On November 27, 2017 Can-Fite BioPharma Ltd. (NYSE MKT: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 nine months ended September 30, 2017 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, NOV 27, 2017, View Source [SID1234522245]).
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Clinical Development Program and Corporate Highlights Include:
Namodenoson (CF102): Advances Phase II Trials and Receives Milestone Payment
First Patient Enrolled in Phase II Trial for Treatment of NAFLD/NASH
Patient enrollment has commenced in Can-Fite’s Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The 12-week trial is enrolling approximately 60 patients and is estimated to cost less than $1 million. There is currently no U.S. FDA approved drug for the indication of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.
Milestone Payment Received for Distribution of Namodenoson in Korea for the Treatment of Liver Cancer
During the third quarter of 2017, Can-Fite received a milestone payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD), which licensed the exclusive right to distribute Namodenoson for the treatment of liver cancer in Korea upon receipt of regulatory approvals. The payment is part of a deal worth up to $3,000,000 in upfront and milestone payments plus 23% royalties.
Patient Enrollment Completed in Phase II Liver Cancer Trial of Namodenoson
Can-Fite completed enrollment during the third quarter of 2017 and randomized all 78 patients in its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Patients with advanced HCC, Child Pugh B, were enrolled in the U.S., Europe and Israel. The primary endpoint of the Phase II study is overall survival. Can-Fite is following the survival data closely and plans to perform the survival analysis at the earliest possible opportunity. The HCC market is expected to generate $1.4 billion in sales in 2019.
Data Presented on Namodenoson at NASH Summit Europe and The Liver Meeting
Dr. Pnina Fishman, Can-Fite’s CEO, joined global thought-leaders in the treatment of NASH at the NASH Summit Europe in October, in Frankfurt, Germany, where she delivered a presentation titled, "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson (CF102): From Preclinical to Human Studies."
Can-Fite also presented two scientific posters at the American Association for the Study of Liver Diseases (AASLD) annual conference, The Liver Meeting in Washington, D.C. in October. The posters were titled "Namodenoson (CF102) Prevents Liver Fibrosis in the CCL4 Model" and "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson (CF102) in a Non-Alcoholic Steatohepatitis model."
Piclidenoson (CF101): Commences Patient Enrollment and Dosing in ACRobat Phase III Trial in Rheumatoid Arthritis
Patient enrollment and dosing has commenced in Can-Fite’s Phase III ACRobat trial that is evaluating Piclidenoson as a first line treatment and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The trial is enrolling approximately 500 patients in Europe, Canada and Israel. The estimated cost of the entire 24-week Phase III study is approximately $5 million. An estimated 90% of rheumatoid arthritis patients receive MTX at some point in their disease. However, studies show that up to 50% of patients stop taking MTX due to reasons including drug intolerance, minor and major side effects, and lack of efficacy, creating a significant need for a new, safe and effective treatment option in the rheumatoid arthritis treatment market which is forecast to reach $34.6 billion by 2020.
Can-Fite is also advancing Piclidenoson towards a Phase III trial in the treatment of psoriasis which is expected to commence in 2018. The upcoming trial will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. The psoriasis market is forecast to be $8.9 billion in 2018 and Otezla sales are estimated to be $2.35 billion by 2020.
Expands Intellectual Property
Can-Fite was issued a new patent from the Korean Intellectual Property Office for Piclidenoson titled, "Pharmaceutical Composition Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) For Treatment of Psoriasis."
A new patent application was filed by Can-Fite to protect the use of its drugs and other ligands which target the A3 adenosine receptor (A3AR) in the treatment of cytokine release syndrome (CRS), a potentially life-threatening complication of CAR-T cell therapy. CAR-T is viewed by the medical community as a very promising cancer immunotherapy, however, CRS, which is caused by an overactive immune response to the treatment, has been identified as a potentially severe and life-threatening side effect of CAR-T. Can Fite’s platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation in CRS, and as such, Can-Fite believes that A3AR targeting may serve as an important treatment option for patients in reducing the risk of CRS without limiting the utility of the underlying cancer immunotherapy.
