Namodenoson
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Can-Fite’s Partner Vetbiolix Completes Enrollment in Phase 2 Osteoarthritis Study in Dogs Treated with Piclidenoson; Data Expected in Q3 2026
Globenewswire· 2026-03-30 11:20
Core Viewpoint - Can-Fite BioPharma Ltd. has signed a deal with Vetbiolix worth up to $325 million for the development of Piclidenoson, a treatment for osteoarthritis in dogs, with Vetbiolix funding all associated development costs [3][4]. Group 1: 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's lead drug candidate, Piclidenoson, has shown efficacy in a Phase III clinical study for psoriasis and is now being evaluated for canine osteoarthritis [6][7]. Group 2: Partnership and Financials - Vetbiolix has exercised its option for a full licensing agreement with Can-Fite, which includes upfront, milestone, and royalty payments potentially totaling $325 million over the next decade [3]. - The global canine osteoarthritis market is projected to reach approximately $3 billion by 2028, driven by increasing pet ownership and demand for effective therapies [4]. Group 3: Clinical Study Details - A Phase 2 clinical study is underway, involving 118 client-owned dogs with osteoarthritis, with primary and secondary endpoints focused on symptom severity, mobility, and pain assessment [2][5]. - Top-line results from the study are expected in the third quarter of 2026 [2]. Group 4: Product Information - Piclidenoson is a first-in-class A3 adenosine receptor agonist with a strong safety and efficacy profile, previously demonstrated in psoriasis treatment [6]. - Current treatment options for canine osteoarthritis are limited and primarily provide symptomatic relief, often with safety concerns [5]. Group 5: Vetbiolix Overview - Vetbiolix develops innovative veterinary products and has a pipeline of first-in-class oral small molecules targeting unmet medical needs in pets [9]. - The company focuses on clinical developments and aims to generate revenue through out-licensing and co-development deals within the veterinary pharmaceutical industry [9].
Can-Fite Reports 2025 Financial Results and Ongoing Clinical Progress Highlighting Positive Data in Phase 2a Pancreatic cancer and 9 Years Cancer-Free Survival in Liver Cancer Patient
Globenewswire· 2026-03-26 13:27
Core Insights - Can-Fite BioPharma Ltd. has made significant clinical advancements and reported financial results for the year ended December 31, 2025, highlighting progress in its drug development pipeline targeting oncological and inflammatory diseases [1] Clinical Updates - The Phase 2a study in pancreatic cancer met its primary safety endpoint, with over 30% of patients alive at the last data cut-off [2] - A patient with advanced hepatocellular carcinoma (HCC) treated with Namodenoson has achieved over 9 years of overall survival and remains cancer-free, supporting its potential as a novel therapeutic option [3] - Complete resolution of esophageal varices was observed in a patient with decompensated liver cirrhosis, indicating Namodenoson's potential as a disease-modifying therapy [4] - Namodenoson has expanded its therapeutic potential into metabolic diseases, including obesity, supported by new scientific findings and patent allowances [5] - The company has strengthened its intellectual property portfolio with multiple patent allowances across key territories, enhancing its long-term commercial positioning [6] Financial Results - Revenues for the year ended December 31, 2025, were $0.41 million, a decrease of 40% from $0.67 million in 2024, primarily due to lower advance payments from distribution agreements [8] - Research and development expenses increased by 16.26% to $6.69 million, driven by ongoing studies for Namodenoson and Piclidenoson [9][10] - General and administrative expenses rose by 20.2% to $3.66 million, mainly due to increased investor relationship expenses [11] - The net loss for the year was $9.83 million, compared to a net loss of $7.88 million in 2024, attributed to higher research and development and administrative expenses [13] - As of December 31, 2025, cash and cash equivalents totaled $8.54 million, an increase from $7.88 million in 2024, mainly due to higher net cash from financing activities [14] Company Overview - Can-Fite BioPharma Ltd. is focused on developing drugs for multi-billion dollar markets in cancer, liver, and inflammatory diseases, with its lead drug candidate, Piclidenoson, recently reporting positive results in a Phase III trial for psoriasis [21][28]
Can-Fite Expands Namodenoson anti-Obesity Franchise with Israeli Patent Allowance
Globenewswire· 2026-03-17 11:47
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]
Can-Fite Announces Exercise of Warrants for Approximately $4.0 Million in Gross Proceeds
Globenewswire· 2026-03-04 15:25
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].
