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Biophytis(BPTS) - 2023 Q4 - Annual Report
2024-04-08 21:02
Financial Performance - The company incurred losses of €31.2 million, €24.3 million, and €17.6 million ($19.5 million) for the years ended December 31, 2021, 2022, and 2023, respectively, primarily due to expenses related to preclinical and clinical programs [64]. - The company expects to continue incurring losses as it develops drug candidates and conducts clinical trials, with no revenue expected from product sales in the foreseeable future [74]. - The company has a history of significant losses since its inception in 2006, raising doubts about its ability to continue as a going concern [62]. - The company anticipates that its current capital resources will only fund planned operating expenses into the first quarter of 2025, indicating a need for additional financing [68]. - The company may need to seek additional funds through public or private equity offerings or debt financings due to changing operating plans and market conditions [68]. Financing and Capital Resources - As of December 31, 2023, the company had cash and cash equivalents of €5.6 million ($6.2 million) and drew down €4 million from its credit facility with ATLAS Special Opportunities LLC [67]. - The company signed a convertible bond financing agreement with ATLAS for up to €32 million, of which €12 million has been issued as of December 2023, with an outstanding debt of €1.45 million [90]. - The company entered into a financing agreement with Kreos Capital VI for up to €10 million, which includes €7.75 million in convertible bonds and €2.25 million in non-convertible bonds [91]. - The company has the capacity to issue two additional tranches of convertible bonds for a total amount of €8 million under the ATLAS agreement, expiring on June 14, 2024 [90]. - The company’s debt agreements impose restrictions that limit operational flexibility, including limitations on incurring additional indebtedness and asset sales [96]. Clinical Development and Drug Candidates - The company has no products approved or authorized for sale, with its lead drug candidate, BIO101 (20-hydroxyecdysone), currently in clinical development, and the second drug candidate, BIO201, still in preclinical development [109]. - The company plans to develop a pipeline of drug candidates targeting age-related diseases, necessitating prioritization of certain candidates and indications [80]. - The company is focused on obtaining necessary marketing approvals from regulatory authorities for its drug candidates [113]. - Future success will depend on the timely completion of clinical trials and the ability to secure additional capital [113]. Clinical Trials and Results - The SARA-PK Phase 1 clinical trial involved 54 healthy adult and elderly subjects, establishing safe dosing levels of 175 and 350 mg b.i.d. for the subsequent Phase 2b trial [122]. - No serious adverse events were reported during the single ascending dose phase of the clinical trial, indicating a favorable safety profile [123]. - The pharmacokinetic analysis showed a short half-life of 3 to 4 hours for BIO101, with steady state reached by the second day of administration [129]. - The company observed a dose-dependent effect on muscle growth and repair, as indicated by plasma Procollagen type III N-terminal peptide (PIIINP) levels [131]. - The SARA-INT Phase 2b study evaluated the safety and effectiveness of two doses of BIO101 (20-hydroxyecdysone) at 175 mg and 350 mg b.i.d. over 26 weeks against a placebo in elderly participants at risk of impaired mobility [189]. Impact of COVID-19 - The company has implemented measures to address disruptions caused by COVID-19, including social distancing and remote work policies, which have affected clinical trial operations [101]. - The company reported a significant impact on clinical trials due to the COVID-19 pandemic, affecting patient movement and healthcare services [166]. - The SARA-INT study involved 233 participants receiving BIO101 at doses of 175 or 350 mg b.i.d. for 6 to 9 months, but only 45% completed the study due to COVID-19 disruptions [135]. - The study was underpowered due to only 45% of participants completing the end-of-study assessments at the clinic [213]. Regulatory and Compliance Risks - The company is subject to various risks, including competition, regulatory scrutiny, and potential product liability lawsuits, which could adversely affect its business [29]. - Regulatory approval may be suspended or withdrawn if compliance with requirements is not maintained [164]. - Regulatory approvals for drug candidates may face delays or denials, impacting commercialization and revenue generation [168]. - The FDA requires compliance with regulations throughout the drug development process, and failure to do so may result in sanctions including license suspension or product recalls [190]. - Legislative changes in the U.S. and EU could impose additional requirements, increasing operating costs and affecting profitability [179]. Market and Economic Conditions - The company may face challenges in obtaining additional financing, which could delay or limit its product development and operations [72]. - The company’s ability to access capital may be negatively impacted by economic downturns resulting from health pandemics, which could affect liquidity and demand for future products [107]. - The cumulative effects of various factors could lead to unpredictability in the company’s annual operating results, making period-to-period comparisons less meaningful [87].
