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EX-99.1 - EXHIBIT 99.1 - GENVEC INCt1600276_ex99-1.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): May 2, 2016

 

 

 

 

GenVec, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(state or other jurisdiction of
incorporation)

000-24469

(Commission

File Number)

23-2705690

(I.R.S. Employer

Identification No.)

 

910 Clopper Road

Suite 220N

Gaithersburg, Maryland

20878
(Address of principal executive offices) (Zip Code)

 

Registrant's telephone number, including area code: (240) 632-0740

 

(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 (see General Instruction A.2. below):

 

q  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

q  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

q  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

q  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 
 

  

INFORMATION TO BE INCLUDED IN THE REPORT

 

Section 8 — Other Events

 

Item 8.01        Other Events.

 

On May 2, 2016, GenVec, Inc. (“GenVec”) issued a press release announcing that it was notified by its collaborator Novartis that the Data Safety Monitoring Board for the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss has recommended that the trial continue, subject to approval by the U.S. Food and Drug Administration. A copy of the press release is attached to this current report as Exhibit 99.1 and is incorporated herein by reference.

 

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including with respect to GenVec's hearing loss and balance disorders program are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Examples of forward-looking statements contained in this report include, among others, statements regarding the future of the clinical study for CGF166, including the expectation that the trial will resume and the expectations with respect to timing for patient enrollment and trial completion. GenVec cautions that the forward-looking statements contained in this release are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in, or implied by, the forward-looking statements or historical experience include risks and uncertainties, such as the failure of Novartis to advance GenVec's hearing loss and balance disorders program, the challenges in clinical development, and the difficulties in business development activities. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov, including the risk factors discussed in Item 1A of Part I of GenVec’s Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date of this report, and GenVec assumes no duty to update forward-looking statements.

 

Section 9 — Financial Statements and Exhibits

 

Item 9.01        Financial Statements and Exhibits.

 

(d)           Exhibits.

 

Exhibit No. Description
     
99.1 GenVec, Inc. press release, dated May 2, 2016

 

 
 

 

SIGNATURES

 

 

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.

  

 

  GENVEC, INC.
   
   
  By:  /s/ Douglas J. Swirsky
    Douglas J. Swirsky
President, Chief Executive Officer and Corporate Secretary

Dated: May 2, 2016

 

 
 

 

EXHIBIT INDEX

 

Exhibit No. Description
     
99.1 GenVec, Inc. press release, dated May 2, 2016