Can-fite Biopharma Ltd. · TASE:CANF
Can-fite Biopharma — Investor Presentation (September 2023)
22 slides from Can-fite Biopharma's investor presentation, Sep 7, 2023
Slide 1: Small Molecules for Big Clinical Needs
Small Molecules for Big Clinical Needs NYSE American:CANF | September 2023 Investor Presentation TM
Slide 2: Forward Looking Statement
Forward Looking Statement 2 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 i
Slide 3: Company Overview
Small Molecule Drugs for the Treatment of Oncological and Inflammatory Diseases Robust Clinical Proof of Concept & Excellent safety profile Successful Out - licensing Deals Company Overview 3 1 2 3 Financial Summary (Ticker: CANF) Listed on NYSE American and Tel - Aviv Stock Exchange ~4 M ADRs outst
Slide 4: A3 Adenosine Receptor Platform Technology
4 Normal Cells • Global leader in discovering and developing drugs that target the A3 adenosine receptor (A3AR) Therapeutic Target • Demonstrated in >1600 patients across clinical trials Excellent Safety Profile • High efficacy and good safety ptofile with anti - inflammatory and anti - cancer effec
Slide 5: Pipeline Drugs
Pipeline Drugs 5 Piclidenoson Psoriasis Phase 1 Phase 3 Phase 2 Pre - Clinical Namodenoson Liver Cancer SLD Pivotal Phase III agreed with FDA & EMA Pivotal Phase 3 Phase 2b CF602 Erectile Dysfunction Cannabinoids Ongoing Drug/Indication Ongoing Pancreatic Cancer Preparatory Work for exploratory Phas
Slide 6: Corporate Partnerships: Current Out-Licensing Deals
Corporate Partnerships: Current Out - Licensing Deals potential based on regulatory and sales milestones $20M received in upfront and milestone payments $130M *$8.5M was from a license with a Japanese company, SKK; the license was terminated due to SKK’s strategic change of focus to ind ications not
Slide 7: Moderate to Severe Psoriasis: Piclidenoson
Moderate to Severe Psoriasis Piclidenoson • Nucleoside derivative • Highly Selective A3AR Agonist • Molecular weight - 510.29 • Water insoluble • Half lifetime in blood – 8 - 9 hours Piclidenoson Drug Candidate Chemical Properties 7
Slide 8: Piclidenoson - Drug Profile
Piclidenoson - Drug Profile • Overexpression of the A3AR target in Keratinocytes of psoriasis patients • Robust anti - inflammatory effect manifested by specific apoptosis of inflammatory cells • Piclidenoson inhibits IL - 17 & IL - 23 production in keratinocytes • Piclidenoson had significant anti
Slide 9: Phase III Study Endpoints - Achieved
9 Phase III Study Endpoints - Achieved PASI 75 Significant Superiority of Piclidenoson 3 mg vs. Placebo Primary Endpoint Secondary Endpoint Subjects Achieving PGA2 for Piclidenoson vs Placebo I Study Design Excellent Safety Profile
Slide 10: Lowe Syndrome Rare Genetic Disease
10 An agreement for co - development has been signed with the Italian Theleton Fund Lowe Syndrome Rare Genetic Disease 10 • Lowe Syndrome - Known as oculo - cerebro - renal syndrome (OCRL), an X - linked genetic condition occurring in males • Piclidenoson - Correct this genetic syndrome in pre - cli
Slide 11: Regulatory Status: Psoriasis Pivotal Phase III
11 • FDA and EMA - agreed on the psoriasis registration Plan • Pivotal Phase III looking at Piclidenoson Vs. Placebo • Primary endpoint – PASI 75 & PGA 2 • Adolescents will be included Regulatory Status Psoriasis Pivotal Phase III 11 II
Slide 12: Oncology & SLD: Namodenoson
Oncology & SLD Namodenoson • MW: 544.73 g/mol • Water Insoluble • Half life: 12 hours • Nucleoside Derivative • Orally Bioavailable • High Stability in the Liver Namodenoson Drug Candidate Chemical Properties 12
Slide 13: Namodenoson for the Treatment of Advanced Liver Cancer
Piclidenoson - Drug Profile • A3AR is over - expressed in human hepatocellular carcinoma (HCC) cells. • Namodenoson induces de - regulation of the Wnt and NF - kB signalling pathways resulting in apoptosis of HCC cells. • In Phase II study in patients with advanced HCC, Namodenoson was safe and well
Slide 14: Complete Response in a Namodenoson Treated Patient
Piclidenoson - Phase II/III Study HCC Phase II Study – Recent Data • Patient was enrolled in Phase II liver cancer study • Continued treatment with Namodenoson for >6 years under Open Label Extension Program in Europe • Patient had Complete Response: Completely cleared all cancer lesions • Over the
Slide 15: Advanced Liver Cancer Pivotal Phase 3
• FDA and EMA agreed on Pivotal Phase 3 study protocol • Interim analysis to be conducted by Independent Data Monitoring Committee (IDMC) after 50% of planned 450 patients are enrolled and treated • Namodenoson evaluated as a 2nd - or 3rd - line treatment for advanced liver cancer patients in whom o
Slide 16: Namodenoson for the Treatment of Pancreatic Cancer
Piclidenoson - Drug Profile • Namodenoson induces 90% growth inhibition of pancreatic cancer cells • The molecular mechanism of action includes de - regulation of the Wnt and the Ras signaling pathways • In vivo studies showed robust inhibition of pancreatic tumor size Rationale for Development Namo
Slide 17: Exploratory Phase II Study in Pancreatic Cancer
17 Pancreatic Cancer Second line therapy • Open label • Oral dose of Namodenoson: 25 mg twice daily • Primary End point: safety • Secondary Endpoints: objective response, progression - free survival, duration of response, disease control (defined as an objective response or stable disease), overall
Slide 18: Namodenoson for Steatotic Liver Disease (SLD)
Piclidenoson - Drug Profile • Induction of anti - inflammatory effect manifested by reduction of NAFLD Activity Score (NAS) • Anti - fibrotic effect • Anti - steatotic effect: significant decrease in steatosis, ballooning and lobular inflammation • A decrease in ALT & AST and triglyceride levels • L
Slide 19: SLD Phase IIa Concluded; Phase IIb Enrolling
19 Phase IIa Study Successfully Concluded: • Reduced liver fat content (LFC) • Anti - Inflammatory effect • Dose selection for Phase 2b determined • Decrease in body weight • Excellent safety profile Designed to Address Severe Unmet Need; No FDA - Approved Treatment Currently Enrolling Patients for
Slide 20: CF602 Erectile Dysfunction (ED)
VEGF a - SMA e - NOS Reverse of Erectile Dysfunction Mechanism of Action • Up - regulation of eNOS and VEGF • Improves vasodilation and smooth muscle relaxation Rationale: Anecdotal reports from patients treated with Can - Fite’s drugs, both women and men, testifying that the drugs reversed their se
Slide 21: Cannabinoids
Rationale: Cannabinoids are known to bind to A3 adenosine receptor (A3AR) and mediate clinical effects 21 Cannabinoids Can - Fite filed a patent protecting the discovery of cannabinoid - based treatment of diseases where A3AR is overexpressed including liver cancer, other cancers, autoimmune inflamm
Slide 22: Closing Highlights
Monetizing advanced portfolio through c orporate partnerships – Piclidenoson and Namodenoson have been out - licensed in select territories with ~$20 million received to date and potentially up an additional $130 million plus royalties Oral drugs with proven safety and efficacy in Phase 2 & 3 – Picl
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