secwatch.observer — SEC 8-K summary
======================================

Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2024-03-28T23:59:59+00:00
Accession:  0000950170-24-038030
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Achieve Life Sciences reports 2023 net loss of $29.8M; FDA agrees on NDA path for cytisinicline
--------------------------------------------------------------------------------

- Net loss Q4 2023: $5.5M; full-year 2023 net loss: $29.8M; operating expenses $27.3M.
- Cash $15.6M at Dec 31, 2023; pro forma $71.8M after Feb 2024 equity financing of up to $124.2M.
- FDA agreed single open-label safety study (ORCA-OL) is sufficient; NDA submission expected H1 2025.
- Phase 3 ORCA-2/3 and Phase 2 ORCA-V1 data at SRNT: 69% of cytisinicline users quit smoking; 97% would recommend.
- Shares outstanding as of March 28, 2024: 34,251,911.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000095017024038030/0000950170-24-038030-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000095017024038030/achv-20240328.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-038030

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