On August 26, 2016 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, 2016 and updates on its drug development programs (Filing, Q2, Can-Fite BioPharma, 2016, AUG 26, 2016, View Source [SID:1234514753]).

Clinical Development Program and Corporate Highlights Include:

● Piclidenoson (CF101) – Upcoming Phase III Trials in Rheumatoid Arthritis & Psoriasis

Rheumatoid Arthritis: Can-Fite reached an agreement with the European Medicine Agency (EMA) on the protocol design of its upcoming Phase III trial of Piclidenoson in the treatment of rheumatoid arthrosis. Based on the suggestion of the EMA, Piclidenoson will be developed as a first line therapy and replacement for the current gold standard, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis, a treatment market forecast to reach $38.5 billion by 2017. The planned Phase III trial will aim to show Piclidenoson is not inferior to MTX. Based on this clinical study design, Can-Fite is now conducting preparatory work for the trial including drug tableting, packaging and labeling work. The Company plans to submit its study protocol to the Institutional Review Boards (IRBs) of clinical sites in the first quarter of 2017.

Psoriasis: Can-Fite submitted a Phase III clinical trial protocol for Piclidenoson in the treatment of moderate-to-severe psoriasis with the EMA in the first half of 2016. Based on a pre-submission meeting the Company had with the EMA, the planned trial will be a head-to-head study comparing Piclidenoson to apremilast (Otezla), a recently approved oral drug from Celgene. Can-Fite expects a meeting with the EMA to discuss the trial’s design in the third quarter of 2016.

New mechanism of action data showing Piclidenoson may offer efficacy similar to industry-leading biologics, without the associated harmful side effects, were presented by Can-Fite at Psoriasis 2016, the 5th Congress of the Psoriasis International Network, in Paris, France. The oral presentation titled, "CF101 via A3AR Activation inhibits IL-17 and IL-23," was delivered on July 7, 2016.

The peer reviewed scientific journal, Journal of Drugs in Dermatology, published data from a Phase II/III trial of Piclidenoson in the treatment of moderate to severe psoriasis. The study titled, "Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial," was published in August 2016.

● CF102 – Ongoing Phase II in Liver Cancer & Plans to Commence Phase II in NASH

Liver Cancer: Can-Fite continues to enroll and dose patients in its global Phase II study of CF102 in the treatment of hepatocellular carcinoma, the most common form of liver cancer. Enrollment of approximately 78 patients in the U.S., Europe, and Israel is expected to conclude in the second half of 2016.

NASH: Can-Fite worked with world renowned Key Opinion Leaders in the field of liver diseases to complete the protocol design for its upcoming Phase II trial of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH). By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion. The Company plans to file its protocol with IRBs in the second half of 2016.

● CF602 – Preparing for Phase I in the Treatment of Sexual Dysfunction

Can-Fite is currently conducting Investigational New Drug (IND) enabling studies of CF602 in the treatment of sexual dysfunction to support commencing a Phase I study in the first quarter of 2017. The Company presented data at the American Urology Association’s Annual 2016 Meeting in San Diego, California. The presentation titled, "CF602 Improves Erectile Dysfunction in Diabetic Rats," was delivered on May 10, 2016. CF602’s mechanism of action, its efficacy in increasing penile intracavernous pressure (ICP), and single dose efficacy were included in the presentation.

"In the first half of 2016, we were particularly encouraged by feedback received from the EMA, indicating we conduct head-to-head studies of Piclidenoson in psoriasis and rheumatoid arthritis. These studies will compare Piclidenoson to drugs that are used as the standard of care today. Because of Piclidenoson’s well established safety profile, proving efficacy that is equivalent to the comparative drugs would highlight the benefits of Piclidenoson in delivering a safe, effective and oral treatment," stated Can-Fite CEO Dr. Pnina Fishman. "In addition to heading into Phase III studies of Piclidenoson, we are pleased to continue the development programs of CF102 and CF602 to address unmet clinical needs."

Revenues for the six months ended June 30, 2016 were NIS 0.43 million (U.S. $0.11 million) compared to NIS 0.27 million (U.S. $0.07 million) in the first six months of 2015. The increase in revenue was due to the recognition of a portion of the NIS 5.14 million (U.S. $1.36 million) upfront payment received in March 2015 under the distribution agreement with Cipher Pharmaceuticals.

Research and development expenses for the six months ended June 30, 2016 were NIS 9.97 million (U.S. $2.59 million) compared with NIS 5.75 million (U.S. $1.5 million) for the same period in 2015. Research and development expenses for the first half of 2016 comprised primarily of expenses associated with the Phase II study for CF102, preclinical study for CF602, as well as expenses for ongoing studies of CF101. The increase is primarily due to costs associated with preparations of the CF101 Phase III studies in the treatment of rheumatoid arthritis and psoriasis.

General and administrative expenses were NIS 4.99 million (U.S. $1.3 million) for the six months ended June 30, 2016 compared to NIS 4.67 million (U.S. $1.21 million) for the same period in 2015. The increase is primarily due to an increase in share based compensation expense.

Financial income, net for the six months ended June 30, 2016 aggregated NIS 3.19 million (U.S. $0.83 million) compared to financial income, net of NIS 1.88 million (U.S. $0.49 million) for the same period in 2015. The increase in financial income, net in the first half of 2016 was mainly due to a larger decrease in the fair value of warrants that are accounted for as financial liability as compared to the same period in 2015. In addition, the increase in financial income, net in the first half of 2016 was attributable to a decrease in financial expenses due to exchange rate differences as compared to the same period in 2015.

Can-Fite’s net loss for the six months ended June 30, 2016 was NIS 11.35 million (U.S. $2.95 million) compared with a net loss of NIS 8.27 million (U.S. $2.15 million) for the same period in 2015. The increase in net loss for the first half of 2016 was primarily attributable to an increase in research and development expenses offset by an increase in financial income, net.

As of June 30, 2016, Can-Fite had cash and cash equivalents of NIS 46.42 million (U.S. $12.07 million) as compared to NIS 66.03 million (U.S. $17.17 million) at December 31, 2015. The decrease in cash during the six months ended June 30, 2016 is due to 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 June 30, 2016 (U.S. $1 = NIS 3.846).

The Company’s consolidated financial results for the six months ended June 30, 2016 are presented in accordance with International Financial Reporting Standards.

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