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 December 2023
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 paragraph of the press release attached
to this Form 6-K is 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 and 333-262055), 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on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 December 4, 2023, Can-Fite BioPharma Ltd. issued
a press release entitled “Can-Fite’s Namodenoson for the Treatment of Pancreatic Cancer Patients: Progress in Clinical Development”.
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: December 4, 2023 |
By: |
/s/ Motti Farbstein |
|
|
Motti Farbstein |
|
|
Chief Executive Officer and Chief Financial Officer |
2
Exhibit 99.1
Can-Fite’s Namodenoson for the Treatment
of Pancreatic Cancer Patients: Progress
in Clinical Development
Study will aim to enroll about
20 patients to establish safety and clinical activity
PETACH TIKVA, Israel,
December 4, 2023 -- 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 completed
the design of a Phase IIa study protocol for the treatment of patients with pancreatic cancer and plans to submit the protocol shortly
to ethical committees for approval.
Can-Fite completed the protocol design of the
CF102-222PC clinical study entitled: “A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of
Advanced Pancreatic Adenocarcinoma”.
This is a multicenter open-label trial in patients
with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy or who refuse standard treatment. The
trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive
oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately
20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the
secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation
Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall
Survival (OS).
The study will be conducted by Dr. Salomon Stemmer,
a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.
“This Phase IIa study is designed as an
open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has
progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive
data in the Phase II advanced liver cancer study, with a patient showing overall survival of 7 years, encouraged us to initiate the current
Phase IIa study,” stated Can-Fite’s Medical Director Dr. Michael Silverman.
Namodenoson recently received peer-reviewed recognition
for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite’s
study titled “Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway”
for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused
on the function and mechanism of bioactive molecules, which published an article titled “Namodenoson Inhibits the Growth of Pancreatic
Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways”.
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. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of steatotic liver disease (SLD), a Phase III 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 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
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