On November 30, 2018 Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported financial results for the nine months ended September 30, 2018 and provided recent clinical development and corporate updates (Press release, Can-Fite BioPharma, NOV 30, 2018, View Source [SID1234531749]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Prolonged longevity of patients in our Namodenoson Phase II advanced liver study was reported this quarter. It is a significant highlight in our clinical trial progress and because of this development, we now expect to release top-line results during the first quarter of 2019," said Pnina Fishman, Ph.D., CEO of Can-Fite. "This development provides further encouragement that this therapy could bring value to patients with chronic liver disease and cirrhosis with a Child Pugh B score, whose disease has progressed on sorafenib therapy."
Dr. Fishman continued, "With the need for better treatments for autoimmune inflammatory conditions such as rheumatoid arthritis and psoriasis, as well as for liver diseases such as liver cancer and NASH, we are encouraged by the progress we are making in our ongoing clinical studies. We believe there is a significant role we can play in a market that has been searching for novel therapeutic solutions for better patient care."
Recent Highlights:
Namodenoson for the Treatment of Liver Diseases
Can-Fite announced that due to patient survival, top-line results of the Namodenoson Phase II advanced liver cancer study were expected to be released in Q1 2019. The statistical plan for this trial requires that the primary efficacy analysis occurs when no more than 3 of the original 78 patients survive.
In anticipation of the Phase II liver cancer data release, Can-Fite brought on board Professor Joseph Llovet, a Key Opinion Leader in the field of liver diseases, founder and director of the Liver Cancer Program and full professor of medicine at the Mount Sinai School of Medicine, New York University (USA). Professor Llovet will assist in the analysis of the Phase II data that are anticipated in Q1 2019.
Can-Fite presented a poster titled "Namodenoson Anti-Fibrogenic Effect is Mediated via De-Regulation of the Wnt/β-catenin Pathway," at the Hepatic Fibrosis Conference of the American Association for the Study of Liver Diseases (AASLD) in September. The data, highlighting the anti-fibrogenic effects of Namodenoson, demonstrated significant decrease in liver fibrosis upon chronic treatment with Namodenoson in the CCL4 NAFLD/NASH model.
Can-Fite’s CEO Dr. Pnina Fishman presented on Namodenoson at NASH Summit Europe 2018 in October. Dr. Fishman spotlighted preclinical data from three experimental animal models showing that the anti-inflammatory, anti-steatotic and anti-fibrogenic effects of Namodenoson are mediated via the Wnt/β-catenin pathway, highly active in the liver of NAFLD/NASH animals or individuals.
Can-Fite CEO Dr. Pnina Fishman presented on Namodenoson at The NYC Oncology Investor Conference 2018 in October. She presented the molecular mechanism mediating the anti-cancer effects of Namodenoson and described clinical data from the Company’s earlier Phase I/II liver cancer study. In addition, she presented the status of the current Phase II study in patients with advanced hepatocellular carcinoma, Child Pugh B.
Piclidenoson for the Treatment of Rheumatoid Arthritis and Psoriasis
Phase III clinical studies for the treatment of psoriasis and rheumatoid arthritis continue to enroll patients.
Financial Results
Revenues for the nine months ended September 30, 2018 were $3.5 million compared to $0.7 million for the same period in 2017. The increase in revenue was mainly due to the recognition of the $2 million advance payment received in August 2018 under the distribution agreement with CMS Medical and from a portion of the $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro.
Research and development expenses for the nine months ended September 30, 2018 were $4 million compared with $3.5 million for the same period in 2017. Research and development expenses for the nine months of 2018 were 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. We expect that the research and development expenses will increase through the rest of 2018 and beyond.
General and administrative expenses for the nine months ended September 30, 2018 were $2.4 million, compared to $2.1 million for the same period in 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that the annual general and administrative expenses for 2018 will be higher compared to 2017.
Financial expenses, net for the nine months ended September 30, 2018 were $0.2 million compared to financial income, net of $0.2 million for the same period in 2017. The increase in financial expenses, net was mainly due to recognition of interest expenses related to implementation of revenue recognition accounting standard IFRS 15, while in the same period in 2017, financial income was mainly due to fair value revaluation of warrants which were offset by financial expenses from exchange rate differences.
Can-Fite’s net loss for the nine months ended September 30, 2018 was $3.1 million compared with a net loss of $4.7 million for the same period in 2017. The difference in net loss was primarily attributable to an increase in revenues in 2018.
As of September 30, 2018, Can-Fite had cash and cash equivalents of $5.7 million as compared to $3.5 million at December 31, 2017. The increase in cash during the nine months ended September 30, 2018 is due to U.S. $4.37 million received from the issuance of shares and warrants, net of issuance expenses, the $2.2 million advance payment received from Gebro, and $2 million advance payment received from CMS Medical which were offset by our operating expenses.
The Company’s consolidated financial results for the nine months ended September 30, 2018 are presented in accordance with International Financial Reporting Standards.