Report of Foreign Issuer (6-k)
February 09 2017 - 4:26PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
W
ashington,
D.C.
20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act
of 1934
For the month of February 2017
Commission File Number: 001-37643
KITOV PHARMACEUTICALS HOLDINGS
LTD.
(Translation of registrant's name into
English)
One
Azrieli Center, Round Tower, 23
rd
Floor,
132
Menachem Begin Road, Tel Aviv 6701101, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant
files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
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1)
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On February 7, 2017, following publication of news reports that the Israeli Securities Authority has begun a formal investigation
into Kitov Pharmaceuticals Holdings Ltd.’s (the “Registrant” or the “Company”) public disclosures
around its lead drug candidate, KIT-302, the Nasdaq Stock Market® announced that trading was halted in the Company’s
securities listed on The NASDAQ Capital Market for "additional information requested" from the Company, and that trading
will remain halted until the Company has fully satisfied Nasdaq's request for additional information. The Company is cooperating
fully with NASDAQ’s request for additional information. As a result of the trading halt by the NASADQ, on February 8, 2017,
the Tel Aviv Stock Exchange (“TASE”) halted trading in the Company’s shares on the TASE.
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2)
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On February 9, 2017, the TASE circulated a notice to the members of the TASE with respect to (i) a special 45 minute trading
session during the pre-closing session on the TASE for the Company's ordinary shares and that the trading halt would then be reinstated
pending the lifting of the NASDAQ trading halt, and (ii) the TASE’s procedures for temporarily excluding the shares of the
Company from a number of TASE trading indices until such time as the trading halt is lifted, and publicized such notice on its
public distribution site.
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Attached as
Exhibit 99.1 hereto is an unofficial summary English translation of the notice.
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3)
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On February 9, 2017, in response to requests made by the NASDAQ Stock Market, the Company provided a further update on the
recently disclosed formal investigation by the Israeli Securities Authority (ISA) into the Company’s public disclosures around
certain aspects of the studies related to its lead drug candidate, KIT-302. To the best of the Company's knowledge, the focus of
the investigation is on matters in connection with the Data Monitoring Committee (DMC) appointed in connection with the Company’s
Phase III trial of KIT-302, the results of which were announced in December 2015, and what information was disclosed publicly by
the Company. A DMC is generally an external independent group of experts who monitor patient safety and treatment efficacy data
while a clinical trial is ongoing, and in the case of the KIT-302 Phase III clinical trial was established in order to analyze
the preliminary results of the initial patient group enrolled in the clinical trial and determine the number of additional patients,
if any, that the Company might have needed to recruit in order to demonstrate statistical validity, and to meet the primary end
point of the clinical trial. The Company is continuing with the process of completing the preparations for submitting a New
Drug Application for KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and hypertension, and which
is still expected to be submitted to the U.S. Food and Drug Administration at the end of the first quarter 2017. In addition, the
Company is continuing with all of its other ongoing activities, including its ongoing research and development activities in connection
with KIT-302 and TyrNovo’s NT 219, further expanding its intellectual property portfolio and seeking commercialization opportunities
for its therapeutic activities. As is standard practice in Israel during ISA investigations and enforcement proceedings, Mr. Isaac
Israel, Kitov’s CEO, was detained for questioning and subsequently released on the same day, under certain limited restrictive
terms established by a court, as per standard practice in such ISA investigations.
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4)
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On February 9, 2017, the NASDAQ Stock Market announced a scheduled resumption of trading in the Company’s securities
for February 9, 2017 at 10:45 EST.
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5)
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On February 9, 2017, the TASE announced that normal trading in the Company’s shares on the TASE would resume on the next
trading date, Sunday February 12, 2017.
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This Form 6-K is incorporated by reference into each of
the Registrant’s Registration Statements on Form F-3 filed with the Securities and Exchange Commission on December 12, 2016
(Registration file numbers 333-207117, 333-211477 and 333-215037) and the Registrant’s Registration Statement on Form S-8
filed with the Securities and Exchange Commission on May 20, 2016 (Registration file number 333-211478).
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, thereunto
duly authorized.
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KITOV PHARMACEUTICALS HOLDINGS LTD.
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February 9, 2017
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By:
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/s/ Avraham Ben-Tzvi
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Avraham Ben-Tzvi
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General Counsel & Company Secretary
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