Welcome to our dedicated page for Can-Fite BioPharma Ltd. news (Ticker: CANF), a resource for investors and traders seeking the latest updates and insights on Can-Fite BioPharma Ltd. stock.
Overview of Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF, TASE: CANF) is a clinical-stage biopharmaceutical company headquartered in Israel. The company specializes in developing orally bioavailable small molecule drugs designed to treat cancer, liver, and inflammatory diseases. With a robust pipeline of advanced clinical-stage drug candidates, Can-Fite leverages its proprietary platform technology centered on the Gi protein-associated A3 adenosine receptor (A3AR). This receptor is highly expressed in diseased cells but shows minimal expression in normal cells, enabling targeted therapies with a favorable safety profile.
Platform Technology and Therapeutic Focus
Can-Fite's innovative platform technology targets the A3AR, a receptor implicated in various pathological conditions. By focusing on this receptor, the company addresses significant unmet medical needs in multi-billion-dollar markets. The A3AR-based approach ensures that their drug candidates selectively affect diseased cells while sparing healthy tissues, minimizing side effects and enhancing therapeutic efficacy. This unique mechanism underpins the development of their lead candidates, Piclidenoson and Namodenoson, which are advancing through late-stage clinical trials.
Pipeline and Drug Candidates
- Piclidenoson: This drug candidate is currently in a Phase III clinical trial for psoriasis, a chronic inflammatory skin condition. By targeting A3AR, Piclidenoson aims to modulate the immune response, offering a potential alternative to existing treatments.
- Namodenoson: Namodenoson is being evaluated in multiple indications, including a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for non-alcoholic steatohepatitis (NASH). Namodenoson has also shown potential for treating other cancers, such as pancreatic, colon, prostate, and melanoma, and has demonstrated liver-protective effects, including anti-steatosis, anti-inflammatory, and anti-fibrotic properties.
- CF602: This preclinical-stage drug candidate targets erectile dysfunction, leveraging the same A3AR platform to address an entirely different therapeutic area.
Intellectual Property and Market Position
Can-Fite has secured broad intellectual property protections for its drug candidates, with patents extending into the 2040s. This strategic advantage positions the company strongly in the competitive biopharmaceutical landscape. Their focus on oral small molecule drugs differentiates them from competitors offering injectable therapies, providing convenience and improved patient compliance.
Regulatory and Clinical Milestones
The company has achieved significant regulatory milestones, including Orphan Drug Designation in the United States and Europe for Namodenoson as a second-line treatment for hepatocellular carcinoma. Additionally, the U.S. FDA has granted Fast Track Designation to Namodenoson for the same indication, underscoring its potential to address critical unmet medical needs.
Strategic Vision
Can-Fite BioPharma aims to commercialize its drug candidates through strategic partnerships, licensing agreements, and direct market entry. With a focus on addressing diseases with limited treatment options, the company is well-positioned to capture significant market share in oncology, liver disease, and inflammatory conditions. Their commitment to innovation and patient-centric solutions continues to drive their clinical and business strategies.
Conclusion
Can-Fite BioPharma Ltd. represents a compelling player in the biopharmaceutical industry, leveraging cutting-edge technology to develop targeted therapies for high-impact diseases. With a strong pipeline, robust intellectual property, and a focus on unmet medical needs, the company is poised for significant contributions to the fields of oncology, liver disease, and inflammation.
Can-Fite BioPharma has completed enrollment of over 400 patients for its Phase III Comfort™ study targeting moderate to severe plaque psoriasis. The study follows a positive interim analysis from October 2020, which recommended continuation based on data from 200 patients. Topline results are anticipated in Q1 2022. This randomized, double-blind study is being conducted in Europe, Israel, and Canada, with primary endpoints focused on patient response rates. Can-Fite’s lead candidate, Piclidenoson, aims to offer an effective oral treatment alternative in a growing $11.3 billion market by 2025.
Can-Fite BioPharma Ltd. (NYSE American: CANF) announced its financial results for Q2 2021. The company reported immaterial revenue decline to $0.39 million compared to $0.40 million in Q2 2020. Notable developments include a $3 billion commercialization agreement for Piclidenoson in veterinary osteoarthritis and a Notice Allowance for a NASH patent in China. The net loss decreased to $5.09 million from $8.23 million year over year. Can-Fite has approximately $7.5 million in cash while anticipating significant milestones in upcoming studies.
