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Purple Biotech Ltd. — Investor Presentation 2016
May 4, 2016
7004_rns_2016-05-04_724a952b-3d7c-4e13-9049-a7b6c040f1fe.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 2016
Commission File Number: 001-37643
KITOV PHARMACEUTICALS HOLDINGS 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): ____
On May 4, 2016, Kitov Pharmaceuticals Holdings Ltd. (the "Company" or the "Registrant") issued a Press Release: "Kitov Pharmaceuticals to Present at Pioneers 2016, Presented by Joseph Gunnar, in NYC on May 5, 2016", which is attached hereto as Exhibit 99.1.
Furthermore, on May 4, 2016 the Registrant made available an updated investor presentation on its website. A copy of the updated investor presentation is attached hereto as Exhibit 99.2 and may be viewed in the Investor Relations section of the Registrant's website at kitovpharma.com
Attached hereto are the following exhibits: Exhibit 99.1 Press Release Exhibit 99.2 Investor Presentation – May 2016
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 PHARMACEUTICALS HOLDINGS LTD.
Date: May 4, 2016 By: /s/ Simcha Rock
Simcha Rock Chief Financial Officer
Kitov Pharmaceuticals to Present at Pioneers 2016, Presented by Joseph Gunnar, in NYC on May 5, 2016
TEL AVIV, Israel, May 4, 2016 /(GLOBE NEWSWIRE)/ -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), a late-stage drug development company, today announced that Dr. J. Paul Waymack, Kitov's Chairman of the Board and Chief Medical Officer will present at the upcoming PIONEERS 2016 conference, presented by Joseph Gunnar & Co. LLC, taking place on May 5, 2016 in New York.
Presentation Details:
PIONEERS 2016, presented by Joseph Gunnar
Date: Thursday, May 5, 2016 Time: 2:30 pm EDT Location: New York Palace Hotel, Hubbard 1, New York City
About Kitov Pharmaceuticals Holdings Ltd.
Kitov Pharmaceuticals Holdings Ltd. is a pharmaceutical company focused on the development of therapeutic candidates for the simultaneous treatment of various clinical conditions. In particular, Kitov focuses on developing combinations of existing drugs in advanced stages of development. Kitov's lead drug, KIT-302, is formulated for the simultaneous treatment of two clinical conditions – pain caused by osteoarthritis (OA) and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for OA. KIT-302 is based on celecoxib, the active ingredient of a known and approved-for-use drug designed primarily to relieve pain caused by OA, and the generic drug amlodipine besylate. Kitov is traded on the Nasdaq Capital Market (KTOV) and the Tel-Aviv Stock Exchange (KTOV).
For more information, the content of which is not part of this press release, please visit http://kitovpharma.com/
Forward-Looking Statements
This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements involve certain risks and uncertainties, including, among others, risks impacting the ability of the Company to complete any public offering of its securities because of general market conditions or other factors and risks that could cause the Company's results to differ materially from those expected by Company management. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Kitov Pharmaceuticals Holdings Ltd.'s Registration Statement on Form F-1 filed with the SEC, which is available on the SEC's website, www.sec.gov.
Contact: Simcha Rock, CFO +972-2-6254124 [email protected]
Bob Yedid Managing Director LifeSci Advisors, LLC 646-597-6989 [email protected]
Kitov Pharmaceuticals Streamlined Late-Stage Drug Development
Company Presentation May 2016
© 2016 Kitov Pharmaceuticals Holdings Ltd.

