Can-Fite BioPharma Ltd. · TASE:CANF
Can-Fite BioPharma — Investor Presentation (January 2017)
20 slides from Can-Fite BioPharma's investor presentation, Jan 6, 2017
Slide 1: Can-Fite Presentation – January 2017
Can - Fite Presentation – January 2017
Slide 2: Forward Looking Statement
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 . In addition, from time to time, Can - Fite o
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: Platform Technology: A3 Adenosine Receptor
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 in Phase II studies; Excellent safety profile A 3 AR is utilized as
Slide 6: Drug Development Pipeline
Drug Development Pipeline 6 Phase III protocol – IRB Submissions Phase III protocol - Reached Agreement with EMA On - going On - going IRB Submissions
Slide 7: Corporate Partnerships
Corporate Partnerships Regional out - licensing deals ~$ 11 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 mi
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: Rheumatoid Arthritis - Positive Data from Phase II Study
Phase IIb study, Placebo controlled; 79 patients Rheumatoid Arthritis - Positive Data from Phase II Study 9 *MTX, Biological Drugs *MTX, Biological Drugs 1 mg *
Slide 10: Piclidenoson for Rheumatoid Arthritis
Naive patients no prior systemic therapy Piclidenoson for Rheumatoid Arthritis Methotrexate (MTX) is the recommended first - line therapy according to EULAR and ACR Approximately 70% of RA patients requiring DMARD therapy will start on MTX 1 » 40% in combination with other drugs Piclidenoson opportu
Slide 11: Piclidenoson Rheumatoid Arthritis Phase III Design
Piclidenoson Rheumatoid Arthritis Phase III Design Phase III clinical study 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 • Primary endpoint will be DAS at week 12
Slide 12: Piclidenoson for Psoriasis
▪ The study did not achieve the primary endpoint of PASI 75 at 12 weeks ▪ Excellent safety profile in all tested dosages ▪ Positive linear data on Weeks 12 to 32 Piclidenoson for Psoriasis 12 63.5% 35.3% 24.7% 10.6% P hase II/III study, Placebo controlled, 325 patients
Slide 13: Piclidenoson Compares Favorably To Celgene's Otezla
Piclidenoson Compares Favorably To Celgene’s Otezla 13 • Celgene off to a very strong start with Otezla®, posting sales of $ 472 million in 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 2015 annual rep
Slide 14: 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 15: Liver Cancer – Positive Data from Phase I/II Study
Liver Cancer – Positive Data from Phase I/II Study • 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 15 Phase I/II Positive
Slide 16: Liver Cancer – Phase II Global Study Ongoing
Phase II - Study Protocol • Second - Line Treatment • Advanced Hepatocellular Carcinoma; Child - Pugh B • 78 patients; • US, Europe and Israel • Primary end point: overall survival Regulatory Status • FDA and EMA have granted Orphan Drug status and FDA granted Fast Track status as a second line trea
Slide 17: Namodenoson for the Treatment of NASH
Namodenoson for the Treatment of NASH 17 Namodenoson markedly improved liver function & pathology in NAFLD and NASH experimental models • Namodenoson reduces NAFLD Activity Score ( NAS) • Significant decrease in steatosis, ballooning and lobular inflammation • A decrease in plasma ALT and triglyc
Slide 18: CF602 – Erectile Dysfunction – A Safe Drug
CF 602 – Erectile Dysfunction – A Safe Drug 18 Properties Cohen et al . Mediators of Inflammation. 2015 • A 3 AR allosteric modulator • Molecular weight – 411.34 • Water insoluble • Orally bioavailable • Belong to the family of imidazoquinoline derivatives Current status • Manufacturing of CF 602 to
Slide 19: CF602 – Reverse Erectile Dysfunction
CF602 – Reverse Erectile Dysfunction 19 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 20: Spotlight on 12 Month Milestones
Piclidenoson – Rheumatoid Arthritis (~$38B Opportunity) Phase III Trial Initiation Based on Agreement Reached with EMA 2017 Piclidenoson – Psoriasis (~$9B Opportunity) Phase III Trial Initiation Based on Agreement Reached with EMA 2017 Namodenoson – Liver Cancer (~$1.4B Opportunity) Complete Patient
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