---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000104"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-05-06T23:59:59+00:00"
generated_at: "2026-05-22T12:54:54.154978+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Denali completes BLA submission for Hunter syndrome; Q1 net loss widens to $133M

## Summary
- Net loss of $133.0M in Q1 2025 vs $101.8M in Q1 2024; R&D expense rose to $116.2M.
- Cash and marketable securities $1.05B as of March 31, 2025.
- BLA for tividenofusp alfa (Hunter syndrome) submitted under FDA accelerated approval pathway.
- Phase 2b LUMA study for BIIB122 (Parkinson's) fully enrolled; readout expected in 2026.
- G&A expenses increased to $29.4M from $25.2M, driven by BLA submission and launch prep.

## SEC filing metadata
- accession: 0001714899-25-000104
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-05-06T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000104/0001714899-25-000104-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000104/dnli-20250506.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000104
- JSON: https://secwatch.observer/filing/0001714899-25-000104.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000104.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.