Can-Fite Biopharma Ltd ADR Dossier
Qualitative Analysis
Business overview
Can-Fite BioPharma Ltd. is an advanced clinical-stage biopharmaceutical company headquartered in Ramat Gan, Israel. The company focuses on developing orally bioavailable small-molecule therapeutics targeting the A3 adenosine receptor (A3AR). A3AR is highly expressed in pathological cells (such as inflammatory and cancer cells) but has low expression in normal cells, providing a highly specific therapeutic target. Can-Fite's pipeline includes Piclidenoson (CF101), which has completed Phase III trials for psoriasis; Namodenoson (CF102), currently in Phase III trials for advanced hepatocellular carcinoma (liver cancer), Phase IIb trials for metabolic associated steatohepatitis (MASH), and Phase IIa/IIb trials for pancreatic cancer; and CF602, a pre-clinical candidate for erectile dysfunction.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Initiation and enrollment of a pivotal, randomized, double-blind, placebo-controlled Phase III clinical study of oral Piclidenoson (3 mg twice daily) in patients with moderate-to-severe plaque psoriasis.
Expected impact: Aims to demonstrate clinical safety and efficacy to support a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA.
Advancing Namodenoson into a Phase IIb combination study with immunotherapy for advanced pancreatic cancer following positive Phase IIa safety and survival data, alongside the ongoing pivotal Phase III LIVERATION study for advanced hepatocellular carcinoma.
Expected impact: Expands the addressable oncology market for Namodenoson and targets high-unmet-need indications.
Preparatory work and protocol development for an open-label Phase II pilot study evaluating the safety and efficacy of Piclidenoson in pediatric patients with the rare genetic disorder Lowe Syndrome.
Expected impact: Establishes a pathway in rare orphan diseases, which benefit from accelerated regulatory review and smaller trial size requirements.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
High
Terms: Vetbiolix is responsible for all development and regulatory costs. Can-Fite is entitled to upfront, milestone, and royalty payments (15% royalty on worldwide sales) potentially totaling up to $325 million over the next decade.
Medium
Terms: Collaborative clinical development of Piclidenoson for Lowe Syndrome, leveraging preclinical research from the Telethon Institute of Genetics and Medicine (TIGEM).