Risk Factors Update Summary

• Emphasis on the need for patent term extension to protect drug candidates and business interests.
• Mention of net losses of $117.7 million in 2023, $95.6 million in 2022, and accumulated deficit of $191.3 million.
• Transition from "product" to "drug" throughout risk factors, emphasizing drug toxicity concerns.
• Highlighting the risks associated with adverse events, toxicities, and side effects of drug candidates.
• Exclusive license agreement with WSU for certain licensed patents generated through U.S. government funding.
• Received a grant from NIA to support ACT-AD clinical trial, potentially impacting operations.
• Introduction of potential Unitary Patent system in Europe affecting patent practices.
• Mention of the Consolidated Appropriations Act, 2023, impacting drug approval and marketing.
• Transition from "product" to "drug" throughout risk factors, emphasizing focus on drug development.
• Importance of raising capital for development programs and potential delays or terminations without adequate funding.
• Emphasis on the need for successful clinical trials and regulatory approvals for future revenue generation.
• Need for sufficient quantities of drug candidates for clinical trials and potential disruptions in supply chain.
• Potential impact of the Inflation Reduction Act of 2022 on drug pricing and industry lawsuits.
• Shift from "peripheral" to "PNS" disorder indications for drug development focus.
• Risks relating to cybersecurity vulnerabilities and potential adverse consequences from security incidents.
• Increased focus on ESG matters may lead to incurring additional costs and heightened scrutiny.
• Changes in patent portfolio from 2031 to 2032, affecting intellectual property protection.
• Discussion on the importance of obtaining marketing approvals and potential limitations on approved products.