---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-24-000168"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2024-08-01T23:59:59+00:00"
generated_at: "2026-05-31T13:58:44.220369+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Denali Q2 net loss $99M; FDA open to accelerated approval for DNL310; regains ATV:Abeta rights

## Summary
- Net loss $99.0M in Q2 2024 vs $183.4M net income in Q2 2023; no collaboration revenue versus $294.1M last year.
- Cash and marketable securities $1.35B as of June 30, 2024.
- FDA CDER open to discussing accelerated approval for DNL310 (MPS II) using CSF HS as surrogate biomarker.
- Biogen terminated ATV:Abeta license; Denali regains all rights; decision not related to efficacy or safety.
- DNL126 (MPS IIIA) selected for FDA START pilot program; Phase 1/2 data expected by end of 2024.

## SEC filing metadata
- accession: 0001714899-24-000168
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2024-08-01T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000168/0001714899-24-000168-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000168/dnli-20240801.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-24-000168
- JSON: https://secwatch.observer/filing/0001714899-24-000168.json
- Plain text: https://secwatch.observer/filing/0001714899-24-000168.txt

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