Achieve Life Sciences, Inc.

Greetings and welcome to the Achieve Life Sciences second 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, Jamie Zenos, Chief Commercial Officer, and Mark Oakey, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks. A replay will be available later today using the information in the earnings press release or by 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, everyone. We appreciate your time and participation in today's call. This quarter marks a defining moment in Achieve's progress toward the first new treatment for nicotine dependence in nearly 20 years. We achieved three transformative milestones. Firstly, the successful submission of our new drug application for cytosinicline as a treatment for nicotine dependence for smoking cessation to the FDA. Secondly, a strategic commercial partnership with the exceptional team at Omnicom. And thirdly, a $49 million capital raise that positions us to reach critical value inflection points in 2026, including potential product approval. The NDA submission starts the regulatory clock, and the PDUFA date will be defined on NDA acceptance, which we expect in mid-September. This is an exciting moment for Achieve after years of dedication to bring cytosinicline to FDA review and for patients and physicians who currently lack adequate tools to successfully quit. The opportunity to collaborate with Omnicom, a world-recognized leader in healthcare marketing, advertising, and technology, positions Achieve to quickly scale and leverage external expertise and infrastructure to execute our commercial launch strategy. Omnicom's deep experience and proven success with pharma and biotech clients includes successfully executing more than 100 product launches and new indications over the last three years. Finally, we're profoundly grateful to our stockholders whose continued investment support reflects an unwavering belief in our potential to create meaningful change in public health. The market opportunity is huge. 29 million Americans smoke. Every year, more than 15 million try to quit with poor success rates. The narrative needs to change to recognize nicotine dependence as a medical condition, much like how the GLP ones did for obesity. Patients and physicians currently lack adequate tools to be successful. For nearly a generation, innovation has stood still in nicotine dependence for smoking cessation, leaving patients frustrated, providers powerless, and public health carrying the burden of over $600 billion in annual costs in the US. Historically, individuals seeking to quit smoking have faced limited options, and we aim to change this. As we move forward, we will work with the FDA through the review process, and should we receive approval, be prepared to launch Cytosine Clean in late 2026. Before the team dives into the details, I want to express our gratitude to those who have been instrumental in supporting our progress. Firstly, the patients and physicians who participated in our clinical program, their engagement and commitment has been invaluable. Secondly, our entire Achieve team for their dedication in delivering the NDA submissions on time through a significant company-wide effort. And thirdly, our investors for their continued support, guidance, and belief in our mission. On today's call, Cindy will update you on regulatory timelines and progress on the Orca OL study. Jamie will provide an update on our commercial planning, and Mark will conclude the details on the recent financing and current cash runway. In short, our three announcements this quarter demonstrate that we are advancing confidently on three fronts, regulatory, commercial, and financial. Our path is clear, and we are committed to executing it to the fullest. With that, I'll turn it over to Cindy.