Financial Performance - The company incurred net losses of 14.1 million for the year ended December 31, 2024, with no revenue generated from product sales [213]. - As of December 31, 2024, the company had approximately 9.2 million in gross proceeds from the sale of 2,830,328 shares under the ATM Program [217]. - The company expects to continue incurring significant operating expenses as it advances its product development activities and seeks regulatory approvals [216]. - The independent registered public accounting firm expressed substantial doubt about the company's ability to continue as a going concern due to significant accumulated deficits and negative operating cash flows [215]. - The company anticipates that its existing capital resources will not be sufficient to fund operations for at least 12 months from the issuance of its financial statements for the year ended December 31, 2024 [217]. Funding and Capital Needs - The company may need substantial additional funding to support ongoing operations and product development, with no committed source of additional capital currently available [221]. - The company completed an IPO in June 2021, raising net cash proceeds of 3.7 million in July 2022 and $3.5 million in May 2023 [217]. Product Development and Market Risks - The company is reliant on the success of its lead product candidate, ibezapolstat, for the treatment of CDI, and any delays in commercialization could materially harm its business [208]. - The company faces high risks in clinical development, including potential adverse side effects that could lead to the abandonment of product candidates [230]. - Market acceptance of ibezapolstat and other product candidates is uncertain, and failure to achieve adequate acceptance could result in limited product revenues [232]. - Clinical trials for product candidates may face delays or negative results, impacting the timeline for regulatory approval and commercialization [270]. - The company must navigate extensive regulatory requirements for product candidates, which are costly and time-consuming, with no guarantee of obtaining necessary approvals [277]. Competition and Market Conditions - The company faces risks associated with competition from larger companies and potential adverse effects from global market conditions [209]. - The company may face competition from generic products sooner than anticipated, which could negatively impact future revenue and profitability [288]. - The Hatch-Waxman Amendments allow the FDA to approve generic drugs, which may lead to competition with the company's products [289]. Regulatory and Compliance Challenges - The company is subject to numerous foreign regulatory requirements, which may include risks associated with local regulations and approval processes [282]. - Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs could have a material adverse effect on the healthcare industry in the U.S. [296]. - The company must comply with ongoing regulatory requirements, and failure to do so could result in penalties, recalls, or withdrawal of approvals [286]. - The company faces significant risks related to compliance with healthcare laws, which could lead to civil and criminal penalties, including exclusion from government-funded healthcare programs [324]. Economic and Environmental Factors - Global economic conditions, including inflation and potential recessions, could negatively impact the company's business and financial condition [250]. - Climate change poses physical risks to the company’s operations, including increased frequency of natural disasters and extreme weather events, potentially leading to higher operational costs [259]. Intellectual Property and Litigation Risks - The company may be involved in costly and time-consuming lawsuits to protect its patents, which could distract management and technical personnel from their normal responsibilities [328]. - The company’s ability to enforce its intellectual property rights is crucial for commercialization, and failure to do so could lead to reduced market share and costly litigation [332]. - The company may incur significant expenses related to intellectual property litigation, which could increase operating losses and reduce resources for development activities [333]. Corporate Governance and Stockholder Issues - The concentration of ownership among major stockholders could limit the influence of other investors on corporate matters [352]. - The company is classified as an "emerging growth company," which allows it to take advantage of reduced reporting requirements, but this may make its stock less attractive to some investors [340]. - The company has never paid cash dividends on its common stock and intends to retain earnings for business growth, meaning capital appreciation will be the sole source of gain for investors [337]. Cybersecurity and Data Privacy - The company faces significant risks related to cybersecurity incidents, which could lead to financial loss and operational disruption [360]. - Legal claims or proceedings may arise from data breaches, potentially resulting in significant legal and financial exposure [366]. - The company may incur substantial costs and potential liabilities to comply with evolving privacy laws [371]. Operational Risks - The company relies on third-party manufacturers for clinical trials and commercialization, which poses risks related to supply and compliance with regulations [310]. - The company is dependent on third-party clinical investigators and CROs, which may lead to less control over the quality and timing of clinical trials [315]. - Internal control systems may fail to prevent errors or fraud, potentially harming the company's financial reporting and operations [390].
Acurx Pharmaceuticals(ACXP) - 2024 Q4 - Annual Report