Can-Fite Reports First Quarter 2022 Financial Results & Provides Clinical Update

Can-Fite Reports First Quarter 2022

Financial Results & Provides Clinical Update

PETACH TIKVA, Israel, May 26, 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 financial results for the quarter ended March 31, 2022.

Corporate and Clinical Development Highlights

Fortified Balance Sheet - On March 31,

2022, Can-Fite had approximately $16.5 million in cash, cash equivalents, and short-term deposits.

Phase III Psoriasis Study Data Expected Q2

2022 - Topline results are expected in Q2 2022 in Can-Fite's Phase III Comfort

psoriasis study for both its 16 week primary endpoint and 32 week secondary endpoint. The study is designed to establish Piclidenoson's

superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla ) at 32 weeks. During the first quarter,

a preclinical study showed Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.

Developing Topical Psoriasis Treatment

- In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured by the psoriasis area

severity index (PASI) calculated based on observation of erythema, thickness, scaling, and a score of skin lesions. The topical treatment

may serve as a complementary product to oral Piclidenoson.

Commenced Enrollment in Phase IIb NASH Study

- In January, Can-Fite enrolled the first patient in its Phase IIb multicenter, randomized, double-blind, placebo-controlled

study in 140 subjects with biopsy-confirmed NASH. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared

to placebo as determined by a histological endpoint. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver

fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect.

Granted U.S. Patent for Liver Fibrosis and

Israeli Patent for NASH - The U.S. Patent and Trademark Office granted Can-Fite a patent for its invention titled "Method

for Treating Fibrotic Liver Tissue Using CL-IB MECA", a broad patent that addresses markets for the treatment of all advanced liver

fibrosis indications. The patent opens an opportunity for much broader market needs which entail all clinical conditions with advanced

liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic

liver disease (ALD) among others. The Israel Patent Office granted Can-Fite a patent titled "An A3 Adenosine Receptor Ligand For

Use In Treating Ectopic Fat Accumulation" which has been issued in approximately 40 other countries.

Opened Enrollment in Pivotal Phase III Liver

Cancer Study - Can-Fite's pivotal Phase III liver cancer study for Namodenoson opened for enrollment of approximately

450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved

therapies. An interim analysis will be conducted after 50% of patients are enrolled and treated. The primary endpoint is overall survival.

Can-Fite has received Orphan Drug Designation in both the U.S. and Europe and has received the U.S. FDA's Fast Track Status.

Presented Data on Cannabinoids in the Treatment

of Liver Cancer at CannX - In March, Can-Fite delivered a presentation titled "Inhibition of Hepatocellular Carcinoma

Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv. The findings

were also published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids highlighting the ability of CBD-rich

T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and

deregulation of the Wnt/ -catenin pathway.

"We look forward to announcing Phase III

psoriasis results before the end of the second quarter as we enroll patients in our other advanced stage clinical trials for NASH and

liver cancer," stated Can-Fite CEO Dr. Pnina Fishman. "Can-Fite is financially well positioned to conduct all our clinical

development programs over the next year, and we continue to evaluate potential new distribution partnerships which may provide additional

non-dilutive funding."

Revenues for the three months ended March 31,

2022 were $0.20 million, an increase of $0.05 million, or 38.5%, compared to $0.15 million for the three months ended March 31, 2021.

The increase in revenues was mainly due to the recognition of a higher portion of advance payments received under a distribution agreement

with Ewopharma than the advance payment received at the end of the first quarter of 2021.

Research and development expenses for the three

months ended March 31, 2022 were $1.82 million, an increase of $0.52 million, or 39.8%, compared to $1.30 million for the three months

ended March 31, 2021. Research and development expenses for the first quarter of 2022 comprised primarily of expenses associated with

an ongoing Phase III study of Piclidenoson for the treatment of psoriasis and two studies for Namodenoson, a Phase III study in the treatment

of liver cancer and a Phase IIb study for NASH. The increase is primarily due to costs incurred in the first quarter of 2022 associated

with the two new studies for Namodenoson.

General and administrative expenses for the three

months ended March 31, 2022 were $0.75 million a decrease of $0.26 million, or 25.8%, compared to $1.01 million for the three months ended

March 31, 2021. The decrease is primarily due to the decrease in professional services for public relations and investor relations. We

expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the three months ended

March 31, 2022 were $0.06 million compared to finance income, net of $0.29 million for the three months ended March 31, 2021. The decrease

in financial income, net was mainly due to revaluation of our short-term investment which in 2021 was recorded as income and in 2022 was

recorded as expense.

Net loss for the three months ended March 31,

2022 was $2.43 million compared with a net loss of $1.87 million for the three months ended March 31, 2021. The increase in net loss for

the three months ended March 31, 2022 was primarily attributable to an increase in research and development expenses which was partly

offset by a decrease in general and administrative expenses and a decrease in finance income, net.

As of March 31, 2022, Can-Fite had cash and cash

equivalents and short term deposits of $16.5 million as compared to $18.9 million at December 31, 2021. The decrease in cash during the

three months ended March 31, 2022 is due to the ongoing operation of the Company.

The Company's consolidated financial results

for the three months ended March 31, 2022 are presented in accordance with US GAAP Reporting Standards.

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 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, and inflammatory disease. The Company's lead drug candidate, Piclidenoson has completed

enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment

of non-alcoholic steatohepatitis (NASH), and a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer.

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