Can-Fite BioPharma Ltd. reports developments for a clinical-stage biotechnology pipeline of proprietary small-molecule drugs targeting the A3 adenosine receptor (A3AR). Recurring news covers Namodenoson and Piclidenoson across oncology, inflammatory disease, liver disorders, metabolic disease, obesity-related uses, and companion-animal osteoarthritis through its veterinary commercialization relationship.
Company updates also include clinical and regulatory disclosures, patent allowances in multiple jurisdictions, operating and financial results, material agreements, capital-structure actions, and governance matters tied to its American Depositary Shares and ordinary-share voting processes.
Can-Fite BioPharma (CANF) announced Eurasian patent allowance for Piclidenoson use in diseases associated with OCRL deficiency, including Lowe syndrome.
The Eurasian Patent Office issued a notification of readiness to grant; claims also cover Dent disease 2. Fondazione Telethon owns the application, and the grant remains subject to required formalities. Can-Fite holds development, commercialization, and out-licensing rights for Lowe syndrome under its agreement with Telethon.
The partners have signed a clinical development collaboration. A Phase 2 open-label, single-center study is designed to assess oral Piclidenoson in 5 adults with genetically confirmed Lowe syndrome. Its primary endpoint measures improvement in renal uptake of a tracer to assess kidney tubular reabsorption capacity.
Can-Fite BioPharma (CANF) presented final Phase IIa pancreatic cancer data at ESMO 2026, with namodenoson meeting its primary safety endpoint. The single-center, open-label study enrolled 20 previously treated patients receiving 25 mg twice daily: 14 third-line, three second-line and three fourth-line patients.
Five related or possibly related adverse events in three patients were mild to moderate; none required treatment changes. No Grade ≥3 treatment-related or treatment-related serious adverse events occurred. A post hoc analysis of eight third-line patients surviving beyond two months found median overall survival of 6.28 months and median progression-free survival of 2.27 months. One second-line patient had progression-free survival of 16.39 months. The survival-selected subgroup and lack of a randomized comparator make the exploratory findings hypothesis-generating, supporting evaluation in a larger randomized study.
Can-Fite BioPharma (CANF) reported a peer-reviewed case study of a patient with advanced decompensated liver cirrhosis treated with its investigational drug Namodenoson. During treatment, the patient’s ascites resolved, diuretic therapy was discontinued, and follow-up endoscopy showed only minimal residual esophageal varices, while hepatic synthetic function continued to deteriorate. The patient remained clinically stable for approximately 28 months on Namodenoson and subsequently underwent successful orthotopic liver transplantation from a deceased donor in January 2026, with favorable post-transplant recovery. The report appears in the Japanese Journal of Gastroenterology and Hepatology.
Can-Fite BioPharma (CANF) reported H1 2026 results with a $4.6 million net loss and highlighted late-stage clinical progress.
Revenues were stable at $0.20 million versus H1 2025, while research and development expenses rose 13.86% to $3.45 million, mainly due to Namodenoson and Piclidenoson trials. General and administrative expenses decreased 31.40% to $1.42 million, narrowing the net loss from $4.87 million to $4.60 million. Cash, cash equivalents and short-term deposits stood at $7.03 million on June 30, 2026, before approximately $4.0 million gross proceeds from September warrant exercises.
Clinically, a Phase IIa pancreatic cancer study of Namodenoson met its primary safety endpoint and showed durable overall survival in heavily pretreated patients. In the pivotal Phase III HCC trial, blinded overall survival appears longer than study design assumptions, prompting evaluation of an earlier interim analysis. Piclidenoson’s pivotal psoriasis Phase 3 reached its pre-specified interim analysis, with results expected in Q1 2027, and new patents expanded protection for both drugs in multiple countries.
Can-Fite BioPharma (CANF) entered a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to 1,591,738 ADSs at a reduced exercise price of $2.50 per ADS, down from $5.00. Gross proceeds are expected to be approximately $4.0 million before fees and expenses.
In consideration for the cash exercise, Can-Fite will issue new unregistered warrants to purchase up to 3,183,476 ADSs, also at $2.50 per ADS, exercisable until 24 months after the effective date of a planned resale registration statement. Closing of the offering is expected on or about September 3, 2026, with H.C. Wainwright & Co. as exclusive placement agent. The company intends to use net proceeds for research and development, clinical trials, and general corporate and working capital purposes.
