Current Report Filing (8-k)
August 13 2021 - 5:02PM
Edgar (US Regulatory)
0001485003
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0001485003
2021-08-13
2021-08-13
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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):
August 13, 2021
SESEN BIO, INC.
(Exact name of registrant as specified in its
charter)
Delaware
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001-36296
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26-2025616
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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245 First Street, Suite 1800
Cambridge, MA
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02142
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(Address of principal executive offices)
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(Zip Code)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a–12 under the Exchange Act (17 CFR 240.14a–12)
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Pre–commencement communications pursuant to Rule 14d–2(b) under the Exchange Act (17 CFR 240.14d–2(b))
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Pre–commencement communications pursuant to Rule 13e–4(c) under the Exchange Act (17 CFR 240.13e–4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.001
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SESN
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The Nasdaq Stock Market LLC
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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 August 13, 2021, Sesen Bio, Inc. (the “Company”)
issued a press release announcing that it had received a complete response letter from the US Food and Drug Administration regarding its
Biologics License Application (“BLA”) for Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder
cancer. The letter indicates that the FDA has determined that it cannot approve the BLA for Vicineum in its present form, and has provided
recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls issues
pertaining to a recent pre-approval inspection and product quality.
A copy of the press release is attached as Exhibit 99.1 to this
report and is incorporated herein by reference.
Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
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: August 13, 2021
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Sesen Bio, Inc.
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By:
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/s/ Thomas R. Cannell, D.V.M.
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Thomas R. Cannell, D.V.M.
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President and Chief Executive Officer
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