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 22, 2019

 

IOVANCE BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State of Incorporation)
 
001-36860   75-3254381
Commission File Number   (I.R.S. Employer Identification No.)
     
999 Skyway Road, Suite 150    
San Carlos, California   94070
(Address of Principal Executive Offices)   (Zip Code)
     
(650) 260-7120
(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 (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 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. ¨

 

Securities registered pursuant to Section 12(b) of the Act:

  

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, par value $0.000041666 per share IOVA The Nasdaq Stock Market, LLC

 

 

 

 

 

 

Item 8.01. Other Events.

 

On May 22, 2019, Iovance Biotherapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to the Company’s autologous tumor-infiltrating lymphocyte (TIL) therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy.

 

The full text of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

  

Item 9.01. Financial Statements and Exhibits.

 

(d)       Exhibits.

 

Exhibit No.   Description
99.1   Press Release dated May 22, 2019.

  

 

 

 

 

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.

 

Date: May 22, 2019 IOVANCE BIOTHERAPEUTICS, INC.
       
       
  By: /s/ MARIA FARDIS  
    Maria Fardis, Chief Executive Officer

 

 

 

 

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