Company Strategy & Priorities - Denali is preparing for the potential launch of tividenofusp alfa for MPS II (Hunter syndrome), aiming for a late 2025 or early 2026 U S launch [13, 32, 68] - The company is focused on expanding its Enzyme TransportVehicle (ETV) franchise to realize the platform's potential for lysosomal storage diseases [13] - Denali is advancing its TransportVehicle (TV) portfolio programs for neurodegeneration and other indications [13] Technology & Pipeline - Denali's TransportVehicle (TV) platform is designed to optimize brain delivery, with over 350 patents and applications, and more than 10 programs [16, 18] - The company's OTV:MAPT program demonstrates sustained brain tau knockdown for over 15 weeks following four IV doses [96] - Denali expects to file 1-2 INDs (Investigational New Drug applications) per year over the next 3 years across its TV franchises [90] Clinical Data & Market Opportunity - Tividenofusp alfa Phase 1/2 data in MPS II shows robust reduction in CSF HS and serum NfL, with the majority of participants reaching the normal range by Week 104 [44] - The company estimates a total addressable market of approximately 2,000 patients worldwide for MPS II [72] - Denali is developing a broad ETV franchise targeting lysosomal storage diseases, with approximately 30,000 people affected worldwide, two-thirds of whom have CNS manifestations [38, 76]