Full Press Release Details
Reports 2017 Financial Results & Provides Clinical Update
TIKVA, Israel, March 23, 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, today announced
it has filed its 2017 Annual Report on Form 20-F with the U.S. Securities and Exchange Commission.
Development Program and Corporate Highlights Include:
multi-million dollar agreement has been signed with Gebro Holdings for the distribution of piclidenoson in 3 European Countries
the terms of the distribution agreement, Gebro made a total upfront and milestone payment of approximately $2,200,000 to Can-Fite.
In addition, the agreement provides that additional payments of up to approximately $7,000,000 will be received by Can-Fite upon
the achievement of certain regulatory, launch and sales milestones plus double-digit percentage royalty payments on net sales.
enrolment for the ACRobat Phase III Trial in Rheumatoid Arthritis is ongoing
the fourth quarter of 2017, Can-Fite commenced enrollment in the pivotal Phase III ACRobat trial of approximately 500 patients
through clinical sites in Europe, Israel and Canada. The study aims to evaluate Piclidenoson (CF101) as a first line treatment
and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The
primary endpoint of ACRobat is low disease activity after 12 weeks of treatment in patients dosed with Piclidenoson compared to
those dosed with MTX. Piclidenoson at 1 mg and 2 mg, or placebo, will be administered twice daily, and MTX or placebo will be
administered once weekly. The total study duration will be 24 weeks.
rheumatoid arthritis market is forecast to reach $34.6 billion by 2020.
patent for Psoriasis has been approved in Korea
Korean Intellectual Property Office issued patent No. 10-1741281 titled, "Pharmaceutical Composition Comprising A3 Adenosine
Receptor Agonist (IB-MECA/CF-101) For Treatment of Psoriasis" for the Company's lead drug candidate Piclidenoson in
its psoriasis indication. Can-Fite has two distribution agreements in Korea, including one with Kwang Dong Pharmaceutical for
Piclidenoson in the treatment of rheumatoid arthritis and another with Chong Kun Dang for Namodenoson in the treatment of liver
of the Phase II Liver Cancer Namodenoson (CF102) Study in the treatment of advanced HCC - Data to be released H2/2018
data indicate potentially favorable drug safety profile. The global Phase II study is being conducted in the U.S., Europe and
Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are being treated twice
daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall
Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and
A3AR expression. A total of approximately 78 patients have been enrolled in the Phase II study. As of December 2017, 15 subjects
have completed at least 12 cycles of treatment (each cycle is 28 days of treatment), of which two completed 24 cycles. The Company
anticipates data release to occur in 2H 2018.
market for hepatocellular carcinoma drugs is expected to generate $1.4 billion in sales in 2019.
II NAFLD/NASH Study is enrolling patients; Data Release Expected in H1 2019
is currently enrolling patients in a Phase II study in the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic
steatohepatitis (NASH) with Namodenoson which plans to enroll 60 patients. Can-Fite's 12-week study is being led by key
opinion leaders in the area of NASH and liver diseases. Clinical trial sites are some of the most prestigious medical institutions
in Israel, including Hadassah Medical Center and Rabin Medical Center. Patients are being enrolled in three arms, including two
different dosages of oral Namodenoson twice daily versus placebo. The study's primary endpoints are the mean percent change from
baseline in serum alanine aminotransferase (ALT) levels and safety. The secondary endpoint is percent change from baseline in
hepatic steatosis measured by magnetic resonance imaging-determined by proton-density fat-fraction (MRI-PDFF) and additional metabolic
Phase II trial design was based on preclinical studies showing Namodenoson's efficacy in reducing liver steatosis, inflammation
and fibrosis in experimental NASH models.
is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach
$35-40 billion by 2025.
