<SEC-DOCUMENT>0001193125-25-249279.txt : 20251024
<SEC-HEADER>0001193125-25-249279.hdr.sgml : 20251024
<ACCEPTANCE-DATETIME>20251024060304
ACCESSION NUMBER:		0001193125-25-249279
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		13
CONFORMED PERIOD OF REPORT:	20251024
FILED AS OF DATE:		20251024
DATE AS OF CHANGE:		20251024

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:		251414189

	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>d21546d6k.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="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:20pt;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:20pt; 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:20pt;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:20pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of October 2025 </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:20pt; 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: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 October 2025, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2, 99.3, 99.4 and
99.5 which are incorporated herein by reference. </P> <P STYLE="margin-top:24pt; 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> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00px solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; ">Exhibit&nbsp;No.</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00px 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="d21546dex991.htm">Press Release dated October&nbsp;
17, 2025: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">graft-vs-host</FONT></FONT> disease </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d21546dex992.htm">Press Release dated October&nbsp;17, 2025: Sanofi&#8217;s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.3</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d21546dex993.htm">Press Release dated October&nbsp;20, 2025: Sanofi&#8217;s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.4</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d21546dex994.htm">Press Release dated October&nbsp;
20, 2025: ESMO: AlphaMedixTM phase 2 data support <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors </A></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:9pt">
<TD VALIGN="top" NOWRAP>Exhibit&nbsp;99.5</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d21546dex995.htm">Press Release dated October&nbsp;
20, 2025: Sanofi&#8217;s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner&#8217;s National Priority Voucher pilot program </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: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:6%; 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: October&nbsp;24, 2025</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
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<TD VALIGN="top" NOWRAP ALIGN="center">SANOFI</TD></TR>
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<TD VALIGN="top" NOWRAP>By&#8195;&#8195;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD></TR>
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<TD VALIGN="top" NOWRAP> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Name: Alexandra Roger</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:Times New Roman">Title: Head of Legal
Corporate&nbsp;&amp; Finance</P></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">3 </P>

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<TYPE>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="#7a00e6"><I>Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">graft-vs-host</FONT></FONT> disease </I></FONT></P> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:10pt; font-family:arial"><B>Paris, October</B><B></B><B>&nbsp;17, 2025. </B>The
European Medicines Agency&#8217;s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the marketing authorisation application for Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients
with chronic graft-versus-host disease (cGVHD). Sanofi will seek a <FONT STYLE="white-space:nowrap">re-examination</FONT> of the CHMP opinion. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">cGVHD is a
life-threatening complication that devastates the lives of up to 50% of patients who undergo a stem cell transplant. cGVHD is considered one of the main causes of morbidity and late <FONT STYLE="white-space:nowrap">non-relapse</FONT> mortality after
stem cell transplant. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:arial">&#8220;<I>We are disappointed by the negative CHMP opinion for Rezurock in the EU and remain committed to serving the
transplant patient community</I>,&#8221;<I> </I>said <B>Olivier Charmeil</B>,<B><I> </I></B>Executive Vice President, General Medicines at Sanofi. &#8220;<I>Sanofi is confident in the body of clinical and real-world evidence that underscores
Rezurock&#8217;s consistent efficacy and well-established safety profile for treating third-line chronic graft-versus-host disease. We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to
patients in the EU who are waiting.</I>&#8221; </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Rezurock is supported by safety and efficacy results from several clinical studies and real-world evidence. This
includes the randomized, multicenter ROCKstar phase 2 study, that demonstrates consistent efficacy and tolerability for patients living with cGVHD after stem cell transplant as well as durable clinical responses over a period of three years. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Rezurock is currently approved in 20 countries, including the US, UK and Canada for the treatment of patients 12 years and older with cGVHD after failure of at least
two prior lines of systemic therapy and in China after failure of one prior line of systemic therapy. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">More than 17,000 patients living with cGVHD worldwide have
been prescribed Rezurock since its first approval in the US in July 2021. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Rezurock </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Rezurock (belumosudil) is a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> selective ROCK2
<FONT STYLE="white-space:nowrap">(Rho-associated</FONT> coiled-coil kinase 2) inhibitor (ROCK2i). </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Sanofi is committed to investigating the benefits of Rezurock in
other age groups and indications, including through ongoing studies for pediatric patients with cGVHD from one year old who have been treated with at least two prior lines of systemic therapy and for patients with chronic lung allograft dysfunction.
