Can-Fite Advances High-Stakes Trials for Cancer and Psoriasis

RAMAT GAN, Israel – December 16, 2025 – Can-Fite BioPharma is pushing forward with its ambitious clinical pipeline, with pivotal late-stage trials for liver cancer and psoriasis now at the forefront of its strategy. The Israeli biotechnology company provided a comprehensive update on its programs, highlighting several critical data readouts expected in 2026 that could define its future and potentially offer new hope for patients with few treatment options.

The company's progress hinges on two lead drug candidates, Namodenoson and Piclidenoson, both orally administered small molecules targeting the A3 adenosine receptor (A3AR), a mechanism designed to selectively act on diseased cells. With recent fundraising bolstering its balance sheet, Can-Fite is navigating the high-cost, high-reward landscape of late-stage drug development as it approaches key inflection points.

Pivotal Data on the Horizon

The most significant developments center on two ongoing Phase III studies. The first, a pivotal trial for Namodenoson, is targeting one of the most challenging patient populations in oncology: individuals with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, and severely compromised liver function known as Child-Pugh B7. This group currently has no approved therapies, representing a critical unmet medical need.

The LIVERATION study (NCT05201404) is actively enrolling an anticipated 450 patients across Europe, Israel, and the United States. An interim analysis of the trial's data is expected in the fourth quarter of 2026. According to the company, positive results from this analysis could pave the way for seeking conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), a potentially accelerated path to market. Namodenoson already holds Fast Track and Orphan Drug designations from the FDA for this indication, underscoring the urgency and seriousness of the condition.

In parallel, Can-Fite is advancing its other lead candidate, Piclidenoson, in a pivotal Phase III study (NCT06643260) for the treatment of moderate-to-severe plaque psoriasis. With an estimated market projected to exceed $30 billion by 2030, the psoriasis space is competitive, but there remains a strong demand for safe and effective oral therapies. An interim analysis for this trial is slated for the second quarter of 2026. This new study builds on a prior Phase III trial, COMFORT-1, which met its primary endpoint and demonstrated an excellent safety profile, notably with fewer gastrointestinal side effects compared to the established oral treatment, Otezla®.

A Pipeline Targeting Unmet Needs

Beyond its flagship programs, Can-Fite’s strategy is rooted in addressing diseases with limited therapeutic options. Namodenoson is also being investigated in a Phase IIb study for metabolic dysfunction-associated steatohepatitis (MASH), a severe and increasingly prevalent form of fatty liver disease that can lead to cirrhosis and liver failure. This trial follows a successful Phase IIa study that showed the drug had anti-inflammatory, anti-steatotic, and anti-fibrotic effects.

Furthermore, Namodenoson is being evaluated in a nearly-enrolled Phase IIa trial for patients with advanced pancreatic cancer who have failed initial treatments. Data from this study is also expected in the second quarter of 2026. Like advanced HCC, pancreatic cancer has grim survival rates and desperately needs new therapeutic approaches.

The company is also expanding the potential applications for Piclidenoson into rare diseases. Can-Fite has completed a Phase II study protocol for Lowe Syndrome, a rare genetic disorder affecting the eyes, brain, and kidneys for which no approved treatments exist. The company plans to submit this protocol to regulators in Italy and the EMA in the first quarter of 2026, signaling a commitment to leveraging its platform technology for orphan conditions.

Balancing Clinical Ambition with Financial Reality

Advancing multiple late-stage clinical trials is a capital-intensive endeavor, and Can-Fite's recent financial maneuvers reflect this reality. As of June 30, 2025, the company reported cash and equivalents of $6.45 million. This was subsequently bolstered by a $5 million public offering in July and an additional $2.2 million raised through its at-the-market (ATM) facility in November, bringing its cash position to approximately $13.65 million.

These funds are critical as the company's operational costs rise with the progression of its trials. Net losses for the first half of 2025 stood at $4.87 million, up from $3.95 million in the same period of 2024, driven by increased research and development spending on the HCC and psoriasis trials. This burn rate suggests the recent capital injections provide a runway to navigate the upcoming data catalysts in 2026. The success of these trials will be paramount not only for patients but also for securing the company's long-term financial stability.

“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, in a statement. “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.”

The coming year is set to be transformative for Can-Fite. The interim data from its two lead candidates will serve as a crucial test of its A3AR platform technology and its strategy of targeting underserved patient populations. For investors, patients, and clinicians alike, the results will determine whether these promising oral drug candidates can move one step closer to becoming approved therapies.