secwatch.observer — SEC 8-K summary
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Issuer:     Amylyx Pharmaceuticals, Inc. (AMLX)
CIK:        0001658551
Form:       8-K
Filed at:   2024-05-09T23:59:59+00:00
Accession:  0000950170-24-056254
Event type: earnings
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Amylyx Q1 net loss $118.8M; discontinues RELYVRIO/ALBRIOZA; inventory write-down $110.5M
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- Net loss of $118.8M ($1.75 diluted per share) vs. net income of $1.6M in Q1 2023.
- Net product revenue $88.6M, up 24% YoY; includes $110.5M non-cash inventory write-down due to product withdrawal.
- Voluntarily discontinuing RELYVRIO/ALBRIOZA for ALS; existing patients transitioned to free drug program.
- Cash $373.3M, expected runway into 2026; interim HELIOS Wolfram data show improvement; topline from 12 patients expected fall 2024.
- Phase 3 ORION PSP trial data expected mid-2025; IND and clinical trial of AMX0114 in ALS planned for H2 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1658551/000095017024056254/0000950170-24-056254-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1658551/000095017024056254/amlx-20240509.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-056254

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