Forward Looking Statements
This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction.
All statements in this communication to historial facts, are "forward-looking statements" within the meaning of applicable securities laws. These forward looking statements related our business and condition, as well as our plans, strategies, objectives and expectations for our business, operations and condition. However, these forward-looking statements are not guarantees of future performance and are subject to a number of assumptions include incown risks, many of which are beyond our control, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actually from our expectations include, among others: the risk that drug development involves with uncertain outcome; Kitov's ablity to successfully develop and commercialize its product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of any changes in regulation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize Kitov's producting business prospecs; lack of sufficient funding to finance the clinical trials; the difficulty of predicting actions of the USA FDA; the regulatory environment and regimes in the countries in the countries in which we operate; changes in the global pharmaceutical indicines Agency and other regultory authority approvals; natural disaster; labor disputes; rising interest rates; general market, politions in the countries in which we operate; volatility or crises In the financial market; arbitration, litigation and regulatory proceedings; and war or acts of terror.
Forward-looking statements reflect our current views with resect to future events and subject to risks and uncertaintes. You should not unduly rely on any forwards. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and circumstances reflected in the fonvard-loking statements will be achieved or will occur. Readers are urged to carefully review and consider the Company's reports, which are designed to advise interested parties of the may affect its business, financial condition, results of operations and prospects. These forward-looking statements speak only as of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason, whether as a result of new information, future events or otherwise, except as required by law.
More detailed information about the risks and under the Company is contained under the heading "Risk Factors" in Kitov Pharmaceuticals Holdings Ltd.'s Registration Statement on Form F-1 filed with is available on the SEC's website, www.sec.gov.

| Attractive, late stage asset |
" Lead drug candidate, KIT-302 addresses a multi-billion dollar market of patients with osteoarthritis and hypertension · In a pivotal Phase III trial KIT-302 met its primary efficacy endpoint. NDA submission planned by the end of 2016 |
|
|---|---|---|
| Operations | Management team with proven track record in drug development, NDA submissions and FDA approvals |
|
| · KIT-302 formulation and manufacturing contracted to Dexcel Pharma - Israel's largest private pharmaceutical company. All of Dexcel's production sites are approved by the FDA and EMA |
||
| Financial Summary |
Market cap: \$22 MM (as of May 2, 2016) | |
| " Cash: \$10.6 MM (as of December 31, 2015), no debt | ||
| · \$22 MM total investment to date | ||
| Founded in 2010. Public on TASE since July 2013; IPO on Nasdag in November 2015. Ticker: KTOV |
||
| 3.8 million ADS. Each ADS represents 20 ordinary shares |
Investment Highlights
- · Lead drug candidate KIT-302, a combination of celecoxib (Celebrex®) and amlodipine (Norvasc®) achieved its primary efficacy endpoint in a pivotal phase III trial for treatment of pain caused by osteoarthritis, and hypertension, a known side effect of NSAIDs
- · Regulatory submission path with FDA is under a Special Protocol Assessment (SPA), and 505(b)2 route
- · Over 27 million people in the U.S. suffer from OA, of whom approximately 13.5 million suffer from both OA and hypertension
- · Kitov's strategy is to leverage its deep regulatory and clinical trial expertise to focus on development of therapeutic candidates while using regulatory mechanisms that will lead to faster pathways to approval
- · Kitov is pursuing both Formulation and Method of Use patents. At minimum, if firstto-file, KIT-302 will be expected to be protected by 3 years of market exclusivity in the U.S., and 7-10 years in EU markets


Key Management
Paul Waymack, M.D., Sc.D. - Chairman of the Board and Chief Medical Officer: Formerly FDA medical officer
Isaac Israel - CEO: Formerly CEO of BeeContact Ltd. (TASE:BCNT), NextGen Biomed (TASE: NXGN)
Simcha Rock, CPA, MBA - CFO: Formerly Senior VP Edmond de Rothschild
William Berlin, PhD - Chemistry Manager: Formerly FDA chemist
Gil Ben-Menachem, Ph.D., MBA - VP BD: Formerly at Paramount, Teva, Ophtalix, Dexcel, NIH








About Kitov Pharmaceuticals
Our Market
Our Drugs
Our Development Plan


Fixed Dose Combination Drugs
- · Provides improved medical treatment of patients diagnosed as suffering from two or more different diseases
- · Cost of developing a combination drug using known molecules can be materially lower than developing a new chemical entity
- · Reduced development risk due to component drugs having established efficacy and safety profiles
- · Potential clinical and marketing advantages for a combination drug versus its individual components


> Kitov's Combination Drug Pipeline
| Product | Indication | Combination | Expected NDA Submission to FDA |
|---|---|---|---|
| KIT-302 | Osteoarthritis | Celecoxib + Amlodipine | H2 2016 |
| KIT-301* | Osteoarthritis | Naproxen + Isradipine |
* The Company is currently focusing on KIT-302

