Risk Factors Update Summary

• FDA and DEA jointly issued a letter on August 1, 2023, to address shortages of prescription stimulant medications.
• Transitioning from a prescription to a non-prescription business model, reducing workforce by 40%.
• Received notification of noncompliance from Nasdaq due to bid price closing below $1.00 per share.
• Increased focus on state and federal privacy laws, potentially requiring data processing modifications and incurring substantial costs.
• Transitioning from a prescription to a non-prescription model, including obtaining regulatory authorization for EndeavorOTC in adults with ADHD, requires substantial funding.
• The company has completed over 20 clinical studies of their SSME technology, focusing primarily on ADHD.
• FDA authorization obtained in December 2023 for expanded EndeavorRx label for ages 13-17.
• Potential delisting from Nasdaq if not compliant with Minimum Bid Price Rule, impacting liquidity.
• Expansion of workforce reductions, with approximately 30% of employees in January 2023 and 40% in September 2023.
• Developing programs outside of ADHD space is contingent on factors, including capital raising.
• Added plan to seek stockholder approval for a reverse stock split to regain compliance.
• Implementing new safeguards to comply with evolving privacy laws and security issues worldwide.
• Strategic plan to pursue over-the-counter labeling for products, focusing on ADHD market.
• Transition from a prescription to a non-prescription business model, pursuing regulatory authorization for over-the-counter labeling.
• The company has obtained marketing authorization for EndeavorRx and plans to seek an expanded label in 2023.
• Strategic plan to manage growth, operational fluctuations, workforce reductions, and realigning business priorities.
• Spending substantial amounts to manage and execute the strategic plan, including completing clinical trials.
• The company has discontinued recruitment of the STARS-ADHD-Adults trial and is focusing on commercializing EndeavorRx.
• Leadership transition announced in October 2023, with the CEO resigning and new appointments made.
• Requiring significant additional funding to launch and commercialize EndeavorOTC or other products.
• The company has entered into agreements with Shionogi for the development and commercialization of certain technologies.
• Focus on commercializing EndeavorOTC in adults with ADHD, pursuing regulatory authorization for labeling products.
• Potential impact on business, results, and financial condition due to reliance on third-party digital pharmacy.
• The company has terminated the license agreement with TALi and does not plan to pursue additional clinical efforts for children under 8 years old.
• Risks associated with cybersecurity threats, data breaches, and disruptions compromising sensitive information.
• The company is actively seeking to obtain patents and trademarks to strengthen its proprietary position in the digital therapeutics field.
• Uncertainty regarding workforce reductions, operational efficiencies, and potential disruptions due to organizational changes.