~35% of erectile dysfunction patients in a $3.2 billion market are non-responders to brands including Viagra and Cialis, and these drugs can be contraindicated for an estimated 16 million men living with diabetes

CF602’s unique mechanism of action enables potential treatment of diabetic patients

RAMAT GAN, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd . (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, announced today it received a Notice of Allowance from the National Institute of Industrial Property of Brazil for its patent application titled “An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction”. The invention addresses the use of Can-Fite’s CF602 drug candidate as an oral or topical treatment for erectile dysfunction (ED) patients living with diabetes and those who are non-responders to ED drugs currently on the market.

“This latest patent in Brazil geographically expands intellectual property protection for CF602 in ED beyond the major markets of the U.S. and Europe where patents have already been granted,” stated Motti Farbstein, Can-Fite CEO. “Given the large percentage of non-responders and those living with diabetes who are contraindicated for taking the most widely prescribed ED medications, we believe CF602 has the potential to meet a large and unmet need.”

Standard of care ED drugs including Viagra, Cialis, Levitra, and Stendra are oral phosphodiesterase type 5 (PDE5) inhibitors that work for approximately 65%-70% of patients in today’s $3.2 billion ED market. Yet, an estimated 30% to 35% of ED patients are non-responders, and these drugs can be contraindicated for people living with diabetes representing 16 million men in the U.S.

A study published in the journal Andrologia by Can-Fite scientists suggests that CF602 could potentially offer an alternative to the current drugs on market.  A full erectile recovery was achieved following 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 dose-dependent improvements in intracavernosal pressure (ICM), smooth muscle/collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase.

About CF602

CF602 is a novel A3AR allosteric modulator that enhances the receptor activity in the presence of the native ligand. The molecule is characterized by high selectivity at the A3AR and is capable of avoiding receptor desensitization, thus magnifying the agonist activity at low doses. CF602 is being developed for the treatment of erectile dysfunction.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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 reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic 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 1,600 patients in clinical studies to date. For more information please visit: https://www.canfite.com/ .

Forward-Looking Statements

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Contact

Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114