secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2021-11-09T23:59:59+00:00
Accession:  0001564590-21-055716
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Achieve Life Sciences Q3 net loss $6.7M; ORCA-2 topline data expected H1 2022
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- Cash equivalents $33.4M; total operating expenses $6.7M for Q3, $26.0M for 9 months.
- ORCA-2 Phase 3 completed treatment; topline data expected first half 2022.
- ORCA-3 Phase 3 enrollment of ~750 subjects to start by early 2022.
- FDA accepted IND for cytisinicline e-cigarette cessation trial; ORCA-V1 to start Q2 2022.
- Two U.S. patents issued for 3.0 mg TID dosing regimen, expiring 2040.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000156459021055716/0001564590-21-055716-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000156459021055716/achv-8k_20211109.htm
  HTML page:      https://secwatch.observer/filing/0001564590-21-055716

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