Full Press Release Details
Receives from CMS Medical Venture Investment Limited $2,000,000 Upfront Payment as Part of Development, Registration and Marketing
Agreement for Piclidenoson and Namodenoson in China
milestone and sales payments total up to $72.5M plus double-digit royalties
signed CMS agreement adds to four existing distribution agreements in Canada, South Korea and three countries in Europe (Spain,
Switzerland and Austria)
TIKVA, Israel, August 7, 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 and inflammatory diseases, today announced it has received
its first payment of $2,000,000 from CMS Medical Venture Investment. Can-Fite recently announced entering into a development,
registration and marketing agreement with CMS for the exclusive right of Can-Fite's lead drug candidates, Piclidenoson (CF101),
for the treatment of rheumatoid arthritis and psoriasis & Namodenoson (CF102) for the treatment of advanced liver cancer and
NAFLD/NASH in China (including Hong Kong, Macao and Taiwan). The recently signed CMS agreement adds to the agreements that the
Company already has in place with Cipher Pharmaceuticals (for the distribution of Piclidenoson in Canada for rheumatoid arthritis
and psoriasis), Kwang Dong Pharmaceutical (for the distribution of Piclidenoson in South Korea for rheumatoid arthritis), Chong
Kun Dang (for distribution of Namodenoson in South Korea for treatment of liver cancer) and Gebro Pharma (for the distribution
of Piclidenoson in Spain, Switzerland and Austria).
the terms of the agreement, in addition to the upfront payment of $2,000,000, CMS is required to pay to Can-Fite milestone payments
of up to $14,000,000 upon the achievement of certain regulatory milestones and payments of up to $58,500,000 upon the achievement
of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.
Medical is a wholly-owned subsidiary of China Medical System Holdings Limited ("CMS"; SEHK: 867), a specialty pharmaceutical
company based in China, focusing on marketing, promotion and sales of prescription drugs and other medicinal products to therapeutic
departments in hospitals. CMS builds up its product portfolio for its target markets by asset acquisition, equity investment,
licensing and distribution as well as in-house R&D. CMS is listed on the Hong Kong Stock Exchange with a current market capitalization
of approximately HK$34 billion as at August 1, 2018.
are pleased to receive this upfront payment of $2,000,000 from CMS and look towards future potential milestone payments as we
advance Piclidenoson and Namodenoson through completion of our current trials," stated Can-Fite CEO Dr. Pnina Fishman. Can-Fite
is currently enrolling patients for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis
and plans to shortly initiate patient enrollment for its Phase III Comfort trial of Piclidenoson for the treatment of psoriasis.
The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via
intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where
rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018. Phase II studies with
Namodenoson for the treatment of advanced liver cancer (hepatocellular carcinoma, Child Pugh B) and NAFLD/NASH are currently ongoing.
The last patient for the advanced liver cancer trial was enrolled in August 2017, and treatment of remaining patients is still
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 in 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
statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe,"
"expect," "intend," "plan," "may," "should" or "anticipate"
or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate
strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various
filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the
approval of one of Can-Fite's authorized executive officers. Forward-looking statements relate to anticipated or expected
events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite's actual
results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could
cause Can-Fite's actual activities or results to differ materially from the activities and results anticipated in such forward-looking
statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking
statements include, but are not limited to: the initiation, timing, progress and results of our preclinical studies, clinical
trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or
to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates,
and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of
our product candidates; our ability to establish and maintain corporate collaborations; the implementation of our business model
and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for
intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual
property rights of others; estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel
on our business; and risks and other risk factors detailed 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.