</P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About chronic graft-versus-host disease </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">GVHD is a complication that can occur following stem cell transplant (or allogeneic hematopoietic stem cell transplant) where the donor&#8217;s (graft) cells attack the
host&#8217;s cells, leading to inflammation and fibrosis (scarring or thickening) that can damage multiple tissues and organs. Chronic GVHD devastates the lives of up to 50% of patients who undergo an allogeneic hematopoietic stem cell transplant.<SUP
STYLE="font-size:75%; vertical-align:top"> </SUP>GVHD is considered one of the main causes of morbidity and late <FONT STYLE="white-space:nowrap">non-relapse</FONT> mortality after stem cell transplant. The consequences are <FONT
STYLE="white-space:nowrap">far-reaching,</FONT> both in terms of the burden it can place on the </P>
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individual&#8217;s physical and emotional well-being, as well as the broader socio-economic impact. </P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #aab5b7">&nbsp;</DIV>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" 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. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Media Relations </I></FONT></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 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Evan Berland</B> | +1 215 432 0234 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@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>L&eacute;o Le
Bourhis</B> | +33 6 75 06 43 81 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>leo.lebourhis@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> | +33 6 70 93 71 40 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@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>Timothy Gilbert</B> | +1 516 521 2929 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>timothy.gilbert@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>L&eacute;a Ubaldi
</B>| +33 6 30 19 66 46 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thomas Kudsk
Larsen</B> | +44 7545 513 693 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thomas.larsen@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>Aliz&eacute; Kaisserian</B> | +33 6 47 04 12 11 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>alize.kaisserian@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> | +1 908 612 7239 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Keita Browne</B> |
+1 781 249 1766 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>keita.browne@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> | +33 7 85 93 30 17 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@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="#7a00e6"><U>tarik.elgoutni@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>Thibaud
Ch&acirc;telet</B> | +33 6 80 80 89 90 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thibaud.chatelet@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>Yun Li</B>&nbsp;| +33 6 84 00 90 72
|&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:10pt; 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" ALIGN="justify">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 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 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, 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> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">All trademarks mentioned in this press release
are the property of the Sanofi group. </P>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi&#8217;s Wayrilz recommended for EU approval by the CHMP to treat immune
thrombocytopenia </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="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Recommendation based on LUNA 3 phase 3 study demonstrating rapid and durable platelet response and significant
improvements in bleeding, quality of life measures, and other ITP symptoms </P></TD></TR></TABLE> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">If approved, Wayrilz will be the first BTK inhibitor for ITP in the EU, targeting the root cause of the disease through
multi-immune modulation </P></TD></TR></TABLE> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;17, 2025.</B> The European Medicines Agency&#8217;s Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Wayrilz (rilzabrutinib) as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. A final
decision is expected in the coming months. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:4%; margin-right:4%; font-size:10pt; font-family:arial" ALIGN="justify"><I>&#8220;The CHMP&#8217;s recommendation of Wayrilz for approval is a
positive step forward for people in the EU living with ITP who continue to experience symptoms that impact their daily living despite treatment with certain other therapies,&#8221; said</I><B><I> </I></B><B>Brian Foard</B>, Executive Vice President,
Head of Specialty Care at Sanofi. <I>&#8220;Through multi-immune modulation, Wayrilz shows promise in addressing the root cause of ITP &#8211; complex immune system dysregulation, reinforcing Sanofi&#8217;s commitment to finding novel ways to
address unmet patient needs in rare and immunological diseases.&#8221;</I> </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The positive CHMP opinion is based on the pivotal LUNA 3 phase 3 study
(clinical study identifier: <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#5400b8"><U>NCT04562766</U></FONT><FONT STYLE="font-family:arial">), </FONT><FONT STYLE="font-family:arial; font-size:10pt" COLOR="#5400b8"><U>presented</U></FONT><FONT
STYLE="font-family:arial"> at the 66th American Society of Hematology&nbsp;Annual Meeting and Exposition in December 2024 and also published in </FONT><FONT STYLE="font-family:arial" COLOR="#5400b8"><I><U>Blood.</U></I></FONT><FONT
STYLE="font-family:arial"> Wayrilz met both the primary and secondary endpoints, making LUNA 3 the first phase 3 study to show a positive impact on sustained platelet counts, bleeding, and other ITP symptoms with an oral, reversible, Bruton&#8217;s
tyrosine kinase (BTK) inhibitor. </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Wayrilz has already been approved in the US and the United Arab Emirates. In addition to the EU, Wayrilz is
currently under regulatory review for ITP in China. It received fast track and orphan drug designations (ODD) in the US for ITP, with similar orphan designations in the EU and Japan. In other indications under investigation, the US Food and Drug
Administration (FDA) granted Wayrilz ODD for three additional rare diseases, including warm autoimmune hemolytic anemia (wAIHA), IgG4-related disease <FONT STYLE="white-space:nowrap">(IgG4-RD),</FONT> and sickle cell disease (SCD). Wayrilz also
received FDA fast track designation and EU orphan designation in <FONT STYLE="white-space:nowrap">IgG4-RD.</FONT> </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the LUNA
3 study </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">LUNA 3 (clinical study identifier: <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#5400b8"><U>NCT04562766</U></FONT><FONT
STYLE="font-family:arial">) was a randomized, multicenter, phase 3 study evaluating the efficacy and safety of Wayrilz vs. placebo in adult and adolescent patients with persistent or chronic ITP. Patients received either oral Wayrilz 400 mg twice a
day or placebo through a <FONT STYLE="white-space:nowrap">12-</FONT> to <FONT STYLE="white-space:nowrap">24-week</FONT> double-blind treatment period, followed by a <FONT STYLE="white-space:nowrap">28-week</FONT> open-label treatment period, and
then a four-week safety <FONT STYLE="white-space:nowrap">follow-up</FONT> or long-term extension period. The adolescent part of the study is ongoing. The primary endpoint for the EU is the proportion of adult participants able to achieve platelet
counts at or above 50,000/&micro;L for at least eight out of the last 12 weeks of the <FONT STYLE="white-space:nowrap">24-week</FONT> blinded treatment period in the absence of rescue therapy. Secondary endpoints included time to platelet response
(platelet&nbsp;count&nbsp;<FONT STYLE="font-family:Times New Roman">&#8805;</FONT>50 x 10<SUP STYLE="font-size:75%; vertical-align:top">9</SUP>/L&nbsp;or&nbsp;between&nbsp;30 x 10<SUP STYLE="font-size:75%; vertical-align:top">9</SUP>/L
and&nbsp;&lt;50 x 10<SUP STYLE="font-size:75%; vertical-align:top">9</SUP>/L&nbsp;and&nbsp;at&nbsp;least&nbsp;doubled&nbsp;from&nbsp;baseline in absence of rescue therapy), number of weeks maintaining a specific platelet response (i.e., doubled or
within range), rescue therapy use, physical fatigue score, and bleeding score as assessed by change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25. </FONT></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Wayrilz </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Wayrilz (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. This innovative
therapy is approved in the US for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Additionally, Wayrilz is approved in the United Arab Emirates for adult patients with
