Risk Factors Update Summary

• The company disclosed a significant need for additional capital to fund operations, with a shortfall of approximately $187.0 million as of December 31, 2023.
• Potential claims challenging inventorship or ownership of patents may result in loss of valuable intellectual property.
• Financial covenants could limit expenditures, impacting liquidity and operations. Non-compliance may lead to significant consequences.
• Misuse of trademarks by licensees may jeopardize rights and diminish goodwill associated with trademarks.
• Failure to meet Nasdaq listing requirements could result in delisting, impacting stock liquidity and investor confidence.
• The company identified a material weakness in internal controls over financial reporting, remaining unremediated as of December 31, 2023.
• Failure to defend against claims could lead to substantial costs, distraction, and adverse effects.
• The company faces intense competition and rapid technological change, potentially leading to dilution for existing stockholders.
• FDA approval for proprietary product names may require significant resources and potential name changes.
• Risk of being found liable for monetary damages, including treble damages and attorneys' fees.
• Need for substantial additional capital to fund operations and utilize operating loss carryforwards.
• Licensing issues may arise, impacting exclusivity and giving competitors access to licensed technologies.
• Regulatory approval uncertainty may hinder revenue generation and harm business operations.
• The company disclosed a substantial influence of six stockholders owning approximately 43% of outstanding common stock.
• Competitors adopting similar trade names may impede brand identity and lead to market confusion.
• Changes in healthcare legislation and payor methods may impact demand, pricing, and profitability.
• The company may issue additional common stock, potentially causing dilution for existing stockholders.
• Intellectual property risks include uncertainties in patent protection, potential challenges, and enforcement limitations in various jurisdictions.
• The company faces uncertainties and increased costs in obtaining approvals for marketing authorization for future product candidates.
• Potential delays or failures in clinical studies could impact product development timelines and commercialization efforts.
• The company may face delays and increased costs due to evolving regulatory processes and requirements for cellular and gene therapy products.