---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-123334"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2024-11-07T23:59:59+00:00"
generated_at: "2026-05-30T04:13:41.389827+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Achieve Life Sciences Q3 net loss $12.5M; ORCA-OL enrollment complete, NDA on track for Q2 2025

## Summary
- Cash, equivalents and investments $42.9M as of Sep 30, 2024; operating expenses $12.5M for Q3.
- Completed enrollment in Phase 3 ORCA-OL trial with 479 participants across 29 U.S. sites.
- FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette (vaping) cessation.
- Leadership: Richard Stewart named CEO, Thomas King Executive Chairman, Jaime Xinos Chief Commercial Officer.
- Planned NDA submission in Q2 2025; Data Safety Monitoring Committee found no safety concerns.

## SEC filing metadata
- accession: 0000950170-24-123334
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2024-11-07T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017024123334/0000950170-24-123334-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017024123334/achv-20241107.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-123334
- JSON: https://secwatch.observer/filing/0000950170-24-123334.json
- Plain text: https://secwatch.observer/filing/0000950170-24-123334.txt

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