persistent or chronic ITP who have had an insufficient response or intolerance to a previous treatment. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and
inflammatory pathways. With the application of Sanofi&#8217;s TAILORED COVALENCY<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP> technology, Wayrilz can selectively inhibit the BTK target. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Wayrilz is being studied across a variety of rare diseases, including wAIHA, <FONT STYLE="white-space:nowrap">IgG4-RD,</FONT> and SCD. These additional
indications are currently under investigation and have not been approved by regulatory authorities. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About ITP </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">ITP is a disease of complex immune dysregulation that causes low platelet counts (&lt;100,000/&micro;L), resulting in a variety of bleeding symptoms and
thromboembolism risk. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive
impairment. </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #aab5b7">&nbsp;</DIV>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" 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. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Media Relations </I></FONT></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 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Evan Berland</B>
| +1 215 432 0234 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@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>L&eacute;o Le Bourhis</B> | + 33 6 75 06 43 81 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>leo.lebourhis@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> | + 33 6 70 93 71 40 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@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>Timothy Gilbert</B>
| + 1 516 521 2929 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>timothy.gilbert@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>L&eacute;a Ubaldi</B><B></B>&nbsp;| +33 6 30 19 66 46 |&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT
STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thomas Kudsk Larsen</B> | +44 7545 513 693 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thomas.larsen@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>Aliz&eacute; Kaisserian</B> | + 33 6 47 04 12 11 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>alize.kaisserian@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>
| +1 908 612 7239 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Keita Browne</B> | +1 781 249 1766 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>keita.browne@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> |
+33 7 85 93 30 17 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@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="#7a00e6"><U>tarik.elgoutni@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>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thibaud.chatelet@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>Yun Li</B>&nbsp;|
+33 6 84 00 90 72 |&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #aab5b7">&nbsp;</DIV>
<P STYLE="margin-top:10pt; 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" ALIGN="justify">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 regarding the
marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect
the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, 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 future litigation and the ultimate outcome of such litigation, and
volatile economic and market conditions, 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 &#8220;Risk Factors&#8221; and &#8220;Cautionary
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<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:14pt; font-family:arial"><B>Press Release</B></P></TD>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi&#8217;s high-dose influenza vaccine demonstrates superior protection for older
adults against hospitalization vs standard-dose </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="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Compared to standard-dose influenza vaccines, Efluelda/Fluzone High-Dose demonstrated a reduction in
laboratory-confirmed influenza hospitalizations by an additional 31.9% (95% CI, 19.7 to 42.2; p&lt;0.001) in adults 65 years and over </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:arial; font-size:10pt">Results come from <FONT STYLE="white-space:nowrap">FLUNITY-HD,</FONT> the largest influenza vaccine effectiveness study
of individually randomized older adults, involving nearly half a million participants across several seasons and two geographic areas </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:arial; font-size:10pt">Efluelda/Fluzone High-Dose also provided superior protection, compared to standard-dose influenza vaccines*, against
hospitalizations due to pneumonia or influenza, hospitalizations caused by cardio-respiratory events, and <FONT STYLE="white-space:nowrap">all-cause</FONT> hospitalizations in older adults </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:arial; font-size:10pt">Efluelda/Fluzone High-Dose is the first vaccine to demonstrate superior protection against both influenza infection and
hospitalizations, compared to standard-dose influenza vaccines, in individually randomized studies in adults 65 years and over </P></TD></TR></TABLE>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;20, 2025</B>. New data from the <FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> study, published on
October&nbsp;17 in <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#467886"><U>The Lancet</U></FONT><FONT STYLE="font-family:arial">, demonstrated that Sanofi&#8217;s Efluelda (known as Fluzone High-Dose in North America) significantly
reduced the risk of hospitalization in adults 65 years and older compared to standard-dose influenza vaccines. The largest study of its kind, conducted across multiple seasons, <FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> provides robust
evidence that the high-dose influenza vaccine offers superior protection compared to standard-dose: </FONT></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">8.8% (95% CI, 1.7 to 15.5; <FONT STYLE="white-space:nowrap">one-sided</FONT> p=0.008) additional protection against
pneumonia/influenza hospitalizations </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:arial; font-size:10pt">6.3% (95% CI, 2.5 to 10.0; p&lt;0.001) additional reduction in hospitalizations for cardio-respiratory events
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">31.9% (95% CI, 19.7 to 42.2; p&lt;0.001) additional reduction in <FONT STYLE="white-space:nowrap">lab-confirmed</FONT>
influenza hospitalizations </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:arial; font-size:10pt">2.2% (95% CI, 0.3 to 4.1; p=0.012) additional protection against <FONT STYLE="white-space:nowrap">all-cause</FONT>
hospitalizations, meaning one additional hospitalization could be averted for every 515 (95% CI, 278 to 3,929) individuals vaccinated with Efluelda instead of standard-dose. </P></TD></TR></TABLE>
<P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:arial" ALIGN="justify"><I>&#8220;The <FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> study, unparalleled in its design and scale, harnesses the power and
scientific rigor of individual randomization in real-world settings,&#8221; shared </I><B>Professor Tor <FONT STYLE="white-space:nowrap">Biering-S&oslash;rensen,</FONT></B><I> </I>Cardiologist, Chief Investigator, and sponsor of the <FONT
STYLE="white-space:nowrap">FLUNITY-HD</FONT> study.<I> &#8220;This <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-of-its-kind</FONT></FONT></FONT> study assessed the benefits of the high-dose
influenza vaccine against severe outcomes compared to standard-dose, including against cardio-respiratory hospitalizations, in a randomized setting, covering two geographic areas. The results provide critical evidence, potentially reshaping public
health strategies and clinical guidelines.&#8221; </I></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:arial" ALIGN="justify"><B>Professor Federico Martinon-Torres</B>,
<FONT STYLE="white-space:nowrap">Co-Principal</FONT> Investigator of <FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> study, <I>added, &#8220;This new evidence reinforces the clinical confidence healthcare professionals have that the high-dose
influenza vaccine achieves superior protection over standard-dose against severe outcomes in older adults, a group considered</I> </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:5.5pt; font-family:arial" ALIGN="justify">*The standard-dose influenza vaccines used in the FLUNITY-HD study were VaxigripTetra (Sanofi) and InfluvacTetra (Viatris). Standard-dose vaccines often
serve as the primary influenza prevention option for the general population. </P>
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<I>vulnerable due to having a weakened immune system and a higher risk of developing serious complications after flu infection.&#8221;</I> </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Beyond clinical evidence, these findings point to potential public health and societal benefits. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:arial" ALIGN="justify"><I>&#8220;Adults 65 and older represent up to 70% of flu hospitalizations. The <FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> data
