Purple Biotech Ltd. — AGM Information 2017

Oct 27, 2017

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, 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 October 2017

Commission File Number: 001-37643

KITOV PHARMACEUTICALS HOLDINGS 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 Pharmaceuticals Holdings Ltd. (the "Company" or the "Registrant") is making the following announcements:

1) Clinical Trial for KIT-302

On October 26, 2017, the Company issued a Press Release: "Kitov Pharmaceuticals Announces Phase III/IV Clinical Trial for KIT-302 Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function", which is attached hereto as Exhibit 99.1.

2) Notice of 2017 Annual General Meeting of the Shareholders

The Company has published a Notice of 2017 Annual General Meeting of the Shareholders of the Company to be held at the Company's executive offices at One Azrieli Center, Round Tower, 19th Floor, Tel Aviv, Israel on Monday, December 4, 2017, at 4:30 p.m. local Israeli time. The Notice of 2017 Annual General Meeting of Shareholders is attached to this Form 6-K as Exhibit 99.2.

We will also publish the Notice of 2017 Annual General Meeting of Shareholders on our corporate website at http://kitovpharma.investorroom.com/Shareholder-Meetings.

The full set of Proxy Materials is expected to be furnished to the SEC on Form 6-K on or before November 6, 2017, and will be available to the public on the SEC's website at https://www.sec.gov. The Proxy Materials will also be submitted to the Israeli Securities Authority and TASE, and available on the websites: www.magna.isa.gov.il or www.maya.tase.co.il. The Proxy Materials will also be made available on our website.

This report on Form 6-K of the Registrant consists of the following documents, which are attached hereto and incorporated by reference herein:

Exhibits

99.1	Press Release
99.2	Notice of 2017 Annual General Meeting of the Shareholders of Kitov Pharmaceuticals Holdings Ltd.

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. Forwardlooking 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 forwardlooking 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) 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.

KITOV PHARMACEUTICALS HOLDINGS LTD.

October 27, 2017 By: /s/ Simcha Rock

Simcha Rock Chief Financial Officer

Kitov Pharmaceuticals Announces Phase III/IV Clinical Trial for KIT-302 Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function

Results Validate Primary Efficacy Endpoint Achieved in Previous Successfully Completed Phase III Clinical Trial

KIT-302 Reduces Creatinine Levels Indicating Improved Renal Function, Compared to Negative Effects of other NSAIDs

Company Recently Submitted, and FDA Accepted for Filing, NDA for KIT-302 for Simultaneous Treatment of Osteoarthritis Pain and Hypertension

Tel Aviv, Israel, October 26, 2017 – Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that its randomized double-blind, placebo-controlled renal function clinical trial for its lead drug candidate, KIT-302, successfully met its primary efficacy endpoint. Data from the trial demonstrated that KIT-302 lowered systolic blood pressure a comparable amount to the widely used antihypertension drug, amlodipine besylate, thus meeting the trial's primary efficacy endpoint of achieving at least 50% of the amlodipine reduction (p=0.019).

KIT-302, a combination drug, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc®). The renal function study enrolled 104 patients randomized to three treatment groups: KIT-302, amlodipine besylate, and placebo. The primary efficacy endpoint of the trial was to show that KIT-302 lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only. Secondary endpoints included various parameters of renal function.

The study also demonstrated that treatment with KIT-302 led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005). In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.

When comparing the effect of KIT-302 to amlodipine besylate in lowering creatinine, it was found that KIT-302 enhanced the creatinine reduction by an average of 102% over that achieved with amlodipine besylate alone, although there was a slight increase in the rate of edema in the KIT-302 treatment arm. Both this creatinine measure and the edema measure were statistically insignificant.

Kitov submitted its New Drug Application (NDA) for marketing approval of KIT-302 to the U.S. Food and Drug Administration (FDA) in July 2017, and in September 2017, FDA filed the NDA, thereby granting a full review. Although the renal clinical trial was not required as part of the initial KIT-302 NDA submission, the Company anticipates completion and submission of the report to FDA by January 2018.

