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 stud ...

Core Insights - Can-Fite BioPharma Ltd. has received patent allowance in Israel for its drug candidate Namodenoson, which targets fat loss and obesity treatment through A3 adenosine receptor agonists [1][2] - The global obesity therapeutics market is projected to grow significantly, reaching $60.5 billion by 2030, with a compound annual growth rate (CAGR) of approximately 22% [4] Company Developments - The allowed patent strengthens Can-Fite's global intellectual property portfolio, following similar advancements in the US, Canada, and Australia [2] - Namodenoson is currently in pivotal Phase III trials for advanced liver cancer and Phase II trials for Metabolic Dysfunction-associated Steatohepatitis (MASH) and pancreatic cancer [5][6] - The drug has shown a strong safety profile and is recognized for its unique mechanism of action, which may provide a competitive edge in the obesity treatment market [3][4] Market Context - The obesity therapeutics market is experiencing rapid growth due to increasing prevalence and the limitations of current treatments, such as gastrointestinal side effects and high costs [3] - Namodenoson offers a differentiated mechanism of action, targeting pathways involved in adipogenesis, inflammation, and metabolic regulation, positioning it as a promising candidate in the obesity treatment landscape [3][4]

Core Viewpoint - Can-Fite BioPharma Ltd. has entered into a definitive agreement for the immediate exercise of outstanding warrants to purchase up to 795,869 American Depositary Shares (ADSs) at a reduced exercise price of $5.00 per ADS, down from $9.34, with expected gross proceeds of approximately $4.0 million to fund research and development and clinical trials [1][3]. Group 1: Financial Details - The exercise of the warrants will generate gross proceeds of approximately $4.0 million before deducting placement agent fees and offering expenses [3]. - Can-Fite will issue new unregistered warrants to purchase up to 1,591,738 ADSs at an exercise price of $5.00 per ADS, which will be immediately exercisable for 24 months [2]. Group 2: Regulatory and Compliance - The new warrants and ADSs are offered in a private placement and have not been registered under the Securities Act of 1933, requiring a registration statement to be filed with the SEC for resale [4]. Group 3: Company Overview - Can-Fite BioPharma is a clinical stage drug development company focusing on proprietary small-molecule drugs for oncological and inflammatory diseases, with lead drug candidates including Piclidenoson and Namodenoson [6]. - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma [6].

Core Viewpoint - Can-Fite BioPharma Ltd. announced positive results from a Phase IIa study of namodenoson for advanced pancreatic ductal adenocarcinoma (PDAC), highlighting its favorable safety profile and potential for further clinical evaluation [1][2][5]. Group 1: Study Results - The Phase IIa study met its primary endpoint of safety, showing that namodenoson was well tolerated in a heavily pretreated patient population with no new safety signals identified [2][3]. - The study enrolled 20 patients with advanced PDAC who had received one or more prior lines of therapy, representing a high-risk population [3]. - Secondary endpoints included overall survival (OS) and progression-free survival (PFS), with ongoing follow-up indicating that one-third of patients were alive at the time of data cut-off [4]. Group 2: Drug Profile and Designation - Namodenoson is a selective A3 adenosine receptor (A3AR) agonist that has shown anti-tumor activity in preclinical models and is also being evaluated for advanced liver cancer [5][6]. - The drug has received Orphan Drug Designation from the U.S. FDA for the treatment of pancreatic cancer, indicating its potential significance in addressing unmet medical needs [6]. Group 3: Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, with a pipeline addressing multi-billion dollar markets [7]. - The company’s lead drug candidate, Piclidenoson, has reported topline results in a Phase 3 trial for psoriasis and is advancing in clinical trials for other indications [7].

