Full Press Release Details
$500,000 Payment as Part of $3 Million Distribution Deal for Liver Cancer Drug Namodenoson (CF102) in South Korea
Additional $2.5 million in milestone payments plus
23% royalties upon commercialization in South Korea
PETACH TIKVA, Israel, December
21, 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 and liver diseases, cancer, and sexual dysfunction, today announced it has
received its first payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS). Can-Fite recently
announced entering a distribution agreement with CKD for the exclusive right to distribute Namodenoson (CF102) for the treatment
of liver cancer in South Korea, upon receipt of regulatory approvals, for up to $3,000,000 in upfront and milestone payments, plus
royalties on net sales of 23%.
"We are pleased to receive
this upfront payment of $500,000 from CKD and look towards future potential milestone payments as we advance Namodenoson through
completion of our current Phase II trial as a second line treatment for hepatocellular carcinoma and into Phase III," stated
Can-Fite CEO Dr. Pnina Fishman.
Per the terms of the distribution
agreement, Can-Fite will deliver finished product to CKD and CKD has a right of first refusal to distribute Namodenoson for other
indications for which Can-Fite develops Namodenoson.
Can-Fite is currently conducting
a global Phase II double-blind, placebo controlled study evaluating the efficacy of Namodenoson as a second-line treatment for
advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase II study of
Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).
About Namodenoson (CF102)
Namodenoson is a small orally bioavailable
drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells
whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
In Can-Fite's pre-clinical and clinical studies, Namodenoson has demonstrated a robust anti-tumor effect via deregulation of the
Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data showing Namodenoson has strong liver
protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for
Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT:
CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address
multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate,
Piclidenoson, is scheduled to enter Phase III trials in 2016 for two indications, rheumatoid arthritis and psoriasis. The rheumatoid
arthritis Phase III protocol has recently been agreed with the European Medicines Agency. Can-Fite's liver cancer drug CF102 is
in Phase II trials for patients with liver cancer and is slated to enter Phase II for the treatment of non-alcoholic steatohepatitis
(NASH). CF102 has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment
for hepatocellular carcinoma by the U.S. Food and Drug Administration. CF102 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 is being prepared for an IND submission to the FDA and a Phase I trial. 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.
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forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development
efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite
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anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Can-Fite's filings with
the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values
are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation
to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.