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The Anti-NASH Effect of Namodenoson will be Presented at the International Conference on Fatty Liver in Berlin

May 23, 2019

PETACH TIKVA, Israel--(BUSINESS WIRE)--May 23, 2019--

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today that it has been selected for a podium presentation in a session of ‘Selected Abstracts of Excellence’ titled, “Namodenoson anti-NAFLD/NASH Activity is Mediated via De-regulation of the Wnt/β-catenin Pathway” at the 2 nd Annual International Conference on Fatty Liver ( ICFL 2019 ) in Berlin, Germany which takes place on June 27-29, 2019. Can-Fite CEO Dr. Pnina Fishman will deliver the presentation at 15:50 on June 28, 2019.

ICFL 2019 is focused on the clinical needs and best practices for diagnosing and treating fatty liver disease to address the challenges and long-term effects of this disease. ICFL 2019 will feature leading experts across the relevant fields to educate and foster knowledge exchange.

“We look forward to presenting data on Namodenoson at this gathering of the world’s thought leaders on fatty liver disease. Our compelling preclinical findings with NASH experimental models as well as our Phase II study design will be discussed. Top line results from our Phase II study in nonalcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are expected in the second half of 2019,” stated Dr. Fishman.

The Phase II NASH study is currently ongoing in Israel and aimed at the enrollment of 60 patients who suffer from NAFLD/NASH with evidence of active inflammation. The patients are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo for 12 weeks. The primary end points of the Phase II study have been recently amended and include the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The Company anticipates the data release in the second half of 2019.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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, 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 in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 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 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190523005054/en/

CONTACT: Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

KEYWORD: EUROPE GERMANY MIDDLE EAST ISRAEL

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL PROFESSIONAL SERVICES FINANCE

SOURCE: Can-Fite BioPharma

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PUB: 05/23/2019 07:00 AM/DISC: 05/23/2019 07:01 AM

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