---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-069804"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2025-05-13T23:59:59+00:00"
generated_at: "2026-05-21T22:38:54.982142+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Q1 net loss $12.8M; on track for cytisinicline NDA submission to FDA in June 2025

## Summary
- Cash, equivalents, and marketable securities totaled $23.2M; operating expenses $12.9M for Q1 2025.
- Plans to submit NDA for cytisinicline to FDA in June 2025; ORCA-3 results published in JAMA Internal Medicine.
- ORCA-OL long-term safety trial met FDA requirements: >300 patients with 6 months, >100 with 1 year treatment.
- DSMC third safety review found no concerns; SAB meeting held in May 2025 with ten nicotine cessation experts.

## SEC filing metadata
- accession: 0000950170-25-069804
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2025-05-13T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017025069804/0000950170-25-069804-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017025069804/achv-20250513.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-069804
- JSON: https://secwatch.observer/filing/0000950170-25-069804.json
- Plain text: https://secwatch.observer/filing/0000950170-25-069804.txt

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