Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Kitov Pharmaceuticals Holdings — Investor Presentation (November 2017)
27 slides from Purple Biotech's investor presentation, Nov 29, 2017
Slide 1: Innovative Biopharmaceuticals Corporate Presentation November 2017
Thank you Innovative Biopharmaceuticals CORPORATE PRESENTATION November 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 th
Slide 3: Company Profile
Company Profile • Founded in 2010 ; publicly traded on TASE 2013 ; IPO on NASDAQ in November 2015 • Tickers: KTOV (ADSs); KTOVW (Warrants) • Cash on hand (as of October 31 , 2017 ): $ ϴ .6 M; no debt • Market Cap: $ 27 M * • Issued & outstanding capital equivalent to 1 ϭ .2 million ADSs ** ϯ PROVEN
Slide 4: Experienced Management
Experienced Management ϰ Paul Waymack, M.D., Sc.D. Chairman of the Board & 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, T
Slide 5: Pipeline
Pipeline ϱ Drug Therapeutic Field Preclinical Phase I/II Phase III Submission Approval KIT - 302 Osteoarthritis pain and hypertension NT - 219 Oncology PDUFA target date: May 31 , 2018 ϱ
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” label 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 endpoint ϴ Newly diagnosed hypertensive pati
Slide 9: Phase III Trial Results
KIT - 302 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 fu
Slide 10: Second Phase III/IV Trial Design
KIT - 302 Second Phase III/IV Trial Design ϭϬ 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 tria
Slide 11: Second Phase III/IV Trial Results
KIT - 302 Second Phase III/IV Trial Results ϭϭ • Primary efficacy endpoint successfully met (p= 0.019 ), thus first Phase III trial results validated • Statistically significant reduction of serum creatinine observed vs. baseline • KIT - 302 enhanced the creatinine reduction by an average of 102 % v
Slide 12: US Target Markets
KIT - 302 US Target Markets ϭϮ KIT - 302 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.arthriti
Slide 13: Benefits All Stakeholders
KIT - 302 Benefits All Stakeholders ϭϯ KIT - 302 KIT - 302 is 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 two conditions simultaneously • Increases convenience (one pill instead of two
Slide 14: Commercialization
KIT - 302 Commercialization ϭϰ South Korea - Exclusively licensed to Kuhnil Pharmaceuticals (March 2017 ) Ongoing partnership discussions in the US and EU
Slide 15: Pipeline
Pipeline ϭϱ Drug Therapeutic Field Preclinical Phase I/II Phase III Submission Approval KIT - 302 Osteoarthritis pain and hypertension NT - 219 Oncology PDUFA target date: May 31 , 2018 ϭϱ
Slide 16: NT-219: Overcoming Cancer Drug Resistance
ϭϲ NT - 219 : Overcoming Cancer Drug Resistance • Recently acquired majority ( 92 %*) shares in privately held TyrNovo Ltd. • TyrNovo develops NT - 219 , a first - in - class small molecule that prevents, reverses, and delays resistance to anti - cancer drugs • Dual inhibitor of STAT 3 and IRS 1 / 2
Slide 17: NT-219: Mechanism of Action
NT - 219 : Mechanism of Action • Anti - cancer drugs induce activation of two feedback pathways, STAT 3 and IRS, leading to drug resistance • NT - 219 simultaneously targets STAT 3 and IRS 1 / 2 , thereby overcoming drug resistance and extending the positive response to the drugs • Inhibition of STA
Slide 18: Prevents Acquired Resistance to EGFR Inhibitor (Tarceva) in Head and Neck Cancer
NT - 219 Prevents Acquired Resistance to EGFR Inhibitor (Tarceva®) in Head and Neck Cancer Results in PDX Models When administered in combination with Tarceva®, no resistance was developed 18
Slide 19: Reverses Existing Resistance to Tarceva in Head and Neck Tumors
NT - 219 Reverses Existing Resistance to Tarceva® in Head and Neck Tumors Results in PDX Models (cont’d) When administered after development of resistance, NT - 219 reversed resistant tumors to sensitive 19
Slide 20: Delays Recurrence of Tumors of Head and Neck with Cetuximab
NT - 219 Delays Recurrence of Tumors of Head and Neck with Cetuximab Results in PDX Models (cont’d) Tumors treated with NT - 219 and Cetuximab took much longer to develop following treatment discontinuation 20
Slide 21: Prevents Acquired Resistance to MEK Inhibitor (Mekinist)
Results in PDX Models (cont’d) 21 When administered in combination with Mekinist® (Trametinib), a prolonged effect was observed ) 3 Tumor volume (mm NT - 219 Prevents Acquired Resistance to MEK Inhibitor (Mekinist®) in Mutated - BRAF Anaplastic Thyroid Cancer
Slide 22: Converts Non-Responding Tumors to Keytruda Responders
NT - 219 Converts Non - Responding Tumors to Keytruda® to Responders in Humanized PDX of Esophagus Cancer Double autologous model - tumors and PBMCs of the same patient Results in Immuno - Oncology PDX Model in Combination with Keytruda® 22
Slide 23: Summary of Demonstrated Efficacy
Summary of Demonstrated Efficacy TYPE DRUG (TRADE NAME) CANCER TYPE COMPANY Targeted Drugs Antibody Cetuximab (Erbitux ® ) Head and Neck Merck / Eli Lilly Cetuximab (Erbitux ® ) + FOLFOX/FOLFIRI Colon (wt KRAS) Kinase Inhibitors Erlotinib (Tarceva ® ) Head and Neck Roche / Astellas Afatinib (Giotrif
Slide 24: Selection of First Indication
Selection of First Indication • Genomic analysis of resistant tumors in the H&N model revealed amplification in KRAS and NF - 1 loss • Since KRAS mutation is associated with 95 % of pancreatic tumors, biopsies from four different pancreatic cancer patients were tested • Results demonstrated benefici
Slide 25: Converts Non-Responding Tumors to Responders to Gemcitabine in Pancreatic Cancer
NT - 219 Converts Non - Responding Tumors to Responders to Gemcitabine in 4 / 4 PDX Models of Pancreatic Cancer Days Days 25 Days Days ) 3 Tumor volume (mm ) 3 Tumor volume (mm ) 3 Tumor volume (mm ) 3 Tumor volume (mm Expected Phase I/II Clinical Trial
Slide 26: Summary
Summary Proven management team • Management team with track record in drug development and regulatory expertise Balanced and diverse pipeline • Lead drug candidate KIT - 302 approval expected in May 2018 • NT - 219 IND submission expected in 12 - 18 months Large m arket potential • KIT - 302 address
Slide 27: Thank you
Thank you Innovative Biopharmaceuticals 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: Info@kitovpharma.com Info@tyrnovopharma.com www.kitovpharma.com www.TyrNov
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