On March 24, 2022 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, reported financial results for the year ended December 31, 2021 (Press release, Can-Fite BioPharma, MAR 24, 2022, View Source [SID1234610867]).
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Corporate and Clinical Development Highlights Include:
Fortified Balance Sheet – On December 31, 2021, Can-Fite had $18.9 million in cash, cash equivalents, and short-term deposits. During the year, the Company received $2.25 million in non-dilutive funding from Ewopharma for an out-licensing deal, $2.74 million from warrant exercises, and raised $10 million through a registered direct offering.
Signed Deal Worth $42.7 Million with Ewopharma – In 2021, Can-Fite signed its largest out-licensing agreement to date with Switzerland-based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland. A $2.25 million upfront payment was received 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.
Liver Cancer Patient Completely Cleared of Cancer; Pivotal Phase III Liver Cancer Study Expected to Commence Enrollment H1 2022 – A prior Phase II liver cancer study patient who continues to be treated with Namodenoson has survived five years and cleared all cancer lesions, in what the Company sees as a very positive sign for its upcoming pivotal Phase III liver cancer study. Enrollment is expected to commence H1 2022 with approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies.
Phase III Psoriasis Study Data Expected Q2 2022 – The Phase III Comfort study completed enrollment of >400 patients with moderate to severe plaque psoriasis and completed 16-weeks of treatment, the primary endpoint duration of the study. Topline results are expected in Q2 2022. The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla) at 32 weeks. In a recently completed preclinical study, Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.
Phase IIb NASH Study Commenced Enrollment – This Phase II multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH enrolled its first patient in January. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, 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. There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $21.9 billion by 2028 driven by increasing incidence.
Several Patents Granted for Liver Diseases – Can-Fite’s IP for Namodenoson in the treatment of liver diseases continues to grow. The Company was issued a Notice of Allowance in the U.S. for a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications including NASH, NAFLD, autoimmune hepatitis, primary biliary cirrhosis, and more. Other patents specific to NASH and NAFLD were granted in 37 countries, most recently issued and allowed in Japan, Hong Kong, and Mexico.
A3AR-based Cannabis Compounds Found to Inhibit Liver Cancer Growth in Preclinical Study – Can-Fite continues to advance its findings for cannabinoids and its platform technology’s target A3AR for which the Company has filed a patent. In 2021, Can-Fite completed pre-clinical studies demonstrating that a CBD rich T3/C15 cannabis fraction induces inhibition of liver cancer cell growth. These findings were published in peer-reviewed journals and presented at industry conferences.
"Our advanced-stage pipeline continues to achieve milestones, with Piclidenoson and Namodenoson both positioned as potentially safe and effective treatments for very large treatment indications including psoriasis, NASH, and liver cancer. In 2021 we signed our largest out-licensing deal to date, and in 2022 we anticipate additional new agreements as well as the potential of milestone payments from current agreements based on results from our current advanced stage trials," stated Can-Fite CEO Dr. Pnina Fishman.
Financial Results
Revenues for the year ended December 31, 2021 were $0.85 million compared to revenues of $0.76 million during the twelve months ended December 31, 2020. The increase in revenues was mainly due to the recognition of a portion of an advance payment received under the Ewopharma distribution agreement entered in 2021 which was offset by the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.
Research and development expenses for the year ended December 31, 2021 were $9.85 million compared to $11.95 million for the year ended December 31, 2020. Research and development expenses in 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase III study in the treatment of psoriasis and a Phase II study in COVID-19 and Phase II studies for Namodenoson in the treatment of liver cancer and NASH. The decrease is primarily due to costs incurred in 2020 associated with the Univo research project which was completed by the end of that year and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis which was ongoing during 2020, partially offset by pre-clinical projects and the two ongoing studies of Piclidenoson. We expect research and development expenses will increase through 2022 and beyond.
General and administrative expenses were $3.84 million for the year ended December 31, 2021 compared to $2.95 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees, increase in employee salaries, increase in public relations expenses, and insurance expenses. We expect general and administrative expenses will remain at the same level for the remainder of 2022 and beyond.
Financial income, net for the year ended December 31, 2021 was $0.23 million compared to financial expense, net of $0.3 million for the same period in 2020. The decrease in financial expense, net was mainly due to an increase in the revaluation of our short-term investment.
Can-Fite’s net loss for the year ended December 31, 2021 was $12.6 million compared with a net loss of $14.4 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance income, net.
As of December 31, 2021, Can-Fite had cash, cash equivalents, and short-term deposits of $18.9 million as compared to $8.3 million at December 31, 2020. The increase in cash during the year ended December 31, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021, an advance payment of $2.25 million from a distribution agreement with Ewopharma and from a $10 million registered direct offering in August 2021 which were offset by the Company’s operating activity.
The Company’s consolidated financial results for the twelve months ended December 31, 2021 are presented in accordance with US GAAP Reporting Standards.
More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.