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Sesen Bio Announces Strategic Decision to Pause Clinical Development of Vicineum™ in the US

Tuesday, July 19, 2022

Sesen Bio has announced a strategic decision to voluntarily pause further development of its lead asset, Vicineum, in the United States. This decision follows a comprehensive reassessment of Vicineum, taking into account the extended development timeline and associated costs for an additional Phase 3 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA). The pause in development allows Sesen Bio to conserve cash while exploring potential strategic alternatives to maximize shareholder value. The company also intends to seek a partner for the future development of Vicineum.

Dr. Thomas Cannell, President and CEO of Sesen Bio, stated that the company has had constructive meetings with the FDA, gaining a clear understanding of the FDA's evolving position and guidance on various variables related to approval pathways, trial designs, and patient populations. Considering the regulatory and commercial landscape, including the increased use of intravesical chemotherapy due to the ongoing BCG shortage, Sesen Bio has made the decision to pause the clinical development of Vicineum.

Dr. Cannell further expressed confidence in the benefits of Vicineum for patients and healthcare providers, emphasizing the importance of a partner with larger infrastructure to realize its full potential. The company's primary focus will now shift towards assessing strategic alternatives, with the aim of completing this process by the end of the year.

As of June 30, 2022, Sesen Bio reported $161.2 million in cash and cash equivalents, no outstanding debt, and a minimal number of outstanding warrants. Please note that these figures are preliminary and subject to change upon completion of the company's financial statements for the quarter ended June 30, 2022.

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