Welcome to our dedicated page for Can-Fite BioPharma Ltd. SEC filings (Ticker: CANF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Can-Fite BioPharma Ltd. filings document foreign-private-issuer disclosures for a clinical-stage biotechnology company whose American Depositary Shares trade under CANF. Its Form 6-K reports furnish press releases, annual and special meeting materials, proxy statements, voting instruction cards for ADS holders, and shareholder-vote results.
The company’s regulatory record covers clinical and regulatory updates for A3AR drug candidates, Namodenoson and Piclidenoson patent matters, partner-related development disclosures, operating and financial results, capital-structure items, registration-statement incorporation for Form S-8 and Form F-3 filings, governance matters, and risks connected to drug development and public-company financing.
Can-Fite BioPharma Ltd. reported new preclinical findings showing that its drug namodenoson enhances the anti-cancer effect of gemcitabine chemotherapy in pancreatic cancer by increasing cleaved caspase-3–mediated apoptosis. These data provide mechanistic support for a planned randomized Phase IIb study in advanced pancreatic adenocarcinoma combining namodenoson with gemcitabine and nab-paclitaxel, following favorable safety and activity seen in a Phase 2a study. Clinical results from the Phase 2a trial have been accepted for presentation at the ESMO Congress 2026. Namodenoson is also in a pivotal Phase 3 trial for advanced liver cancer and a Phase 2b trial for MASH, while lead candidate piclidenoson is in Phase 3 for psoriasis and CF602 targets erectile dysfunction, with an overall clinical safety database of more than 1,600 patients.
Can-Fite BioPharma Ltd. reports that its two lead oral A3 adenosine receptor agonists, Namodenoson and Piclidenoson, are both in Phase III development under regulatory frameworks agreed with the FDA and EMA, providing defined pathways toward potential marketing applications.
Namodenoson is in a pivotal Phase III trial for hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 cirrhosis and holds FDA Fast Track status plus Orphan Drug Designation in both the U.S. and Europe as a second-line HCC treatment. Piclidenoson is in a Phase III program for moderate-to-severe plaque psoriasis. The company also advances Namodenoson in Phase 2b for MASH and Phase 2a in pancreatic cancer, and has a third candidate, CF602, for erectile dysfunction. Across its programs, Can-Fite reports clinical experience in over 1,600 patients, supporting an established safety profile.
Can-Fite BioPharma Ltd. launched its first clinical program of Piclidenoson in Lowe syndrome, submitting a Phase 2 study protocol to Bambino Gesù Children’s Hospital in Rome. The open-label, single-center trial will treat 5 adult patients with genetically confirmed Lowe syndrome using oral Piclidenoson twice daily for six months.
The primary endpoint is improvement in renal uptake of 99mTc-DMSA, with secondary endpoints covering urinary biomarkers, Fanconi syndrome parameters, and safety. The program is conducted under a collaboration with Fondazione Telethon. Piclidenoson is already in a pivotal Phase 3 psoriasis study, while Namodenoson and CF602 advance other oncology and inflammatory indications in Can-Fite’s pipeline.
Can-Fite BioPharma Ltd. reported that positive data from its Phase 2a study of oral Namodenoson in advanced pancreatic ductal adenocarcinoma have been accepted for poster presentation at the ESMO Congress 2026, a leading global oncology meeting. The study in heavily pretreated, predominantly third-line patients achieved its primary safety endpoint and showed encouraging survival with durable disease stabilization, including a patient treated in second line who remains alive for more than 18 months.
Namodenoson, a highly selective A3 adenosine receptor agonist, is also in a pivotal Phase 3 trial for hepatocellular carcinoma and a Phase 2b trial in MASH, while a Phase 2b pancreatic cancer study combining Namodenoson with chemotherapy is being planned.
Can-Fite BioPharma Ltd. reported that the Australian Patent Office has allowed Patent Application No. 2021290439, titled "Treatment of Advanced Metastatic Cancer," supporting development and potential marketing of its liver and pancreatic cancer drug Namodenoson in Australia.
Namodenoson is in a pivotal Phase 3 trial for advanced hepatocellular carcinoma under FDA and EMA protocol agreement, has completed a Phase 2a pancreatic cancer study demonstrating an excellent safety profile with encouraging survival and durable disease stabilization, and is planned for a Phase 2b pancreatic study with gemcitabine. It is also being evaluated in a Phase 2b trial for MASH and has Orphan Drug and Fast Track designations. Can-Fite’s broader pipeline includes Piclidenoson in Phase 3 for psoriasis and CF602 for erectile dysfunction, with its drug candidates tested in over 1,600 patients to date.
