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 2024

 

001-36203

(Commission File Number)

 

CAN-FITE BIOPHARMA LTD.

(Exact name of Registrant as specified in its charter)

 

10 Bareket Street

Kiryat Matalon, P.O. Box 7537

Petach-Tikva 4951778, 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 ☐

 

The first and third paragraphs of the press release attached to this Form 6-K are hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File Nos. 333-227753 and 333-271384) and Form F-3 (File Nos. 333-195124, 333-236064, 333-249063, 333-262055 and 333-276000), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

 

 

On January 30, 2024, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication”. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Exhibit Index

 

Exhibit No.		Description
99.1		Press Release dated January 30, 2024

 

 

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 30, 2024	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

 

 

2 

Exhibit 99.1 

 

Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication

 

PETACH TIKVA, Israel, January 30, 2024 -- 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 it has expanded its out licensing transaction with Ewopharma AG. to include the pancreatic cancer indication of Can-Fite.

 

During 2021, Can-Fite entered into an exclusive distribution agreement for Piclidenoson with Switzerland-based Ewopharma AG for the treatment of psoriasis and Namodenoson for the treatment of hepatocellular carcinoma (HCC) and nonalcoholic steatohepatitis (NASH). Under the terms of the distribution agreement, Ewopharma AG paid Can-Fite an upfront payment of US$2.25 million with up to an additional US$40.45 million, payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. In exchange, Ewopharma AG received the exclusive right to market and sell Piclidenoson in Central Eastern European (CEE) countries and Namodenoson in CEE countries and Switzerland.

 

Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.

 

Ewopharma is a pharmaceutical sales and marketing firm that helps pharma companies access markets in CEE and Switzerland. In addition to Can-Fite, Ewopharma AG has distribution agreements with many leading healthcare companies including Eisai and Biogen.

 

“We are very pleased to expand the distribution agreement with Ewopharma, a leader in pharmaceutical distribution in Central Eastern Europe and Switzerland and include the pancreatic cancer indication. We consider this to be an important transaction for Can-Fite that will enable penetration into Ewopharma’ s territory right after approval of the drug for this indication, where there are no other efficacious drugs,” stated Can-Fite VP Business Development Dr. Sari Fishman.

 

About Namodenoson

 

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and 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. In the last 2 years Can-Fite started to develop Namodenoson for the treatment of pancreatic carcinoma. Based on pre-clinical studies which demonstrated robust anti-tumor effect of the drug on experimental models of pancreatic carcinoma, the company decided to initiate an exploratory Phase II study in patients with pancreatic carcinoma who failed first line treatment.

 

 

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 cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning 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.canfite.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 the COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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

 

 

 

 

---