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Purple Biotech Ltd.

Investor Presentation May 4, 2020

7004_rns_2020-05-04_daf3d5d4-f67a-4015-aadc-ec763504d1cc.pdf

Investor Presentation

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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 2020

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 – May 2020

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 4, 2020 By: /s/ Isaac Israel

Isaac Israel CEO and Director

Exhibit 99.1

Thank you Corporate Presentation May 2020

Forward-Looking Statements and Safe Harbor

Certain statements in this presentation that are forward-looking statements within the nearly of the safe harthin the mearing of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Such forward-looking statements included on proceeds and statements that are not statements of historical fast, and may be identified by words such as "believe", "expect", "intent", "seek", "target", "will", "project", "ontinue" or "anticipate" or their negatives r viations of these words or other comparable words or by the fact the to not relate sticity to historical matters. You should not planes on these forward-looking statements, which are not guarantees of future performance for current views, expectations belies or intentions with respect of future events, and are subject o a number of asumptions, involve known and unknown risks, nany of which as well as uncertainter and other factors that may cause our actual results performance or activernetts to be significantly different from any fute estity of the engressed or impled by the forward-looking statements. Incornant factors that coud cause or ontribute to such differences indude, anone others, risks relating to: different results synergies and costs of the acquisition of FamelWave by Kity, management plans, strategies and objectives of management for NT219 and CN-24; the potential finacial impact of the transction; and any asumptions inderling any of the foresping the process by unitiates such as NT219 and CM-24 could potentially lead to an approved one product is one and subject to high informical risk. particularly with respect o a joint development and commercialization involves a lengthy and expersive process with uncertain outcomes, ou ability to successfuly develop and commecutical products; the expense, length, progress and results of any clinical trails; the last of sufficient funing to finance the cinical trials; any changes in regulation that could affect the pharmaceuitial in receing the tregulatory approvals necessary in order to commercialize ou product; the difficulty of predicting actions of the U.S. Food and Drug Administration of charmaceuical products; the regulator environment and changes in the health polices and egines in the countries in which we operate; the uncertainty surround o our pharmaceutcal products once cleared for market; the introduction of competing products; patents attained by competitors; of our patents and other probections for innovative product; our ability to obtain, maintain and defent issued patents with protective clains; the commencenent of any patent interent action; our ability to preval, obtain a favorable decision or recover damages in any such action; and the exposure litigation, including patent litigation, and other factors that are discussed in our in our Annual Report on Form 20-Ffor the year ended December 3, 20.9 and in our other fil with the SC, including our cautionary discussion of risk Factors' in our Registration Statements and Annual Reports. These are actual results to differ naterially from expected those we have listed could ats adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is nade. We disclaim any intention or oblick update or reise any forward-looking statement, or cher information chure events or otherwise, exept as required by applicately and can additional disclosures we make in our reports to the SEC, which are wailable on the SEC's website, http://www.sec.gov.

Kitov Pharma (NASDAQ/TASE:KTOV)

A clinical-stage company advancing first-in-class oncology therapies

CM-24 - Inhibitor of CEACAM1 NT-219 - Dual inhibitor of IRS 1/2 and STAT3

kitov

  • Two novel assets targeting significant unmet needs
  • Strong partners and collaborators
  • Consensi ™: Commercial stage drug to support pipeline development
    • \$28M-36M of revenues expected in 2020-2022

  • Institutional healthcare focused investors
  • . Financials:
    • V Market cap. ~\$24M*
    • < \$19M cash as of January 1st, 2020 (pro forma**)
    • 2.8M shares 3-month avg. trading volume

* As of April 30th , 2020
** including net \$3.5M + \$5.8M raised in January 20, March 20 and April 20 financing transactions respectively

From Development to Commercialization

Program Indication Preclinical Phase 1 Phase 2 Phase 3 Partners Value Drivers
CM-24 NSCLC and Pancreatic Cancer
(combination with nivolumab)
Bristol-Myers Squibb Study initiation Q4:20
Phase 1 data H1:21
NT-219 R/M solid tumors and Head
and Neck (monotherapy and
in combination with Erbitux®)
Study initiation Q2:20
Phase 1 data H1:21
Product Indication Status Partners Value Drivers
Consensi™ Simultaneous treatment of
osteoarthritic pain and
hypertension
Approved for marketing by
U.S. FDA
U.S .: Coeptis Pharmaceuticals
China: CSBio
S. Korea: Kuhnil Pharmaceutical
U.S. Launch: Q2:20

Multiple data read-outs expected within 15 months

kitov -

Experienced Leadership

Isaac Israel Chief Executive Officer

Eric K. Rowinsky, MD Chairman of the Board Formerly CMO at ImClone, Stemline, Board member at Biogen Inc.

Bertrand Liang, MD, PhD, MBA, AMP Chief Medical Officer Formerly at Biogen Idec, Amgen, NCI

Hadas Reuveni, Ph.D.

