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
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