confirm that our high-dose flu vaccine provides superior protection against hospitalizations compared to standard-dose vaccines in older adults,&#8221; said </I><B>Bogdana Coudsy, MD</B>, Global Head of Medical, Sanofi, Vaccines<I>. &#8220;For every
515 older adults who receive our high-dose flu vaccine instead of standard-dose vaccines, one <FONT STYLE="white-space:nowrap">all-cause</FONT> hospitalization is prevented. This can mean a lot, especially for vulnerable seniors, decreasing the
burden on their quality of life and helping them to maintain their autonomy for longer. Additionally, preventing influenza hospitalizations may bring societal benefits such as lower healthcare costs, less pressure on medical systems, and reduced
burden on caregivers.&#8221;</I> </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">With the addition of these new data, comprehensive research on our high-dose influenza vaccine covers 15 years of
clinical evidence spanning over 45&nbsp;million older adults. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the <FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> Study
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> is a <FONT STYLE="white-space:nowrap">pre-specified</FONT> pooled analysis of two
pragmatic individually randomized trials involving 466,320 participants aged 65 and older: <FONT STYLE="white-space:nowrap">DANFLU-2</FONT> and GALFLU. <FONT STYLE="white-space:nowrap">DANFLU-2</FONT> was conducted over three influenza seasons <FONT
STYLE="white-space:nowrap">(2022-23,</FONT> <FONT STYLE="white-space:nowrap">2023-24</FONT> and <FONT STYLE="white-space:nowrap">2024-25)</FONT> with over 332,000 participants aged 65 and above in Denmark. GALFLU was conducted over two influenza
seasons <FONT STYLE="white-space:nowrap">(2023-24</FONT> and <FONT STYLE="white-space:nowrap">2024-25)</FONT> with over 134,000 participants aged 65 to 79 in the region of Galicia in Spain. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The largest influenza vaccine study of its kind, this multi-season analysis is designed to evaluate the real-world effectiveness of Efluelda (high-dose
influenza vaccine) compared to standard-dose influenza vaccines in preventing hospitalizations, ensuring scientific rigor through individual randomization. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><FONT STYLE="white-space:nowrap">FLUNITY-HD</FONT> achieved its primary endpoint, demonstrating 8.8% additional protection against pneumonia/influenza
hospitalizations (vs standard dose). Secondary endpoints include reduction in hospitalizations for cardio-respiratory events, <FONT STYLE="white-space:nowrap">lab-confirmed</FONT> influenza hospitalizations and
<FONT STYLE="white-space:nowrap">all-cause</FONT> hospitalizations. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About&nbsp;Efluelda / Fluzone&nbsp;High-Dose </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Efluelda is a high-dose influenza vaccine, indicated for adults aged 60 and older in Europe. It is also licensed under the brand name Fluzone High-Dose
in North America where it is indicated for adults aged 65 and older. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">This high-dose influenza vaccine is specifically tailored for older adults
whose immune systems gradually decline and weaken with age, increasing their risk for severe <FONT STYLE="white-space:nowrap">influenza-related</FONT> illness and hospitalization compared with younger populations. It provides 4x the antigen compared
to a standard-dose vaccine to deliver a better immune response against influenza for older adults. </P>
<P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #aab5b7">&nbsp;</DIV>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" 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 </P>
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<P STYLE="margin-top:0pt; 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
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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
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including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic
and market conditions, 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 &#8220;Risk Factors&#8221; and &#8220;Cautionary Statement
Regarding Forward-Looking Statements&#8221; in Sanofi&#8217;s annual report on <FONT STYLE="white-space:nowrap">Form&nbsp;20-F</FONT> for the year ended December&nbsp;31, 2024. Other than as required by applicable law, Sanofi does not undertake any
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><B>Exhibit 99.4 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:14pt; font-family:arial"><B>Press Release</B></P></TD>
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 </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>ESMO: AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">TM</SUP> phase 2 data support <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors </I></FONT></P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">New AlphaMedix data showed sustained and clinically meaningful responses across both
<FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> and <FONT STYLE="white-space:nowrap">RLT-exposed</FONT> patients with unresectable or metastatic <FONT STYLE="white-space:nowrap">GEP-NETs</FONT> </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">First phase 2 study to evaluate TAT with <FONT STYLE="white-space:nowrap">lead-212</FONT> supporting its potential to
address high unmet medical needs in <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat,</FONT></FONT> rare cancers </P></TD></TR></TABLE>
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<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">Phase 2 study met all primary efficacy endpoints and was presented across two oral presentations at the 2025 ESMO
Congress in Berlin, Germany </P></TD></TR></TABLE> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;20, 2025.</B>&nbsp;New data from the <FONT
STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> phase 2 study (clinical study identifier: <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#5400b8"><U>NCT05153772</U></FONT><FONT STYLE="font-family:arial">) evaluating AlphaMedix<SUP
STYLE="font-size:75%; vertical-align:top"> </SUP>(<SUP STYLE="font-size:75%; vertical-align:top">212</SUP><FONT STYLE="white-space:nowrap">Pb-DOTAMTATE),</FONT> an investigational somatostatin receptor (SSTR) targeted alpha therapy (TAT) using the <FONT
STYLE="white-space:nowrap">lead-212</FONT> isotope, underscore the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> potential of this investigational medicine for the treatment of patients with advanced
gastroenteropancreatic neuroendocrine tumors <FONT STYLE="white-space:nowrap">(GEP-NETs).</FONT> Detailed results from the phase 2 study, the first to evaluate a TAT across both radioligand therapy
<FONT STYLE="white-space:nowrap">(RLT)-na&iuml;ve</FONT> and <FONT STYLE="white-space:nowrap">RLT-exposed</FONT> patients affected by <FONT STYLE="white-space:nowrap">GEP-NETs,</FONT> were presented in two oral presentations at the 2025 European
Society for Medical Oncology (ESMO) Congress, Berlin, Germany. </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial"><I><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">&#8220;Lead-212-based</FONT></FONT> Targeted Alpha Therapy (TAT) could have a
transformative impact across a broad range of solid tumors. With AlphaMedix&#8217;s consistent and clinically meaningful responses across both <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> and
<FONT STYLE="white-space:nowrap">RLT-exposed</FONT> gastroenteropancreatic neuroendocrine tumor <FONT STYLE="white-space:nowrap">(GEP-NET)</FONT> patients, the positive results underscore its potential in this rare and
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> cancer,</I>&#8221;<I> </I>said <B>Volker Wagner</B>, MD, PhD, Chief Medical Officer at Orano Med.<I> &#8220;These data strongly encourage us to
further advance the clinical development of AlphaMedix, and jointly with our partner, Sanofi, make this innovative TAT available to patients in need.&#8221;</I> </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I><FONT STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> phase 2 study </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><FONT STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix in
patients with unresectable or metastatic SSTR+ <FONT STYLE="white-space:nowrap">GEP-NETs.</FONT> The study included two cohorts evaluating <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> and <FONT STYLE="white-space:nowrap">RLT-exposed</FONT>
patients. The primary efficacy endpoint across both cohorts was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS) and overall survival (OS). </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The study&#8217;s efficacy endpoints are based on local investigator assessment, per protocol. In addition, a blinded independent central review (BICR)