Micro-Cap Can-Fite BioPharma Shares Surge On Successful Pancreatic Cancer Drug Study
Benzinga· 2026-03-04 15:07
Core Viewpoint - Can-Fite BioPharma Ltd. announced positive results from its Phase 2a study of Namodenoson for pretreated pancreatic cancer patients, leading to a significant increase in its stock price [1][6]. Group 1: Clinical Trial Results - The Phase 2a study showed that Namodenoson significantly improved overall survival rates among patients, which analysts consider a promising development for the company [2]. - The treatment was reported to be well-tolerated and exhibited a favorable safety profile [2]. - Ongoing survival follow-up indicates that one-third of patients are currently alive at the time of data cut-off, with further survival outcomes expected to mature and be announced at upcoming scientific meetings [3]. Group 2: Future Developments - Can-Fite is expanding its clinical trials to explore the efficacy of Namodenoson in advanced liver cancer [3]. - The company completed patient enrollment for the Phase 2a pancreatic cancer clinical trial in January, with topline efficacy data anticipated in the third quarter of 2026 [4]. Group 3: Intellectual Property and Additional Indications - In February, Can-Fite received a Canadian patent for the use of Namodenoson in reducing fat mass and body weight, providing intellectual property protection as an anti-obesity therapy [5]. - A patient with advanced decompensated liver cirrhosis treated with Namodenoson successfully underwent liver transplantation, indicating potential additional therapeutic applications [5]. Group 4: Stock Performance - Can-Fite's shares rose by 108.00% to $10.40 at the time of publication, trading near its 52-week low of $3.63 [6].
Can-Fite’s Namodenoson Successfully Meets Primary Endpoint in Phase 2a Pancreatic Cancer Study
Globenewswire· 2026-03-04 12:00
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].
Can-Fite Announces Scientific Breakthrough Publication Demonstrating Anti-Obesity Effect of Namodenoson
Globenewswire· 2026-02-17 12:00
Core Viewpoint - Can-Fite BioPharma Ltd. has announced promising results for its lead drug candidate, namodenoson, in treating obesity, supported by a peer-reviewed study demonstrating its anti-obesity effects and favorable safety profile [1][4][6]. Group 1: Study Findings - The study published in the International Journal of Obesity shows that namodenoson significantly inhibits adipocyte proliferation and lipid droplet accumulation in a dose-dependent manner [4]. - In a murine high-fat diet model, daily oral administration of namodenoson for four weeks resulted in a statistically significant reduction in weight gain compared to placebo-treated controls [4]. - The findings align with previous Phase IIa clinical study results, where namodenoson treatment for three months led to reductions in liver fat and body weight in patients with metabolic dysfunction-associated steatohepatitis (MASH) [3][4]. Group 2: Mechanism of Action - Namodenoson modulates key molecular pathways involved in adipogenesis and inflammation, upregulating adiponectin and suppressing various signaling pathways such as PI3K, NF-κB, Akt, and Wnt/β-catenin [5]. - The drug's mechanism suggests a multi-pathway metabolic approach to obesity treatment [5]. Group 3: Market Potential - 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 safe, effective oral therapies [7]. - Namodenoson's favorable safety profile and broad patent portfolio position it as a promising candidate in this rapidly growing market [4][6]. Group 4: Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][9]. - Namodenoson is currently in advanced clinical development for MASH and is also being evaluated in pivotal trials for advanced liver cancer and pancreatic cancer [8][10].
Can-Fite: Receives Canadian Patent Allowance for Namodenoson as an Anti-Obesity Therapy
Globenewswire· 2026-02-09 12:00
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]
Can-Fite: Patient with Decompensated Liver Cirrhosis Successfully Undergoes Liver Transplantation Following Treatment with Namodenoson
Globenewswire· 2026-02-05 12:00
Core Insights - Can-Fite BioPharma Ltd. announced that Namodenoson provided clinical stabilization for a patient with advanced decompensated liver cirrhosis, leading to a successful liver transplantation [1][2] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases, with a pipeline that includes Namodenoson [1][6] - The company is currently evaluating Namodenoson in multiple clinical trials, including a Phase III trial for hepatocellular carcinoma and a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) [5][6] Product Details - Namodenoson is an orally bioavailable A3 adenosine receptor (A3AR) agonist known for its anti-inflammatory and anti-fibrotic properties, with a favorable safety profile demonstrated in previous studies [3][5] - The drug has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma by the U.S. FDA [6] Market Context - In 2017, approximately 10.6 million people globally were affected by decompensated cirrhosis, with limited treatment options available for advanced stages of the disease [4] - The global liver cirrhosis treatment market is projected to grow from around $7.6 billion in 2024 to over $15 billion by 2031, indicating a significant opportunity for new therapies [4]
Can-Fite Completes Patient Enrollment in Phase 2a Pancreatic Cancer Study of Namodenoson
Globenewswire· 2026-01-20 12:00
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]