Current Report Filing (8-k)
December 09 2020 - 9:23AM
Edgar (US Regulatory)
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): December 9, 2020 (December 9, 2020)
PLURISTEM
THERAPEUTICS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
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001-31392
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98-0351734
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(State
or Other Jurisdiction
of Incorporation)
|
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(Commission
File Number)
|
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(IRS
Employer
Identification No.)
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MATAM
Advanced Technology Park
|
|
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Building
No. 5
|
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Haifa,
Israel
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3508409
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(Address
of Principal Executive Offices)
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(Zip
Code)
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011
972 74 710 7171
(Registrant’s
telephone number, including area code)
Not
applicable
(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:
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☐
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
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☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Common Stock, par
value $0.00001 per share
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PSTI
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The Nasdaq Capital
Market
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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. ☐
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Item
7.01
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Regulation
FD Disclosure.
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On
December 9, 2020, Pluristem Therapeutics Inc., or the registrant, held an investor and analyst call pursuant to which it shared
a presentation. The presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On
December 9, 2020, the registrant announced that the independent Data Monitoring Committee, or DMC, of its global pivotal
Phase III study of the registrant’s PLX-PLD product for the treatment of critical limb ischemia, or CLI, issued its
recommendation letter following an interim analysis. The clinical dataset was reviewed by the independent DMC for safety and
analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index
leg or death. Based on the review, the DMC advised that the CLI study is unlikely to
meet the primary endpoint by the time of the final analysis. The DMC advised the registrant that the CLI study
population has experienced a substantial low number of events (major amputation of the index leg or death), different from
what is known in clinical medicine for the rate of these events in this patient population. The lower than anticipated event
rate in the placebo group reduced the statistical power of the study to meet its primary endpoint. The DMC
noted that PLX-PAD was well tolerated, and no significant safety concerns were raised during the study. Following
the DMC’s recommendation, the registrant decided to terminate the CLI study. Currently, the registrant continues
to be blinded to the CLI study clinical data.
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Item
9.01
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Financial
Statements and Exhibits.
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(d)
Exhibits.
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.
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PLURISTEM THERAPEUTICS INC.
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By:
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/s/
Chen Franco-Yehuda
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Name:
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Chen Franco-Yehuda
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Title:
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Chief Financial Officer
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Date:
December 9, 2020
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