<SEC-DOCUMENT>0001193125-24-072508.txt : 20240320
<SEC-HEADER>0001193125-24-072508.hdr.sgml : 20240320
<ACCEPTANCE-DATETIME>20240320140726
ACCESSION NUMBER:		0001193125-24-072508
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20240320
FILED AS OF DATE:		20240320
DATE AS OF CHANGE:		20240320

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				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:		24767353

	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>d765008d6k.htm
<DESCRIPTION>6-K
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<TITLE>6-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <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>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></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>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></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 March 2024 </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> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></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>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></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> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></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;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> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In March 2024, 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"> <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">Exhibit&nbsp;No.</P></TD>
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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: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>
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<TD VALIGN="top"><A HREF="d765008dex991.htm">Press Release dated March&nbsp;
11, 2024: New Phase 2b results for amlitelimab support potential for <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> maintenance of response in 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: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:6pt; 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">Dated: March&nbsp;20, 2024</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">SANOFI</TD></TR>
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<TD VALIGN="bottom">By</TD>
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<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>
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<TD VALIGN="bottom">Name: Alexandra Roger</TD></TR>
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<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:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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<TYPE>EX-99.1
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<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: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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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#7900e6"><I>New Phase 2b results for amlitelimab support potential for <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">best-in-class</FONT></FONT> maintenance of response in atopic dermatitis </I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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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">Late-breaking data at AAD show sustained <FONT STYLE="white-space:nowrap">off-drug</FONT> improvements of AD signs and
symptoms with amlitelimab for 28 weeks </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:arial; font-size:10pt">The safety profile for patients dosed to 52 weeks was consistent with amlitelimab 24 weeks data showing it to be
well-tolerated with no new safety concerns identified </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:arial; font-size:10pt">Durability of response supports quarterly dosing currently being investigated in Phase 3 pivotal program
</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:arial; font-size:10pt">Sustained biomarker reduction suggests the modulation of immune response and durable disease control via the blockade of
OX40L, a <FONT STYLE="white-space:nowrap">non-T</FONT> cell depleting mechanism </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:arial; font-size:10pt">Amlitelimab is one of 12 potential blockbusters in Sanofi&#146;s leading immunology pipeline, results for a Phase 2 asthma
study expected in H2 2024 and three additional Phase 2 study starts expected by <FONT STYLE="white-space:nowrap">year-end</FONT> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Paris,
March</B><B></B><B>&nbsp;11, 2024</B>. Positive results from Part 2 of the investigational amlitelimab Phase 2b study <FONT STYLE="white-space:nowrap">STREAM-AD</FONT> showed sustained improvement of signs and symptoms for 28 weeks in adults with
moderate to severe AD who previously responded to amlitelimab and continued treatment. High responder rates were also observed in participants who were taken off amlitelimab. The safety profile was consistent with Part 1 of the study with
amlitelimab being well-tolerated and no new safety concerns identified. These results were presented as part of a late-breaking session at the American Academy of Dermatology (AAD) 2024 Conference in San Diego and support the quarterly (every <FONT
STYLE="white-space:nowrap">12-week)</FONT> dosing of amlitelimab 250 mg with 500 mg loading dose (LD) now being investigated in a larger Phase 3 clinical program (OCEANA). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7900e6"><B><I>Professor Stephan Weidinger, M.D, Ph.D</I></B></FONT></P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; margin-left:4%; font-size:9pt; font-family:arial">Director, Professor, Chair of Department of Dermatology and Allergy, University Hospital Schleswig-Holstein</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:9pt; font-family:arial"><I>&#147;Despite available treatment options, not all patients with
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis respond sufficiently to these treatments, and many continue to suffer from skin lesions and symptoms such as persistent itch, which
can have a high impact on their <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">day-to-day</FONT></FONT> lives. Results from this part of the study indicate amlitelimab&#146;s potential for durable
<FONT STYLE="white-space:nowrap">off-drug</FONT> efficacy which supports the evaluation of a less frequent every <FONT STYLE="white-space:nowrap">12-week</FONT> dosing. This could offer an important benefit in the treatment of AD patients.&#148;
</I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In the second part of the dose-ranging <FONT STYLE="white-space:nowrap">STREAM-AD</FONT> study, responders to amlitelimab who achieved a 75% improvement in
Eczema Area and Severity Index <FONT STYLE="white-space:nowrap">(EASI-75)</FONT> score and/or Investigator Global Assessment (IGA) score of 0 or 1 during the <FONT STYLE="white-space:nowrap">24-week</FONT> treatment period (Part 1) were <FONT
STYLE="white-space:nowrap">re-randomized</FONT> to explore the maintenance of clinical response over an additional <FONT STYLE="white-space:nowrap">28-week</FONT> period with continued amlitelimab treatment or amlitelimab withdrawal. Across all dose
