secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2026-05-07T23:59:59+00:00
Accession:  0001714899-26-000062
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/0001714899-26-000062-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000062/dnli-20260507.htm
  HTML page:      https://secwatch.observer/filing/0001714899-26-000062

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer