secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2025-03-11T23:59:59+00:00
Accession:  0000950170-25-036830
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Achieve Life Sciences reports Q4 net loss $12.4M; reiterates cytisinicline NDA by end of Q2 2025
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- Cash, cash equivalents and marketable securities $34.4M as of Dec 31, 2024.
- Net loss for Q4 2024 was $12.4M; full-year net loss $39.8M (pre-revenue).
- NDA submission for smoking cessation cytisinicline expected end of Q2 2025; ORCA-OL enrollment complete.
- Appointed Mark Oki as CFO, Dr. Kristen Slaoui and Nancy Phelan to Board.
- FDA agreed Phase 3 ORCA-V2 trial design for vaping cessation; plans to initiate in H1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000095017025036830/0000950170-25-036830-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000095017025036830/achv-20250311.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-036830

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