On August 27, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, reported financial results for the six months ended June 30, 2015 and updates on its drug development programs (Filing, 6-K, Can-Fite BioPharma, AUG 27, 2015, View Source [SID:1234507355]).
Clinical Development Program and Corporate Highlights Include:
● CF101 – Favorable Psoriasis Data, New U.S. Patent, Proposed Generic Name, and Next Advanced Clinical Studies in Rheumatoid Arthritis & Psoriasis
During the second quarter of 2015, Can-Fite reported positive data from further analysis of its completed Phase II/III study that suggests CF101 as a potential systemic therapy for patients with moderate-severe psoriasis, this despite the study not meeting its primary endpoint, as previously announced during the first quarter of 2015. Based on these findings, the Company is preparing the protocol for its next advanced psoriasis trial. During the second quarter of 2015, Can-Fite also completed the design of a Phase III clinical study for the treatment of rheumatoid arthritis and plans to submit the protocol to Institutional Review Boards (IRBs) for approval in the fourth quarter of 2015. The Company is discussing the protocol and the registration plan with its EU notified body. Further, the U.S. Patent and Trademark Office granted Can-Fite a patent covering the manufacturing process for CF101 in the U.S., and the World Health Organization accepted "piclidenoson" as the proposed generic name for CF101, both are important steps prior to bringing a new drug to market.
● CF102 – Ongoing Phase II Liver Cancer Trial & Application for Orphan Drug Status in Europe
Can-Fite is continuing to enroll and dose patients in its global Phase II liver cancer study. Approximately 78 patients are expected to be enrolled in the trial in the U.S., Europe, and Israel by the end of the first half of 2016. Can-Fite previously received Orphan Drug Designation in the U.S. for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.
● CF602 – New Pre-clinical Data Supports Upcoming IND Submission for Sexual Dysfunction Drug
As Can-Fite prepares to file an investigational new drug (IND) application with the U.S. Food and Drug Administration prior to a Phase I clinical study of CF602 in the treatment of sexual dysfunction, the Company announced new data showing efficacy in a diabetic rat preclinical study. The animals were treated twice daily with CF602 for a period of 1 and 5 days. Treated animals showed a significant response rate resulting in a 188% and 250% increase in penial intra-cavernosal pressure, respectively compared to placebo.
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● Update on Licensing and Distribution Agreements in Canada and Japan
During the second quarter of 2015, Can-Fite received an upfront payment of CDN$1.7 million when it entered into a distribution agreement with Canada-based Cipher Pharmaceuticals. More recently, on August 27, 2015, Can-Fite entered into an agreement with Japan-based Seikagaku Corporation terminating its license agreement. Seikagaku informed Can-Fite that it is strategically focused on expanding its core research and development activities in the field of glyco-science. Under the license agreement, Seikagaku was granted a license for the use, development and marketing of CF101 in Japan with respect to inflammatory indications, except for ophthalmic disease indications. The termination agreement provides, among other things, that all licenses and rights granted to Seikagaku terminate and all clinical and non-clinical studies conducted by Seikagaku shall be transferred free of charge to Can-Fite. Over the life of the license, Can-Fite received an aggregate of approximately $8 million from Seikagaku. Can-Fite recently participated in an Israeli life sciences delegation to Japan with Israel’s Office of the Chief Scientist and signed Non-Disclosure Agreements with selected Japanese companies interested in licensing CF101 and CF102. The Company’s agreement with Korea-based Kwang Dong remains in place.
● Definitive Agreement to Acquire Improved Vision System by Can-Fite Subsidiary OphthaliX
During the second quarter of 2015, OphthaliX, Can-Fite’s subsidiary, which develops ophthalmic indications of CF101, signed a definitive agreement to acquire Israel-based Improved Vision Systems, LTD. (I.V.S.). The strategic acquisition aims to combine medical devices and pharmaceutical products to address multi-billion dollar markets in treating ophthalmic diseases.
● Ongoing Phase II Study in Glaucoma by Can-Fite Subsidiary OphthaliX
OphthaliX continues to enroll patients in a Phase II clinical study of CF101 for glaucoma and data release is expected during the first half of 2016.
"We look forward to starting advanced stage trials in the coming quarters for CF101 for both the treatment of rheumatoid arthritis and psoriasis, addressing multi-billion dollar markets. Prior Phase II trials for both of these indications have produced valuable data that have helped us optimize the design of the pivotal studies, which move us closer towards applying for marketing approval," stated Can-Fite CEO Dr. Pnina Fishman. "With CF102 in Phase II for liver cancer and our anticipated IND filing for CF602 in sexual dysfunction in Q3 2016, we believe we are well positioned with four distinct clinical programs. During the first half of 2015 we have forged a strategic partnership in Canada and are excited about new opportunities in the Japanese market."
Research and development expenses for the six months ended June 30, 2015 were NIS 5.75 million (U.S. $1.53 million) compared with NIS 8.64 million (U.S. $2.29 million) for the same period in 2014. Research and developments expenses for the first half of 2015 comprised primarily of expenses associated with the Phase II study for CF102 as well as expenses for ongoing studies of CF101. The decrease is primarily due to the completion of the psoriasis Phase II/III study during the first quarter of 2015 and a decrease in the scope of the non-clinical expenses during the first six months of 2015 compared to the same period in 2014.
General and administrative expenses were NIS 4.67 million (U.S. $1.24 million) for the six months ended June 30, 2015 compared to NIS 5.43 million (U.S. $1.44 million) for the same period in 2014. The decrease is primarily due to a reduction in salary and professional services expenses.
Financial income, net for the six months ended June 30, 2015 was NIS 1.88 million (U.S. $0.49 million) compared to NIS 1.71 million (U.S. $0.45 million) for the same period in 2014. The increase in financial income, net in the first half of 2015 was mainly due to a decrease in the fair value of warrants that are accounted as financial liability.
Can-Fite’s loss for the six months ended June 30, 2015 was NIS 8.27 million (U.S. $2.19 million) compared with a loss of NIS 12.36 million (U.S. $3.28 million) for the same period in 2014. The decrease in net loss for the first half of 2015 was attributable mainly to a decrease in operating expenses.
As of June 30, 2015, Can-Fite had cash and cash equivalents of NIS 29.20 million (U.S. $7.74 million) as compared to NIS 36.09 million (U.S. $9.57 million) at December 31, 2014. The decrease in cash during the six months ended June 30, 2015 is due to operating expenses offset by NIS 5.14 million (U.S. $1.36 million) received from Cipher Pharmaceuticals as upfront payment for entering into the distribution agreement with Cipher.
For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on June 30, 2015 (U.S. $ 1 = NIS 3.769).
The Company’s consolidated financial statements for the six months ended June 30, 2015 are presented in accordance with International Financial Reporting Standards.