Regulatory Filings • Sep 10, 2019
Regulatory Filings
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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 September 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 – September 2019
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.
September 10, 2019 By: /s/ Isaac Israel
Isaac Israel CEO and Director

Thank you Corporate Presentation September 2019

This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction.
Certain statements in this presentation in the nearing of the sate hartor provisors of the Private Scorites Uitgation Reform Act of 1995 and other applicables securites laws statements an be tentified by the use of forwards sub at "bein", "plan", "nay", "hay", "hay", "tage", "wil", "project", "toreast", "tantinue" of "anticipat" or "anticipat" or negatives or variations of the comparable worls or by the fact that these statements do not relates fou should not platenents, which are not guaratees of the performance. For arrent reless, expectations, belies or intentions with resect of future events, and are subject to a number of assumptions, involve unknown iss, nany of whith are beyond our ontrol, as well as a uner factors that may case or actual results on be signitiarity different from any foure esults, performance or achievenents expressed or inclied by the forwards. Incors that could cause or confibute to such offerences include, anong others, risks elating to the manner in wirdt the ransation for the aquistion of Fanellave by Kitvy plan to effect the epected benefits, ynergis and costs of the transation; mangement plans relating to the cransation; the e completion of the transation to conqler the tansaction the varios cosing confliors; the yans, strategic and objectives of manageners for furre operations; product development and CM-24, the potential impact of the transactions underlying any of the freeping the process by whith early stage products such as CM-24 could potentialy lead to a a apprev long and subject o hight the spect to a joint development collaboration; the fat that or development and commercialization involves a inghy and expersive process with uner ou tablity to successful) a guice, develop or commercial products, the experse, length, progress and results of sufficient funding of mance the clinital traing to finat it in change in regulation and exist the pharmaced al misuly in reeking the equilator approvals neassary in order to ocommercialize our roducts the difficulty of nedicing and the U.S. Food and Irup Administration or any other of probocs; the regulator environment and changes in the health policis and regimes in the countries in which we career the mor survunding the actual market resert in marketing in a particular narket, the introduction of competing poblus; patents attained by competitor; dependence on the effectivenss of our pated on for inneative products our ablik to obtain and deinds with protective cams the commencement of any atern interestion. our ability to preval, obtain a favorale decision or resore to literion, including atest litigation, and or egalatory adders, and other factors hat are discussed in our Anna Report on For for the year ended December 3, 2008 and in the SC, including or cautionary discussion of risks and uner filsts Fators' in our Registeri Statences and Annal Reports. These are fact and results to differ material y from expected results. Other factors besides those we have lised could also adversely affect us. Any forwar-looking s press release speaks only a of the date We listin any intertion or obligation o publicy update or review and or other information contained herein, whether as a reul of new information, future events or chrenite, exept as readyed, however, to corsult any additional discosures we make in our reports o the SC, virich are available on the SCC vebst http://www.sec.gov

Kitov Pharma is a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance

* As of September 6th, 2019, including CM-24 transaction and investment shares




| Program | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 | Market | Partners |
|---|---|---|---|---|---|---|---|
| Consensi™ | Osteoarthritis Pain and Hypertension |
Commercial partners: Coeptis Pharmaceuticals - U.S. CSBio - China Kuhnil Pharmaceuticals - S. Korea |
|||||
| CM-24 | Non-Small Cell Lung Cancer (combination with nivolumab) |
Bristol-Myers Squibb (Clinical Collaboration) |
|||||
| NT-219 | Head and Neck Cancer (combination with cetuximab) |


CM - 24


CM-24 is a first-in-class mAb blocking CEACAM1, a novel immune checkpoint inhibitor, conceptually analogous to PD1-PDL1

Demonstrated Efficacy in Preclinical Models CM-24 enhances anti-tumor immune activity at the tumor site through multiple pathways

Well Tolerated in a Phase 1 Study CM-24 was well tolerated as a monotherapy in a Phase 1 study in doses up to 10 mg/kg

Phase 1/2 Trial to Start in 2020 Clinical collaboration with Bristol Myers-Squibb for Phase 1/2 trial in combination with nivolumab (Opdivo®) in non-small cell lung cancer (NSCLC) starting at dose of 8mg/kg


(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
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| %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


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











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



· Exploring further studies in other tumor types as well as monotherapy



NT - 219


NT-219 is an inhibitor of two signaling proteins involved in drug resistance: Insulin Receptor Substrate 1 and 2 (IRS1/2) and Signal Transducer and Activator of Transcription 3 (STAT3)

Efficacy in PDX models was demonstrated in combination with targeted therapies, chemotherapies and immuno-oncology therapies


Demonstrated outstanding efficacy in delaying onset and reversing resistance to anti-cancer drugs in head and neck, colon, lung, and pancreatic cancers

Key Signal Transducers Activated as a Feedback Response to Anti-Cancer Drugs, Leading to Drug Resistance

Adapted from Clinics vol.73 supl.1 2018






Drugs
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· NT-219 + cetuximab has the potential to become



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



kitov

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




| Milestone | Expected Date |
|---|---|
| CM-24 - Closing of the transaction | 03:19 |
| NT-219 - IND submission to FDA | Q4:19 |
| NT-219 - Initiation of a phase 1/2 clinical study | Q1:20 |
| NT-219 - Collaboration agreement with potential strategic partner | H2:19 |
| Consensi™ - Complete manufacturing and prepare for U.S. launch | H2.19 |
| Consensi™ - U.S. launch | Q1:20 |
| CM-24 - IND amendment submission | H1:20 |
| CM-24 - Initiation of a phase 1/2 clinical study in collaboration with Bristol Myers-Squibb | H2:20 |

Kitov Pharma is a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance

* As of September 6th, 2019, including CM-24 transaction and investment shares




Our mission is to provide cancer patients with first-in-class therapies to overcome tumor drug resistance, enhance treatment response and slow tumor progréssion
1
Email: [email protected] www.kitovpharma.com


Appendix A - CM 24

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



Appendix B - NT 219





| IRS1 | Ki67 (Proliferation marker) | |||||||
|---|---|---|---|---|---|---|---|---|
| PDX model | 100% | 44% | 63% | 100% | 69% | 79% | ||
| Pancreatic Cancer | Control | NT219 Gemzar | 17% Gemzar +NT219 |
Control | NT219 Gemzar | 17% Gemzar +NT219 |
||
| 100% | FOXM1 | 100% | TGFbeta (EMT Driver) 101% |
|||||
| Drug Gemcitabine (Gemzar®) |
45% | 67% | 60% | 26% | ||||
| Control | NT219 Gemzar Gemzar +NT219 |
Control | NT219 Gemzar Gemzar | +NT219 | ||||
| 110V |
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Appendix C - Consensi ™ Clinical Data





Consensi™ demonstrated even better BP reduction than same amount of amlodipine given without celecoxib
* Error bars – standard error of mean
| 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





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