Can-Fite BioPharma Ltd. reports a key milestone in its pivotal Phase 3 trial of Piclidenoson for moderate-to-severe plaque psoriasis, having completed enrolment of the first 247 patients for a pre-specified interim analysis. The study is being run under a protocol agreed with both the FDA and EMA.
The randomized, double-blind, placebo-controlled trial compares 3 mg Piclidenoson tablets taken orally twice daily against placebo, with co-primary goals of achieving PASI 75 and an sPGA score of 0 or 1 at Week 16. Interim efficacy and safety data are expected in Q4 2026/Q1 2027.
Piclidenoson is described as a first-in-class oral A3 adenosine receptor agonist that targets key inflammatory pathways in psoriasis and has shown a favourable safety profile in more than 1,500 treated subjects, supporting its potential as a chronic treatment option. Can-Fite highlights the growing psoriasis therapeutics market and positions Piclidenoson as a differentiated oral small-molecule candidate within this space.
Can-Fite BioPharma reported Phase 2a results for its drug Namodenoson in advanced pancreatic ductal adenocarcinoma. The trial met its primary safety endpoint and showed durable overall survival in a subset of heavily pretreated patients.
The open-label study enrolled 20 patients who had progressed after standard therapies, including 14 on third-line treatment, five on second-line and one on fourth-line. One second-line patient remains alive more than 18 months after starting Namodenoson. Based on these outcomes and supporting preclinical data, Can-Fite plans a Phase 2b study combining Namodenoson with chemotherapy.
Can-Fite BioPharma Ltd. reports that the Japan Patent Office has allowed a patent covering the use of A3 adenosine receptor agonists, including its lead drug Namodenoson, for fat loss, obesity and related metabolic disorders. This strengthens protection for Namodenoson’s anti-obesity technology in a major pharmaceutical market and adds to existing patents in the United States, Canada, Australia and Israel.
The company highlights preclinical and clinical findings suggesting Namodenoson’s potential to reduce fat accumulation and improve metabolic parameters as an oral, highly selective A3 adenosine receptor agonist with an established safety profile. Management views the growing patent estate, alongside a pivotal Phase 3 liver cancer trial and other oncology and liver indications, as enhancing Namodenoson’s value and future partnering opportunities in an obesity therapeutics market forecast to exceed $60 billion by 2030.
Can-Fite BioPharma Ltd. filed a Form 6-K highlighting a new peer-reviewed article that reviews the broad therapeutic potential of its lead A3 adenosine receptor (A3AR) agonists, Piclidenoson and Namodenoson, across multiple major diseases. The article, published in the Biomolecules journal, compiles data from the company and independent research groups worldwide, which the company views as important scientific validation of its A3AR platform.
The filing reiterates that Namodenoson is in Phase 3 development for hepatocellular carcinoma, Phase 2 for pancreatic cancer, and Phase 2b for MASH, while Piclidenoson is in a pivotal Phase 3 study for psoriasis. It also notes Orphan Drug and Fast Track designations for Namodenoson, and states that Can-Fite’s drug candidates have shown an excellent safety profile in more than 1,600 patients to date.
Can-Fite BioPharma Ltd. is highlighting its late-stage clinical pipeline and licensing opportunities at the BIO International Convention 2026, held June 22–25, 2026 in San Diego. The company plans partnering meetings with pharmaceutical and biotech firms to discuss licensing and commercialization of its clinical-stage assets.
The lead liver drug Namodenoson is in a pivotal Phase III study for advanced hepatocellular carcinoma, a Phase IIb trial for MASH, and a Phase IIa study in pancreatic cancer. Piclidenoson is in a pivotal Phase III trial for psoriasis, with preparatory work underway for a Phase II study in Lowe Syndrome. A third candidate, CF602, has shown efficacy for erectile dysfunction.
Can-Fite’s A3 adenosine receptor platform has shown a favorable safety profile in more than 1,600 treated patients. The company reports multiple regional licensing deals that have generated approximately $20 million in upfront and milestone payments, with potential for additional milestones and royalties.