RAMAT GAN, Israel, Sept. 08, 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 H1 2026.
Advances in Clinical Programs
Pancreatic Cancer
Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes. The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated. Overall survival findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy. A Phase IIb study protocol which combines chemotherapy and Namodenoson is under development. An abstract highlighting the positive results has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026.
Hepatocellular Carcinoma $(HCC)$
Blinded overall survival observed across the entire patient population in the Company's ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions underlying the study design.
In view of the longer-than-anticipated survival observed in the study population, Can-Fite is evaluating an earlier timing for the study's planned interim analysis.
Clinical Progress in Psoriasis
The Company completed enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency $(EMA)$. The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q1 2027.
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, Brazil, Australia and Japan, covering novel therapeutic uses of Namodenoson and Piclidenoson. These additions further strengthen the Company's long-term commercial positioning and pipeline value.
Motti Farbstein Can-Fite's CEO&CFO stated: "The first half of 2026 was marked by meaningful progress across our clinical programs. We are particularly encouraged by the longer-than-anticipated overall survival observed to date in our ongoing pivotal Phase III liver cancer study, while recognizing that the study remains blinded. In parallel, the durable survival outcomes observed in heavily pretreated pancreatic cancer patients and the advancement of our pivotal psoriasis study to its interim analysis stage further strengthen our clinical pipeline. We remain focused on disciplined execution of these late-stage programs and on advancing Namodenoson and Piclidenoson toward important clinical and regulatory milestones."
Financial Results
Revenues
Revenues for the six months ended June 30, 2026 were $0.20 million compared to $0.20 million for the six months ended June 30, 2025. Revenues for the six months ended June 30, 2026 and for the six months ended June 30, 2026 comprise of a portion of advance payments received under our existing out-licensing agreements with Cipher, CKD Gebro and Ewopharma.
Research and development expenses
Research and development expenses for the six months ended June 30, 2026 were $3.45 million, an increase of $0.42 million, or 13.86%, compared to $3.03 million for the six months ended June 30, 2025. Research and development expenses for the first half of 2026 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 the Namodenoson and Piclidenoson programs.
General and administrative expenses
General and administrative expenses for the six months ended June 30, 2026 were $1.42 million, a decrease of $0.65 million, or 31.40%, compared to $2.07 million for the six months ended June 30, 2025. The decrease is primarily due to lower investors relations expenses. We expect that general and administrative expenses will remain at the same level through 2026.
Financial income, net
Financial income, net for the six months ended June 30, 2026 was $0.08 million compared to $0.02 million for the six months ended June 30, 2025. The increase in financial income, net was mainly due to higher interest income from bank deposits.
Net loss for the six months period ended June 30, 2026 was $4.60 million compared with a net loss of $4.87 million for the six months period ended June 30, 2025 . The decrease in net loss for the six months period ended June 30, 2026 was primarily attributable to a decrease in general and administrative expenses which was offset by an increase in research and development expenses .
As of June 30, 2026, Can-Fite had cash and cash equivalents and short term deposits of $7.03 million as compared to $8.53 million at December 31, 2025. The decrease in cash during the six months period ended June 30, 2026 is mainly due to the Company's operating loss which was offset by proceeds from issuance of shares and warrants. During September 2026, the Company received aggregate gross proceeds of approximately $4.0 million from warrant exercises and a warrant inducement.
The Company's consolidated financial results for the six months period ended June 30, 2026 are presented in accordance with US GAAP Reporting Standards.
CONDENSED CONSOLIDATED BALANCE SHEETS
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U.S. dollars in thousands (except for share and per
share data)
June 30, December 31,
2026 2025
----------- --------------
Unaudited
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ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,985 $ 5,528
Short term deposits 4,052 3,011
Prepaid expenses and other current assets 960 900
Short-term investment 6 1
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Total current assets 8,003 9,440
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NON-CURRENT ASSETS:
Operating lease right of use assets 47 69
Property, plant and equipment, net 5 5
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Total non-current assets 52 74
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Total assets $ 8,055 $ 9,514
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CONDENSED CONSOLIDATED BALANCE SHEETS
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U.S. dollars in thousands (except for share and per
share data)
June 30, December 31,
2026 2025
--------- --------------
Unaudited
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LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables $ 681 $ 1,161
Current maturity of operating lease
liability 48 56
Deferred revenues 405 405
Other accounts payable 1,091 1,109
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Total current liabilities 2,225 2,731
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NON-CURRENT LIABILITIES:
Long - term operating lease liability 1 15
Deferred revenues 974 1,176
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Total long-term liabilities 975 1,191
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CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS' EQUITY:
Ordinary shares of no-par value -
Authorized: 30,000,000 and
14,000,000 shares at June 30, 2026
and December 31, 2025, respectively;
Issued and outstanding: 4,285,093
and 2,618,425 shares as of June 30,
2026 and December 31, 2025,
respectively - -
Additional paid-in capital 184,518 180,654
Accumulated other comprehensive
income 1,127 1,127
Accumulated deficit (180,790) (176,189)
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Total shareholders' equity 4,855 5,592
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