Achieve Life Sciences, Inc.

Greetings. Welcome to the Achieve Life Sciences fourth quarter and year-end 2023 earnings conference call and webcast. At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would like to hand the call over to Nicole Jones, Investor Relations. Thank you. You may begin.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by John Bincich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry Wan, Principal Accounting Officer. Management will be available for a Q&A session following today's prepared remarks. I'd like to remind everyone that today's conference call contains forward-looking statements based on current expectations. These statements are only predictions, and actual results may vary materially from those projected. Please refer to Achieve documents available on our website and files with the SEC concerning factors that may affect the company. At this time, I will turn the call over to John.

Thank you, Nicole, and thank you for joining us as we discuss Achieve's financial results for the fourth quarter and year-ended 2023, along with providing key updates on the cytosinicline development program. 2023 was a transformative year for Achieve. marked by significant clinical, regulatory, and financial milestones. Our commitment to developing cytosinicline for smoking cessation and nicotine dependence has yielded remarkable progress, and we're excited for the year ahead. During 2023, we completed and announced results from the Phase III ORCA III and Phase II ORCA V1 trials, which have been instrumental in demonstrating cytosinicline's potential for treating nicotine dependence. The ORCA3 trial again confirmed the promise of cytosinicline for smoking cessation, with significant efficacy and tolerability benefits observed in treated patients. Furthermore, the ORCAV1 trial highlighted cytosinicline's effectiveness in treating nicotine dependence for vaping cessation, marking a pioneering step in helping to address this emerging public health challenge, in which currently over 11 million adults and an additional 2.1 million youth have reported vaping in the United States alone. Late last year, we conducted our pre-NDA meeting with FDA to review NDA submission requirements and timing. During the meeting, agreement was reached on many of the expected requirements, including that we have sufficient data sets from an efficacy perspective to proceed with submission. At that time, the FDA indicated that they would need additional safety exposure data beyond 12 weeks to assess the long-term exposure risk for patients receiving multiple courses of treatment over a lifetime due to the repetitive and chronic nature of smoking cessation attempts. In February this year, we reached agreement with the FDA that a single open-label study would meet the requirements for long-term cytosinicline exposure data, which clears the path for driving forward the cytosinicline program towards an NDA submission. I will now turn the call over to Cindy to go into further detail on our study design and planned initiation of this open-label safety study, which we are calling the ORCA-OL trial. Cindy?