<SEC-DOCUMENT>0001213900-23-028391.txt : 20230410
<SEC-HEADER>0001213900-23-028391.hdr.sgml : 20230410
<ACCEPTANCE-DATETIME>20230410070620
ACCESSION NUMBER:		0001213900-23-028391
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20230410
FILED AS OF DATE:		20230410
DATE AS OF CHANGE:		20230410

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Can-Fite BioPharma Ltd.
		CENTRAL INDEX KEY:			0001536196
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36203
		FILM NUMBER:		23809659

	BUSINESS ADDRESS:	
		STREET 1:		10 BAREKET STREET, KIRYAT MATALON
		STREET 2:		P.O. BOX 7537
		CITY:			PETACH TIKVA
		STATE:			L3
		ZIP:			4951778
		BUSINESS PHONE:		972 39241114

	MAIL ADDRESS:	
		STREET 1:		10 BAREKET STREET, KIRYAT MATALON
		STREET 2:		P.O. BOX 7537
		CITY:			PETACH TIKVA
		STATE:			L3
		ZIP:			4951778
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>ea176726-6k_canfitebio.htm
<DESCRIPTION>REPORT OF FOREIGN PRIVATE ISSUER
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM 6-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Report of Foreign Private Issuer</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Pursuant to Rule&nbsp;13a-16 or 15d-16</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Under the Securities Exchange Act of 1934</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">For the Month of April 2023</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">001-36203</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Commission File Number)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>CAN-FITE BIOPHARMA LTD.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Exact name of Registrant as specified in its charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>10 Bareket Street</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Kiryat Matalon, P.O. Box 7537</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Petach-Tikva 4951778, Israel</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Address of principal executive offices)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the registrant
files or will file annual reports under cover Form&nbsp;20-F or Form&nbsp;40-F.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Form&nbsp;20-F&nbsp;<FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form&nbsp;40-F&nbsp;<FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The first paragraph of the press release attached to this Form 6-K
is hereby incorporated by reference into the registrant&rsquo;s Registration Statements on <A HREF="http://www.sec.gov/Archives/edgar/data/1536196/000121390018013702/fs82018_canfitebiopharma.htm">Form S-8</A> (File No. 333-227753), Form F-3 (File
Nos. <A HREF="http://www.sec.gov/Archives/edgar/data/1536196/000121390014006702/posam2014a1_canfitebiopharma.htm">333-195124</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1536196/000121390020008630/ea120459-posam_canfitebio.htm">333-236064</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1536196/000121390020028478/ea127289-f3_canfite.htm">333-249063</A> and <A HREF="http://www.sec.gov/Archives/edgar/data/1536196/000121390022001135/ea153627-f3_canfite.htm">333-262055</A>) and <A HREF="http://www.sec.gov/Archives/edgar/data/1536196/000121390021045052/ea146433-f1_canfite.htm">Form F-1</A> (File No. 333-259085), 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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On April 10, 2023, Can-Fite BioPharma Ltd. issued
a press release entitled &ldquo;Can-Fite: EMA Gives Green Light for Piclidenoson Pivotal Phase III Clinical Trial for Psoriasis Treatment&rdquo;.
A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Exhibit Index</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD STYLE="vertical-align: top; width: 10%; border-bottom: black 1.5pt solid"><FONT STYLE="font-size: 10pt"><B>Exhibit No.</B></FONT></TD>
    <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 89%; border-bottom: black 1.5pt solid"><FONT STYLE="font-size: 10pt"><B>Description</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD><FONT STYLE="font-size: 10pt">99.1</FONT></TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt"><A HREF="ea176726ex99-1_canfite.htm">Press Release dated April 10, 2023</A></FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>


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<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 29.7pt">&nbsp;</P>

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    <TD STYLE="width: 60%"><FONT STYLE="font-size: 10pt">Date: April 10, 2023</FONT></TD>
    <TD STYLE="width: 4%"><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; width: 36%"><FONT STYLE="font-size: 10pt">/s/ Pnina Fishman</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Pnina Fishman</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Chief Executive Officer</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>


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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ea176726ex99-1_canfite.htm
<DESCRIPTION>PRESS RELEASE DATED APRIL 10, 2023
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Can-Fite: EMA Gives Green Light for Piclidenoson
Pivotal Phase III Clinical Trial for Psoriasis Treatment</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: center"><B>The Pivotal Study is Aimed to Support
a Marketing Authorization Application</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">PETACH TIKVA, Israel, April 10, 2023 -- Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that
address inflammatory, cancer and liver diseases, today announced that it received a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) with respect to the submission of a registration plan for a pivotal
Phase III clinical trial for the treatment of moderate to severe psoriasis. The pivotal Phase III study and the safety of the 3 mg twice
daily dose of Piclidenoson are accepted by the agency.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company intends to initiate a prospective
double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson aimed at demonstrating clinical safety
and efficacy for the treatment of moderate to severe psoriasis sufficient to support a marketing authorization application.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The agency also commented on the registration
plan submitted by the Company relating to the chemistry, manufacturing, and controls (CMC), nonclinical data, and clinical pharmacology
data. Can-Fite is currently submitting a comparable data package to the US Food and Drug Administration.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Can-Fite recently reported topline results from
its Phase III COMFORT&trade; study which met its primary endpoint with statistically significant improvement over placebo in psoriasis
patients and an excellent safety profile for Piclidenoson.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&ldquo;Piclidenoson&rsquo;s oral dosage and excellent
safety record combined with its progressive effectiveness over time make it ideally suited for the treatment of psoriasis, a chronic disease.
Should this market registration study produce positive results similar to our COMFORT study, we believe Piclidenoson will be well positioned
in a very large market which needs more safe and effective oral drug options,&rdquo; stated Can-Fite CEO Dr. Pnina Fishman.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About Can-Fite BioPharma Ltd.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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&rsquo;s lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis. Can-Fite&rsquo;s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma
(HCC), the most common form of liver 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&rsquo;s third drug candidate, has shown efficacy
in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical
studies to date. For more information please visit: www.can-fite.com.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Forward-Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">This press release may contain forward-looking
statements, about Can-Fite&rsquo;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 &ldquo;forward looking statements&rdquo;. Forward-looking statements can be identified by the use of
forward-looking words such as &ldquo;believe,&rdquo; &ldquo;expect,&rdquo; &ldquo;intend,&rdquo; &ldquo;plan,&rdquo; &ldquo;may,&rdquo;
&ldquo;should&rdquo; or &ldquo;anticipate&rdquo; 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&rsquo;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 &ldquo;Risk Factors&rdquo; section of Can-Fite&rsquo;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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Contact</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Can-Fite BioPharma</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Motti Farbstein</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">info@canfite.com</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">+972-3-9241114</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>

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