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 2019

 

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  þ       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 two paragraphs 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 S-8 (File No. 333-227753) and Form F-3 (File Nos. 333-195124, 333-204795, 333-209037 and 333-220644), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 1, 2019, Can-Fite BioPharma Ltd. (the “Company”) issued a press release announcing that it signed a distribution agreement with Kyongbo Pharm Co., Ltd., to distribute the Company’s lead drug candidate, Piclidenoson, for the treatment of psoriasis in South 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.

 

1

 

 

Exhibit Index

 

Exhibit No.   Description
99.1     Press Release dated August 1, 2019

 

2

 

 

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: August 1, 2019 By: /s/ Pnina Fishman
    Pnina Fishman
    Chief Executive Officer

 

 

3

 

 

Exhibit 99.1

 

Can-Fite Signs Agreement with Kyongbo Pharm for the Distribution in South Korea of Piclidenoson in the Treatment of Psoriasis

 

- Up to $4,000,000 in upfront and milestone payments, plus a transfer price for delivering finished product

 

- Piclidenoson is currently in Phase 3 for the treatment of psoriasis

 

PETACH TIKVA, Israel, August 1, 2019 -- 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 signed a distribution agreement with Kyongbo Pharm Co., Ltd., to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of psoriasis in South Korea, upon receipt of regulatory approvals.

 

Under the terms of the distribution agreement, Kyongbo Pharm, in exchange for exclusive distribution rights to sell Piclidenoson in the treatment of psoriasis in South Korea, is making a total upfront payment of $750,000 to Can-Fite, with additional payments of up to $3,250,000 upon achievement of certain milestones Can-Fite will also be entitled to a transfer price for delivering finished product to Kyongbo Pharm.

 

“We are very excited to sign this distribution agreement with Kyongbo, a highly prestigious company in South Korea and we believe that they are the right partner for us to penetrate the Korean market in the indication of psoriasis,” stated Sari Fishman, VP Business Development of Can-Fite. “We believe that Kyongbo’s commitment to us is a strong validation of our development efforts to date.”

 

Can-Fite is currently enrolling over 400 patients in Europe, Canada, and Israel for its Phase III Comfort trial of Piclidenoson in the treatment of psoriasis. The study is designed to establish Piclidenoson’s superiority as compared to placebo and non-inferiority versus Otezla in patients with moderate-to-severe plaque psoriasis.

 

The global psoriasis therapeutic market, estimated to reach $11.4 billion by 2020, is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects.

 

About Can-Fite BioPharma Ltd.

 

Can-Fite BioPharma Ltd. (NYSE American: 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 currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite’s liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). 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 in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. 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: 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; 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