was conducted subsequently. The key efficacy endpoints were met within both the investigator-assessed and BICR results. </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">The following results were presented: </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial"><B><I><FONT
STYLE="white-space:nowrap">RLT-Na&iuml;ve</FONT></I></B></P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial"><B><I>(n=35)</I></B></P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;">&nbsp;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center"><B><I>Investigator assessment</I></B></P>
<P STYLE="font-size:10pt; margin-top:0pt; margin-bottom:1pt" align="left">&nbsp;</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center"><B><I>Independent
assessment</I></B></P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center"><B><I>(BICR)</I></B></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:6pt">
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<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:6pt; font-family:arial" ALIGN="center"><B></B><I>*DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST
1.1</I><B></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:6pt; font-family:arial" ALIGN="center"><B></B><I>**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1</I><B></B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:6pt; font-family:arial" ALIGN="center"><B></B><I>***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a</I><B></B></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>ORR</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">60.0%<BR>(95% CI: <FONT STYLE="white-space:nowrap">42.1-76.1)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">57.1%</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI:
<FONT STYLE="white-space:nowrap">39.4-73.7)</FONT></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; padding-left:8pt;"><B>Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)<SUP STYLE="font-size:75%; vertical-align:top">*</SUP></B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">71.9% for <FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 24 months</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">44.6-87.4)</FONT></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; padding-right:2pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">81.7% for
<FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 24 months</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">53.1-93.8)</FONT></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>Complete Response (CR)</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">-</TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">2.9%</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; padding-left:8pt;"><B>Partial Response (PR)</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000;">60.0%</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; padding-right:2pt;">54.3%</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>Stable Disease (SD)</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">34.3%</TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">28.6%</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; padding-left:8pt;"><B>Disease control rate (DCR)<SUP STYLE="font-size:75%; vertical-align:top">**</SUP></B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">94.3%</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">80.8-99.3)</FONT></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; padding-right:2pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">85.7%</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">69.7-95.2)</FONT></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>PFS</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;"><FONT STYLE="white-space:nowrap">36-month</FONT> PFS rate of 72.3%<BR>(95% CI:
<FONT STYLE="white-space:nowrap">53.3-84.5)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;"><FONT STYLE="white-space:nowrap">36-month</FONT> PFS rate of 63.3%<BR>(95% CI: <FONT
STYLE="white-space:nowrap">40.3-79.4)</FONT></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>OS</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;"><FONT STYLE="white-space:nowrap">36-month</FONT> OS rate of 88.2%<BR>(95% CI: <FONT STYLE="white-space:nowrap">71.5-95.4)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">Not applicable<SUP STYLE="font-size:75%; vertical-align:top">***</SUP></TD></TR>
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<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial"><B><I><FONT
STYLE="white-space:nowrap">RLT-Exposed</FONT></I></B></P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial"><B><I>(n=26)</I></B></P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">&nbsp;</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;">&nbsp;</TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center"><B><I>Investigator assessment</I></B></P>
<P STYLE="font-size:10pt; margin-top:0pt; margin-bottom:1pt" align="left">&nbsp;</P></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center"><B><I>Independent
assessment</I></B></P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center"><B><I>(BICR)</I></B></P></TD></TR>
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<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:6pt; font-family:arial" ALIGN="center"><B></B><I>*DOR is determined only for participants who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST
1.1</I><B></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:6pt; font-family:arial" ALIGN="center"><B></B><I>**Defined as the percentage of patients achieving CR or PR or SD per RECIST 1.1</I><B></B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:6pt; font-family:arial" ALIGN="center"><B></B><I>***OS assessment is independent of RECIST 1.1 criteria, so BICR is n/a</I><B></B></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; padding-left:8pt;"><B>ORR</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000;">34.6%<BR>(95% CI: <FONT STYLE="white-space:nowrap">17.2-55.7)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; padding-right:2pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">19.2%</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">6.6-39.4)</FONT></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>Duration of Response (DoR) per Kaplan-Meier (KM) estimate (95% CI)<SUP
STYLE="font-size:75%; vertical-align:top">*</SUP></B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">100% for <FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 18 months<BR>(95% CI: <FONT
STYLE="white-space:nowrap">100-100)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">100% for <FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 18 months<BR>(95% CI: <FONT
STYLE="white-space:nowrap">100-100)</FONT></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; padding-left:8pt;"><B>Partial Response (PR)</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000;">34.6%</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; padding-right:2pt;">19.2%</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>Stable Disease (SD)</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">61.5%</TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">80.8%</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; padding-left:8pt;"><B>Disease control rate (DCR)<SUP STYLE="font-size:75%; vertical-align:top">**</SUP></B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">96.2%</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">80.4-99.9)</FONT></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; padding-right:2pt;"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:arial" ALIGN="center">100%</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:9pt; font-family:arial" ALIGN="center">(95% CI: <FONT STYLE="white-space:nowrap">86.8-100)</FONT></P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>PFS</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;"><FONT STYLE="white-space:nowrap">18-month</FONT> PFS rate of 82.6%<BR>(95% CI: <FONT
STYLE="white-space:nowrap">59.0-93.3)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-TOP:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" NOWRAP ALIGN="center" STYLE="BORDER-TOP:1px solid #000000; BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;"><FONT STYLE="white-space:nowrap">18-month</FONT> PFS rate of 88%<BR>(95% CI: <FONT
STYLE="white-space:nowrap">67.3-96.0)</FONT></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:arial; font-size:9pt">
<TD VALIGN="top" STYLE="BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-left:8pt;"><B>OS</B></TD>
<TD VALIGN="bottom" STYLE=" BORDER-LEFT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000;"><FONT STYLE="white-space:nowrap">18-month</FONT> OS rate of 85.1%<BR>(95% CI: <FONT STYLE="white-space:nowrap">58.5-95.2)</FONT></TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000;">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="center" STYLE="BORDER-RIGHT:1px solid #000000; BORDER-BOTTOM:1px solid #000000; padding-right:2pt;">Not applicable<SUP STYLE="font-size:75%; vertical-align:top">***</SUP></TD></TR>
</TABLE> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP> had a similar safety profile across both cohorts.
