Investor Presentation • May 4, 2020
Investor Presentation
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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 May 2020
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 – May 2020
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.
May 4, 2020 By: /s/ Isaac Israel
Isaac Israel CEO and Director
Exhibit 99.1

Thank you Corporate Presentation May 2020

Certain statements in this presentation that are forward-looking statements within the nearly of the safe harthin the mearing of the safe harbor provisions of the Private Securities Litigation Reform Act of 1955. Such forward-looking statements included on proceeds and statements that are not statements of historical fast, and may be identified by words such as "believe", "expect", "intent", "seek", "target", "will", "project", "ontinue" or "anticipate" or their negatives r viations of these words or other comparable words or by the fact the to not relate sticity to historical matters. You should not planes on these forward-looking statements, which are not guarantees of future performance for current views, expectations belies or intentions with respect of future events, and are subject o a number of asumptions, involve known and unknown risks, nany of which as well as uncertainter and other factors that may cause our actual results performance or activernetts to be significantly different from any fute estity of the engressed or impled by the forward-looking statements. Incornant factors that coud cause or ontribute to such differences indude, anone others, risks relating to: different results synergies and costs of the acquisition of FamelWave by Kity, management plans, strategies and objectives of management for NT219 and CN-24; the potential finacial impact of the transction; and any asumptions inderling any of the foresping the process by unitiates such as NT219 and CM-24 could potentially lead to an approved one product is one and subject to high informical risk. particularly with respect o a joint development and commercialization involves a lengthy and expersive process with uncertain outcomes, ou ability to successfuly develop and commecutical products; the expense, length, progress and results of any clinical trails; the last of sufficient funing to finance the cinical trials; any changes in regulation that could affect the pharmaceuitial in receing the tregulatory approvals necessary in order to commercialize ou product; the difficulty of predicting actions of the U.S. Food and Drug Administration of charmaceuical products; the regulator environment and changes in the health polices and egines in the countries in which we operate; the uncertainty surround o our pharmaceutcal products once cleared for market; the introduction of competing products; patents attained by competitors; of our patents and other probections for innovative product; our ability to obtain, maintain and defent issued patents with protective clains; the commencenent of any patent interent action; our ability to preval, obtain a favorable decision or recover damages in any such action; and the exposure litigation, including patent litigation, and other factors that are discussed in our in our Annual Report on Form 20-Ffor the year ended December 3, 20.9 and in our other fil with the SC, including our cautionary discussion of risk Factors' in our Registration Statements and Annual Reports. These are actual results to differ naterially from expected those we have listed could ats adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is nade. We disclaim any intention or oblick update or reise any forward-looking statement, or cher information chure events or otherwise, exept as required by applicately and can additional disclosures we make in our reports to the SEC, which are wailable on the SEC's website, http://www.sec.gov.


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
kitov
\$28M-36M of revenues expected in 2020-2022
2.8M shares 3-month avg. trading volume
* As of April 30th , 2020
** including net \$3.5M + \$5.8M raised in January 20, March 20 and April 20 financing transactions respectively

| Program | Indication | Preclinical Phase 1 | Phase 2 | Phase 3 | Partners | Value Drivers |
|---|---|---|---|---|---|---|
| CM-24 | NSCLC and Pancreatic Cancer (combination with nivolumab) |
Bristol-Myers Squibb | Study initiation Q4:20 Phase 1 data H1:21 |
|||
| NT-219 | R/M solid tumors and Head and Neck (monotherapy and in combination with Erbitux®) |
Study initiation Q2:20 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 |
U.S .: Coeptis Pharmaceuticals China: CSBio S. Korea: Kuhnil Pharmaceutical |
U.S. Launch: Q2:20 |
kitov -
Isaac Israel Chief Executive Officer

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

Bertrand Liang, MD, PhD, MBA, AMP Chief Medical Officer Formerly at Biogen Idec, Amgen, NCI
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)
NextGen Biomed (TASE: NXGN)
Formerly CEO of BeeContact Ltd. (TASE:BCNT),

Michael Schickler, Ph.D Head of Clinical Operations Formerly at Hoffmann-La Roche, CEO at CureTech,




CM-24 – Inhibitor of CEACAM1


K1TOV

*Gray-Owen and Blumberg, CEACAM1: control of immunity, Nature Review Immunology , 2006, DOI: https://doi.org/10.1038/nr/1864



Markel et d., I mmunol 2003; Cancer Inmunol Immunother 2010; Orterberg et al, Mol Cancer Ther 2012; Zhou, 2009; Li, 2013; Huang, 2015


100
Significant benefits as both single agent and in combination with α-PD-1 kitov

✓ 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



· 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

KTTOV KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., OPDIVO® is a registered trademark of Bristol-Myers Squibb.

