Can-Fite BioPharma Ltd. Stock Price, News & Analysis

Can-Fite BioPharma (NYSE American: CANF) announced significant advancements in its clinical program for Namodenoson, targeting hepatocellular carcinoma (HCC). A pivotal Phase III study is now open for enrollment focusing on patients with advanced liver cancer. Notably, a CPB liver cancer patient remains cancer-free six years post-treatment with Namodenoson. Previous Phase II data indicated improved overall survival rates for CPB7 patients treated with Namodenoson compared to placebo. The FDA and EMA have granted Orphan Drug and Fast Track status for this drug.

Can-Fite BioPharma announced advancements in developing Piclidenoson, aimed at treating canine osteoarthritis, supported by its partner Vetbiolix. The canine osteoarthritis market is projected to reach $3 billion by 2028. Vetbiolix's recent studies indicate Piclidenoson has optimal safety and efficacy for upcoming European clinical trials, with a favorable safety profile established. If successful, this could lead to regulatory approval and significant revenues for Can-Fite. The drug could offer a superior alternative to current treatments.

Can-Fite BioPharma Ltd. (CANF) reported financial results for the quarter ending September 30, 2022, indicating a 6.1% revenue decline to $0.61 million compared to 2021. R&D expenses dropped 21.3% to $5.31 million, primarily due to completing the Phase III Piclidenoson study. The net loss decreased to $7.15 million from $8.50 million, largely thanks to reduced expenses. Can-Fite also highlighted significant clinical developments, including the clearance of cancer in a patient treated with Namodenoson and the positive Phase III results for Piclidenoson in psoriasis.

Can-Fite BioPharma (NYSE American: CANF) announced positive results from the Phase III COMFORT study for its drug Piclidenoson, targeting psoriasis. The study showed significant efficacy, surpassing placebo and demonstrating a safety profile comparable to that of placebo and better tolerated than Otezla®. CEO Dr. Pnina Fishman will present the findings at the 6th Annual Dermatology Drug Development Summit in Boston on November 2, 2022. With over 400 adults assessed, the promising outcomes set the stage for an upcoming pivotal Phase III registration trial.

Can-Fite BioPharma has announced the initiation of a global pivotal Phase III study for Namodenoson, a treatment for advanced liver cancer, also known as hepatocellular carcinoma (HCC). A case report presented at the AASLD’s The Liver Meeting highlights a patient who achieved a complete response after five years of treatment. The pivotal study is open for patient enrollment in various countries, including Israel and the U.S. Namodenoson holds Orphan Drug and Fast Track Status in both the U.S. and Europe.

Can-Fite BioPharma is advancing its Namodenoson liver drug candidate in a Phase IIb NASH study after a successful Phase IIa trial. CEO Dr. Pnina Fishman will present at the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022. NASH represents a significant market opportunity, expected to reach $35-$40 billion by 2025. The ongoing Phase IIb trial will evaluate Namodenoson’s efficacy against placebo in 140 subjects. Namodenoson has shown promise as a treatment for NASH and hepatocellular carcinoma, achieving Orphan Drug and Fast Track Designations.

Can-Fite BioPharma Ltd. (NYSE American: CANF) will be featured in an interview on The RedChip Money Report airing on Bloomberg TV on September 24, 2022, at 7 p.m. ET. CEO Dr. Pnina Fishman will discuss key topics including the Company's Phase 3 trials for Psoriasis and Liver Cancer, and potential $100 million in milestone payments. Can-Fite is advancing therapies in inflammatory, cancer, and liver diseases, with drugs like Namodenoson and Piclidenoson showing promising results in clinical trials. The interview can be accessed in full on Can-Fite’s website.

Can-Fite BioPharma (NYSE American: CANF) announced positive results from the Phase III COMFORT™ study of its psoriasis treatment, Piclidenoson, presented by Dr. Kim Papp at the EADV Congress. The study met its primary endpoint, showing a statistically significant improvement over placebo (p=0.037) at 16 weeks. Piclidenoson demonstrated a safety profile comparable to placebo and better tolerability than Otezla®. The drug is set to progress into a pivotal Phase III registration trial for moderate to severe psoriasis and has shown promise for long-term treatment.

Can-Fite BioPharma Ltd. (NYSE American: CANF) reported financial results for the quarter ending June 30, 2022, showcasing a strong balance sheet with $12.72 million in cash. Key developments include the approval of Namodenoson for compassionate use in Romania and the initiation of a pivotal Phase III study for liver cancer. The Phase III COMFORT trial for psoriasis successfully met its primary endpoint with Piclidenoson. Revenues reached $0.40 million, up 2.7%, while net loss declined to $4.62 million. The company plans to submit registration for Piclidenoson to FDA and EMA.