# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-25-162275
**Filing Date:** 2025-7
**Character Count:** 20537
**Document Hash:** ec01845a4564946d1ff69de21b92cded
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-162275.hdr.sgml**: 20250722

**ACCESSION NUMBER**: 0001193125-25-162275

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 6

**CONFORMED PERIOD OF REPORT**: 20250722

**FILED AS OF DATE**: 20250722

**DATE AS OF CHANGE**: 20250722

**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:** 251138782

**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

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

**FORM 6-K** 

**REPORT OF FOREIGN PRIVATE ISSUER** 

**PURSUANT TO RULE 13a-16 OR 15d-16** 

**UNDER THE SECURITIES EXCHANGE ACT OF 1934** 

For the month of July 2025

Commission File Number: 001-31368

**SANOFI** 

(Translation of registrant's name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

------

In July 2025, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are incorporated herein by reference.

**Exhibit Index** 

---

| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| Exhibit 99.1 | [Press Release dated July 16, 2025: Sanofi's SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration](d945124dex991.htm) |
| Exhibit 99.2 | [Press Release dated July 22, 2025: Sanofi to acquire Vicebio, expanding respiratory vaccines pipeline](d945124dex992.htm) |

---

------

SIGNATURES

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.

---

| | | | |
|:---|:---|:---|:---|
| Dated: July 22, 2025 | SANOFI | SANOFI | SANOFI |
|  | By | /s/ | Alexandra Roger |
|  |  |  | Name: Alexandra Roger |
|  |  |  | Title: Head of Legal Corporate & Finance |

---

## Exhibit 99.1

**Exhibit 99.1** 

---

| | |
|:---|:---|
| **Press Release** | ![LOGO](g945124im02.jpg) |

---

*Sanofi's SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Designation earned for a one-time intravitreal gene therapy designed to
inhibit two key complement cascade pathways

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Geographic atrophy is an advanced form of dry age-related macular
degeneration, that can lead to permanent vision loss

**Paris, July 16, 2025**. The US Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The fast track designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses.

SAR446597 delivers genetic material encoding two therapeutic antibody fragments that target and inhibit two critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway. This dual-targeting approach potentially offers clinical advantages by providing sustained complement suppression within the retinal microenvironment while significantly reducing treatment burden through elimination of frequent intravitreal injections. The therapy aims to address the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins following a single intervention.

Sanofi plans to start a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597.

Sanofi is also currently evaluating SAR402663, a one-time intravitreal gene therapy, in a phase 1/2 study (clinical study identifier: <u>NCT06660667</u>), for the treatment of patients with neovascular wet age-related macular degeneration.

*About age-related macular degeneration and geographic atrophy* 

AMD is an acquired progressive degeneration of the retina that affects approximately 200 million people globally. Geographic atrophy is an advanced form of dry AMD. It is characterized by enlarging irreversible atrophic lesions due to degeneration of retinal cells leading to permanent vision loss in many patients. GA affects approximately 1 million people in the US, more than 2.5 million in Europe, and over 5 million people worldwide and has a profound impact on quality of life, including ability to read, drive and perform other daily activities.

*About Sanofi in neurology* 

Our goal is to improve the lives of people with serious neuroinflammatory and neurodegenerative diseases. We are testing the bounds of clinical possibility to research therapies that may address multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy (CIDP), Alzheimer's Disease (AD), Parkinson's disease (PD), Age-Related Macular Degeneration (AMD) and other neurological diseases for the people who need them most. Emerging scientific innovations and investments in ophthalmology have the potential to drive a new phase of growth for Sanofi. We are exploring innovative therapies in retinal diseases with unmet need especially where they connect with immune system conditions.

---

| | |
|:---|:---|
| ![LOGO](g945124im01.jpg) | 1/2 |

---

------

*About Sanofi* 

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people'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's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

*Media Relations* 

**Sandrine Guendoul** \| +33 6 25 09 14 25 \| <u>sandrine.guendoul@sanofi.com</u>

**Evan Berland** \| +1 215 432 0234 \| <u>evan.berland@sanofi.com</u>

**Léo Le Bourhis** \| +33 6 75 06 43 81 \| <u>leo.lebourhis@sanofi.com</u>

**Victor Rouault** \| +33 6 70 93 71 40 \| <u>victor.rouault@sanofi.com</u>

**Timothy Gilbert** \| +1 516 521 2929 \| <u>timothy.gilbert@sanofi.com</u>

**Léa Ubaldi** \| +33 6 30 19 66 46 \| <u>lea.ubaldi@sanofi.com</u>

*Investor Relations* 

**Thomas Kudsk Larsen** \|+44 7545 513 693 \| <u>thomas.larsen@sanofi.com</u>

**Alizé Kaisserian** \| +33 6 47 04 12 11 \| <u>alize.kaisserian@sanofi.com</u>

**Felix Lauscher** \| +1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Keita Browne** \| +1 781 249 1766 \| <u>keita.browne@sanofi.com</u>

**Nathalie Pham** \| +33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

**Tarik Elgoutni** \| +1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u>

**Thibaud Châtelet** \| +33 6 80 80 89 90 \| <u>thibaud.chatelet@sanofi.com</u>

**Yun Li** \| +33 6 84 00 90 72 \| <u>yun.li3@sanofi.com</u>

**Sanofi forward-looking statements** 

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 "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi'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'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 "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 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.

All trademarks mentioned in this press release are the property of the Sanofi group.

