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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
Pursuant to Section 13 OR 15 (d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 31, 2021
 
 
SESEN BIO, INC.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware001-3629626-2025616
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
245 First Street, Suite 1800
Cambridge, MA
02142
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (617) 444-8550
Not Applicable
(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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001SESNThe 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.

FerGene previously announced in May 2020 that the U.S. Food and Drug Administration ("FDA”) had issued a response letter to FerGene's Biologics License Application for Adstiladrin (nadofaragene firadenovec) (“Adstiladrin BLA”) in which the FDA indicated there were outstanding questions that FerGene’s manufacturing partner needed to further address regarding its CMC (Chemistry Manufacturing and Controls) and manufacturing processes.

On March 29, 2021, FerGene announced that it will request an extension from the FDA for the re-submission of the Adstiladrin BLA in order to obtain additional manufacturing information.

On March 31, 2021, Sesen Bio, Inc. posted an updated corporate presentation on its website www.sesenbio.com. Of note, slide 68 provides an updated competitive scan to reflect additional delays in the Adstiladrin BLA. A copy of the corporate presentation is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 - Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.Description
99.1






SIGNATURE
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: March 31, 2021
 
Sesen Bio, Inc.
By:/s/ Thomas R. Cannell, D.V.M.
Thomas R. Cannell, D.V.M.
President and Chief Executive Officer