Purple Biotech Ltd.

Regulatory Filings • Apr 15, 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 April 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 in connection with a previously announced conference call to be held on Monday, April 15, 2019, at 8:30 a.m. EDT to discuss the FameWave acquisition deal and new asset CM-24, the conference call presentation is attached hereto as Exhibit 99.1

Exhibit 99.1 Kitov Pharma Investors Call Presentation – April 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.

April 15, 2019 By: /s/ Isaac Israel

Isaac Israel CEO and Director

Forward-Looking Statements and Kitov's Safe Harbor Statement

Certain statements in this presentation the nearing of the safe harder provisions of the Printer Securities Litggiton Reform and 1995 and other applicables seur the slaws Forward-holding satements an be dentified by the use of believe", "enect", "intend", "par", "nay", "hould", "nold", "nould", "noted", "tope", "tope", "tope", "tope", "foreet" "continue" or "anticipat" or their negative or ther comparable words or your be fact that these statements do not relate stricty to historical natures. Samples of forward-loo statements include, and enake regarding. (i) the therapeut and commercial potential of CM-24 (ii) research and development plans reated to the CM-24 the poential of CM-24 for the treatment of againe unor cellines; (i) the potential for the collaboration between Ktor (FameWave) and fistol Myers Squibb; and (i the closing of the closing of th the shareholders of Famellare and Kitco, which in and one approval of the transations by Klov-shareholders. You should not planed-oplines on these forward-boking statements, witch are not gurantees of truce performance reflect our current views, expectations, beliefs or interitions with respect of future event, and are subject on anumber of assum invelye known and untrown isk, many of which are beyond our control, as vell as uncertaintes and other for actual results, performance or achievements to be significantly dif any future results, performance or achever a presed or included and the market on tould cause or contribute to such offerences include, anong other, riske elating co. the manner in which he so the tansaction of famelyae by Klov plan to effect the transaction, the expected benefits, synergles and osts of the transction; managener plaast ela the transaction; he expected the cansaction; the partes' ability to conplet the rariseting the various conditions, including corditions, including corditions nelated of Kity approvals, the plans, strategies of nanagement for CM-24; the potential for CM-24; the potential forum in intering and any assumption undering any of the foreging, the process by which early stage of an approved product is long and subject to highty significant risk, particularly with espect to a joint development. colluboration, the fact the drimersalization involves a lengty and expensive process with uncetian outcomes; our ability to successfuly develop and commercialize our pharmace products the expense, length, of any clinicals; the last of sufficient unding to finance the clinical trials; the impect of any changes in regulation and egistion and eqisati pharmacedtal habstry the difficulty in receintry and recessary in order to commercialize our products, the U.S. Food and Intel S. Food and Internation of the U.S. Food and In applicable regulator of pharmaced and changes in the heath polices and regimes in the countries in which we operate; the uncertainty surrounding the actual narket reeption to our pharmacedial products one clear market the introduction of conneting roducts patents attained by competitions degendere on the effectives of or atens and other protections for inneative productions and defend issued patents with protective clains; the commencement of any patent interence or infringenent action, our ablily previl, obtain a favorable decision or recover damation, including netert literion, neluding actions; be uncertainty surrounding an investigation or investigation or the soel Securities Authority into our historial impact of such investigation on the trading of our securities on our drincel, commercial and other business relationships, or or recei the regilatory approvals neessary in order to comments and other factors that are discussed in our in our in variant of for the year ended December 3, 2008 and in our other f with the SC, including our cautionary discussion of risk. Factors' in our Registration Statements and Annual Reports. There are actual results to differ naterially from expected results. Other factors be have listed could also abersely affect us. Ay forward-boking statement in this press elease only as of the date. We discialm any intention or obligation or public or reise and or other information contained herein, whether as a esult of new information, future events or otherwise, eccept a required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SCC's website, http://www.se.gov

CM-24 Opportunity

• · Monoclonal Ab targeting CEACAM1, a novel immune checkpoint with high potential to treat multiple oncology indications
• · CM-24 was well tolerated in a Phase 1 study in doses up to 10mg/kg
• · Only clinical stage therapeutic candidate currently targeting CEACAM1
• · Plan to develop in a clinical collaboration with Bristol Myers-Squibb for Phase 1/2 trial in combination with nivolumab (Opdivo®) in non-small cell lung cancer (NSCLC)
• · Kitov to acquire all rights to CM-24
• · Program is supported by new investment from blue-chip investors Orbimed, Pontifax and Arkin Holdings

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

• Known to interact with both CEACAM1 and CEACAM5
• Also known to interact with TIM3
• Only member expressed on lymphocytes
• · Modulator of T-cell function and activity at the tumor site
• · Conceptually, analogous to PD-1/PDL-1

CEACAM1 is Expressed in Both Tumor and Tumorinfiltrating 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

Conceptually, analogous to PD-1/PDL-1

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

CM-24 - Mechanism of Action (cont.)

