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Can-Fite (NYSE: CANF) reports 2025 loss and promising liver cancer data

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Rhea-AI Filing Summary

Can-Fite BioPharma reported 2025 results showing continued investment in its pipeline and a wider loss. Revenues were $0.41 million, down about 40% from $0.67 million in 2024, reflecting lower recognition of upfront distribution payments.

Research and development expenses rose to $6.69 million and general and administrative expenses to $3.66 million, driving a net loss of $9.83 million versus $7.88 million a year earlier. Cash, cash equivalents and short-term deposits totaled $8.54 million as of December 31, 2025, helped by financing activity, and the company received an additional $4.3 million from warrant exercises and an inducement in March 2026.

Clinically, a Phase 2a pancreatic cancer trial of Namodenoson met its primary safety endpoint, and more than 30% of heavily pretreated patients were alive at the latest cut-off. In hepatocellular carcinoma, one Namodenoson-treated patient has remained cancer-free for over nine years, while a Phase 3 HCC study and a Phase 2b trial in metabolic liver disease are ongoing. The company also highlighted a favorable case in decompensated cirrhosis, expansion into obesity indications, and new patents in several countries.

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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 March 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

 

 

 

 

 

On March 26, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Reports 2025 Financial Results and Ongoing Clinical Progress Highlighting Positive Data in Phase 2a Pancreatic cancer and 9 Years Cancer-Free Survival in Liver Cancer Patient”. A copy of this press release is furnished herewith as Exhibit 99.1.

 

1

 

Exhibit Index

 

Exhibit No.   Description
99.1   Press Release dated March 26, 2026

 

2

 

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: March 26, 2026 By: /s/ Motti Farbstein
    Motti Farbstein
    Chief Executive Officer and
Chief Financial Officer

 

3

 

Exhibit 99.1

 

Can-Fite Reports 2025 Financial Results and Ongoing Clinical Progress

Highlighting Positive Data in Phase 2a Pancreatic cancer

and 9 Years Cancer-Free Survival in Liver Cancer Patient

 

Ramat Gan, Israel, March 26, 2026 -- 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 clinical updates and financial results for the year ended December 31, 2025 and early 2026.

 

Advances in Clinical Programs

 

Pancreatic Cancer

 

Phase 2a study in pancreatic cancer met its primary endpoint of safety in heavily pretreated patients. The study continues to follow patients for overall survival, with data maturing over time; currently more than 30% of patients are alive at last data cut-off.

 

Hepatocellular Carcinoma (HCC)

 

A patient with advanced HCC, treated with Namodenoson has reached an overall survival of more than 9 years with complete response to treatment. The patient was enrolled into a Phase 2 study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappearance of all tumor lesions and good quality of life. Namodenoson continues to advance in a Phase 3 study for hepatocellular carcinoma, supported by Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, reinforcing its potential as a novel therapeutic option in liver oncology.

 

Clinical Progress in Decompensated Liver Cirrhosis

 

The Company observed complete resolution of esophageal varices in a patient with decompensated cirrhosis—an uncommon outcome in this population, along with overall clinical stabilization. The patient subsequently underwent successful liver transplantation following prolonged treatment, supporting the potential role of Namodenoson as a disease-modifying therapy and a bridge to transplant in end-stage liver disease.

 

Expansion into Metabolic and Obesity Indications

 

The Company expanded Namodenoson’s therapeutic potential into metabolic diseases, including obesity, supported by new scientific findings and patent allowances. These developments further highlight the versatility of the A3 adenosine receptor (A3AR) platform and its applicability across multiple high-value indications.

 

Strengthening of Intellectual Property Portfolio

 

Can-Fite continued to expand its global intellectual property estate with multiple patent allowances across key territories, including Israel, Canada, and Brazil, covering novel therapeutic uses of Namodenoson. These additions further strengthen the Company’s long-term commercial positioning and pipeline value.

 

Motti Farbstein Can-Fite’s CEO&CFO stated: “The past months have marked a period of significant progress for Can-Fite, highlighted by encouraging clinical signals across multiple indications and continued expansion of our intellectual property portfolio. Notably, clinical observations in advanced liver disease suggest that Namodenoson may have the potential to modify disease course and serve as a bridge to transplantation. Together with our advancing oncology programs and expanding metabolic pipeline, we believe these developments position Can-Fite for meaningful value creation in the near and long term.”

 

 

 

Financial Results

 

Revenues

 

Revenues for the year ended December 31, 2025 were $0.41 million, a decrease of $0.27 million, or 40% compared to $0.67 million for the year ended December 31, 2024. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

 

Research and development expenses

 

Research and development expenses for the year ended December 31, 2025 were $6.69 million, an increase of $0.9 million, or 16.26% compared to $5.75 million for the year ended December 31, 2024. Research and development expenses for the year ended December 31, 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both Namodenoson and Piclidenoson.

