Can-fite Biopharma Ltd. · TASE:CANF
Can-fite Biopharma — Investor Presentation (February 2025)
23 slides from Can-fite Biopharma's investor presentation, Feb 5, 2025
Slide 1: Small Molecules for Big Clinical Needs
Small Molecules for Big Clinical Needs TM NYSE American:CANF February 2025
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation may contain 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
Slide 3: Safe Drugs for the Treatment of Oncological and Inflammatory Diseases
Safe Drugs for the Treatment of Oncological and Inflammatory Diseases Advanced Clinical Stage Pipeline; Short Regulatory Approval Pathway (FDA & EMA) Successful Out - licensing Deals Company Overview 1 2 3 Financial Summary 4 NYSE American: CANF
Slide 4: Global leader in drugs that target the A3 adenosine receptor (A3AR)
Global leader in discovering and developing drugs that target the A3 adenosine receptor (A3AR) Therapeutic Target • Demonstrated in > 1600 patients Excellent Safety Profile • Good efficacy and safety with anti - inflammatory and anti - cancer effects shown in Phase 2 and Phase 3 studies Proven Thera
Slide 5: Pipeline Drugs
Pipeline Drugs Piclidenoson Phase 1 Phase 3 Phase 2 Pre - Clinical Namodenoson Psoriasis Pivotal Phase III agreed with FDA & EMA MASH Phase IIb Ongoing CF602 Erectile Dysfunction Ongoing Drug/Indication Pancreatic Cancer Phase IIa Ongoing Liver Cancer Pivotal Phase III agreed with FDA & EMA; Ongoing
Slide 6: Corporate Partnerships: Current Out-Licensing Deals
potential based on regulatory and sales milestones $ 20M received in upfront and milestone payments $ 130 M Psoriasis, Liver Cancer, MASH Liver Cancer, MASH Psoriasis Psoriasis Psoriasis, Liver Cancer, MASH Pancreatic cancer Typical Deal Structure • Up - front money upon signing a distribution deal
Slide 7: Piclidenoson Drug Candidate Chemical Properties
Inflammatory Indications Piclidenoson • Nucleoside derivative • Highly Selective A 3 AR Agonist • Molecular weight - 510.29 • Water insoluble • Half lifetime in blood – 8 - 9 hours Piclidenoson Drug Candidate Chemical Properties
Slide 8: Moderate to Severe Psoriasis Piclidenoson
Moderate to Severe Psoriasis Piclidenoson
Slide 9: Piclidenoson for the Treatment of Plaque Psoriasis
• 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 - psoriatic effects and prom
Slide 10: Phase III Study Endpoints Achieved
Phase III Study Endpoints - Achieved PASI 75 Significant Superiority of Piclidenoson 3 mg vs. Placebo Primary Endpoint Secondary Endpoint Subjects Achieving PGA 2 for Piclidenoson vs Placebo I Study Design Excellent Safety Profile 10 NYSE American: CANF
Slide 11: Pivotal Phase III
Pivotal Phase III II • Pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). • Oral piclidenoson 3 mg twice daily (BID) in subjects with moderate - to - severe plaque psoriasis, compared with placebo • The co - pri
Slide 12: Osteoarthritis in Pets Piclidenoson
Osteoarthritis in Pets Piclidenoson Partnership with Veterinarian Company Vetbiolix
Slide 13: Inhibition of Osteoarthritis in Dogs
A 3 AR is over - expressed in inflamed synovial cells • Piclidenoson has robust anti - inflammatory effect manifested by inhibition of osteoarthritis in murine models • Clinical study in beagles has been successfully concluded reaching primary and secondary endpoints • Primary objective was LOAD (Li
Slide 14: Namodenoson Drug Candidate Chemical Properties
Oncology & MASH (NASH) 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
Slide 15: Advanced Liver Cancer: Rationale for Development
A 3 AR 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 tolerated. Evidence of ant
Slide 16: HCC Phase II Study – Recent Data
HCC Phase II Study – Recent Data • Patient was enrolled in Phase II liver cancer study • Continued treatment with Namodenoson for > 7 years under Open Label Extension Program in Europe • Patient had Complete Response: Completely cleared all cancer lesions • Over the course of 7 years, clinical benef
Slide 17: Liver Cancer Pivotal Phase III Ongoing
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 2 nd - or 3 rd - line treatment for advanced liver cancer patients in whom
Slide 18: Pancreatic Cancer Rationale for Development
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 Pancreatic Cancer NYSE American:
Slide 19: Phase IIa Study in Pancreatic Cancer
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 sur
Slide 20: MASH: Rationale for Development
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 • Decrease in ALT, AST, Triglyceride levels • Namodenoson protects the liver agains
Slide 21: MASH Phase IIa Concluded; Phase IIb Enrolling
Phase IIa Study Successfully Concluded: • Reduced liver fat content (LFC) • Anti - Inflammatory effect • Dose selection for Phase IIb determined • Decrease in body weight • Excellent safety profile Addressing Severe Unmet Need Currently Enrolling Patients for a Phase IIb Study US Patent Office Grant
Slide 22: CF602 Erectile Dysfunction
VEGF - 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 drugs, both women and men, testifying that the drugs reversed their sexual d
Slide 23: Closing Highlights
Monetizing advanced portfolio through corporate 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 Pivotal Phase III
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