Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Kitov Pharmaceuticals Holdings — Investor Presentation (June 2017)
27 slides from Purple Biotech's investor presentation, Jun 15, 2017
Slide 1: Corporate Presentation June 2017
Thank you CORPORATE PRESENTATION June 2017
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 the
Slide 3: Kitov Company Profile
KITOV Company Profile • Founded in 2010 ; Publicly traded on TASE 2013 ; IPO on NASDAQ November 2015 • Tickers: KTOV (ADSs); KTOVW (Warrants) • Cash on hand (as of December 31 , 2016 ): $ 15.6 M; No debt • Market Cap: $ 15 M * • Issued & outstanding capital equivalent to 8.2 million ADSs** ϯ DIVERSE
Slide 4: Experienced Management
Experienced Management ϰ Paul Waymack, M.D., Sc.D . Chairman of the Board and Chief Medical Officer Former FDA medical officer Simcha Rock, CPA, MBA Chief Financial Officer Former Senior VP Edmond de Rothschild Gil Ben - Menachem, Ph.D., MBA Vice President, Business Development Formerly at Paramount
Slide 5: Pipeline
Pipeline ϱ * Through majority held subsidiary TyrNovo Drug Therapeutic Field Pre - clinical Phase I/ II Phase III Submission Approval KIT - 302 NT219* Osteoarthritis Pain & Hypertension Oncology
Slide 6: About KIT-302
About KIT - 302 • KIT - 302 's pivotal Phase III trial successfully met its primary efficacy endpoint - announced in December 2015 . Data showed that KIT - 302 is more effective at lowering blood pressure than amlodipine alone • Formulated with 200 mg celecoxib and three different dosages ( 2.5 , 5
Slide 7: Medical Rationale
Medical Rationale ϳ Celecoxib (the active ingredient in Pfizer's Celebrex ®) • The only widely prescribed selective COX - 2 NSAID approved in the US (unlike non - selective NSAIDs, celecoxib carries limited gastrointestinal risks) • Since 2005 has an FDA mandated “Black Box” labeling warning of incr
Slide 8: Phase III Trial Design
KIT - 302 Phase III Trial Design (under Special Protocol Assessment from FDA) Demonstrate that the reduction in blood pressure in the KIT - 302 arm is at least 50 % of the reduction in the amlodipine arm Measurement of pain was not required by FDA Primary End - point ϴ Newly diagnosed hypertensive p
Slide 9: Phase III Trial Results
KIT - 302 Phase III Trial Results • Primary efficacy end - point 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 ϵ * Error Bars – Standard
Slide 10: Beneficial Renal Outcomes
KIT - 302 Beneficial Renal Outcomes ϭϬ Measure KIT - 302 Amlodipine Creatinine plasma levels reduction - 3.22 μ mol/L - 2.55 μ mol/L Peripheral edema (% patients) 8.2% 15.6% Lower Creatinine level ( a measure of renal function) indicates better kidney function 2 Approx. 1 % - 5 % of all patients usi
Slide 11: US Target Markets
KIT - 302 US Target Markets ϭϭ KIT - 302 targets osteoarthritic patients currently treated with NSAIDs (both celecoxib and others) who also suffer from existing or newly diagnosed hypertension KIT - 302 OSTEOARTHRITIS 50 Million patients* NSAIDs 60 % of all OA Rx’s HYPERTENSION Celecoxib 24 % of all
Slide 12: Market Assessment
Market Assessment ϭϮ • IMS Health - Analysis of patient - level data of more than 85 % of all dispensed Rx’s in the U . S . • Physician Survey of 110 Key Opinion Leaders (KOLs) and High - Volume Prescribers (HVPs) of Celecoxib in the U . S . - General Practitioners, Internal Medicine, Pain Specialis
Slide 13: NSAIDs Prescribing Behavior Analysis
NSAIDs Prescribing Behavior Analysis - NSAIDs and celecoxib usage for osteoarthritis : NSAID’s - 60 % Celecoxib - 27 % KIT - 302 - 40 % of celecoxib Rx’s Osteoarthritis Rx’s Physicians provided their predicted prescribing beh avi or of KIT - 302 based on a description of the Target Product Profile,
Slide 14: NSAIDs Prescribing Behavior (non-celecoxib)
NSAIDs Prescribing Behavior NSAID’s - 60 % Non - celecoxib - 73 % KIT - 302 - 25 % of non - celecoxib Rx’s Osteoarthritis Rx’s Physicians provided their predicted prescribing behavior of KIT - 302 based on a description of the Target Product Profile, which was constructed based on the Phase 3 clinic
