<SEC-DOCUMENT>0001193125-25-195777.txt : 20250904
<SEC-HEADER>0001193125-25-195777.hdr.sgml : 20250904
<ACCEPTANCE-DATETIME>20250904125500
ACCESSION NUMBER:		0001193125-25-195777
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		5
CONFORMED PERIOD OF REPORT:	20250904
FILED AS OF DATE:		20250904
DATE AS OF CHANGE:		20250904

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				133529324
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		251292552

	BUSINESS ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI-AVENTIS
		DATE OF NAME CHANGE:	20040826

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d32034d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:23%">&nbsp;</DIV></center>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT STYLE="white-space:nowrap">6-K</FONT> </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:23%">&nbsp;</DIV></center>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of September 2025 </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#8217;s name into English) </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">46, avenue de la Grande Arm&eacute;e, 75017 Paris, FRANCE </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Address of principal executive offices) </P> <P STYLE="margin-top:30pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate
by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&#8195;&#8195;Form <FONT STYLE="white-space:nowrap">40-F</FONT> &#9744; </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">1 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">In September 2025, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated
herein by reference. </P> <P STYLE="margin-top:30pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:24pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d32034dex991.htm">Press Release dated September&nbsp;4, 2025: Sanofi&#8217;s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis</A></TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:9pt; font-family:Times New Roman">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-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: September&nbsp;4, 2025</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top">By&#8195;&#8195;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:-0.56em; font-size:9pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top"></TD>
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:-0.56em; font-size:9pt; font-family:Times New Roman">Name: Alexandra Roger</P></TD></TR>
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<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:-0.56em; font-size:9pt; font-family:Times New Roman">Title: Head of Legal Corporate&nbsp;&amp; Finance</P></TD></TR>
</TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d32034dex991.htm
<DESCRIPTION>EX-99.1
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><FONT STYLE="font-family:Verdana; font-size:14pt"><B>Press Release</B></FONT></TD>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; line-height:22.0pt; font-size:18pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>Sanofi&#8217;s amlitelimab met all primary and key secondary endpoints in
the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Amlitelimab, dosed every four weeks or every 12 weeks, demonstrated statistically significant and clinically meaningful
efficacy in skin clearance and disease severity compared to placebo at Week&nbsp;24, with efficacy progressively increasing throughout the treatment period </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Study results reinforce the potential of amlitelimab as the first and only atopic dermatitis treatment with possible
dosing of only four times per year </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Additional phase 3 data will provide a comprehensive understanding of amlitelimab&#8217;s efficacy and safety profile,
including the role of long-term maintenance treatment and the potential for <FONT STYLE="white-space:nowrap">off-treatment</FONT> efficacy across diverse treatment populations </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, September</B><B></B><B>&nbsp;4, 2025.</B> Positive results from the global COAST 1 phase 3 study (clinical study identifier: <FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#5400b8"><U>NCT06130566</U></FONT><FONT STYLE="font-family:Verdana">) showed that amlitelimab, a fully human <FONT STYLE="white-space:nowrap">non-T</FONT> cell depleting monoclonal antibody that
targets OX40-ligand (OX40L), dosed either every four weeks (Q4W) or every 12 weeks (Q12W), met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to
placebo at Week 24 in patients aged 12 years and older with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis (AD). Amlitelimab was well-tolerated, with no new safety concerns
identified in this study. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:6%; margin-right:6%; font-size:10pt; font-family:Georgia" ALIGN="justify"><I>&#8220;These positive first phase&nbsp;3 results of amlitelimab reinforce
the potential of targeting the OX40-ligand to normalize the overactive immune system, without depleting T cells,&#8221; said </I><B>Houman Ashrafian</B><I>, Executive Vice President, Head of Research&nbsp;&amp; Development at Sanofi.