Streamlined Late-Stage Drug Development
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Osteoarthritis & Hypertension
- · Osteoarthritis, the most common type of arthritis, causes loss of cartilage, decreased mobility, and significant pain; the incidence of osteoarthritis increases with age
- · NSAIDs are effective for treating osteoarthritis related pain. However, NSAIDs have a significant deleterious side effect: elevated blood pressure
- · Hypertension, known as the "silent killer", increases the risk of heart attack, stroke, and death
- · 27 million people in the US suffer from osteoarthritis of whom, 13.5 million people may suffer from hypertension as well
- " Over half of the 50+ age group in US/EU suffer from hypertension
- · There is no single medication on the market that simultaneously treats both osteoarthritis and hypertension


NSAIDs and Antihypertensive Drugs
Since 2005 in the U.S., NSAIDs carry an FDA-mandated "Black Box" label warning of increased cardiovascular risks:
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 cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS and CLINICAL TRIALS).
- CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
In July 2015 the FDA issued a Safety Announcement stating its intention to:
- · Require labels for prescription NSAIDs to indicate that the risk of heart attack or stroke associated with NSAIDs, can occur as early as the first weeks of using an NSAID and may increase with longer use
- · Strengthen the current Label Warning, in effect since 2005


Rationale for KIT-302
- · Many osteoarthritis sufferers do not receive NSAIDs due to physicians' and patients' fear of elevated blood pressure
- · KIT-302 combines celecoxib, the only COX-2 selective NSAID approved in U.S., with amlodipine, a well-known anti-hypertensive, to:
- Treat osteoarthritis pain
- Treat NSAIDs' side effect of elevated blood pressure (which may cause hypertension), or
- Treat pre-existing hypertension
- · In August 2011, the FDA issued a Safety Information Announcement stating:
" .. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists ... or ACE inhibitors, may result in deterioration of renal function, including possible acute renal failure."
No such Safety Information Announcement was issued by the FDA with regard to amlodipine, a calcium channel blocker, used in KIT-302

KIT-302's Advantages vs. Current Treatment
- · Currently, poor patient compliance in taking prescribed anti-hypertensive medications
- · KIT-302 provides a combination solution that does not exist in the market today and offers real advantages

KITO
KIT-302 Should Enjoy Labeling Advantage
· FDA policy (March 2011) states that a drug that lowers blood pressure will be permitted to carry the following in its labeling:
DRUGNAME is a [name of pharmacologic class] indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- · FDA informed Kitov in writing this labeling may be used on the package insert of KIT-302
- · Following FDA approval of KIT-302, physicians' choice in treating osteoarthritis pain will be:
12 NSAID - Pain relief drug with its "black box", warning of the risk of heart attack, stroke, and death
KIT-302 With labeling noting reduction of blood pressure and lowering the risk of heart attack, stroke and death
Moreover, if approved by FDA, KIT-302 will be the only drug in the market able to claim simultaneous treatment of OA pain and treatment of hypertension
OR

Intellectual Property and Market Exclusivity
- · Two Patent Families Pending:
- · Pharmaceutical Formulation and Methods-Of-Use patents which combine NSAID compounds with Anti-Hypertensive compounds
- · Methods for ameliorating Drug-Induced Elevations in Blood Pressure via Adjunctive Use of at least one Anti-Hypertensive
- · Expected market exclusivity:
- U.S. 3 years*
- Europe 7-10 years

14
* Subject to the Company being the first to file an NDA


About Kitov Pharmaceuticals
Our Market
Our Drugs
Our Development Plan

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Phase III Trial Design
- · Double-blind, placebo controlled, multi-center Phase III clinical trial in 152 patients
- · Four arms, each of 30-45 patients, treated for 2 weeks with once daily oral dosage of placebo, celecoxib (200 mg), amlodipine (10 mg), and KIT-302 (200 mg celecoxib + 10 mg amlodipine)
- · Primary end-point:
- · Demonstrate that the reduction in blood pressure in KIT-302 arm is at least 50% of the reduction in the amlodipine arm
- · No need to demonstrate or measure efficacy in treatment of pain caused by osteoarthritis

