Can-Fite BioPharma Ltd. American Depositary Shares, each representing three hundred (300) Ordinary Shares - CANF STOCK NEWS

Can-Fite BioPharma (NYSE American: CANF) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding its registration plan for a pivotal Phase III clinical trial targeting moderate to severe psoriasis. The trial will evaluate the safety and efficacy of Piclidenoson, the company's lead drug candidate. This follows the recent successful topline results from the Phase III COMFORT™ study, which demonstrated significant improvement over placebo. Can-Fite is also preparing a comparable data package for the US FDA. The CEO emphasized the drug's oral dosage, safety profile, and potential in a large market for effective psoriasis treatments.

Can-Fite BioPharma Ltd. (NYSE American: CANF) announced its financial results for the year ended December 31, 2022, reporting revenues of $0.81 million, a 4.7% decrease from $0.85 million in 2021. Research and development expenses decreased by 21.2% to $7.76 million, while general and administrative expenses fell 18.2% to $3.14 million. The net loss was reduced to $10.17 million from $12.61 million in 2021. Can-Fite highlighted significant clinical achievements, including a successful Phase III trial for Piclidenoson in psoriasis and promising preclinical results for Namodenoson against pancreatic cancer. The company also secured a patent for liver fibrosis treatment.

Can-Fite BioPharma (NYSE American: CANF) announced regional deals that include upfront payments, regulatory and sales milestones, and double-digit royalties. The company's VP of Business Development, Dr. Sari Fishman, will participate in the BIO-Europe Spring conference in Basel, Switzerland from March 20 to 22, 2023, aiming to establish licensing and distribution agreements for its advanced drug candidates, Piclidenoson and Namodenoson. Both drugs have shown promising results in clinical trials, with Piclidenoson moving into a Phase III trial. Can-Fite aims to accelerate drug distribution, enhancing partnership agreements in Europe, Asia, and Canada.

Can-Fite BioPharma (NYSE American: CANF) announced compassionate use of its drug Namodenoson for patients with decompensated cirrhosis at Soroka Medical Center in Israel. This condition currently has no approved therapeutic options aside from liver transplants. Namodenoson, undergoing pivotal Phase III studies for liver cancer, has shown potential benefits in clinical trials for cirrhosis and NASH, highlighting the urgent need for effective treatments as the liver cirrhosis market is projected to reach $15 billion in the U.S. by 2030.

Can-Fite BioPharma (NYSE American: CANF) announced progress on its drug Namodenoson, currently undergoing a pivotal Phase III study approved by the FDA and EMA. Namodenoson, an orally bioavailable drug, targets liver cancer cells while sparing normal liver cells, demonstrating improved survival rates in advanced liver cancer patients. The drug holds Orphan Drug and Fast Track designations in both the U.S. and Europe. Published research indicates a very favorable safety profile and its potential effectiveness based on Phase II trial outcomes. The study aims to enroll 450 patients across Israel, Europe, and the U.S., with an interim data analysis planned.

Can-Fite BioPharma (NYSE: CANF) announced that its anti-cancer drug, Namodenoson, exhibits significant inhibition of pancreatic carcinoma growth, both alone and in combination with gemcitabine, the standard chemotherapy. These pre-clinical studies highlighted Namodenoson's excellent safety profile and potential effectiveness against pancreatic cancer, a disease with a bleak 11% 5-year survival rate in the U.S. The company has filed a patent application for Namodenoson aimed at treating this aggressive cancer. The global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow significantly by 2030.

Can-Fite BioPharma (NYSE American: CANF) announced definitive agreements for a registered direct offering of 1,000,000 American Depositary Shares (ADSs) at $5.50 each, expected to yield approximately $7.5 million, alongside a private placement of 363,637 ADSs at the same price. The offerings include Series A warrants with an exercise price of $6.00 and Series B warrants at $5.50. Proceeds will fund R&D and clinical trials. The closing is anticipated by January 13, 2023, and the warrants will have a term of up to 5.5 years and 20 months respectively.

Can-Fite BioPharma has submitted a market registration plan for its lead drug candidate, Piclidenoson, to the European Medicines Agency. This follows successful topline results from the Phase III COMFORT study, which showed significant improvement over placebo in treating moderate to severe psoriasis. The drug boasts a superior safety profile compared to Otezla, the leading oral psoriasis therapy. With a focus on the $26 billion psoriasis market, Can-Fite aims to position Piclidenoson as a preferred treatment.

Can-Fite BioPharma Ltd. (NYSE American: CANF) announced a change to its American Depositary Shares (ADSs) ratio, effective January 9, 2023. The new ratio will be one ADS representing 300 ordinary shares, equivalent to a one-for-ten reverse split. Existing ADS holders will exchange ten ADSs for one new ADS. There will be no changes to ordinary shares, and the new ADSs will continue trading under the symbol 'CANF'. Following this, the ADS price is expected to increase proportionally, though there's no guarantee of reaching ten times the previous price.