Risk Factors Update Summary

• Limited experience in preparing regulatory filings may hinder successful execution of clinical trials.
• Extensive regulatory obligations and surveillance required for product candidates, leading to significant additional expenses.
• The addition of "could materially and adversely affect" emphasizes potential significant impacts on the business.
• Addition of "shares of" emphasizes the high degree of risk in investing in the company.
• Increased emphasis on the need to manage future growth, recruit qualified personnel, and expand facilities.
• The mention of "significant net losses" and specific values ($36 million and $57 million) highlights financial challenges.
• Increased risk of intellectual property litigation due to potential invalidation of patents or trademarks.
• The company is in early stages of developing NGN-401 and NGN-101, with a small patient population.
• Disclosure of a security breach resulting in the misappropriation of approximately $0.9 million.
• Completed business combination with Neurogene OpCo, issuing one CVR for each outstanding share.
• The company may face delays due to a global shortage of NHPs for preclinical studies.
• Risks related to misconduct by employees, contractors, and collaborators, including noncompliance with regulations.
• Discovery of unknown product problems may lead to restrictions, recalls, penalties, and negative publicity.
• Dependence on key personnel highlighted, with risks of losing executives and challenges in attracting talent.
• Shifted focus to strategic alternatives, incurring additional costs and increased demands on management.
• Potential adverse impact on competitive position due to competitors' ability to sustain complex litigation costs.
• The inclusion of "risks and uncertainties" broadens the scope of factors investors should consider.
• Manufacturing gene therapies is complex; delays or failures could harm development and commercialization.
• Concerns raised about potential security breaches and data privacy issues affecting operations and reputation.
• The mention of "available for distribution to our stockholders" indicates potential losses in case of liquidation.
• Changes in healthcare legislation may hinder revenue generation, profitability, and product commercialization.
• Market acceptance of NGN-401 and NGN-101 depends on factors beyond the company's control.
• Increased litigation risk from stockholders and third parties due to recent merger activity.
• Reliance on third parties for clinical trials may lead to delays or termination, impacting regulatory approval.
• Identification of a material weakness in internal control over financial reporting, with remediation efforts ongoing.
• Changes in patent laws, including the Leahy-Smith Act, may increase uncertainties and costs.
• Expansion into foreign markets and collaborations with third parties emphasized for future growth.
• The mention of "an investment decision" highlights the importance of careful consideration before investing.
• The addition of "face" in "face competition" underscores the competitive landscape the company operates in.
• Uncertainties in patent protection due to evolving U.S. Supreme Court rulings and changes in patent laws.
• Increased focus on compliance with healthcare laws and regulations may result in substantial costs and penalties.
• Risks related to government regulations, including delays in obtaining regulatory approvals for product candidates.
• Market volatility and disruptions may impact business operations, financial condition, and prospects.
• Reliance on third-party manufacturers for drug manufacturing may lead to supply chain disruptions.
• Challenges in meeting chemistry, manufacturing, and control requirements for FDA approval.
• Market price fluctuations of common stock influenced by various factors, including financial projections and market conditions.
• Risks associated with conducting international clinical trials, including regulatory differences and administrative burdens.