Core Insights - Can-Fite BioPharma Ltd. has received a notice of allowance for a Canadian patent on Namodenoson, an A3 adenosine receptor agonist, for its use in reducing fat mass and body weight, positioning it as a potential anti-obesity therapy [1][2] - The global obesity treatment market is projected to reach $60.5 billion by 2030, with a compound annual growth rate (CAGR) of approximately 22%, driven by increasing disease prevalence and demand for effective oral therapies [5] Company Overview - Can-Fite BioPharma is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases, with Namodenoson currently in clinical trials for various conditions including Metabolic Dysfunction-Associated Steatohepatitis (MASH) and advanced liver cancer [3][7] - The company holds patents for Namodenoson in the United States and Australia, and it has demonstrated a strong safety profile in clinical studies [3][6] Clinical Development - Namodenoson has shown efficacy in reducing fat levels by increasing adiponectin hormone and has resulted in a 2.3% weight loss in a Phase IIa study for MASH after three months [4] - The drug is currently undergoing pivotal Phase III trials for advanced liver cancer and Phase IIb trials for MASH, indicating its potential in multiple therapeutic areas [6][7]

Core Insights - Can-Fite BioPharma Ltd. has completed patient enrollment in its Phase 2a clinical trial for Namodenoson, a drug targeting advanced pancreatic adenocarcinoma, with top-line efficacy data expected in Q3 2026 [1][3] Group 1: Clinical Trial Details - The Phase 2a study is a multicenter, open-label trial focusing on patients with advanced pancreatic adenocarcinoma who have progressed after at least one prior therapy [2] - The primary endpoint of the study is safety, with additional evaluations of clinical activity and pharmacokinetics of Namodenoson, administered at a dose of 25 mg twice daily in 28-day cycles [2] - Namodenoson has shown a favorable safety profile to date, with ongoing monitoring of participants [2][3] Group 2: Drug Profile and Designations - Namodenoson is a selective A3 adenosine receptor agonist that has demonstrated anti-tumor activity in preclinical models for pancreatic cancer and is also being tested for advanced liver cancer [3] - The drug has received Orphan Drug Designation from the U.S. FDA for the treatment of pancreatic cancer, indicating its potential significance in addressing unmet medical needs [4] Group 3: Company Overview - Can-Fite BioPharma is an advanced clinical-stage drug development company with a focus on multi-billion dollar markets in cancer, liver, and inflammatory diseases [5] - The company’s lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is advancing in pivotal trials [5] - Can-Fite's pipeline includes Namodenoson, which is also in a Phase III trial for hepatocellular carcinoma and has shown potential for treating other cancers [5]

Core Insights - Can-Fite BioPharma Ltd. has received a patent from the Brazilian Patent Office for the use of A3 Adenosine Receptor Agonists in treating sexual dysfunction, enhancing its intellectual property portfolio in a significant pharmaceutical market [1][3] Group 1: Patent and Market Implications - The granted patent provides protection in Brazil for Can-Fite's proprietary A3AR agonists, which is crucial as Brazil is one of the largest pharmaceutical markets in Latin America with increasing demand for innovative sexual health therapies [1][2] - The patent validates the therapeutic versatility of A3 adenosine receptor agonists and may lead to future commercialization opportunities in Latin America [3] Group 2: Company Overview and Drug Development - Can-Fite is an advanced clinical stage drug development company targeting multi-billion-dollar markets in cancer, liver, and inflammatory diseases [4] - The company's lead drug candidate, Piclidenoson, has reported topline results in a Phase III trial for psoriasis and is advancing in other trials for hepatocellular carcinoma and pancreatic cancer [4] - Can-Fite's drug candidate Namodenoson has received Orphan Drug Designation in the U.S. and Europe and is being evaluated in multiple clinical trials [4]

