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 May 2024
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 May 13, 2024, Can-Fite BioPharma Ltd. issued a press release
entitled “Can-Fite: 75 Oncologists and Coordinators from Europe US and Israel Participated in a Conference Aimed at Accelerating
Patient Enrolment for the Pivotal Phase 3 Advanced Liver Cancer Study”. A copy of this press release is attached hereto as Exhibit
99.1 and is incorporated herein by reference.
Exhibit Index
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: May 13, 2024 |
By: |
/s/ Motti Farbstein |
|
|
Motti Farbstein |
|
|
Chief Executive Officer and Chief Financial Officer |
2
Exhibit 99.1
Can-Fite: 75 Oncologists and Coordinators from
Europe US and Israel Participated in
a Conference Aimed at Accelerating Patient Enrolment for the Pivotal Phase 3
Advanced Liver Cancer
Study
Can-Fite has received agreement
from both the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) on the current pivotal Phase 3 clinical study
RAMAT GAN, Israel, May 13, 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 announces that it held a conference for 75 oncologists and coordinators who are conducting the pivotal
Phase 3 advanced liver cancer study, to accelerate patient enrolment.
The participants have been presented with the drug chemical and biological
profile and the study protocol as well as study procedures. Dr. Lencioni, a key opinion leader in radiology of liver tumors, Department
of Radiology, Pisa University School of Medicine Italy, educated the oncologists on the way to measure tumor lesion size prior and post
namodenoson treatment. The difference in tumor growth or regression defines progression free survival (PFS) and the objective response
rate (ORR) to the drug, serving as part of the study objectives. US experts presented to the participants the electronic data entry of
the patients’ data during the trial.
“The conference was very successful and we are very pleased with
the enthusiasm of the participants with respect to the drug characteristics. They are looking forward to complete patient enrolment and
conclude the data of this very promising anti-cancer drug,” said Dr. Pnina Fishman, Can-Fite CSO and Executive Chairperson.
Can-Fite has received agreement from both the
U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase 3 clinical study which is now enrolling
patients is Israel, Europe and the US. The study is designed to perform an interim analysis by an Independent Data Monitoring Committee
(IDMC) upon enrollment of 50% patients. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved
therapies have not been effective.
Namodenoson has Orphan Drug status with both the
FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel
and Romania.
According to the American Cancer Society, liver
cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that
effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1
billion by 2027 for the G8 countries.
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.
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.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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