On August 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 June 30, 2021 (Press release, Can-Fite BioPharma, AUG 26, 2021, View Source [SID1234586935]).
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Corporate and Clinical Development Highlights Include:
Can-Fite Entered into Development and Commercialization Agreement in $3 Billion Veterinary Osteoarthritis Market – Can-Fite entered into a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use. The canine osteoarthritis market is projected to reach $3 billion by 2024.
Can-Fite Received a Notice Allowance in China for its NASH Patent – During the second quarter, Can-Fite received a Notice Allowance in China for its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This patent, which has subsequently been issued to Can-Fite, addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, to reduce liver fat particularly in patients with NASH.
Patent Filed for A3AR-based Cannabis Compounds in the Treatment of Liver Diseases – Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis, which is associated with NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.
Phase III Psoriasis Study Nears Completion of Enrollment – The Phase III Comfort study completed enrollment of 75% of planned patients during the second quarter, with full enrollment expected in the coming weeks. 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. Topline results are expected Q1 2022.
Phase II COVID-19 Study Expands into Europe – Can-Fite’s ongoing Phase II study, under a U.S. FDA protocol, has been enrolling patients in Israel and expanded enrollment into Europe during the second quarter. The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in 40 patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.
Phase IIb NASH Study Receives Clearance from Israeli Ministry of Health – Can-Fite received clearance from the Israeli Ministry of Health to commence a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. Patient enrollment is expected to commence Q3 2021, ahead of the prior expected start date of Q4 2021. The Company expects to expand the study to additional clinical sites in Europe. A prior Phase IIa clinical trial of Namodenoson in the treatment of NASH met study endpoints showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.
Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has completed preparatory work for its pivotal Phase III study and plans to submit its study protocol and plans to Institutional Review Boards (IRBs) at potential clinical sites. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival.
Fortified Balance Sheet
On June 30, 2021 Can-Fite had approximately $7.5 million in cash, cash equivalents, and short-term deposits. The Company closed an additional $10 million registered direct offering in August 2021.
"We expect multiple milestones in the coming months including topline results from our Phase III psoriasis study, in addition to the commencement of our pivotal Phase III in liver cancer and Phase IIb in NASH. We believe positive topline results may lead to further expansion of our global distribution strategy which has included significant non-dilutive funding," stated Can-Fite CEO Dr. Pnina Fishman.
Financial Results
Revenues for the six months ended June 30, 2021 were $0.39 million compared to revenues of $0.40 million during the six months ended June 30, 2020. The decrease is considered immaterial.
Research and development expenses for the six months ended June 30, 2021 were $3.81 million compared with $7.05 million for the same period in 2020. Research and development expenses for the first half of 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 six 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 six months of 2021. We expect research and development expenses will increase through 2021 and beyond.
General and administrative expenses were $1.89 million for the six months ended June 30, 2021 compared to $1.45 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. We expect general and administrative expenses will remain at the same level through 2021.
Financial income, net for the six months ended June 30, 2021 was $0.20 million compared to financial expense, net of $0.12 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 investment.
Can-Fite’s net loss for the six months ended June 30, 2021 was $5.09 million compared with a net loss of $8.23 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 June 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $7.53 million as compared to $8.26 million at December 31, 2020. The decrease in cash during the six months ended June 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 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma which were offset by Company’s operating activity.
The Company’s consolidated financial results for the six months ended June 30, 2021 are presented in accordance with US GAAP Reporting Standards.