• CF602’s unique mechanism of action enables potential treatment of diabetic patients and may offer an alternative to PDE5 non-responders (Viagra, Cialis, Levitra and Stendra) accounting for 30-35% of the $3.6 billion ER market

  • Patents granted in numerous healthcare markets, including the United States, Australia and Japan

PETACH TIKVA, Israel, June 24, 2022–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company developing a pipeline of proprietary small molecule drugs that treat inflammatory, cancerous and liver diseases, today announced its study titled “The Allosteric Modulator of the Receptor adenosine A3 CF602 reverses erectile dysfunction in a diabetic rat model” was published in the peer-reviewed journal Andrology.

Full erectile recovery was achieved after a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite’s CF602, an allosteric modulator of the A3 adenosine receptor (A3AR), applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant improvements as a function of intracavernous pressure (ICM) dose, smooth muscle: collagen ratio, vascular endothelial growth factor, and endothelial nitric oxide synthase.

While oral phosphodiesterase type 5 (PDE5) inhibitors are the current standard of care for erectile dysfunction (ED), with brands such as Viagra, Cialis, Levitra and Stendra, an estimated 30% to 35% of ED patients do not respond, and these drugs may be contraindicated for people with diabetes.

The data published in the article suggests that CF602 could potentially offer an alternative treatment to PDE5 inhibitors, especially for PDE5 non-responders and diabetics.

“There is a clear and unmet need on the market today for an effective alternative to PDE5 inhibitors for non-responders to major sexual dysfunction drugs and diabetics, many of whom cannot be prescribed in safety of PDE5 inhibitors. With a growing body of data and intellectual property real estate surrounding CF602, we are evaluating potential strategic partnerships to advance CF602 to market, said Can-Fite CEO Dr. Pnina Fishman.

According to Zion Market Research, the global ED Market was valued at $3.64 Billion in 2021 and is expected to reach $5.94 Billion by 2028.

About the CF602

CF602 is a novel A3AR allosteric modulator that enhances receptor activity in the presence of the native ligand. The molecule is characterized by a high selectivity at the A3AR level and is able to avoid the desensitization of the receptors, thus amplifying the agonist activity at low doses.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is a late-stage clinical-stage drug development company with a technology platform designed to address multi-billion dollar markets in the treatment of cancer, liver and inflammatory diseases. . 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 carcinoma hepatocellular (HCC), the most common form of liver cancer. Namodenoson has received orphan drug designation in the United States and Europe and Fast Track designation as a second-line treatment for HCC by the United States 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 demonstrated its 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 operations, strategies or prospects. Additionally, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, either 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 that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included, but not limited to, in various documents filed by Can-Fite with the United States Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized officers. 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 address matters that have not yet occurred, such 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 operations or results to differ materially from the operations and results anticipated in these forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to: our history of losses and our need for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or not at all; cash flow uncertainties and the inability to meet working capital requirements; 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 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 business collaborations; the implementation of our business model and strategic plans for our businesses and product candidates; the extent of protection we are able to establish and maintain for the intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive businesses, technologies and our industry; statements regarding the impact of the political and security situation in Israel on our business; and the 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 affected by economic and other factors beyond its control. Can-Fite undertakes no obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

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Can-Fite BioPharma
Motti Farbstein