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