Can-fite Biopharma Ltd. · TASE:CANF
Can-fite Biopharma — Investor Presentation (September 2017)
22 slides from Can-fite Biopharma's investor presentation, Sep 8, 2017
Slide 1: Can-Fite Presentation – September 2017
Can - Fite Presentation – September 2017
Slide 2: Forward-looking statements
This presentation contains forward - looking statements, about Can - Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects . All statements in this communication, other
Slide 3: Company Profile, Operations, Financial Summary
3 Company Profile Operations Financial Summary Proprietary Core Technology • Headquarters & Discovery Labs – Petach - Tikva, Israel • Drug Development & Clinical Trials Group – Boston • Highly experienced team in clinical trials / regulatory • Advanced clinical stage drug development company with a
Slide 4: From Concept to Technology
From Concept to Technology 4 Company platform technology mimics natural body mechanism to combat cancer and inflammation
Slide 5: A3 Adenosine Receptor Platform Technology
Therapeutic Target • A 3 adenosine receptor (A 3 AR ) • Highly expressed in inflammatory and cancer cells Drug product • Small molecules • Orally bioavailable drugs Therapeutic Effect • Anti - inflammatory and anti - cancer effects shown in Phase II studies; Excellent safety profile A 3 AR is utiliz
Slide 6: Drug Development Pipeline
Drug Development Pipeline 6 Enrollment to Commence 2018 Enrollment to Commence Q3 2017 On - going Completed Enrollment Q 3 2017 Enrollment to Commence Q 3 2017
Slide 7: Corporate Partnerships
Corporate Partnerships Regional out - licensing deals ~$ 11.5 million* received to date [Traded on South Korean Stock Exchange (Ticker : A 009290 )] • Exclusive regional license to develop and commercialize Piclidenoson for the treatment of rheumatoid arthritis in Korea • Up to $1.5M in upfront and
Slide 8: Piclidenoson (CF101) – Anti-Inflammatory Effect
Piclidenoson (CF101) – Anti - Inflammatory Effect • Highly Selective A 3 AR Agonist • Nucleoside derivative • Molecular weight - 510.29 • Water insoluble • Orally bioavailable • Half life time in blood – 8 - 9 hours • Is not metabolized in the body; secreted unchanged Properties Proof of concept in
Slide 9: Piclidenoson as First-Line RA Oral DMARD Therapy
Naive patients no prior systemic therapy Piclidenoson as First - Line RA Oral DMARD Therapy • Entering Phase III for treatment of Rheumatoid Arthritis (RA) • Methotrexate (MTX) is the recommended first - line therapy according to EULAR and ACR • Approximately 70 % of RA patients requiring DMARD ther
Slide 10: Piclidenoson Phase IIb Results in RA
Phase IIb study, Placebo controlled; 79 patients – Positively concluded Piclidenoson Phase IIb Results in RA 10 *MTX, Biological Drugs *MTX, Biological Drugs 1 mg *
Slide 11: Piclidenoson ACRobat Phase III
Piclidenoson ACRobat Phase III to Commence Q3 2017 ACRobat – Can - Fite’s Phase III clinical study is designed to establish Piclidenoson is non - inferior to MTX in newly diagnosed patients with moderate - to - severe RA • Randomized , double - blind, active and placebo - controlled • 500 patients t
Slide 12: Piclidenoson for Moderate to Severe Psoriasis
Piclidenoson for Moderate to Severe Psoriasis • Entering Phase III for treatment of moderate - to - severe plaque Psoriasis • Excellent safety profile for long - term use • Compares very favorably with leading oral therapy Oztela® • Phase II/III study did not achieve the primary endpoint of PASI 75
Slide 13: Piclidenoson Compares Favorably To Celgene's Otezla
Piclidenoson Compares Favorably To Celgene’s Otezla 13 • Otezla® sales were $1 billion in 2016, a 116% increase over 2015 1 • Peak Otezla® sales estimated at $2.35 billion in 2020 2 • Piclidenoson compares well to Otezla® at weeks 24 - 32 3 Sources: 1 ) Celgene 2016 annual report 2 ) DrugAnalyst, Lt
Slide 14: Piclidenoson Comfort Phase III
Piclidenoson Comfort Phase III Comfort – Phase III clinical study is designed to establish Piclidenoson superiority vs. placebo and non - inferiorty vs. Otezla in patients with moderate - to - severe Plaque Psoriasis • Randomized , double - blind, active and placebo - controlled • 407 patients to be
Slide 15: Namodenoson (CF102) – Anti-Cancer & NAFLD/NASH
Namodenoson (CF102) – Anti - Cancer & NAFLD/NASH • Highly Selective A 3 AR Agonist • Nucleoside derivative • Molecular weight - 544.73 • Water insoluble • Orally bioavailable • Half life time in blood – 12 hours Drug Profile Proof of concept in pre - clinical pharmacology studies: • Hepatocellular C
Slide 16: Namodenoson for the Treatment of Liver Cancer
Namodenoson for the Treatment of Liver Cancer • Very favorable safety profile and lack of hepatotoxicity • Prolongation of survival time • Regression of skin tumor metastases • Stable disease (22%) • Proof of concept for A3AR utilization as a biomarker Market Opportunity 16 Phase I/II Positive Resul
Slide 17: Liver Cancer Phase II Study Completed Enrollment
Phase II - Study Protocol • Second - Line Treatment • Advanced Hepatocellular Carcinoma; Child - Pugh B • 78 patients • US, Europe and Israel • Primary end point: overall survival • Patient enrollment completed August 2017 • Currently following survival data and will perform survival analysis at ear
Slide 18: Namodenoson for the Treatment of NASH
Namodenoson for the Treatment of NASH 18 Sources: 1) Study published in Hepatology, 2) NIH, 3) Study published in Gastroenterology, 4 ) Deutsche Bank “ America’s Greatest Health Risk” – Scientific American, 2015 x 17% - 33% Prevalence of NAFLD in the U.S. 1 x 2 - 5 % of U.S. Population has NASH 2
Slide 19: Namodenoson's Efficacy in NAFLD & NASH
Namodenoson’s Efficacy in NAFLD & NASH 19 Namodenoson markedly improved liver function & pathology in NAFLD and NASH experimental models (STAM & CCL4) x Namodenoson reduces NAFLD Activity Score (NAS) in STAM model x Robust anti - Fibrogenic effect in vitro and in the CCL4 model x Significant decr
Slide 20: Namodenoson – Phase II in Treatment NAFLD/NASH
Namodenoson – Phase II in Treatment NAFLD/NASH 20 Phase II - Study Protocol • Namodenoson in the treatment of non - alcoholic fatty liver disease (NAFLD), the precursor to non - alcoholic steatohepatitis (NASH) • Multicenter, randomized, double - blinded, placebo - controlled, dose - finding effi
Slide 21: CF602 – Reverse Erectile Dysfunction
CF602 – Reverse Erectile Dysfunction 21 Significant full recovery from erectile dysfunction in diabetic rat model • Dose - dependent, linear effect • Response after single dose of CF602 Novel mechanism of action • Up - regulation of eNOS and VEGF • Improves vasodilation and smooth muscle relaxation
Slide 22: Spotlight on 12 Month Milestones
Piclidenoson – Rheumatoid Arthritis (~$ 35 B Opportunity) Phase III Trial Initiation Based on Agreement Reached with EMA Q3 2017 Piclidenoson – Psoriasis (~$9B Opportunity) Phase III Trial Initiation Based on Agreement Reached with EMA 2018 Namodenoson – Liver Cancer (~$1.4B Opportunity) Announce Ph
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