Vice President, Research and Development Formerly at Keryx (NASDAQ:KERX)

Gil Efron Deputy CEO and Chief Financial Officer Formerly CFO at Kamada (NASDAQ:KMDA)

NextGen Biomed (TASE: NXGN)

Formerly CEO of BeeContact Ltd. (TASE:BCNT),

Michael Schickler, Ph.D Head of Clinical Operations Formerly at Hoffmann-La Roche, CEO at CureTech,

Advancing first-in-class Oncology Therapies

CM-24 – Inhibitor of CEACAM1

CEACAM1 Plays a pivotal role in the immune system

  • · CEACAM1 (Carcinoembryonic Antigen Cell Adhesion Molecule 1) - member of the Human CEA Family
  • · Interacts with both CEACAM1 and CEACAM5
  • · Regulates TIM-3-mediated tolerance and exhaustion *
  • · High expression in tumor and in tumorinfiltrating immune cells

K1TOV

*Gray-Owen and Blumberg, CEACAM1: control of immunity, Nature Review Immunology , 2006, DOI: https://doi.org/10.1038/nr/1864

CM-24 MOA: Blocks CEACAM1-mediated interactions

  • · CM-24 is a humanized IgG4 mAb highly specific to the extracellular domain of CEACAM1 with Nano-molar affinity
  • · CM-24 prevents CEACAM1-CEACAM1 or CEACAM1-CEACAM5 interaction, thus enhancing the cytotoxic activity of the lymphocytes
  • · CM-24 activity is manifested in the blockade of:
    • Immune inhibitory signals
    • Angiogenesis -
    • Tumor-stroma interaction

Markel et d., I mmunol 2003; Cancer Inmunol Immunother 2010; Orterberg et al, Mol Cancer Ther 2012; Zhou, 2009; Li, 2013; Huang, 2015

Anti-Cancer Effect Following Treatment with CM-24 + TIL and CM-24 + Anti-PD1

100

Significant benefits as both single agent and in combination with α-PD-1 kitov

CM-24 Phase 1 Monotherapy Trial

  • · Open-label, multi-dose escalation study to assess safety and tolerability of CM-24
  • · Conducted by Merck in 4 centers US: UCLA, Yale; Israel: Sheba, Sourasky
  • · Heavily pre-treated patients with a median of 3 prior regimens (range 2-7) and a median of 4 prior regimens at the 3mg/kg & 10mg/kg doses

✓ No DLTs up to 10 mg/kg √ No discontinuation of study drug due to an AE √ No drug related mortalities √ 29.6% SD (RECIST)

Overall, treatment with CM-24 was well tolerated

PK/PD Modeling Suggests Saturation Kinetics Higher Doses and Shorter Schedule Required

Simulated TMDD saturation at Ctrough with Q2W regimen

· Consistent with observed PK showing high clearance at doses <10 mg/kg, plot shows low TMDD saturation at low doses

· 10 mg/kg approaches > 90% saturation but >10 mg/kg dose is needed for saturation across population

Predictions with Q3W regimen (not clinically tested)

• Keytruda®'s administration regimen is Q3W

· With Q3W, 10 mg/kg is predicted to achieve only > 50% saturation

OPDIVO® is administered Q2W or Q4W, and thus represents a better clinical and commercial fit for CM-24 than KEYTRUDA®

KTTOV KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., OPDIVO® is a registered trademark of Bristol-Myers Squibb.

Market opportunity: Non-Small Cell Lung Cancer

Rationale for combining Opdivo® + CM-24

  • · CEACAM1 expression correlates with poor prognosis in NSCLC*
  • · Preclinical data supports significant synergism
  • · Receptor saturation with CM-24 is better achieved with a Q2W regimen and is aligned with the Opdivo® protocol
  • Collaboration with Bristol-Myers Squibb, a leader in immuno-Oncology (I/O) research, to address an urgent need

Targeting the unmet medical need

  • · Non-small cell lung cancer accounts for 85% of all lung cancer diagnoses, approx. 193,927 new cases/year; with a 5-year relative survival rate of 23%**
  • · Immunotherapy is now recommended as first line therapy in all patients with NSCLC and no driver mutations***
  • · 5-year overall survival rates with chemotherapy in 2L is 2.6% and with I/O Opdivo® is 13.4%***

Opdivo® + CM-24 has the potential to provide long lasting effective treatment

* Dango et al, Lung Cancer 2008; 60:426

**American Cancer Society, Cancer Facts & Figures 2019, and the ACS website

** Economopoulou P, Mountzios G. The emerging treatment Inn-small cell ung cancer. Ann Transl Med. 2018,6(8):138. doi:10.2007.11.07

** Gettinger S, et al "Five-year outcomes from the randomized, phose II trials CheckMate 017/057: Nivolumab vs docetously treated NSCC" WCLC 2019; Abstract OA14.04.

