Financial Performance and Capital Needs - The company has incurred significant net losses in each period since inception and expects to continue incurring net losses for the foreseeable future [170]. - The company will need to raise substantial additional capital to develop and fully commercialize its product candidates, which may force delays or reductions in product development programs [170]. Internal Controls and Accounting - The company has identified material weaknesses in its internal control over financial reporting, which could lead to material misstatements in financial statements [161]. - The company is in the process of implementing measures to address identified material weaknesses, including hiring additional accounting personnel and developing an accounting policy manual [163]. - The company has not maintained adequate formal accounting policies and processes due to a lack of qualified finance and accounting staff [162]. Product Development and Regulatory Considerations - The company plans to seek special designations, such as orphan drug designation, for its product candidates for various diseases [7]. - The company anticipates that its product candidates' commercial viability remains subject to successful completion of clinical trials and regulatory approvals [172]. Strategic Alternatives and Competition - The company may consider strategic alternatives, including financing and strategic alliances, to maximize stockholder value [171]. - The company faces risks related to competition from marketed drugs targeting similar indications as its product candidates [175]. Intellectual Property - The company recognizes the need to protect its intellectual property rights to maintain its competitive advantage [176].
RenovoRx(RNXT) - 2024 Q3 - Quarterly Report