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]

Core Insights - Can-Fite BioPharma Ltd. is collaborating with Vetbiolix to advance the clinical study of Piclidenoson for treating osteoarthritis in dogs, with projected revenues of $325 million over the next decade upon regulatory approval [1][2][4] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases, with a lead drug candidate Piclidenoson showing promise in both human and animal studies [1][7] - The company has a pipeline that includes drugs for various conditions, including cancer and liver diseases, with ongoing clinical trials for its lead candidates [7][8] Market Opportunity - The arthritis market for companion animals is valued at $3.8 billion in 2023 and is expected to grow to $6.3 billion by 2030, with Piclidenoson potentially capturing up to 6% of this market, leading to peak sales of $445 million by 2034 [2][4] - Can-Fite is entitled to a 15% royalty on worldwide sales of Piclidenoson in this indication, indicating a significant revenue potential for the company [2][4] Product Development - Current treatments for canine osteoarthritis are limited and often come with significant side effects, while Piclidenoson offers a safer and potentially more effective oral treatment option [3][5] - Vetbiolix has successfully completed a clinical study for Piclidenoson, which supports its pharmacological profile as a viable treatment for osteoarthritis in pets [2][5] Strategic Partnerships - The collaboration with Vetbiolix is aimed at leveraging the veterinary market, which presents shorter timelines for regulatory approval compared to human medicine, thus enhancing revenue opportunities for Can-Fite [4][6]

Core Viewpoint - Can-Fite BioPharma Ltd. is advancing its clinical study for Piclidenoson, targeting the rare genetic disease Lowe Syndrome, with a Phase II trial set to begin soon [1][3]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][11]. - The company’s lead drug candidate, Piclidenoson, is currently in pivotal Phase III trials for psoriasis and has shown efficacy in preclinical studies for Lowe Syndrome [6][11]. Clinical Study Details - The Phase II study for Lowe Syndrome will enroll 5 patients, who will receive 3 mg of Piclidenoson twice daily for 12 months, with the primary endpoint being the efficacy in increasing renal uptake [2][3]. - The study is led by Dr. Franchesca Emma from Bambino Gesù Children's Hospital in Rome, Italy [2]. Disease Background - Lowe Syndrome, an X-linked genetic condition, primarily affects males and is characterized by vision problems, kidney issues, and intellectual disabilities, with a prevalence of approximately 1 in 500,000 [4][5]. - There are currently no available drugs for Lowe Syndrome, highlighting the medical need for effective treatments [3][4]. Research Collaboration - Can-Fite has partnered with Fondazione Telethon for the clinical development of Piclidenoson, leveraging their expertise in rare genetic diseases [3][8]. Piclidenoson Overview - Piclidenoson is a first-in-class A3 adenosine receptor agonist with a strong safety profile and evidence of efficacy in both Phase II and Phase III studies [7][11]. - The drug works by inhibiting inflammatory cytokines IL-17 and IL-23 and inducing apoptosis in skin cell keratinocytes [7]. Fondazione Telethon Contributions - Fondazione Telethon has invested over 660 million euros in research, funding nearly 3,000 projects and studying 630 diseases, aiming to develop therapies for rare genetic conditions [9][10].

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].