8-K: Achieve Life Sciences Announces Year-End 2024 Financial Results and Cytisinicline Development Update

Achieve Life Sciences reports its year-end 2024 financial results and reiterates its plan to submit a New Drug Application (NDA) for cytisinicline at the end of Q2 2025.

Summary

• Achieve Life Sciences announced its financial results for the fourth quarter and year ended December 31, 2024.
• The company is on track to submit its New Drug Application (NDA) for cytisinicline at the end of the second quarter of 2025.
• Key milestones were reached in the ORCA-OL long-term exposure trial, including completing enrollment and meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment.
• Two positive data safety monitoring committee (DSMC) reviews were announced with no safety concerns in the ORCA-OL clinical trial.
• Dr. Kristen Slaoui and Nancy Phelan were appointed to the Board of Directors.
• Mark Oki was appointed as Chief Financial Officer.
• The company announced the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for defining cytisinicline development as a treatment for vaping cessation.
• As of December 31, 2024, the company's cash, cash equivalents, and marketable securities were $34.4 million.
• Total operating expenses for the year ended December 31, 2024, were $39.1 million.
• Total net loss for the year ended December 31, 2024, was $39.8 million.
• As of March 11, 2025, Achieve had 34,685,072 shares outstanding.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the progress in clinical trials, the upcoming NDA submission, and the strengthening of the leadership team. However, the significant net loss tempers the overall optimism.

Positives

• The company is on track to submit its NDA for cytisinicline in Q2 2025.
• The ORCA-OL trial met key milestones, including enrollment completion and participant treatment duration.
• DSMC reviews showed no safety concerns in the ORCA-OL trial.
• The FDA agreed on the Phase 3 trial design for vaping cessation.
• The company has $34.4 million in cash, cash equivalents, and marketable securities.

Negatives

• The company reported a net loss of $39.8 million for the year ended December 31, 2024.
• Total operating expenses for the year ended December 31, 2024 were $39.1 million.

Risks

• The company's future success depends on the successful development and commercialization of cytisinicline.
• Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline.
• Cytisinicline may not receive regulatory approval in a timely manner or at all.
• New developments in the smoking and vaping cessation landscapes may require changes in business strategy or clinical development plans.
• Achieve's intellectual property may not be adequately protected.

Future Outlook

Achieve plans to submit its NDA for cytisinicline at the end of Q2 2025 and, dependent on funding, initiate the Phase 3 ORCA-V2 trial in the first half of 2026.

Management Comments

• We are thrilled with our progress to date and excited to have the NDA submission on track for the end of next quarter, furthering our mission to bring cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years, said Rick Stewart, Achieves Chief Executive Officer.
• Over the last several months, we've reached key milestones enabling the NDA submission and deepened our leadership expertise to execute our strategy.
• We have a unique opportunity in the very near-term to make a significant impact on a critical public health crisis while driving long-term shareholder value.

Industry Context

Achieve Life Sciences is focused on addressing the global smoking and nicotine dependence epidemic. The company's cytisinicline is being developed as a treatment for both smoking and vaping cessation, targeting a significant unmet need in the market.

Comparison to Industry Standards

• The document mentions that cytisinicline aims to be the first new FDA-approved nicotine dependence treatment in nearly 20 years, highlighting a potential competitive advantage.
• Compared to companies like Pfizer (maker of Chantix) and Johnson & Johnson (maker of nicotine replacement therapies), Achieve is focusing on cytisinicline, a plant-based alkaloid with a different mechanism of action.
• The ORCA-OL trial's goal of 300 participants completing six months of treatment aligns with FDA requirements for long-term safety data, a standard practice in pharmaceutical development.

Management Changes

Stakeholder Impact

• Shareholders: The NDA submission and potential commercialization of cytisinicline could drive long-term shareholder value.
• Patients: Cytisinicline could provide a new treatment option for nicotine dependence.
• Employees: The company's progress could lead to job creation and growth opportunities.

Next Steps

• Submission of the New Drug Application (NDA) for cytisinicline at the end of Q2 2025.
• Potential initiation of the Phase 3 ORCA-V2 trial in the first half of 2026, dependent on funding availability.

Key Dates