Achieve Life Sciences, Inc. Q2 FY2024 earnings call

• Achieve has made progress on the Cytisinicline Development Program, including FDA breakthrough therapy designation for cytisinicline for treating e-cigarette or vaping nicotine dependence, initiation and traction on the ORCA-OL trial evaluating long-term safety effects, inclusion in U.S. Russell 3000 and Russell Microcap Indexes, and refinancing of debt with SVB.
• Cindy Jacobs provided updates on regulatory and clinical advances, including the FDA breakthrough therapy designation's benefits, progress on the ORCA-OL trial with enrollment going well, and plans for NDA submission in the first half of 2025.
• John Bencich discussed financial updates from the debt refinancing with SVB, which extended the maturity date and lowered the cost of capital, and highlighted the importance of cytisinicline in addressing nicotine dependence and creating shareholder value.

No specific product segment financial performance detailed as the transcript focuses on overall company updates rather than breakdown by product segments. Financials: As of June 30, 2024, cash, cash equivalents, restricted cash and short-term investments were $61.3 million. Net loss for the quarter ended June 30, 2024 was $8.5 million, and net loss for the six months ended June 30, 2024 was $15 million.

• NDA submission for smoking cessation remains on track for filing in the first half of 2025.
• The refinancing of debt with SVB extends the cash runway and provides access to additional capital as cytisinicline moves through the regulatory process.
• Expectations to close out enrollment and continue monitoring subjects in the ORCA-OL trial while preparing for the NDA submission.

Q: What are the intentions regarding starting a study after the end of Phase 2 meeting with FDA?

A: After the end of Phase 2 meeting, will understand what's required going forward, and next steps on the vaping program would likely be in the middle of next year at the earliest, with focus on NDA submission in the first half of 2025