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Purple Biotech Ltd.

Regulatory Filings Sep 10, 2019

7004_rns_2019-09-10_535d8afc-b122-48ae-98a5-f52ffb1c2e87.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 September 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 an updated Company Presentation on its website. A copy of the updated Company Presentation is attached hereto as Exhibit 99.1 and may be viewed at the Company's website at www.kitovpharma.com.

Exhibit 99.1 Kitov Pharma Company Presentation – September 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.

September 10, 2019 By: /s/ Isaac Israel

Isaac Israel CEO and Director

Thank you Corporate Presentation September 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 in the nearing of the sate hartor provisors of the Private Scorites Uitgation Reform Act of 1995 and other applicables securites laws statements an be tentified by the use of forwards sub at "bein", "plan", "nay", "hay", "hay", "tage", "wil", "project", "toreast", "tantinue" of "anticipat" or "anticipat" or negatives or variations of the comparable worls or by the fact that these statements do not relates fou should not platenents, which are not guaratees of the performance. For arrent reless, expectations, belies or intentions with resect of future events, and are subject to a number of assumptions, involve unknown iss, nany of whith are beyond our ontrol, as well as a uner factors that may case or actual results on be signitiarity different from any foure esults, performance or achievenents expressed or inclied by the forwards. Incors that could cause or confibute to such offerences include, anong others, risks elating to the manner in wirdt the ransation for the aquistion of Fanellave by Kitvy plan to effect the epected benefits, ynergis and costs of the transation; mangement plans relating to the cransation; the e completion of the transation to conqler the tansaction the varios cosing confliors; the yans, strategic and objectives of manageners for furre operations; product development and CM-24, the potential impact of the transactions underlying any of the freeping the process by whith early stage products such as CM-24 could potentialy lead to a a apprev long and subject o hight the spect to a joint development collaboration; the fat that or development and commercialization involves a inghy and expersive process with uner ou tablity to successful) a guice, develop or commercial products, the experse, length, progress and results of sufficient funding of mance the clinital traing to finat it in change in regulation and exist the pharmaced al misuly in reeking the equilator approvals neassary in order to ocommercialize our roducts the difficulty of nedicing and the U.S. Food and Irup Administration or any other of probocs; the regulator environment and changes in the health policis and regimes in the countries in which we career the mor survunding the actual market resert in marketing in a particular narket, the introduction of competing poblus; patents attained by competitor; dependence on the effectivenss of our pated on for inneative products our ablik to obtain and deinds with protective cams the commencement of any atern interestion. our ability to preval, obtain a favorale decision or resore to literion, including atest litigation, and or egalatory adders, and other factors hat are discussed in our Anna Report on For for the year ended December 3, 2008 and in the SC, including or cautionary discussion of risks and uner filsts Fators' in our Registeri Statences and Annal Reports. These are fact and results to differ material y from expected results. Other factors besides those we have lised could also adversely affect us. Any forwar-looking s press release speaks only a of the date We listin any intertion or obligation o publicy update or review and or other information contained herein, whether as a reul of new information, future events or chrenite, exept as readyed, however, to corsult any additional discosures we make in our reports o the SC, virich are available on the SCC vebst http://www.sec.gov

About Kitov

Kitov Pharma is a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance

DIVERSE PIPELINE LARGE MARKETS

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

* As of September 6th, 2019, including CM-24 transaction and investment shares

PROVEN TEAM STRONG PARTNERS

  • 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 Pharmaceuticals
  • 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 June 30, 2019): ~\$8M + \$3.5M of investment pending closing of CM-24 transaction
  • Market Cap: ~\$27M*
  • ~35% of the shares held by blue-chip, institutional healthcare focused investors*

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 kitov

CM - 24

About CM-24

Targets a Novel Immune Checkpoint

CM-24 is a first-in-class mAb blocking CEACAM1, a novel immune checkpoint inhibitor, conceptually analogous to PD1-PDL1

Demonstrated Efficacy in Preclinical Models CM-24 enhances anti-tumor immune activity at the tumor site through multiple pathways

Well Tolerated in a Phase 1 Study CM-24 was well tolerated as a monotherapy in a Phase 1 study in doses up to 10 mg/kg

