Market Overview

Can-Fite Announces Enrollment of First Patient in its ACRobat Phase III Trial of Piclidenoson in Rheumatoid Arthritis

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  • Piclidenoson is being developed as a first line therapy and
    replacement for the current standard of care, Methotrexate (MTX), the
    most widely used drug for rheumatoid arthritis
  • Rheumatoid Arthritis is forecast to be $34.6 billion market by 2020

Can-Fite
BioPharma Ltd
. (NYSE:CANF) (TASE:CFBI), a biotechnology
company advancing a pipeline of proprietary small molecule drugs that
address cancer, liver and inflammatory diseases, today announced the
first patient has been enrolled and dosed in its Phase III ACRobat trial
to evaluate its lead drug candidate, 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.

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. Piclidenoson compares favorably with MTX based on an analysis of
data from Phase III trials that evaluated MTX in patients with no prior
systemic therapy.

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 in order to provide
more data on long term efficacy and safety. This randomized,
double-blind, active and placebo-controlled study will enroll
approximately 500 patients through clinical sites in Europe, Israel and
Canada.

"Dosing the first patient in our Phase III ACRobat trial marks a
significant milestone for Can-Fite. We believe Piclidenoson is a
potentially superior option to the standard of care, MTX, and we believe
that rheumatologists are looking for a safer and more effective
alternative," stated Can-Fite CEO Dr. Pnina Fishman.

About Piclidenoson (CF101)

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist
(A3AR) small molecule, orally bioavailable drug with a favorable
therapeutic index demonstrated in Phase II clinical studies.
Piclidenoson is currently under development for the treatment of
autoimmune inflammatory diseases. It is being evaluated in a Phase III
study as a first line treatment, to replace MTX, in the treatment of
rheumatoid arthritis. Piclidenoson is also slated to enter a Phase III
study in the treatment of moderate-to-severe psoriasis in 2018.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE: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 inflammatory diseases, cancer, and NAFLD/NASH. The
Company's lead drug candidate Piclidenoson is currently being evaluated
in a global Phase III trial as a first line therapy for rheumatoid
arthritis. Piclidenoson is also slated to enter a Phase III trial for
psoriasis in early 2018. Can-Fite's liver cancer drug CF102 concluded
patient enrollment in a Phase II study for patients with liver cancer,
and it 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 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.

Forward-Looking Statements

This 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.

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