 

General and administrative expenses

 

General and administrative expenses were $3.66 million for the year ended December 31, 2025, an increase of $0.6 million, or 20.2% compared to $3.04 million for the year ended December 31, 2024. The increase is primarily due to the increase in investors relationship expenses. We expect that general and administrative expenses will remain at the same level through 2026.

 

Financial income, net

 

Financial income, net for the year ended December 31, 2025 aggregated $0.12 million compared to $0.25 million for the year ended December 31, 2024. The decrease in financial income, net was mainly due to lower income on short term deposits.

 

Net loss for the year ended December 31, 2025 was $9.83 million compared with a net loss of $7.88 million for the year ended December 31, 2024. The increase in net loss for the year ended December 31, 2025 was primarily attributable to an increase in research and development expenses and an increase in general and administrative expenses.

 

As of December 31, 2025, Can-Fite had cash and cash equivalents and short term deposits of $8.54 million as compared to $7.88 million at December 31, 2024. The increase in cash during the year ended December 31, 2025 is mainly due to higher net cash provided by financing activities. On March 4, 2026, the Company received aggregate gross proceeds of approximately $4.3 million from warrant exercises and a warrant inducement.

 

The Company’s consolidated financial results for the year ended December 31, 2025 are presented in accordance with US GAAP Reporting Standards. 

 

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at http://www.sec.gov/ as well as via the Company’s investor relations website at https://ir.canfite.com. The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 26 Ben Gurion Street, Ramat Gan, 5257346, Israel or by phone at +972-3-9241114.

 

2

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

U.S. dollars in thousands (except for share and per share data)

 

   December 31,   December 31, 
   2025   2024 
         
ASSETS        
         
CURRENT ASSETS:        
         
Cash and cash equivalents  $5,528   $4,825 
Short term deposits   3,011    3,057 
Prepaid expenses and other current assets   900    1,095 
Short-term investment   1    5 
           
Total current assets   9,440    8,982 
           
NON-CURRENT ASSETS:          
           
Operating lease right of use assets   69    111 
Property, plant and equipment, net   5    27 
           
Total non-current assets   74    138 
           
Total assets  $9,514   $9,120 

 

3

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

U.S. dollars in thousands (except for share and per share data)

 

   December 31,   December 31, 
   2025   2024 
         
LIABILITIES AND SHAREHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
         
Trade payables  $1,161   $618 
Current maturity of operating lease liability   56    53 
Deferred revenues   405    405 
Other accounts payable   1,109    976 
           
Total current liabilities   2,731    2,052 
           
NON-CURRENT LIABILITIES:          
           
Long - term operating lease liability   15    51 
Deferred revenues   1,176    1,581 
           
Total long-term liabilities   1,191    1,632 
           
CONTIGENT LIABILITIES AND COMMITMENTS          
           
SHAREHOLDERS’ EQUITY:          
           
Ordinary shares of no-par value - Authorized: 14,000,000 and 3,333,334 shares at December 31, 2025 and December 31, 2024, respectively; Issued and outstanding: : 2,618,425 and 994,394 shares as of December 31, 2025 and December 31, 2024, respectively (*)   -    - 
Additional paid-in capital   180,654    170,670 
Accumulated other comprehensive income   1,127    1,127 
Accumulated deficit   (176,189)   (166,361)
           
Total shareholders’ equity   5,592    5,436 
           
Total liabilities and shareholders’ equity  $9,514   $9,120 

 

(*) Retroactively adjusted to give effect to the reverse share split.

 

4

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

U.S. dollars in thousands (except for share and per share data)

 

   Year ended December 31, 
   2025   2024   2023 
             
Revenues  $405   $674    743 
                
Research and development expenses   (6,693)   (5,757)   (5,983)
General and administrative expenses   (3,662)   (3,047)   (2,955)
                
Total operating expenses   (10,355)   (8,804)   (8,938)
                
Operating loss   (9,950)   (8,130)   (8,195)
                
Financial income, net   122    250    561 
                
Loss before taxes on income   (9,828)   (7,880)   (7,634)
                
Net loss  $(9,828)  $(7,880)   (7,634)
                
Basic and diluted net loss per share  $(5.97)  $(10.86)   (17.92)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share (*)   1,646,208    725,309    426,111 

 

(*) Retroactively adjusted to give effect to the reverse share split.

