# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-25-239836
**Filing Date:** 2025-10
**Character Count:** 14002
**Document Hash:** 6c0874932b3abfbaf14fa2b2cc6c38fd
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-239836.hdr.sgml**: 20251015

**ACCESSION NUMBER**: 0001193125-25-239836

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 4

**CONFORMED PERIOD OF REPORT**: 20251015

**FILED AS OF DATE**: 20251015

**DATE AS OF CHANGE**: 20251015

**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:** 251394068

**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 October 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 ☐

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In October 2025, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein by reference.

**Exhibit Index** 

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| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| Exhibit 99.1 | [Press Release dated October 8, 2025: AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors](d10882dex991.htm) |

---

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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: October 15, 2025 | SANOFI | SANOFI |
|  | By | /s/ Alexandra Roger |
|  |  | Name: Alexandra Roger |
|  |  | Title: Head of Legal Corporate & Finance |

---

## Exhibit 99.1

**Exhibit 99.1** 

---

| | |
|:---|:---|
| **Press Release** | ![LOGO](g10882img1.jpg) |

---

![LOGO](g10882img2.jpg)

*AlphaMedix<sup>TM</sup> (<sup>212</sup>Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors* 

• AlphaMedix<sup>TM</sup> showed prolonged and clinically meaningful benefits
across PRRT-naïve and PRRT-exposed patients with unresectable or metastatic GEP-NETs, highlighting the potential of Targeted Alpha Therapy with lead-212 as a new treatment option

• Results will form the basis of future discussions with health authorities

**Paris, October 8, 2025.** Positive results from the ALPHAMEDIX-02 phase 2 study (clinical study identifier: <u>NCT05153772</u>) showed AlphaMedix<sup>TM</sup> (<sup>212</sup>Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR)-Targeted Alpha Therapy using the lead-212 isotope, met all primary efficacy endpoints and showed clinically meaningful overall response rates (ORR) and prolonged clinical benefits in both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients with unresectable or metastatic SSTR positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Benefits in key secondary endpoints, including progression-free survival (PFS) and overall survival (OS), were also observed across both cohorts. AlphaMedix<sup>™</sup> had a manageable safety profile that was similar across both cohorts.

*"The positive results from the ALPHAMEDIX-02 study represent a pivotal movement for the Orano Med <sup>212</sup>Pb-based platform and underscore the profound potential of lead-212-based radiopharmaceuticals in addressing critical unmet needs for patients with GEP-NETs. We are very encouraged by AlphaMedix<sup>™</sup>'s consistent and clinically meaningful activity across both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients," said* **Volker Wagner***, MD, PhD, Chief Medical Officer at Orano Med. "These data reinforce our belief that delivering highly potent alpha-emitters directly to cancer cells could potentially offer a meaningful new treatment option for people living with GEP-NETs."* 

Alpha-emitters are being studied to determine their relative potency and targeted tumor activity compared to current approved therapies. It is believed they could potentially reduce exposure of surrounding healthy tissue due to the short range of alpha particles. In February 2024, AlphaMedix<sup>™</sup> was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for treatment of PRRT-naïve patients with unresectable or metastatic, progressive SSTR-expressing GEP-NETs, recognizing the potential clinical benefits and potential of this lead-212–based therapy.

*"The promising ALPHAMEDIX-02 results represent a significant step forward, reinforcing the potential of targeted alpha therapy to deliver precise treatment for GEP-NETs," said* **Christopher Corsico***, MD, Global Head of Development at Sanofi. "These data, demonstrating clinically meaningful activity and a manageable safety profile, underscore our unrelenting commitment to developing innovative therapies for patients with difficult-to-treat cancers. We look forward to advancing AlphaMedix<sup>™</sup> and working with Orano Med and regulators to bring this important treatment to the GEP-NET community as soon as possible."* 

The study is ongoing, and the full results will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress. The results will also form the basis of discussions with health authorities. AlphaMedix<sup>™</sup> has not been approved by any regulatory authority.

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*About the ALPHAMEDIX-02 study* 

ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix<sup>™</sup> (<sup>212</sup>Pb-DOTAMTATE) in patients with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least one site of measurable disease. The study included two cohorts evaluating PRRT-naïve (n=35) and PRRT-exposed (n=26) patients. PRRT-exposed patients had progressive disease after receiving up to four doses of <sup>177</sup>Lu-DOTATATE and received their last dose at least six months prior to Day 1. In both cohorts, AlphaMedix<sup>™</sup> was administered at 67.6 µCi/kg every eight weeks for up to four cycles (6 mCi maximum per cycle). Primary endpoints included ORR per RECIST1.1 and safety. Secondary endpoints included PFS and OS.

*About NETs* 

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 patients annually are expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate of 60% at a metastatic stage.

*About Orano Med* 

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 lead-212 (<sup>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>212</sup>Pb, the company is developing several treatments using <sup>212</sup>Pb combined with various targeting agents. Orano Med has <sup>212</sup>Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently expanding its GMP-manufacturing capacities for <sup>212</sup>Pb radiolabeled pharmaceuticals in North America and Europe.

*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>

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*<u>Orano Med</u>* 

**Sophie Letournel** \| +33 6 38 44 34 11\| <u>sophie.letournel@orano.group</u>

**Orano Press Office** \| +33 (0)1 34 96 12 15\| <u>press@orano.group</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 except for Orano Med and AlphaMedix<sup>™</sup>.* 

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