Risk Factors Update Summary

• The company incurred net losses of $75.4 million for the year ended September 30, 2024, compared to $66.1 million in 2022. This change might result in increased investor concern regarding financial stability.
• New data privacy laws may impose fines of up to €20 million or 4% of annual global revenue. This change might result in significant financial penalties for non-compliance.
• ONS-5010 / LYTENAVA has received marketing authorization for the treatment of wet AMD in the EU and UK. This approval could significantly enhance revenue potential in these markets.
• The California Consumer Privacy Act allows fines of up to $7,500 per intentional violation, increasing legal risks. This could lead to substantial financial liabilities.
• The company has entered into a strategic collaboration agreement with Cencora for the global launch of ONS - 5010 / LYTENAVA, focusing on the EU and UK.
• The company anticipates incurring approximately $0.3 million in restructuring charges due to workforce reduction, impacting operational costs and cash flow.
• Generative AI use may incur additional compliance costs and regulatory scrutiny, impacting operational efficiency and competitive advantage.
• ONS - 5010 / LYTENAVA has not yet been approved in the United States, impacting potential revenue.
• The European Commission's proposal to revise pharmaceutical legislation could reduce data exclusivity for ONS - 5010 / LYTENAVA, increasing competition.
• The preliminary data from the NORSE EIGHT trial indicated an improvement in vision, although it did not meet the pre-specified non-inferiority endpoint. This could affect future regulatory approvals and market perception.
• Increased scrutiny from regulators on data transfers could disrupt operations and lead to significant legal challenges, affecting business continuity.
• The company reduced its workforce by five people, approximately 23% of existing headcount, affecting operational capacity.
• The company may begin generating revenue from product sales in Europe as early as the first half of 2025, contingent on successful commercialization efforts.
• New cybersecurity threats, including ransomware attacks, could lead to operational disruptions and reputational harm, increasing costs for recovery and compliance.
• There is significant uncertainty regarding third-party coverage and reimbursement status for ONS - 5010 / LYTENAVA, which may hinder commercialization efforts.