Phase III Trial Results
- · Data announced Dec. 15, 2015
- · Primary efficacy end-point has been successfully achieved
- · Number of patients (n=152) was adequate to provide statistical significance
Changes in Blood Pressure from Baseline to Finish (mm Hg [sEM])
| Daytime Systolic |
Daytime Diastolic |
Nighttime Systolic |
Nighttime Diastolic |
|
|---|---|---|---|---|
| KIT-302 | -10.6 [1.3] | - 7.5 [0.9] | -10.5 [1.5] | -7.0 [1.2] |
| Amlodipine | 23 8 12 | -5.5 [0.8] | -6.4 [1.7] | -3.2 [1.2] |
| Celecoxib | -0.5 [1.6] | -1.5 [1.0] | -1.7 [2.2] | 0.3 [1.3] |
| Placebo | -2.1 [1.6] | -0.3 [1.1] | -1.4 [1.8] | 0.0 [1.2] |

Streamlined Late-Stage Drug Development
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> KIT-302 - NDA Approval Expected H2 2017

Planned Milestones
A
| Milestone | Due Date | Status |
|---|---|---|
| Complete patient enrollment in Phase III Trial | Complete | |
| Phase III clinical trial top-line results | Q4 2015 | V Complete |
| Phase III clinical trial final results | V Complete |
|
| Pre-NDA meeting | Q1 2016 | > Complete |
| Pre-NDA meeting - FDA response | Q2 2016 | |
| Complete CMC manufacturing | Q2 2016 | |
| Final PK study results | Q2 2016 | |
| NDA submission | H2 2016 | |
| NDA approval | H2 2017 |

Streamlined Late-Stage Drug Development
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Market Considerations
- " World-wide sales of Celebrex® were \$2.7 billion in 2014, ~\$1B in 2015 (due to generic erosion)
- · Following the successful completion of the Phase III clinical trial, Kitov intends to:
- · Partner KIT-302 with pharmaceutical marketing partners
- · Negotiate reimbursement arrangements with insurers
Case Study: Vimovo® (naproxen/esomeprazole magnesium)
- · Fixed-dose combination developed by Pozen Inc., primarily commercialized by Astra Zeneca
- · Treats gastro-intestinal side effects of a non-selective NSAID
- · Approved by the FDA in 2010; Horizon Pharma acquired the U.S. rights in November 2013 for \$35 million + royalty and milestone payments
- Vimovo's net sales in the U.S. reached \$167 million in 2015

Streamlined Late-Stage Drug Development
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CMC Outsourced to Dexcel Pharma
- · KIT-302 CMC is partnered with Dexcel Pharma Israel's largest private pharmaceutical company
- · 47 years in operation; 1,000+ employees; 5 billion tablets produced per year; 3 state of-the art FDA-inspected manufacturing plants; 300 marketing authorizations; 39 distribution countries
- · Strategic agreement with Dexcel for KIT-302 (April, 2014):
- · Dexcel to provide chemistry, manufacturing and control (CMC) services, including:
- · Analytical methods and validation, stability testing
- · Production of batches for pharmacokinetic studies
- · Scale-up and manufacture supplies of KIT-302 adequate to submit NDA to FDA
- · Dexcel to provide chemistry, manufacturing and control (CMC) services, including:

Streamlined Late-Stage Drug Development

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Summary: Why Kitov?
- · Proven management team with deep FDA experience and fast-track regulatory expertise
- · KIT-302 is innovative solution for the simultaneous treatment of both osteoarthritis and hypertension
- · Attractive alternative, with clear marketing advantages, to currently available drugs in a large, multi-billion dollar market
- · SPA-mandated Phase III trial completed in Q4 2015 and successful results announced on December 15, 2015
- " Using 505(b)(2) pathway, NDA submission planned for late 2016 / Expect timely NDA Approval
- · Kitov has solid cash position with limited cash burn

Thank you Kitov Pharmaceuticals Ltd.

Israel Address: One Azrieli Center Round Tower 132 Menahem Begin Rd. Tel Aviv 6701101 Tel: +972-2-625-4124
US Address: 1615 Suter's Lane NW Washington DC 20007
www.kitovpharma.com
