Risk Factors Update Summary

• Patent term extension details added, allowing only one extension per marketing approval, potentially impacting exclusivity.
• The company had $1.03 billion in cash, cash equivalents, and marketable securities as of December 31, 2023.
• Potential spin-out of preclinical small molecule portfolio announced, subject to various risks.
• The company incurred net losses of $145.2 million, $326.0 million, and $290.6 million for the years ended December 31, 2023, 2022, and 2021, respectively.
• The company received orphan drug designation for DNL310 from the FDA and plans to seek orphan drug designation for additional product candidates.
• Cybersecurity risks highlighted, emphasizing increased frequency and sophistication of cyber threats.
• The accumulated deficit increased from $971 million to $1.12 billion.
• The company discontinued clinical development of TAK-920/DNL919 in Alzheimer's disease.
• The company implemented various safety protocols for on-site personnel due to telecommuting patterns and modified work schedules.
• Increase in total employees from 427 to 445, indicating potential growth and operational changes.
• The company initiated a Phase 1 study in the Netherlands and plans to continue engaging with Takeda.
• Financial data changes: Federal net operating loss carryforwards increased from $231 million to $290 million.
• Registration rights agreements with investors disclosed, affecting potential stock sales and dilution.
• Recent equity financing activities detailed, including a PIPE financing and underwritten public offering.