&#8220;Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing efficacy, with the potential of dosing only four times per year. These promising data seen in a
study population that more closely resembles today&#8217;s diverse patient landscape, including a substantial proportion previously treated with advanced therapies, support our ambition to deliver a differentiated medicine. We look forward to
sharing additional phase 3 results from the OCEANA clinical development program.&#8221; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The key endpoints were measured at Week 24 in
patients who received amlitelimab either Q4W or Q12W. For US and US reference countries, the primary endpoint was the proportion of patients with a validated investigator global assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) and
a reduction from baseline score of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2 points. For the EU, EU reference countries and Japan, the <FONT STYLE="white-space:nowrap">co-primary</FONT> endpoints comprised the proportion of patients
with vIGA-AD 0/1 and a reduction from baseline score of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>2 points along with the proportion of patients reaching a 75% or greater improvement in the eczema area and severity index total score <FONT
STYLE="white-space:nowrap">(EASI-75).</FONT> </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-LEFT:1px solid #000000; padding-left:8pt"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">Key endpoints</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="center"><FONT STYLE="font-family:Verdana; font-size:9pt"><I>Proportion of</I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Verdana" ALIGN="center"><FONT STYLE="font-family:Verdana; font-size:9pt"><I>patients</I></FONT></P></TD>
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<TD VALIGN="top" COLSPAN="5" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; "><FONT STYLE="white-space:nowrap">Non-responder</FONT> imputation*</FONT></TD>
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<TD VALIGN="top" COLSPAN="5" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-RIGHT:1px solid #000000"><FONT STYLE="font-family:Verdana; ">Treatment policy**</FONT></TD></TR>
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<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; ">Q4W</FONT></TD>
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<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; ">Placebo</FONT></TD>
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<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-RIGHT:1px solid #000000"><FONT STYLE="font-family:Verdana; ">Placebo</FONT></TD></TR>
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<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:10pt">
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-LEFT:1px solid #000000; padding-left:8pt"><FONT STYLE="font-family:Verdana; ">vIGA-AD 0/1</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">21.1%</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="center"><FONT STYLE="white-space:nowrap">p-value&nbsp;(p)</FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Verdana" ALIGN="center">&lt;0.01</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; ">22.5%</FONT><BR> <P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&#8199;&lt;0.01</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; ">9.2%</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; ">26.5%</FONT><BR> <P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&#8199;&lt;0.001</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;"><FONT STYLE="font-family:Verdana; ">29.1%</FONT><BR> <P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&#8199;&lt;0.001</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-RIGHT:1px solid #000000"><FONT STYLE="font-family:Verdana; ">10.5%</FONT></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; padding-left:8pt">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000">&nbsp;</TD>
<TD HEIGHT="2" COLSPAN="2" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:10pt">
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt"><FONT STYLE="font-family:Verdana; "><FONT STYLE="white-space:nowrap">EASI-75</FONT></FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-BOTTOM:1px solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">35.9%</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&lt;0.001</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-BOTTOM:1px solid #000000"><FONT STYLE="font-family:Verdana; ">39.1%</FONT><BR>
<P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&#8199;&lt;0.001</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-BOTTOM:1px solid #000000"><FONT STYLE="font-family:Verdana; ">19.1%</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-BOTTOM:1px solid #000000"><FONT STYLE="font-family:Verdana; ">46.0%</FONT><BR>
<P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&#8199;&lt;0.001</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-BOTTOM:1px solid #000000"><FONT STYLE="font-family:Verdana; ">50.3%</FONT><BR>
<P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Verdana" ALIGN="center">p&#8199;&lt;0.001</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="padding-bottom:2pt ;BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000"><FONT STYLE="font-family:Verdana; ">27.6%</FONT></TD></TR>
</TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana" ALIGN="justify"><I>* <FONT STYLE="white-space:nowrap">Non-responder</FONT> imputation: includes patients with rescue/prohibited
medication use prior to Week 24 and missing data. </I></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Verdana" ALIGN="justify"><I>** Treatment policy: includes data for patients with rescue medication use prior to Week 24. Note:
In both analyses <FONT STYLE="white-space:nowrap">non-responder</FONT> imputation for patients with prohibited medication use and missing data. </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">In both treatment arms, a progressive increase in efficacy without plateau was observed during the treatment period: </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="font-size:0pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt" ALIGN="center">


<IMG SRC="g32034g05g05.jpg" ALT="LOGO" STYLE="width:8.56319in;height:5.74792in;">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">(Treatment effects at Week 24 are modeled and do not reconcile with the table). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The study&#8217;s key secondary endpoints were also achieved across both dosing arms at Week 24, including the proportion of patients who achieved a
vIGA-AD 0/1 with only barely perceptible erythema and a reduction from baseline of <FONT STYLE="font-family:Times New Roman">&#8805;</FONT><FONT STYLE="white-space:nowrap">2-points,</FONT> and the proportion of patients who achieved a <FONT
STYLE="font-family:Times New Roman">&#8805;</FONT><FONT STYLE="white-space:nowrap">4-point</FONT> reduction in peak pruritus-numerical rating scale <FONT STYLE="white-space:nowrap">(PP-NRS)</FONT> from baseline in patients with a baseline <FONT
STYLE="white-space:nowrap">PP-NRS</FONT> <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>4. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The most common treatment emergent adverse
events (TEAEs) in COAST 1 (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>5% in any dose arm) were AD, nasopharyngitis and upper respiratory tract infection. All were more common in the placebo arm compared to amlitelimab-treated arms.
