On December 16, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, reported an update on its clinical development activities and financial status.

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Namodenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function. This patient population represents a significant unmet medical need, as no approved therapies are currently available. An interim analysis from the Phase III study is expected to be in approximately Q4 2026. Subject to positive interim results, the Company may be eligible to seek conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In parallel, Can-Fite is enrolling patients in a Phase IIb clinical study of Namodenoson for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This study follows positive results from a completed Phase IIa trial, which demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature.

In addition, Namodenoson is being evaluated in a Phase IIa clinical study in patients with pancreatic cancer who have failed first-line treatment. Patient enrollment in this study is nearing completion, and the Company expects to report data during the second quarter of 2026.

Piclidenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study for the treatment of psoriasis. In this study, patients receive Piclidenoson orally, administered twice daily. The primary efficacy endpoints of the trial are PASI 75 (Psoriasis Area and Severity Index) and Physician’s Global Assessment (PGA), consistent with regulatory guidance for late-stage psoriasis studies. Based on the Company’s current assumptions, interim analysis data is expected to be released in the second quarter of 2026. The Company also completed the development of a Phase II study protocol for the rare genetic disease Lowe Syndrome and plans to submit it to regulatory authorities in Italy and EMA during Q1 2026.

Cash and cash equivalents: As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million. On July 28, 2025, Can-Fite completed a public offering for aggregate gross proceeds of $5 million. In November 2025 Can-Fite Raised $2.2M through its ATM facility.

"Our advancing clinical programs reflect Can-Fite’s focused strategy of addressing significant unmet medical needs with orally administered, well-characterized drug candidates," said Motti Farbstein, Chief Executive Officer of Can-Fite BioPharma. "With pivotal Phase III studies ongoing in liver cancer and psoriasis, alongside progressing mid-stage programs in MASH and pancreatic cancer, we believe we are well positioned to generate meaningful clinical data over the coming quarters while maintaining disciplined execution."

(Press release, Can-Fite BioPharma, DEC 16, 2025, View Source [SID1234661453])