Core Insights - Can-Fite BioPharma Ltd. has received FDA approval for compassionate use of its anti-cancer drug Namodenoson for a pancreatic cancer patient in the U.S. [1][3] - Namodenoson is currently undergoing multiple clinical trials, including a pivotal Phase III study for advanced liver cancer and a Phase IIa study for pancreatic cancer [3][5] - The drug has been granted Orphan Drug Designation by the FDA for pancreatic cancer, which may provide market exclusivity for seven years post-approval [4][6] Company Overview - Can-Fite BioPharma is a clinical-stage biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][6] - The company’s lead drug candidate, Piclidenoson, has recently reported positive results in a Phase III trial for psoriasis [6] - Namodenoson has shown potential efficacy in treating various cancers, including colon, prostate, and melanoma, and has an excellent safety profile based on clinical studies involving over 1,600 patients [5][6]

Core Insights - Can-Fite BioPharma Ltd. announced the publication of a study on Namodenoson, highlighting its protective effects against toxicity compared to traditional chemotherapy [1][2][3] - The study demonstrates Namodenoson's anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body systems, particularly the liver, central nervous system, and cardiovascular system [2][3] - Namodenoson is currently undergoing pivotal Phase III trials for advanced liver cancer, with Orphan Drug and Fast Track designations from the FDA and EMA [4][5] Company Overview - Can-Fite BioPharma is focused on developing small molecule drugs for oncological and inflammatory diseases, targeting multi-billion-dollar markets [6] - The company’s lead drug candidate, Piclidenoson, has shown promising results in a Phase III trial for psoriasis and is expected to enter another pivotal Phase III trial [6] - Namodenoson has shown potential in treating various cancers, including hepatocellular carcinoma, metabolic dysfunction-associated steatohepatitis, and pancreatic cancer, with a strong safety profile demonstrated in over 1,600 patients [5][6]

Core Insights - The U.S. liver cirrhosis treatment market is projected to reach approximately $15 billion by 2030, highlighting significant growth potential in this sector [3]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases, with its lead drug candidate Namodenoson showing promise in treating decompensated liver cirrhosis [1][5]. - Namodenoson is currently undergoing multiple clinical trials, including a pivotal Phase III trial for advanced liver cancer and a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) [4][5]. Clinical Development - A patient treated with Namodenoson under a compassionate use program has shown significant improvements, including the resolution of moderate ascites and a decrease in liver stiffness, indicating the drug's potential effectiveness [2][3]. - The positive response to Namodenoson is particularly noteworthy given the limited treatment options for decompensated liver disease, which often leads to liver transplantation [3]. Market Need - In 2017, approximately 10.6 million people globally were affected by decompensated cirrhosis, underscoring the urgent need for new therapeutic options as many patients face long wait times for liver transplants [3]. - The American Liver Foundation has indicated a critical shortage of donor organs, with some patients waiting over five years for a transplant, further emphasizing the market opportunity for effective treatments like Namodenoson [3].

Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [5] - The company is currently advancing its lead drug candidate, Namodenoson, which is being evaluated in multiple clinical trials for liver and other cancers [5] Clinical Development - Namodenoson has shown promising results in treating decompensated liver cirrhosis, with a patient experiencing significant symptom improvement after 20 months of treatment [2][3] - The treatment led to the disappearance of episodes of decompensated liver cirrhosis and improvements in liver stiffness and elevated globulin levels, markers of advanced liver disease [2][3] Market Potential - The U.S. market for liver cirrhosis treatment is projected to grow to approximately $15 billion by 2030, highlighting the urgent need for effective therapies [3] - In 2017, an estimated 10.6 million people globally were affected by decompensated cirrhosis, indicating a significant patient population in need of treatment options [3] Drug Profile - Namodenoson is an orally bioavailable drug that selectively binds to the A3 adenosine receptor, which is highly expressed in diseased cells, contributing to its favorable safety profile [4] - The drug has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma by the FDA [5]

Core Insights - Can-Fite BioPharma Ltd. is hosting a webinar on February 25, 2025, to discuss its development pipeline and milestones [1][2] - The company has multiple out-licensing deals and potential regulatory and sales milestone payments exceeding $130 million, with $20 million already received [2] - Can-Fite's advanced-stage assets target unmet medical needs in markets valued over $70 billion, positioning the company for potential commercialization [2] Company Overview - Can-Fite BioPharma Ltd. is focused on developing proprietary small molecule drugs for oncological and inflammatory diseases [1][4] - The lead drug candidate, Piclidenoson, has reported positive Phase III trial results for psoriasis and is set to begin a pivotal Phase III trial [4] - Namodenoson, another key drug, is in various stages of clinical trials for conditions such as Metabolic Dysfunction-associated Steatohepatitis (MASH) and hepatocellular carcinoma (HCC) [4] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC treatment [4] - CF602, a third drug candidate, has shown efficacy in treating erectile dysfunction [4] Financial Highlights - Can-Fite has secured $20 million in upfront and milestone payments, indicating strong potential for its therapies [2] - The company is strategically positioned to capitalize on a market with a combined value exceeding $70 billion [2]

