---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-24-000215"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2024-11-06T23:59:59+00:00"
generated_at: "2026-05-30T04:39:42.592841+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Denali Q3 net loss $107.2M; tividenofusp BLA planned early 2025; DNL126 shows biomarker reduction

## Summary
- Net loss $107.2M vs $99.4M YoY; no collaboration revenue; cash $1.28B at Sep 30, 2024.
- Updated 2024 cash opex guidance: +5-10% vs 2023 (prior: ≤2023) due to BLA prep and commercial readiness.
- Tividenofusp alfa (MPS II): FDA agrees CSF HS as surrogate endpoint; BLA submission on track for early 2025.
- DNL126 (MPS IIIA): preliminary data show CSF HS reduction and normalization; study expanded for accelerated path.
- SAR443820/DNL788 (MS): Sanofi's K2 Phase 2 discontinued after missing primary and key secondary endpoints.

## SEC filing metadata
- accession: 0001714899-24-000215
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2024-11-06T23:59:59+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/1714899/000171489924000215/0001714899-24-000215-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000215/dnli-20241106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-24-000215
- JSON: https://secwatch.observer/filing/0001714899-24-000215.json
- Plain text: https://secwatch.observer/filing/0001714899-24-000215.txt

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