BPTS Biophytis SA

 

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: November 2, 2023

 

Commission File Number: 001-38974

 

BIOPHYTIS S.A.

(Translation of registrant’s name into English)

 

 

Stanislas Veillet
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:

 

x 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 October 30, 2023, Biophytis S.A. issued a press release announcing that Biophytis and Innovation Solutions Pharma sign a partnership agreement to accelerate market access for Sarconeos (BIO101) in Brazil. A copy of the press release is attached as Exhibit 99.1 to this Form 6-K.

 

EXHIBIT LIST

 

Exhibit		Description
99.1		Press Release dated October 30, 2023.

 

 

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.
Date: November 2, 2023	By:	/s/ Stanislas Veillet
		Name: Stanislas Veillet
		Title: Chairman and Chief Executive Officer

 

Exhibit 99.1

 

 

Press Release

 

Biophytis and Innovation Solutions Pharma sign a partnership agreement to accelerate market access for Sarconeos (BIO101) in Brazil

 

Paris (France) and Cambridge (Massachusetts, USA), October 30 ,2023 – 06:00 – Biophytis SA (Nasdaq CM : BPTS, Euronext Growth Paris : ALBPS), («Biophytis»), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, announces the signature of a partnership with Innovation Solutions Pharma, a company specializing in support for clinical development and drug registration operations in South America, with a view to accelerate market access for Sarconeos (BIO101) in Brazil.

 

As part of this partnership, Innovative Solutions Pharma will represent Biophytis in front of the Brazilian agency ANVISA to lift the suspension of the Early Access Program (EAP) authorized at the beginning of 2022. This program will enable a maximum of 80 patients suffering from critical forms of COVID-19 to be treated for 28 days under mechanical ventilation in the intensive care units of Brazilian hospitals. The aim is to offer a therapeutic alternative to prevent death of these patients.

 

While the number of patients hospitalized with COVID-19 is currently rising sharply in Brazil and around the world, there are still very few options available for treating severe forms of the disease.

 

ANVISA's approval of an EAP is based primarily on the following criteria:

 

§

The product is intended for patients suffering from a serious disabling and/or life-threatening disease.

§

There is no satisfactory therapeutic alternative in the treatments already registered in Brazil.

§

Authorization to use the product is granted on request, and only under the responsibility of the prescribing practitioner, as it is likely to be of significant benefit to the patient.

 

Stanislas Veillet, Chief Executive Officer of Biophytis, stated: “Making Sarconeos (BIO101) available to Brazilian patients hospitalized in intensive care due to Covid-19 represents a key step towards bringing our treatment to market. This program will enable us to treat critical patients and generate important new information on the safety and efficacy of our treatment in real-life conditions. Biophytis aims to start this early access program in Brazil in the first quarter of 2024, and to continue expanding our early access program in France and in other countries.”

 

***.

 

About BIOPHYTIS

 

Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. Sarconeos (BIO101), our lead drug candidate, is a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (Covid-19) diseases. Promising clinical results were obtained in the treatment of sarcopenia in an international phase 2 study, enabling the launch of a phase 3 study in this indication (SARA project). The safety and efficacy of Sarconeos (BIO101) in the treatment of severe COVID-19 were studied in a positive international phase 2-3 clinical trial (COVA project). A pediatric formulation of Sarconeos (BIO101) is currently being developed for the treatment of Duchenne Muscular Dystrophy (DMD, MYODA project). 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 ADSs (American Depositary Shares) are listed on Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040).

 

 

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 2022 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 as a result of new information, future developments or otherwise, except as required by law.

 

Biophytis contacts

 

Investor relations

Nicolas Fellmann, CFO

Investors@biophytis.com

 

Media

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

Nizar Berrada: nizar.berrada@taddeo.fr – +33 6 38 31 90 50

 

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