Achieve Life Sciences, Inc.

Welcome to Achieve Life Sciences first quarter 2025 earnings conference 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 call over to 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, and Mark Oke, Chief Financial Officer. The management team will be available for Q&A following the 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 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 replay. 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 SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to Rick.

Thank you, Nicole, and good morning to everyone, and thank you for joining us on today's call. It's good to be able to say that Achieve is on track to submit the NDA for Scientists in the Clean next month. It's been a long road to get us here, and all internal resources are now focused on a successful NDA submission, acceptance, and approval. Today's focus is primarily on the NDA submission. The role that cytosinicline can play as a treatment for nicotine dependence is immense. In the US alone, over 29 million adults smoke cigarettes and 11 million adults vape. More than half want to quit, but fewer than 10% succeed because they have inadequate tools to help them overcome nicotine dependence successfully. Cytosinicline can change that and improve the probability and the opportunity to quit smoking and vaping with excellent efficacy and tolerability. If approved, cytosinicline will be the first new nicotine dependence drug in nearly 20 years, providing Achieve the opportunity to offer new hope to patients and their healthcare providers. We want to change the conversation, reminding the patient and medical community that nicotine dependence is a serious, medical condition and need to be treated as such. It's not about willpower, it's about science. Nicotine is the third most addictive drug after heroin and cocaine. We believe that cytosinicline can be a part of the solution and help reframe this medical condition much like GLP-1s did for obesity. As Cindy will review shortly, we conducted a scientific advisory board meeting in March with experts in nicotine and tobacco cessation research to discuss cytosinicline. And in April, we were pleased to have our ORCA III clinical trial results published in JAMA Internal Medicine. Since our call in March, further progress has been made and ACHIEVE now has over 100 patients with the FDA's required one-year exposure to cytosinicline in the ORCA-OL open label study. The fact that so many patients remain on the study and continue on the drug is a testimony to cytosinicline's tolerability. Additionally, the Data Safety Monitoring Committee completed another successful review of the ORCA-OL safety data, and the trial is continuing as planned. With that, I'll turn the call over to Cindy to provide more details on the ORCA-OL trial and the overall clinical development and regulatory process.