Item 8.01 - Other Events.

On March 28, 2022, Sesen Bio Inc., (the "Company") participated in a Type C Meeting with the U.S. Food and Drug Administration ("FDA"). During the meeting, the FDA agreed to a majority of the Company's proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial that the Company plans to conduct for potential resubmission of a Biologics License Application for Vicineum™ for the treatment of non-muscle invasive bladder cancer. The Company plans to further engage the FDA in the coming months to align on the remaining outstanding items related to the additional Phase 3 clinical trial.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:

This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements regarding the Company's plans to further engage the FDA in the coming months to align on the remaining outstanding items related to the additional Phase 3 clinical trial, which are based on the Company's current expectations and inherently involve significant risks and uncertainties. The Company's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including the risk that the Company may not be able to align with the FDA on the remaining outstanding items related to the additional Phase 3 clinical trial, among other risks and uncertainties. A further description of the risks and uncertainties relating to the business of the Company is contained in the Company's most recent annual report on Form 10-K and the Company's quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the Securities and Exchange Commission. The Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in its expectations.

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