# EDGAR Filing Document

**Accession Number:** 0001768946
**File Stem:** 0001104659-23-027453
**Filing Date:** 2023-3
**Character Count:** 9353
**Document Hash:** 8cd26a54f6a479c972586650cfea9b67
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-027453.hdr.sgml**: 20230301

**ACCESSION NUMBER**: 0001104659-23-027453

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20230228

**FILED AS OF DATE**: 20230301

**DATE AS OF CHANGE**: 20230301

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Biophytis SA
- **CENTRAL INDEX KEY:** 0001768946
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** I0

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38974
- **FILM NUMBER:** 23695103

**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: February 28, 2023**

**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)**

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 February 23, 2023, Biophytis S.A. issued a press release it is initiating the regulatory process for an early access authorization in France from the French National Authority for Health (HAS) for the treatment with Sarconeos (BIO101) of severe forms of COVID-19.

. A copy of the press release is attached as Exhibit 99.1 to this Form 6-K.

**EXHIBIT LIST**

---

| | |
|:---|:---|
| **Exhibit** | **Description** |
| [<u>99.1</u>](tm238225d1_ex99-1.htm) | [<u>Press Release dated February 28, 2023.</u>](tm238225d1_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: February 28, 2023 | By: | /s/ Stanislas Veillet |
|  |  | Name: Stanislas Veillet |
|  |  | Title: Chairman and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm238225d1_ex99-1img001.jpg)

**Press release**

**Biophytis initiates the regulatory process for an early access authorization in France from the French National Authority for Health (HAS) for the treatment with Sarconeos (BIO101) of severe forms of COVID-19**

&nbsp;&nbsp;&nbsp;&nbsp;· **Biophytis to present the early access application in France at a pre-filing meeting in March with the HAS** 

&nbsp;&nbsp;&nbsp;&nbsp;· **Biophytis plans to file the application shortly after with the objective of obtaining early access authorization in France in the second quarter of 2023** 

&nbsp;&nbsp;&nbsp;&nbsp;· **Biophytis is pursuing in parallel the preparation of the conditional marketing authorization application due to the health emergency in Europe and the United States** 

**Paris (France), Cambridge (Massachusetts, USA), February 27, 2023, 8:00 a.m. CET** - Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS) (the "Company" or "Biophytis"), a biotechnology company focused on the development of drugs to slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, announced today that it has begun the process of early access application in France from the French National Authority for Health (HAS) for the treatment of severe COVID-19 with Sarconeos (BIO101). A pre-submission meeting with the HAS is scheduled for March and the application for early access authorisation should be submitted shortly after with the aim of obtaining authorisation in the second quarter of 2023. This programme would allow patients hospitalised in France with a severe form of COVID-19 to access treatment with Sarconeos (BIO101), which has been shown to reduce the risk of respiratory failure and early death by 44% in the positive phase 2-3 COVA clinical trial. Biophytis continues to prepare conditional marketing authorisation applications in Europe and in the US due to the health emergency.

 

*Stanislas Veillet, CEO of Biophytis, said: "We aim to accelerate the availability of Sarconeos (BIO101) to hospitalized patients in France with severe forms of COVID-19 through an early access program that we will present to the HAS in the coming weeks. Sarconeos (BIO101) is a drug candidate that has been shown in the positive phase 2-3 COVA clinical trial to reduce the risk of respiratory failure and early death in these patients by 44%. We plan to file the application formally shortly after with the objective of obtaining approval to start this programme in the second quarter of 2023. In parallel, we are also preparing a conditional approval application due to the health emergency in Europe and the US."*

![](tm238225d1_ex99-1img001.jpg)

**Press release**

The early access in France is granted by the HAS after the National Agency for the Safety of Medicines and Health Products (ANSM) has given its opinion on the presumption of efficacy and safety. This is a system that allows the provision and early financial coverage, on an exceptional and derogatory basis, of certain medicinal products that meet an unmet medical need, that are likely to be innovative but have not yet been authorised in a therapeutic indication.

**About BIOPHYTIS**

Biophytis SA is a clinical stage biotechnology company focused on the development of therapeutics aimed at slowing the degenerative processes associated with aging and improving functional outcomes in patients suffering from age-related diseases, including severe respiratory failure in patients with COVID-19. Sarconeos (BIO101), our lead drug candidate, is a small molecule, orally administered drug that is planned to be developed as a treatment for sarcopenia in upcoming Phase 3 clinical trials in the US, Brazil and Europe (SARA-31 and SARA-32). It has also been studied in a two-part Phase 2-3 clinical trial (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America and the US. A paediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne muscular dystrophy (DMD). The company is based in Paris, France and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and the American Depositary Shares (ADS) are listed on the Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040). For more information, visit <u>www.biophytis.com</u>

**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 of these words or other comparable words. These forward-looking statements are based on assumptions that Biophytis believes are reasonable. However, there can be no assurance that the statements contained in these forward-looking statements will prove to be accurate, as they are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not presently known to Biophytis or that are not presently considered material by Biophytis. Therefore, important factors exist or will exist that could cause actual results to differ materially from those indicated in these statements. Please also refer to the "Risks and Uncertainties Facing the Company" section of the company's 2022 interim financial report available on the BIOPHYTIS website (www.biophytis.com) and as set forth in the "Risk Factors" section of the company's Form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We do not undertake to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.

![](tm238225d1_ex99-1img001.jpg)

**Press release**

**Investor Relations Contact**

Philippe Rousseau CFO

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

**Media contact**

Antoine Denry : <u>antoine.denry@taddeo.fr</u> +33 6 18 07 83 27<br> Agathe Boggio : <u>agathe.boggio@taddeo.fr</u> +33 7 62 77 69 42