Can-Fite BioPharma Ltd. (AMEX:CANF) (TASE: CFBI) released financial results for the quarter ended March 31, 2022, revealing revenue of $200,000, an increase of or 38.5%, compared to $150,000 in Q1 2021.
Q1 Financial Highlights
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Net loss for the Q1 2022 was $2.43 million compared with a net loss of $1.87 million for the Q1 2021. The increase in net loss was primarily attributable to an increase in research and development expenses which was partly offset by a decrease in general and administrative expenses and a decrease in finance income, net.
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Research and development expenses for the Q1 2022 were $1.82 million, an increase of $520,000, or 39.8%, compared to $1.30 million for the Q1 2021. Research and development expenses for the Q1 2022 comprised primarily of expenses associated with an ongoing Phase III study of Piclidenoson for the treatment of psoriasis and two studies for Namodenoson, a Phase III study in the treatment of liver cancer and a Phase IIb study for NASH. The increase is primarily due to costs incurred in the Q1 2022 associated with the two new studies for Namodenoson.
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General and administrative expenses for the Q1 2022 were $750,000 a decrease of $260,000, or 25.8%, compared to $1.01 million for the Q1 2021. The decrease is primarily due to the decrease in professional services for public relations and investor relations.
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Financial expenses, net for the Q1 2022 were $60,000 compared to finance income, net of $290,000 for the Q1 2021. The decrease in financial income, net was mainly due to revaluation of our short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.
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As of March 31, 2022, Can-Fite had cash and cash equivalents and short term deposits of $16.5 million as compared to $18.9 million at December 31, 2021.
Corporate and Clinical Development Highlights
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Phase III Psoriasis Study Data Expected Q2 2022 – The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast at 32 weeks. During the first quarter, a preclinical study showed Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.
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Commenced Enrollment in Phase IIb NASH Study – In January, Can-Fite enrolled the first patient in its Phase IIb multicenter, randomized, double-blind, placebo-controlled study in 140 subjects with biopsy-confirmed NASH. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo as determined by a histological endpoint. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect.
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Granted U.S. Patent for Liver Fibrosis and Israeli Patent for NASH
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Opened Enrollment in Pivotal Phase III Liver Cancer Study – Can-Fite’s pivotal Phase III liver cancer study for Namodenoson opened for enrollment of approximately 450 patients diagnosed with hepatocellular carcinoma and underlying Child Pugh B7 who have not responded to other approved therapies. An interim analysis will be conducted after 50% of patients are enrolled and treated. The primary endpoint is overall survival. Can-Fite has received Orphan Drug Designation in both the U.S. and Europe and has received the U.S. FDA’s Fast Track Status.
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Presented Data on Cannabinoids in the Treatment of Liver Cancer at CannX – In March, Can-Fite delivered a presentation titled “Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations” at the CannX Medical Cannabis Conference in Tel Aviv. The findings were also published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids highlighting the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and deregulation of the Wnt/β-catenin pathway.
“We look forward to announcing Phase III psoriasis results before the end of the second quarter as we enroll patients in our other advanced stage clinical trials for NASH and liver cancer,” stated Can-Fite CEO Dr. Pnina Fishman. “Can-Fite is financially well positioned to conduct all our clinical development programs over the next year, and we continue to evaluate potential new distribution partnerships which may provide additional non-dilutive funding.”
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