Can-Fite: Patient with Decompensated Liver Cirrhosis Successfully Undergoes Liver Transplantation Following Treatment with Namodenoson

Namodenoson Provided Clinical Stabilization as a Potential Bridge to Transplant in Advanced Liver Failure

Ramat Gan, Israel, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that a patient with advanced decompensated liver cirrhosis who was treated with Namodenoson subsequently underwent a successful liver transplantation.

The patient received Namodenoson treatment under a compassionate use framework while suffering from liver disease and complications consistent with decompensated cirrhosis. Throughout the treatment period, Namodenoson contributed to clinical stabilization, allowing the patient to remain a suitable candidate for liver transplantation until a compatible donor organ became available, ultimately resulting in a successful, life-saving liver transplantation. While this is a single case, the outcome suggests a potential supportive role for Namodenoson in patients with severe liver dysfunction awaiting transplantation. Due to the ongoing shortage of donor organs, many patients with decompensated cirrhosis deteriorate rapidly and, tragically, do not survive long enough to receive a suitable transplant, highlighting the importance of therapies that may help maintain stability during this critical period.

Namodenoson is an orally bioavailable A3 adenosine receptor (A3AR) agonist with anti-inflammatory and anti-fibrotic properties, which has demonstrated a favourable safety profile in previous clinical studies. The drug is currently being evaluated in advanced liver diseases, including MASH and hepatocellular carcinoma.

“This case represents an encouraging clinical observation in a patient with advanced liver disease,” stated Prof. Ohad Etzion, Chief of Gastroenterology and Liver Diseases at Soroka Medical Center in Israel. “Although individual cases must be interpreted with caution, the ability to maintain clinical stability in such a fragile patient population is highly meaningful. We believe these findings support the continued clinical development of Namodenoson in  liver disorders where treatment options remain extremely limited.”

In 2017, an estimated 10.6 million people globally were affected by decompensated cirrhosis, and the available treatment options remain scarce, especially for patients who have reached the advanced stages of the disease. Highlighting the urgent need for new therapies, the American Liver Foundation has stated that there are more patients in need of a liver transplant than available organs, with some patients waiting over five years for a transplant. The global liver cirrhosis treatment market is projected to grow from approximately $7.6 billion in 2024 to more than $15 billion by 2031.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion-dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: .

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on April 14, 2025 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contact

Can-Fite BioPharma

Motti Farbstein