Risk Factors Update Summary

• The company may need to raise additional funding to finance operations into the second quarter of 2027.
• Dependency on lead product AMT-130 success in clinical development, with significant investment and updated interim data, including 30 months follow-up from 39 patients enrolled. This change highlights the critical stage of the lead product and the substantial investment made. The announcement of updated interim data and plans for further clinical trials indicate a pivotal moment for the company.
• Shareholder approval required before issuing ordinary shares in equity financing. This could affect capital raising.
• Expect to be classified as a PFIC for U.S. federal income tax for 2023.
• Potential need for additional randomized studies beyond existing clinical trials for AMT-130, which could be costly and significantly delay potential approval. This change underscores the financial and time implications of potential additional studies required for AMT-130, impacting the company's development timeline and resources.
• Net losses were $126.8 million in 2022 and $308.5 million in 2023, with accumulated deficit of $890 million.
• Expansion of the product pipeline with investigational gene therapies for various diseases, including AMT-260, AMT-162, and AMT-191. This change highlights the company's strategic focus on developing a diverse pipeline of gene therapies, potentially increasing future revenue streams and market opportunities.
• A significant portion of assets located outside the U.S.
• The company is advancing various gene therapy programs and may incur costs related to manufacturing.
• Regulatory changes, such as the Inflation Reduction Act of 2022, could impact pricing and reimbursement.
• Utilization of exploratory biomarkers in clinical trials to optimize drug development, with a caution that reliance on unvalidated data may lead to inefficient resource allocation. This change emphasizes the company's innovative approach to drug development but also highlights the risks associated with unvalidated biomarkers, impacting resource allocation efficiency.
• The company faces risks related to employee matters and managing growth, including restructuring challenges.
• Regulatory uncertainties and evolving criteria for orphan drug designation, potentially affecting market exclusivity and commercialization strategies. This change indicates the evolving regulatory landscape and the need for adaptability in the company's commercialization plans.
• Climate change initiatives may result in regulatory changes impacting operational costs and demand.
• Increased competition from large pharmaceutical and biotechnology companies worldwide, posing a challenge to the company's current and future product candidates. This change underscores the competitive landscape the company faces, potentially impacting market share and revenue generation.
• The company's stock price experienced significant volatility, with price fluctuations unrelated to performance.
• Dependence on third parties for development activities, reducing control over trials and financial interests, with potential delays and additional costs. This change highlights the risks associated with reliance on external parties, impacting the company's operational efficiency and financial obligations.