Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
June 14 2024 - 10:49AM
Edgar (US Regulatory)
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: June 14, 2024
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 June 12, 2024, Biophytis S.A. issued a press release announcing
the successful industrial transfer of BIO101 (20-hydroxyecdysone) production by its service provider Seqens. A copy of the press release
is attached as Exhibit 99.1 to this Form 6-K.
EXHIBIT LIST
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.
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BIOPHYTIS S.A. |
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Date: June 14, 2024 |
By: |
/s/ Stanislas Veillet |
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Name: Stanislas Veillet |
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Title: Chairman and Chief Executive Officer |
Exhibit 99.1
Press release
Biophytis
announces the successful industrial transfer
of BIO101 (20-hydroxyecdysone) production by its service provider Seqens
Paris (France)
and Cambridge (Massachusetts, USA), June 12, 2024 – 07:00 am CET – Biophytis SA (Euronext Growth Paris : ALBPS), ("Biophytis"
or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases,
announces the successful transfer of BIO101 (20-hydroxyecdysone) production to industrial scale by Seqens.
Seqens, an integrated
global player in solutions and ingredients for the pharmaceutical and speciality markets, offering a broad portfolio of active ingredients,
pharmaceutical intermediates and speciality products, has produced the first GMP-compliant batch of BIO101 (20-hydroxyecdysone) at its
plant in Villeneuve La Garenne (Île-de-France). This batch is now available for use in Biophytis' clinical development programme
to treat respiratory deterioration in patients with Duchenne Muscular Dystrophy (DMD).
DMD is a rare genetic
disease that causes severe and progressive muscle degeneration, mainly affecting boys. BIO101 (20-hydroxyecdysone) has significant potential
to improve respiratory capacity and quality of life in non-ambulatory patients in the advanced stages of the disease.
Stanislas Veillet,
CEO of Biophytis, stated: "This is a crucial step in the development of our drug candidate. The successful transfer of production
to industrial scale by Seqens strengthens our ability to provide unique therapeutic solutions. It also reflects our commitment to collaborate
with leading partners to accelerate the development and availability of innovative treatments and the launch of our clinical programmes
in Duchenne muscular dystrophy."
Biophytis, which
has already orphan drug designation in Europe and the United States in the DMD indication and has refined its protocol, submitted to
the European and American regulatory agencies, is seeking partners and funding to launch a phase 1-2 clinical trial in non-ambulant DMD
patients suffering from respiratory failure. The aim of this clinical trial will be to assess the pharmacokinetics, safety and clinical
efficacy of BIO101 (20-hydroxyecdysone) in this indication.
* * * *
About BIOPHYTIS
Biophytis SA is
a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone),
our lead drug candidate, is a small molecule in development for muscular (sarcopenia, phase 3 ready and Duchenne muscular dystrophy),
respiratory (Covid-19 phase 2-3 completed) and metabolic diseases (obesity, phase 2 to be started). 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 OTC market (Ticker: BPTSY – ISIN: US09076G4010). For more information, visit www.biophytis.com
Press release
Forward-looking
statements
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 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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