Can-Fite’s Former Subsidiary OphthaliX Successfully Completes Merger with Wize Pharma
Can-Fite’s former majority-owned subsidiary, OphthaliX Inc. (since renamed Wize Pharma, Inc.) recently completed a merger with Wize Pharma Ltd. As a result of the merger, Can-Fite’s ownership of OphthaliX, immediately post-merger, became approximately 8% of the outstanding shares of common stock. In addition, immediately prior to the merger, OphthaliX sold on an "as is" basis to Can-Fite all the ordinary shares of Eyefite Ltd., a former wholly owned subsidiary of OphthaliX, in exchange for the irrevocable cancellation and waiver of all indebtedness owed by OphthaliX and Eyefite to Can-Fite, including approximately $5 million of deferred payments and, as part of the purchase of Eyefite, Can-Fite also assumed certain accrued milestone payments in the amount of $175,000 under a license agreement previously entered into with the U.S. National Institutes of Health (NIH). In addition, as a result of the merger, an exclusive license of Piclidenoson (CF101) for the treatment of ophthalmic diseases previously granted by Can-Fite to OphthaliX and a related services agreement was terminated.
"We are pleased to be on target with commencing patient enrollment in our Phase III rheumatoid arthritis and Phase II in NAFLD/NASH studies. Namodenoson is gaining increasing recognition in the medical community, as evidenced by our recent scientific presentations, for its liver protective properties in both NASH and liver cancer. In 2018, we look forward to initiating our Phase III study of Piclidenoson in psoriasis, as well as potentially announcing top line data on our Phase II liver cancer study of Namodenoson," Dr. Fishman stated.
Financial Results
Revenues for the nine months ended September 30, 2017 were NIS 2.61 million (U.S. $0.74 million) compared to NIS 0.64 million (U.S. $0.18 million) in the first nine months of 2016. The increase in revenue was mainly due to payment received of NIS 1.8 million (U.S. $0.5 million) in August 2017 under the distribution agreement with CKD.
Research and development expenses for the nine months ended September 30, 2017 were NIS 12.7 million (U.S. $3.6 million) compared with NIS 15.45 million (U.S. $4.38 million) for the same period in 2016. Research and development expenses for the nine months ended September 30, 2017 comprised primarily of expenses associated with the Phase II study for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The decrease is primarily due to a reduction in preclinical studies of CF602 conducted during the nine months ended September 30, 2017.
General and administrative expenses were NIS 7.48 million (U.S. $2.12 million) for the nine months ended September 30, 2017, compared to NIS 7.88 million (U.S. $2.23 million) for the same period in 2016. The decrease in general and administrative expenses was mainly due to a decrease in investor relations expenses.
Financial income, net for the nine months ended September 30, 2017 aggregated NIS 3.91 million (U.S. $1.11 million) compared to financial income, net of NIS 3.12 million (U.S. $0.88 million) for the same period in 2016. The increase in financial income, net in the nine months ended September 30, 2017 was mainly from a larger decrease in the fair value of warrants that are accounted for as financial liability as compared to the same period in 2016, offset by exchange rate differences as compared to the same period in 2016 and from issuance expenses.
Can-Fite’s net loss for the nine months ended September 30, 2017 was NIS 13.75 million (U.S. $3.90 million) compared with a net loss of NIS 19.56 million (U.S. $5.54 million) for the same period in 2016. The decrease in net loss for the nine months ended September 30, 2017 was primarily attributable to a decrease in research and development expenses.
As of September 30, 2017, Can-Fite had cash and cash equivalents of NIS 18.02 million (U.S. $5.11 million) as compared to NIS 31.2 million (U.S. $8.84 million) at December 31, 2016. The decrease in cash during the nine months ended September 30, 2017 is due to use of cash to fund 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 September 30, 2017 (U.S. $1 = NIS 3.529).
The Company’s consolidated financial results for the nine months ended September 30, 2017 are presented in accordance with International Financial Reporting Standards.