Purple Biotech Ltd.

Regulatory Filings • Nov 12, 2020

Submission Data File

General Information
Form Type*	6-K
Contact Name	Edgar Agents
Contact Phone	732-780-5036
Filer File Number
Filer CIK*	0001614744
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SROS*	NASD
Period*	11-12-2020
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File Count*	41
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Document Type 1*	6-K
Document Description 1	Report of Foreign Private Issuer
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Document Description 2	Kitov Pharma Company Presentation November 2020
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ea129752-6k_kitovpharma.htm Form Type: 6-K Page 1

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 November 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): ☐

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Edgar Agents LLC	KITOV PHARMA LTD.	11/12/2020 08:14 AM

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.

Exhibits

99.1 Kitov Pharma Company Presentation November 2020

Incorporation by Reference

This Form 6-K, including all exhibits attached hereto, is hereby 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 and 333-211477), 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), 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), the Registrant's Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission on July 16, 2018 (Registration file number 333-226195), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on March 28, 2019 (Registration file number 333-230584), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 16, 2019 (Registration file number 333-233795), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on December 2, 2019 (Registration file number 333-235327), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on May 13, 2020 (Registration file number 333- 238229), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 18, 2020 (Registration file number 333-238481) and each of the Registrant's Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 10, 2020 (Registration file numbers 333-239807 and 333-233793), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

1

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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.

November 12, 2020 KITOV PHARMA LTD.

By: /s/ Isaac Israel

Isaac Israel Chief Executive Officer

ea129752ex99-1_kitovpharma.htm	Form Type: EX-99.1	Page 1
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Exhibit 99.1

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Edgar Agents LLC	KITOV PHARMA LTD.	1/12/2020 08:14 AM

FORWARD-LOOKING STATEMENTS AND SAFE HARBOR

Certain statements in this presentation that are forward-boking and are forward-boking statements within the meaning of the safe harbor provisions of the Priste Securities Liigation Reform Act of 1995. Such forward-look, but are not initied to, statements of historical fact, and may be identified by words such as f'elieve", "intend", "pan", "may", "should", "might", "seek", "wil", "project", "foreast", "continue" or ther negatives or ther negatives or ther negatives or ther negor other comparable words. You should not place on these forwards which are not guarantees of foure performance. Forward-looking statements relect our current views, expectations, beliefs or intentions with respect of are subject to a number of ssumptions, involve known and unition are beyond our ontrol, as well as uncertaintes and other factor that may actual results, performants to be signitiantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important to such differences incide, anone others, inist relating to the plans, stretees and dejectives of managener. for future operations production in the process by which early stage therapeuts candidates such as NT219 and CM24 could potentially eat o an approved drup groduct is long and subject to high with respect to a joint development collaboration; the fact that drug development and commercialization inolves a length and experisive process with uncessfuly develop and commercialize our phamasential products the experse, length of any clinical trials; the latt of sufficient formation in enemation regulation and legistion that could affect the pharmaceutical industry; the difficulty in receiving the difficulty in r regulatory approals neessary in order to commerciality of predicing actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmacutical products; the regulatory enviroment and cames in the countries in which we operate; the uncertain's surrunding the actual market reeption to our pharmaceutical products once deared for market, the introduction of competing products, patents attained by ompetitors, dependence on the effectivenes of our patents and dther protections for innovative products; our ability to defend issued patents; the commencement of any patent interference or infringenent action againts, and our ability to preval), obtain a favorable demages in any such action, and the exposure to litgetion, and/or regulatory and or regulatory and other factors hat are discussed in our Annual Report on For the year ended December 31, 2019 and in our other filings with the "SE", including our cautionary discussion of risks and uncer "Risk Factor" in our Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors bested could also adversely affect us. Any forward-looking statemer' in this presentation speaks only as of the date wich it made. We discian any intention or oblight on public or revise any fonward-looking statement, or other information, whether s a result of new infornation, future events or other wise, as required o y applicable aw. You additional disclosures we make in our reports to the SEC, wich are aralable on the SEC's website, http://www.sec.gov

ea129752ex99-1 kitovpharma.htm	Form Type: EX-99.1	Page 3
Edgar Agents LLC	KITOV PHARMA I TD	11/12/2020 08:14 AM

OUR TRANSFORMATION INTO ONCOLOGY

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Edgar Agents LLC	KITOV PHARMA LTD.	11/12/2020 08:14 AM

KITOV PHARMA (NASDAQ/TASE: KTOV)

