CANF Can Fite BioPharma Ltd

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of January 2025

 

001-36203

(Commission File Number)

 

CAN-FITE BIOPHARMA LTD.

(Exact name of Registrant as specified in its charter)

 

26 Ben Gurion Street

Ramat Gan 5257346 Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒           Form 40-F ☐

 

 

 

On January 27, 2025, Can-Fite BioPharma Ltd. issued a press release entitled “US Patent Office Granted Can-Fite Namodenoson Patent for Use as anti-Obesity Drug.” A copy of this press release is furnished herewith as Exhibit 99.1.

 

 

Exhibit Index

 

Exhibit No.		Description
99.1		Press Release dated January 27, 2025

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: January 27, 2025	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

 

 

Exhibit 99.1

 

US Patent Office Granted Can-Fite Namodenoson Patent for Use as anti-Obesity Drug

 

The Namodenoson oral drug is well positioned in the field of anti-obesity agents due to its activity and favorable safety profile

 

Ramat Gan, Israel, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that its lead drug candidate Namodenoson was granted a patent for its use as an anti-obesity drug by the US patent office.  Namodenoson is currently being developed for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), advanced liver cancer and pancreatic cancer. In all clinical studies that have been conducted, Namodenoson had a very favorable safety profile when administered orally.

 

The patent application No. 17/309,952 entitled “An A3 adenosine receptor ligand for use for achieving a fat loss effect”, has been accepted by the US Patent Office, will be issued on February 2^nd and expires in 2042.

 

The patent application covers methods of treating obese patients by administering Namodenoson in an oral formulation. Can-Fite has already multiple approved patents and corresponding applications in a variety of territories around the world, for different clinical applications of the drug.

 

The anti-obesity patent application is based on data demonstrating that treatment of fat cells with Namodenoson reduced fat levels via the increase of the hormone adiponectin, a regulator of fat production in the body. Namodenoson also reduced body weight in an experimental animal model of obesity, induced by high fat diet. In a MASH Phase IIa study, in patients treated with Namodenoson, a 2.3% weight loss has been observed after 3 months with a significant increase in serum adiponectin levels.

 

“We are delighted that the product protection of Namodenoson in the area of obesity has been accepted in the US and will be valid till 2042. Namodenoson is currently being developed for the treatment of MASH in a Phase IIb study where most patients are obese. We look forward to seeing the anti-obesity effect in this clinical study”, said Motti Farbstein, Can-Fite CE&CFO.

 

The obesity treatment industry worldwide is expected to reach a projected revenue of US$ 60.5 billion by 2030. A compound annual growth rate of 22.3% is expected of the worldwide obesity treatment industry from 2025 2030.

 

About Namodenoson

 

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

 

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 recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. 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: 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, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. 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. 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 known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, 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; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

 

Contact

 

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

 

 

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