Can-Fite BioPharma Ltd. Stock Price, News & Analysis

Can-Fite (NYSE American: CANF) said it will attend BioFIT 2025 in Strasbourg on Dec 2–3, 2025 to pursue veterinary partnerships for Namodenoson, its Phase III anti-cancer candidate.

The company cites prior BioFIT participation that led to a Piclidenoson veterinary deal with Vetbiolix, an agreement noted as potentially worth an estimated $325 million in royalty revenues. Can-Fite will hold partnering meetings with major animal-health companies including Elanco and Zoetis to explore bringing Namodenoson into veterinary oncology.

Namodenoson has shown strong anti-tumor activity, a reported complete response in a human liver cancer patient, and an excellent safety profile; human trials include a Phase III liver cancer study and a Phase II pancreatic study.

Can-Fite (NYSE:CANF) received a Notice of Allowance in Brazil for a patent titled “An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction,” extending IP protection for its CF602 erectile dysfunction candidate beyond previously granted U.S. and European patents.

The release highlights a $3.2 billion ED market, where 30%–35% of patients are non-responders to PDE5 inhibitors and an estimated 16 million U.S. men with diabetes may be contraindicated for those drugs. Preclinical results in a diabetic rat model reported a single-dose full erectile recovery, increased arterial blood flow, and dose-dependent improvements in intracavernosal pressure, smooth muscle/collagen ratio, VEGF, and eNOS.

Can-Fite (NYSE American: CANF) reported that a patient with advanced hepatocellular carcinoma treated with Namodenoson reached 9 years overall survival with a complete response and remains cancer-free while on compassionate use treatment.

The company is enrolling a pivotal Phase III HCC study in Israel, Europe and the U.S.; the protocol was agreed with the FDA and EMA. Namodenoson holds Orphan Drug status from both agencies and Fast Track status from the FDA. A compassionate use program is active in Israel and Romania.

Can-Fite BioPharma (NYSE American: CANF) reported a significant clinical breakthrough in their compassionate use program for Namodenoson in decompensated liver cirrhosis. A patient demonstrated complete resolution of esophageal varices, a severe complication of advanced liver disease that can cause life-threatening bleeding.

The treatment shows potential disease-modifying effects, as confirmed by endoscopic evaluation. Namodenoson is currently in a Phase III clinical trial for hepatocellular carcinoma (HCC) in patients with advanced liver disease. The development is particularly significant given that approximately 10.6 million people globally were affected by decompensated cirrhosis as of 2017, with the U.S. liver cirrhosis treatment market expected to reach $15 billion by 2030.

Can-Fite BioPharma (NYSE American: CANF) reported H1 2025 financial results and clinical updates. The company reached significant milestones in its drug development programs, with Namodenoson achieving over 50% enrollment in its Phase 2a pancreatic cancer trial and receiving FDA compassionate use approval. A breakthrough UCLA study demonstrated Piclidenoson's potential for treating vascular dementia, targeting a $6 billion market.

Financial results showed revenues of $0.20 million, down 36.07% year-over-year. Net loss increased to $4.87 million from $3.95 million in H1 2024. The company held $6.45 million in cash and equivalents as of June 30, 2025, and completed a $5 million public offering in July 2025.

Can-Fite BioPharma (NYSE American: CANF) announced achieving over 50% enrollment in its Phase 2a trial of Namodenoson for pancreatic cancer. The multicenter, open-label study evaluates the drug's safety, clinical activity, and pharmacokinetics in patients with advanced pancreatic adenocarcinoma who progressed after prior therapy.

Patients receive 25 mg of oral Namodenoson twice daily in 28-day cycles. The drug, which has received FDA Orphan Drug Designation for pancreatic cancer treatment, continues to demonstrate a favorable safety profile. The study is being conducted under the leadership of Prof. Salomon Stemmer at the Davidoff Center, Rabin Medical Center, Israel.

Can-Fite BioPharma (NYSE American: CANF) has announced a public offering to raise up to $15.0 million in gross proceeds. The offering includes 8,333,333 American Depositary Shares (ADSs) at $0.60 per ADS, along with short-term warrants to purchase up to 16,666,666 ADSs.

The initial gross proceeds are expected to be $5.0 million, with potential additional proceeds of $10.0 million if all warrants are exercised. The warrants have an exercise price of $0.60 per ADS and will expire in 24 months. The offering is expected to close around July 29, 2025, with H.C. Wainwright & Co. acting as the exclusive placement agent.

Can-Fite BioPharma (NYSE American: CANF) announced breakthrough results from a UCLA study demonstrating the efficacy of Piclidenoson in treating vascular dementia. The study, led by Dr. S. Thomas Carmichael at UCLA's Geffen School of Medicine, showed that Piclidenoson successfully restored tissue integrity and behavioral function in a vascular dementia mouse model.

Vascular dementia, the second most common form of dementia after Alzheimer's, currently has no FDA-approved treatments. The global market for vascular dementia treatments is valued at $6 billion as of 2025, with a projected 5% CAGR through 2035. Piclidenoson, a selective A3 adenosine receptor agonist, has already demonstrated a strong safety profile in hundreds of psoriasis patients through Phase 2 and Phase 3 clinical studies.

Can-Fite BioPharma announced that Dr. Sari Fishman will present updates on their ongoing Phase IIa pancreatic cancer study at the 2025 BIO International Convention in Boston. The open-label study is evaluating Namodenoson, which has received FDA Orphan Drug Designation, in patients with advanced pancreatic adenocarcinoma who have progressed after prior therapy. The trial, led by Prof. Salomon Stemmer at the Davidoff Center, aims to assess safety, clinical activity, and pharmacokinetics of Namodenoson administered at 25 mg twice daily in 28-day cycles. Currently, 50% of the planned 20 evaluable patients have been enrolled, with the drug showing a favorable safety profile so far. The study represents an effort to address the unmet need for effective treatments in advanced pancreatic cancer patients who have exhausted standard therapies.