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): ____
On
February 16, 2017, Kitov Pharmaceuticals Holdings Ltd. (the “Company” or the “Registrant”) announced
the following:
1)
Class Action Motions in Israel
Four
lawsuits and motions to approve the lawsuits as a class action lawsuit (each, a “Motion”), were filed against the
Registrant and certain of its office holders at the Tel Aviv District Court (Economic Division), and served on the Registrant, with
each Motion relating to 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.
The
first Motion was filed against the Company, its executive directors and certain former directors of the Company, by the law offices
of Tadmor & Co. and Prof. Yuval Levy & Co. acting on behalf of a shareholder of the Company, Mr. Kobi Koren, who is requesting
to act as representative of all shareholders of record from December 10, 2015 until February 6, 2017. The plaintiff alleges, among
other things, that the Registrant included misleading information in its public filings, which caused the class for which the
plaintiff is seeking recognition an aggregate loss of NIS 25,545,206 (approximately US$ 6,818,000).
The
second Motion was filed against the Company, its executive directors and certain present and former directors of the Company,
by the law offices of Yanay & Co. acting on behalf of Mr. Ilan Vainreb, Ms. Merav Shir, Mr. Dimitry Braverman and Mr. Tzhaci
Tal Gaon, shareholders of the Company, who are requesting to act as representatives of all shareholders of the Company on February
6, 2017, the date the ISA's investigation was reported, excluding the respondents named on the Motion. The plaintiffs allege,
among other things, that the Registrant included misleading information in its public filings which caused the class for which
the plaintiffs are seeking recognition an aggregate loss of NIS 36,525,592.51 (approximately US$ 9,748,000).
The
third Motion was filed against the Company, its executive directors, certain former directors, and the former internal auditor
of the Company, by the law offices of Redei-Gadot acting on behalf of Messrs. Reuven Hay Refua and Binyamin Gabay, shareholders
of the Company, who are requesting to act as representatives of all shareholders of record from December 15, 2015 until February
6, 2017, excluding the respondents in the Motion. The plaintiffs allege, among other things, that the Registrant included misleading
information in its public filings which caused the class for which the plaintiffs are seeking recognition, an aggregate loss of
NIS 33,235,000 (approximately US$8,870,000).
The
fourth Motion was filed against the Company, its executive directors and certain present and former directors of the
Company, by the law offices of Kalai, Rosen & Co. acting on behalf of by Messrs. Yoram Chayut and Gur Tzemach,
shareholders of the Company, who are requesting to act as representatives of all shareholders of record from December 10,
2015 until February 6, 2017. The plaintiffs allege, among other things, that the Registrant included misleading information
in its public filings which caused the class for which the plaintiffs are seeking recognition, an aggregate loss of NIS
29,094,290 (approximately US$ 7,765,000).
Under
applicable Israeli law, a motion to approve a lawsuit as a class action initially needs to be approved as such by the court. Only
after such approval is granted by the court, will the court proceed to the second stage of hearing the underlying claims of the
class action lawsuit. The court may also determine to combine the Motions, based on, among other things, considering the underlying
facts and circumstances of each Motion.
The
Company is reviewing the Motions and intends to deliver its responses to the court in accordance with applicable law.
2)
Increase of Weight Cap Factor
The
TASE Indices Manager notified the Registrant and the members of the TASE, following its notification dated February 9, 2017, that
the index weight cap factor of the Registrant's shares will be increased to 1 in two steps, as follows:
Security: Kitov Pharmaceuticals Holdings Ltd. (Security No.: 765016)
|
|
Number
|
|
|
Index
|
|
Factor as of
Close of
Trading on
March 2,
2017
|
|
|
Factor as of
Close of
Trading on
April 6,
2017
|
|
|
1
|
|
|
TA- All Share
|
|
|
0.5
|
|
|
|
1
|
|
|
2
|
|
|
TA - Growth
|
|
|
0.5
|
|
|
|
1
|
|
|
3
|
|
|
TA- Global- BlueTech
|
|
|
0.5
|
|
|
|
1
|
|
|
4
|
|
|
TA- Biomed
|
|
|
0.5
|
|
|
|
1
|
|
Forward-Looking
Statements and the Company's Safe Harbor Statement
Certain
statements in this
Report on Form 6-K
are forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements
can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan",
"may", "should", "could", "might", "seek", "target", "will",
"project", "forecast", "continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should
not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking
statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a
number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other
factors that may cause our actual results, performance or achievements to be significantly different from any future results,
performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute
to such differences include, among others, risks relating to: the fact that drug development and commercialization involves a
lengthy and expensive process with uncertain outcomes; our ability to successfully acquire, develop or commercialize our pharmaceutical
products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical
trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty
in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of
the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment
and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market
reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products;
patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products;
our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference
or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure
to litigation, including patent litigation, and/or regulatory actions; the uncertainty surrounding an investigation by the Israel
Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading of our
securities or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary
in order to commercialize our products, and other factors that are discussed in our Registration Statements on Form F-3 filed
with the U.S. Securities and Exchange Commission (the "SEC") (file numbers 333-211477, 333-207117, and 333-215037),
in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the SEC, including our cautionary
discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These
are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those
we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date
which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other
information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable
law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on
the SEC's website, http://www.sec.gov.
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
16, 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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3
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