On November 26, 2021 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 quarter ended September 30, 2021 (Press release, Can-Fite BioPharma, NOV 26, 2021, View Source [SID1234596106]).
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Corporate and Clinical Development Highlights Include:
Completed Patient Enrollment in Phase III Psoriasis Study – The Phase III Comfort study completed patient enrollment. Topline results are expected in Q1 2022. The study 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.
Can-Fite Ends Phase II COVID-19 Trial to Focus on Core Indications – In 2020, with the aim of developing a much-needed drug to treat manifestations of COVID-19, mainly the Cytokine Release Syndrome, Can-Fite initiated a Phase II COVID-19 study of its lead drug candidate, Piclidenoson, with patient enrollment in Israel and Europe. With the anticipated launch of Pfizer’s oral COVID-19 antiviral drug candidate, Can-Fite has made a strategic decision to end its COVID-19 program and to focus its resources on its other clinical programs, all in advanced clinical trials.
Patents Granted for NASH in Japan, Hong Kong, and Mexico – Can-Fite continues to build its IP portfolio for NASH which now includes patents granted and allowed in 37 countries. Most recently, patents were issued and allowed in Japan, Hong Kong, and Mexico for the patent titled "An A3 Adenosine Receptor Ligand for Use In Treating Ectopic Fat Accumulation". This patent addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, in the treatment of NASH.
Data on A3AR-based Cannabis Compounds in the Treatment of Liver Diseases Presented at AASLD and Published in HEPATOLOGY – Can-Fite delivered a poster presentation titled "Growth Inhibition of Hepatocellular Carcinoma (HCC) by CBD Rich T3/C15 Cannabis Fraction is Mediated via the A3 Adenosine Receptor" at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting during the Hepatobiliary Neoplasia: Experimental Hepatocarcinogenesis; Diagnostics and Liver Imaging session. The findings were also published in an abstract in the October 2021 supplement of HEPATOLOGY, a premier peer-reviewed publication in the field of liver disease published on behalf of the AASLD.
Positive Phase IIa NASH Data Published in Alimentary Pharmacology & Therapeutics – The peer-reviewed scientific journal focused on gastroenterology and hepatology published an article titled "Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis". The article includes highlights from Can-Fite’s Phase IIa NASH study of Namodenoson which achieved its study endpoints including significant anti-steatotic, anti-fibrotic, and anti-inflammatory effects.
Fortified Balance Sheet
On September 30, 2021, Can-Fite had approximately $13.3 million in cash, cash equivalents, and short-term deposits.
"Our NASH program has received a high level of interest at scientific conferences based on our positive Phase IIa results, and we continue to fortify our IP around this indication. We expect to commence enrollment in our pivotal Phase III liver cancer and Phase IIb NASH studies, as we look forward to topline results from our Phase III in psoriasis in the first quarter of 2022. Our advanced pipeline with a growing body of safety and efficacy data has significant potential to help patients with unmet needs," stated Can-Fite CEO Dr. Pnina Fishman.
Financial Results
Revenues for the nine months ended September 30, 2021 were $0.65 million compared to revenues of $0.61 million during the nine months ended September 30, 2020. The increase is considered immaterial.
Research and development expenses for the nine months ended September 30, 2021 were $6.75 million compared with $9.06 million for the same period in 2020. Research and development expenses for the nine months period ended September 30, 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first nine months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first nine months of 2021. We expect research and development expenses will increase for the remainder of 2021 and beyond.
General and administrative expenses were $2.71 million for the nine months ended September 30, 2021 compared to $2.14 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 public relations expenses and insurance expenses. We expect general and administrative expenses will remain at the same level for the remainder of 2021 and beyond.
Financial income, net for the nine months ended September 30, 2021 was $0.31 million compared to financial expense, net of $0.22 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investments.
Can-Fite’s net loss for the nine months ended September 30, 2021 was $8.49 million compared with a net loss of $10.81 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 expenses, net.
As of September 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $13.3 million as compared to $8.26 million at December 31, 2020. The increase in cash during the nine months ended September 30, 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 Company’s operating activity.
The Company’s consolidated financial results for the nine months ended September 30, 2021 are presented in accordance with US GAAP Reporting Standards.