 

5

 

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 recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning 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: www.can-fite.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, 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 the security situation in Israel; 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

 

6

 

CONSOLIDATED BALANCE SHEETS

 

U.S dollars in thousands (except for share and per share data)

 

   December 31, 
   2024   2023 
         
ASSETS        
         
CURRENT ASSETS:        
         
Cash and cash equivalents  $4,825   $4,278 
Short term deposits   3,057    4,625 
Prepaid expenses and other current assets   1,095    986 
Short-term investment   5    19 
           
Total current assets   8,982    9,908 
           
NON-CURRENT ASSETS:          
           
Operating lease right of use assets   111    52 
Property, plant and equipment, net   27    29 
           
Total non-current assets   138    81 
           
Total assets  $9,120   $9,989 

 

7

 

CONSOLIDATED BALANCE SHEETS

 

U.S dollars in thousands (except for share and per share data)

 

   December 31, 
   2024   2023 
         
LIABILITIES AND SHAREHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
         
Trade payables  $618   $427 
Current maturity of operating lease liability   53    27 
Deferred revenues   405    622 
Other accounts payable   976    944 
           
Total current liabilities   2,052    2,020 
           
NON-CURRENT LIABILITIES:          
           
Long - term operating lease liability   51    13 
Deferred revenues   1,581    1,713 
           
Total long-term liabilities   1,632    1,726 
           
CONTIGENT LIABILITIES AND COMMITMENTS          
           
SHAREHOLDERS’ EQUITY:          
           
Ordinary shares of no-par value - Authorized: 10,000,000 and 5,000,000,000 shares at December 31, 2024 and December 31, 2023; Issued and outstanding: 2,983,181,793 and 1,359,837,393 shares as of December 31, 2024 and December 31, 2023   -    - 
Additional paid-in capital   170,670    163,597 
Accumulated other comprehensive income   1,127    1,127 
Accumulated deficit   (166,361)   (158,481)
           
Total shareholders’ equity   5,436    6,243 
           
Total liabilities and shareholders’ equity  $9,120   $9,989 

 

8

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

U.S dollars in thousands (except for share and per share data)

 

   Year ended December 31, 
   2023   2022 
         
Revenues  $674   $743 
           
Research and development expenses   (5,757)   (5,983)
General and administrative expenses   (3,047)   (2,955)
           
Operating loss   (8,130)   (8,195)
           
Total financial income, net   250    561 
           
Net loss   (7,880)   (7,634)
           
Basic and diluted net loss per share   (0.00)   (0.01)
           
Weighted average number of ordinary shares used in computing basic and diluted net loss per share   2,176,148,857    1,278,333,912 

 

9

 

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: https://www.canfite.com/.

 

Forward-Looking Statements

 

This press release contains 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, including statements regarding projected revenue. 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 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 7, 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

info@canfite.com

+972-3-9241114

 

10

 

FAQ

How did Can-Fite (CANF) perform financially in 2025?

Can-Fite posted a larger net loss in 2025. Revenue was $0.41 million while research and development and administrative spending increased, leading to a net loss of $9.83 million compared with $7.88 million in 2024 as the company advanced its clinical programs.

What is the status of Can-Fite (CANF) clinical trials for Namodenoson?

Namodenoson is in multiple late-stage studies. It is being evaluated in a Phase 3 trial for hepatocellular carcinoma, a Phase 2b trial in metabolic steatohepatitis, and showed safety in a Phase 2a pancreatic cancer study, with additional work in decompensated cirrhosis.

What notable clinical outcomes did Can-Fite (CANF) report in liver cancer?

Can-Fite highlighted a long-term complete response in liver cancer. One advanced hepatocellular carcinoma patient treated with Namodenoson has remained cancer-free for more than nine years with continued treatment under compassionate use, supporting Namodenoson’s potential in liver oncology.

How strong is Can-Fite (CANF) cash position at year-end 2025?

Can-Fite ended 2025 with modest cash resources. Cash, cash equivalents and short-term deposits totaled $8.54 million as of December 31, 2025, and the company subsequently raised about $4.3 million in March 2026 through warrant exercises and a warrant inducement.

How did Can-Fite (CANF) revenues change in 2025 versus 2024?

Revenues declined in 2025 from the prior year. The company reported $0.41 million in revenue, down from $0.67 million in 2024, mainly because it recognized a smaller portion of advance payments from several existing distribution agreements.

What pipeline assets besides Namodenoson does Can-Fite (CANF) emphasize?

Can-Fite is also developing Piclidenoson and CF602. Piclidenoson, for psoriasis, reported topline Phase III results and is expected to enter a pivotal Phase III, while CF602 has shown efficacy in treating erectile dysfunction in earlier-stage studies.

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Can-Fite BioPharma Ltd.

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