<SEC-DOCUMENT>0001213900-23-079717.txt : 20230927
<SEC-HEADER>0001213900-23-079717.hdr.sgml : 20230927
<ACCEPTANCE-DATETIME>20230927070359
ACCESSION NUMBER:		0001213900-23-079717
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20230927
FILED AS OF DATE:		20230927
DATE AS OF CHANGE:		20230927

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:		231281796

	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>ea185789-6k_canfitebio.htm
<DESCRIPTION>REPORT OF FOREIGN PRIVATE ISSUER
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Under the Securities Exchange Act of 1934</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">For the Month of September 2023</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">001-36203</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)</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">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">&nbsp;</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 September 27, 2023, Can-Fite BioPharma Ltd.
issued a press release entitled &ldquo;Can-Fite Novel Approach for the Treatment of Pancreatic Carcinoma with Namodenoson Receives Appreciation
of the American Association of Cancer Research (AACR)&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="border-bottom: black 1.5pt solid; vertical-align: top; width: 9%"><FONT STYLE="font-size: 10pt"><B>Exhibit No.</B></FONT></TD>
    <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 90%"><FONT STYLE="font-size: 10pt"><B>Description</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD><FONT STYLE="font-size: 10pt">99.1</FONT></TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt"><A HREF="ea185789ex99-1_canfitebio.htm">Press Release dated September 27, 2023</A></FONT></TD></TR>
  </TABLE>
<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"></P>

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<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>SIGNATURES</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: 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: September 27, 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/ Motti Farbstein</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Motti Farbstein</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Chief Executive Officer and Chief Financial Officer</FONT></TD></TR>
  </TABLE>
<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">&nbsp;</P>

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">2</P>

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<TYPE>EX-99.1
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<FILENAME>ea185789ex99-1_canfitebio.htm
<DESCRIPTION>PRESS RELEASE DATED SEPTEMBER 27, 2023
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<P STYLE="text-align: right; margin: 0"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Can-Fite Novel Approach for the Treatment
of Pancreatic Carcinoma with <BR>
Namodenoson Receives Appreciation of the American Association of Cancer Research (AACR) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: center"><B>&nbsp;</B></P>

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<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">&#9679;</TD><TD STYLE="text-align: justify"><B><I>Namodenoson robustly inhibits pancreatic carcinoma growth in pre-clinical studies, via inhibition of KRAS and Wnt pathways</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

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<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">&#9679;</TD><TD STYLE="text-align: justify"><B><I>Poster summarizing the inhibitory effect of Namodenoson in pancreatic carcinoma is presented today at the AACR conference</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

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<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">&#9679;</TD><TD STYLE="text-align: justify"><B><I>Exploratory Phase II pancreatic cancer study protocol has been developed and is to be submitted to ethical committees in Israel
and the U.S. </I></B></TD></TR></TABLE>

<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">PETACH TIKVA, Israel, September 27, 2023 -- Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that
address oncology, inflammatory and liver diseases, today announced that its study titled &ldquo;Namodenoson Inhibits the Growth of Pancreatic
Carcinoma via De-regulation of the Wnt/&beta;-catenin Signaling Pathway&rdquo; has been accepted for a poster presentation at the AACR
Special Conference on Pancreatic Cancer, held from September 27-30, 2023, in Boston, Massachusetts.</P>

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

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The pre-clinical studies presented in the poster used advanced pancreatic
carcinoma patient cells that were treated with Namodenoson both in tissue cultures and in <I>in vivo</I> studies. Namodenoson treatment
resulted in a significant growth inhibition and de-regulation of two signal transduction pathways, the Wnt and the KRAS, both of which
are responsible for the etiology and pathology of this devastating disease.</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 completed the development of an exploratory
Phase II protocol in patients with pancreatic carcinoma who have failed first line treatment and plans to shortly submit it for approval
to medical sites in Israel and the U.S. Safety and efficacy endpoints including objective response, progression-free survival, duration
of response, disease control, and overall survival will be monitored.</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;The robust inhibition of pancreatic carcinoma
growth both <I>in vitro</I> and <I>in vivo</I>, together with the definitive mechanism of action is a strong basis for evaluating Namodenoson
in patients with pancreatic carcinoma where chemotherapeutic drugs have a very limited effect. We are very happy that the AACR granted
us the opportunity to present these encouraging data and to discuss the very important results with the leading global experts in this
field,&rdquo; stated Prof. Pnina Fishman, CSO &amp; Executive Chairman of Can-Fite.</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>About Pancreatic Cancer</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; background-color: #FEFEFE">The highest incidence&nbsp;<U>rates</U>&nbsp;for
pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an
estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival
rate for people with pancreatic cancer in the U.S. is 11%.&nbsp;<U>Acumen Research</U>&nbsp;estimates the global pancreatic cancer therapeutics
market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE"><B>About Namodenoson</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: #FEFEFE">Namodenoson was evaluated
in Phase 2 trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic
fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase 2b trial for steatotic liver disease
and a pivotal Phase 3 for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3
adenosine receptor (A3AR). 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.</P>

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

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

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<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 and is expected to commence a pivotal Phase III. Can-Fite&rsquo;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&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 1,600 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">&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; text-align: justify"><B>&nbsp;</B></P>

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