On May 29, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the three months ended March 31, 2019 (Press release, Can-Fite BioPharma, MAY 29, 2019, View Source [SID1234536649]).
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Clinical Development and Corporate Highlights During Q1 2019 Include:
●Top Line Results from Phase II Trial of Namodenoson in Liver Cancer – Namodenoson was found to increase overall survival in hepatocellular carcinoma (HCC) patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint. The Company is now preparing for an end-of-Phase II meeting with the FDA to initiate a Phase III study in liver cancer.
●Liver Cancer Data Presentations Accepted at Leading Scientific Conferences – Findings from the Phase II study have been accepted for presentation at two medical conferences that are highly influential in the field of liver cancer. Can-Fite is scheduled to deliver a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 2 and is scheduled to deliver an oral presentation at the International Liver Cancer Association (ILCA) annual meeting on September 22.
●Additional Distribution Deal for Namodenoson in Korea – Can-Fite expanded its distribution deal for Namodenoson with Chong Kun Dang Pharmaceuticals (CKD) in South Korea to include the indication of NASH, in addition to the original distribution deal with CKD for Namodenoson in the treatment of liver cancer. For the expanded distribution, CKD paid Can-Fite $1,000,000 upfront, with up to an additional $5,000,000 due upon completion of milestones.
●Manuscript on Can-Fite’s Drugs in CAR-T Published – Drug Design, Development and Therapy published an article about Can-Fite’s drugs’ potential ability to treat Cytokine Release Syndrome (CRS), a potentially fatal side effect of CAR-T and other immune-oncology therapies.
●New Patent Granted in U.S. – The U.S. Patent and Trademark Office issued a Notice of Allowance for Can-Fite’s patent application titled, "Use of A3 adenosine receptor agonist in the treatment of Osteoarthritis." The patent addresses methods for treating osteoarthritis with A3 adenosine receptor (A3AR) agonists and has been granted to Can-Fite in major global markets including North and South America, Europe and Asia.
●Up-Front Money from Newly Signed Deal and Equity Fund Raise – Following the end of the first quarter, Can-Fite received approximately $10.2 million in gross proceeds of which $1 million was received from CKD for the expanded distribution of Namodenoson in South Korea in April and $9.2 million was raised through two registered direct offerings that were completed in April and May. Effective May 10, 2019, Can-Fite changed the ratio of its American Depository Shares (ADSs) to ordinary shares from one ADS representing two ordinary shares to a new ratio of one ADS representing 30 ordinary shares.
"We are effectively advancing our drug pipeline through late stage clinical trials including two Phase III studies for Piclidenoson in auto immune diseases and a planned Phase III for Namodenoson in liver cancer. In the coming months we expect to announce top line results from our Phase II study of Namodenoson in the treatment of NASH," stated Can-Fite CEO Pnina Fishman. "Each one of the four indications we are pursuing addresses unmet needs in multi-billion dollar markets."
Financial Results
Revenues for the three months ended March 31, 2019 were $0.30 million compared to revenues of $0.63 million during the three months ended March 31, 2018. The decrease in revenues for the first quarter of 2019 was mainly due to the recognition of a $0.3 million advance payment received in January 2018 under the Distribution and Supply Agreement with Gebro compared to none in 2019.
Research and development expenses for the three months ended March 31, 2019 were $1.44 million compared with $1.31 million for the same period in 2018. Research and development expenses for the first quarter of 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis.
General and administrative expenses were $0.57 million for the three months ended March 31, 2019 compared to $0.90 million for the same period in 2018. The decrease is primarily due to a decrease in professional services and investor relations expenses.
Financial expense, net for the three months ended March 31, 2019 was $0.12 million compared to financial expense, net of $0.13 million for the same period in 2018. The decrease in financial expense, net in the first quarter of 2019 is considered immaterial.
Can-Fite’s net loss for the three months ended March 31, 2019 was $1.83 million compared with a net loss of $1.72 million for the same period in 2018. As of March 31, 2019, Can-Fite had cash and cash equivalents of $2.96 million as compared to $3.62 million at December 31, 2018. The decrease in cash during the three months ended March 31, 2019 is due to a decrease in net cash used in operating activity of $1.46 million and a decrease in net cash provided by financing activity of $2.4 million.
In April and May 2019, the Company raised $3.2 million and $6 million in gross proceeds, respectively, in registered direct offerings.
The Company’s consolidated financial results for the three months ended March 31, 2019 are presented in accordance with International Financial Reporting Standards.