Can Fite Announces First Patient Enrolled in Phase IIb NASH Clinical Trial with Namodenoson Namodenoson met primary endpoint in Phase IIa NASH study by reducing liver fat, inhibiting fibrosis, and demonstrating anti-infl

Can Fite Announces First Patient Enrolled in Phase IIb NASH Clinical Trial with Namodenoson

Namodenoson met primary endpoint

in Phase IIa NASH study by reducing liver fat, inhibiting fibrosis, and demonstrating anti-inflammatory effect

PETACH TIKVA, Israel, January 31, 2022 -- Can-Fite

BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that

address inflammatory, cancer and liver diseases, today announced it has enrolled the first patient in a Phase IIb study of its drug candidate

Namodenoson in the treatment of NASH.

The Phase IIb trial is a multicenter, randomized,

double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH. The primary efficacy objective of the trial is to evaluate

the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, as determined by a histological endpoint. Eligible subjects

are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.

There is currently no U.S. FDA approved treatment

for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. The U.S. National

Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants

among women and second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for

liver transplants in males as well.

"Our Phase IIa study demonstrated very encouraging

results based on key liver fibrosis and NASH biomarkers. We hope to see a similar therapeutic effect in a larger patient population as

measured by liver biopsy," stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite has out-licensing agreements for Namodenoson

in the treatment of NASH in Eastern Europe, China, and South Korea which include milestone payments and double-digit royalties upon approval

and commercialization.

About Can-Fite BioPharma Ltd.

Can-Fite 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, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson, is currently

in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma

(HCC), the most common form of liver cancer, and a Phase IIb 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.

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: our history of losses and needs for additional capital to fund our operations and our inability to obtain

additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact

of the COVID-19 pandemic; 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 strategic

partnerships and other 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; 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.