* Dango et al, Lung Cancer 2008; 60:426
**American Cancer Society, Cancer Facts & Figures 2019, and the ACS website
** Economopoulou P, Mountzios G. The emerging treatment Inn-small cell ung cancer. Ann Transl Med. 2018,6(8):138. doi:10.2007.11.07
** Gettinger S, et al "Five-year outcomes from the randomized, phose II trials CheckMate 017/057: Nivolumab vs docetously treated NSCC" WCLC 2019; Abstract OA14.04.



NT219 – Dual inhibitor of IRS 1/2 and STAT3



IRS1/2 and STAT3 are key signal transducers activated as a feedback response to anti-cancer drugs, leading to drug resistance
kitov










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

Title: A phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT219, alone and in combination with Erbitux® (cetuximab) in adults with recurrent or metastatic solid turnors and Head and Neck cancer
| Q2 > Q4 > Q1:21 > Q2 > Q3 > Q4 > Q1:22 > Q2 > Q3 > Q4 > Q1:23 > Q2 > Q3 > Q4 > Q1:24 > Q3 > NT219 as a single agent in subjects with R/R solid tumors |
|||||
|---|---|---|---|---|---|
| Dose Escalation NT219 q1w 18<n<30 |
Expansion Topline NT219 q1w @ RP2D Results n=11+18 (Simon 2 stage design) |
||||
| NT219 + cetuximab in subjects with R/M Head and Neck cancer* | |||||
| Dose Escalation NT219 q1w + cetuximab q1w |
Expansion NT219 q1w + cetuximab q1w |
Topline ★ |
|||
| 9<n<18 | n=11+18 (Simon 2 stage design) | Results | |||
| Acres of Children American Arrants | * Colorectal Adenocarcinoma pts will be recruited in the Dose Escalation phase | ||||
| = Indication TBD (expansion not part of the study protocol) |

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: : http://coeptispharma.com/wp-content/uploads/2020/01/Consensi Pl.pdf

*Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.).
Norvasc® is a registered trademark of Pfizer Inc.


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




| Consensi™ U.S. launch |
NT-219 IND clearance |
NT-219 Collaboration agreement with potential strategic partner |
NT-219 Initiation of phase 1/2 clinical study |
CM-24 IND amendment clearance |
CM-24 Initiation of a phase 1/2 clinical study in collaboration with Bristol Myers-Squibb |
|---|---|---|---|---|---|
| Q2 | Q3 | Q4 |
|||
| Q2 2020 |
Q2 2020 |
Q2 2020 |
2020 | 2020 | 2020 |
| KITOV | 25 | ||||
kitov

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 April 30th , 2020 ** including net \$3.5M + \$5.8M raised in January 20, March 20 and April 20 financing transactions respectively

We are committed to providing cancer patients with R first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression
Email: [email protected] www.kitovpharma.com


Appendix A - CM 24

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



kitov
30


Appendix B - NT 219





| IRS1 | Ki67 (Proliferation marker) | |||||||
|---|---|---|---|---|---|---|---|---|
| PDX model | 100% | 44% | 63% | 17% | 100% | 69% | 79% | 17% |
| Pancreatic Cancer | Control | NT219 Gemzar Gemzar | +NT219 | Control | NT219 | Gemzar | Gemzar +NT219 |
|
| Drug Gemcitabine (Gemzar®) |
100% | 45% | FOXM1 67% |
100% | 60% | TGFbeta (EMT Driver) 101% |
26% | |
| Control | NT219 Gemzar Gemzar | +NT219 | Control | NT219 | Gemzar | Gemzar +NT219 |
||
kitov




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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