Denali Therapeutics (NASDAQ: DNLI) reported financial results for Q4 and full year 2024. The company reported net losses of $114.8M for Q4 and $422.8M for full year 2024. Cash position stood at $1.19B as of December 31, 2024.
Key highlights include progress with their Enzyme Transport Vehicle (ETV) programs, particularly tividenofusp alfa for Hunter syndrome, which is on track for BLA submission in early 2025 with potential commercial launch in late 2025 or early 2026. The drug received FDA Breakthrough Therapy designation in January 2025.
The company expects a 10-15% increase in cash operating expenses for 2025 compared to 2024. R&D expenses decreased to $396.4M in 2024 from $423.9M in 2023, while G&A expenses increased slightly to $105.4M from $103.4M, primarily due to preparation for tividenofusp alfa launch.
- FDA Breakthrough Therapy designation received for tividenofusp alfa
- Strong cash position of $1.19B as of December 31, 2024
- R&D expenses decreased by $27.4M in 2024
- Tividenofusp alfa showed positive long-term safety and efficacy data
- Net loss increased to $422.8M in 2024 from $145.2M in 2023
- No collaboration revenue in 2024 vs $330.5M in 2023
- DNL343 failed to meet primary endpoint in ALS trial
- Expected 10-15% increase in cash operating expenses for 2025
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