Sesen Bio (SESN) Regulatory Update - Slideshow

Regulatory & Clinical - Sesen Bio initiated its BLA submission for Vicinium under Rolling Review on December 6th, significantly de-risking the regulatory path to approval[12] - The FDA accepted Sesen's analytical comparability plan, potentially eliminating the need for additional clinical trials to support the BLA and commercialization of Vicinium[10, 145] - In a Phase III trial, Vicinium achieved a 40% complete response rate (CRR) at 3 months in CIS patients[54, 59] - 52% of CIS patients who had a complete response at 3 months remained disease-free for a total of 12 months after starting Vicinium treatment in Phase III trial[54, 59] - In Phase III trial, the median time to recurrence for papillary patients treated with Vicinium was 402 days[54, 59] Commercial & Financial - Sesen Bio had $57.9 million in cash and cash equivalents as of September 30, 2019, sufficient to fund key strategic priorities into 4Q 2020[8] - Approximately 84% of high-prescribing Urologists stated they would prescribe Vicinium to their patients after reviewing the data[119, 122] - The company estimates that the OUS opportunity for Vicinium is 2-3 times larger than the US market[136] Manufacturing & Pipeline - Vicinium is manufactured using a robust, industry-standard microbial expression system, reducing the risk of supply shortages and leading to a relatively low cost-of-goods[140] - Sesen Bio is exploring Vicinium in combination with AstraZeneca's anti-PD-LI, Imfinzi (durvalumab), in a Phase I study run by the National Cancer Institute[116, 117]