arms, patients who continued amlitelimab treatment maintained high <FONT STYLE="white-space:nowrap">EASI-75</FONT> and/or IGA 0/1, IGA 0/1, and <FONT STYLE="white-space:nowrap">EASI-75</FONT> responder rates through 28 weeks. High responder rates
were also demonstrated among patients who were taken off treatment. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">In 69.2% of patients with continued treatment with amlitelimab 250 mg Q4W with 500 mg loading
dose (LD) vs 58.8% of patients withdrawn from treatment IGA 0/1 and/or <FONT STYLE="white-space:nowrap">EASI-75</FONT> response was maintained. </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:10pt; font-family:arial">An analysis including pooled dose-arms showed that IGA 0/1 response was maintained in 71.9% of patients with continued
treatment vs 57% of patients withdrawn from treatment. In this analysis, <FONT STYLE="white-space:nowrap">EASI-75</FONT> response was maintained in 69% of patients with continued treatment vs. 61.6% of patients withdrawn from treatment. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><FONT STYLE="white-space:nowrap">AD-related</FONT> biomarkers remained reduced at Week 52 in both amlitelimab withdrawn and continuing groups, despite amlitelimab
reaching negligible levels in serum. Reduction of TARC, eosinophils, and <FONT STYLE="white-space:nowrap">IL-22</FONT> observed at Week 24 was maintained during withdrawal as well as in patients continuing treatment to Week 52. These biomarker data
suggest the modulation of inflammatory T cells via the blockade of OX40L and durable control of AD after amlitelimab withdrawal. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7900e6"><B><I>Naimish Patel, M.D. </I></B></FONT></P> <P STYLE="margin-top:2pt; margin-bottom:0pt; margin-left:4%; font-size:9pt; font-family:arial">Head of Global Development, Immunology and Inflammation, Sanofi </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:9pt; font-family:arial"><I>&#147;It&#146;s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the
reason why we selected an every <FONT STYLE="white-space:nowrap">12-week</FONT> dosing regimen in the AD pivotal program. AD is a chronic, lifelong disease, which means we must strive to provide a portfolio of solutions to patients that matches
their individual needs and puts as little burden on them as possible. We are also moving with speed in our exploration of amlitelimab&#146;s potential in 5 other chronic inflammatory diseases, including asthma, hidradenitis suppurativa, scleroderma,
celiac disease, and alopecia. In addition, we are exploring 6 other innovative MOAs in 8 dermatologic indications underscoring our commitment to patients with high unmet medical needs.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The aggregated safety profile of amlitelimab in Part 2 of this study was consistent with that of Part 1, with amlitelimab being well-tolerated, and no new safety
concerns were identified during the <FONT STYLE="white-space:nowrap">28-week</FONT> maintenance/withdrawal period. Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab <FONT
STYLE="white-space:nowrap">withdrawal-arm</FONT> and 66.7% for placebo. TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab
continuation, 5.5% amlitelimab withdrawal, 20% placebo). No adverse events such as fever or chills, oral ulcers or conjunctivitis were observed across doses.</P>
<P STYLE="margin-top:12pt; 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 <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
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis (Phase 3), asthma (Phase 2), hidradenitis suppurativa (Phase 2), scleroderma, celiac disease, and alopecia (Phase 2 studies to be
initiated in 2024). By targeting OX40-Ligand, amlitelimab aims to restore balance between <FONT STYLE="white-space:nowrap">pro-inflammatory</FONT> and regulatory T cells. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">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:12pt; font-family:Times New Roman"><FONT COLOR="#7900e6"><I>About <FONT STYLE="white-space:nowrap">STREAM-AD</FONT> </I></FONT></P>
<P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><FONT STYLE="white-space:nowrap">STREAM-AD,</FONT> a Phase 2b study, is a randomized double-blind, placebo-controlled study, evaluating amlitelimab in adult patients
with <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">moderate-to-severe</FONT></FONT> atopic dermatitis whose disease was inadequately controlled with topical therapies or where such therapies were not advisable. This study is
designed with two parts and is double-blind through both. Part 1 was a <FONT STYLE="white-space:nowrap">24-week</FONT> treatment period, and Part 2 was a <FONT STYLE="white-space:nowrap">28-week</FONT> maintenance/withdrawal period, which included
clinical responders from Part 1, defined as participants achieving <FONT STYLE="white-space:nowrap">EASI-75</FONT> and/or IGA 0/1 at Week 24. Of 390 participants enrolled in Part 1, 190 entered Part 2. Participants were <FONT
STYLE="white-space:nowrap">re-randomized</FONT> 3:1 to withdraw treatment or continue <FONT STYLE="white-space:nowrap">pre-Week</FONT> 24 subcutaneous Q4W dose (250mg with 500mg loading dose (LD), 250mg, 125mg, 62.5mg, placebo responders continuing
placebo), and were followed to Week 52 for efficacy. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:arial">The study enrolled 390 people in Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain,
Taiwan, the United Kingdom and the United States. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7900e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:2pt; 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 some 100
countries, 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:0pt; 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"><FONT COLOR="#7900e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Sandrine
Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Sally Bain</B><B></B>&nbsp;|&nbsp;+ 1 617 834 6026 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>sally.bain@sanofi.com</U></FONT><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Victor Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7900e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:2pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Eva Schaefer-Jansen</B><B></B>&nbsp;|&nbsp;+ 33 7 86 80 56 39 |&nbsp;<FONT
STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Arnaud
Del&eacute;pine</B><B></B>&nbsp;|&nbsp;+ 33 6 73 69 36 93 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>arnaud.delepine@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Corentine Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>corentine.driancourt@sanofi.com</U></FONT><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><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>felix.lauscher@sanofi.com</U></FONT><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 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>tarik.elqoutni@sanofi.com</U></FONT><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><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7900e6"><U>natalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #cccccc">&nbsp;</P> <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, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or
other 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 <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2023. 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>
