Ramat Gan, Israel, November 26, 2025 — Can-Fite BioPharma has announced key updates across its advanced-stage clinical pipeline ahead of a major presentation at the Noble Capital Markets Emerging Growth Equity Conference. The company is preparing to showcase significant progress for its lead drug candidates Namodenoson and Piclidenoson, both of which are currently advancing through Phase III and Phase II clinical programs in multiple therapeutic areas, including hepatocellular carcinoma (HCC), psoriasis, metabolic dysfunction-associated steatohepatitis (MASH), pancreatic cancer, and a rare genetic disorder. This broad development activity underscores Can-Fite’s commitment to applying its targeted A3 adenosine receptor (A3AR) technology across several high-need disease areas.
Science Significance
Can-Fite’s technology hinges on the selective targeting of the A3 adenosine receptor, a biomarker highly expressed in diseased tissues such as tumor cells, inflamed psoriatic skin, and fibrotic liver tissue. This receptor-specific expression enables Namodenoson and Piclidenoson to exert anti-inflammatory, anti-proliferative, and anti-fibrotic effects while sparing healthy cells, offering a scientifically compelling therapeutic advantage. Namodenoson has demonstrated tumor growth inhibition and survival benefits in HCC through modulation of pathways such as NF-κB and Wnt signaling, both critical in cancer biology. In MASH, the molecule’s anti-fibrotic effects and favourable metabolic influence position it as a promising candidate for a disease with growing global prevalence. Piclidenoson, meanwhile, acts on inflammatory pathways relevant to autoimmune conditions and has shown meaningful improvements in psoriasis by reducing inflammatory cytokine expression. The ability of a single molecular target to address diverse diseases highlights the versatility and scientific depth of the A3AR platform.
Regulatory Significance
Several of Can-Fite’s programs are approaching key regulatory milestones. Namodenoson is currently undergoing a pivotal Phase III trial in hepatocellular carcinoma, a disease area with limited treatment options, and its progress may lead to regulatory submissions if primary endpoints are met. The drug also holds regulatory advantages, including Orphan Drug designation in certain jurisdictions for HCC, which provides incentives such as market exclusivity and assistance during the approval process. Meanwhile, Piclidenoson’s Phase III psoriasis trial may establish a new oral therapeutic alternative to injectable biologics, offering accessibility benefits that could appeal to regulators, providers, and patients. The advancements across these trials position Can-Fite to engage with global regulatory agencies on multiple fronts, reflecting an increasingly mature clinical portfolio.
Business Significance
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For Can-Fite, the convergence of multiple late-stage trials represents a moment of substantial business opportunity. Success in any one indication could generate strong commercial traction, while positive data across several programs would significantly elevate the company’s valuation and partnership potential. Can-Fite has already secured multiple licensing agreements across different regions, creating pathways for global distribution and revenue generation.
The breadth of the pipeline — spanning oncology, dermatology, metabolic disease, and rare disorders — positions the company to compete in several lucrative markets. Its focus on orally administered small molecules provides additional advantages in scalability, pricing flexibility, and global accessibility, making its products particularly attractive to regions that struggle with the cost and logistics of biologics.
Patients’ Significance
For patients living with HCC, psoriasis, MASH, or pancreatic cancer, Can-Fite’s drug candidates represent the possibility of effective, targeted, and more tolerable therapies compared with existing options. HCC patients often face limited choices and poor prognosis, making Namodenoson’s potential impact especially meaningful. In psoriasis, Piclidenoson could offer patients a convenient oral therapy that avoids the burden of injections and long-term immunosuppression. For MASH patients — a growing global population with few approved treatments — Namodenoson’s anti-fibrotic potential offers hope for slowing or reversing liver damage. Each advancement moves patients closer to accessible treatments that address underlying disease mechanisms rather than offering symptom management alone.
Policy Significance
The progress across Can-Fite’s pipeline aligns with global health priorities that emphasize innovation in cancer care, chronic disease management, metabolic health, and equitable access to therapies. The company’s focus on oral small-molecule therapeutics supports policies aimed at reducing treatment burden and healthcare costs by minimizing reliance on expensive biologics and advanced infusion infrastructure.
If Namodenoson or Piclidenoson progress toward approval, they may influence clinical guideline updates and reimbursement policies, particularly in regions where affordability and accessibility remain major barriers to care. The company’s multi-indication approach also supports policy goals related to accelerating drug development through biomarker-driven mechanisms and targeted therapies
Can-Fite BioPharma’s upcoming presentation highlights a pivotal moment in its evolution, with multiple late-stage clinical candidates advancing across a diverse set of high-need indications. Through its scientifically validated A3AR platform, the company is driving forward a portfolio that holds promise for meaningful therapeutic innovation across oncology, inflammatory disease, and metabolic disorders. As the company prepares for key readouts and potential regulatory pathways, its expanding clinical progress may soon translate into accessible, targeted therapies for patients worldwide.
Source: Can-Fite BioPharma press release
