BPTS Biophytis SA

8.1
+0.15  (+2%)
Previous Close 7.95
Open 8.1
52 Week Low 7.895
52 Week High 18.5
Market Cap $101,813,971
Shares 12,569,626
Float 12,569,626
Enterprise Value $85,413,863
Volume 137
Av. Daily Volume 1,673
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Upcoming Catalysts

Drug Stage Catalyst Date
Sarconeos (BIO101) - COVA
COVID-19
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
Sarconeos (BIO101) - MYODA
Duchenne Muscular Dystrophy
Phase 1/2
Phase 1/2
Phase 1/2 study to be initiated in 2022.
Sarconeos (BIO101) - SARA-INT
Sarcopenia
Phase 2
Phase 2
Phase 2 top-line data released August 2, 2021. High dose met primary endpoint. Low dose did not meet primary endpoint. Phase 3 trial planned, noted September 17, 2021.
Macuneos (BIO201)
Dry Age-Related Macular Degeneration (AMD)
Phase 1
Phase 1
Phase 1 clinical trial to be initiated 2H 2021.

Latest News

    • SARA-INT: Positive top line results of Phase 2 study demonstrate efficacy of Sarconeos (BIO101) in sarcopenia and support progress into Phase 3
    • COVA: DMC second interim analysis shows efficacy results in the promising zone allowing continuation of the phase 2/3 study with Sarconeos (BIO101) in COVID-19. Top line results of the full study are expected in Q1 2022
    • Manufacturing scale up signed with a major global CDMO to increase potential supply of Sarconeos (BIO10) in anticipation of COVA positive results
    • Biophytis leadership team reinforced with new senior appointments
    • Cash on hand increased to €23 million as of June 30th 2021, compared to €18.8 million as of December 31 2020, following successful IPO on Nasdaq in February 2021. In addition, new
    • SARA-INT: Positive top line results of Phase 2 study demonstrate efficacy of Sarconeos (BIO101) in sarcopenia and support progress into Phase 3
    • COVA: DMC second interim analysis shows efficacy results in the promising zone allowing continuation of the phase 2/3 study with Sarconeos (BIO101) in COVID-19. Top line results of the full study are expected in Q1 2022
    • Manufacturing scale up signed with a major global CDMO to increase potential supply of Sarconeos (BIO10) in anticipation of COVA positive results
    • Biophytis leadership team reinforced with new senior appointments
    • Cash on hand increased to €23 million as of June 30th 2021, compared to €18.8 million as of December 31 2020, following successful IPO on Nasdaq in February 2021. In addition, new convertible bond financing of €32 million signed with Atlas

    PARIS and CAMBRIDGE, Mass., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today publishes its interim financial report for the first half of 2021 and provides updates on key operational developments and financing transactions.

    Stanislas Veillet, CEO of Biophytis, said: "During the first half of 2021 Biophytis reached a major milestone with positive results from the SARA-INT Phase 2 trial, which demonstrated the efficacy of Sarconeos (BIO101) in sarcopenia. Indeed Sarconeos (BIO101) at the highest dose (350 mg bid) showed a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study. We are now committed to progressing Sarconeos (BIO101) into phase 3 for this indication either alone or through partnerships with pharmaceutical companies.

    Moreover, recommendations from DMC a few days ago for our COVA study to continue without any modification, based upon efficacy results in the promising zone following the second interim analysis, are very encouraging. We hope that Sarconeos (BIO101) will become one of the first drug candidates able to restore breathing capabilities for hospitalized patients in severe conditions, and therefore avoiding their admission to ICUs. The whole Company is now focused on the next milestones, ie complete the trial as soon as possible, as well as industrial scaling up and regulatory approvals in Europe, USA and Brazil. We want to be ready for commercialization of our Sarconeos (BIO101) in COVID-19 first half of 2022.

    From a financial perspective, our cash position was strengthened following our successful IPO in the US market. We also closed a new ORNANE contract with Atlas up to 32M€ securing the outlook of the Company's financing."

    Income Statement Summary (*)

      For the Half Years Ended June 30,
    (amounts in thousands of euros, except share data)       2020  2021 
    Research and development, net of research tax credit (5,192) (7,594)
    General and administrative expenses (2,269) (2,919)
    Operating Loss (7,461) (10,513)
    Net financial expense (1,999) (5,352)
    Loss before taxes (9,460) (15,865)
    Net loss (9,460) (15,865)
    Basic and diluted weighted average number of shares outstanding  37,211,432  110,680,727 
    Basic and diluted loss per share (€/share)  (0.25) (0.14)

    (*) the interim 2021 consolidated financial statements were subject to limited review by the Statutory Auditors.