Can-Fite BioPharma Ltd. (NYSE: CANF) has signed a definitive agreement with a healthcare-focused institutional investor to sell 5,000,000 American Depositary Shares (ADSs) at $2.00 each, raising gross proceeds of $10 million for research, development, and working capital. A concurrent private placement of warrants to purchase up to 5,000,000 ADSs will also occur at the same price. The offering, expected to close around August 16, 2021, is facilitated by H.C. Wainwright & Co. The ADSs are offered under a shelf registration statement filed with the SEC.
Can-Fite BioPharma Ltd. (NYSE American: CANF) has appointed Yossi Borenstein as an External Director during its recent annual general meeting. Borenstein, CEO of Shizim Group and a veteran in the Israeli biomed industry, brings over 35 years of experience, having previously managed Bristol-Myers Squibb (Israel) and served in various leadership roles across multiple organizations. Can-Fite, engaged in developing therapies for cancer, liver, and inflammatory diseases, continues its clinical progress with drug candidates like Piclidenoson and Namodenoson.
Can-Fite BioPharma Ltd (NYSE: CANF) has completed preparatory work for its pivotal Phase III trial of Namodenoson, targeting hepatocellular carcinoma (HCC), the most prevalent liver cancer. The trial will enroll 450 patients globally and is designed to assess overall survival and safety. Both the FDA and EMA have agreed to the trial protocol, and Namodenoson has received Orphan Drug and Fast Track designations. This advancement comes amid a global market for HCC treatments projected to reach $3.8 billion by 2027.
Can-Fite BioPharma (NYSE: CANF) has entered a development and commercialization agreement with Vetbiolix for its drug, Piclidenoson, targeting osteoarthritis in pets. Vetbiolix will conduct proof-of-concept studies over two years, covering all associated costs, and may obtain a license for further development if the data is positive. The canine osteoarthritis market is projected to reach $3 billion by 2024, with the broader companion animal health market expected to grow to $27 billion by 2028. Piclidenoson offers a potentially effective oral treatment alternative to existing NSAIDs.
Can-Fite BioPharma Ltd (NYSE American: CANF) announced that the Chinese National Intellectual Property Administration granted a Notice of Allowance for its patent on an A3 Adenosine Receptor ligand aimed at treating ectopic fat accumulation. This patent supports their liver drug candidate, Namodenoson, which is set to enter Phase IIb trials for non-alcoholic steatohepatitis (NASH) in Q3 2021, following successful Phase IIa results. Namodenoson has been licensed in China with potential milestone payments of up to $74.5 million. The NASH market in China is projected to reach $6.4 billion by 2027.
Can-Fite BioPharma Ltd (NYSE American: CANF) received clearance from the Israeli Ministry of Health to initiate a Phase IIb study of its drug candidate Namodenoson for treating NASH. Enrollment is expected to start in Q3 2021, earlier than previously anticipated. The study aims to assess Namodenoson's efficacy in 140 subjects, comparing its effects against a placebo over 36 weeks. Given the urgent unmet medical need for NASH treatments, the market for NASH pharmaceuticals could reach $35-40 billion by 2025.
Can-Fite BioPharma Ltd. (NYSE American: CANF) announces that Dr. Sari Fishman will present at the BIO Digital Convention on June 10-11 & 14-18, 2021. Can-Fite has secured approximately $20 million from out-licensing agreements for its drug candidates, with potential milestone payments of up to $130 million. The company anticipates key developments, including topline data from Phase III psoriasis and Phase II COVID-19 trials, as well as initiating pivotal trials in liver cancer and NASH by year-end.
Can-Fite BioPharma Ltd (NYSE American: CANF) reported its financial results for Q1 2021, revealing revenues of $0.15 million, down 25.2% from $0.20 million in Q1 2020. The company secured a $42.7 million out-licensing deal with Ewopharma, including $2.25 million upfront and up to $40.45 million contingent on milestones. The Phase III Comfort™ psoriasis study reached 75% enrollment, with topline results anticipated in Q4 2021. Can-Fite’s R&D expenses declined by 65.5% to $1.30 million, while general and administrative expenses rose to $1.01 million. Future trials for liver cancer and NASH are set for late 2021.
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