|6 Months Ended|
Jun. 30, 2022
|Subsequent Events [Abstract]|
11. Subsequent Events
On July 7, 2022, the DSMB of the Phase 3 DISRUPT study conducted an interim futility analysis and recommended that the study be stopped because the conditional power of the study was below the pre-specified threshold for futility. Based on the DSMB’s recommendation, patient enrollment in the Phase 3 trial was stopped (“Trial Closure”). The Company continues to monitor <20 already enrolled patients as they complete their follow-up visits and to perform ongoing data review. The Company also expects to complete all clinical study reports as required by the FDA.
On July 29, 2022, the Company implemented a restructuring plan resulting in a reduction to the Company’s workforce of 16 employees, or approximately 37% of the Company’s headcount as of June 30, 2022. This reduction includes the resignation of Cara Cassino, M.D. as Chief Medical Officer and Executive Vice President of Research and Development of the Company. The Company expects to recognize a restructuring charge in the third quarter of 2022 of approximately $1.5 million consisting primarily of severance, one-time termination and other related costs, all of which will result in future cash expenditures. Any further financial statement impact of the Trial Closure cannot be estimated by the Company at this time.
The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
Reference 1: http://www.xbrl.org/2003/role/disclosureRef