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
MWN-AI** Summary
Can-Fite BioPharma Ltd. (NYSE American: CANF) reported its financial results for the year ended December 31, 2025, alongside significant clinical advancements in its drug development pipeline. The company's focus on oncological and inflammatory diseases continues to show promising outcomes, notably in its Phase 2a study for pancreatic cancer, which successfully met its primary safety endpoint in heavily treated patients. Notably, over 30% of participants remain alive at the last data cutoff, indicating potential for improved overall survival rates.
Additionally, in hepatocellular carcinoma (HCC), a patient treated with Can-Fite's lead drug Namodenoson has reached over nine years in sustained cancer-free status, showcasing a complete response to the treatment. This remarkable outcome supports Namodenoson's ongoing Phase 3 study for HCC, bolstered by Orphan Drug and Fast Track designations from the U.S. FDA. The company also reported the unusual reversal of esophageal varices in a patient with decompensated liver cirrhosis, followed by successful liver transplantation, emphasizing Namodenoson's potential as a disease-modifying agent.
On the financial side, Can-Fite saw a revenue decrease to $0.41 million for 2025, a 40% decline attributed primarily to lower advance payments under distribution agreements. R&D expenses increased by 16% to $6.69 million, driven by the progression of multiple clinical trials. The net loss for the period widened to $9.83 million, partly due to these rising costs.
CEO and CFO Motti Farbstein highlighted the promising clinical signals across multiple indications, aiming for significant value creation in the near future. Furthermore, the expansion of the company's intellectual property portfolio reinforces its strategic positioning in the marketplace.
MWN-AI** Analysis
Can-Fite BioPharma Ltd. (NYSE American: CANF) demonstrated notable clinical advancements in their recent 2025 financial results, emphasizing the promising data from their Phase 2a study in pancreatic cancer and the impressive nine-year cancer-free survival of a liver cancer patient treated with Namodenoson. This emerging data, aligned with significant progress in their research and development pipeline, not only strengthens Can-Fite's position in the oncology market but also enhances its attractiveness to investors.
The successful Phase 2a trial in pancreatic cancer, particularly achieving a key safety endpoint, could significantly bolster investor confidence as the company continues to monitor long-term survival rates. Additionally, the remarkable outcome of a patient with advanced hepatocellular carcinoma achieving over nine years of survival marks a pivotal highlight that reinforces Namodenoson's potential as a leading treatment in liver oncology. With ongoing Phase 3 studies and expanding indications for Namodenoson, including obesity and cirrhosis management, the breadth of Can-Fite's pipeline underscores a diverse revenue potential.
However, potential investors should temper their enthusiasm with an understanding of the financial context. While Can-Fite’s revenue saw a decline to $0.41 million, attributed to variations in advance payments from distribution agreements, R&D expenditures rose, reflecting the company’s commitment to advancing their clinical trials. Notably, their net loss widened to $9.83 million, indicating ongoing investment in their development pipeline.
Looking ahead, Can-Fite’s prospects hinge on the successful execution of upcoming trials and effective commercialization strategies. The strengthened intellectual property portfolio offers further assurance for investors regarding the company's long-term viability and potential market leadership. Given these factors, investors should consider leveraging current market positioning while closely monitoring upcoming clinical results as key indicators of future performance.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
RAMAT GAN, Israel, March 26, 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 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.
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 |
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 | ||||||
| CONTINGENT 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. |
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. |
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
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 |
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 | ||||||
| CONTINGENT 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 |
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 | ||||||
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
FAQ**
How do the recent clinical trial results for Can-Fite BioPharma Ltd Sponsored ADR CANF, particularly regarding Namodenoson in advanced HCC, influence its market potential and investor interest moving forward?
Given the reported net loss for 2025, what strategies is Can-Fite BioPharma Ltd Sponsored ADR CANF planning to implement to enhance revenue generation and reduce operational expenses in the coming years?
With the expansion of Namodenoson into metabolic diseases and obesity, how does Can-Fite BioPharma Ltd Sponsored ADR CANF plan to leverage this versatility to attract investors and partners in these high-value markets?
What steps is Can-Fite BioPharma Ltd Sponsored ADR CANF taking to secure additional funding, considering the recent decreases in revenues and increases in R&D expenses reflected in the 2025 financial results?
**MWN-AI FAQ is based on asking OpenAI questions about Can-Fite Biopharma Ltd American Depositary Shares each representing two (2) (NYSE: CANF).
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