UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): June 4, 2013
PLURISTEM THERAPEUTICS INC.
(Exact Name of Registrant as Specified in Its Charter)
Nevada
(State or Other Jurisdiction of Incorporation)
|
001-31392
|
98-0351734
|
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
MATAM Advanced Technology Park
Building No. 5
Haifa, Israel
|
31905
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
011 972 74 710 7171
(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:
|
o
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
o
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
o
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
o
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Item 8.01. Other Events.
On June 4, 2013, the registrant announced that it has received notification from the U.S. Food and Drug Administration (FDA) that its United States phase II Intermittent Claudication (IC) study (IND 15038) has been placed on clinical hold due to a serious allergic reaction in a case which required hospitalization. The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information from the registrant.
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.
| |
PLURISTEM THERAPEUTICS INC.
|
|
| |
|
|
|
|
|
By:
|
/s/ Yaky Yanay |
|
| |
Name:
|
Yaky Yanay
|
|
| |
Title:
|
Chief Financial Officer
|
|
3