Within the <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> cohort, 85.7% of patients received all four doses of AlphaMedix, and 84.6% of patients within the <FONT STYLE="white-space:nowrap">RLT-exposed</FONT> cohort. All <FONT
STYLE="white-space:nowrap">GEP-NET</FONT> patients experienced at least one treatment-emergent adverse event (TEAE). Grade <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>3 TEAEs occurred in 42.3% of
<FONT STYLE="white-space:nowrap">RLT-exposed</FONT> patients and 54.3% of <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> patients. The most common Grade <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>3 TEAEs in both groups was
lymphocyte count decrease (25.7% of <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> patients and 15.4% of <FONT STYLE="white-space:nowrap">RLT-exposed</FONT> patients). </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial"><I>&#8220;The future of oncology research will be driven by cutting-edge science and next-generation modalities, such as radioligand therapies.
AlphaMedix, a promising targeted alpha therapy, embodies the type of solution Sanofi is working to advance,&#8221; </I>said<I> </I><B>Christopher Corsico</B><I></I>, MD, Global Head of Development at Sanofi.<I> &#8220;We are excited to share these
robust scientific findings at ESMO as the data could represent a significant advancement in how we treat gastroenteropancreatic neuroendocrine tumors. As we engage with health authorities and advance the clinical program, we remain focused on
bringing this innovative modality to patients who need new treatment options&#8221; </I></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Advancing AlphaMedix in <FONT STYLE="white-space:nowrap">GEP-NETs</FONT>
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">RLTs, which work by delivering radiation directly to tumor cells, represent an emerging area of oncology research. While current approved
beta-emitting RLTs have improved outcomes in patients with <FONT STYLE="white-space:nowrap">GEP-NETs,</FONT> there remains a critical gap in care, including in those who have progressed following previous RLT. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">TAT represents an innovative modality in RLT, harnessing high-energy, short-range alpha emissions to precisely target cancer cells while reducing
potential exposure to surrounding tissue. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:arial"><I>&#8220;The results observed in the <FONT STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> trial clearly
demonstrate exceptional levels of efficacy for a Targeted Alpha Therapy (TAT), based on current available therapies, in both radioligand therapy <FONT STYLE="white-space:nowrap">(RLT)-na&iuml;ve</FONT> and
<FONT STYLE="white-space:nowrap">RLT-exposed</FONT> populations and could potentially set new expectations when treating gastroenteropancreatic neuroendocrine tumor <FONT STYLE="white-space:nowrap">(GEP-NET)</FONT> patients with RLTs&#8221;
</I>said<I> </I><B>Ebrahim Delpassand</B><I></I>, MD, Founder and Chairman, CEO of RadioMedix.<I> &#8220;For too long, this patient population has experienced inadequate disease control with current approved therapies. This important work provides
hope for a new treatment for <FONT STYLE="white-space:nowrap">GEP-NET</FONT> patients, their caregivers, and their healthcare providers.&#8221; </I></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In February 2024, AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP> was designated as a breakthrough therapy by the US Food and Drug
Administration in <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> patients with unresectable or metastatic <FONT STYLE="white-space:nowrap">GEP-NETs,</FONT> recognizing the potential clinical benefits of
<FONT STYLE="white-space:nowrap">lead-212&#8211;based</FONT> TATs. The <FONT STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> results will form the basis for further discussions with health authorities. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">An international phase 3 study to further evaluate AlphaMedix in <FONT STYLE="white-space:nowrap">GEP-NETs</FONT> is actively being planned. AlphaMedix
is an investigational medicine and has not been approved by any regulatory authority. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">In September 2024, Sanofi entered an exclusive licensing
agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About the
<FONT STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> study </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><FONT STYLE="white-space:nowrap">ALPHAMEDIX-02</FONT> is a phase 2,
open-label, multicenter study evaluating the efficacy and safety of AlphaMedix (<SUP STYLE="font-size:75%; vertical-align:top">212</SUP><FONT STYLE="white-space:nowrap">Pb-DOTAMTATE)</FONT> in patients with histologically confirmed unresectable or
metastatic <FONT STYLE="white-space:nowrap">GEP-NETs,</FONT> positive somatostatin analogue imaging and at least one site of measurable disease. The study included two cohorts evaluating <FONT STYLE="white-space:nowrap">RLT-na&iuml;ve</FONT> (n=35)
and <FONT STYLE="white-space:nowrap">RLT-exposed</FONT> (n=26) <FONT STYLE="white-space:nowrap">GEP-NET</FONT> patients. <FONT STYLE="white-space:nowrap">RLT-exposed</FONT> patients had progressive disease after receiving up to four doses of <SUP
STYLE="font-size:75%; vertical-align:top">177</SUP><FONT STYLE="white-space:nowrap">Lu-DOTATATE</FONT> and received their last dose at least six months prior to Day 1. In both cohorts, AlphaMedix was administered at 67.6 &micro;Ci/kg every eight
weeks for up to four cycles (6 mCi maximum per cycle). The primary efficacy endpoint across both cohorts was ORR per RECIST 1.1. Secondary endpoints included PFS and OS. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About NETs </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">NETs are a
heterogeneous group of cancers that originate from neuroendocrine cells. These cancers occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as the
ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors. Despite the global prevalence of NETs increasing each year, it is considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide.
