SUBSEQUENT EVENTS

6 Months Ended

Jun. 30, 2021

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

On July 13, 2021, the Company participated in a productive Late-Cycle Meeting with the FDA regarding the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC. In the meeting, the FDA confirmed that there is no Advisory Committee meeting planned at this time, and that no post-marketing requirements, including a confirmatory trial, have been identified at this time. Also in the meeting, the Company and the FDA discussed remaining questions related to manufacturing facilities inspection, product quality information requests and additional information related to CMC, and a timeline to submit additional supporting information was agreed upon. In the US, the Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date of August 18, 2021.

On July 14, 2021, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of up to $100 million of shares of the Company’s common stock, par value $0.001 per share, from time to time pursuant to the previously disclosed Open Market Sale Agreement with Jefferies LLC, as sales agent. The Company may sell this amount efficiently from time to time over the coming months.

On July 21, 2021, the Company announced the appointments of Dr. Peter K Honig, MPH, former Senior Vice President and Head of Global Regulatory Affairs and Group Head of Development China and Japan at Pfizer, and Dr. Michael A.S. Jewett, FRCSC, FACS, a practicing Oncologist and global Key Opinion Leader (KOL) to the Sesen Bio Board of Directors.

On August 5, 2021, the Company entered into an exclusive license agreement with Eczacibasi Pharmaceuticals Marketing (“EIP”) pursuant to which the Company granted EIP an exclusive license to register and commercialize Vicineum for the treatment of BCG-unresponsive NMIBC in Turkey and Northern Cyprus. Under the terms of the licensing agreement, the Company is entitled to receive an upfront payment of $1.5 million, is eligible to receive additional regulatory and commercial milestone payments and is also entitled to receive a 30% royalty on net sales in Turkey.