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Denali Therapeutics
Denali Therapeutics (DNLI) investor relations material
Denali Therapeutics Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary26 Feb, 2026
Executive summary
Commercial launch readiness for tividenofusp alfa (DNL310) established ahead of April 2026 FDA decision for Hunter syndrome.
Preliminary Phase 1/2 data for DNL126 in Sanfilippo syndrome type A support accelerated approval plans; global Phase 3 study in planning.
Start-up activities underway for DNL628 (Alzheimer's) and DNL952 (Pompe disease) Phase 1 studies.
Multiple programs advancing in lysosomal storage disorders and neurodegenerative diseases.
$275M synthetic royalty funding and $200M public offering completed in December 2025.
Financial highlights
Net loss was $128.5M for Q4 2025 and $512.5M for FY 2025, compared to $114.8M and $422.8M in 2024.
R&D expenses were $97.9M for Q4 and $418.8M for FY 2025, up $22.4M year-over-year due to higher external costs and manufacturing expansion.
General and administrative expenses rose to $39.5M for Q4 and $136.6M for FY 2025, driven by headcount and launch preparation.
Cash, cash equivalents, and marketable securities totaled $966.2M as of December 31, 2025.
Outlook and guidance
Anticipated FDA decision and commercial launch for tividenofusp alfa in April 2026.
Initial patient data for TAK-594/DNL593 (FTD-GRN) and Phase 2b LUMA study (Parkinson's) expected in 2026.
Four to six additional programs expected to enter the clinic over the next three years.
DNL310 launch prep: key commercial steps?
Strategy for 4-6 new clinical programs?
R&D spend shift: small molecule to TV programs?
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Next Denali Therapeutics earnings date
TD Cowen 46th Annual Health Care Conference4 Mar, 2026
Denali Therapeutics
Next Denali Therapeutics earnings date
TD Cowen 46th Annual Health Care Conference4 Mar, 2026
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Frequently asked questions
Denali Therapeutics Inc is a biotechnology company focused on developing therapies for neurodegenerative diseases. The company researches and creates treatments targeting conditions such as Alzheimer's disease, Parkinson’s disease, and other disorders affecting the central nervous system. Denali Therapeutics operates within the healthcare and biotechnology sectors. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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