By blocking CEACAM-1 heterodimerization with TIM-3, immune exhaustion of T-cells is abrogated, allowing cooperative tumor inhibition

Huang et al, CEACAM1 regulates TIM-3-mediated toleronce and exhaustion; Nature, 2015 DOI: https://dol.org/10.1038/noture13848

GSK (Tesaro) and Novartis have initiated clinical studies targeting TIM3, noting the relevance of this target in the tumorigenic phenotype, with high potential CEACAM-1 + TIM3 combination therapies

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

• · Xenograft, lung lesion melanoma model
• · Tumor burden was monitored 26 days post last CM-24 treatment

Synergistic Anti-Cancer Effect Following Treatment with CM-24 + Anti PD-1

Phase 1 CM-24 Trial Data

• · Open-label, multi-dose escalation study to assess the safety and tolerability of CM-24 as a monotherapy and in combination with pembrolizumab (Keytruda®)*
• · Conducted by Merck in 4 centers (US: UCLA, Yale; Israel: Sheba, Ichilov)

			Dose	Hot
27 patients:			0.01mg/kg	T
Colorectal	11		0.03mg/kg	1
Melanoma	7		0.1 mg/kg	3
			0.3 mg/kg	37	6 week q2wks x4 observation only	q2wks x20
Ovarian	4	ﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ	1.0 mg/kg	3
Gastric	3		3.0 mg/kg
NSCIEC	2		10.0 mg/kg

• · No DLTs up to 10 mg/kg
• Drug-related AEs were observed in 63% of the subjects
• · Grade 3-5 occurred in 3.7% of the patients
• No discontinuation of study drug due to an AE
• No drug related mortalities
• Overall, treatment with CM-24 was well tolerated

* Combination with keytruda® was not clinically tested

Phase 1 CM-24 Trial Data Saturation Was Not Reached With Doses Up to 10mg/Kg

kıtov

Moving Forward With CM-24

• · CM-24 has a good safety and tolerability profile
• · CM-24 + aPD-1 antibody combination demonstrated synergistic anti-cancer effect
  • Opdivo® is a good candidate for a combination therapy replicating the Opdivo®/Yervoy® success
  • Dosing level based on PK start at 8mg/kg and escalate to predicted saturation levels
  • CEACAM1 expression in tumor specimens will be measured
• · Significant amount of data for the IND package, including safety and PK, is available to support additional clinical studies
• · Clinical collaboration with Bristol Myers-Squibb for next Phase 1/2 trial to evaluate CM-24 in combination with nivolumab (Opdivo®) in subjects with non-small cell lung cancer:
  • BMS to collaborate with Kitov on designing the study protocol, including BMS supplying Opdivo®
  • Estimated cost ~\$10-13M

Upcoming Milestones (Post CM-24 Transaction)

Milestone	Expected Date
CM-24 - Shareholders approval of the transaction	Q2:19
NT-219 - Complete pre-clinical development plan	H1:19
CM-24 - Closing of the transaction	03:19
NT-219 - Submit IND application to FDA	H2:19
NT-219 - Initiation of a clinical study	H2:19
Consensi™ - Complete preparation for U.S. launch	H2:19
CM-24 - IND amendment	H1:20
CM-24 - Initiation of a clinical study in collaboration with Bristol Myers-Squibb	H1:20

Company Overview (Post CM-24 Transaction)

Kitov Pharma is advancing first-in-class combination oncology therapies to overcome tumor drug resistance, increase treatment response rate, and slow tumor progression

DIVERSE PIPELINE ADDRESSING LARGE MARKETS

• NT-219 small molecule designed to overcome cancer drug resistance
• · CM-24 a novel immune checkpoint with high potential to treat multiple oncology indications
• · Consensi™ approved by FDA to treat osteoarthritic pain and hypertension, licensed for marketing in the U.S., China and S. Korea

* As of April 120, 2019, including CM-24 transaction and investment shares

PROVEN TEAM AND 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 Pharmaceutical's experienced team
• 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 January 2019): ~\$13M + \$3.5M of investment pending closing of CM-24 transaction
• . Market Cap: ~\$38M*
• ~35% of the shares held by blue-chip, institutional healthcare focused investors

One Azrieli Center

Round Tower, Floor 19 132 Begin Road Tel Aviv 670110 Israel

Company Headquarters US Medical Research Office Contact Us 1615 Suter's Lane NW
Washington DC 20007

Email: IR@kitovpharma.com www.kitovpharma.com Tel. 972 3 9333121

Human CEACAM1 is a Modulator of T cell Function

• · Human CEACAM1 is a modulator of T-cell function
• · CEACAM1 expression up-regulated on
  • · Activated T and NK cells
  • Various cancer cells
• · CEACAM1(tumor) and CEACAM1 (T-cell) interaction prevents killing of tumor cell
• · CEACAM-1 inhibition also noted to remove immune exhaustion by heterodimerization with TIM-3, creating multiple MOA
• · Conceptually, analogous to PD-1/PDL-1
• · Predominantly modulation of T cell activity at the tumor site

Adapted and modified from Freeman G J PNAS 2008

Saturation Was Not Reached With Doses Up to 10mg/Kg (cont.)

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

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

Bristol Myers-Squibb's Opdivo® administration regimen is Q2W, thus CM-24's saturation is expected to be better than in combination with Keytruda®

KITOV

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

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