    Operational Update

    • SARA clinical program in sarcopenia. On August 2, 2021, Biophytis announced top line results of the SARA-INT phase 2 clinical study with Sarconeos (BIO101) in Sarcopenia.



      Sarconeos (BIO101) at the highest dose (350 mg bid) showed a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study. Sarconeos (BIO101) also showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse Events (AE) related to the product.



      The results of Sarconeos (BIO101) on the 400MWT as the primary endpoint are promising since no other alternative treatment exists as of today. This paves the way towards an upcoming confirmatory phase 3 study in sarcopenia and allows further development of Sarconeos (BIO101) in this indication.



      This is a key milestone for Biophytis after 15 years of research and development with Sorbonne University.
    • Phase 2/3 COVA study for acute respiratory failure associated with COVID-19. On September 10 2021, the Data Monitoring Committee (DMC) recommended to continue the Phase 2-3 COVA study without any modification of the protocol after the Interim Analysis 2 found efficacy results in the promising zone, based on 155 COVID-19 patients hospitalized with respiratory failure. This recommendation completes previous safety evaluation performed by DMC last August that confirmed the good safety profile of Sarconeos (BIO101).



      As of September 15, 35 clinical centers are opened to recruit COVID-19 patients in the USA, Brazil, France and Belgium. 200 patients are randomized in COVA trial to this date.



      15 additional sites will be opened to accelerate recruitment in USA, Brazil, France, UK and Belgium, where the COVA study is already approved.



      With this new network of 50 sites, top line results of the study are expected in Q1 2022, depending on the evolution of the pandemic.



      On June 30, 2021, Biophytis announced it had secured contracts with a major global Custom Development and Manufacturing Organization (CDMO) for the manufacturing of registration batches of Sarconeos (BIO101). These contracts were signed in preparation of the potential filing of the product in COVID-19 for Emergency Use Authorization with the FDA, and/or Conditional Marketing Authorization with the EMA.
    • MYODA clinical program in Duchenne muscular dystrophy (DMD). Following Biophytis' receipt of the Investigational New Drug Application obtained from the FDA and authorization from the Belgian authorities in early 2020, the study was delayed due to the COVID-19 pandemic.



      Biophytis now intends to resume preparations for launching the MYODA phase 1/2 clinical trial of Sarconeos (BIO101) in Duchenne muscular dystrophy, which will now be initiated in 2022, depending on the evolution of the pandemic.
    • New senior appointments reinforce Biophytis' leadership teams. On July 8, 2021, Biophytis announced the appointment of Claude Allary as Board member. Claude Allary has 40 years of experience with pharmaceuticals industries and was co-founder of Bionest Partners.



      The Company also hired new experienced healthcare executives:

      - Benoit Canolle, was appointed Chief Business Officer. Benoît brings extensive background in R&D and business development, mostly from Sanofi and Pierre Fabre,

      - Rob van Maanen MD, MBA, FFPM, was named new Chief Medical Officer. Rob was previously CMO of Khondrion, a Dutch clinical-stage company, and has held several senior positions, leading Medical Affairs in numerous global pharma companies: Astellas, Eisai, Novartis and Organon.



      The appointment of these highly experienced healthcare executives strengthens Biophytis' leadership teams at an important time in the development of the Company.

    Financial update

    • Nasdaq IPO successfully closed in February 2021. On February 12, 2021, Biophytis closed its announced initial public offering (IPO) on the Nasdaq Capital Market by way of a capital increase of 12,000,000 ordinary shares represented by 1,200,000 American Depositary Shares (ADSs), with each ADS representing 10 ordinary shares, at a price of $16.75 per ADS. Total gross proceeds were approximately $20.1 million. The Company received net proceeds of approximately $16.35 million or €13.5 million, after deducting underwriting discounts and commissions, management fees and estimated offering expenses payable by the Company. Since February 10, 2021, Biophytis ADSs are listed on the Nasdaq Capital Market (NASDAQ:BPTS).



    • New convertible bond financing signed with Atlas. On June 18, 2021, Biophytis announced a new ORNANE contract with Atlas Capital for €32 million (the "2021 Atlas Contract"). This line of financing can be drawn by Biophytis over the next three years, without obligation, through 8 successive tranches of €4 million each. This facility will allow to secure the Company treasury in order to continue the development of its clinical activities, in particular the further development of Sarconeos (BIO101).