Core Viewpoint - Can-Fite BioPharma Ltd. has announced a 1-for-3,000 reverse split of its ordinary shares, which will take effect on January 2, 2026, with the first trading of the consolidated shares on January 5, 2026 [1][4]. Share Structure Changes - Each outstanding 3,000 pre-split ordinary shares will combine into one new ordinary share automatically, with no action required from shareholders [2]. - The ratio of ordinary shares underlying the Company's American Depositary Shares (ADSs) will change from 1 ADS representing 300 ordinary shares to 1 ADS representing 2 ordinary shares, effective January 5, 2026 [2][3]. - The total number of outstanding ordinary shares will decrease from 42 billion to 14 million as a result of the reverse split [4]. Impact on ADS Holders - For ADS holders, the ratio change equates to a one-for-twenty ADS split, requiring the exchange of every 20 ADSs for one new ADS [3]. - No fractional new ADSs will be issued; instead, fractional entitlements will be aggregated and sold, with net cash proceeds distributed to ADS holders [6]. Ownership and Voting Power - The reverse split and ADS ratio change will not affect shareholders' percentage ownership or voting power, aside from minimal effects from fractional shares [5]. Market Expectations - The ADS price is expected to increase proportionally due to the change in the ADS ratio, although there is no assurance that the price will be equal to or greater than twenty times the pre-split price [7]. Company Overview - Can-Fite BioPharma Ltd. is focused on developing small-molecule drugs for oncological and inflammatory diseases, with its lead drug candidate, Piclidenoson, in Phase III trials for psoriasis [8]. - The company is also advancing Namodenoson, which is in various stages of trials for liver cancer and has received Orphan Drug Designation in the U.S. and Europe [8].

Core Insights - Can-Fite BioPharma Ltd. is advancing its clinical development activities and financial status, focusing on proprietary small-molecule drugs for oncological and inflammatory diseases [1] Clinical Development - Can-Fite is enrolling patients in a pivotal Phase III clinical study for Namodenoson, targeting advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function, addressing a significant unmet medical need [2] - An interim analysis for the Phase III study of Namodenoson is expected in Q4 2026, with potential eligibility for conditional regulatory approval from the FDA and EMA based on positive results [2] - A Phase IIb clinical study of Namodenoson for metabolic dysfunction-associated steatohepatitis (MASH) is ongoing, following positive Phase IIa trial results [3] - Namodenoson is also being evaluated in a Phase IIa study for pancreatic cancer, with data expected in Q2 2026 [4] - Can-Fite is conducting a pivotal Phase III clinical study for Piclidenoson in psoriasis, with interim analysis data anticipated in Q2 2026 [5] - The company has developed a Phase II study protocol for Lowe Syndrome, planning to submit it to regulatory authorities in Italy and EMA in Q1 2026 [5] Financial Status - As of June 30, 2025, Can-Fite had cash and cash equivalents of $6.45 million, and raised $5 million from a public offering in July 2025, followed by an additional $2.2 million through an ATM facility in November 2025 [6] Company Strategy - The company aims to address significant unmet medical needs with orally administered drug candidates, with ongoing pivotal studies in liver cancer and psoriasis, alongside mid-stage programs in MASH and pancreatic cancer [7] - Can-Fite's lead drug candidate, Piclidenoson, is positioned in multi-billion-dollar markets for cancer, liver, and inflammatory diseases, with a strong safety profile demonstrated in over 1,600 patients [8]

Core Insights - Can-Fite BioPharma Ltd. is advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, with CEO Motti Farbstein scheduled to present at NobleCon21 on December 3, 2025 [1][2] Company Overview - Can-Fite BioPharma Ltd. is an advanced clinical stage drug development company with a platform technology aimed at addressing multi-billion-dollar markets in cancer, liver, and inflammatory disease treatment [4] - The lead drug candidate, Piclidenoson, has reported topline results in a Phase III trial for psoriasis and has commenced a pivotal Phase III trial [4] - The liver drug, Namodenoson, is being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma (HCC) and has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA [4] - CF602, the third drug candidate, has shown efficacy in treating erectile dysfunction, with all drugs demonstrating an excellent safety profile in over 1,600 patients [4] Financial Agreements - Can-Fite has secured numerous out-licensing and global distribution agreements valued at up to $130 million for pharmaceutical indications and an additional up to $325 million for veterinary indications [2]