• ✓ CM24 First-in-class α-CEACAM1 mAb, clinical collaboration with ("Bristol Myers Squib"
• √ NT219 First-in-class, small molecule, dual inhibitor of IRS 1/2 and STAT3
• √ H2:21 Two phase 1 study readouts
• Strong balance sheet and cash position
  • · Market cap. ~\$75*
  • · \$63M cash as of June 30th, 2020
  • · CONSENSI® commercial royalties supports pipeline development
  • · ~600K ADSs 3-month avg. trading volume*
  • · Current clinical programs fully funded

Advancing clinical-stage novel oncology therapies

* As November 11th , 2020

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EXPANDING PIPELINE

6 Eric K. Rowinsky, MD Chairman of the Board Former CMO at ImClone, Stemline, Board member at Biogen Inc. Isaac Israel Chief Executive Officer Former CEO of BeeContact Ltd. (TASE:BCNT), NextGen Biomed (TASE: NXGN) Bertrand Liang, MD, PhD, MBA, AMP Chief Medical Officer Formerly at Biogen Idec, Amgen, NCI Gil Efron Deputy CEO and Chief Financial Officer Former Deputy CEO & CFO at Kamada (NASDAQ:KMDA) Hadas Reuveni, Ph.D. Vice President, Research and Development Formerly at Keryx (NASDAQ:KERX) Michael Schickler, Ph.D Head of Clinical & Regulatory Formerly at Hoffmann - La Roche, CEO at CureTech EXPERIENCED LEADERSHIP

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CEACAM1 (Carcinoembryonic Antigen Cell Adhesion Molecule 1): PLAYS A KEY ROLE IN CANCER BIOLOGY

ADHESION: Oncogene	"CEACAM1 creates a pro-angiogenic tumor microenvironment that supports tumor vessel	4 Immunology	"Neutrophil extracellular trap-associated CEACAM1 as a putative therapeutic target to prevent
Horst, 2011	maturation"	Ferri, 2020	metastatic progression of colon carcinoma"
	IMMUNE CELLS/IMMUNE EXCLUSION:
Journal of Cancer Science and Research Tsuzuki, 2020	"Immune-checkpoint molecules on regulatory T-cells as a potential therapeutic target in head and neck squamous cell cancers"	Tsang, 2020	"[Blockade] enhances natural killer cell cytotoxicity against tumor cells through blockade of the inhibitory CEACAM1 / CEACAM5 immune checkpoint pathway"
IMMUNO-ONCOLOGY: mature	"CEACAM1 regulates TIM-3-mediated tolerance and exhaustion"		"CEACAM1 regulates Fas-mediated apoptosis in Jurkat T-cells via its interaction with B-catenin"
Bloomberg, 2015		Shively, 2013

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CM24: SELECTIVE BLOCKING OF CEACAM1

• IgG4 humanized monoclonal antibody, similar to anti-PD-1 IO agents (no elicitation of ADCC or CDC)
• Nanomolar efficiency of binding to extracellular domain of CEACAM1
• · Anticipated to impact triple mechanisms of action of CEACAM1 in the neoplastic phenotype

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Edgar Agents LLC	KITOV PHARMA LTD.	11/12/2020 08:14 AM

ANTI-CANCER EFFECT FOLLOWING TREATMENT PRECLINICAL DATA WITH CM24 + TIL AND CM24 + α-PD1

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

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CM24 PHASE 1 MONOTHERAPY TRIAL

$$
\mathsf{UCLA} \quad \mathsf{V} \mathsf{V}^{\mathsf{Aux} \cdot \mathsf{N} \mathsf{w} \mathsf{H} \mathsf{w} \mathsf{w}}
$$

$\bullet \text{ Open-label}$ $\text{multi-dose}$ $\text{escalation}$ $\text{monto}$ $\text{therray}$ $\text{stutdy}$ $\text{to asssess safety}$ $\text{and}$ $\text{tolerability}$

• Heavily pre-treated patients with a median of 3 prior regimens (range 2-8) and a median of 4 prior regimens at the 3mg/kg & 10mg/kg
• Overall, treatment was well tolerated
• ° Most of the responding patients were treated with the highest dose levels of 3mg/kg & 10mg/kg
• PK analysis revealed non-linearity, modeling recommended to continue administration of higher doses to reach saturation

	No DLTs up to 10 mg/kg

No discontinuation of study drug due to an AE

33.3% SD (RECIST)

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PK/PD MODELING PROVIDES DOSAGE & SCHEDULE GUIDANCE

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

1 3

Dose (mg/kg)