"We are very pleased with the results of our renal function clinical trial and look forward to submitting the related clinical study report to FDA. Although FDA has publicly warned against using NSAIDs in patients receiving antihypertensive drugs from the diuretic, beta blocker, ACE inhibitor and angiotensin receptor blocker classes, this study once again demonstrated that our combination lacks the toxicities of these other classes and combinations. This makes our combination uniquely suited for the millions of Americans with both osteoarthritis and hypertension. The reduction of creatinine levels by KIT-302, indicating improved renal function, as compared to the negative effects on renal function of other NSAIDs, further demonstrates the value of KIT-302," said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.

About Kitov Pharmaceuticals

Kitov Pharmaceuticals (NASDAQ: KTOV, TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial. Kitov's newest drug, NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.

Forward-Looking Statements and Kitov's Safe Harbor Statement

Certain statements in this press release 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 forwardlooking 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

For further information, contact:

Simcha Rock Chief Financial Officer +972-3-9333-121 ext. #105 simcha@kitovpharma.com

Bob Yedid LifeSci Advisors, LLC +1-646-597-6989 Bob@LifeSciAdvisors.com

KITOV PHARMACEUTICALS HOLDINGS LIMITED

Notice of 2017 Annual General Meeting of Shareholders

Notice is hereby given that the 2017 Annual General Meeting of Shareholders (the "Meeting" or the "Annual Meeting") of Kitov Pharmaceuticals Holdings Limited ("Kitov" or the "Company") will be held at Kitov's executive offices at One Azrieli Center, Round Tower, 19th Floor, Tel Aviv, Israel on Monday, December 4, 2017, at 4:30 p.m. local Israeli time, for the following purposes:

• 1. To review the Company's Financial Statements and Annual Report for the year ended December 31, 2016.
• 1. To review the compensation paid by the Company during 2016 to Somekh Chaikin, Certified Public Accountants (Israel), a member of KPMG International, the independent public accountants of the Company, and to approve their re-appointment as the independent public accountants of the Company for three years until the 2020 Annual General Meeting, and to authorize the Audit Committee of the Board of Directors of the Company to fix the compensation of said auditors in accordance with the scope and nature of their services.
• 1. To vote on a proposal to a change of the Company's name to Kitov Biopharma Ltd. or such similar name containing the name "Kitov" as determined by the Company's management and approved by the Israeli Registrar of Companies, and approve the applicable amendments to the Company's Memorandum of Association and Articles of Association to reflect such name change (the change of the Company's name will be effective only following the approval and authorization of the Israeli Registrar of Companies).
• 1. To re-appoint each of Messrs. Steven Steinberg, Ido Agmon and Ran Tzror to the Board of Directors, as members of the second class of directors, each to serve for a three-year term until the 2020 Annual General Meeting, and until their successors have been duly elected.
• 1. To transact such other business as may properly come before the Meeting

Only shareholders of record at the close of business in New York on Thursday, November 2, 2017 will be entitled to vote at the Annual Meeting. Two shareholders who are present at the Annual Meeting, in person or by proxy or represented by their authorized persons, and who hold in the aggregate twenty-five percent or more of the paid-up share capital of the Company, shall constitute a legal quorum. Should no legal quorum be present one half hour after the scheduled time, the Meeting shall be adjourned to one week from that day, at the same time and place.

As permitted under the Israeli Companies Law 5759-1999 and Regulations enacted pursuant to such law, and as set forth in our Amended and Restated Articles of Association, we are not required to physically deliver a notice of a shareholders meeting and a proxy statement. We have prepared this Notice of Annual General Meeting of Shareholders, and will prepare the Proxy Statement, Voting Slip and Voting Instruction Forms, (collectively, the "Proxy Materials") in accordance with applicable rules, regulations and disclosure requirements in the State of Israel, as such are applicable to a Company whose securities are traded on both the Tel Aviv Stock Exchange and the NASDAQ. Our Proxy Materials may not necessarily be mailed to beneficial shareholders in Israel, nor to beneficial ADS holders in the United States.

