Current Report Filing (8-k)

False000148500300014850032021-07-202021-07-20

 

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): July 20, 2021

 

 

SESEN BIO, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

001-36296

26-2025616

(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: [phone]

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 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 July 20, 2021, Sesen Bio, Inc. (the “Company”) issued a press release with the Company’s partner in Greater China, Qilu Pharmaceutical, announcing that the first patient has been enrolled in China in the clinical trial to assess the efficacy and safety of Vicineum™ in patients with BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”).

A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.

In the US, the Company believes it remains on track for an FDA decision on its Biologics License Application for Vicineum1 by the target PDUFA date of August 18, 2021.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:

This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, the Company’s beliefs regarding the timing for the U.S. Food and Drug Administration’s decision on the Company’s Biologics License Application for Vicineum for the treatment of BCG-unresponsive NMIBC. 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, including the risk that the FDA may not approve the BLA for Vicineum on or before the target PDUFA date, or at all, among other 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.

1 For the treatment of BCG-unresponsive NMIBC

Item 9.01 - Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Press Release dated July 20, 2021
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

---

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: July 20, 2021

 

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