10 20

0.1 0.3

• 10 mg/kg has a broad range of saturation, and >10 mg/kg dose is needed for saturation across population

Predictions with Q3W regimen

• Modeling with increased interval between doses demonstrates lower TMDD at 10mg/kg dose
• With Q3W, 20mg/kg dosing is not sufficient for saturation across population

Nivolumab (OPDIVO®2) administered Q2W or Q4W, representing good clinical and commercial fit for CM24

1 Target-mediated drug disposition 2 OPDIVO® is a registered trademark of Bristol-Myers Squibb.

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LARGE MARKET OPPORTUNITY | NSCLC & PANCREATIC CANCER

Combining nivolumab with CM24 in a clinical collaboration with ‫(1866) byers Squib"

• · CEACAM1 expression correlates with poor prognosis in NSCLC and Pancreatic cancer2
• · Preclinical data supports significant synergy
• · Receptor saturation with CM24 is better achieved with a Q2W regimen, aligning with the nivolumab schedule

Targeting unmet medical needs

• · NSCLC accounts for ~200K new cases/year in the US; with a 5-year relative survival rate of 23%2
• Immunotherapy is now recommended as first line therapy in all patients with NSCLC and no driver mutations3
• 5-year overall survival rates with chemotherapy in 2L is 2.6% and with I/O Opdivo® is 13.4%4
• · Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 10%2
• · I/O approaches has been limited to patients with high microsatellite instability (MSI-H) or high tumor mutational burden (TMB-H)
• · 5-year overall survival rates with chemotherapy in 2L is 3%2

1 Dango et al, Lung Cancer 2008; 60:426 & Calinescu et al, Journal of Immunology Research 2018: 7169081.

2 American Cancer Society, Cancer Facts & Figures 2019, and the ACS website, https://seer.cancer.gov/statfacts/html/pancreas.html

ैं Economopoulou P, Mountzios G. The emerging treatment lon-snall cell lung cancer. Ann Transl Med. 2013/6/8/:138. doi:10.2007.11.07 4 Gettinger S, et al "Five-year outcomed, phase III trids CheckMate 0.7/057: Nivolumabys docetaxel in previously treated NSCC" WCLC 2019; Abstract OA1.4.4.

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CM24 PHASE 1/2 COMBINATION STUDY DESIGN

• A Phase 1/2 open label multi center study of CM24 in combination with:
  • · Nivolumab in selected cancer indications (Phase 1) and NSCLC (Phase 2)
  • · Nivolumab and nab-paclitaxel in Pancreatic cancer (Phase 2)
• · 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 2nd line NSCLC and pancreatic cancer
• · Exploring further studies in other tumor types as well as monotherapy

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NT219 - DUAL INHIBITOR OF IRS1/2 & STAT3

IRS1/2

• · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti-apoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumor types2
• Regulates major survival pathways such as the PI3K/AKT, MEK/ERK and Wnt/β-catenin²
• · Activated as a feedback response to anti-cancer therapies3

STAT3

• Well-established transcription factor associated with the tumorigenic phenotype4
• · Provides a crucial axis to support cell proliferation and survival5
• Active in tumor JAK/STAT3 and TGF beta resistance mechanisms6

1Hadas Reuveni et al.; Cancer Res 2013;73:4383-4394. 2013; Machado-Neto, et al. Oct. 2018, doi:10.6061/clinics/2018/e566s 3 Naokazu Ibuki1,2, Mazyar Ghaffari1,3, Hadas Reuveni4 et al. DOI: 10.1158/1535-7163.MCT-13-0842 Published December 2014; 4Rampias T, Favicchio R, Stebbing J, Giamas G. 2016 May 19;35(20):2562-4. doi: 10.1038/onc.2015.392. Epub 2015 Oct 19. PMD: 26477311 5.6Flashner-Abramsonet al.. Oncogene. 2016 May 19:35(20):2675-80. doi: 10.1038/onc.2015.229. Epub 2015 Jun 29. PMID: 26119932, Sanchez-Lopez E, Oncogene. 2016 May 19:35(20):2634-44. doi: 10.1038/onc.2015.326. Epub 2015 Sep 14. PMID: PMC4791217.; ohnson, Donie E et al. "Targeting the IL-6/JAK/STAT3 signding axis in careevs. Clinical oncology vol. 15,4 (2018): 234-248. doi:10.1038/nrclinon:.2018 8; Zhao C, et al. Trends Pharmacol Sci. 2016 Jan;37(1):47-61. doi: 10.1016/j.tips.2015.10.001. Epub 2015 Nov 12

