Financial Performance - The company incurred net losses of $11.7 million and $7.8 million for the years ended December 31, 2021, and 2020, respectively, with an accumulated deficit of $94.0 million as of December 31, 2021[250]. - As of December 31, 2021, the company had $54.7 million in cash and cash equivalents and has not generated positive cash flows from operations[261]. - The company anticipates that the net proceeds from its IPO, along with existing cash and non-dilutive grants, will fund operations into the second half of 2023[261]. - The company may need to raise substantial additional capital to complete the development and commercialization of CT1812 and other product candidates[262]. - The company expects to incur significant expenses and operating losses over the next several years as it conducts ongoing and planned clinical trials for CT1812 and seeks regulatory approval for various age-related diseases[251]. Clinical Development and Regulatory Approval - The company currently has no products approved for sale, with its lead product candidate, CT1812, in early stages of clinical development[290]. - The success of the company is heavily dependent on the successful development, regulatory approval, and commercialization of CT1812, which may take many years[291]. - The FDA may require additional clinical trials for CT1812, which could delay the approval process and limit its market potential[295]. - The company has not yet completed Phase 2 clinical trials and lacks a history of commercializing products, making it challenging for investors to evaluate its business success[255]. - The company may face substantial costs and delays if required to conduct additional clinical trials beyond current plans[310]. Impact of COVID-19 - The ongoing COVID-19 pandemic has caused delays in patient enrollment and retention in clinical trials, impacting the progress of product candidates[276]. - The company has experienced disruptions in clinical trial operations due to COVID-19, including difficulties in recruiting clinical site investigators and staff[277]. - The economic impact of COVID-19 may reduce the company's ability to access capital, negatively affecting liquidity and financial position[287]. - Adjustments to clinical trial protocols have been made to enable remote visits, but these may affect data integrity and trial progress[284]. - The company is unable to predict the duration of patient enrollment delays, which could adversely affect ongoing or future clinical trials[282]. Intellectual Property Risks - The company relies on a combination of patents and trade secrets to protect its intellectual property, but faces challenges in obtaining and maintaining sufficient patent protection for its product candidates[390]. - There is a risk that the company's patent applications may fail to issue or provide meaningful exclusivity, which could hinder collaboration opportunities and commercialization of future products[395]. - The company’s commercial success is partly dependent on avoiding infringement of third-party intellectual property rights, with potential litigation posing significant financial and operational risks[427]. - The company cannot guarantee that its patent searches are complete, which may lead to unrecognized third-party patents that could impact product development and commercialization[431]. - The company may struggle to protect its intellectual property rights globally, as filing and defending patents can be prohibitively expensive, allowing competitors to exploit its technologies in jurisdictions without patent protection[444]. Cybersecurity and Compliance - The company experienced a phishing scheme in November 2021, resulting in a loss of approximately $0.5 million in corporate funds, which was later recovered through cyber-security insurance[377]. - The company has established various security measures to safeguard its information technology systems, but remains vulnerable to cyber-attacks and data breaches, which could lead to significant costs for investigation and remediation[376]. - Compliance with U.S. and foreign data protection laws, such as HIPAA and GDPR, may impose additional obligations and increase compliance costs, potentially affecting the company's operations and financial results[384][383]. - The company has implemented control enhancements following the phishing incident to prevent future occurrences, but acknowledges the ongoing risk of cyber threats[377]. - The potential for regulatory scrutiny and litigation exists if the company experiences a data breach or fails to comply with privacy laws, which could materially affect its financial condition[379]. Market and Competitive Landscape - The company is focused on developing product candidates for age-related degenerative diseases and disorders of the CNS and retina, prioritizing resource allocation among its programs[269]. - Competition with other clinical trials in the same therapeutic areas may reduce the number and types of patients available for the company's trials, potentially increasing costs and delaying outcomes[314]. - The approval process for product candidates varies by country, and failure to obtain international approvals could limit market opportunities[352]. - The company may explore strategic collaborations to broaden its platform but faces significant competition and uncertainty in forming such partnerships[370]. - The company may consider acquisitions to enhance capabilities and expand markets, but risks include integration challenges and unanticipated costs[372].
Cognition Therapeutics(CGTX) - 2021 Q4 - Annual Report