Biophytis (BPTS) Investor Presentation - Slideshow
2023-04-21 15:15
• Sarconeos (BIO101) 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 Rare, genetic neuromuscular disease in male children characterized by accelerated degeneration of muscles, responsible for loss of mobility, respiratory failure and cardiomyopathy, leading to premature death. 20 21 LIVE HEALTHIER LONGER Forward Looking Statements Change from baseline at M6 Gait speed Full Analysis Set Per-Protocol Population p = 0.008 ...
Biophytis(BPTS) - 2022 Q4 - Annual Report
2023-04-18 16:00
Financial Position - As of December 31, 2022, the company had cash and cash equivalents of €11.1 million ($11.8 million) to support its operations[41]. - The company has incurred significant losses since inception and anticipates continued losses for the foreseeable future[40]. - The company expects its existing capital resources will be sufficient to fund planned operating expenses for the next 12 months[198]. - The company may need to seek additional funds sooner than planned due to various unknown factors[198]. - As of December 31, 2022, the company had 238,297,642 ordinary shares outstanding[175]. - The company is classified as an emerging growth company[180]. Drug Development and Regulatory Challenges - The company plans to develop a pipeline of drug candidates targeting age-related diseases, focusing resources on specific diseases and pathways[44]. - The company has no products approved for sale, with its lead drug candidate Sarconeos (BIO101) in clinical development and Macuneos (BIO201) in preclinical development[73]. - The company may face challenges in obtaining regulatory approvals, which are critical for commercialization[64]. - The company is not permitted to market investigational drug candidates in the EU, the United States, or other countries until receiving requisite regulatory approvals[77]. - A small percentage of biotechnology and pharmaceutical products in development successfully complete regulatory approval processes and are commercialized[78]. - Clinical development is lengthy and expensive, with uncertain outcomes; earlier study results may not predict future trial results[79]. - The company may experience delays in obtaining regulatory approval, recruiting suitable patients, and accessing trial sites due to COVID-19 restrictions[82]. - The company may face challenges in demonstrating the safety and efficacy of drug candidates, which could lead to marketing approval delays or restrictions[85]. - The company may incur unplanned costs and may not obtain marketing approval for broader indications or patient populations as intended[99]. - Regulatory authorities may impose additional restrictions or withdraw approvals if undesirable side effects are identified, which could significantly impact revenue[122]. - The contract manufacturer must comply with strict regulatory requirements, and any failure to do so could significantly impact the ability to develop and market drug candidates[140]. - The company may need to secure alternative sources of commercial supply to meet anticipated market demand, which could involve significant challenges and additional regulatory approvals[142]. - The company does not currently have the ability to independently conduct GLP-compliant preclinical studies or GCP-compliant clinical trials, relying on third parties for these activities[143]. - The company faces significant risks related to health pandemics, which could disrupt business operations and delay clinical programs[161]. - Regulatory authorities may experience increased workloads, potentially prolonging review timelines for drug applications and impacting commercialization schedules[152]. - The company may experience delays in obtaining necessary regulatory authorizations for clinical programs, affecting the timeline for initiating studies and trials[166]. Supply Chain and Manufacturing Risks - The company relies on third parties for raw materials and clinical trials, which may impact its operations[32]. - The company relies on a single supplier for the plant material required for Sarconeos (BIO101) and has not established a long-term supply agreement, which poses a risk to clinical trials and future commercialization[111]. - Macuneos (BIO201) relies on a single supplier for the plant material required for its clinical program, with no long-term supply agreement in place, which poses a risk to future clinical trials and commercialization[139]. - The company has not entered into a long-term manufacturing agreement with its contract manufacturing partner, Patheon, which could affect the ability to produce drug candidates for commercialization[127]. - The company is evaluating alternative methods for producing 20-hydroxyecdysone to optimize the supply chain for Sarconeos (BIO101) in anticipation of commercial needs[126]. - The company is evaluating alternative methods for producing norbixin to optimize the supply chain for projected commercial needs[139]. Competition and Market Dynamics - The