Achieve Life Sciences, Inc.

Greetings and welcome to the Achieve Life Sciences fourth quarter and year-end 2024 earnings call and webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Nicole Jones, Achieve Investor Relations. Thank you. You may begin.

Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Mark Oke, Chief Financial Officer, Jamie Zenos, Chief Commercial Officer, and Jerry Wan, Vice President of Finance and Principal Accounting Officer. Management will be available for a Q&A session following our prepared remarks. As a reminder, A replay will be available later today by using the information provided in the earnings press release issued prior to this call or visiting the Achieve website. Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions, and projections as projections as of today, These statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast reply. Actual results may differ materially as a result of risk, uncertainties, and other factors including, but not limited to, the factors set forth in the company's filings with the FCC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and files with the FCC concerning factors that could affect the company. I'll now turn the call over to Rick.

Thank you, Nicole, and good morning. It's great to be with you today at this exciting time for Achieve. Achieve expects to submit the NDA for cytosinicline as a treatment for nicotine dependence for smoking cessation with the FDA at the end of next quarter. Cytosinicline will be the first new drug for nicotine dependence in nearly 20 years and will provide patients and doctors with a desperately needed new tool to combat the impact of nicotine dependence for cigarette smoking and vaping. All of our resources are now dedicated to a successful NDA submission, acceptance, and approval. Execution of the successful submission is critical. There's an increasing urgency for new nicotine dependence treatments. because existing treatments are either less effective or have side effects that deter compliance. This, combined with the rapid expansion of vaping and nicotine pouches, puts greater emphasis on the importance of Achieve's mission and the role of cytosinicline to become the only nicotine-dependent product being promoted to healthcare providers. The health risks of smoking are well established, and vaping perils are are only now starting to become evidence with lung injury and disease being seen in a much younger population. We're extremely proud of the progress we have made in 2024 toward bringing cytosinicline to patients and doctors with a planned commercial launch in the third quarter of 2026. With each milestone met, Our confidence and momentum grow as we work to solve this challenging public health crisis while creating long-term shareholder value. Looking back at 2024, we've hit some key milestones that are driving us toward the next stages of development and commercial launch. Here's a quick recap of those accomplishments. We completed enrollment in the ORCA Open Label Long-Term Safety Exposure Clinical Trial and reached the requirement of at least 300 participants receiving six months of cumulative cytosinicline treatment, which was a necessary step required by the FDA for submission of the NDA. We also received breakthrough therapy designation to cytosinicline as a treatment for vaping cessation. We completed the end of phase two meeting with the FDA for vaping cessation as a future indication which included agreement on the design of a phase three trial. We strengthened our leadership team with the hire of our CFO, Mark Oakey, to oversee our financial strategy and operational initiatives. We appointed Dr. Kristin Slaoui and Nancy Thielen to the board of directors, bringing extensive leadership experience in corporate strategy and commercialization. And finally, we advanced our commercial readiness efforts. The steps we've been taking all year bring us to where we are today, transitioning from a clinical company towards a commercial one. As a reminder of our mission, nicotine dependence is one of the most pressing yet underserved public health crises of our time, claiming lives, driving severe comorbidities, and burdening the US healthcare system with over $300 billion in costs annually. By some reports, nicotine is the third most addictive drug, trailing only heroin and cocaine. Let that sink in for a moment. Right now, 29 million Americans are battling nicotine dependence, with 15 million attempting to quit each and every year. Yet, most fail, not for a lack of willpower, but because available treatment options are inadequate. There have been no new FDA-approved products for the treatment of nicotine dependence in nearly 20 years. Instead, multiple new nicotine delivery systems have been put on the market, all effectively enhancing nicotine dependence rather than decreasing or stopping it. It is time to recognize nicotine dependence for what it truly is, a medical condition, not a moral failing. Millions are being left behind to deal with their nicotine dependence without the effective tools they need to quit, and that must change in the same way that the GLP-1s changed the treatment for obesity. We're excited about the milestones we've accomplished and have reached a pivotal moment for the company. To provide more details on our next steps, including updates on the ORCA-OL trial and the NDA submission timing, I'll turn over to Cindy.