Can-Fite BioPharma Ltd. reports developments for a clinical-stage biotechnology pipeline of proprietary small-molecule drugs targeting the A3 adenosine receptor (A3AR). Recurring news covers Namodenoson and Piclidenoson across oncology, inflammatory disease, liver disorders, metabolic disease, obesity-related uses, and companion-animal osteoarthritis through its veterinary commercialization relationship.
Company updates also include clinical and regulatory disclosures, patent allowances in multiple jurisdictions, operating and financial results, material agreements, capital-structure actions, and governance matters tied to its American Depositary Shares and ordinary-share voting processes.
Can-Fite BioPharma (NYSE American: CANF) announced an unexpected delay in releasing top-line data from its Phase III Comfort™ study of Piclidenoson for treating plaque psoriasis, now expected in Q2 2022. The study involves over 400 patients across Europe, Israel, and Canada. Piclidenoson aims to target key cytokines involved in skin lesions. The psoriasis market is projected to reach $11.3 billion by 2025, with potential milestone payments from out-licensing agreements. The company remains optimistic about the drug's effectiveness with minimal side effects.
Can-Fite BioPharma (NYSE American: CANF) announced the enrollment of the first patient in a Phase IIb study for its drug candidate Namodenoson, targeting non-alcoholic steatohepatitis (NASH). This multicenter, randomized trial aims to assess Namodenoson's efficacy compared to placebo in 140 subjects over 36 weeks. The NASH market is projected to reach $35-$40 billion by 2025, highlighting the growth potential. Previous Phase IIa results indicated promising outcomes related to liver fibrosis and inflammation.
Can-Fite BioPharma (NYSE American: CANF) has out-licensed its psoriasis drug, Piclidenoson, in major markets including Canada, Europe, and Asia. Recent pre-clinical studies show that Piclidenoson effectively destroys pathological skin cells, supporting its potential in treating psoriasis. The ongoing Phase III trial in Europe and Canada aims to demonstrate efficacy via PASI score improvements. The psoriasis market is projected to reach $11.3 billion by 2025, which could enhance Can-Fite's market position with milestone payments and royalties expected upon regulatory approval.
Can-Fite BioPharma (NYSE American: CANF) announced plans to hold virtual investor meetings at the J.P. Morgan Healthcare Conference. The company reported a complete response to Namodenoson for hepatocellular carcinoma (HCC) in its Phase II study. In Q1 2022, patient enrollment for a pivotal Phase III trial for HCC is expected to commence, supported by the FDA and EMA’s approval of the study design. Namodenoson has Orphan Drug Designation in the U.S. and Europe, with Fast Track Status in the U.S.
These developments position Can-Fite favorably in the competitive biopharma landscape.
Can-Fite BioPharma Ltd (NYSE American: CANF) announced key upcoming events expected to enhance shareholder value throughout 2022. The company plans to release topline data from a Phase III psoriasis study in Q1 2022, examining a primary endpoint related to Piclidenoson. Additionally, it will commence enrollment in a Phase IIb NASH study and a Phase III liver cancer study in H1 2022. Can-Fite has raised $10 million recently, complementing $13.3 million reported in Q3 2021, positioning the company well for ongoing clinical trials.
Can-Fite BioPharma Ltd (NYSE American: CANF) announced plans to file new patent applications for Namodenoson, a treatment targeting advanced liver cancer. This follows clinical data where a patient with advanced hepatocellular carcinoma (HCC) exhibited complete tumor clearance after treatment. The company is set to begin patient enrollment for a pivotal Phase III trial in Q1 2022 to support a New Drug Application (NDA). Can-Fite's IP portfolio now includes approximately 200 patents across 16 families, reinforcing its position in treating advanced cancers.
Can-Fite BioPharma Ltd. (NYSE American: CANF) announced the exercise of warrants by a healthcare-focused institutional investor to purchase 150 million ordinary shares (5 million ADSs) at $2.00 each, generating gross proceeds of $10 million. The ADSs and ordinary shares are registered under a SEC Form F-1. The new warrants will allow for future purchases of up to 180 million ordinary shares at the same price. Proceeds will be used for working capital, including advancing Phase II and Phase III clinical trials for liver diseases.
Can-Fite BioPharma (NYSE American: CANF) announced that a patient in its Phase II study of Namodenoson for hepatocellular carcinoma (HCC) achieved a Complete Response, with all cancer lesions cleared. The patient has survived five years post-treatment, showcasing significant clinical benefits including normal liver function. Can-Fite plans to start a pivotal Phase III trial in Q1 2022, aiming for New Drug Application submissions. The drug has Orphan Drug Designation and Fast Track Status in the U.S. and Europe, highlighting its potential in the treatment of liver cancer.
Can-Fite BioPharma Ltd (NYSE American: CANF) announced the completion of treatment for approximately 400 psoriasis patients in its Phase III Comfort™ study. The study uses Piclidenoson, an A3 adenosine receptor agonist, with a primary endpoint of PASI 75 response at week 16. Positive interim data has been reported. The psoriasis market is projected to reach $11.3 billion by 2025. Can-Fite has out-licensed Piclidenoson in multiple regions, pending regulatory approval, with potential milestone payments and royalties.
Can-Fite BioPharma Ltd. (NYSE American: CANF) reported financial results for the quarter ended September 30, 2021, highlighting key developments in its clinical pipeline. The company completed patient enrollment in its Phase III Comfort™ psoriasis study, with results expected in Q1 2022. Notably, Can-Fite discontinued its Phase II COVID-19 trial to focus on its primary indications. The financial results show revenues of $0.65 million, a slight increase from $0.61 million, while net loss decreased to $8.49 million, down from $10.81 million in 2020. The company’s cash and equivalents reached $13.3 million, bolstered by fundraising activities.