---

| | |
|:---|:---|
| ![LOGO](g945124im01.jpg) | 2/2 |

---

## Exhibit 99.2

**Exhibit 99.2** 

---

| | |
|:---|:---|
| **Press Release** | ![LOGO](g945124g0722145236733.jpg) |

---

*Sanofi to acquire Vicebio, expanding respiratory vaccines pipeline* 

**Paris, July 22, 2025.** Sanofi today announces it has entered into an agreement to acquire Vicebio Ltd ("Vicebio"), a privately held biotechnology company headquartered in London, UK. The acquisition brings an early-stage combination vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), both respiratory viruses, and expands the capabilities in vaccine design and development with Vicebio's 'Molecular Clamp' technology.

The vaccine candidate complements Sanofi's position in the respiratory vaccines space where the company is present in flu and RSV prevention. It allows Sanofi to offer increased physician and patient choice in RSV and hMPV by adding a non-mRNA vaccine to its pipeline.

In addition, the acquisition adds 'Molecular Clamp', an innovative technology that stabilizes viral proteins in their native shape, enabling the immune system to recognize and respond to them more effectively. This approach enables quicker development of fully liquid combination vaccines that can be stored at standard refrigeration temperatures (2–8°C), eliminating the need for freezing or freeze-drying, thereby simplifying manufacturing and distribution. Furthermore, fully liquid vaccines can be made available in prefilled syringes, enhancing ease of use, safety, and operational efficiency across healthcare settings.

"*Vicebio's 'Molecular Clamp' technology introduces a purposefully simple but thoughtful approach to further improve vaccine designs at a time when respiratory viral infections continue to impact millions globally*", said **Jean-François Toussaint**, Global Head of Research and Development Vaccines at Sanofi. "*This acquisition furthers Sanofi's dedication to vaccine innovation with the potential to develop next-generation combination vaccines that could provide protection to older adults against multiple respiratory viruses with a single immunization.*"

*"We are excited to join Sanofi",* said **Emmanuel Hanon**, Chief Executive Officer at Vicebio. *"Their global scale and deep expertise in vaccine development provide the ideal environment to fully realize the potential of our innovative technology. As part of the Sanofi team, we look forward to advancing our platform and pipeline to deliver meaningful benefits for patients and public health."*

Vicebio's pipeline includes VXB-241, a bivalent vaccine candidate targeting RSV and hMPV, currently in an exploratory phase 1 study in older adults, and VXB-251, a preclinical trivalent vaccine candidate targeting RSV, hMPV and parainfluenza virus Type 3 (PIV3). RSV, HMPV and PIV3 are leading causes of lower respiratory tract infections such as pneumonia. While often causing overlapping symptoms such as cough, fever, and respiratory distress, these viruses are antigenically distinct, frequently co-circulating and contributing to seasonal surges in respiratory illness that can lead to older adult frailty, hospitalization and, in some cases, death.

*Financial considerations* 

Under the terms of the agreement, Sanofi would acquire all of Vicebio's share capital for a total upfront payment of $1.15 billion, with potential milestone payments of up to $450 million based on development and regulatory achievements. The transaction is expected to close in Q4 2025, subject to customary closing conditions, including receipt of regulatory approvals. The acquisition will not have a significant impact on Sanofi's financial guidance for 2025.

---

| | |
|:---|:---|
| ![LOGO](g945124im01.jpg) | 1/2 |

---

------

*About Sanofi* 

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people'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's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

*About Vicebio* 

Vicebio is focused on developing next-generation respiratory virus vaccines using the Molecular Clamp Technology. The company was founded with investment from Medicxi and acquired the rights to the Molecular Clamp technology through a license from UniQuest, the commercialization arm of The University of Queensland, Australia. This proprietary technology was developed by Prof. Paul Young, Prof. Daniel Watterson, and Prof. Keith Chappell at UQ. For more information, please visit: <u>https://www.vicebio.com/</u>

*Sanofi Media Relations* 

**Sandrine Guendoul** \| +33 6 25 09 14 25 \| <u>sandrine.guendoul@sanofi.com</u>

**Evan Berland** \| +1 215 432 0234 \| <u>evan.berland@sanofi.com</u> 

**Léo Le Bourhis** \| +33 6 75 06 43 81 \| <u>leo.lebourhis@sanofi.com</u> 

**Victor Rouault** \| +33 6 70 93 71 40 \| <u>victor.rouault@sanofi.com</u> 

**Timothy Gilbert** \| +1 516 521 2929 \| <u>timothy.gilbert@sanofi.com</u> 

**Léa Ubaldi** \| +33 6 30 19 66 46 \| <u>lea.ubaldi@sanofi.com</u> 

*Sanofi Investor Relations* 

**Thomas Kudsk Larsen** \| +44 7545 513 693 \| <u>thomas.larsen@sanofi.com</u> 

**Alizé Kaisserian** \| +33 6 47 04 12 11 \| <u>alize.kaisserian@sanofi.com</u> 

**Felix Lauscher** \| +1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u> 

**Keita Browne** \| +1 781 249 1766 \| <u>keita.browne@sanofi.com</u> 

**Nathalie Pham** \| +33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u> 

**Tarik Elgoutni** \| +1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u> 

**Thibaud Châtelet** \| +33 6 80 80 89 90 \| <u>thibaud.chatelet@sanofi.com</u> 

**Yun Li** \| +33 6 84 00 90 72 \| <u>yun.li3@sanofi.com</u> 

**Sanofi forward-looking statements** 

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 "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi'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'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 "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 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.

---

| | |
|:---|:---|
| ![LOGO](g945124im01.jpg) | 2/2 |

---