Now they can concentrate on finding some positive results with FDA guidelines set and letting go unneeded personal. $5.00 stock again soon.
"The in vitro assays we presented to the FDA reflect Zafgen's deep understanding of the significant difference of ZGN-1061 on endothelial cell biology as compared to our prior compound and we believe represent a truly sophisticated and optimized approach to evaluate important safety information about ZGN-1061," said Priya Singhal, M.D., M.P.H, Head of Research and Development. "We are working to rapidly implement the in vivo animal study, which aims to establish the relevance of the in vitro mechanism and safety margins. We appreciate the FDA's thorough feedback and continuing collaboration throughout this process."
Given the current status and expected timelines of Zafgen's development programs, the Company has implemented plans to reduce its operating expenses and prioritize key resources, with an immediate corporate restructuring as well as other strategies to preserve resources. This restructuring includes a workforce reduction of approximately 25%, in addition to other attrition in 2019. With these changes, Zafgen now expects its projected cash runway to last greater than two years, given its current operating plan.
"Since our constructive Type A meeting with the FDA earlier this year, we've been focused on gaining clarity on the path forward, reaching agreement on the in vivo study design and protocol, and preparing for strong initiation and execution of the study," said Jeffrey Hatfield, Chief Executive Officer. "As we move ahead with ZGN-1061 having accomplished these goals, we have also taken steps to ensure the effective use of capital as we look to the future. This includes the difficult but prudent decision to restructure at this time. We are deeply grateful for the entire team's dedication and many contributions."
