SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2020

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

On January 13, 2021, the Company issued a press release announcing that the Investigational New Drug application for Vicineum submitted by the Company’s licensee in China, Qilu Pharmaceutical Co., Ltd., was accepted for review by the China National Medical Products Administration.

On February 16, 2021, the Company announced that the FDA has accepted for filing the Company’s BLA for Vicineum, for the treatment of BCG-unresponsive NMIBC, and granted the application Priority Review. With Priority Review, the anticipated target Prescription Drug User Fee Act (“PDUFA”) date for a decision on the BLA is August 18, 2021. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

On February 17, 2021, the Company entered into Amendment No. 2 (the “Second Amendment”) to the Sale Agreement with Jefferies, dated November 29, 2019, as amended by Amendment No. 1 to the Sale Agreement. The Second Amendment allows for the Company to issue and sell through Jefferies up to an additional $34.5 million of shares of its common stock, par value $0.001 per share, under the Sale Agreement. As of the effective date of the Second Amendment, the Company had approximately $35.5 million in total remaining capacity under the Sale Agreement.

On March 8, 2021, the Company issued a press release announcing the March 5, 2021 submission of the Marketing Authorization Application to the EMA for Vicineum for the treatment of BCG-unresponsive NMIBC under the EMA’s centralized procedure.

The Company raised $60.3 million of net proceeds from the sale of 26.3 million shares of common stock under the ATM Offering from January 1, 2021 through March 8, 2021.

Stock Options Granted

In February 2021, the Company's board of directors granted 4.1 million stock options with an exercise price of $3.17 to employees and officers under the Company's 2014 Plan. These stock options had a grant-date fair value of $2.06 and vest at the rate of 6.25% of the grant every three months over a period of four years, subject to the recipient's continued service with the Company through the applicable vesting dates.