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NOVEL MOA: IRS DEGRADATION BY NT219 BLOCKING IGF1R-AKT PATHWAY1

KITCON Reuveni et al. Cancer Res 2013

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NT219 | EFFICACY AS MONOTHERAPY

1 NSG mice were injected SC with SCC-9 cells. PBMCs (18*106 cells per mouse) administered 4 weeks prior to first treatment. NT219, c-PD1, and cetuximab were administered IV (NT219) and IP (α-PD1 and cetuximab) twice a week for 4 weeks. Graph reflects relevant data adapted from 2020 Multidisciplinary Head and Neck Cancers Symposium Poster presentation

18

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STAT3 AND IRS ARE ESSENTIAL IN THERAPEUTIC RESISTANCE

By blocking both STAT3 and IRS pathways, NT219 prevents tumor resistance and re-sensitizes tumors to anti-cancer therapies

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NT219 + TARGETED THERAPIES ESTABLISHED EFFICACY IN PDX MODELS

Treatments on days 0, 3 and 10, cetuximab - 1mg/mouse, 3 mice/group; PBMCs (1.4M cells/mouse) were injected on day 6

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NT219 + α-PD1 RE-SENSITIZES TO REFRACTORY α-PD1 TUMORS

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FIRST MARKET OPPORTUNITY | RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF HEAD AND NECK (SCCHN)

Rationale for combining Cetuximab + NT219

• 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 has shifted from chemotherapy towards immuno-oncology + chemotherapy
• Only < 20% of R/M SCCHN patients respond to α-PD1s
• · 175k new cases/year are expected by 20241

NT219 + cetuximab has the potential to become an attractive 2-3L therapy

K 11 (UV ) 2 Internal best current estimates of patient numbers based on external research, 5 major global territories

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NT219 MONOTHERAPY AND COMBINATION PHASE 1/2 STUDY DESIGN

Title: A phase 1/2 study with open-label, dose followed by single-arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT219, alone in adults with recurrent or metastatic sold tumors and in combination with Erbitux® (in head and neck cancer

• · Primary endpoints: Safety, pharmacokinetics and to determine the MTD
• · Secondary endpoints: Obtain preliminary efficacy data

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Edgar Agents LLC	KITOV PHARMA LTD.	11/12/2020 08:14 AM

KITOV PHARMA (NASDAQ/TASE: KTOV)

• ✓ CM24 First-in-class α-CEACAM1 mAb, clinical collaboration with ("Bristol Myers Squib"
• √ NT219 First-in-class, small molecule, dual inhibitor of IRS 1/2 and STAT3
• √ H2:21 Two phase 1 study readouts
• Strong balance sheet and cash position
  • · Market cap. ~\$75*
  • · \$63M cash as of June 30th, 2020
  • · CONSENSI® commercial royalties supports pipeline development
  • · ~600K ADSs 3-month avg. trading volume*
  • · Current clinical programs fully funded

Advancing clinical-stage novel oncology therapies

* As November 11th , 2020

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kıtov

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INHIBITION OF MELANOMA GROWTH FOLLOWING CM24 AND CM24 + TIL TREATMENT

CM24 ACTIVITY IS DEMONSTRATED AS SINGLE AGENT AND IN COMBINATION WITH TILS

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PHASE 1 PK DATA SATURATION WAS NOT REACHED WITH DOSES UP TO 10MG/KG

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SELECTED PUBLICATIONS

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NT219 | SUPPRESSES β-CATENIN ACTIVITY IN CRC CELLS

AACR Virtual Special Conference on Epigenetics and Metabolism, Oct 2020 Prof. Ido Wolf, Head of Oncology Division, Tel Aviv Sourasky Medical Center

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NT219 | PANCREATIC CANCER IN COMBINATION WITH GEMCITABINE

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RNA SEQUENCING | ANALYSIS OF TUMORS FOLLOWING TREATMENT

PDX model Pancreatic Cancer

Drug Gemcitabine (Gemzar®)

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CONSENSI® | FROM IND TO THE U.S. MARKET

successful Phase III clinical trials, to FDA approval

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CONSENSI® PHASE III TRIAL RESULTS

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

• 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

* Error bars – standard error of mean

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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://www.consensi.com

• · Clinical data showed Consensi™ was more effective at lowering blood pressure than amlodipine alone
• ° Clinical data also demonstrated beneficial renal function measures
• •
• °

kıtov

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

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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

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