Allegations
(1) Sesen Bio’s clinical trial for its cancer treatment product, Vicineum, had more than 2,000 violations of trial protocol, including 215 classified as “major”; (2) three of Sesen Bio’s clinical investigators were found guilty of “serious noncompliance,” including “back-dating data”; (3) Sesen Bio had submitted the tainted data in connection with the Biologics License Application (“BLA”) for Vicineum; (4) Sesen Bio’s clinical trials showed that Vicineum leaked out into the body, leading to side effects including liver failure and liver toxicity, and increasing the risks for fatal, drug-induced liver injury; (5) as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved; (6) as a result of the foregoing, there was a reasonable likelihood that Sesen Bio would be required to conduct additional trials to support the efficacy and safety of Vicineum; and (7) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.