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EX-99.1 - EXHIBIT 99.1 - Sesen Bio, Inc.ebiocompletionofmanufactur.htm

 

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): September 19, 2017
 
 

ELEVEN BIOTHERAPEUTICS, 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: (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))
 
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 5.02    Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On September 19, 2017, Arthur DeCillis, M.D. announced that, while he will continue to provide senior advice and guidance to Eleven Biotherapeutics regarding its clinical trials, he will do so in a consulting and advisory role. In connection with this transition, on September 19, 2017, Mr. DeCillis resigned his position as Chief Medical Officer effective as of October 3, 2017.


Item 8.01    Other Events.

On September 21, 2017, the Company announced that it has completed the manufacturing of all drug supply necessary for its ongoing Phase 3 registration trial evaluating Vicinium™ in patients with non-muscle invasive bladder cancer, and for its Cooperative Research and Development Agreement with the National Cancer Institute. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01    Financial Statements and Exhibits
(d) Exhibits.
The exhibit filed as part of this Current Report on Form 8-K is set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.





EXHIBIT INDEX
 
 
 
 
Exhibit
No.
 
Document
 
 
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: September 22, 2017
 
 
 
 
Eleven Biotherapeutics, Inc.
 
 
By:
 
/s/ John J. McCabe
 
 
John J. McCabe
 
 
Chief Financial Officer