    Interim 2021 Financial Results

    • Cash and Cash Equivalents. Cash and cash equivalents as of June 30, 2021 were €23 million, an increase of €4.7 million as compared to €18.3 million as of December 31, 2020, and an increase of €10.8 million vs €12.2 million as of June 2020.



      During the 1st half of 2021, cash used in operating activities and investing activities amounted to €-0.9 million, compared to 0 last year. Cash provided by financing activities amounted to €18.1 million for the first half of 2021, compared to €5.8 million last year.
    • Research and Development Expenses. Net research and development expenses were €7.6 million for the 1st half of 2021, an increase of €2.4 million as compared to €5.2 million for the 1st half of 2020. This increase was primarily related to the advancement of our lead drug candidate, Sarconeos (BIO101), in the COVA phase 2-3 program, and activities related to the final completion of our SARA-INT phase 2 program.



    • General and Administrative Expenses. General and administrative expenses were €2.9 million for the 1st half of 2021, an increase of €0.6 million as compared to €2.3 million for the 1st half of 2020 linked to our Nasdaq listing.



    • Financial loss. Our financial loss increased from €2.0 million last year to €5.4 this year. reflecting the accrual of financial costs incurred by Biophytis following the execution of the judgment rendered on July 16, 2021, by the Paris Judicial Court in the proceedings between Biophytis and Negma Group Ltd.



    • Net Loss. Net loss was €15.9 million for the 1st half of 2021, as compared to €9.5 million for the 1st half of 2020. In addition to clinical costs ramping up linked to our COVA development, net loss was highly impacted by financial loss (re above). Net loss per share (based on weighted-average number of shares outstanding over the period) was €0.14 for the 1st half of 2021 and €0.25 for the 1st half of 2020.

    The cash and cash equivalents available as of June 30, 2021, amounted to €23 million. The Company believes that this amount, supplemented by existing lines of credit, is sufficient to cover the Company's cash requirements for the next 12 months.



    The share capital of Biophytis is comprised of 125 762 242 ordinary shares outstanding as of September 16, 2021.

    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 and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial 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) and 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 2020 Annual 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 Contact for Investor Relations

    Evelyne Nguyen, CFO

    Investors@biophytis.com

    Media contact

    Life Sci Advisors

    Sophie Baumont

    E: sophie@lifesciadvisors.com 

    T: +33 6 27 74 74 49 



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    • The independent DMC (Data Monitoring Committee) recommends continuation of Part 2 of the Phase 2-3 Study ("the COVA Study") without any protocol amendment
    • The second Interim Analysis ("IA2") based on 155 hospitalized patients shows no futility, with efficacy results in the promising zone, indicating that BIO101 remains a candidate treatment for acute respiratory failure associated with COVID-19
    • To date, 200 patients have been enrolled in COVA study and 15 additional sites in USA, Brazil, France, UK and Belgium will be opened to accelerate patient recruitment and report top line results depending on the evolution of the pandemic in Q1 2022

    PARIS and CAMBRIDGE, Mass., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth…

    • The independent DMC (Data Monitoring Committee) recommends continuation of Part 2 of the Phase 2-3 Study ("the COVA Study") without any protocol amendment

    • The second Interim Analysis ("IA2") based on 155 hospitalized patients shows no futility, with efficacy results in the promising zone, indicating that BIO101 remains a candidate treatment for acute respiratory failure associated with COVID-19
    • To date, 200 patients have been enrolled in COVA study and 15 additional sites in USA, Brazil, France, UK and Belgium will be opened to accelerate patient recruitment and report top line results depending on the evolution of the pandemic in Q1 2022

    PARIS and CAMBRIDGE, Mass., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces the recommendation by the Data Monitoring Committee (DMC) to continue the Phase 2-3 COVA study without any modification of the protocol, after the interim efficacy data were found in the promising zone in the Interim Analysis 2 based on 155 COVID-19 patients hospitalized with respiratory failure. This recommendation completes previous safety evaluation performed by DMC last August (Press Release August, 16th) that confirmed the good safety profile of Sarconeos (BIO101).

    Dr Muriel Lins, COVA trial coordinator in Belgium declared: "with the emergence of the delta variant in Europe, we are happy that this second interim analysis leads to continuation of the COVA study. Patient recruitment will be continued intensively in Belgium and in France to reach full completion of the study."  

    Dr Girish Nair COVA trial coordinator in USA declared: "USA Investigators are welcoming the continuation of the COVA trial as a very good opportunity to restart recruitment when the DMC meeting outcome will be shared with the FDA."

