Can-Fite Implements Interim Analysis for its Phase III Psoriasis Trial with Data Expected Q4 2020

Implements Interim Analysis for its Phase III Psoriasis Trial with Data Expected Q4 2020

TIKVA, Israel, March 30, 2020 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI),

a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases,

announced today it is implementing an interim analysis of the Phase III Comfort trial designed to evaluate the Company's

drug candidate, Piclidenoson, in the treatment of moderate-to-severe plaque psoriasis. Following the independent data monitoring

committee's evaluation of the data, Can-Fite expects to announce interim results in the fourth quarter of 2020.

Comfort Phase III psoriasis study is designed to establish Piclidenoson's superiority compared to placebo and non-inferiority

compared to Apremilast (Otezla ) in patients with moderate to severe plaque psoriasis. The randomized, double blind study

is being conducted in Europe, Israel, and Canada. The study's primary endpoint is the proportion of subjects who achieve

a PASI score response of 75% (PASI 75) vs. placebo at week 16. The secondary endpoints include non-inferiority to Otezla

on weeks 16 and 32. A Drug Safety Update Report filed in February 2020 with regulatory agencies reported that Piclidenoson, which

has been dosed in over 1,400 patients, is well tolerated and has no emerging safety concerns.

implementing this interim analysis, we gain earlier access to data on Piclidenoson's efficacy in the treatment of psoriasis,

as well as more safety data on Piclidenoson, which is also currently being evaluated as a treatment for rheumatoid arthritis,

and being considered as a potential treatment for COVID-19. By increasing the amount of data available, we believe we will accelerate

our development timelines across each indication, and also optimize the use of our corporate resources," stated Can-Fite

CEO Dr. Pnina Fishman.

has been out-licensed for the indication of psoriasis in Canada, South Korea, Spain, Austria, Switzerland, Hong Kong, Macau, Taiwan,

and China. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025.

Message Regarding COVID-19

health epidemics or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19, also known as coronavirus,

was reported in Wuhan, China. While initially the outbreak was largely concentrated in China, it has now spread to several other

countries, including in Israel, and infections have been reported globally. The extent to which the coronavirus impacts the Company's

operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the

duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. In

particular, the continued spread of the coronavirus globally, could adversely impact the Company's operations and workforce,

including the Company's research and clinical trials and ability to raise capital, which in turn could have an adverse impact

on the Company's business, financial condition and results of operation.

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 multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.

The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's

liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of

liver cancer, and is in a Phase II trial 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. These drugs

have an excellent safety profile with experience in over 1,500 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

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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.