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Dec 31, 2024
Denali Therapeutics Q4 2024 Earnings Report
Denali Therapeutics reported its financial results for the fourth quarter and full year ended December 31, 2024.
Key Takeaways
Denali Therapeutics reported a net loss of $114.8 million for the fourth quarter of 2024, compared to a net loss of $119.5 million in the same period last year. The company had no collaboration revenue for the quarter. Total research and development expenses decreased, while general and administrative expenses increased.
Net loss for Q4 2024 was $114.8 million, an improvement from $119.5 million in Q4 2023.
No collaboration revenue was reported for Q4 2024, consistent with Q4 2023.
Research and development expenses decreased to $99.8 million in Q4 2024 from $107.8 million in Q4 2023.
General and administrative expenses increased to $30.1 million in Q4 2024 from $24.8 million in Q4 2023.
Forward Guidance
Denali anticipates an increase of approximately 10% to 15% in cash operating expenses for 2025 compared to 2024. The company plans to advance one to two additional programs to the clinic per year over the next three years.
Positive Outlook
- Anticipates submitting a Biologics License Application (BLA) for tividenofusp alfa under accelerated approval pathway in early 2025.
- Preparing for a U.S. commercial launch of tividenofusp alfa in late 2025 or early 2026.
- FDA Breakthrough Therapy designation granted for tividenofusp alfa, providing enhanced regulatory support.
- Plans to engage with the FDA to align on a pathway for accelerated approval of DNL126.
- Aims to advance one to two additional programs to the clinic annually over the next three years.
Challenges Ahead
- Anticipates an increase of approximately 10% to 15% in cash operating expenses for 2025.
- Primary endpoint not met in the HEALEY ALS platform trial for DNL343.
- Enrollment for BIIB122/DNL151 LUMA study expected to complete in 2025.
Historical Earnings Impact
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