Purple Biotech Ltd.

Regulatory Filings • Feb 12, 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 February 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 – February 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.

February 11, 2019 By: /s/ Isaac Israel

Isaac Israel CEO and Director

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 are forward-looking the sale harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements on forward-looking words such as "believe", "expect", "intend", "could", "could", "might", "seek", "target", "will", "project", "continue" or their negatives or their negatives or other comparable words or by the fact that these statements do not relate strictly to historial not place under reliance on these forward-oding statements, which are not guarantes of tuture performance. Forward-looking statenents reflect our current vith respect of then intentions with respect to turner of assumptions, incolve anown and unknown risks, many of which are beyond our control, and other factors that may cause our actual results, performance or achievements to be significanty different from any future results, performance or accessed or inplied by the forward-looking statements. Innortant factors that could cause or contribute to such differences include, annon other that that drup development and commercialization involves a engthy and expensive process with uncertain out only to successfully acouire. develop or connectical products; the experse, length, progress and results of any clinical trails; the lock of sufficient funding of france the clinical trials; the impet of any charges in regulation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessor in order commercialize our products the difficulty of the U.S. Food and Drug. Administration or any other opplicable regulator of pharmaceuted products; he regulator environment and changes in the heath policies in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmazeuicial products once cleared for market ; in a particular maket; the intrade spatents attained by competitors; dependence on the effectivenes of our patents and other protections for inravative products, our ability to obtants with protective claims; the commencenent of any patent interference or infringence or infringence or infringence action; our ability to preval, obtain a favorable in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; he uncertainty surrunding an investigation by the Israel public disclosures and the potential impact of such investigation on the trading of our securities or our clinical, commercial and other he regulatory approvals necessary in order to commercialize our products, and other factors that are discussed in our Annual Report on Form 20-F for the filings with the SC, including our cautonary discussion of risks and uncertaintes under "flsk Factors" in our Registration Statements. These are factors that we believe could couse our actual results to differ materially from expected results. Other factors besides those we have lised us any forward-looking statement in this press release speaks only as of the date which it is nade. We disclaim any intention or obligation to publicy update or revise and of other information contained herein, whether as a result of new information, foure events on otherwise, except as required by applicable law. You are additional discloures we make in our reports on the SEC, which are wailsble on the SECs website, http://www.sec.gov.

Company Profile

Innovative Pharmaceutical Company Leveraging Deep Regulatory and Drug Development Expertise

DIVERSE PIPELINE ADDRESSING LARGE MARKETS

• · NT-219 small molecule designed to overcome cancer drug resistance
• · Consensi™ approved by FDA to treat osteoarthritic pain and hypertension
• · Consensi™ is 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 activity partnered with Dexcel Pharma, Israel's largest private pharmaceutical company

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
• · Market Cap: \$24M*
• Issued & outstanding capital equivalent to 19.5 million ADSs

Experienced Management

Paul Waymack, M.D., Sc.D.
Chairman of the Board & Chief Medical Officer Former FDA medical officer

Isaac Israel Chief Executive Officer Former CEO of BeeContact (TASE: BCNT),
NextGen Biomed (TASE: NXGN)

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

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Hadas Reuveni, Ph.D. Founder & Chief Technology Officer - TyrNovo
Formerly at Keryx (NASDAQ: KERX)

Deputy CEO and Chief Financial Officer

Formerly at Kamada (NASDAQ: KMDA)

Gil Efron

Dexcel

Milestone Schedule

Expected Date
H1/2019
H2/2019
H2/2019
H2/2019
H2/2019
2019

About Consensi™

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

• · Approved for marketing by U.S. FDA on May 31, 2018
• · 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
• · Manufactured by Dexcel Pharma Israel's largest private pharmaceutical company

*Celebrex® is a registered trademark of G.D. Seatle LLC (o subsidiory of Pfeer Inc.).
Norvasc® is a registered trademark of Pficer inc.

