Can-Fite Secures $175M for Phase 3 Trials of Namodenoson and Piclidenoson

In Ramat Gan, Israel, on May 5, 2025, Can-Fite BioPharma Ltd., a prominent biotechnology firm, announced its significant achievement in securing $175 million in funding. This financial milestone has been pivotal in advancing the company's premier drug candidates, Namodenoson and Piclidenoson, into critical Phase III clinical trials targeting liver cancer and psoriasis, respectively. Can-Fite is renowned for its specialized focus on developing small-molecule drugs that target the A3 adenosine receptor (A3AR), a receptor notably found in both cancerous and inflammatory cells.

Namodenoson, an orally administered agonist of A3AR, is currently enrolling patients in a pivotal Phase III trial aimed at treating advanced liver cancer. This drug has shown the ability to selectively target liver and pancreatic cancer cells while leaving healthy tissues unaffected. Meanwhile, Piclidenoson, which is also taken orally, is undergoing a Phase III trial designed for individuals suffering from moderate-to-severe psoriasis. Both Namodenoson and Piclidenoson have demonstrated encouraging results in previous Phase II trials, showcasing their safety, efficacy, and potential anti-cancer and anti-inflammatory benefits.

The cumulative funding has not only propelled these clinical trials but also fueled the company's efforts in drug manufacturing and regulatory submissions to authorities like the FDA and EMA. Additionally, the funds have supported the expansion of Can-Fite's comprehensive patent portfolio, ensuring robust intellectual property protection for its innovations.

In addition to its primary focus on Namodenoson and Piclidenoson, Can-Fite is actively pursuing other research endeavors. The company is conducting a Phase IIa study of Namodenoson for pancreatic cancer, following positive preclinical studies that indicated its capability to impede tumor growth through modulation of the Wnt/β-catenin, NF-κB, and RAS signaling pathways. A Phase IIb trial is also in progress for metabolic dysfunction-associated steatohepatitis (MASH), under an open Investigational New Drug (IND) application with the FDA, leveraging Namodenoson’s protective effects on the liver.

To date, Can-Fite has successfully signed seven commercialization agreements with strategic partners, positioning itself for the future market introduction of its drug candidates upon obtaining regulatory approval. The company remains proactive in its pursuit to form additional partnerships to expand its commercialization efforts.

Motti Farbstein, CEO of Can-Fite, expressed confidence in the company's strategic direction, stating, "This funding milestone reflects the strong confidence our investors and partners have in Can-Fite’s scientific platform and clinical strategy. Progressing into pivotal Phase III trials marks a significant step toward bringing innovative, oral therapies to patients with serious unmet needs in liver cancer and psoriasis."

Can-Fite BioPharma Ltd. is an advanced clinical-stage drug development company, renowned for its platform technology primed to tackle multi-billion dollar markets in cancer, liver, and inflammatory diseases. The company’s leading drug candidate, Piclidenoson, has recently reported positive topline results from a Phase III trial for psoriasis and has commenced a pivotal Phase III trial. Namodenoson, a key player in Can-Fite's portfolio, is being evaluated in several clinical trials, including a Phase III trial for hepatocellular carcinoma (HCC) and other Phase II trials for MASH and pancreatic cancer. Namodenoson has received Orphan Drug Designation in the U.S. and Europe, as well as Fast Track Designation as a second-line treatment for HCC from the U.S. FDA, showing potential for treating other cancers like colon, prostate, and melanoma. Additionally, CF602, another of the company’s drug candidates, has shown promise in treating erectile dysfunction. Can-Fite's drugs have so far demonstrated an impressive safety profile across over 1,600 patients involved in clinical studies.