Denali Therapeutics (DNLI) Q4 2025 earnings summary

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.