Can-Fite BioPharma Ltd 6-K, filed Sep 9, 2026
Can-Fite BioPharma Ltd. (CANF)
About this 6-K
Can-Fite BioPharma Ltd filed this 6-K on September 9, 2026.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of September 2026
001-36203
(Commission File Number)
CAN-FITE BIOPHARMA LTD.
(Exact name of Registrant as specified in its charter)
26 Ben Gurion Street
Ramat Gan 5257346 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
The first paragraph of the press release attached hereto as Exhibit 99.1 is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-227753, 333-271384 and 333-278525) and Form F-3 (File Nos. 333-236064, 333-276000, 333-274316, 333-281872, 333-262055, and 333-294760), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
On September 9, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite: Publication Reports Improvement in Decompensated Cirrhosis with Namodenoson and Successful Bridging to Liver Transplantation”. A copy of this press release is furnished herewith as Exhibit 99.1.
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Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release dated September 9, 2026 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Date: September 9, 2026 | By: | /s/ Motti Farbstein |
| Motti Farbstein | ||
| Chief Executive Officer and Chief Financial Officer |
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Exhibit 99.1
Can-Fite: Publication Reports Improvement in Decompensated Cirrhosis with Namodenoson and Successful Bridging to Liver Transplantation
Patient Experienced Resolution of Ascites, Regression of Esophageal Varices and Remained Clinically Stable for Approximately 28 Months Prior to Successful Liver Transplantation
Ramat Gan, Israel, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced the publication of a peer-reviewed case report describing the clinical course of a patient with advanced decompensated liver cirrhosis treated with Namodenoson. During treatment, the patient experienced resolution of ascites and regression of esophageal varices. The article, titled “Namodenoson Treatment in Decompensated Cirrhosis: Hemodynamic–Clinical Improvement Enabling Bridging to Liver Transplantation” was published in the Japanese Journal of Gastroenterology and Hepatology (Link).
During Namodenoson treatment, ascites resolved, allowing discontinuation of diuretic therapy, while follow-up endoscopy showed only minimal residual esophageal varices. Notably, these clinical improvements occurred despite continued deterioration in hepatic synthetic function. After approximately 28 months of Namodenoson treatment, the patient underwent successful orthotopic liver transplantation from a deceased donor in January 2026, with a favorable post-transplant recovery.
“Patients with decompensated cirrhosis have very limited therapeutic options, and liver transplantation remains the only definitive treatment,” said Prof. Ohad Etzion, M.D., Director of the Department of Gastroenterology and Liver Diseases at Soroka University Medical Center, Beer-Sheva, Israel, who treated the patient. “This case is particularly interesting because the improvement in clinically important complications of portal hypertension occurred despite continued deterioration in underlying liver function. The patient remained clinically stable for approximately 28 months and was successfully bridged to liver transplantation. While this is a single-patient observation, the findings support further evaluation of Namodenoson as a potential therapeutic approach in advanced liver disease.”
Namodenoson is a highly selective agonist of the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and pathological cells. Activation of A3AR has been reported to exert anti-inflammatory and anti-fibrotic effects, including through modulation of NF-κB and Wnt/β-catenin signaling pathways. Namodenoson has demonstrated activity in preclinical and clinical studies in liver diseases, including metabolic dysfunction-associated steatohepatitis and hepatocellular carcinoma in patients with underlying cirrhosis.
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 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and is enrolling patients in a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). 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 biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological, inflammatory, and metabolic diseases. The Company’s lead drug candidate, Piclidenoson, is currently being evaluated in a pivotal Phase III study for the treatment of psoriasis. Can-Fite’s oncology and liver drug candidate, Namodenoson, is being evaluated in a pivotal Phase III study for the treatment of hepatocellular carcinoma (HCC) and in a Phase IIb study for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Namodenoson has also demonstrated encouraging clinical activity in a Phase IIa study in patients with advanced pancreatic cancer, supporting its further clinical development in this indication. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation by the U.S. Food and Drug Administration as a second-line treatment for HCC. In addition, Namodenoson has demonstrated potential in other oncological indications, while preclinical and clinical findings support the broader therapeutic potential of Can-Fite’s A3 adenosine receptor platform. CF602, the Company’s third drug candidate, has demonstrated preclinical efficacy in the treatment of erectile dysfunction. Can-Fite’s drug candidates have demonstrated a favorable safety profile in clinical studies involving more than 1,700 patients to date. For more information, please visit Can-Fite’s website: www.canfite.com.
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. 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 market and other conditions, 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 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 March 26, 2026 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
info@canfite.com
+972-3-9241114