|Histogenics historically focused on the development of restorative cell therapies, including its product candidate, NeoCart, which is an innovative cell therapy that utilizes various aspects of Histogenics’ restorative cell therapy platform to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. In the third quarter of 2018, Histogenics announced that its Phase 3 clinical trial of NeoCart did not meet the primary endpoint of a statistically significant improvement in pain and function in a dual threshold responder analysis one year after treatment as compared to microfracture. Based on the totality of the data, Histogenics initiated a dialogue with the FDA in the third quarter of 2018 to discuss the regulatory path forward for NeoCart. Histogenics’ primary objective in these discussions was to determine whether the FDA would accept a submission of a BLA for NeoCart without data from an additional clinical trial. Histogenics had a constructive dialogue with the FDA, which included requests for, and review of, additional statistical analyses, different subgroup analyses, and secondary endpoints. These additional analyses did not change the conclusion that the NeoCart Phase 3 trial failed to meet its primary and secondary endpoints.
In December 2018, Histogenics received final feedback from the FDA indicating that while the NeoCart Phase 3 Trial resulted in certain compelling data, particularly the early response in pain and function and the data in certain lesion sizes, an additional Phase 3 clinical trial would need to be completed before the FDA would accept the submission of a BLA for NeoCart. The FDA indicated receptivity to novel clinical trial methodologies and regenerative medicine advanced therapy designations in order to support additional data for a future potential submission. However, considering the time and funding required to conduct such a trial, Histogenics discontinued the development of NeoCart. As a result of the FDA feedback, Histogenics initiated a process to evaluate strategic alternatives including but not limited to acquisitions, business combinations, joint ventures, public and private capital raises and a recapitalization, sale transaction options (including a sale of assets or intellectual property) and other possible alternatives, including a wind-down of operations and a liquidation and dissolution of Histogenics, or Chapter 11 bankruptcy protection to complete or execute a restructuring transaction or liquidation all with a goal of maximizing value for its stakeholders. In January and March 2019, Histogenics implemented restructuring plans that were approved by the Histogenics Board involving reductions in headcount to reduce operating costs and conserve cash, along with other cash conservation measures relating to Histogenics facilities.