<SEC-DOCUMENT>0001193125-25-082251.txt : 20250416
<SEC-HEADER>0001193125-25-082251.hdr.sgml : 20250416
<ACCEPTANCE-DATETIME>20250416091813
ACCESSION NUMBER:		0001193125-25-082251
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20250416
FILED AS OF DATE:		20250416
DATE AS OF CHANGE:		20250416

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:		25841373

	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>d941050d6k.htm
<DESCRIPTION>6-K
<TEXT>
<HTML><HEAD>
<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
<DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;
</DIV><DIV STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</DIV> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; 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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT STYLE="white-space:nowrap">6-K</FONT> </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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; 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:12pt; 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:12pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>For the month of April 2025 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of
registrant&#146;s name into English) </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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>46, avenue de la Grande Arm&eacute;e, 75017 Paris, FRANCE </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices) </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:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; 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:10pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F&#8194;&#9746;&#8195;&#8195;&#8195;&#8195;Form</FONT> <FONT
STYLE="white-space:nowrap">40-F&#8194;&#9744;</FONT> </P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In April 2025, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated
herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="border-bottom:1.00pt solid #000000">Exhibit<br>No.</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; 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="d941050dex991.htm">Press Release dated April&nbsp;15, 2025: Sanofi&#146;s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD </A></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:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; 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="bottom" COLSPAN="3">Dated: April&nbsp;16, 2025</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">SANOFI</TD></TR>
<TR STYLE="font-size:1pt">
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<TD HEIGHT="16" COLSPAN="2"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Alexandra Roger</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Head of Legal Corporate&nbsp;&amp; Finance</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:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d941050dex991.htm
<DESCRIPTION>EX-99.1
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<TITLE>EX-99.1</TITLE>
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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:arial" 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-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:Times New Roman"><I><FONT STYLE="font-family:Times New Roman" COLOR="#7a00e6">Sanofi&#146;s respiratory pipeline advances with new data in
asthma and plans for new clinical studies in COPD</FONT> </I></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<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:arial; font-size:10pt">New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma </P></TD></TR></TABLE>
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<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:arial; font-size:10pt">Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma </P></TD></TR></TABLE>
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<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:arial; font-size:10pt">Itepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025
and phase 2 readout in bronchiectasis in 2026 </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Paris, April&nbsp;15, 2025. </B>Sanofi today shared new progress from its mid- to late-stage
respiratory pipeline, including preliminary phase 2 results for amlitelimab in adults with moderate-to-severe asthma. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Amlitelimab: clinically meaningful
efficacy in asthma </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Preliminary results from the TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) show that the primary endpoint of annualized
exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium dose. However, the study demonstrates amlitelimab&#146;s compelling efficacy in heterogeneous inflammatory asthma, potentially
representing a breakthrough for this underserved patient population if observed in later studies. Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a
numerically greater reduction in exacerbations at the high dose at week 60. The study also demonstrated nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control. Notably, in a patient
sub-group defined by biomarkers (eosinophils <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>300 cells/ml and elevated neutrophils), amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a
reduction of more than 70%), lung function and asthma control at week 60. These results demonstrate that amlitelimab has potential to improve key disease outcomes in asthma patients with continued unmet need. The phase 3 program is currently being
planned. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#8195;&#8195;&#8195;</P></TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><FONT COLOR="#7a00e6">Houman Ashrafian</FONT></I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Executive Vice President, Head of Research&nbsp;&amp; Development</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;We are pleased by the significant progress we have made with our pipeline across respiratory indications. In asthma, amlitelimab shows
potential as an effective, long-acting medicine, including in patients with moderate-to-severe heterogenous inflammation. If the preliminary effect we have seen is confirmed in phase 3 studies, amlitelimab could become a differentiated treatment
option in asthma. These data validate our strategy to advance innovative science and provide new solutions for patients with challenging-to-treat respiratory diseases.&#148;</I></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">&#8195;&#8195;</P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Amlitelimab has a unique non-depleting mechanism of action targeting OX40-Ligand with the potential to durably restore
immune balance, with a sustained effect and infrequent dosing. In the TIDE-Asthma study, patients were treated every four weeks for the first 24 weeks and every 12 weeks for the remaining 36 weeks. The durable efficacy shown by amlitelimab through
60 weeks of treatment supports a quarterly maintenance dosing schedule. The safety profile was consistent with previous studies across indications, with no new safety signals identified throughout the 60-week treatment period. The incidence of
treatment emergent adverse effects (TEAEs) or treatment discontinuation was similar between the amlitelimab and the placebo groups. The most frequent TEAEs (<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>&nbsp;5% in any arm) more common (<FONT
STYLE="font-family:Times New Roman">&#8805;</FONT>&nbsp;1%) than placebo were COVID-19, bronchitis, acute sinusitis and headache. All were mild-to-moderate in severity and all non-serious. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Full and final results will be presented at a forthcoming medical meeting. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Lunsekimig: potential for broader use in chronic obstructive pulmonary disease (COPD) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Lunsekimig is being explored in a broad population of asthma patients, regardless of their inflammation and severity status. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The readout of the AIRCULES phase 2 study (clinical study identifier: NCT06102005) in moderate to severe asthma is anticipated in 2026 while the AIRLYMPUS phase 2 study
(clinical study identifier: NCT06676319) in high-risk asthma was initiated in Q4 2024. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The readout of the phase 2 study in patients with chronic rhinosinusitis
with nasal polyps (clinical study identifier: NCT06454240) is anticipated in 2026. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">A phase 2/3 study in COPD is anticipated to begin in 2025. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Itepekimab: expanding clinical studies beyond COPD into chronic rhinosinusitis </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In partnership with Regeneron, two phase 3 studies in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), CEREN 1 (clinical study identifier: NCT06834347)
and CEREN 2 (clinical study identifier: NCT06834360) and one phase 2 study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) (clinical study identifier: NCT06691113) were initiated in Q1 2025. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Itepekimab is currently being explored in patients with COPD in two phase 3 studies AERIFY-1 (clinical study identifier: NCT04701983) and AERIFY-2 (clinical study
identifier: NCT04751487) with the readout anticipated in H2 2025, and in one phase 2 study, AERIFY-3 (clinical study identifier: NCT05326412), with the readout anticipated in H2 2025. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Finally, itepekimab is being explored in a phase 2 study (clinical study identifier: NCT06280391) in bronchiectasis, with the readout anticipated in 2026. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About amlitelimab </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Amlitelimab is a fully human non-T cell depleting
monoclonal antibody that blocks OX40-Ligand, a key immune regulator, and has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis
(phase 3), asthma (phase 2), hidradenitis suppurativa (phase 2), systemic sclerosis (phase 2), celiac disease (phase 2), and alopecia (phase 2). By targeting OX40-Ligand, amlitelimab aims to preserve the balance between pro-inflammatory and
regulatory T cells. Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About TIDE-Asthma </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The phase 2 TIDE-Asthma study is a randomized,
double-blind, placebo-controlled, dose-ranging study, evaluating amlitelimab as an add-on therapy in 437 adults with moderate-to-severe asthma. Participants were on standard-of-care medicines with medium-to-high doses of inhaled corticosteroids and
up to two other controllers. The study included three dose levels of amlitelimab, each with a loading dose administered every four weeks for the first 24 weeks, followed by once every 12 weeks until week 60, with participants randomized 2:1:2:2 to
receive one of the three active doses or placebo. The primary endpoint was the annualized rate of severe asthma exacerbations. Key secondary endpoints include lung function (pre-BD FEV1) and asthma control (ACQ-5). </P>
</DIV></Center>