    Stanislas Veillet, CEO of Biophytis declared: "We are thrilled with the DMC recommendation following the second Interim Analysis to continue the COVA study unmodified. The DMC recommendation suggests that the trial is well on track to lead to conclusive efficacy results at final analysis. We hope that Sarconeos (BIO101) will become one of the first drug candidates able to restore breathing capabilities of hospitalized patients in severe conditions, and therefore avoiding their admission to ICUs. The whole Company is now focused on the next milestones, i.e. complete the trial as soon as possible, as well as its industrial scaling up and regulatory approval in Europe, USA and Brazil. We want to be ready for commercialization of our Sarconeos (BIO101) in COVID-19 first half of 2022."

    The COVA DMC has met on September 10th 2021 for the Interim Analysis 2 to review the safety and efficacy data of the first 155 randomized patients. The DMCs recommendation is based on the promising zone analysis published by Mehta and Pocock in 2011, and especially on the conditional power for the primary endpoint evaluated with interim analysis. The COVA study primary endpoint is the proportion of participants with "negative events" of either the following: all cause mortality; respiratory failure defined as requiring mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO).

    Interim analysis 2 results shows that the study is currently in the promising zone, therefore the sample size remains unmodified per the current protocol i.e. between 310 and 465 patients, indicating that Sarconeos (BIO101) remains a candidate treatment for acute respiratory failure associated with COVID-19. The study is not in the unfavourable zone, that would have led to stopping for futility, and has not demonstrated statistically significant efficacy yet, which would have led to early stopping for efficacy.

    The DMC recommendation will be shared with all regulatory agencies to continue patient recruitment. 35 clinical centers are now opened to recruit COVID-19 patients in the USA, Brazil, France and Belgium. Today, 200 patients are randomised in COVA trial. To accelerate recruitment, 15 additional sites will be opened in USA, Brazil, France, UK and Belgium, where the COVA study is already approved. With this new network of 50 sites, top line results of the study are expected in Q1 2022, depending on the evolution of the pandemic.

    The COVA clinical program (clinicaltrials.gov identifier: NCT04472728) is a global, multicentre, double-blind, placebo-controlled, group-sequential and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19. Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, and tolerability and efficacy of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19. Part 2 of the COVA Study is a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function of 310 to 465 COVID-19 patients (including the 50 patients from Part 1 of the study).

    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 and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19.Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial 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) 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 2020 Annual Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risks 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 Contact for Investor Relations

    Evelyne Nguyen

    Investors@biophytis.com

    Media contact

    LifeSciAdvisors

    Sophie Baumont

    E: sophie@lifesciadvisors.com

    T: +33 6 27 74 74 49



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  1. PARIS and CAMBRIDGE, Mass., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces its management will participate and meet with investors at the following upcoming events and conferences:

    • H. C. Wainwright 23rd Annual Global Investment Conference
      September 13 to 15 - Virtual
    • Amsterdam MidCap Event
      September 20 to 21 - Virtual
    • Investor Access Event
      September 27 to 28 - Paris
    • HealthTech Innovation…

    PARIS and CAMBRIDGE, Mass., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces its management will participate and meet with investors at the following upcoming events and conferences:

    • H. C. Wainwright 23rd Annual Global Investment Conference

      September 13 to 15 - Virtual
    • Amsterdam MidCap Event

      September 20 to 21 - Virtual

    • Investor Access Event

      September 27 to 28 - Paris

    • HealthTech Innovation Days

      October 4 to 5 - Paris

    • European MidCap Event

      October 19 to 22

    • Galien Medstartup 2021

      October 25 to 29 - New York
    • Geneva MidCap Event

      December 1 to 2

    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 and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, in development for the treatment of sarcopenia in a Phase 2 clinical trial 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) and 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 2020 Annual 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 Contact for Investor Relations

    Evelyne Nguyen, CFO

    Investors@biophytis.com

    Media contact Life Sci Advisors

    Sophie Baumont

    E: sophie@lifesciadvisors.com 

    T: +33 6 27 74 74 49



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    • Rob van Maanen MD, MBA, FFPM, becomes Chief Medical Officer, member of the Executive Committee

    PARIS and CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, today announces the appointment of Rob van Maanen MD MBA as Chief Medical Officer, member of the Executive Committee.

    Stanislas Veillet, CEO of Biophytis, said: "I am very pleased to welcome Rob van Maanen to Biophytis. Rob brings with him extensive experience in drug development from both global pharma…

    • Rob van Maanen MD, MBA, FFPM, becomes Chief Medical Officer, member of the Executive Committee

    PARIS and CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, today announces the appointment of Rob van Maanen MD MBA as Chief Medical Officer, member of the Executive Committee.

