0001104659-22-047125.txt : 20220419 0001104659-22-047125.hdr.sgml : 20220419 20220419095139 ACCESSION NUMBER: 0001104659-22-047125 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20220419 FILED AS OF DATE: 20220419 DATE AS OF CHANGE: 20220419 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: 22833650 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 6-K 1 tm2213020d1_6k.htm FORM 6-K

 

 

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: April 19, 2022

 

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 April 19, 2022, Biophytis S.A. issued a press release announcing that the company will present Sarconeos (Bio101) Development Program in Sarcopenia at the 12th annual International Conference on Frailty and Sarcopenia Research (ICFSR) in Boston, April 20-22, 2022. 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 April 19, 2022.

 

 

 

 

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: April 19, 2022 By: /s/ Stanislas Veillet
    Name: Stanislas Veillet
    Title: Chairman and Chief Executive Officer

 

 

 

EX-99.1 2 tm2213020d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Press release

 

Biophytis presents Sarconeos (BIO101) Development Program
in Sarcopenia at the 12th annual International Conference on
Frailty and Sarcopenia Research (ICFSR) in Boston
April 20-22, 2022

 

Paris, France, Cambridge (Massachusetts, United States), April 19th, 2022 – 8am CET - Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today announces it will present and discuss the results of Sarconeos (BIO101) development program in Sarcopenia at the 12th annual International Conference on Frailty and Sarcopenia Research (ICFSR) to be held virtually and on site in Boston from April 20 to April 22, 2022.

 

ICFSR is the key international scientific event on Frailty and Sarcopenia and is attended by leading researchers, physicians and Biotech/Pharma in this field. On Friday 22, April, Cendrine Tourette, PhD (SARA Project Leader) and Pr. Jean Mariani, MD, PhD (Board Director) will give an oral presentation on the results of the Phase 2 SARA-INT trial for the treatment of Sarcopenia.

 

About SARA development program

 

Major operational milestones achieved during 2021 as regards to our Phase 2 SARA-INT trial for the treatment of Sarcopenia:

 

üOn October 4th, the Company announced full results of the study: Sarconeos (BIO101) at the highest dose of 350 mg bid showed an increase of 0.09 meter per second (m/s) in the FAS population and of 0.10 m/s in the PP population compared to placebo in observed data, for the 400MWT in gait speed, after 6 months of treatment in observed data. The Minimal Clinically Important Difference (MCID) for the 400MWT in sarcopenia is 0.1 m/s.

 

üThe product also showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse Events (SAE) related to the product.

 

2022 outlook and perspectives for the SARA program in Sarcopenia:

 

üFollowing the first meeting with the FDA in January 2022, a second meeting is planned in Q3 2022 to discuss the SARA development plan including the Phase 2-3 protocol. The objective is to have a FPI (First patient In) for this new study at the end of H2 2022.

 

üWe also plan to have discussions with EMA during H2 2022, in order to obtain scientific advice on the Phase 2 results and the progression toward a Phase 2-3.

 

üThese plans remain subject to regulatory authorizations and procedures, any delays in patient recruitment or retention, interruptions in sourcing or supply chain, and to COVID-19-related delays.

 

* * * *

 

Page 1 of 2

 

 

 

 

Press release

 

About BIOPHYTIS

 

Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally,) just achieved its phase 2 development as a treatment for sarcopenia in the United States and Europe (SARA-INT). It is also being studied in a clinical two-part Phase 2-3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America, and the US. A pediatric 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 ADS (American Depositary Shares) are listed on Nasdaq (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 "Risks and uncertainties the Company is to face" section from the Company's 2021 Full Year Report and as exposed in the “Risks Factors” section of form 20-F as well as other forms to be filed respectively with AMF and 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 Contact for Investor Relations

Philippe Rousseau, CFO

Investors@biophytis.com

 

Media Contacts

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

Agathe Boggio : agathe.boggio@taddeo.fr – +33 7 62 77 69 42

 

Page 2 of 2

 

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