Achieve Life Sciences Announces Q3 2024 Financial Results and Corporate Update

Achieve Life Sciences, Inc., a pharmaceutical company focused on developing cytisinicline for nicotine dependence, revealed its financial results for Q3 2024 and provided updates on its cytisinicline program.

Key Developments:

1. ORCA-OL Clinical Trial: Achieve completed enrollment for the Phase 3 ORCA-OL trial, which includes 479 participants across 29 U.S. sites. This trial is aimed at evaluating the long-term safety of a 3 mg cytisinicline regimen for smoking and vaping cessation, a crucial requirement for Achieve’s New Drug Application (NDA) submission planned for Q2 2025. The trial’s Data Safety Monitoring Committee's initial review concluded that the overall safety profile appears excellent, with no modifications needed.

2. FDA and NIH Public Meeting: Dr. Cindy Jacobs, President and Chief Medical Officer, represented Achieve at a joint public meeting by the FDA and NIH. Dr. Jacobs emphasized the need for collaborative efforts to advance smoking cessation treatments. Cytisinicline, the only late-stage treatment in clinical development, has shown efficacy and excellent tolerability in two Phase 3 trials with over 1,600 participants. Comments from this meeting are accessible on the FDA website.

3. Breakthrough Therapy Designation: In July, the FDA granted Breakthrough Therapy designation to cytisinicline for nicotine e-cigarette cessation. This designation aims to expedite the development and review of treatments for serious conditions that show significant improvement over existing therapies.

4. Leadership Changes: Achieve announced leadership changes with Richard Stewart appointed as CEO and Thomas King as Executive Chairman of the Board. These appointments are expected to drive Achieve’s strategic growth. Jaime Xinos was promoted to Chief Commercial Officer, leading the U.S. product launch readiness team. Dr. Mark Rubinstein, an expert in nicotine dependence, joined as the new Head of Medical Affairs to enhance stakeholder awareness.

5. Financial Performance: As of September 30, 2024, Achieve reported cash, cash equivalents, restricted cash, and short-term investments totaling $42.9 million. For the three and nine months ended September 30, 2024, total operating expenses were $12.5 million and $26.9 million, respectively. Net losses for these periods were $12.5 million and $27.5 million, respectively. As of November 7, 2024, Achieve had 34,389,946 shares outstanding.

6. Conference Call: Achieve will host a conference call at 4:30 PM EST today, November 7, 2024, to discuss these results.

Achieve Life Sciences is committed to addressing the global smoking health crisis through the development of cytisinicline. With an estimated 29 million adults smoking combustible cigarettes and over 11 million using e-cigarettes in the U.S., cytisinicline aims to provide an effective cessation treatment. Smoking is the leading cause of preventable death, responsible for over eight million deaths globally and nearly half a million in the U.S. annually. Cytisinicline, a plant-based alkaloid, interacts with nicotine receptors in the brain to reduce craving symptoms and the rewarding effects of nicotine products. It is currently being developed for nicotine addiction treatment but has not yet received FDA approval.

Achieve’s efforts are focused on bringing cytisinicline to market, hoping to provide the first new prescription therapy for smoking and vaping cessation in over 20 years. With regulatory support and innovative leadership, Achieve aims to make a significant impact on public health.