    Stanislas Veillet, CEO of Biophytis, said: "I am very pleased to welcome Rob van Maanen to Biophytis. Rob brings with him extensive experience in drug development from both global pharma and biotech companies. He joins us at an important time for the Company after we recently announced encouraging results of Sarconeos (BIO101) in the COVID-19 and sarcopenia studies. Rob replaces Pr Jean Mariani who has held the CMO's responsibilities in the past 2 months transition period. I would like to thank Jean for taking on the role in the interim for us."

    Rob van Maanen is an MD graduate from the University of Utrecht (NL), holds an MBA from University of Amsterdam (NL), as well as medical licences in the UK and the Netherlands. He is an expert in global drug development, medical affairs, and pharmacovigilance with more than 20 years of experience in both large pharmaceutical companies and small biotechs. With large pharma companies, his past roles include Senior Medical Director with Astellas, but also numerous clinical management and pharmacovigilance positions for Roche, Novartis, Eisai and Organon, where he has led multiple studies through both FDA and EMA requirements. With the Biotech sector, just before joining Biophytis, Rob was holding the CMO position for Khondrion, a dutch clinical-stage company discovering and developing therapies targeting orphan inherited mitochondrial diseases.

    Rob van Maanen, CMO of Biophytis, said: "I'm very excited to be joining Biophytis at a crucial time where the Company is making strong progress in its clinical programs, and with its leading product Sarconeos (BIO101) potentially reaching the market in a short time frame. I look forward to working on Biophytis' next strategic milestones."

    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 and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, in development for the treatment of sarcopenia in a Phase 2 clinical trial 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) and 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 2020 Annual 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.

    Investor Relations contact

    Biophytis

    Evelyne Nguyen, CFO

    Investors@biophytis.com

    Media contact

    Life Sci Advisors

    Sophie Baumont

    sophie@lifesciadvisors.com

    +33 6 27 74 74 49



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    • The independent DMC (Data Monitoring Committee) of the COVA study recommends to continue patients recruitment into Part 2 of the phase 2-3 study following randomization of the first 155 patients
    • Efficacy data from the second Interim Analysis is expected to be reviewed by DMC in Q3 2021
    • Top line results of the full study on 310 patients are expected in Q4 2021, depending on COVID-19 pandemic

    PARIS and CAMBRIDGE, Mass., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe…

    • The independent DMC (Data Monitoring Committee) of the COVA study recommends to continue patients recruitment into Part 2 of the phase 2-3 study following randomization of the first 155 patients
    • Efficacy data from the second Interim Analysis is expected to be reviewed by DMC in Q3 2021
    • Top line results of the full study on 310 patients are expected in Q4 2021, depending on COVID-19 pandemic

    PARIS and CAMBRIDGE, Mass., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces the recommendation by the Data Monitoring Committee (DMC) to continue patient recruitment into part 2 of the COVA study with the protocol unmodified after review of safety data.

    The independent DMC meeting was dedicated to the analysis of safety data from the first 155 patients randomized in the Phase 2-3 COVA Study in COVID-19. The efficacy data of those 155 patients will be reviewed by the DMC in Q3 2021 as part of the second Interim analysis to make recommendation regarding futility and final sample size.

    As of today 191 patients have been randomized in 36 clinical centers opened in the USA, Brasil, France and Belgium.

    Stanislas Veillet, CEO of Biophytis, declared: "The DMC recommendation to continue the COVA study with an unchanged protocol based on the safety analysis of the first 155 patients is a very positive news. It's confirming the good safety profile of Sarconeos (BIO101) in hospitalized COVID-19 patients. We are now waiting for DMC recommendation based on efficacy analysis in Q3 2021. The COVA team is working hard to complete recruitment of the 310 patients and report top line results in Q4 of 2021."

    The COVA clinical program (clinicaltrials.gov identifier: NCT04472728) is a global, multicentric, double-blind, placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19.

    Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, and tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19.

    Part 2 of the COVA Study will be a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function of 310 or up to 465 COVID-19 patients (including the 50 patients from Part 1 of the study).

    The final sample size will depend upon DMC recommendations from the second interim analysis.

    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 and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19.Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial 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) 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 2020 Annual Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risks 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 Contact for Investor Relations

    Evelyne Nguyen

    Investors@biophytis.com 

    Media contact

    LifeSciAdvisors

    Sophie Baumont

    E: sophie@lifesciadvisors.com

    T: +33 6 27 74 74 49



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