<p style="margin-top:1em; margin-bottom:0em; page-break-before:always"> </p>
<HR SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About lunsekimig </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Lunsekimig is a novel Nanobody VHH<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> that combines targeting of IL13, a downstream cytokine causing tissue organ
damage in respiratory diseases and TSLP, an upstream initiator of inflammation. Pre-clinical research suggests that the combination of these targets simultaneously can potentially lead to additive and synergistic benefits in immune-mediated diseases
such as asthma. Lunsekimig is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>About
itepekimab </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In partnership with Regeneron, Sanofi is exploring itepekimab, a fully human monoclonal antibody that binds to and inhibits IL33, an initiator and
amplifier of broad inflammation in respiratory diseases. Itepekimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I><FONT STYLE="font-family:Times New Roman" COLOR="#7a00e6">About Sanofi</FONT> </I></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives. Our team, across the world, is
dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting
sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:arial">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><FONT STYLE="font-family:Times New Roman" COLOR="#7a00e6">Media Relations</FONT> </I></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Sandrine Guendoul</B> | +33 6 25 09 14 25 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>sandrine.guendoul@sanofi.com</B> </FONT></U><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Evan Berland</B> | +1 215 432 0234 |
<U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>evan.berland@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Nicolas Obrist</B> | +33 6 77
21 27 55 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>nicolas.obrist@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>L&eacute;o Le
Bourhis</B> | +33 6 75 06 43 81 |<B> <U><FONT STYLE="font-family:arial" COLOR="#7a00e6">leo.lebourhis@sanofi.com</FONT></U></B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Victor Rouault</B> | +33 6 70 93
71 40 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>victor.rouault@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Timothy Gilbert</B>
| +1 516 521 2929 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>timothy.gilbert@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I><FONT STYLE="font-family:Times New Roman" COLOR="#7a00e6">Investor Relations</FONT> </I></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thomas Kudsk Larsen</B> |+44 7545 513 693 |
<U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>thomas.larsen@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Aliz&eacute; Kaisserian</B> |
+33 6 47 04 12 11 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>alize.kaisserian@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Felix
Lauscher</B> | +1 908 612 7239 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>felix.lauscher@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Keita Browne</B> | +1 781 249 1766 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>keita.browne@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial">
</FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Nathalie Pham</B> | +33 7 85 93 30 17 | <U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>nathalie.pham@sanofi.com</B></FONT></U><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Tarik Elgoutni</B> | +1 617 710 3587 |<B>
<U><FONT STYLE="font-family:arial" COLOR="#7a00e6">tarik.elgoutni@sanofi.com</FONT></U></B> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 | <U><FONT
STYLE="font-family:arial" COLOR="#7a00e6"><B>thibaud.chatelet@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Yun Li</B> | +33 6 84 00 90 72 |
<U><FONT STYLE="font-family:arial" COLOR="#7a00e6"><B>yun.li3@sanofi.com</B></FONT></U><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</DIV>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:arial"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:arial">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 &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;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&#146;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,&nbsp;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 AMF made by Sanofi, including those listed under &#147;Risk
Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form 20-F for the year ended December&nbsp;31, 2024. Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
