<SEC-DOCUMENT>0001193125-26-260613.txt : 20260608
<SEC-HEADER>0001193125-26-260613.hdr.sgml : 20260608
<ACCEPTANCE-DATETIME>20260608060642
ACCESSION NUMBER:		0001193125-26-260613
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20260608
FILED AS OF DATE:		20260608
DATE AS OF CHANGE:		20260608

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:		261070935

	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>
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<TYPE>6-K
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<FILENAME>d123884d6k.htm
<DESCRIPTION>6-K
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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:16pt;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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:24pt; 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:16pt;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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of June 2026 </P>
<P STYLE="margin-top:12pt; 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:24pt; 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:12pt; 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:36pt; 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:Verdana" 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 May 2026, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein
by reference. </P> <P STYLE="margin-top:42pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:33pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" 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;</TD>
<TD VALIGN="top"><A HREF="d123884dex991.htm">Press Release dated May&nbsp;28, 2026: Sanofi&#8217;s venglustat accepted for priority review in the US to treat type 3 Gaucher disease. </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:Verdana" 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:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: June&nbsp;8, 2026</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:9pt">By</P></TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman" ALIGN="justify">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name: Alexandra Roger</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title: Head of Legal Corporate&nbsp;&amp; Finance</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:Verdana" ALIGN="center">3 </P>

