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Purple Biotech Ltd.

Regulatory Filings May 16, 2019

7004_rns_2019-05-16_83b94f58-fd7b-4499-8d75-3ef9838abb56.pdf

Regulatory Filings

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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 May 2019

Commission File Number: 001-37643

KITOV PHARMA 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): ____

Kitov Pharma Ltd. (the "Company" or the "Registrant") is announcing that it has made available a presentation that its CEO, Isaac Israel, is presenting at the 18th MIXiii-BIOMED Conference and Exhibition, on May 16, 2019 in Tel Aviv, Israel. The presentation gives an overview of Kitov's clinical development plans for its oncology candidate NT-219, including disclosing its first indication for a phase 1/2 clinical trial and trial design. The presentation is attached hereto as Exhibit 99.1

Exhibit 99.1 Kitov Presentation at 18th MIXiii-BIOMED Conference and Exhibition - May 2019

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.

May 16, 2019 By: /s/ Isaac Israel

Isaac Israel CEO and Director

Thank you Kitov Pharma NT219 - Overcoming Cancer Drug Resistance Isaac Israel - Chief Executive Officer MIXiii - Biomed - May 16 th , 2019

Forward-Looking Statements and Kitov's Safe Harbor Statement

This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction.

Certain statements in this presentation and the mening of the sate harbor provisions of the Private Scurites Uigation Reform Act of 1995 and other applicable securities laws. Forward-looling statements can believe", "sepec", "intend", "super", "intend", "plan", "ntend", "might", "see", "arget", "mil", "should", "might", "see", "ar "project", "forecast", "continue" of "anticipate" or their evers or other comparable words or by the fact that that that that that the storical natters You should not place undere on thee in the real parantees of future performance. Forwar-looking statements refect our current views, epectations belefs or intentions with respect to four events, and are sumptons, Involve known and unknown risks, may of which are beyond our control, a well as uncertaintes and diser factors that my cause our actual results, performants to be lentillance in on any future results, performance or achievents expressed or implied by the formers. Important for that could cause or contribute to such of mong others, risks realing to the fact hat dough and comment and comments in and exercive process with uncertain outcome; our billy to successfuly accumentation our pharmaceuted product; the expense, length, progress and results of any clinical thas; the ack of sufficer: funding to finance the clinical the inpact of any could affect the pharmaceutal industry the efficulty in receing the eleficulty in receing the regulatory approvals neessary order to commercialize our products, the U.S. Fod and Drug Administration or any other applicable regulator of pharmaceutcal products the regulator environment and changes in the heather in the countries in which we counting the actual market reception to our pharmaged call goducts once cleared or narket a n a particular market the intrade products patents attined by competitors; dependence on the effectivenes of our paterts and other product; our ablis postections for novative p obtain, maintain and defend spective callers the commencement of any patent interference or infringement action; our ability to recole becolon or recore demage in any such edge including patent litgetion, and/or regulatory the uncertainly surounding an investigation by the Urely Securities Authority into butinity into but historical public discloures and the potential in the training of our securites or our clinical, commercial and other buiness realing the regulary approvals necessary in order to conmectative a a e discussed in our Anual Report on form 20-For the year ended December 3, 2018 and in our obler fillers with the SEC, Including our caution of risk and uncertaintes under "Risk Factor" in our Registration Statements and Annual Reports. These are facture our actual result result result r differ material results. Chief factors belotes that in the listed could also adversely offict us. Any forward in this press reesse poly as of the dote which is of the dote wh made. Ve discin any intention or obligation opublicating statement, or ober information contained herin, whether as a reult of new information, future events of otherwis, exest as required by applicale law. You are additional disclosures we make in our reports to the SC, which are walled on the SCC which are walled on the SCC website http://www.sec.gov

About Kitov

Kitov Pharma is advancing first-in-class combination oncology therapies to overcome t umor drug resistance, increase treatment response rate, and slow tumor progression

DIVERSE PIPELINE LARGE MARKETS

  • CM-24 Novel immune checkpoint inhibitor with high potential to treat multiple oncology indications
  • · NT-219 Small molecule targeting novel cancer drug resistance pathways
  • · Consensi™ Commercial candidate approved by FDA to treat osteoarthritic pain and hypertension. Licensed for marketing in the U.S., China and S. Korea

  • Management team with proven track record in drug development. NDA submissions and FDA approvals
  • · Consensi™ manufacturing and CMC by Dexcel Pharma, to be distributed in the U.S. by Coeptis Pharmaceutical's
  • CM-24 clinical collaboration with Bristol Myers-Squibb

COMPELLING VALUE

  • Publicly traded on TASE 2013; IPO on NASDAQ in November 2015
  • · Tickers: KTOV (ADSs); KTOVW (Warrants)
  • · Cash on hand (as of January 2019): ~\$13M + \$3.5M of investment pending closing of CM-24 transaction
  • Market Cap: ~\$31M*
  • *35% of the shares held by blue-chip, institutional healthcare focused investors

