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 December 2017
Commission File Number: 001-37643
KITOV PHARMACEUTICALS HOLDINGS
LTD.
(Translation of registrant's name into English)
One
Azrieli Center, Round Tower,
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 December 14, 2017, Kitov Pharmaceuticals Holdings Ltd. (the “Company”
or the “Registrant”) announced that the U.S. Food and Drug Administration (the “FDA”) has granted permission
to use the brand name Consensi™ for marketing KIT-302, its lead drug candidate, subject to receipt of marketing approval
from the FDA. As previously announced by the Company, in connection with its determination that the Company’s New Drug Application
application is sufficiently complete to permit a substantive review, the FDA, under the Prescription Drug User Fee Act (PDUFA),
has set a target date of May 31, 2018 to complete its review. On December 14, 2017, the Company issued a press release in connection
with the permission of the FDA to use the brand name Consensi™ for marketing KIT-302, “
Kitov Announces Consensi™
as Brand Name for KIT-302
”, which is attached hereto as Exhibit 99.1
The Company has applied to the United States Patent and Trademark
Office (“USPTO”) for registered trademark protection for Consensi™, and the application has been published in
the Trademark Official Gazette. The Company has been informed by the USPTO that should no one file an opposition or extension request
to the trademark within 30 days of November 28, 2017, then a Notice of Allowance should be issued within 11 weeks following November
28, 2017.
Attached hereto are the following exhibits:
This Form 6-K, excluding Exhibit 99.1, 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), 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), and the Registrant’s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on
June 6, 2017 (Registration file number 333-218538).
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 develop and 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 in our Annual Report on Form 20-F for the year ended December 31, 2016 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), 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), and the Registrant’s
Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 6, 2017 (Registration file number
333-218538).
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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December 14, 2017
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By:
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/s/ Simcha Rock
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Simcha Rock
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CFO and Director
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