~35% of erectile dysfunction patients in a $3.2 billion market are non-responders to brands including Viagra and Cialis, and these drugs can be contraindicated for an estimated 16 million men living with diabetes  CF602’s unique mechanism of action enables potential treatment of diabetic patients  RAMAT GAN, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncologic ...

Pivotal Phase III liver cancer study enrolling in Europe and Israel RAMAT GAN, Israel, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, announced today that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete response to treatment. The patient, who suffered from advanced liver cancer, was ...

Core Insights - Can-Fite BioPharma Ltd. announced a significant clinical finding regarding Namodenoson, which has led to the complete resolution of esophageal varices in a patient with decompensated liver cirrhosis, indicating a potential disease-modifying effect [1][2][3] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][8] - The company is currently advancing its lead drug candidate, Namodenoson, which is in a Phase III clinical trial for hepatocellular carcinoma (HCC) and has shown promise in treating other conditions [5][9] Clinical Development - Namodenoson is being evaluated in multiple clinical trials, including a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase IIa study in pancreatic cancer [7][9] - The drug has been granted Orphan Drug Designation in the U.S. and Europe, as well as Fast Track Designation for HCC treatment by the FDA [9] Market Context - In 2017, approximately 10.6 million people globally were affected by decompensated cirrhosis, highlighting the urgent need for effective treatments [6] - The U.S. market for liver cirrhosis treatment is projected to reach around $15 billion by 2030, indicating a significant growth opportunity for Can-Fite's products [6]

Core Viewpoint - Can-Fite BioPharma Ltd. reported financial results and clinical updates for the first half of 2025, highlighting advancements in its drug candidates and financial performance. Clinical & Development Milestones - The Phase 2a study of Namodenoson for advanced pancreatic cancer has achieved over 50% enrollment, focusing on safety, clinical activity, and pharmacokinetics [2] - Namodenoson, an A3 adenosine receptor agonist, has shown a favorable safety profile and anti-tumor activity in preclinical models [3] - The drug has received Orphan Drug Designation from the FDA, providing potential market exclusivity for seven years post-approval [4] - Following FDA Compassionate Use Approval, interest from leading U.S. medical centers has increased for treating pancreatic cancer patients with Namodenoson [5] - Piclidenoson has shown promise in treating vascular dementia, with a study from UCLA demonstrating its ability to restore tissue integrity in a mouse model [6][7] - The global market for vascular dementia is estimated at $6 billion in 2025, with a projected CAGR of 5% through 2035 [7] - Piclidenoson has a strong safety profile and has demonstrated anti-inflammatory activity in previous clinical studies [8] Financial Results - Revenues for H1 2025 were $0.20 million, a decrease of $0.11 million or 36.07% compared to $0.31 million in H1 2024, primarily due to lower advance payments from distribution agreements [10] - Research and development expenses increased to $3.03 million, up $0.15 million or 5.16% from $2.88 million in H1 2024, driven by ongoing studies for Namodenoson and Piclidenoson [11] - General and administrative expenses rose to $2.07 million, an increase of $0.54 million or 35.47% compared to $1.52 million in H1 2024, mainly due to investor relationship expenses [12] - Net loss for H1 2025 was $4.87 million, compared to a net loss of $3.95 million in H1 2024, attributed to increased R&D and administrative expenses [14] - As of June 30, 2025, cash and cash equivalents totaled $6.45 million, down from $7.88 million at the end of 2024, with a public offering completed in July 2025 raising $5 million [15] Company Overview - Can-Fite BioPharma Ltd. is focused on developing drugs for cancer, liver, and inflammatory diseases, with lead candidates Piclidenoson and Namodenoson in advanced clinical trials [23]

Core Insights - Can-Fite BioPharma Ltd. has achieved over 50% enrollment in its Phase 2a trial of Namodenoson for pancreatic cancer, indicating strong interest from both investigators and patients [1][3] - The primary endpoint of the trial is safety, and Namodenoson has demonstrated a favorable safety profile to date [2][3] - Namodenoson is a selective A3 adenosine receptor agonist showing anti-tumor activity in preclinical models and is also being evaluated for advanced liver cancer [3][4] Company Overview - Can-Fite BioPharma is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, targeting multi-billion dollar markets [5] - The company’s lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is advancing in clinical trials for other indications [5] - Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer and is also being evaluated in trials for hepatocellular carcinoma and other cancers [4][5]

Group 1 - Can-Fite BioPharma Ltd. announced a public offering of 8,333,333 American Depositary Shares (ADSs) at a price of $0.60 per ADS, with short-term warrants to purchase up to 16,666,666 additional ADSs [1][3] - The gross proceeds from the offering are expected to be approximately $5.0 million, with potential additional proceeds of up to $10.0 million from the exercise of short-term warrants [3] - The offering is expected to close on or about July 29, 2025, subject to customary closing conditions [1][3] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The proceeds from the offering will be used for funding research and development, clinical trials, and other working capital and general corporate purposes [3] Group 3 - Can-Fite is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, with a lead drug candidate, Piclidenoson, currently in Phase 3 trials [6] - The company’s liver drug, Namodenoson, is being evaluated in multiple trials for hepatocellular carcinoma and has received Orphan Drug Designation and Fast Track Designation from the FDA [6] - Can-Fite's drug candidates have shown efficacy in various conditions and have been tested in over 1,600 patients in clinical studies [6]

