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 June 2018
Commission
File Number: 001-37643
KITOV
PHARMA
LTD.
(Translation
of registrant’s name into English)
One
Azrieli Center, Round Tower,
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): ____
Kitov
Pharma Ltd. (the “Company” or the “Registrant”), today announced results in a pre-clinical study testing
NT219, conducted by Kitov’s majority-owned subsidiary, TyrNovo Ltd. (“TyrNovo”), a privately-held developer
of novel small molecules in the oncology therapeutic field. The study evaluated NT219 in combination with gemcitabine in a patient-derived
xenograft (PDX) model of pancreatic cancer, and was conducted in accordance with guidance from the U.S. Food and Drug Administration
(FDA). The Company believes that the results support the planned submission of the Investigational New Drug (IND) Application
for NT219. NT219 was tested at three dose levels in combination with gemcitabine vs. gemcitabine alone. A clear dose response
effect was observed among treatment arms with statistically significant differences among groups (p-value <= 0.0166).
In addition, the study confirmed previous findings that demonstrated the beneficial effect of the combination of NT219 with gemcitabine
vs. gemcitabine alone (p-value <0.0001).
The Company also today announced the
acquisition of an additional approximately 3.1% stake in TyrNovo, , from Taoz – Company for Management and Holdings of Companies
Ltd. (“Taoz”), the final remaining unaffiliated minority shareholder of TyrNovo, and with whom the Company entered
into a shareholders’ agreement in February 2017. Pursuant to this new share exchange agreement with Taoz, in exchange for
Taoz’s entire holding in TyrNovo and the termination of the existing shareholder and investment agreements amongst the Company,
TyrNovo and Taoz, the Company will issue to Taoz 2,816,900 newly issued ordinary shares (equivalent to 140,845 American Depositary
Shares or ADSs) of the Company (the “Taoz Shares”), which will represent approximately 0.9% of the Company’s
issued and outstanding share capital following the closing of the share exchange transaction. For more information on the shareholder
and investment agreements amongst the Company, TyrNovo, and Taoz which will be terminated at the closing of the share exchange
transaction, see Item 7.B – Related Party Transactions – TyrNovo Ltd. in our Annual Report on Form 20-F for the year
ended December 31, 2017
After the closing of this new share
exchange transaction, which is pending completion of customary closing conditions, including receipt of the listing consent of
the Tel Aviv Stock Exchange, the Company will hold approximately 97.1% of TyrNovo’s issued and outstanding ordinary shares.
Approximately 2.9% of TyrNovo’s issued and outstanding ordinary shares are owned by Dr. Hadas Reuveni Ph.D., the founder
and Chief Technology Officer of TyrNovo.
Pursuant to the share exchange agreement,
following the closing of the transaction if at any time during the seven trading days following such date on which there is either
(i) an effective registration statement registering, or prospectus available for, the resale of Taoz Shares or ADSs representing
the Taoz Shares, or (ii) an available exemption permitting the resale of the Taoz Shares without having to satisfy the registration
or prospectus requirements under applicable law in any trading market; and, the lowest VWAP of the Company’s ADSs for any
day during such seven day period (the “Consideration Adjustment VWAP”) is below $2.84 per ADS, then the consideration
to be paid by the Company for Taoz’s entire holding in TyrNovo shall be adjusted such that the Company shall pay, as additional
consideration for the TyrNovo shares sold by Taoz, an amount in cash such that the value of the 140,845 ADSs based on the Consideration
Adjustment VWAP plus such additional cash consideration is equal to $400,000.
In connection with the share exchange
transaction, at closing of the transaction the Company will enter into a Registration Rights Agreement with Taoz (the “Registration
Rights Agreement”) providing for the filing of a registration statement (the “Registration Statement”) with the
Securities and Exchange Commission registering the Taoz Shares represented by ADSs. Pursuant to the Registration Rights Agreement,
in the event that the Taoz Shares would not be able to be sold or otherwise transferred, without volume or manner-of-sale restrictions,
pursuant to either (i) SEC Rule 144 in the absence of any registration, or (ii) any other applicable rule permitting the Taoz Shares
to be sold, or otherwise transferred, in any applicable trading market, without volume or manner-of-sale restrictions, the Company
is then obligated to cause the Registration Statement to be declared effective no later than 60 days after the date of closing
of the share exchange transaction.
The Taoz Shares were offered, and will
be issued, to Taoz in Israel on a private placement basis pursuant to applicable exemptions from the prospectus requirements under
applicable Israeli securities laws and exempt from the registration requirements of the United States Securities Act of 1933,
as amended, (the “Act”) and/or Regulation S, promulgated pursuant to the Act. Taoz is not a U.S. person, no sales
efforts were conducted in the U.S., and the Taoz Shares will contain upon issuance, a legend restricting the sale of such securities
in accordance with applicable exemptions from the registration requirements of the Act. The Taoz Shares subject to statutory resale
restrictions in under applicable Israeli securities laws and regulations, and to statutory resale restrictions in the U.S. under
the Act.
The
securities offered have not been, and will not necessarily be, registered under the U.S. Securities Act or any U.S. state or Israeli
securities laws, and may not be offered or sold in the United States or in Israel, or to, or for the account or benefit of, United
States persons or persons in Israel absent registration or any applicable exemption from the registration and/or prospectus requirements
of the Act and applicable U.S. state and/or Israeli securities laws. This release does not constitute an offer to sell or
the solicitation of an offer to buy securities in the United States or in the State of Israel, nor in any other jurisdiction.
On
June 15, 2018, the Company issued a press release in connection with the transaction with Taoz and a TyrNovo business update,
“
Kitov Announces Positive Pre-Clinical Data from NT219 Demonstrating its Dose-Dependent Anti-Tumor Efficacy
”,
which is attached hereto as Exhibit 99.1
Attached
hereto are the following exhibits:
Forward-Looking
Statements and Registrant’s Safe Harbor Statement
Certain
statements in this 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, 2017 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, 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).
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.
|
KITOV
PHARMA LTD.
|
|
|
June
15, 2018
|
By:
|
/s/
Simcha Rock
|
|
|
Simcha
Rock
|
|
|
CFO
& Director
|
3
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