Purple Biotech Ltd.

Regulatory Filings • Oct 19, 2019

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 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 – October 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.

October 18, 2019 By: /s/ Isaac Israel

Isaac Israel CEO and Director

Exhibit 99.1

Thank you Corporate Presentation October 2019

Forward-Looking Statements and Safe Harbor

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

Certain statements in this presentation are forwards within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities lavs. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "intend", "plan", "nay", "should", "might", "seek", "target", "will", "project", "forecast", "continue" or "ariations of these words or other comparable words or by the fact that these statements do not relates. You should not place undue reliance on these forvard-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expect to future events, and are subject to a number of assumptions, involve isks, 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 significant from any future results, performance or achievements expressed or implied by the forward-looking statenents. Inportant factors that could cause or contribute to such differences include, among others, relating to: the fact that drug development and commercialization involves a lengthy and expersion outcomes; our ability to succesfully acquire, develop or commercialize our pharmaceutical products; the expense, length, progress and results of any clificient funding to finance the clinical trials; the impact of any changes in regulation and legistion that could affect the pharmacedical in receiving the regulatory approvals necessary in order to commercialize our product; the difficulty of predicting actions of the U.S. Food and the applicable regulator of pharmacutical products; the regulator environment and changes in the heath policies and regires in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain with protective claims; the commencement of any patent interference or infringenent action, our ability to precover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; and other factors on Form 20-F for the year ended December 31, 2018 and in our other filings with the SEC, including our cautionary discussion of risk Factors" in our Registration Statements and Annual Reports. These are factors hat we believe could cause our actually from expected results. Other factors besides those we have listed could also adversely affect us. Any forwardlooking statement in this press release speaks only it is made. We disclaim any intention or obligation to publicy update or revise any forvard-looking statement, or other information contained herein when 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's website, http://www.set.gov.

Kitov Pharma

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

• · NASDAQ/TASE:KTOV
  • 33% of shares held by healthcare focused investors* including Orbimed Advisors, Pontifax
  • Market Cap: \$22M* (\$0.74/ADS)
  • 6-month average trading volume: 265K shares
• · \$8M Cash on hand (as of June 30, 2019)
  • Additional \$3.5M following CM-24 transaction closing by year end
  • \$7.5M minimum revenues from Consensi™ in next 3 years

From Development Through FDA Approval to Commercialization

As of October 15th, 2019, including CM-24 transaction and investment shares

Experienced Leadership

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

Bertrand Liang, MD, PhD, MBA, AMP Medical Director Oncology Formerly at Biogen Idec, Amgen, NCI

lsaac Israel Chief Executive Officer Formerly CEO of BeeContact Ltd. (TASE:BCNT),
NextGen Biomed (TASE: NXGN)

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)

Gil Ben-Menachem, Ph.D., MBA Vice President, Business Development
Formerly at Teva, Dexcel, NIH

From Development to Commercialization

Program	Indication	Preclinical Phase 1		Phase 2	Phase 3	Partners	Value Drivers
CM-24	Non-Small Cell Lung Cancer combination with nivolumab)					Bristol-Myers Squibb	Study initiation H2:20 Phase 1 data H1:21
NT-219	Head and Neck Cancer (combination with cetuximab)						Study initiation Q1:20 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 on May 31, 2018			U.S .: Coeptis Pharmaceuticals China: CSBio S. Korea: Kuhnil Pharmaceutical	U.S. Launch: Q1:20

Targeting indications with substantial unmet need

kitov

Advancing first-in-class Oncology Therapies

CM-24 – Inhibitor of CEACAM1

CM-24 Immune checkpoint inhibitor

Targets a Novel Immune Checkpoint

• · First-in-class mAb blocking CEACAM1
• Conceptually analogous to anti-PD(L)1

Demonstrated Efficacy in Preclinical Models

• · Enhances anti-tumor immune activity through multiple pathways
• · Demonstrated sunergy with anti- PD(L)1

Well Tolerated in a Clinical Trial

• . Studied as a monotherapy in a phase 1
• · Doses up to 10 mg/kg

Phase 1/2 Trial to start in 2020

• In combination with nivolumab (Opdivo®) in NSCLC
• · Starting at dose of 8mg/kg

CEACAM1 Plays a pivotal role in the immune system

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

"Gray-Owen and Blumberg, CEACAM1: contact-dependent control of immunity, Nature Review Immunology , 2006, DOI: https://doi.org/10.1038/m/1864

CEACAM1 and TIM-3

By blocking CEACAM-1 heterodimerization with TIM-3, immune exhaustion of T-cells is

abrogated, allowing cooperative tumor inhibition

• · TIM-3 is co-expressed and forms a heterodimer with CEACAM1
• · The presence of CEACAM1 endows TIM-3 with inhibitory function
• · CEACAM1-deficient T cells are hyper-inflammatory with reduced cell surface expression of TIM-3
• · Anti-CEACAM-1 combined with anti-TIM3 showed significant prevention of tumor growth in aggressive tumor model (CT26 mouse CRC)