CM-24 Phase 1/2 Study Design

  • · A Phase 1/2 open label multi center study of CM-24 in combination with nivolumab (Opdivo®) in selected cancer indications (Phase 1), NSCLC and Pancreatic cancer (Phase 2)
  • · Clinical collaboration with Bristol-Myers Squibb
  • · Measurement of CEACAM1 based bio-marker

Primary endpoints:

  • Phase 1: Evaluate the safety, PK and the MTD/RP2 dose
  • Phase 2: Evaluate preliminary efficacy in 2ൻ line NSCLC and Pancreatic cancer
  • · Exploring further studies in other tumor types as well as monotherapy

Advancing first-in-class oncology therapies

NT219 – Dual inhibitor of IRS 1/2 and STAT3

IRS1/2 and STAT3 Role in Cancer Drug Resistance

IRS1/2 and STAT3 are key signal transducers activated as a feedback response to anti-cancer drugs, leading to drug resistance

kitov

NT-219 MOA: Inhibition of Both STAT3 and IRS is Required to Overcome Resistance

NT219 Prevents Acquired Resistance to Erlotinib

NT219 Reverses Erlotinib-acquired Resistance

NT219 Delays Tumor Recurrence

Market Opportunity: Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Rationale for combining Cetuximab + NT-219

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

Targeting the unmet medical need

  • · 1L Standard of care is shifting from chemotherapy towards immuno-oncology + chemotherapy*
  • · Only < 20% of R/M SCCHN patients respond to anti-PD1s
  • . Number of new cases/year is expected to be 174,000 by 2024

KITOV

* 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 + cetuximab has the potential to become an attractive 2-3L therapy

NT-219 Phase 1/2 Study Design

Title: A phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT219, alone and in combination with Erbitux® (cetuximab) in adults with recurrent or metastatic solid turnors and Head and Neck cancer

  • Primary endpoint: Safety, pharmacokinetics and to determine the MTD
  • Secondary endpoint: Obtain preliminary efficacy data
Q2 >
Q4 > Q1:21 > Q2 > Q3 > Q4 > Q1:22 > Q2 > Q3 > Q4 > Q1:23 > Q2 > Q3 > Q4 > Q1:24 >
Q3 >
NT219 as a single agent in subjects with R/R solid tumors
Dose Escalation
NT219 q1w
18<n<30
Expansion
Topline
NT219 q1w @ RP2D
Results
n=11+18 (Simon 2 stage design)
NT219 + cetuximab in subjects with R/M Head and Neck cancer*
Dose Escalation
NT219 q1w + cetuximab q1w
Expansion
NT219 q1w + cetuximab q1w
Topline
9<n<18 n=11+18 (Simon 2 stage design) Results
Acres of Children American Arrants * Colorectal Adenocarcinoma pts will be recruited in the Dose Escalation phase
= Indication TBD (expansion not part of the study protocol)

Kitov Commercial Drug: 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: : http://coeptispharma.com/wp-content/uploads/2020/01/Consensi Pl.pdf

  • . Clinical data showed Consensi™ was more effective at lowering blood pressure than amlodipine alone
  • Clinical data also demonstrated beneficial renal function measures
  • · Formulated with 200 mg celecoxib and three different dosages (2.5, 5, 10 mg) of amlodipine
  • ·

*Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.).
Norvasc® is a registered trademark of Pfizer Inc.

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

Milestones

Consensi™
U.S. launch
NT-219
IND clearance
NT-219
Collaboration
agreement with
potential
strategic partner
NT-219
Initiation of
phase 1/2
clinical study
CM-24
IND
amendment
clearance
CM-24
Initiation of a phase
1/2 clinical study in
collaboration with
Bristol Myers-Squibb
Q2 Q3
Q4
Q2
2020
Q2
2020
Q2
2020
2020 2020 2020
KITOV 25

Attractive opportunity

kitov

A clinical-stage company advancing first-in-class oncology therapies

CM-24 - Inhibitor of CEACAM1 NT-219 – Dual inhibitor of IRS 1/2 and STAT3

  • Two clinical stage assets targeting significant unmet needs
  • Strong partners and collaborators
  • Commercial stage drug to provide additional cash flow
  • Institutional healthcare focused investors
  • " Cash resources:
    • √ \$28M-36M of revenues from Consensi™ expected in 2020-2022
    • ✔ \$19M cash as of January 2019 (pro forma**)
  • Current market cap. ~\$24M*

* As of April 30th , 2020 ** including net \$3.5M + \$5.8M raised in January 20, March 20 and April 20 financing transactions respectively

We are committed to providing cancer patients with R first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression

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

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

kitov

30

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% 17% 100% 69% 79% 17%
Pancreatic Cancer Control NT219 Gemzar Gemzar +NT219 Control NT219 Gemzar Gemzar
+NT219
Drug
Gemcitabine (Gemzar®)
100% 45% FOXM1
67%
100% 60% TGFbeta (EMT Driver)
101%
26%
Control NT219 Gemzar Gemzar +NT219 Control NT219 Gemzar Gemzar
+NT219

Selected Publications

kitov

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

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