Slide 15: Celecoxib Therapy Duration
Celecoxib Therapy Duration ϭϱ Analysis - Average duration of c elecoxib therapy : Celecoxib Rx’s Chronic use (All indications) % 60 According to IMS data (April 2015 - March 2016 ), ~ 60 % of celecoxib users take it for more than 90 days. FDA issued a Safety Announcement (July 2015 ) stating that th
Slide 16: Benefits All Stakeholders
KIT - 302 Benefits All Stakeholders ϭϲ KIT - 302 KIT - 302 expected to be the only NSAID whose labeling will indicate reduction of blood pressure and consequent risk reduction of heart attack, stroke and death • Treats 2 conditions simultaneously • Convenience (one pill instead of two) • Lower co -
Slide 17: Insight into Payers' Views
Insight into Payers ’ views Pharmacy Benefit Managers (PBMs) were interviewed as part of Market Assessment in order to obtain insight into their views of KIT - 302 : – Interviewed organizations which insure ~ 150 million lives – Most PBMs were intrigued with KIT - 302 ’s potential to increase compli
Slide 18: Intellectual Property
Intellectual Property KIT - 302 ϭϴ • U.S. Patent 9,408,837 was issued August 2016 • Divisional patent expanding the patent coverage was issued February 2017 • Expected patent protection in U.S. until February 2030 • Additional formulation patents expected to be filed • Expected EU market exclusivity
Slide 19: Commercialization
KIT - 302 Commercialization ϭϵ South Korea - Exclusively licensed to Kuhnil Pharmaceuticals (March 2017 ) Partnership discussions in the US and the EU are ongoing
Slide 20: Pipeline
Pipeline ϮϬ Drug Therapeutic Field Pre - clinical Phase I/ II Phase III Submission Approval KIT - 302 NT219* Osteoarthritis Pain & Hypertension Oncology * Through majority held subsidiary TyrNovo
Slide 21: About NT219
Ϯϭ About NT 219 • NT 219 is a small molecule developed jointly by Prof. Alexander Levitzki ( 2005 Wolf Prize in Medicine laureate) at the Hebrew University of Jerusalem, and Hadas Reuveni, Ph.D., founder and CTO of TyrNovo • In patient - derived xenograft (PDX ) models, NT 219 prevented acquired res
Slide 22: NT219 Mechanism of Action
NT 219 - Mechanism of Action ϮϮ • Anti - cancer drugs induce activation of two major feedback pathways, STAT 3 and IRS , leading to drug resistance • NT 219 effectively targets these feedback pathways and thereby overcomes drug resistance and extends the positive response to the drugs • Inhibition o
Slide 23: NT219 Prevents Resistance to Erlotinib
24 Response Erlotinib: Acquired resistance NT 219 prevents resistance to Erlotinib NT 219 : 100 Tumor Regression of Patient - Derived Head & Neck Cancer Implanted in mice (PDX model) Days (n= 8 ) (n= 8 ) (n= 8 ) (n= 8 ) NT 219 Prevents R esistance of Head & Neck tumors to EGFR Inhibitor erlotinib (
Slide 24: NT219 Converts Pancreatic Tumors Non-Responding to Gemcitabine to Responders
NT 219 Converts Pancreatic Tumors Non - Responding to Gemcitabine to Responders 25 Non - Responders Responders Tumor Regression of Patient - Derived Pancreatic Cancer Implanted in mice (PDX model)
Slide 25: NT219 Partnership Opportunities
NT 219 Partnership Opportunities 26 • Combination with NT 219 could expand efficacy, target population and patent lifespan of major oncology drugs • Accumulated annual global sales of the relevant cancer drugs exceeds $ 6 B NT - 219
Slide 26: Summary
Summary Ϯϲ Proven management team Proven management team with deep FDA experience and fast - track regulatory expertise Primary efficacy endpoint achieved Lead drug candidate KIT - 302 achieved its primary efficacy endpoint in a pivotal Phase III trial Marketing potential Pipeline candidates a ddres
Slide 27: Thank you
Thank you Company Headquarters One Azrieli Center Round Tower 132 Menahem Begin Road Tel Aviv 6701101 , Israel US Medical Research Office 1615 Suter's Lane NW Washington DC 20007 Contact Us Tel : + 972 - 3 - 9333121 Email: Info@kitovpharma.com Info@tyrnovopharma.com www.kitovpharma.com www.TyrNovoph
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