secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2024-11-07T23:59:59+00:00
Accession:  0000950170-24-123334
Event type: earnings
Sentiment:  neutral
Materiality: 0.60
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Achieve Life Sciences Q3 net loss $12.5M; ORCA-OL enrollment complete, NDA on track for Q2 2025
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- Cash, equivalents and investments $42.9M as of Sep 30, 2024; operating expenses $12.5M for Q3.
- Completed enrollment in Phase 3 ORCA-OL trial with 479 participants across 29 U.S. sites.
- FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette (vaping) cessation.
- Leadership: Richard Stewart named CEO, Thomas King Executive Chairman, Jaime Xinos Chief Commercial Officer.
- Planned NDA submission in Q2 2025; Data Safety Monitoring Committee found no safety concerns.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000095017024123334/0000950170-24-123334-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000095017024123334/achv-20241107.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-123334

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