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): February 3, 2016

 

ADVAXIS, INC.

(Exact Name of Registrant as Specified in Charter)

   
Delaware   000-28489 02-0563870  
(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

305 College Road East

Princeton, New Jersey, 08540

(Address of Principal Executive Offices)

 

(609) 452-9813

(Registrant’s telephone number, including area code)

 

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.
     
  [  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
     
  [  ] Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
     
  [  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

 

 

   
   

 

Item 1.01. Entry into a Material Definitive Agreement.

 

On February 3, 2016, Advaxis, Inc. (“Advaxis” or the “Company”) entered into a Co-Development and Commercialization Agreement (the “Agreement”) with Especificos Stendhal SA de CV (“Stendhal”), for Advaxis’ lead Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated cancers.

 

Under the terms of the Agreement, Stendhal will pay $10 million towards the expense of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment will be made over the duration of the trial and covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Upon approval and commercialization of axalimogene filolisbac, Advaxis and Stendhal will share profits on a pre-determined basis.

 

Item 8.01. Other Events.

 

On February 3, 2016, the Company issued a press release announcing its entry into the Agreement. A copy of the press release is being filed as Exhibit 99.1 and incorporated in this Item by reference.

 

Item 9.01 Financial Statements And Exhibits.

 

(d) Exhibits.

 

99.1 Press Release, dated February 3, 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.

 

  ADVAXIS, INC.
  (Registrant)
     
  By /s/ Daniel J. O’Connor
    Daniel J. O’Connor
    President and Chief Executive Officer

 

Date: February 4, 2016

 

   
   

 

INDEX TO EXHIBITS

 

Exhibit    
Number   Description
     
99.1   Press Release, dated February 3, 2016.