Injection site reactions were numerically higher in amlitelimab arms (pooled amlitelimab 2.2%, placebo 0.7%). All were mild, patients recovered, and study medication was continued in all cases. Rates of pyrexia (1.1% in pooled amlitelimab arms vs.
0.7% in placebo arm) and chills (0.4% in pooled amlitelimab arms vs. 0% in placebo arm) were low. Overall, rates of treatment-emergent adverse events (TEAEs), serious adverse events, and TEAEs resulting in treatment discontinuation were similar in
the placebo arm and pooled amlitelimab arms. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Full results will be submitted for presentation at a forthcoming medical meeting. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The OCEANA clinical development program of amlitelimab in AD, which includes COAST 1 and four other phase 3 studies (SHORE, COAST 2, AQUA, and
ESTUARY) is anticipated to read out through 2026 and comprises the foundation for potential global regulatory submissions. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Amlitelimab is
currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About the COAST 1 study </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">COAST 1 was a randomized, double-blind, placebo-controlled, parallel-group, <FONT STYLE="white-space:nowrap">3-arm,</FONT> global, multicenter phase 3
study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in 601 adults and adolescents aged 12 years and older with
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> AD. Key objectives included measuring the efficacy and safety of amlitelimab compared to placebo at Week 24. In the study, amlitelimab was
administered at a dose of 250 mg (125 mg for those with body weight &lt;40 kg) on either a Q4W or Q12W schedule following a loading dose of 500 mg (250 mg for those with body weight &lt;40&nbsp;kg). The study included sites in 15 countries across
North America, Latin America, Europe, Asia-Pacific and the Middle East, reflecting a diverse study population. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About amlitelimab
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Amlitelimab (SAR445229, KY1005) is a fully human, <FONT STYLE="white-space:nowrap">non-T</FONT> cell depleting monoclonal antibody that
blocks OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab aims to normalize the overactive immune system, without depleting T cells. It has the potential to be a first- or <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">best-in-class</FONT></FONT> treatment for a range of immune-mediated diseases and inflammatory disorders, including the anchor indication of
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> AD, and potentially in <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> asthma, systemic sclerosis,
celiac disease, and alopecia areata. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sanofi is an R&amp;D driven, <FONT STYLE="white-space:nowrap">AI-powered</FONT> biopharma company committed to improving people&#8217;s lives and
delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more.&nbsp;Our
team is guided by one purpose: we chase the miracles of science to improve people&#8217;s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare,
environmental, and societal challenges of our time. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Sandrine Guendoul</B> |
+33 6 25 09 14 25 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;o Le Bourhis</B> | +33 6 75 06 43 81 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Victor
Rouault</B> | +33 6 70 93 71 40 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Timothy Gilbert</B> | +1 516 521 2929 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;a Ubaldi</B><B></B>&nbsp;| +33 6 30 19 66 46 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT
 COLOR="#7900e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thomas Kudsk Larsen</B> | +44 7545 513 693 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Aliz&eacute;
Kaisserian</B> | +33 6 47 04 12 11 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Felix Lauscher</B> | +1 908 612 7239 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Keita Browne</B> | +1 781 249 1766 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>keita.browne@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nathalie
Pham</B> | +33 7 85 93 30 17 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Tarik Elgoutni</B> | +1 617 710 3587 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Yun
Li</B>&nbsp;| +33 6 84 00 90 72 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #b7b7b7">&nbsp;</DIV>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><I>This press release
contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words &#8220;expects&#8221;, &#8220;anticipates&#8221;, &#8220;believes&#8221;, &#8220;intends&#8221;, &#8220;estimates&#8221;, &#8220;plans&#8221; and similar expressions. Although
Sanofi&#8217;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding
whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of
such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi&#8217;s ability to benefit from external growth opportunities,
to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing
interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises </I></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><I>
may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.
The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under &#8220;Risk Factors&#8221; and &#8220;Cautionary Statement Regarding
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update or revise any forward-looking information or statements. </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><I>All trademarks mentioned in this press release are the property of the
Sanofi group. </I></P>
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<TD VALIGN="top" ALIGN="right">4/4</TD></TR></TABLE>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
