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Denali Therapeutics Q1 2025 Earnings Report
Denali Therapeutics reported its first quarter 2025 financial results, including the completion of the BLA rolling submission for tividenofusp alfa for Hunter Syndrome.
Key Takeaways
Denali Therapeutics reported a net loss of $133.0 million for the first quarter of 2025, an increase from the $101.8 million net loss in the same period last year. Total research and development expenses increased to $116.2 million, primarily due to increased spending on TV programs and manufacturing facility operations. The company completed the BLA submission for tividenofusp alfa and is preparing for its commercial launch.
Net loss for Q1 2025 was $133.0 million, compared to $101.8 million in Q1 2024.
Total research and development expenses increased to $116.2 million in Q1 2025 from $107.0 million in Q1 2024.
General and administrative expenses rose to $29.4 million in Q1 2025, driven by BLA submission activities and commercial launch preparations.
Denali completed the BLA rolling submission for tividenofusp alfa for Hunter Syndrome and is preparing for commercial launch in late 2025 or early 2026.
Denali Therapeutics
Denali Therapeutics
Forward Guidance
Denali Therapeutics is preparing for the commercial launch of tividenofusp alfa in late 2025 or early 2026, pending FDA approval. The company continues to advance its TransportVehicle-enabled pipeline, including DNL126 for Sanfilippo syndrome Type A and DNL593 for GRN-related frontotemporal dementia. They also anticipate a readout for the Phase 2b LUMA study of BIIB122 in 2026.
Positive Outlook
- Completion of BLA submission for tividenofusp alfa, positioning it as a potential first FDA-approved enzyme replacement therapy for Hunter syndrome.
- Ongoing and productive collaboration with the FDA for DNL126 under the START program, aiming for an accelerated development and approval path.
- Advancement of the DNL593 program for GRN-related frontotemporal dementia with an ongoing Phase 1/2 study.
- Full enrollment of the Phase 2b LUMA study for BIIB122, with readout expected in 2026.
- Expansion of U.S. manufacturing capabilities with the opening of a clinical biomanufacturing facility in Salt Lake City.
Challenges Ahead
- Primary endpoint not met in Regimen G of the Phase 2/3 HEALEY ALS Platform Trial for DNL343.
- Additional analyses for DNL343 did not demonstrate a treatment effect on neurofilament light (NfL), leading to discontinuation of the active treatment extension.
- Reliance on third parties for the manufacture and supply of product candidates for clinical trials.
- The risk that preclinical profiles of product candidates may not translate in clinical trials.
- The uncertainty that product candidates will receive regulatory approval necessary to be commercialized.