On August 28, 2025 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, reported financial results and clinical updates for H1, 2025 (Press release, Can-Fite BioPharma, AUG 28, 2025, View Source [SID1234655544]).
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Clinical & Development Milestones Achieved
Namodenoson Drug Candidate –
Pancreatic Cancer Phase 2a Study with Can-Fite’s Namodenoson Achieved Over 50% Enrollment Milestone
The Phase 2a study (NCT06387342) is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages (View Source).
Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients
Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.
Piclidenoson Drug Candidate –
Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia
The study headed by Dr. S. Thomas Carmichael, M.D., Ph.D., Professor and Chair Frances Stark Chair, Department of Neurology, Geffen School of Medicine at UCLA, utilized a vascular dementia mouse model with focal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model.
Vascular dementia is the second most common cause of dementia after Alzheimer’s disease, and caused by impaired blood flow to the brain, often due to stroke or chronic small vessel disease. There are no U.S. FDA approved therapies for this condition. Drugs that are used off-label, including donepezil or memantine, are used symptomatically or to address co-morbidities. Additionally, antihypertensives, antiplatelets, and statins are used to prevent further vascular damage, but none of these medications are disease-modifying. Nevertheless, due to an aging population and increasing diagnosis, the global market for Vascular Dementia is estimated at $6 billion as of 2025, with an expected CAGR of 5% through 2035.
Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile in hundreds of patients with Psoriasis and demonstrated anti-inflammatory activity in Phase 2 and Phase 3 clinical studies.
Financial Results
Revenues for the six months ended June 30, 2025 were $0.20 million, a decrease of $0.11 million, or 36.07%, compared to $0.31 million for the six months ended June 30, 2024. The decrease in revenues was mainly due to the recognition 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 for the six months ended June 30, 2025 were $3.03 million, an increase of $0.15 million, or 5.16%, compared to $2.88 million for the six months ended June 30, 2024. Research and development expenses for the first half of 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 for the six months ended June 30, 2025 were $2.07 million an increase of $0.54 million, or 35.47%, compared to $1.52 million for the six months ended June 30, 2024. The increase is primarily due to the increase in investors relationship expenses following one time project occurred during the first half of 2025. We expect that general and administrative expenses will remain at the same level through 2025.
Financial income, net for the six months ended June 30, 2025 was $0.02 million compared to $0.13 million for the six months ended June 30, 2024. The decrease in financial income, net was mainly due to lower income on short term deposits.
Net loss for the six months ended June 30, 2025 was $4.87 million compared with a net loss of $3.95 million for the six months ended June 30, 2024. The increase in net loss for the six months ended June 30, 2025 was primarily attributable to an increase in research and development expenses and an increase in general and administrative expenses.
As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million as compared to $7.88 million at December 31, 2024. The decrease in cash during the six months ended June 30, 2025 is mainly due to ongoing operations of the Company. On July 28, 2025, the Company completed a public offering for aggregate gross proceeds of $5 million.
The Company’s consolidated financial results for the six months ended June 30, 2025 are presented in accordance with US GAAP Reporting Standards.