Denali Therapeutics Q4 2024 Earnings Report
Key Takeaways
Denali Therapeutics reported net losses of $114.8 million for the fourth quarter of 2024. The company is preparing for a potential accelerated approval for its lead program in MPS II and plans to expand its TV portfolio.
Presented results of the primary analysis of the Phase 1/2 study in Hunter syndrome, in addition to long-term data in the ongoing study, showing robust and sustained reductions in key biomarkers, along with continued improvements in hearing, cognition, and adaptive behavior.
Remains on track to submit a Biologics License Application (BLA) under the accelerated approval pathway in early 2025 and is preparing for a U.S. commercial launch in late 2025 or early 2026 for Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II).
Expanded target enrollment for neuronopathic participants (Cohort A) to 42 patients in the global Phase 2/3 COMPASS study for Tividenofusp alfa, reflecting steady progress in recruitment and data collection.
Dosing in BEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease, began in December 2024 for BIIB122/DNL151 (small molecule LRRK2 inhibitor) for the treatment of Parkinson’s disease (PD).
Denali Therapeutics
Denali Therapeutics
Forward Guidance
Denali anticipates an increase of approximately 10% to 15% in cash operating expenses compared to 2024.