commercial success of drug candidates will depend significantly on physician and patient adoption, influenced by factors such as safety, efficacy, and competitive pricing[123]. - The company faces competition from larger pharmaceutical and biotechnology firms with greater resources, which may inhibit market penetration efforts[133]. - Competition in the biotechnology and pharmaceutical industries is intense, with numerous companies developing similar healthcare products, which could hinder market penetration[144]. - The company must navigate public misperceptions regarding its therapies, particularly those related to "anti-aging," which could hinder adoption and market success[110]. Financing and Debt Obligations - The company signed a convertible bond financing agreement of €24 million with ATLAS to support the development of Sarconeos (BIO101)[226]. - All convertible bonds related to the ATLAS contract have been converted as of December 31, 2022[226]. - Company signed a new convertible bond financing agreement with ATLAS for €32 million, issuing two tranches totaling €10 million as of December 2022[227]. - Kreos Capital financing agreement provides up to €10 million, including €7.75 million in convertible bonds and €2.25 million in non-convertible bonds[228]. - Non-convertible bonds from Kreos bear a 10% annual interest rate, repayable in 36 monthly installments starting April 2022[228]. - Convertible bonds from Kreos have a 9.5% annual interest rate, with repayment or conversion required by March 31, 2025[228]. - Company issued 2,218,293 warrants to Kreos, allowing the purchase of new ordinary shares at €0.56 per share over seven years[228]. - Potential inability to make required payments may necessitate refinancing, asset sales, or delays in capital expenditures[229]. - Existing debt agreements may restrict refinancing options, potentially leading to higher interest rates and more onerous covenants[229]. - Failure to meet debt obligations could adversely affect the company's financial condition and operations[229]. - Changes in credit and capital markets may increase financing costs and restrict access to liquidity[229]. - Inability to generate sufficient cash flow could materially impact the company's ability to satisfy debt obligations[229].
Biophytis(BPTS) - 2022 Q4 - Annual Report
2023-04-18 16:00
Compliance and Market Status - Biophytis has regained compliance with the Nasdaq Global Select Market minimum bid price requirement, with the closing bid price of its American Depositary Shares at $1.00 or greater for the last 10 consecutive business days from March 30, 2023 to April 13, 2023[7]. - The notification from Nasdaq was received on April 14, 2022, indicating the company's compliance status[6]. Product Development and Clinical Trials - The company is developing Sarconeos (BIO101) as a treatment for sarcopenia, currently in a Phase 2 clinical trial in the United States and Europe[2]. - Sarconeos (BIO101) has shown positive results in a Phase 2-3 study for severe COVID-19 patients, with results released in Q1 2023[2]. - A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy (DMD)[2]. Company Focus and Operations - Biophytis is focused on therapeutics aimed at slowing degenerative processes associated with aging and improving functional outcomes for patients with age-related diseases[2]. - The company is based in Paris, France, and Cambridge, Massachusetts, with its ordinary shares listed on Euronext Growth and ADSs on Nasdaq Capital Market[2]. Forward-Looking Statements - The company considers its forward-looking statements to be based on reasonable assumptions, but acknowledges various risks and uncertainties that could affect actual outcomes[8]. - Biophytis has no obligation to publicly update or review any forward-looking statements except as required by law[8]. Investor Relations - The company’s contact for investor relations is Philippe Rousseau, CFO, available via email for inquiries[10].
Biophytis(BPTS) - 2023 Q1 - Quarterly Report
2023-03-31 14:18
Exhibit 99.1 Press release The Combined General Meeting will be held on second call on April 17, 2023 Paris (France), Cambridge (Massachusetts, U.S.), March 30th, 2023, 11 Pm CET – Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS) (the "Company" or "Biophytis"), 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 informed that the ...
Biophytis(BPTS) - 2021 Q4 - Annual Report
2022-04-20 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...
Biophytis(BPTS) - 2020 Q4 - Annual Report
2021-03-11 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Biophytis(BPTS) - 2020 Q4 - Annual Report
2021-03-11 16:00
Exhibit 99.1 Press release Biophytis' Combined Annual General Meeting Will Take Place on April 26, 2021 behind closed doors Legally required documents for shareholders' votes are available on Biophytis website Paris, France, Cambridge (Massachusetts, United States), March 10, 2021, 8:00 pm 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 are aimed at slowing the degenerati ...