Risk Factors Update Summary

• Failure to achieve FDA-approved labeling could hinder advertising and differentiation of products.
• Legal proceedings may now involve others beyond executives, potentially affecting reputation and financial results.
• Concentrated substantial research efforts on simufilam, lead product candidate, still under development.
• Inflation rate decreased from 6% to 4% over the last three years.
• Clinical trials for neurodegenerative diseases historically have much higher failure rates than in other areas.
• Reliance on success of simufilam; failure in Phase 3 trials will harm revenue and business.
• Market price of common stock fluctuated from $33 to $11 in the past year.
• The Inflation Reduction Act may reduce prices obtained for product candidates, affecting revenue.
• New product candidates aim to achieve greater acceptance, convenience, and cost-effectiveness than competitors.
• Federal net operating loss carryforwards increased from $133 million to $158 million.
• Changes in laws and regulations could hinder operations, with potential fines or sanctions impacting financial condition.
• Reliance on mild Alzheimer's patients for Phase 3 trials may limit marketability if approved.
• Insufficient insurance coverage may not cover all losses or claims, impacting financial outcomes.
• Potential delays in clinical studies due to patient enrollment challenges and study completion uncertainties.
• Reliance on third parties for clinical studies and research, performance failures could harm studies.
• Failure to lift FDA clinical hold may significantly impact business operations and results.
• Clinical studies conducted outside the U.S. may face FDA data acceptance challenges.