Piclidenoson
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Can-Fite Granted Brazilian Patent for Treatment of Sexual Dysfunction
Globenewswire· 2025-12-26 12:00
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]
Can-Fite Announces Reverse Split of its Ordinary Shares and ADS Ratio Change
Globenewswire· 2025-12-23 21:46
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].
Can-Fite Provides Update on Clinical and Financial Status
Globenewswire· 2025-12-16 14:19
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]
Can-Fite’s Latest Developments of its Advanced Stage Drug Pipeline will be Presented at Noble Capital Markets 21st Annual Emerging Growth Equity Conference
Globenewswire· 2025-11-26 12:00
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]
Can-Fite to Advance New Veterinary Partnership Opportunities for Namodenoson at the BioFIT 2025 Conference
Globenewswire· 2025-11-24 12:00
Core Insights - Can-Fite BioPharma is advancing its veterinary oncology pipeline with Namodenoson, a Phase III cancer drug, targeting a market projected to reach $3.1 billion by 2030 [1] - The company is also developing Piclidenoson for osteoarthritis in pets, with clinical studies showing efficacy in dogs, representing a $3 billion market [1] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [4] - The company's lead drug candidate, Piclidenoson, has reported topline results in a Phase III trial for psoriasis and is in a pivotal Phase III trial [4] - Namodenoson is being evaluated in multiple clinical trials, including a Phase III trial for hepatocellular carcinoma and a Phase II study for pancreatic cancer [4] Upcoming Events - Can-Fite will participate in BioFIT 2025, a major European life sciences conference, to explore collaboration opportunities for Namodenoson [1][2] - The company aims to establish a second veterinary partnership focused on Namodenoson during the conference [2] Strategic Partnerships - Previous participation at BioFIT led to a successful partnership with Vetbiolix for Piclidenoson, potentially worth $325 million in royalty revenues for Can-Fite [2] - Can-Fite plans to hold partnering meetings with major animal health companies, including Elanco Animal Health and Zoetis, to discuss collaboration for Namodenoson [3]
Can-Fite's CF602 Erectile Dysfunction Treatment Receives Notice of Patent Allowance in Brazil
Globenewswire· 2025-11-20 12:00
Core Insights - Can-Fite BioPharma's CF602 targets erectile dysfunction (ED) in diabetic patients and non-responders to existing medications, addressing a significant unmet need in a $3.2 billion market [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][5] - The company has received a Notice of Allowance for its patent application in Brazil, expanding intellectual property protection for CF602 beyond the U.S. and Europe [2] Market Context - The current ED market is valued at $3.2 billion, with standard treatments like Viagra and Cialis effective for approximately 65%-70% of patients [2] - An estimated 30%-35% of ED patients are non-responders to these treatments, and around 16 million men with diabetes are contraindicated from using them [2] Product Details - CF602 is an A3 adenosine receptor (A3AR) allosteric modulator that enhances receptor activity and avoids desensitization, potentially offering a new treatment option for ED [4] - Preclinical studies indicate that CF602 can improve erectile function and vascular health in diabetic models, showing promise for restoring muscle collagen and endothelial function [3][4] Clinical Development - Can-Fite's lead drug candidate, Piclidenoson, is in Phase III trials for psoriasis, while Namodenoson is being evaluated for hepatocellular carcinoma and other cancers [5] - CF602 is positioned as a third drug candidate with demonstrated efficacy in treating erectile dysfunction [5]
Can-Fite: 9-Year Survival with Complete Cure in an Advanced Liver Cancer Patient Treated with Namodenoson
Globenewswire· 2025-11-18 12:00
Core Insights - Can-Fite BioPharma Ltd. announced a patient treated with Namodenoson has achieved an overall survival of 9 years with a complete response to treatment [1][2] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][7] - The company is advancing its lead drug candidate, Namodenoson, which is currently in a pivotal Phase III clinical study for advanced hepatocellular carcinoma (HCC) [3][7] Clinical Development - Namodenoson has shown promising results in a completed Phase II study, with a patient remaining cancer-free for 9 years [2][4] - The drug 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 [6][7] - The U.S. FDA and European Medicines Agency have granted Namodenoson Orphan Drug status and Fast Track status for HCC treatment [3][7] Market Potential - The global market for HCC treatments is projected to reach $6.1 billion by 2027 for the G8 countries, driven by the need for effective and safe treatment options [5] - Liver cancer accounts for over 700,000 deaths globally each year, highlighting the urgent need for new therapies [5] Drug Mechanism - Namodenoson is a small orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells, contributing to its excellent safety profile [6]
Can-Fite Reports Complete Resolution of Esophageal Varices in Decompensated Cirrhosis Patient Treated with Namodenoson
Globenewswire· 2025-09-15 11:00
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]
Can-Fite Reports H1 2025 Financial Results and Clinical Update
Globenewswire· 2025-08-28 12:47
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]
Pancreatic Cancer Phase 2a Study with Can-Fite's Namodenoson Achieved Over 50% Enrollment Milestone
Globenewswire· 2025-07-30 11:04
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]