---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-038030"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2024-03-28T23:59:59+00:00"
generated_at: "2026-06-04T06:54:07.640119+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-038030
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2024-03-28T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017024038030/0000950170-24-038030-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017024038030/achv-20240328.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-038030
- JSON: https://secwatch.observer/filing/0000950170-24-038030.json
- Plain text: https://secwatch.observer/filing/0000950170-24-038030.txt

## Key facts
- Earnings Releases
  ACHIEVE LIFE SCIENCES, INC. reported fourth quarter and year ended December 31, 2023 results: net income $5.5 million and $29.8 million.
  - Period: fourth quarter and year ended December 31, 2023
  - Net income: $5.5 million and $29.8 million
  - Result: reported results
  source text: Total net loss for the fourth quarter and year ended December 31, 2023 was $5.5 million and $29.8 million, respectively.
  evidence_url: https://www.sec.gov/Archives/edgar/data/949858/000095017024038030/0000950170-24-038030-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.