In the United States, around 12,000&nbsp;patients annually are expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate of 60% at a metastatic stage. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Orano Med </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Orano
Med is a subsidiary of the Orano Group. Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of <FONT STYLE="white-space:nowrap">lead-212</FONT> (<SUP
STYLE="font-size:75%; vertical-align:top">212</SUP>Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT). Leveraging its unique and secured access to <SUP
STYLE="font-size:75%; vertical-align:top">212</SUP>Pb, the company is developing several <SUP STYLE="font-size:75%; vertical-align:top">212</SUP><FONT STYLE="white-space:nowrap">Pb-based</FONT> </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" ALIGN="justify">
radioligand therapies combined with various targeting agents. Orano Med has<SUP STYLE="font-size:75%; vertical-align:top">&nbsp;212</SUP>Pb manufacturing facilities, laboratories, and R&amp;D
centers in France and in the US and is currently expanding its <FONT STYLE="white-space:nowrap">GMP-manufacturing</FONT> capacities for<SUP STYLE="font-size:75%; vertical-align:top">&nbsp;212</SUP>Pb radiolabeled pharmaceuticals in North America and
Europe. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About RadioMedix </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">RadioMedix, Inc., a clinical-stage biotechnology company and former sponsor of the AlphaMedix trial, is based in Houston and Humble, Texas. The company
is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract
service facilities for academic and industrial partners. including a cGMP and analytical suite for Phase <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">I-II-III</FONT></FONT> clinical trials and commercial launch. To learn more,
visit&nbsp;<FONT STYLE="font-family:arial; font-size:10pt" COLOR="#7a00e6"><U>www.radiomedix.com</U></FONT><FONT STYLE="font-family:arial">&nbsp;and LinkedIn. </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" 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:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Media Relations </I></FONT></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 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Evan Berland</B>
| +1 215 432 0234 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@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>L&eacute;o Le Bourhis</B> | +33 6 75 06 43 81 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT
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<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@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>Timothy Gilbert</B>
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STYLE="font-family:arial"> </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Investor Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thomas Kudsk Larsen</B> | +44 7545 513 693 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thomas.larsen@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>Aliz&eacute; Kaisserian</B> | +33 6 47 04 12 11 |
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| +1 908 612 7239 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
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+33 7 85 93 30 17 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@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="#7a00e6"><U>tarik.elgoutni@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>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thibaud.chatelet@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>Yun Li</B>&nbsp;|
+33 6 84 00 90 72 |&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Orano Med </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Regina Jehle
</B>|&nbsp;+33 6 74 56 11 31 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>regina.jehle@orano.group</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
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<P STYLE="margin-top:10pt; 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" ALIGN="justify"><I>This press release
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including those listed under &#8220;Risk Factors&#8221; and &#8220;Cautionary </I></P>
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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, 2024. Other than as
required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify"><I>All
trademarks mentioned in this press release are the property of the Sanofi group with the exception of Orano Med and AlphaMedix<SUP STYLE="font-size:75%; vertical-align:top">&#153;</SUP>. </I></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="right"><B>Exhibit 99.5 </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" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi&#8217;s Tzield accepted for expedited review in the US for stage 3 type 1
diabetes through FDA Commissioner&#8217;s National Priority Voucher pilot program </I></FONT></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:arial; font-size:10pt">If approved, Tzield would be the first disease-modifying therapy to delay the progression of stage 3 T1D in adults and
pediatric patients eight years of age and older recently diagnosed with stage 3 T1D </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:arial; font-size:10pt">Tzield is also being reviewed under the accelerated approval program </P></TD></TR></TABLE>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;20, 2025. </B>The US Food and Drug Administration (FDA) has accepted for expedited review the supplemental
biologics license application (sBLA) for Tzield <FONT STYLE="white-space:nowrap">(teplizumab-mzwv)</FONT> to delay the progression of stage 3 type 1 diabetes (T1D) in adults and pediatric patients eight years of age and older recently diagnosed with
stage 3 T1D. The FDA nominated Tzield for the Commissioner&#8217;s National Priority Voucher (CNPV) pilot program based on its potential to address a large unmet medical need. The CNPV program aims to shorten the review process from what normally
takes <FONT STYLE="white-space:nowrap">10-12</FONT> months to <FONT STYLE="white-space:nowrap">1-2</FONT> months, while maintaining FDA&#8217;s rigorous safety and efficacy standards. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; margin-left:5%; margin-right:5%; font-size:10pt; font-family:arial" ALIGN="justify"><I>&#8220;We welcome that Tzield has been accepted for expedited review by the FDA under the Commissioner&#8217;s
National Priority Voucher pilot program, potentially enabling us to go further and faster for patients and lead the way with breakthrough science,&#8221; said </I><B>Olivier Charmeil</B><I>, </I>Executive Vice President, General Medicines,
Sanofi.<I> &#8220;This is a recognition of the breakthrough innovative profile of Tzield, its ability to potentially prevent the natural progression of T1D, and the significant unmet medical need that remains in this area which has seen limited
treatment advances in the last 100 years.&#8221; </I></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The sBLA is supported by the results from the <FONT
STYLE="font-family:arial; font-size:10pt" COLOR="#0000ff"><U>PROTECT phase 3 study</U></FONT><FONT STYLE="font-family:arial">, which met its primary endpoint, evaluating preservation of beta cell function as assessed by significantly slowing the
decrease in mean <FONT STYLE="white-space:nowrap">C-peptide</FONT> levels (area under the curve [AUC] after a four-hour mixed meal tolerance test) at trial study completion, compared to placebo. Additionally, the sBLA builds on the clinical
development program of Tzield including approximately~1,000 patients. </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Adverse events observed in the PROTECT phase 3 study were consistent
with previous studies. Most common adverse events were headache, nausea, rash, lymphopenia, leukopenia and gastrointestinal symptoms, consistent with the mode of action of cytokine release. 1.8% of those who received Tzield in the PROTECT study
developed cytokine release syndrome possibly or probably related to Tzield. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Additionally, Tzield is being reviewed under the accelerated approval
program, a pathway that allows the FDA to review therapies intended to treat serious conditions that fill an unmet medical need, based on a surrogate endpoint reasonably likely to predict clinical benefit. In line with this requirement, the
confirmatory BETA-PRESERVE phase 3 study (clinical study identifier: <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0000ff"><U>NCT07088068</U></FONT><FONT STYLE="font-family:arial">) was initiated recently and is currently enrolling
