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EX-99.1 - EXHIBIT 99.1 - Protalix BioTherapeutics, Inc.tv509254_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): December 17, 2018

 

 

 

Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-33357   65-0643773

(State or other jurisdiction

of incorporation)

  (Commission File Number)

(IRS Employer

Identification No.)

 

2 Snunit Street 20100
Science Park, POB 455  
Carmiel, Israel  
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code +972-4-988-9488

  

(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):

 

¨Written communication 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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

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 December 17, 2018, the Company issued a press release announcing the completion of enrollment for the Company’s BRIDGE phase III clinical trial of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. Additionally, the Company provided an update on the enrollment for its BALANCE and BRIGHT phase III clinical trials. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits

 

(d)Exhibits

 

99.1Press release dated December 17, 2018.

 

 

 

 

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.

 

  PROTALIX BIOTHERAPEUTICS, INC.
     
Date: December 17, 2018 By: /s/ Moshe Manor
  Name: Moshe Manor
  Title: President and
    Chief Executive Officer