made several notable accomplishments during this past year which validate the strength of our drug portfolio and demonstrate our
commitment in execution. We believe these events position us well for the year ahead in which we anticipate a marked progress
with our Piclidenoson and Namodenoson drug candidates. We are pleased with the progress thus far and recently announced the submission
of safety reports for Piclidenoson and Namodenoson to the FDA and other regulatory authorities so that we may continue with the
various clinical studies. Our drug candidates are highly unique due to our favorable safety profile and the specific anti-inflammatory
and anti-cancer effects. In the coming year 2018, we remain focused on execution with the goal of providing our patients a better
alternative option and treatment for autoimmune inflammatory, oncology and NASH/NAFLD," stated Can-Fite CEO Dr. Pnina Fishman.
for the year ended December 31, 2017 were NIS 2.9 million (U.S. $0.85 million), an increase of NIS 2.3 million (U.S. $0.66 million),
or 350%, compared to NIS 0.65 million (U.S. $0.2 million) for the year ended December 31, 2016. The revenues during 2017 were
mainly due to a portion of the NIS 0.76 million (U.S. $0.22 million or CAD 0.2 million) advance payment received in March 2015
under the distribution agreement with Cipher and from the recognition of the milestone payment of NIS 1.8 million (U.S. $0.5 million)
and the recognition of a portion of the NIS 0.4 million (U.S. $0.1 million) advance payment received in December 2016 under the
distribution agreement with CKD.
and development expenses for the year ended December 31, 2017 were NIS 18.3 million (U.S. $5.28 million), a decrease of NIS 5
million (U.S. 1.44 million), or 22%, compared to NIS 23.4 million (U.S. $6.74 million) for the year ended December 31, 2016. Research
and developments expenses for the year ended 2017 comprised primarily of expenses associated with the Phase II studies for Namodenoson
as well as expenses for ongoing studies of Piclidenoson. The decrease is primarily due to costs associated with CF602 expenses
that decreased since the postponement of a planned IND submission for this indication and decreased costs associated with the
ongoing clinical trial of Namodenoson for treatment in liver cancer. The Company expects that the research and development expenses
will increase through 2018 and beyond.
and administrative expenses were NIS 10.2 million (U.S. $2.94 million) for the year ended December 31, 2017 a decrease of NIS
0.2 million (U.S. $0.06 million), or 2%, compared to NIS 10.5 million (U.S. $3.02 million) for the year ended December 31, 2016.
The minor decrease is primarily due to a decrease in investor and public relations expenses. The Company expects that general
and administrative expenses will remain at the same level through 2018.
income, net for the year ended December 31, 2017 aggregated NIS 6.6 million (U.S. $1.89 million) compared to financial income,
net of NIS 6.31 million (U.S. $1.82 million) for the same period in 2016. The slight increase in financial income, net in the
year ended December 31, 2017 was mainly due to issuance expenses recorded in 2017 which were not recorded in 2016, a decrease
in net change in fair value of warrants exercisable into shares and a decrease in exchange rate difference expenses.
net loss for the year ended December 31, 2017 was NIS 17.3 million (U.S. $4.99 million) compared with a net loss of NIS 27 million
(U.S. $7.78 million) for the year ended December 31, 2016. The decrease in net loss for the year ended December 31, 2017 was primarily
attributable to a decrease in research and development expenses.
of December 31, 2017, Can-Fite had cash and cash equivalents of NIS 12.1 million (U.S. $3.51 million) as compared to NIS 31.2
million (U.S. $8.99 million) at December 31, 2016. The decrease in cash during the year ended December 31, 2017 is due to use of
cash to fund operating expenses.
the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of
exchange on December 31, 2017 (U.S. $1 = NIS 3.467).
Company's consolidated financial results for the year ended December 31, 2017 are presented in accordance with International Financial
Reporting Standards.
2017 Annual Report can be found on the Company's website at www.canfite.com as well as on the SEC website at www.sec.gov. In addition,
security holders may request a hard copy of the Annual Report, which includes the Company's complete audited financial statements,
free of charge. Requests can be made by contacting Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva
4951778, Israel or by phone at +972-3-9241114.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology
that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected
to enter a Phase III trial for psoriasis during 2018. Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for
hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH).
Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment
for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers
including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment
of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the
treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical
studies to date. For more information please visit: www.can-fite.com.
press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among
other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations,
strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking