# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-26-268874
**Filing Date:** 2026-6
**Character Count:** 34683
**Document Hash:** 4a4ba7d942c8b7eaeb3591afc4e5394f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-268874.hdr.sgml**: 20260612

**ACCESSION NUMBER**: 0001193125-26-268874

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 6

**CONFORMED PERIOD OF REPORT**: 20260612

**FILED AS OF DATE**: 20260612

**DATE AS OF CHANGE**: 20260612

**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:** 261085497

**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 June 2026

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 June 2026, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2 and 99.3 which are incorporated herein by reference.

**Exhibit Index** 

---

| | |
|:---|:---|
| Exhibit No. | Description |
| Exhibit 99.1 | [Press Release dated June 4, 2026: Sanofi launches 2026 global employee stock purchase plan.](d25308dex991.htm) |
| Exhibit 99.2 | [Press Release dated June 8, 2026: Sanofi's Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector.](d25308dex992.htm) |
| Exhibit 99.3 | [Press Release dated June 10, 2026: Sanofi provides update on MOBILIZE phase 3 study of riliprubart in chronic inflammatory demyelinating polyneuropathy](d25308dex993.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: June 12, 2026 | By  | SANOFI<br>/s/ Alexandra Roger |
|  |  | Name: Alexandra Roger |
|  |  | Title: Head of Legal Corporate & Finance |

---

## Exhibit 99.1

**Exhibit 99.1** 

---

| | |
|:---|:---|
| **Press Release** | ![LOGO](g25308g0605181646095.jpg) |

---

*Sanofi launches 2026 global employee stock purchase plan* 

**Paris, June 4, 2026.** Sanofi's global employee shareholder plan, Action 2026, opens on June 9, 2026, to around 75,000 employees in 52 countries. Now in its 12th year, the program demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve employees in the company's growth and results. In 2025 alone, more than 31,000 Sanofi employees - 44% of the total workforce, chose to invest in the company through the program. Today, nearly 90,000 current or former Sanofi employees are shareholders, and hold approximately 2.93% of its capital.

*"The growing participation in our global employee share purchase plan speaks for itself: our employees believe in Sanofi's transformation and are proud to be part of it. This trust is our greatest asset to accelerate the execution of our strategy and maintain our success in the biopharmaceutical sector."* **Belén Garijo, Chief Executive Officer**

From June 9-29, 2026, employees will be offered shares at a subscription price of €59.87, which is equal to a 20% discount on the average of the 20 opening prices of Sanofi shares from May 6 to June 2, 2026. For every five shares subscribed, employees will be offered one free matching share (up to a maximum of four matching shares per employee). Every eligible employee may purchase up to 1,500 Sanofi shares within the legal limit (maximum payment amount may not exceed 25% of their gross annual salary, minus any voluntary contributions already made in employee savings schemes, such as the Company savings plan and/or the Group savings plan and/or the Group retirement savings plan (PERCO) — voluntary contributions to the separate PERCOL are not concerned by this limit) during 2026.

<u>Detailed conditions</u> 

An eligibility condition of three months employment by the closing date of the offer period will apply. Eligible staff will be able to subscribe for shares from June 9, 2026 (inclusive) to June 29, 2026 (inclusive). The issue is expected to be completed and the delivery of the securities carried out by the end of July 2026. The number of shares offered is limited to 9,816,701 shares.

The new shares, including the matching shares (the "Shares"), will be subscribed (or delivered) either directly or through the intermediary of employee mutual funds ("FCPE"), depending on the regulations and/or tax regime applicable in the various countries of residence of those eligible for the capital increase. The Shares will be fully fungible with the existing ordinary shares comprising the share capital of Sanofi and will be entitled to dividends as from their issuance.

The voting rights attached to the subscribed Shares will be exercised directly by the employees. Shares and the corresponding FCPE units subscribed, in France, within the framework of the Sanofi Group savings plan must be held for a period of approximately five years, i.e., until May 31, 2031, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labor Code. For shares subscribed outside of France within the framework of the Sanofi International group shareholding plan, this period could be shortened to three years, i.e., until May 31, 2029, depending on the legal and tax implications that may arise in the subscriber's country.

Admission of the Shares to trading on the Euronext Paris market (ISIN Code: FR0000120578) on the same line as the existing shares will be requested as soon as possible after the completion of the capital increase.

This press release does not constitute an offer to sell or a solicitation to buy Sanofi shares. The offer of Sanofi shares reserved for employees will only be made in countries where such an offer has been registered with or notified to the competent local authorities and/or following the approval of a prospectus by the competent local authorities, or in consideration of an exemption from the requirement to prepare a prospectus or to register or notify of the offer, where such procedure is required.

![LOGO](g25308g0205182740684.jpg)

------

More generally, the offer will only be made in countries where all required registration and/or notification procedures have been carried out, approvals obtained, and procedures for consulting or informing employee representatives followed.

This press release is not intended for and should not be copied to or distributed in countries where such a prospectus has not been approved or such exemption is not available or where all necessary registration, notification, consultation and/or information procedures have not been completed or authorizations obtained. This relates in particular to Japan, Morocco, and the Philippines, where to date formalities are still pending with the authorities but could also relate to other countries.

*This press release is prepared in accordance with the exemption from publication of a prospectus under Article 1 4°i) and 5°h) of the Prospectus Regulation (EU) 2017/1129. It constitutes the document required to meet the conditions for exemption from publication of a prospectus as defined by the Prospectus Regulation.* 

*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** \| +1 617 356 4751 \| <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>

**Ekaterina Pesheva** \| +1 410 926 6780 \| <u>ekaterina.pescheva@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>

**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>

**Nina Goworek** \| +1 908 569 7086 \| <u>nina.goworek@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>

![LOGO](g25308g0205182740684.jpg)

## Exhibit 99.2

**Exhibit 99.2** 

---

| | |
|:---|:---|
| **Press Release** | ![LOGO](g25308g0605181646095.jpg) |

---

*Sanofi's Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sarclisa administered via the CirCLIQ<sup>®</sup> OBI offers a treatment
experience designed around the needs of patients and HCPs and enables flexible administration in either home or outpatient settings

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Sarclisa is the first anticancer treatment to be administered through an OBI and the first MM treatment available by
both SC OBI and manual injection in the EU

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Efficacy of Sarclisa demonstrated in SC formulation with innovative OBI across all indications and combinations
currently approved for the IV formulation

**Paris, June 8, 2026**. The European Commission has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation. Sarclisa is the first anticancer therapy in the EU to be administered through an on-body injector (OBI) and manual SC administration and can provide the flexibility of administration at patients' homes and in the outpatient setting.

*"Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them. There has been a need for innovative approaches to ease this aspect of the treatment journey,"* said **Mohamad Mohty**, MD, PhD, Professor of Hematology at the Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department at the Saint-Antoine Hospital, Paris, France. *"The ability to administer a therapy through an on-body injector, particularly an anti-CD38 monoclonal antibody with well-established efficacy, either in the clinic or at home represents a meaningful step forward. With this new option now approved, we have an opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care."*

Since launching in 2020, Sarclisa has been prescribed to patients worldwide. Sarclisa IV is currently approved across four indications in the EU, including in combination with bortezomib, lenalidomide, and dexamethasone in both transplant-ineligible newly diagnosed MM (NDMM, TI) and transplant-eligible NDMM (NDMM, TE). In relapsed and/or refractory (R/R) MM, Sarclisa is approved in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib and dexamethasone. The approval of Sarclisa SC, which follows a <u>positive opinion</u> from the European Medicines Agency's Committee for Medicinal Products for Human Use, is based on the <u>results</u> from the pivotal IRAKLIA phase 3 study in R/R MM (<u>NCT05405166</u>), which demonstrated non-inferiority of the SC formulation compared to IV, as well as <u>additional studies</u>.

*"Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered,"* said **Olivier Nataf**, Global Head of Oncology at Sanofi. *"Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the multiple myeloma care continuum. With today's EU approval, we're combining that foundation with the added convenience, flexibility, and accessibility of the CirCLIQ on-body injector, which could offer a meaningful difference in the treatment experience."*

---

| | |
|:---|:---|
| ![LOGO](g25308g0205182740684.jpg)  | 1/4 |

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The IRAKLIA and IZALCO studies suggest the use of an OBI may be associated with greater simplicity, flexibility, convenience and patient satisfaction compared to IV, and that patients and healthcare providers (HCPs) prefer the OBI compared to manual SC administration. In the IRAKLIA phase 3 study, 70% of patients treated with Sarclisa SC administered via an OBI reported being satisfied or very satisfied with their injection compared to 53.4% patients receiving Sarclisa IV (OR 2.036; 95% CI: 1.425-2.908; p=0.0001). In the IZALCO phase 2 study, after experiencing both administration methods, 74.5% of patients preferred Sarclisa SC administered via an OBI over manual injection, compared with only 17% who preferred manual injection and 8.5% with no preference (p=0.0004; binomial test against the null hypothesis of <50% rate), reinforcing strong patient preference for simplified, hands-free administration.

Sarclisa will be used in conjunction with Enable Injections' CirCLIQ<sup>®</sup> OBI, an automated injector developed using the enFuse<sup>®</sup> platform, designed to subcutaneously deliver Sarclisa with the push of a button in either outpatient or home settings. Sarclisa SC administered via the CirCLIQ<sup>®</sup> OBI uses a hidden retractable needle that is shorter and thinner compared to the needles commonly used for large-volume subcutaneous injections.

In the IRAKLIA study, the first phase 3 study to incorporate the use of an OBI in the treatment of MM, Sarclisa SC administered via an OBI in combination with Pd resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio [RR]: 1.008; 95% confidence interval [CI]: 0.903-1.126; p=0.0006), in adult patients with R/R MM who have received at least one prior line of treatment.

The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced systemic infusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in .4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

The most common grade ≥3 nonhematologic adverse events (AEs) were pneumonia (14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract infection (1.5% both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV), thrombocytopenia (26.1%, 23%) and anemia (17.6%, 19.5%).

In patients from countries where at-home administration was permissible, median injection duration with Sarclisa SC via an OBI was the same between clinic and at-home administration (13 minutes). Home administration was well tolerated with no new safety signals and all injections were completed.

**About the IRAKLIA study**

IRAKLIA (clinical study identifier: <u>NCT05405166</u>) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee (IRC), and observed Sarclisa SC mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa SC plasma concentrations.

**About the IZALCO study** 

IZALCO (clinical study identifier: <u>NCT05704049</u>) was a two-part randomized, open-label phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via an OBI or by manual push, in combination with Kd, for the treatment of patients with R/R MM who have received one to three prior lines of therapy. The primary objective was ORR, as assessed by IRC. The secondary objectives were patient and healthcare provider preference for the OBI versus manual administration of Sarclisa SC.

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|:---|:---|
| ![LOGO](g25308g0205182740684.jpg)  | 2/4 |

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**About Enable Injections**

Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse<sup>®</sup> On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit <u>www.enableinjections.com</u>.

**About Sarclisa** 

Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM.

Sarclisa-based regimens have been prescribed to treat nearly 70,000 patients worldwide.

Sarclisa subcutaneous is approved in the EU in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in the EU. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration. Additional regulatory submissions for Sarclisa subcutaneous are currently under review with regulatory authorities worldwide, including in the United States, China, and Japan.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on Sarclisa clinical studies, please visit <u>www.clinicaltrials.gov</u>.