participants. </FONT></P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Tzield is approved in the US, the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait
to delay the onset of stage 3 T1D in adults and pediatric patients eight years and older diagnosed with stage 2 T1D. Regulatory reviews are ongoing in </P>
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the EU and other jurisdictions around the world. Tzield was previously designated by the FDA as Breakthrough Therapy and was granted orphan drug designation, for investigational medicines that
treat rare diseases affecting fewer than 200,000 people in the US. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The safety and efficacy of Tzield in stage 3 T1D have not yet been approved by
any regulatory authority. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About PROTECT </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">PROTECT (clinical study identifier: <FONT STYLE="font-family:arial; font-size:10pt" COLOR="#0563c1"><U>NCT03875729</U></FONT><FONT
STYLE="font-family:arial">) was a phase 3, randomized, double blind, placebo-controlled, multi-national study. It enrolled 328 children and adolescents (Tzield n=217, placebo n=111) aged <FONT STYLE="white-space:nowrap">eight-17</FONT> years
diagnosed with clinical, stage 3 T1D in the preceding six weeks; randomization ratio of Tzield to placebo was 2:1. Participants received a first course of 12 daily infusions (of either Tzield or placebo) at randomization, followed by a second course
of 12 daily infusions after 26 weeks (approx. six months). All participants received <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">standard-of-care</FONT></FONT> medicines as required. </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">The primary objective of PROTECT was to determine whether Tzield could preserve beta cell function measured by
<FONT STYLE="white-space:nowrap">C-peptide,</FONT> compared to placebo. This was assessed via the trial&#8217;s primary endpoint, which measured the difference in mean change of <FONT STYLE="white-space:nowrap">C-peptide</FONT> level (area under the
time-concentration curve [AUC] measured after a four-hour mixed meal tolerance test) from baseline to Week 78 between both groups. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Key secondary
endpoints included change in HbA1c, time in range as measured with a CGM, clinically important low blood sugar (hypoglycemia) events and exogenous insulin use. Time in range was defined as: <FONT STYLE="font-family:Times New Roman">&#8805;</FONT> 70
but <FONT STYLE="font-family:Times New Roman">&#8804;</FONT>180 mg/dL. Clinically relevant hypoglycemic events were defined: level 2 hypoglycemia (&lt;54 mg/dL / 3.0 mmol/L) and level 3 hypoglycemia as episodes of severe cognitive impairment
requiring external assistance for recovery, even in the absence of a blood glucose reading. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Other secondary endpoints were adverse events and
overall safety aspects, as well as pharmacokinetics and immunogenicity of Tzield. An observational extension study following participants for a further 42 months is ongoing. </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Tzield </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">Tzield <FONT
STYLE="white-space:nowrap">(teplizumab-mzwv)</FONT> is a <FONT STYLE="white-space:nowrap">CD3-directed</FONT> monoclonal antibody. Tzield is the first and only disease modifying therapy in autoimmune T1D; it was approved in the US in November 2022
to delay the onset of Stage 3 type 1 diabetes in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for
the same indication. Regulatory reviews are ongoing in the EU and other jurisdictions around the world. </P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About autoimmune T1D
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial" ALIGN="justify">T1D is a progressive autoimmune condition where the body&#8217;s ability to regulate blood sugar levels is impacted due to the gradual
destruction of insulin producing beta cells by one&#8217;s own immune system. There are four stages to the progression of T1D: </P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:arial; " ALIGN="justify">In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more
<FONT STYLE="white-space:nowrap">T1D-related</FONT> autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic. </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:arial; " ALIGN="justify">In stage 2 (also presymptomatic), in addition to the presence of 2 or more
<FONT STYLE="white-space:nowrap">T1D-related</FONT> autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells / beta cell function. </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:arial; " ALIGN="justify">Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this
point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic </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:arial; font-size:10pt">
symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue. Management of stage 3 T1D requires daily
and burdensome insulin replacement therapy. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:arial; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left">-</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:arial; " ALIGN="justify">Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications,
where little to no beta-cell function remain (it&#8217;s been estimated that beta-cell mass is reduced by up to 95%). At this point, the <FONT STYLE="white-space:nowrap">T1D-related</FONT> autoantibodies might not be present anymore in the blood, as
most beta-cells have been rendered useless by the autoimmune attack. </P></TD></TR></TABLE> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:arial">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:10pt; margin-bottom:0pt; font-size:10pt; font-family:arial">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Media Relations </I></FONT></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 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Evan Berland</B> | +1 215 432 0234 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>evan.berland@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>L&eacute;o Le
Bourhis</B> | +33 6 75 06 43 81 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>leo.lebourhis@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> | +33 6 70 93 71 40 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@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>Timothy Gilbert</B> | +1 516 521 2929 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>timothy.gilbert@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>L&eacute;a
Ubaldi</B><B></B>&nbsp;| +33 6 30 19 66 46 |&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </FONT></P>
<P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:arial"><B>Thomas Kudsk
Larsen</B> | +44 7545 513 693 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thomas.larsen@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>Aliz&eacute; Kaisserian</B> | +33 6 47 04 12 11 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>alize.kaisserian@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> | +1 908 612 7239 |
<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><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>Keita Browne</B> |
+1 781 249 1766 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>keita.browne@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> | +33 7 85 93 30 17 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@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="#7a00e6"><U>tarik.elgoutni@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>Thibaud
Ch&acirc;telet</B> | +33 6 80 80 89 90 | <FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>thibaud.chatelet@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>Yun Li</B>&nbsp;| +33 6 84 00 90 72
|&nbsp;<FONT STYLE="font-family:arial; font-size:8pt" COLOR="#7a00e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:arial"> </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:2pt;border-bottom:1px solid #aab5b7">&nbsp;</DIV>
<P STYLE="margin-top:0pt; 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" ALIGN="justify">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,&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 &#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, 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>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:7pt; font-family:arial" ALIGN="justify">All trademarks mentioned in this press release are the property of the Sanofi group. </P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