MENU > nature Letter | Published: 26 October 2014 CEACAM1 regulates TIM-3-mediated tolerance and exhaustion Yu-Hwa Huang, Chen Zhu, Yasuyuki Kondo, Ana C. Anderson, Amit Gandhi, Andrew Russell, Stephanie K. Dougan, Britt-Sabina Petersen, Espen Melum, Thomas Pertel, Kiera L. Clayton, Monika Raab, Qiang Chen, Nicole Beauchemin, Paul J. Yazaki, Michal Pyzik, Mario A. Ostrowski, Jonathan N. Glickman, Christopher E. Rudd, Hidde L. Ploegh, Andre Franke, Gregory A. Petsko, Vijay K. Kuchroo & Richard S. Blumberg 12

Nature \$17, 386-390 (15 January 2015) | Download Citation ±

CEACAM-1 + TIM3 combination introduces an innovative approach to TIM-3 regulation

ng et al, CEACAM1 regulates TIM-3-medioted tolerance and exhaustion; Nature, 2015 DOI: https://doi.org/10.1038/noture13848

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

Markel et al, J Immunol 2002, 2006; Immunology, 2008; Cancer Immunol Immunother 2010; Ortenberg et al, Mol Cancer Ther 2012

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

100

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

Merck Concluded that Saturation Likely Requires > 10mg/kg

Merck models simulated to characterize TMDD saturation

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

· Keytruda®'s administration regimen is Q3W

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

The simulation suggests CM-24 administered Q2W (similar to BMS' Opdivo®) is expected to saturate the target with dosing at 20 mg/kg

kitov

Market opportunity: Non-Small Cell Lung Cancer

Rationale for combining Opdivo® + CM-24

• · Preclinical data supports significant synergistic benefit
• · 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 second 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%**

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

* Economopolou P. Mountzios G. The energing treatment lan-small cell lung concer. Ann Transl Med. 2018/6/138. doi:10.2007/01/2017.11.07 ** * Gettinger S, et all "Fre-year outcomized, phose III trials CheckMate 017/057: Nivolumab vs docetoxel in previously treated NSCC" WCC 2019, Abstract OA14.04.

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

CM-24 Accelerated Biomarker-driven Clinical Development

1. In a clinical 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

1. 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

NT-219 Drug Resistance Prevention

Unique MoA

Inhibits two key resistance signaling proteins: IRS1/2 and STAT3

Efficacious in Multiple PDX Models

Prevents, delay and reverses resistance to anti-cancer drugs in Head and Neck, Colon, Lung, and Pancreatic cancers models

Enhances Every Treatment Regimen

• In combination with immuno-oncology, targeted and chemo therapies

Phase 1/2 to Start in Q1:2020

• First-in-human clinical trial in SCC of the Head and Neck cancer in combination with cetuximab (Erbitux®)

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

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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
• · 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 Clinical Development Plan

1. A Phase 1/2 open label multi center study of NT-219 in combination with cetuximab in patients with recurrent or metastatic SCCHN

2. 1. Dose escalation
3. 1. Expansion cohort
4. · Primary endpoint: Evaluate the safety, pharmacokinetics and to determine the MTD
5. · Secondary endpoint: Obtain preliminary efficacy data

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

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: 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

Milestones

CM-74 Transaction closing	NT-219 Collaboration agreement with potential strategic partner	Consensi™ complete manufacturing and prepare for U.S. launch	NT-219 IND clarance	NT-219 Initiation of phase 1/2 clinical study	Consensi™	CM-24 IND U.S. launch amendment clearance	CM-24 Initiation of a phase 1/2 clinical study in collaboration with Bristol Myers-Squibb
Q4	Q4	Q4				HI	H2
2019	2019	2019	Q1 2020	Q1 2020	Q1 2020	2020	2020

Attractive opportunity

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

As of October 15th, 2019, including CM-24 transaction and investment shares

• ✔ Two clinical stage assets targeting significant unmet needs
• V Strong partners and collaborators
• ✔ Commercial stage drug to provide additional cash flow
• ✔ Institutional healthcare focused investors
• √ Cash resources:
  • ✔ \$8M cash as of June 19
  • ✔ Additional \$3.5M upon CM-24 closing
  • ✔ \$7.5M minimum revenues from Consensi™ in next 3 years
• / Current market cap. \$22M*

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

Contact us: Email: IR@kitovpharma.com 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

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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 Pancreatic Cancer	100%	44% Control NT219 Gemzar	63%	1796 Gemzar +NT219	100% Control	69%	79% NT219 Gemzar Gemzar	17% +NT219
	100%		FOXM1		100%		TGFbeta (EMT Driver) 101%
Drug Gemcitabine (Gemzar®)		45%	67%	Control NT219 Gemzar Gemzar	Control	60%	NT219 Gemzar	26% Gemzar
KITOV				+NT219				+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

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