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

Can-Fite Reports Third Quarter 2021

Financial Results & Provides Clinical Update

PETACH TIKVA, Israel, November 26, 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 September 30, 2021.

Corporate and Clinical Development Highlights

Completed Patient Enrollment in Phase III Psoriasis

Study - The Phase III Comfort study completed patient enrollment. Topline results are expected in Q1 2022. The 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.

Can-Fite Ends Phase II COVID-19 Trial to Focus

on Core Indications - In 2020, with the aim of developing a much-needed drug to treat manifestations of COVID-19, mainly the Cytokine

Release Syndrome, Can-Fite initiated a Phase II COVID-19 study of its lead drug candidate, Piclidenoson, with patient enrollment in Israel

and Europe. With the anticipated launch of Pfizer's oral COVID-19 antiviral drug candidate, Can-Fite has made a strategic decision

to end its COVID-19 program and to focus its resources on its other clinical programs, all in advanced clinical trials.

Patents Granted for NASH in Japan, Hong Kong,

and Mexico - Can-Fite continues to build its IP portfolio for NASH which now includes patents granted and allowed in 37 countries.

Most recently, patents were issued and allowed in Japan, Hong Kong, and Mexico for the patent titled "An A3 Adenosine Receptor Ligand

for Use In Treating Ectopic Fat Accumulation". This patent addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target

receptor for Can-Fite's drug platform technology, in the treatment of NASH.

Data on A3AR-based Cannabis Compounds in the

Treatment of Liver Diseases Presented at AASLD and Published in HEPATOLOGY - Can-Fite delivered a poster presentation titled

"Growth Inhibition of Hepatocellular Carcinoma (HCC) by CBD Rich T3/C15 Cannabis Fraction is Mediated via the A3 Adenosine Receptor"

at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting during the Hepatobiliary Neoplasia: Experimental

Hepatocarcinogenesis; Diagnostics and Liver Imaging session. The findings were also published in an abstract in the October 2021 supplement

of HEPATOLOGY, a premier peer-reviewed publication in the field of liver disease published on behalf of the AASLD.

Positive Phase IIa NASH Data Published in Alimentary

Pharmacology & Therapeutics - The peer-reviewed scientific journal focused on gastroenterology and hepatology published

an article titled "Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and

steatohepatitis". The article includes highlights from Can-Fite's Phase IIa NASH study of Namodenoson which achieved its study

endpoints including significant anti-steatotic, anti-fibrotic, and anti-inflammatory effects.

Fortified Balance Sheet

On September 30, 2021, Can-Fite had approximately

$13.3 million in cash, cash equivalents, and short-term deposits.

"Our NASH program has received a high level

of interest at scientific conferences based on our positive Phase IIa results, and we continue to fortify our IP around this indication.

We expect to commence enrollment in our pivotal Phase III liver cancer and Phase IIb NASH studies, as we look forward to topline results

from our Phase III in psoriasis in the first quarter of 2022. Our advanced pipeline with a growing body of safety and efficacy data has

significant potential to help patients with unmet needs," stated Can-Fite CEO Dr. Pnina Fishman.

Revenues for the nine months ended September 30,

2021 were $0.65 million compared to revenues of $0.61 million during the nine months ended September 30, 2020. The increase is considered

Research and development expenses for the nine

months ended September 30, 2021 were $6.75 million compared with $9.06 million for the same period in 2020. Research and development expenses

for the nine months period ended September 30, 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

nine months 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 nine

months of 2021. We expect research and development expenses will increase for the remainder of 2021 and beyond.

General and administrative expenses were $2.71

million for the nine months ended September 30, 2021 compared to $2.14 million for the same period in 2020. The increase is primarily

due to the increase in salaries and related benefits due to the distribution of bonuses to employees, increase in public relations expenses

and insurance expenses. We expect general and administrative expenses will remain at the same level for the remainder of 2021 and beyond.

Financial income, net for the nine months ended

September 30, 2021 was $0.31 million compared to financial expense, net of $0.22 million for the same period in 2020. The decrease in

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

Can-Fite's net loss for the nine months ended

September 30, 2021 was $8.49 million compared with a net loss of $10.81 million for the same period in 2020. The decrease in net loss

was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative

expenses and a decrease in finance expenses, net.

As of September 30, 2021, Can-Fite had cash, cash

equivalents and short-term deposits of $13.3 million as compared to $8.26 million at December 31, 2020. The increase in cash during the

nine months ended September 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions

during the first quarter of 2021, an advance payment of $2.25 million from a distribution agreement with Ewopharma and from a $10 million

registered direct offering in August 2021 which were offset by Company's operating activity.

The Company's consolidated financial results

for the nine months ended September 30, 2021 are presented in accordance with US GAAP Reporting Standards.

CONDENSED CONSOLIDATED BALANCE

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

CONDENSED CONSOLIDATED BALANCE

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

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

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 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