Current Report Filing (8-k)
August 27 2020 - 9:29AM
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): August 27, 2020 (August 27, 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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Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425)
|
☐
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Soliciting material pursuant to Rule 14a-12
under the Exchange Act (17 CFR 240.14a-12)
|
☐
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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. ☐
Item
8.01. Other Events.
On
August 27, 2020, Pluristem Therapeutics Inc., or the registrant, announced that the U.S. Food and Drug Administration has
cleared the registrant’s Expanded Access Program, or EAP, for the use of its PLX-PAD cells to treat Acute Respiratory Distress
Syndrome caused by COVID-19 outside of the registrant’s ongoing Phase II COVID-19 study in the U.S. The EAP will include
up to 100 patients with the resulting data being collected and evaluated alongside the registrant’s existing clinical trial.
Warning
Concerning Forward Looking Statements
This
Current Report on Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions
of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are
being used when the registrant discusses that the EAP will include up to 100 patients and that the resulting data will be collected
and evaluated alongside its clinical trial. These forward-looking statements and their implications are based on the current expectations
of the management of the registrant only, and are subject to a number of factors and uncertainties that could cause actual results
to differ materially from those described in the forward-looking statements. The following factors, among others, could cause
actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements;
the registrant may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the registrant’s
products may not be approved by regulatory agencies, the registrant’s technology may not be validated as it progresses further
and its methods may not be accepted by the scientific community; the registrant may be unable to retain or attract key employees
whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process;
the registrant’s products may wind up being more expensive than the registrant anticipates; results in the laboratory may
not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results
of human clinical trials; the registrant’s patents may not be sufficient; the registrant’s products may harm recipients;
changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market
share and pressure on pricing resulting from competition, which could cause the actual results or performance of the registrant
to differ materially from those contemplated in such forward-looking statements. In addition, historic results of scientific research
do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results would
not be interpreted differently in light of additional research or otherwise. Except as otherwise required by law, the registrant
undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties
affecting the registrant, reference is made to the registrant’s reports filed from time to time with the Securities and
Exchange Commission.
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:
August 27, 2020
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