SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15 (d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 19, 2021
SESEN BIO, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction|
245 First Street, Suite 1800
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (617) 444-8550
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8–K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a–12 under the Exchange Act (17 CFR 240.14a–12)|
|☐||Pre–commencement communications pursuant to Rule 14d–2(b) under the Exchange Act (17 CFR 240.14d–2(b))|
|☐||Pre–commencement communications pursuant to Rule 13e–4(c) under the Exchange Act (17 CFR 240.13e–4(c))|
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.001||SESN||The Nasdaq Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 – Other Events.
On January 18, 2021, Sesen Bio, Inc. (the “Company”) completed an Assessment Aid submission to the FDA in connection with the Company’s Biologics License Application (“BLA”) for VicineumTM as part of a voluntary program developed by the FDA’s Oncology Center of Excellence. Following the Company’s submission of the BLA, the Company was selected to participate in the Assessment Aid program as part of the BLA review process.
The Assessment Aid is based on the FDA Multidisciplinary Review template with the main objectives of focusing the FDA review on the benefit-risk profile, increasing efficiency to decrease review time and, should Vicineum be approved, the Assessment Aid helps support the summary basis for approval.
In addition, the Company has been invited to participate in an FDA Application Orientation Meeting (AOM) in late January 2021 in order to educate the FDA review team on the BLA submission to further facilitate the FDA’s review.
For more information on FDA programs designed to facilitate BLA/NDA review, please refer to www.fda.gov.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, expectations regarding the FDA’s review process and the potential FDA approval of Vicineum. These forward-looking statements 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. 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 SEC. 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: January 19, 2021
|Sesen Bio, Inc.|
|By:||/s/ Thomas R. Cannell, D.V.M.|
|Thomas R. Cannell, D.V.M.|
|President and Chief Executive Officer|