Consensi™ U.S. Target Markets

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

Consensi™ Benefits All Stakeholders

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

Consensi™ Commercialization

NT-219: Overcoming Cancer Drug Resistance

• · A novel small molecule that prevents, reverses, and delays resistance to anti-cancer drugs
• · Demonstrated outstanding efficacy in patient-derived xenograft (PDX) models
• · Favorable response received from FDA in pre-IND meeting
• · Ongoing preclinical work; IND expected in 2019
• · Initial dose escalation clinical study in combination with approved oncology drugs expected H2/2019
• · Long-term strategy to develop NT-219, in combination with other oncology drugs for additional indications, either alone or in collaboration with strategic partners

NT-219: Mechanism of Action

• Anti-cancer drugs induce activation of two feedback pathways, STAT3 and IRS, both known modulators of tumor survival, metastasis and drug resistance
• · NT-219 binds directly to STAT3 and IRS1/2, and enhances the tumors' response to the approved drugs
• · STAT3 is known to be active in the immune evasion mechanism of the tumor
• · Short exposure of cancerous cells to NT-219 was sufficient to trigger irreversible shutdown of these pathways, resulting in a long-term anti-cancer effect

Results in PDX Models

Results in Immuno-Oncology PDX Model in Combination with Keytruda®

NT-219 Converts Non-Responding Tumors to Keytruda® to Responders in Humanized PDX of Esophagus Cancer

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Efficacy in Pancreatic Cancer Models

NT-219 Converts Non-Responding Tumors to Responders to Gemcitabine in 4/4 PDX Models of Pancreatic Cancer

Summary of Demonstrated Efficacy

NT-219 will be developed in combination with approved oncology drugs to increase efficacy, expand target population, and extend treatment duration

	TYPE	DRUG (TRADE NAME)	CANCER TYPE	OWNED BY
		Cetuximab (Erbitux®)	Head and Neck	Lilly
	Antibody	Cetuximab (Erbitux®) + FOLFOX/FOLFIRI	Colon (wt KRAS)
		Erlotinib (Tarceva®)	Head and Neck	Roche > Trastellas
		Afatinib (Glotrif®)	Head and Neck	Boehringer Ingelheim
Targeted Drugs	Kinase	Osimertinib (Tagrisso®)	Lung	AstraZenoca De
	Inhibitors	Vemurafenib (Zelboraf®)	Melanoma	(Roche)
		Trametinib (Mekinist®)	Thyroid
		Everolimus (Afinitor®)	Uterine Adenosarcoma	& NOVARTIS
		Gemcitabine (Gemzar®)	Pancreatic	Sille
Chemotherapy		5FU, Oxaliplatin (FOLFOX)	Colon
		Docetaxel (Taxotere® )	Prostate	SANOFIL
Immunotherapy	Antibody	Pembrolizumab (Keytruda®)	Melanoma, NSCLC, Head and Neck	MERCK

NT-219 Development Plan

Proven management team	· Management team with track record in drug development and regulatory expertise
Balanced and diverse pipeline	Consensi™ approved for marketing in the U.S. by FDA, licensed in the U.S., China and S. Korea · NT-219 IND expected in 2019
Large market potential	· Consensi™ addresses large target population · NT-219 has blockbuster potential in multiple malignancies
Strong IP portfolio	· Consensi™ is U.S. patent protected through 2030 · NT-219 composition patent was granted, combination patents are pending

Medical Rationale

22

Celecoxib (the active ingredient in Pfizer's Celebrex®)
· The only widely prescribed selective COX-2 NSAID approved in the U.S. (unlike non-selective NSAIDs, celecoxib carries limited gastrointestinal risks}
· Since 2005, has an FDA-mandated "black box" label warning of increased cardiovascular risks
· According to FDA, cardiovascular risks can occur as early as the first few weeks of using an NSAID, and may increase with longer use
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning Cardiovascular Risk · CELEBREX, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with cardlovascular disease or risk factors for cardiovascular disoase may bo at greater risk. (5.1,14.7)
Amlodipine (the active ingredient in Pfizer's Norvasc®)
· Calcium channel blocker; anti-hypertensive
· Unlike other blood pressure-lowering drug groups - such as diuretics, ACE inhibitors, and angiotensin II receptor antagonists - calcium channel blockers do not cause deterioration of renal function, including possible acute renal failure®
* The FDA Safety hformation and Adverse Ever Reporting Program; Introy/www.foll.gov/5dfetylifornation/scripTop/script/script/script/script/scriptions/scripTop/scripTop/scripT

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 - stondard 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

Demonstrate that the reduction in blood pressure in the Consensi™ arm is at least 50% of the reduction in the amlodipine arm Improvements of renal function measurements

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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

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