Market Overview

Can-Fite Announces Enrollment of First Patient in its Comfort™ Phase III Trial of Piclidenoson in Psoriasis

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  • Study initiation will prompt a milestone payment from the recently
    signed deal with Gebro Holding
  • Psoriasis Therapeutic Market is Estimated to Reach $11.4B in 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 Comfort™
trial to evaluate its lead drug candidate, Piclidenoson (CF101), a small
orally bioavailable drug for the treatment of moderate-to-severe plaque
psoriasis, which makes up about 90 percent of cases.

The Comfort™ Phase III Psoriasis study, is designed to evaluate the
efficacy and safety of daily Piclidenoson, administered orally compared
to Apremilast (Otezla®) and placebo, in 407 patients with
moderate-to-severe plaque psoriasis. The study will be conducted in 5
countries in Europe, Israel and Canada. The first patient has been
enrolled and dosed in Israel with enrollment in Europe and Canada
expected to follow shortly.

Study initiation will prompt a milestone payment of 300,000 Euro from
the recently signed deal with Gebro Holding which will distribute the
drug upon regulatory approval in Spain, Austria and Switzerland.
According to Visiongain, the psoriasis therapeutic market is estimated
to reach $11.4B in 2020.

"Dosing the first patient in our Phase III Comfort™ trial marks a
significant milestone for Can-Fite. We believe Piclidenoson is a
potentially efficacious and safe option to the patients which need to
take drugs chronically for a life time," 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 and a Phase III study in the treatment of
moderate-to-severe psoriasis.

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 and a Phase III trial for moderate-to-severe psoriasis.
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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