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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:18pt; margin-bottom:0pt; font-size:18pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi&#8217;s venglustat accepted for priority review in the US to treat type 3 Gaucher
disease </I></FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, May</B><B></B><B>&nbsp;28, 2026</B>. The US Food and Drug Administration (FDA) has granted priority review to the
new drug application (NDA) for venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">If approved, venglustat would become the first treatment available in the US to address the progressive neurological manifestations associated with
GD3 and expand Sanofi&#8217;s portfolio of treatment options for patients living with lysosomal storage diseases. The target action date for the FDA decision is November&nbsp;25, 2026. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Gaucher disease is marked by the abnormal buildup of <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">sugar-and-fat</FONT></FONT>
molecules called glycosphingolipids (GSL) in the spleen, liver, bone marrow, and lungs. In patients with GD3, these molecules also accumulate in the central nervous system (CNS) where they drive neuroinflammation, which can result in neurological
manifestations, including cognitive deficits and difficulty in coordination and balance (ataxia), in addition to the disease&#8217;s systemic effects. There are currently no approved targeted treatments that specifically address the neurological
symptoms of GD3. By crossing the blood brain barrier, venglustat has the potential to treat neurological manifestations of GD3. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The NDA is
supported by positive data from the LEAP2MONO phase 3 study (clinical study identifier: <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7a00e6"><U>NCT05222906</U></FONT><FONT STYLE="font-family:Verdana">), evaluating the efficacy and
safety of venglustat in adults and pediatric patients, with neurological manifestations of GD3, who previously achieved stabilization of systemic manifestations with enzyme replacement therapy (ERT). In </FONT><FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7a00e6"><U>results</U> </FONT><FONT STYLE="font-family:Verdana">shared at the WORLDSymposium<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> earlier this year, venglustat met both of the
study&#8217;s primary endpoints and three out of four key secondary endpoints. In the study, venglustat was well tolerated overall with no new safety signals compared with previous studies. The most commonly reported adverse events were headache
(14.3% in the venglustat arm versus 18.2% in the ERT arm), nausea (14.3% versus 4.5%), spleen enlargement (14.3% versus 0), and diarrhea (14.3% versus 0). </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Venglustat previously earned breakthrough therapy designation and fast-track designation from the FDA for its potential in GD3, as well as orphan
designation for GD3 in the US, EU, and Japan. Venglustat is also currently under regulatory review for GD3 in the EU. Sanofi will pursue additional global regulatory filings for venglustat in GD3 in 2026. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The safety and efficacy of&nbsp;venglustat for GD3 have not been evaluated by any regulatory authority. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Priority review is given to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the
treatment, diagnosis, or prevention of serious conditions. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7a00e6"><I>About LEAP2MONO </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">The LEAP2MONO phase 3 study was a double-blind, double-dummy, active-comparator, <FONT STYLE="white-space:nowrap">two-arm</FONT> study that evaluated the efficacy and
safety of once daily oral venglustat versus intravenous ERT every two weeks in adults and pediatric patients aged 12 and older with GD3. Forty-three patients were randomized [1:1] to receive venglustat and placebo infusion or ERT and placebo tablet.
Patients must have been treated with ERT for at least three years and achieved therapeutic goals for systemic disease manifestations. The primary endpoints for the study were change in scale for assessment and rating of ataxia (SARA) modified total
score and change in repeatable battery for the assessment of neuropsychological status (RBANS) total scale index score for patients receiving venglustat versus those receiving ERT from baseline to week 52. Systemic key secondary endpoints include
percent change in spleen volume, liver volume and platelet count and change in hemoglobin levels. Biomarker key secondary endpoints include percent change in cerebrospinal fluid and plasma GL1 and <FONT STYLE="white-space:nowrap">lyso-GL1.</FONT>
The LEAP2MONO study is ongoing and results from its open-label phase will be presented in the future when available. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7a00e6"><I>About venglustat </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Venglustat is a novel, investigational oral GCSi, designed to cross the blood brain barrier (i.e., brain-penetrant), that has the potential to slow the
progression of certain diseases by inhibiting abnormal GSL accumulation and its pathophysiology consequences. GSLs are cellular building blocks whose abnormal accumulation is implicated in several rare diseases leading to both cell dysfunction and
disease progression. Venglustat was previously granted orphan designation in the EU, the US, and Japan for its potential treatment of both GD3 and Fabry disease. It also received fast-track designation by the FDA for its potential use in GD3 and
Fabry disease. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7a00e6"><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. 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. 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="#7a00e6"><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="#7a00e6"><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="#7a00e6"><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="#7a00e6"><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> | +1 617 356 4751 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7a00e6"><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="#7a00e6"><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>| +33 6 30 19 66 46 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7a00e6"><U>lea.ubaldi@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>Ekaterina Pesheva </B>| +1 410 926 6780 |&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7a00e6"><U>ekaterina.pesheva@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="#7a00e6"><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="#7a00e6"><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="#7a00e6"><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>Keita
Browne</B> | +1 781 249 1766 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7a00e6"><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="#7a00e6"><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>Nina Goworek </B>| +1 908 569 7086 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7a00e6"><U>nina.goworek@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="#7a00e6"><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> | +33 6 84 00 90 72 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7a00e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana">
</FONT></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B><I>Sanofi forward-looking statements </I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify">This press release contains forward-looking statements within the meaning of applicable securities laws, including 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 events and economic performance. Words such as &#8220;expect,&#8221; &#8220;anticipate,&#8221;
&#8220;believe,&#8221; &#8220;intend,&#8221; &#8220;estimate,&#8221; &#8220;plan,&#8221; &#8220;can,&#8221; &#8220;contemplate,&#8221; &#8220;could,&#8221; &#8220;is designed to,&#8221; &#8220;may,&#8221; &#8220;might,&#8221;
&#8220;potential,&#8221; &#8220;objective,&#8221; &#8220;attempt,&#8221; &#8220;target,&#8221; &#8220;project,&#8221; &#8220;strategy,&#8221; &#8220;strive,&#8221; &#8220;desire,&#8221; &#8220;predict,&#8221; &#8220;forecast,&#8221;
&#8220;ambition,&#8221; &#8220;guideline,&#8221; &#8220;seek,&#8221; &#8220;should,&#8221; &#8220;will,&#8221; &#8220;goal,&#8221; or the negative of these, and similar expressions are intended to identify forward-looking statements. 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 U.S Food and Drug
Administration or the European Medicines Agency, 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; unexpected regulatory actions or delays, or government regulation generally;
authorities&#8217; decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including &#8220;most favored nation&#8221; pricing for State Medicaid programs; 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, including future clinical data and analysis of
existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; 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 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 French Markets Authority (AMF) made by Sanofi, including those listed under &#8220;Risk Factors&#8221; and &#8220;Cautionary Statement Regarding Forward-Looking Statements&#8221; in
Sanofi&#8217;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2025, or contained in our periodic reports on Form <FONT STYLE="white-space:nowrap">6-K.</FONT> Other than as required by
applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties, and assumptions, you should not place undue reliance on any forward-looking
statements contained herein. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana">All trademarks mentioned in this press release are the property of the Sanofi group. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt ; margin-bottom:0pt" ALIGN="justify">


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