical development in COVID-19 due to emerging variants and a more stringent regulatory environment, reallocating resources to sepsis and oncology[6] - Enlivex's Phase IIb COVID-19 trial has seen slow recruitment, with only 11 patients enrolled, leading to the decision to cease recruitment[7] Financial Performance - The company's cash runway is expected to extend to Q3 2024 due to the re-prioritization of resources, with cash and marketable securities totaling $84.1 million as of December 31, 2021[11][14] - Research and development expenses for 2021 were $12.8 million, up from $6.0 million in 2020, while general and administrative expenses increased to $6.4 million from $3.7 million[13] - The net loss for 2021 was $14.4 million, compared to a net loss of $11.8 million in 2020[13] Manufacturing - The construction of Enlivex's new cGMP manufacturing plant in Israel is on schedule, with an initial size of approximately 17,000 square feet and potential expansion to 21,500 square feet[9]