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, today reported financial results for the three months ended March 31, 2015 and updates on its drug development programs.
Clinical Development Program and Corporate Highlights Include:
- CF101 – Finalizing Design for Next Advanced Clinical Studies
Can-Fite completed the design of a Phase III clinical study for the treatment of patients with rheumatoid arthritis. The Phase III design is based on positive data received from the Company's completed Phase IIb study in which CF101 was administered as a monotherapy. Can-Fite plans on submitting the Phase III study protocol to Institutional Review Boards (IRBs) for approval in the fourth quarter of 2015. Can-Fite also plans to finalize the design of its next advanced psoriasis study based on the positive data that were released recently from its further analysis of its completed Phase II/III study. Study design for the advanced psoriasis trial is expected to be completed during the second half of 2015.
- CF102 – Enrolling and Dosing Patients in Liver Cancer Trial
Can-Fite continues to enroll and dose patients in its global Phase II liver cancer study. Approximately 78 patients are expected to be enrolled in the trial by the end of the first half of 2016.
- CF602 – Conducting Pre-Clinical Program and Preparatory Work for IND Submission
Can-Fite is developing its third drug candidate, CF602, for the indication of sexual dysfunction. The Company is continuing its pre-clinical program and preparatory work for its upcoming Investigational New Drug (IND) submission that it intends to make to the U.S. FDA.
- Signed Partnership with Cipher Pharmaceuticals
During the first quarter of 2015, Can-Fite signed a distribution agreement with Canada-based Cipher Pharmaceuticals for the distribution of CF101, for the treatment of moderate to severe psoriasis and rheumatoid arthritis in the Canadian market upon receipt of regulatory approvals. Following signing of the agreement, Cipher made an upfront payment of CDN$1.65 million to Can-Fite.
- Planned Acquisition of Medical Device Company by Can-Fite Subsidiary
OphthaliX, Can-Fite's subsidiary, which develops ophthalmic indications of CF101, signed a non-binding term sheet to acquire Israel-based Improved Vision Systems, LTD. (I.V.S.). I.V.S. develops breakthrough medical device technology to improve sight and diagnose and offer therapy for a variety of ocular diseases and eye conditions including glaucoma, age macular degeneration (AMD), diabetic retinopathy and ocular motor pathologies, addressing multi-billion dollar markets. 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 advanced each of our four clinical programs in a meaningful way during the first quarter and are pleased with the pace and number of studies we are pursuing in parallel for a company of our size," stated Can-Fite CEO Dr. Pnina Fishman. "Despite not achieving its primary endpoint, we are encouraged by further analysis of our completed Phase II/III psoriasis study which showed that CF101 could serve as a first-line therapy for moderate-severe psoriasis based on the higher efficacy in patients who were previously not treated with systemic therapy."
Research and development expenses for the three months ended March 31, 2015 were NIS 2.33 million (U.S. $0.58 million) compared with NIS 3.82 million (U.S. $0.96 million) for the same period in 2014. Research and development expenses for the first quarter 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 Phase II/III psoriasis study during the first quarter of 2015.
General and administrative expenses were NIS 2.48 million (U.S. $0.62 million) for the three months ended March 31, 2015 compared to NIS 2.94 million (U.S. $0.74 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 three months ended March 31, 2015 aggregated NIS 3.3 million (U.S. $0.83 million) compared to NIS 0.5 million (U.S. $0.13 million) for the same period in 2014. The increase in financial income, net in the first quarter of 2015 was mainly due to a decrease in the fair value of warrants that are accounted as a financial liability.
Can-Fite's loss for the three months ended March 31, 2015 was NIS 1.51 million (U.S. $0.38 million) compared with a loss of NIS 6.26 million (U.S. $1.57 million) for the same period in 2014. The decrease in net loss for the first quarter of 2015 was attributable both to an increase in finance income, net, and a decrease in operating expenses.
As of March 31, 2015, Can-Fite had cash and cash equivalents of NIS 35.68 million (U.S. $8.96 million) as compared to NIS 36.09 million (U.S. $9.07 million) at December 31, 2014. The slight decrease in cash during the three months ended March 31, 2015 is due to NIS 5.14 million (U.S. $1.29 million) received from Cipher Pharmaceuticals as upfront payment for entering into the distribution agreement with Cipher offset by operating expenses.
For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on March 31, 2015 (U.S. $ 1 = NIS 3.98).
The Company's consolidated financial results for the three months ended March 31, 2015 are presented in accordance with International Financial Reporting Standards.
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