Core Insights - Can-Fite BioPharma Ltd. is hosting a webinar on February 25, 2025, to discuss its development pipeline and milestones [1][2] - The company has multiple out-licensing deals and potential regulatory and sales milestone payments exceeding $130 million, with $20 million already received [2] - Can-Fite's advanced-stage assets target unmet medical needs in markets valued over $70 billion, positioning the company for potential commercialization [2] Company Overview - Can-Fite BioPharma Ltd. is focused on developing small molecule drugs for oncological and inflammatory diseases, with a lead drug candidate, Piclidenoson, recently reporting Phase III trial results for psoriasis [4] - The company is also evaluating Namodenoson in various trials, including a Phase IIb for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase III for hepatocellular carcinoma (HCC) [4] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC treatment [4] - CF602, another drug candidate, has shown efficacy in treating erectile dysfunction, with all drugs demonstrating a strong safety profile in over 1,600 patients [4]

Core Insights - Can-Fite BioPharma Ltd. is set to present at the BIO CEO & Investor Conference on February 10-11, 2025, in New York City, focusing on its business strategy and clinical milestones [1][2]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company specializing in small molecule drugs for oncological and inflammatory diseases, targeting multi-billion-dollar markets [4]. - The company’s lead drug candidate, Namodenoson, is currently in a pivotal Phase III trial for advanced liver cancer and a Phase IIb study for Metabolic Dysfunction-associated Steatohepatitis (MASH) [3][4]. - Another key drug candidate, Piclidenoson, is preparing to enter a pivotal Phase III trial for psoriasis [3][4]. - Can-Fite's third drug candidate, CF602, has shown efficacy in treating erectile dysfunction [4]. Clinical Development - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC treatment by the U.S. FDA [4]. - The company has reported positive topline results for Piclidenoson in a Phase III trial for psoriasis and is expected to advance further [4]. - Can-Fite has conducted clinical studies involving over 1,600 patients, demonstrating an excellent safety profile for its drug candidates [4]. Presentation Details - The presentation at the BIO CEO & Investor Conference will be led by Motti Farbstein, the Chief Executive & Chief Financial Officer, on February 10, 2025, at 3:45 pm EST [6]. - The management team will hold one-on-one meetings with investors and potential partners to discuss the company's future development plans [2].

Namodenoson Drug Development - Namodenoson, a small orally bioavailable drug, has been granted a US patent for its use as an anti-obesity drug, valid until 2042 [1][2] - The drug is currently being developed for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), advanced liver cancer, and pancreatic cancer [1][6] - In clinical studies, Namodenoson demonstrated a favorable safety profile and a 2.3% weight loss in patients after 3 months, with increased serum adiponectin levels [1][3] Anti-Obesity Mechanism and Market Potential - Namodenoson reduces fat levels by increasing adiponectin, a hormone that regulates fat production, and has shown weight loss in animal models of obesity [3] - The global obesity treatment industry is projected to reach $60.5 billion by 2030, with a compound annual growth rate of 22.3% from 2025 to 2030 [5] Can-Fite BioPharma Overview - Can-Fite BioPharma is an advanced clinical-stage drug development company focusing on cancer, liver, and inflammatory diseases [8] - The company's platform technology targets multi-billion dollar markets, with Namodenoson being a key drug candidate in Phase III trials for liver cancer and Phase IIb trials for MASH [6][8] - Namodenoson has received Orphan Drug Designation in the US and Europe and Fast Track Designation for hepatocellular carcinoma (HCC) treatment [8]

Core Viewpoint - Can-Fite Biopharma Ltd (CANF) has received a Zacks Rank 1 (Strong Buy) upgrade due to a positive trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Can-Fite Biopharma indicates an expected earnings per share (EPS) of -$1.25 for the fiscal year ending December 2024, reflecting a 30.2% change from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for Can-Fite Biopharma has increased by 95.5%, indicating a strong upward revision trend [9]. Zacks Rating System - The Zacks rating system is based on changes in a company's earnings picture, which is crucial for predicting near-term stock price movements [2][3]. - The system classifies stocks into five groups, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - Can-Fite Biopharma's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [11].

Can-Fite’s data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium Can-Fite enrolls patients for its pivotal Phase III advanced liver cancer study Ramat Gan, Israel, Dec. 30, 2024 (GLOBE NEWSWIRE) --  Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address Oncology and Inflammatory diseases, today announced that its work titled “The Liver Protective Effect of the anti-Cancer Drug Candidate N ...