Earnings release
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May 27 , 2021 Can - Fite Reports First Quarter 2021 Financial Results & Provides Clinical Update PETACH TIKVA , Israel -- ( BUSINESS WIRE ) -- Can - Fite BioPharma Ltd. ( NYSE American : CANF ) ( TASE : CFBI ) , a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory , cancer and liver diseases , today announced financial results for the quarter ended March 31 , 2021 . Clinical Developments and Corporate Highlights Include : Signed Large Out - licensing Deal Worth $ 42.7 Million with Ewopharma - During the first quarter , Can - Fite signed a large out - licensing agreement with Swiss - based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland , receiving $ 2.25 million upfront with up to an additional $ 40.45 million payable upon the achievement of regulatory and sales milestones , plus 17.5 % royalties on net sales . Together with Ewopharma , Can - Fite's existing out - licensing deals are worth a potential $ 130 million in future milestone payments plus double - digit royalties on net sales upon regulatory approvals . Can - Fite has received over $ 20 million in non - dilutive funding to date . Phase III Psoriasis Study Achieves 75 % Enrollment- The Phase III Comfort ™ study completed enrollment of 75 % of planned patients for the study which is designed to establish Piclidenoson's superiority compared to placebo and non - inferiority compared to Apremilast ( Otezla® ) in patients with moderate to severe plaque psoriasis . The majority of costs associated with the Phase III Comfort ™ study have been previously paid . The Company expects to complete enrollment in Q3 2021 and report topline results in Q4 2021 . Phase II COVID - 19 Study Expands to Europe- Can - Fite is enrolling 40 patients hospitalized with moderate to severe COVID - 19 in its Phase II study , under a U.S. Food and Drug Administration ( FDA ) approved protocol , in Israel and Europe . Phase llb NASH Study Expected to Commence Q4 2021- Based on a successfully concluded Phase Ila NASH / NAFLD study with Namodenoson which met its primary endpoint , Can - Fite completed the design of a Phase IIb study with the help of top NASH Key Opinion Leaders , Dr. Friedman and Dr. Harrison , and the Company plans to commence the Phase llb study before the end of 2021 . Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021- Can - Fite is preparing to commence its pivotal Phase III trial for the treatment of hepatocellular carcinoma ( HCC ) based on a protocol agreed upon with the U.S. FDA and the European Medicines Agency . Should the study meet its efficacy endpoint and be approved by the FDA and EMA , Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients . Recently announced data from Can - Fite's Phase II advanced liver cancer study included overall survival of 4 years in two patients . Additional findings show disappearance of ascites , normal liver function and good quality of life . A scientific paper