# EDGAR Filing Document

**Accession Number:** 0001768946
**File Stem:** 0001104659-25-086148
**Filing Date:** 2025-9
**Character Count:** 9458
**Document Hash:** bc1d2205e0bc7c9ab10dd7e25e8ab99a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-086148.hdr.sgml**: 20250902

**ACCESSION NUMBER**: 0001104659-25-086148

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20250901

**FILED AS OF DATE**: 20250902

**DATE AS OF CHANGE**: 20250902

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Biophytis SA
- **CENTRAL INDEX KEY:** 0001768946
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** I0

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38974
- **FILM NUMBER:** 251283615

**BUSINESS ADDRESS:**
- **STREET 1:** SORBONNE UNIVERSITY, BC 9
- **STREET 2:** BATIMENT A 4EME ETAGE, 4 PLACE JUSSIEU
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75001
- **BUSINESS PHONE:** 33 1 44 37 23 00

**MAIL ADDRESS:**
- **STREET 1:** SORBONNE UNIVERSITY, BC 9
- **STREET 2:** BATIMENT A 4EME ETAGE, 4 PLACE JUSSIEU
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75001

**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**

**Date of report: September 1, 2025**

**Commission File Number: 001-38974**

**BIOPHYTIS S.A.**

**(Translation of registrant's name into English)**

------

**Stanislas Veillet<br> Biophytis S.A.**

**Sorbonne University—BC 9, Bâtiment A 4ème étage**

**4 place Jussieu**

**75005 Paris, France**

**+33 1 44 27 23 00**

**(Address of principal executive office)**

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

⌧ Form 20-F ◻ Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ◻

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ◻

On September 1, 2025, Biophytis S.A. issued a press release unveiling Phase-2 Obesity Trial Strategy with BIO101 in Europe and Brazil. A copy of the press release is attached as Exhibit 99.1 to this Form 6-K.

**EXHIBIT LIST**

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| | |
|:---|:---|
| **Exhibit** | **Description** |
| [**99.1**](tm2525001d1_ex99-1.htm) | [**Press Release dated September 1, 2025.**](tm2525001d1_ex99-1.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.

---

| | | |
|:---|:---|:---|
|  | **BIOPHYTIS S.A.** | **BIOPHYTIS S.A.** |
| **Date: September 2, 2025** | By: | /s/ Stanislas Veillet |
|  |  | Name: Stanislas Veillet |
|  |  | Title: Chairman and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

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| | |
|:---|:---|
| ![](tm2525001d1_ex99-1img01.jpg)<br>| **Press release** |

---

**Biophytis unveils Phase 2 Obesity Trial Strategy**

**with BIO101 in Europe and Brazil**

**Paris, France, Cambridge (Massachusetts, United States), September 1<sup>st</sup>, 2025 – 7:00 a.m. CET** – Biophytis SA ("the Company"), a pioneer in the development of transformative therapies for obesity, sarcopenia, and longevity, today provides a detailed update on its clinical and regulatory plan for the Phase 2 OBA trial of BIO101, targeting muscle wasting associated with obesity. This new program underscores Biophytis's ambition to broaden the potential of its lead candidate BIO101 into high-prevalence global indications, opening significant new value-creation opportunities for the Company and its shareholders.

**Phase 2 OBA Clinical Trial Design**

The OBA Phase 2 trial will be a randomized, double-blind, placebo-controlled study recruiting 164 patients across two key geographies, strategically selected to accelerate development:

&nbsp;&nbsp;&nbsp;&nbsp;· Brazil: 122 patients – providing rapid
recruitment potential in a large target population,

&nbsp;&nbsp;&nbsp;&nbsp;· Europe: 42 patients – enabling early
interaction with European regulators and positioning BIO101 for future EU filings.

These geographies were strategically selected to balance rapid recruitment capabilities in Brazil's large population base (where Biophytis has already signed an exclusive license agreement with Blanver for Latin America) with early regulatory engagement in Europe, ensuring a robust, global dataset to support future registration efforts.

**Strategic Rationale and Business Opportunity**

&nbsp;&nbsp;&nbsp;&nbsp;· Obesity prevalence: Over 1 billion people
worldwide are obese today, including ~150 million adults in Europe and nearly 70 million in Brazil.

&nbsp;&nbsp;&nbsp;&nbsp;· Muscle wasting in obesity (sarcopenic obesity) affects
an estimated up to 40% of obese individuals, translating into a several tens of millions of patients across target regions.

&nbsp;&nbsp;&nbsp;&nbsp;· Direct healthcare costs associated with obesity
and related functional decline exceed hundreds of billions of euros annually across OECD countries, with muscle wasting and
loss of mobility emerging as major cost and disability drivers.

By focusing BIO101 on this intersection of metabolic and muscular health, Biophytis is positioning itself in a first-in-class therapeutic field, with potential addressable markets estimated in the multi-billion-euro range globally.

"*BIO101 has already demonstrated its potential in age-related sarcopenia, and we now see the opportunity to extend its benefits to the vast, underserved population of obese patients suffering from muscle decline*," said Stanislas Veillet, President and CEO. "*This trial not only expands our therapeutic horizons but also significantly enhances the commercial prospects of BIO101*."

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| | |
|:---|:---|
| ![](tm2525001d1_ex99-1img01.jpg)<br>| **Press release** |

---

**Next Development and Investor Milestones**

Biophytis is focused on advancing quickly toward trial initiation, with key steps including:

&nbsp;&nbsp;&nbsp;&nbsp;· Regulatory approvals: Completion of trial authorization
processes in Europe (EMA CTA) and Brazil (IND with ANVISA),

&nbsp;&nbsp;&nbsp;&nbsp;· Site selection and activation: Finalizing agreements
with leading clinical centers in both regions to accelerate patient recruitment,

&nbsp;&nbsp;&nbsp;&nbsp;· Funding strategy: Leveraging a diversified model
including non-dilutive public financing programs, in combination with private and institutional capital.

These milestones are expected to generate upcoming value catalysts, as Biophytis expands its addressable markets and establishes BIO101 as a potential first-in-class therapy for muscle wasting in obesity.

**\*\*\***

**About BIOPHYTIS**

Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start) and metabolic disorders (obesity, Phase 2 ready to start). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company's ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit www.biophytis.com.

**Disclaimer**

This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward- looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face" section from the Company's 2023 Financial Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether because of new information or otherwise, except as required by law.

**Biophytis Contacts**

<u>Investor Relations</u>

<u>Investors@biophytis.com</u>

<u>US Investors</u>

<u>Pascal Nigen – Alpha Bronze</u>

<u>pnigen@alphabronzellc.com</u>

<u>Media contacts</u>

Antoine Denry: <u>antoine.denry@taddeo.fr</u> – +33 6 18 07 83 27

Inès de Mandiargues: <u>ines.demandiargues@taddeo.fr</u> - +33 6 16 16 51 78

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