SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): February 5, 2019
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|(Commission File Number)||
|2 Snunit Street||20100|
|Science Park, POB 455|
|(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 February 5, 2019, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that preliminary pharmacokinetic (PK) data from its phase III BRIGHT study of pegunigalsidse alfa, or PRX-102, for the treatment of Fabry disease is the subject of an oral presentation at the 15th Annual WORLDSymposiumTM 2019. The conference is taking place February 4-8, 2019 at the Hyatt Regency Orlando, Orlando, Florida, and the oral presentation is scheduled for Thursday, February 7, 2019 at 8:30 AM ET.
PRX-102 is the Company’s plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A drug candidate for the treatment of Fabry disease.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
|Item 9.01.||Financial Statements and Exhibits|
|99.1||Press release dated February 5, 2019.|
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: February 5, 2019||PROTALIX BIOTHERAPEUTICS, INC.|
/s/ Yossi Maimon
Vice President and
Chief Financial Officer