· As of May 14°, 2019, Including CM-24 transaction and investment shares

Commercial and Development Pipeline

Program Indication Preclinical Phase 1 Phase 2 Phase 3 Market Partners
Consensi™ Osteoarthritis Pain
and Hypertension
Commercial partners:
Coeptis Pharmaceuticals - U.S.
CSBio - China
Kuhnil Pharmaceuticals - S. Korea
CM-24 Non-Small Cell Lung Cancer
(combination with nivolumab)
Bristol-Myers Squibb
(Clinical Collaboration)
NT-219 Head and Neck Cancer
(combination with cetuximab)

kitov

kıtov

Targeting cancer drug resistance

  • · Many cancer patients either don't respond to single agent therapies or relapse quickly after initially responding
  • · Overcoming cancer drug resistance (intrinsic and acquired) is a major unmet need in cancer treatment
  • · Effective combination therapies that act synergistically on multiple pathways are necessary for the development of successful and long-lasting cancer treatments

Kitov is developing NT-219, a first-in-class small molecule dual inhibitor of two key pathways involved in cancer drug resistance, STAT3 and IRS1/2

IRS1/2 and STAT3

Key Signal Transducers activated as a feedback response to anti-cancer drugs, leading to drug resistance

IRS1/2:

  • · Part of the IGFR complex
  • · Phosphorylated on tyrosine residues and triggers activation of PI3K/AKT and MEK/ERK signaling pathways
  • · Regulates cell proliferation, protein synthesis, survival, gene expression and apoptosis

STAT3:

  • · Active in the JAK/STAT3 immune evasion mechanism of the tumor
  • · Provides a crucial axis to support cell proliferation and survival

Adapted from Clinics vol. 73 supl. 1 2018

NT-219 is a First-in-class Dual Inhibitor of STAT3 and IRS1/2

Blocking both pathways is required to overcome resistance and to re-sensitize tumors to anti-cancer therapies

kitov ------------------------------------------------------------------------------------------------------------------------------------------------------------------------

NT-219 Preclinical Data

Prevents Acquired Resistance to Erlotinib in Head and Neck Cancer - PDX Model

NT-219 Preclinical Data

Reverses Acquired Resistance to Erlotinib in Head and Neck Cancer - PDX Model

NT-219 Preclinical Data

Delays Tumor Recurrence with Cetuximab in Head and Neck Cancer PDX Model

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Rational of combining Cetuximab + NT-219

  • · EGFR and PD(L)-1 are the only clinically validated targets in SCCHN
  • · Cetuximab inhibits EGFR signaling and promotes ADCC
  • · Activation of STAT3 and IRS-to-AKT contributes to resistance to cetuximab in SCCHN

Market Landscape

  • · Standard of care is shifting from chemotherapy towards immuno-oncology*
  • · Only < 20% of R/M SCCHN patients respond to anti-PD-1s
  • · NT-219 + cetuximab could become an attractive 3L therapy and potentially expand into 2 and 1L with or w/o anti-PD-1 inhibitors

* Global Data 2018: Head and Neck Squamous Cell Carcinoma: Opportunity Analysis and Forecasts to 2026 ** Internal best current estimates of patient numbers based on external research, 5 major global territories

NT-219 Clinical Development Plan

  • · A Phase 1/2 open label multi center study of NT-219 in combination with cetuximab in patients with recurrent or metastatic SCCHN
      1. Dose escalation of NT-219 in combination with cetuximab
      1. Expansion cohort NT-219 + cetuximab
  • · Primary endpoint: Evaluate the safety pharmacokinetics and to determine the MTD
  • · Secondary endpoint: Obtain preliminary efficacy data

NT-219 Summary

  • · Cancer drug resistance (intrinsic and acquired) is a major unmet need in cancer treatment
  • · NT-219 is a first-in-class dual inhibitor of STAT3 and IRS1/2
  • · Broad efficacy demonstrated in various patient-derived xenograft (PDX) SCCHN models in combination with cetuximab
  • · Our data suggest that NT-219 has a potential to increase efficacy, expand target patient population, and prolong treatment duration
  • · Phase 1/2 planed for recurrent or metastatic SCCHN patients expected to start 2H 2019

kitov /

About Kitov

Kitov Pharma is advancing first-in-class combination oncology therapies to overcome t umor drug resistance, increase treatment response rate, and slow tumor progression

DIVERSE PIPELINE LARGE MARKETS

  • CM-24 Novel immune checkpoint inhibitor with high potential to treat multiple oncology indications
  • · NT-219 Small molecule targeting novel cancer drug resistance pathways
  • · Consensi™ Commercial candidate approved by FDA to treat osteoarthritic pain and hypertension. Licensed for marketing in the U.S., China and S. Korea

  • Management team with proven track record in drug development. NDA submissions and FDA approvals
  • · Consensi™ manufacturing and CMC by Dexcel Pharma, to be distributed in the U.S. by Coeptis Pharmaceutical's
  • CM-24 clinical collaboration with Bristol Myers-Squibb

COMPELLING VALUE

  • Publicly traded on TASE 2013; IPO on NASDAQ in November 2015
  • · Tickers: KTOV (ADSs); KTOVW (Warrants)
  • · Cash on hand (as of January 2019): ~\$13M + \$3.5M of investment pending closing of CM-24 transaction
  • Market Cap: ~\$31M*
  • *35% of the shares held by blue-chip, institutional healthcare focused investors

· As of May 14°, 2019, Including CM-24 transaction and investment shares

Thank you Our mission is to provide cancer patients with first - in - class therapies to overcome tumor drug resistance , enhance treatment response and slow tumor progression

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