---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-26-000062"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2026-05-07T23:59:59+00:00"
generated_at: "2026-05-14T21:53:36.829507+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Denali reports Q1 2026 net loss $128.4M; AVLAYAH approved and launched for Hunter syndrome

## Summary
- Net loss of $128.4M for Q1 2026 vs $133.0M in Q1 2025; R&D expenses down $12.4M to $103.8M.
- FDA granted accelerated approval for AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome on March 25, 2026; first commercial patients dosed in April.
- Cash and marketable securities at $1.05B as of March 31, 2026; $200M gross proceeds received from Royalty Pharma synthetic royalty agreement.
- Takeda terminated DNL593 (FTD-GRN) collaboration; Denali retains full rights, Phase 1/2 data expected by end of 2026.
- First patient dosed in Phase 1b study of DNL628 (OTV:MAPT) for Alzheimer's disease; data expected in 1H 2027.

## SEC filing metadata
- accession: 0001714899-26-000062
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2026-05-07T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/0001714899-26-000062-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/dnli-20260507.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-26-000062
- JSON: https://secwatch.observer/filing/0001714899-26-000062.json
- Plain text: https://secwatch.observer/filing/0001714899-26-000062.txt

## Key facts
- Earnings Releases
  Denali Therapeutics Inc. reported financial results for the first quarter ended March 31, 2026.
  - Period: the first quarter ended March 31, 2026
  - Result: reported results
  source text: On May 7, 2026, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2026.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/0001714899-26-000062-index.htm

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