Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Kitov Pharma — Investor Presentation (February 2019)
26 slides from Purple Biotech's investor presentation, Feb 11, 2019
Slide 1: Corporate Presentation February 2019
Thank you CORPORATE PRESENTATION February 2019
Slide 2: Forward-Looking Statements and Kitov's Safe Harbor Statement
Forward - Looking Statements and Kitov ’ s Safe Harbor Statement Ϯ 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 statements within the meaning of the safe harbor provisions of
Slide 3: Company Profile
Company Profile • Publicly traded on TASE 2013 ; IPO on NASDAQ in November 2015 • Tickers: KTOV (ADSs); KTOVW (Warrants) • Cash on hand (as of January 2019 ): Ε $ 13 M • Market Cap: $ 24 M* • Issued & outstanding capital equivalent to 19.5 million ADSs ϯ • Management team with proven track record in
Slide 4: Experienced Management
Experienced Management ϰ Paul Waymack, M.D., Sc.D. Chairman of the Board & Chief Medical Officer Former FDA medical officer Gil Efron Deputy CEO and Chief Financial Officer Formerly at Kamada (NASDAQ: KMDA) Gil Ben - Menachem, Ph.D., MBA Vice President, Business Development Formerly at Paramount, Te
Slide 5: Milestone Schedule
ϱ Expected Date Milestone H 1 / 2019 NT - 219 - Complete pre - clinical development plan H 2 / 2019 NT - 219 - Submit IND application to FDA H 2 / 2019 NT - 219 - Collaboration agreement with potential strategic partner H 2 / 2019 NT - 219 - Initiation of a clinical study H 2 / 2019 Consensi™ - Comp
Slide 6: Consensi
ϲ Consensi ™
Slide 7: About Consensi
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
Slide 8: Consensi U.S. Target Markets
Consensi ™ U.S. Target Markets ϴ Consensi ™ targets osteoarthritic patients currently treated with NSAIDs (celecoxib as well as others) who also suffer from existing or newly diagnosed hypertension OSTEOARTHRITIS 50 million patients* NSAIDs 60 % of all OA Rxs * Arthritis Foundation: http://www.arthr
Slide 9: Consensi Benefits All Stakeholders
Consensi ™ Benefits All Stakeholders ϵ Consensi ™ is the only NSAID whose labeling indicates reduction of blood pressure and consequent risk reduction of heart attack, stroke and death Consensi ™ • Treats two conditions simultaneously • Increases convenience (one pill instead of two) • Lowers co - p
Slide 10: Consensi Commercialization
Consensi ™ Commercialization ϭϬ South Korea - Exclusively licensed to Kuhnil Pharmaceuticals (March 2017 ) U.S. - Exclusively licensed to Coeptis Pharmaceuticals. Milestone payments $ 3.5 M, 60 % - 40 % profit sharing (January 2019 ) China - Exclusively licensed to Changshan Pharma. Milestone paymen
Slide 11: ϭϭ
ϭϭ NT - 219
Slide 12: NT-219: Overcoming Cancer Drug Resistance
NT - 219 : Overcoming Cancer Drug Resistance ϭϮ • 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 preclin
Slide 13: NT-219: Mechanism of Action
NT - 219 : Mechanism of Action • Anti - cancer drugs induce activation of two feedback pathways, STAT 3 and IRS, both known modulators of tumor survival, metastasis and drug resistance • NT - 219 binds directly to STAT 3 and IRS 1 / 2 , and enhances the tumors ’ response to the approved drugs • STAT
Slide 14: Prevents Acquired Resistance in PDX Models
NT - 219 Prevents Acquired Resistance to EGFR Inhibitor (Tarceva®) in Head and Neck Cancer Results in PDX Models 14 NT - 219 Reverses Existing Resistance to Tarceva® in Head and Neck Tumors NT - 219 Delays Recurrence of Tumors of Head and Neck with Cetuximab ) 3 mm Tumor volume ( NT - 219 Prevents A
Slide 15: Converts Non-Responding Tumors to Keytruda Responders
NT - 219 Converts Non - Responding Tumors to Keytruda® to Responders in Humanized PDX of Esophagus Cancer Results in Immuno - Oncology PDX Model in Combination with Keytruda® 15 Double autologous model - tumors and PBMCs of the same patient
Slide 16: Efficacy in Pancreatic Cancer Models
NT - 219 Converts Non - Responding Tumors to Responders to Gemcitabine in 4 / 4 PDX Models of Pancreatic Cancer Days Days 25 Days Days ) 3 mm Tumor volume ( ) 3 mm Tumor volume ( ) 3 mm Tumor volume ( ) 3 mm Tumor volume ( Efficacy in Pancreatic Cancer Models 16
Slide 17: Summary of Demonstrated Efficacy
Summary of Demonstrated Efficacy TYPE DRUG ( TRADE NAME) CANCER TYPE OWNED BY Targeted Drugs Antibody Cetuximab (Erbitux ® ) Head and Neck Cetuximab (Erbitux ® ) + FOLFOX/FOLFIRI Colon (wt KRAS) Kinase Inhibitors Erlotinib (Tarceva ® ) Head and Neck Afatinib ( Giotrif ® ) Head and Neck Osimertinib (
Slide 18: Development Plan
NT - 219 Development Plan ϭϴ H 1 2019 2020 Complete pre - clinical development plan H 2 2019 submit IND application to FDA H 2 2019 Initiation of Phase II expansion arm Completion of Phase I H 2 2020 Initiation of Phase I/II does escalation study
Slide 19: Summary
Summary 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 m arket potential • Con
Slide 20: Thank you
Thank you Company Headquarters One Azrieli Center Round Tower, Floor 19 132 Begin Road Tel Aviv 670110 Israel US Medical Research Office 1615 Suter's Lane NW Washington DC 20007 Contact Us Email: IR@kitovpharma.com www.kitovpharma.com Tel . 972 3 9333121
Slide 21: Appendix A - Consensi Clinical Data
Ϯϭ Appendix A - Consensi ™ Clinical Data
Slide 22: Medical Rationale
Medical Rationale ϮϮ 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
Slide 23: Consensi Phase III Trial Design
Consensi ™ Phase III Trial Design Ϯϯ Demonstrate that the reduction in blood pressure in the Consensi ™ arm is at least 50 % of the reduction in the amlodipine arm Measurement of pain was not required by FDA Primary endpoint Newly diagnosed hypertensive patients Celecoxib 200 mg + Amlodipine 10 mg A
Slide 24: Consensi Phase III Trial Results
Consensi ™ Phase III Trial Results • Primary efficacy endpoint was successfully achieved (P= 0.001 ) • Demonstrated 2.5 x better blood pressure reduction than FDA requirement ( 50 % of amlodipine arm) • Demonstrated consistent reduction in all measures of blood pressure • Observed beneficial renal f
Slide 25: Consensi Phase III/IV Clinical Trial Design
Consensi™ Phase III/IV Clinical Trial Design Ϯϱ Hypertensive patients (following a wash - out period) Celecoxib 200 mg + Amlodipine 10 mg AMLODIPINE 10 mg CELECOXIB 200 mg PLACEBO Data Collection and Statistical Analysis Double - blind, placebo - controlled, multi - center study N = 1 Ϭ 2 3 - arm tr
Slide 26: Consensi Phase III/IV Clinical Trial Results
Consensi ™ Phase III/IV Clinical Trial Results Ϯϲ • 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.