Can-Fite BioPharma (CANF) reported that blinded overall survival in its ongoing pivotal Phase III Namodenoson study in advanced hepatocellular carcinoma appears longer than originally anticipated based on the study’s design assumptions.
The randomized, double-blind, placebo-controlled trial enrolls patients with advanced HCC and Child-Pugh B7 cirrhosis, allocating them 2:1 to Namodenoson or placebo, with overall survival as the primary endpoint. The observed survival data are pooled and blinded, covering both treatment and placebo arms, so no conclusions about Namodenoson’s efficacy or differences between groups can currently be drawn. In response to the longer-than-expected survival, Can-Fite is evaluating advancing the timing of the trial’s planned interim analysis, which will allow an independent assessment of overall survival between the two arms under the statistical analysis plan and relevant regulatory requirements. The company’s CEO and CFO stated that, while the study remains blinded, an earlier interim look may offer important information on Namodenoson’s potential clinical benefit in this high unmet-need population.
Can-Fite (NYSE American: CANF) reported new preclinical data showing its drug candidate namodenoson enhanced the anti-cancer effect of gemcitabine in pancreatic cancer models by increasing cleaved caspase-3, a key apoptosis protein. According to Can-Fite, these mechanistic findings support the design of its planned randomized Phase IIb study in advanced pancreatic adenocarcinoma, which will test namodenoson combined with gemcitabine and Nab-paclitaxel. The company noted this approach builds on a favorable safety profile and encouraging clinical activity from its prior Phase IIa monotherapy study, whose results have been accepted for presentation at the ESMO Congress 2026.
Can-Fite BioPharma (NYSE American: CANF) reported that its two lead oral A3 adenosine receptor agonists, Namodenoson and Piclidenoson, are advancing in Phase III programs under regulatory frameworks established with the FDA and EMA, defining pathways toward potential marketing approval.
Namodenoson is in a pivotal Phase III trial for advanced hepatocellular carcinoma with underlying Child-Pugh B7 cirrhosis, conducted under FDA and EMA guidance and intended to support potential marketing authorization applications if predefined efficacy and safety endpoints are met. Namodenoson also holds FDA Fast Track and orphan drug designations in both the United States and Europe. Piclidenoson is being evaluated in a Phase III program for moderate-to-severe plaque psoriasis. According to Can-Fite, the advanced regulatory status of both programs strengthens its late-stage clinical pipeline and provides a clear framework toward potential regulatory submissions and commercialization.
Can-Fite (NYSE American: CANF) submitted a Phase 2 clinical study protocol to Bambino Gesù Children's Hospital in Rome for the first clinical evaluation of Piclidenoson in patients with Lowe syndrome, a rare inherited OCRL-related disorder with severe renal, neurological, and ocular manifestations and no approved disease-modifying therapies.
The open-label, single-center Phase 2 trial will treat 5 adult patients with genetically confirmed Lowe syndrome with oral Piclidenoson twice daily for six months. The primary endpoint is improvement in renal uptake of 99mTc-DMSA as a measure of proximal tubular reabsorption, with secondary endpoints including urinary tubular biomarkers, Fanconi syndrome parameters, and safety. Piclidenoson entered clinical evaluation following preclinical data showing restoration of OCRL-dependent cellular function, and Can-Fite signed a collaboration agreement with Fondazione Telethon to develop Piclidenoson for this high unmet-need indication.
Can-Fite BioPharma (NYSE American/TASE: CANF) reported that an abstract with positive data from its Phase 2a study of oral Namodenoson in advanced pancreatic ductal adenocarcinoma has been accepted for poster presentation at the ESMO Congress 2026, a leading global oncology meeting.
The Phase 2a trial enrolled patients with advanced pancreatic cancer who had progressed after standard therapies, predominantly in the third-line setting. According to Can-Fite, the study met its primary safety endpoint and showed encouraging survival with durable disease stabilization; one patient treated in second line remains alive for more than 18 months.
Namodenoson is a highly selective A3 adenosine receptor agonist that induces cancer cell apoptosis and has shown anti-tumor activity in multiple preclinical models. The company is planning a Phase 2b study evaluating Namodenoson in combination with chemotherapy in pancreatic cancer, with further poster details to be provided later.