Core Insights - Can-Fite BioPharma Ltd. announced that Piclidenoson demonstrated efficacy in an experimental model of vascular dementia, as shown by a study from UCLA [1][2] Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases [1][6] - The company's lead drug candidate, Piclidenoson, has shown a compelling safety profile in clinical studies and is currently in pivotal Phase 3 trials for psoriasis [5][6] Vascular Dementia Market - Vascular dementia is the second most common cause of dementia, with no FDA-approved therapies available, leading to a significant unmet medical need [3][4] - The global market for vascular dementia is estimated at $6 billion in 2025, with a projected CAGR of 5% through 2035 [3] Drug Mechanism and Potential - Piclidenoson is a selective A3 adenosine receptor agonist that has shown neuroprotective effects and the potential to improve vascular health, addressing a significant gap in the current treatment landscape for vascular dementia [4][5]

Core Viewpoint - Can-Fite BioPharma Ltd. is advancing its clinical pipeline, particularly focusing on the Phase IIa study of Namodenoson for advanced pancreatic cancer, which addresses a significant unmet medical need in this area [1][4]. Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company developing small molecule drugs for cancer and inflammatory diseases, with a focus on multi-billion dollar markets [5]. - The company's lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is progressing to a pivotal Phase 3 trial [5]. - Namodenoson, another key drug, is being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma (HCC) and a Phase 2a study for pancreatic cancer [5]. Clinical Trial Details - The Phase IIa clinical trial of Namodenoson is an open-label study involving patients with advanced pancreatic adenocarcinoma who have progressed after at least one prior therapy [2]. - The trial is assessing the safety, clinical activity, and pharmacokinetics of Namodenoson, administered at a dose of 25 mg twice daily in 28-day cycles, with approximately 20 evaluable patients expected to be enrolled [2]. - The trial is led by Prof. Salomon Stemmer, a prominent oncologist, and Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer treatment [3]. Enrollment and Safety Profile - As of the latest update, 50% of the planned patient cohort has been enrolled, and Namodenoson has shown a favorable safety profile [4]. - The study aims to provide a novel therapeutic approach for patients with advanced pancreatic cancer who have exhausted standard treatment options [4].

Core Insights - Can-Fite BioPharma Ltd. has raised $175 million in funding to advance its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis respectively [1][6] Group 1: Company Overview - Can-Fite is a biotechnology company focused on developing small-molecule drugs targeting oncological and inflammatory diseases, specifically through the A3 adenosine receptor (A3AR) [2][6] - The company is currently conducting pivotal Phase III trials for Namodenoson in advanced liver cancer and Piclidenoson in moderate-to-severe psoriasis [2][6] Group 2: Drug Development and Trials - Namodenoson has shown selective targeting of liver and pancreatic tumor cells while sparing healthy tissue, and is currently enrolling patients for its Phase III study [2][3] - Piclidenoson is also in a pivotal Phase III trial for psoriasis, with both candidates demonstrating favorable safety profiles and promising efficacy in previous Phase II trials [3][4] Group 3: Funding and Commercialization - The cumulative funding has supported drug manufacturing, regulatory activities with the FDA and EMA, and the development of a broad patent portfolio [3] - Can-Fite has signed seven commercialization agreements with strategic partners for future marketing of its drug candidates upon regulatory approval [5] Group 4: Future Prospects - The company is also conducting a Phase IIa study of Namodenoson in pancreatic cancer and a Phase IIb trial in metabolic dysfunction-associated steatohepatitis (MASH) [4][6] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma by the FDA [6]

Industry Overview - The psoriasis market is projected to reach $30 billion by 2030, with a significant shift towards oral drugs [1] Company Developments - Can-Fite BioPharma Ltd. has initiated a pivotal Phase 3 study for its oral drug Piclidenoson, targeting moderate to severe plaque psoriasis, with patient enrollment starting in Europe and expected to follow in the US and Canada [1][3] - The Phase 3 study is randomized, double-blind, and placebo-controlled, focusing on the safety and efficacy of Piclidenoson, with co-primary efficacy objectives including achieving a PASI score response of ≥75% and a sPGA score of 0 or 1 at Week 16 [2] - The FDA has requested two Phase 3 studies and encouraged the enrollment of adolescent patients due to the drug's strong safety profile [2] - Upon successful completion of the Phase 3 program, the company plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Plan (MAA) to the EMA [3] Product Information - Piclidenoson is a first-in-class A3 adenosine receptor agonist, demonstrating an excellent safety profile and efficacy in previous clinical studies, targeting inflammatory cytokines IL-17 and IL-23 [4] - Can-Fite's lead drug candidate, Piclidenoson, is part of a broader pipeline that includes other drugs like Namodenoson, which is being evaluated for various cancers and has received Orphan Drug Designation and Fast Track Designation from the FDA [5]