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
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
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
Research and development expenses
Research and development expenses for the year ended
General and administrative expenses
General and administrative expenses were
Financial income, net
Financial income, net for the year ended
Net loss for the year ended
As of
The Company's consolidated financial results for the year ended
More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended
CONDENSED CONSOLIDATED BALANCE SHEETS
| 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
| 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 | - | - | ||||||
| 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
| Year ended | ||||||||||||
| 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
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
Contact
info@canfite.com
+972-3-9241114
CONSOLIDATED BALANCE SHEETS
| 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
| 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 | - | - | ||||||
| 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
| Year ended | ||||||||
| 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
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
Contact
info@canfite.com
+972-3-9241114
