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 August 2017

 

001-36203

(Commission File Number)

 

CAN-FITE BIOPHARMA LTD.

(Exact name of Registrant as specified in its charter)

 

10 Bareket Street

KiryatMatalon, 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 ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(7): ____

 

The first paragraph and “Forward Looking Statements” of the press release attached to this Form 6-K are hereby incorporated by reference into the registrant's Registration Statements on Form F-3 (File Nos. 333-195124, 333-199033, 333-204795 and 333-209037), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 August 23, 2017, Can-Fite BioPharma Ltd. (the “Company”) issued a press release announcing that it has received a milestone payment in the amount of $500,000 from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS), which has licensed the exclusive right to distribute Namodenoson (CF102) for the treatment of liver cancer in Korea upon receipt of regulatory approvals. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

  2  

 

 

Exhibit Index

 

Exhibit No.   Description
     
99.1   Press Release dated August 23, 2017

 

  3  

 

 

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.

 

  Can-Fite BioPharma Ltd.
     
Date: August 23, 2017 By: /s/ Pnina Fishman
    Pnina Fishman
    Chief Executive Officer

 

 

4

 

 

Exhibit 99.1

 

Can-Fite Receives Milestone Payment From CKD Pharmaceuticals its Distribution Partner in Korea

 

- Deal provides for up to $3,000,000 in upfront and milestone payments & 23% royalties

 

- Agreement includes distributor’s right of first refusal to distribute Namodenoson for other indications including NASH

 

PETACH TIKVA, Israel, August 23, 2017 -- Can-Fite BioPharma Ltd . (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced it has received a milestone payment in the amount of $500,000 from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS), which has licensed the exclusive right to distribute Namodenoson (CF102) for the treatment of liver cancer in Korea upon receipt of regulatory approvals. This is the second payment received by Can-Fite, as part of the Korean distribution agreement with CKD which is valued at up to $3,000,000 in upfront and milestone payments plus 23% royalties on sales of Namodenoson. Can-Fite has received $1,000,000 to date from CKD and may receive up to an additional $2,000,000 in milestone payments.

 

“Namodenoson’s clinical development in the treatment of liver cancer is advancing, as marked by our recent completion of patient enrollment in the U.S., Europe and Israel in our Phase II study of patients with advanced hepatocellular carcinoma with underlying Child-Pugh Class B cirrhosis,” stated Can-Fite CEO Dr. Pnina Fishman. “We are pleased to work with CKD in Korea to advance Namodenoson.”

 

Under the distribution agreement with CKD, Can-Fite will supply Namodenoson to CKD, which will be responsible for all costs and activities associated with development, regulatory approvals, marketing, sales and distribution of Namodenoson in Korea. This agreement with CKD marks Can-Fite’s second distribution and licensing deal in Korea, where the Company’s drug candidate Piclidenoson has been out-licensed to Kwang Dong Pharmaceutical Co. for the treatment of rheumatoid arthritis.

 

51,000 people had liver cancer in Korea, with 11,000 deaths, in 2012 according to a study published in Cancer Research and Treatment: Official Journal of Korean Cancer Association 2015.

 

About Namodenoson (CF102)

 

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being 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. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.

 

 

 

 

About Can-Fite BioPharma Ltd.

 

Can-Fite BioPharma Ltd. (NYSE MKT: 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 scheduled to enter a Phase III trial for rheumatoid arthritis in 2017 and a Phase III trial for psoriasis in early 2018. The rheumatoid arthritis Phase III protocol has recently been agreed with the European Medicines Agency. Can-Fite's liver cancer drug CF102 is in Phase II trials for patients with liver cancer and is slated to enter Phase II for the treatment of non-alcoholic steatohepatitis (NASH). CF102 has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration. CF102 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 is being prepared for an IND submission to the FDA and a Phase I trial. 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: 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 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; estimates of our expenses, future revenues, capital requirements and our needs for additional financing; 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.

  

Contact

 

Can-Fite BioPharma

 

Motti Farbstein

 

info@canfite.com

 

+972-3-9241114