Can-Fite Reports First Quarter 2021 Financial Results & Provides Clinical Update Can-Fite

Can-Fite Reports First Quarter 2021

Financial Results & Provides Clinical Update

Can-Fite PETACH TIKVA, Israel, May 27, 2021 --

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 financial results for the quarter ended March 31, 2021.

Clinical Developments and Corporate Highlights

Signed Large Out-licensing Deal Worth $42.7

Million with Ewopharma -During the first quarter, Can-Fite signed a large out-licensing agreement with Swiss-based Ewopharma

for distribution of its drug candidates in Central Eastern Europe and Switzerland, receiving $2.25 million upfront with up to an additional

$40.45 million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Together with Ewopharma,

Can-Fite's existing out-licensing deals are worth a potential $130 million in future milestone payments plus double-digit royalties

on net sales upon regulatory approvals. Can-Fite has received over $20 million in non-dilutive funding to date.

Phase III Psoriasis Study Achieves 75% Enrollment

- The Phase III Comfort study completed enrollment of 75% of planned patients for the study which 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 majority of costs associated with the Phase III Comfort study have been previously paid. The Company

expects to complete enrollment in Q3 2021 and report topline results in Q4 2021.

Phase II COVID-19 Study Expands to Europe

- Can-Fite is enrolling 40 patients hospitalized with moderate to severe COVID-19 in its Phase II study, under a U.S. Food and Drug

Administration (FDA) approved protocol, in Israel and Europe.

Phase IIb NASH Study Expected to Commence Q4

2021 - Based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson which met its primary endpoint, Can-Fite

completed the design of a Phase IIb study with the help of top NASH Key Opinion Leaders, Dr. Friedman and Dr. Harrison, and the Company

plans to commence the Phase IIb study before the end of 2021.

Pivotal Phase III Liver Cancer Study Expected

to Commence Q4 2021 - Can-Fite is preparing to commence its pivotal Phase III trial for the treatment of hepatocellular carcinoma

(HCC) based on a protocol agreed upon with the U.S. FDA and the European Medicines Agency. Should the study meet its efficacy endpoint

and be approved by the FDA and EMA, Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients.

Recently announced data from Can-Fite's Phase II advanced liver cancer study included overall survival of 4 years in two patients.

Additional findings show disappearance of ascites, normal liver function and good quality of life. A scientific paper titled, "Namodenoson

in Advanced Hepatocellular Carcinoma and Child-Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial" published in

the peer reviewed journal Cancers provided more in-depth data from the Phase II study including a significant 12-month overall

survival benefit in the CPB7 population, the target population for the pivotal Phase III study.

Cannabis Compounds May Have Role in Treatment

of Liver Diseases - Can-Fite's preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer

cell growth and also had an inhibitory effect on liver fibrosis. Liver fibrosis is associated with increased liver disease including NAFLD/NASH,

cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the

A3AR target is overexpressed.

Topical CF602 Shows Preclinical Efficacy in

Erectile Dysfunction (ED) - A new preclinical study of Can-Fite's drug candidate CF602 in the treatment of ED in a diabetes

experimental rat model showed that topically applied CF602 resulted in a statistically significant improvement in ED compared to controls.

CF602 may be an ideal candidate for development due to topical efficacy, as ED is a common complication of diabetes and is difficult to

treat with systemic drugs due to the high risk profile of these patients.

"Our robust advanced stage clinical pipeline,

including a pivotal trial in liver cancer expected to commence in the fourth quarter, is supported by our growing number of global distribution

agreements and accompanying non-dilutive funding," stated Can-Fite CEO Dr. Pnina Fishman. "Recent efficacy findings in cannabis

and ED create additional co-development and funding opportunities for Can-Fite with pharma partners."

Revenues for the three months ended March 31,

2021 were $0.15 million, a decrease of $0.05 million, or 25.2%, compared to $0.20 million for the three months ended March 31, 2020. The

decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from

Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals which were offset by the recognition of an advance payment portion received

under a distribution agreement with Ewopharma.

Research and development expenses for the three

months ended March 31, 2021 were $1.30 million, a decrease of $2.47 million, or 65.5%, compared to $3.77 million for the three months

ended March 31, 2020. Research and development expenses for the first quarter of 2021 comprised primarily of expenses associated with

two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily

due to costs incurred in the first quarter of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and

NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis partially offset by the two ongoing studies of Piclidenoson

in the first quarter of 2021. We expect that the research and development expenses will increase through 2021 and beyond.

General and administrative expenses for the three

months ended March 31, 2021 were $1.01 million an increase of $0.31 million, or 44.5%, compared to $0.70 million for the three months

ended March 31, 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses

to employees. We expect that general and administrative expenses will remain at the same level through 2021.

Financial income, net for the three months ended

March 31, 2021 were $0.3 million compared to finance expenses, net of $0.07 million for the three months ended March 31, 2020. The decrease

in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investment.

Net loss for the three months ended March 31,

2021 was $1.87 million compared with a net loss of $4.34 million for the three months ended March 31, 2020. The decrease in net loss for

the three months ended March 31, 2021 was primarily attributable to a decrease in revenues in 2021, a decrease in research and development

expenses which was partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of March 31, 2021, Can-Fite had cash and cash

equivalents and short term deposits of $11.24 million as compared to $8.26 million at December 31, 2020. The increase in cash during the

three months ended March 31, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercises during the

first quarter of 2021 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma.

CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

CONSOLIDATED STATEMENTS OF COMPREHENSIVE

U.S dollars in thousands (except for share and per share data)

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, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson,

is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. 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 successfully achieved its

primary endpoint 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.

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,"