*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** \| +1 617 356 4751 \| <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>

**Ekaterina Pesheva** \| +1 410 926 6780 \| <u>ekaterina.pesheva@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>

**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>

**Nina Goworek** \| +1 908 569 7086 \| <u>nina.goworek@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>yu.li3@sanofi.com</u>

---

| | |
|:---|:---|
| ![LOGO](g25308g0205182740684.jpg)  | 3/4 |

---

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**Sanofi Forward-Looking Statements** 

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as "expect," "anticipate," "believe," "intend," "estimate," "plan," "can," "contemplate," "could," "is designed to," "may," "might," "potential," "objective," "attempt," "target," "project," "strategy," "strive," "desire," "predict," "forecast," "ambition," "guideline," "seek," "should," "will," "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. 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, uncertainties and assumptions 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; authorities' decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including "most favored nation" pricing for State Medicaid programs; 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 pending or 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 French Markets Authority (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, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein.

All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse and CirCLIQ.

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|:---|:---|
| ![LOGO](g25308g0205182740684.jpg)  | 4/4 |

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## Exhibit 99.3

**Exhibit 99.3** 

---

| | |
|:---|:---|
| **Press Release** | ![LOGO](g25308g0605181646095.jpg) |

---

*Sanofi provides update on MOBILIZE phase 3 study of riliprubart in chronic inflammatory demyelinating polyneuropathy* 

**Paris, June 10, 2026.** Sanofi today announced that the riliprubart MOBILIZE phase 3 study (clinical study identifier: NCT06290128) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care treatment will be stopped. This decision follows an interim analysis by an independent data monitoring committee, which determined that the MOBILIZE study is unlikely to provide sufficient efficacy. No safety signals related to riliprubart were identified as part of this interim analysis. The continuation of other ongoing studies with riliprubart, including the VITALIZE phase 3 study (clinical study identifier: NCT06290141) in IVIg-treated patients with CIDP, will be evaluated accordingly.

Sanofi is deeply grateful to the patients, caregivers, and investigators who participated in the MOBILIZE study.

Sanofi will work closely with investigators and site teams to ensure a wind-down of the MOBILIZE study, with appropriate transition of care for all enrolled patients. Sanofi will conduct a thorough analysis of the MOBILIZE data to inform future research directions and contribute to the broader scientific understanding of CIDP.

**Financial considerations** 

The termination of the MOBILIZE phase 3 study will not incur any significant financial cost. There is no change to the financial guidance for 2026.

*About riliprubart* 

Riliprubart (SAR445088, BIVV020) is an IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. By blocking C1s, riliprubart has the potential to inhibit key inflammatory mechanisms that drive demyelination and axonal damage in CIDP. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit <u>www.clinicaltrials.gov</u>.

*About CIDP* 

CIDP is a rare neurological condition that causes progressive weakness and sensory impairment in the arms and legs. CIDP occurs when the body's immune system attacks the myelin sheaths around nerve cells in the peripheral nervous system. Timely diagnosis of CIDP is important because it allows for appropriate treatment, which is essential to preventing long-term disability. However, despite available therapies, many individuals are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality-of-life. Approximately 30% of people with CIDP do not respond to standard therapies. In people with CIDP who do respond, about 70% of the response is considered incomplete. Less than one-third of people with CIDP remain in remission without continued therapy.

------

*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** \| +1 617 356 4751 \| <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>

**Ekaterina Pesheva** \| +1 410 926 6780 \| <u>ekaterina.pesheva@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>

**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>

**Nina Goworek** \| +1 908 569 7086 \| <u>nina.goworek@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 within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as "expect," "anticipate," "believe," "intend," "estimate," "plan," "can," "contemplate," "could," "is designed to," "may," "might," "potential," "objective," "attempt," "target," "project," "strategy," "strive," "desire," "predict," "forecast," "ambition," "guideline," "seek," "should," "will," "goal," or the negative of these, and similar expressions are intended to identify forward-looking statements. 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 U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities' decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including "most favored nation" pricing for State Medicaid programs; 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, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation; trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2025, or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties, and assumptions, you should not place undue reliance on any forward-looking statements contained herein.* 

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