Histogenics (NSDQ:HSGX) said today that its board of directors approved a restructuring plan with a 65% reduction in its workforce, including the the company’s chief medical officer Dr. Lynne Kelley and chief business officer Donald Haut, according to an SEC filing.
The move comes after the Waltham, Mass.-based company decided to discontinue development of its NeoCart product following a pivotal trial of the device that failed to meet its primary endpoint last September, sending shares in the company plummeting.
In December, Histogenics said it had finished discussions with the FDA on the future of the NeoCart product, which is designed to repair knee cartilage damage using cells harvested from the surface of patients’ femur.
The agency indicated that the company would need to engage in an additional clinical trial before it could submit a Biologics License Application to the FDA, after which Histogenics said it expects to “suspend the development of NeoCart and does not plan to submit a BLA at this time,” according to a press release.
In its recent SEC release, the company said that it expects to incur a one-time charge for severance and related expenses of approximately $1.4 million related to the restructuring during its first quarter of 2019. The expenses are estimate, the company cautioned, and “actual results may differ materially,” according to the SEC filing.