The full set of Proxy Materials are expected to be furnished to the Securities and Exchange Commission ("SEC") on Form 6-K on or before November 6, 2017, and will be available to the public on the SEC's website at https://www.sec.gov. The Proxy Materials will also be submitted to the Israeli Securities Authority and TASE, and available on the websites: www.magna.isa.gov.il or www.maya.tase.co.il. This Notice of Annual General Meeting of Shareholders and the Proxy Materials will also be made available on our corporate website at http://kitovpharma.investorroom.com/Shareholder-Meetings, as required under the Companies Law and Regulations governing publication of this Notice of Annual General Meeting of Shareholders and distribution of the Proxy Materials.

Under Israeli law, one or more shareholders holding 1% or more of the voting rights of the Company may request to include a proposal on the agenda of a shareholders meeting (including proposing the nomination of a candidate to the Company's Board of Directors (the "Board of Directors") for consideration by the Board of Directors) by submitting such proposal within seven days of publication of the Company's notice with respect to its general meeting of shareholders (a "Meeting Agenda Addition"). Accordingly, any shareholder, or group of shareholders, holding 1% or more of the voting rights of the Company may request to include a Meeting Agenda Addition proposal on the agenda of this Meeting by submitting such proposal in writing to the Company no later than Friday, November 3, 2017, 11:30 p.m. Israel time, at the Company Offices, Attn: Avraham Ben-Tzvi, Adv., Company Secretary. If a Meeting Agenda Addition is to nominate a candidate for election to the Board of Directors, the proposing shareholder(s) must provide (a) a declaration signed by the nominee and any other information required under the Companies Law, (b) all of the information set forth under Regulation 26(a) of the Securities Regulations (Periodic and Immediate Reports), 5730- 1970, (c) additional information in respect of the nominee as would be required in response to the applicable disclosure requirements in Israel or abroad, including those of Item 6A (directors and senior management), Item 6E (share ownership) and Item 7B (related party transactions) of Form 20-F of the SEC, to the extent applicable, (d) a representation made by the nominee of whether the nominee meets the objective criteria for an independent director and/or statutory unaffiliated director of a company such as the Company under the Companies Law and/or under any applicable law, regulation or stock exchange rules, in Israel or abroad, and if not, then an explanation of why not, and (e) details of all relationships and understandings between the proposing shareholder(s) and the nominee.

Under Israeli law, shareholders wishing to express their position on an agenda item for this Meeting may do so by submitting a written Position Statement ("Position Statement") to the Company Offices, Attn: Avraham Ben-Tzvi, Adv., General Counsel and Company Secretary. Any Position Statement received will be furnished to the SEC on Form 6-K, and will be made available to the public on the SEC's website at http://www.sec.gov, and in addition at http://www.magna.isa.gov.il or http://maya.tase.co.il. Position Statements should be submitted to the Company no later than Friday, November 24, 2017 at 4:30 p.m. Israel time. Any Position Statements so submitted must comply with the requirements set forth under the Companies Law and any applicable regulations, including the Companies Regulations (Voting in Writing and Position Statements), 5766-2005.

Beneficial ADS holders in the United States should return their form of Voting Instruction Form for holders of the Company's ADSs by no later than the date and time which will be set forth on such Voting Instruction Form. Proxies must be deposited at the Company Offices or the place designated for the Meeting no later than 48 hours prior to the time scheduled for the Meeting. However, the Meeting chairman is entitled to waive this requirement with respect to all participants at the Meeting, and to accept all the proxies at the commencement of the Meeting, subject to the presentation of proof of share ownership.

All Voting Slips (together with proofs of share ownership, and all documents required to be submitted therewith) must be delivered to the Company Offices set forth above, such that the Voting Slip arrives no later 4 hours prior to the designated time of the Meeting, namely by no later than on Monday, December 4, 2017, at 12:30 p.m. Israel Time. Voting via Electronic Voting Slips, which will be delivered to the Company via the Electronic Voting System being operated pursuant to Section B of Chapter G'2 of the Securities Law, 5728-1968, will be allowed until six (6) hours prior to the Meeting commencement, namely by no later than Monday, December 4, 2017, 10:30 a.m. Israel Time.

By Order of the Board of Directors,

/s/ Avraham Ben-Tzvi

Avraham Ben-Tzvi Company Secretary

October 27, 2017