Phase 1/2 Trial to Start in 2020 Clinical collaboration with Bristol Myers-Squibb for Phase 1/2 trial in combination with nivolumab (Opdivo®) in non-small cell lung cancer (NSCLC) starting at dose of 8mg/kg

CEACAM1 is a Member of the Human CEA Family

(Carcinoembryonic Antigen Cell Adhesion Molecule)

Gray-Owen and Blumberg, CEACAM1: contact-dependent control of immunity, Nature Review Immunology , 2006, DOI: https://doi.org/10.1038/nri1864

kitov

  • Known to interact with both CEACAM1 and CEACAM5
  • Also known to interact with TIM-3
  • Only member expressed on . lymphocytes
  • Modulator of T-cell function and activity at the tumor site
  • · Conceptually, analogous to PD-1/PDL-1

CEACAM1 Expression in Tumor and in Tumor-Infiltrating Immune Cells

%CEACAM1 staining in tumor CEACAM1 + Immune cells
Melanoma (70%) Bladder (96%) Lung (50%) Gastric (74%) Bladder carcinoma Colon
Colon (92%) Pancreas (94%) Prostate (63%) Pancreas

CEACAM1 staining with MGR1 (murine version of CM-24) on various tissue microarrays from different cancer types

CM-24 - Mechanism of Action

CM24 blocks CEACAM1/1 and CEACAM1/5 interactions evoking anti tumor immune response

Sustained Inhibition of Lung Tumor Growth Following Treatment with CM-24 + TIL

Synergistic Anti-Cancer Effect Following Treatment with CM-24 + Anti-PD1

Phase 1 CM-24 Trial Data

Phase 1 PK Data Saturation was not reached with doses up to 10mg/kg

kitov -

Phase 1 PK Data

kıtov

2-compartment PK model including TMDD was performed by Merck. Model was simulated to characterize TMDD saturation:

CM-24 Clinical Development Plan

  • · In Collaboration with Bristol Myers-Squibb:
    • · A Phase 1/2 open label multi center study of CM-24 in combination with nivolumab (Opdivo®) in NSCLC
        1. Dose escalation starting at 8mg/kg
        1. Expansion cohort
    • · Primary endpoint: Evaluate the safety, pharmacokinetics and to-determine the MTD
    • · Secondary endpoint: Obtain preliminary efficacy data
    • · Measurement of CEACAM1 expression levels to identify a potential correlative biomarker

· Exploring further studies in other tumor types as well as monotherapy

NT - 219

About NT-219

Unique MoA

NT-219 is an inhibitor of two signaling proteins involved in drug resistance: Insulin Receptor Substrate 1 and 2 (IRS1/2) and Signal Transducer and Activator of Transcription 3 (STAT3)

Enhances Every Treatment Regimen

Efficacy in PDX models was demonstrated in combination with targeted therapies, chemotherapies and immuno-oncology therapies

Efficacious in Multiple PDX Models

Demonstrated outstanding efficacy in delaying onset and reversing resistance to anti-cancer drugs in head and neck, colon, lung, and pancreatic cancers

Phase 1/2 IND in Q4:2019 IND submission for a first-in-human clinical trial in squamous cell carcinoma of the Head and Neck in combination with cetuximab (Erbitux®) expected in Q4 2019

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

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Adapted from Clinics vol.73 supl.1 2018

NT219 - Mechanism of Action

Inhibition of Both STAT3 and IRS/P13K is Required to Overcome Resistance

NT219 Prevents Acquired Resistance to erlotinib

Drugs

kitov

NT219 Reverses erlotinib-acquired Resistance

NT219 Delays Tumor Recurrence 3500 3000 PDX model Tumor volume (cm³) 2500 Head & neck cancer 2000 1500 1000 Drug 500 Cetuximab (Erbitux®) 0 0 ഗ 10 Treatment period kitov

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer (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
  • · STAT3 and IRS-to-AKT activation contributes to resistance to cetuximab in HNSCC

Market Landscape

  • · 1L Standard of care is shifting from chemotherapy towards immuno-oncology + chemotherapy*
  • · Only < 20% of R/M SCCHN patients respond to anti-PD1s

· NT-219 + cetuximab has the potential to become

  • 1L 2L 3L 60k** 24k ** 13k ** IO +/- CT IO Mono NT-219 + cetuximab
  • an attractive 2-3L therapy
    • 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
      1. Expansion cohort
  • Primary endpoint: Evaluate the safety, pharmacokinetics and to determine the MTD
  • Secondary endpoint: Obtain preliminary efficacy data

· Plan to clinically explore NT-219's efficacy in multiple hard-to-treat oncology indications

kitov

About Consensi™

Consensi™ is the only NSAID whose labeling indicates reduction of blood pressure and consequent risk reduction of heart attack, stroke and death

Full U.S. Prescribing Information is available at: www.consensi.com

Consensi™ U.S. Target Markets

Consensi™ targets osteoarthritis (OA) patients currently treated with NSAIDs (celecoxib as well as others) who also suffer from existing or newly diagnosed hypertension

Consensi™ Commercialization Partners

Upcoming Milestones

Milestone Expected Date
CM-24 - Closing of the transaction 03:19
NT-219 - IND submission to FDA Q4:19
NT-219 - Initiation of a phase 1/2 clinical study Q1:20
NT-219 - Collaboration agreement with potential strategic partner H2:19
Consensi™ - Complete manufacturing and prepare for U.S. launch H2.19
Consensi™ - U.S. launch Q1:20
CM-24 - IND amendment submission H1:20
CM-24 - Initiation of a phase 1/2 clinical study in collaboration with Bristol Myers-Squibb H2:20

About Kitov

Kitov Pharma is a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance

DIVERSE PIPELINE LARGE MARKETS

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

* As of September 6th, 2019, including CM-24 transaction and investment shares

PROVEN TEAM STRONG PARTNERS

  • 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 Pharmaceuticals
  • 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 June 30, 2019): ~\$8M + \$3.5M of investment pending closing of CM-24 transaction
  • Market Cap: ~\$27M*
  • ~35% of the shares held by blue-chip, institutional healthcare focused investors*

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

1

Contact us:

Email: [email protected] www.kitovpharma.com

Appendix A - CM 24

Inhibition of Melanoma Growth Following CM-24 and CM24 + TIL Treatment

CM-24 activity is demonstrated as single agent and in combination with TILs

Appendix B - NT 219

NT219 Re-sensitizes Tumors to Anti-PD1

NT219 Overcomes Resistance to Gemcitabine in Pancreatic Cancer PDX Models

RNAseq Analysis of Tumors Following Treatment Confirming NT-219 Mechanism of Action

IRS1 Ki67 (Proliferation marker)
PDX model 100% 44% 63% 100% 69% 79%
Pancreatic Cancer Control NT219 Gemzar 17%
Gemzar
+NT219
Control NT219 Gemzar 17%
Gemzar
+NT219
100% FOXM1 100% TGFbeta (EMT Driver)
101%
Drug
Gemcitabine (Gemzar®)
45% 67% 60% 26%
Control NT219 Gemzar Gemzar
+NT219
Control NT219 Gemzar Gemzar +NT219
110V

Selected Publications

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Appendix C - Consensi ™ Clinical Data

Medical Rationale

Consensi™ Phase III Trial Design

Consensi™ Phase III Trial Results

Consensi™ demonstrated even better BP reduction than same amount of amlodipine given without celecoxib

* Error bars – standard error of mean

  • Primary efficacy endpoint was successfully achieved (P=0.001)
  • Demonstrated 2.5x better blood pressure reduction than FDA . . requirement (50% of amlodipine arm)
  • Demonstrated consistent reduction in all measures of blood pressure .
  • . Observed beneficial renal functions:
Measure Consensi™ Amlodipine
Creatinine
plasma level
reduction
-3.22
umol/L
-2.55
umol/L
Peripheral
edema
(% patients)
8.2% 15.6%

• Additional Phase III/IV clinical trial to scientifically validate the renal benefits (not required for NDA submission) was completed. Topline results were announced in October, 2017

Consensi™ Phase III/IV Clinical Trial Design

Consensi™ Phase III/IV Clinical Trial Results

  • · Primary efficacy endpoint successfully met (p=0.019), thus Phase III trial results validated
  • · Statistically significant reduction of serum creatinine observed vs. baseline
  • · Consensi™ enhanced the creatinine reduction by an average of 102% vs. amlodipine alone
  • Consensi™ demonstrated systolic blood-pressure reduction comparable to amlodipine

kitov

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