Achieve Life Sciences, Inc.

Greetings and welcome to the Achieve Life Sciences second quarter 2024 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. And as a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones with Investor Relations. Thank you, Nicole. 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. Before we begin, 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 achieved documents available on our website and filed with the FCC concerning factors that could affect the company. I'll now turn the call over to John.

Thank you, Nicole, and thanks, everyone, for joining us. We are excited to provide an update today on the tremendous progress we have made on the cytosine and clean development program from both the clinical and regulatory fronts. In recent weeks, several key accomplishments have provided excellent momentum for furthering our mission of bringing cytosinicline to the millions of people who are battling nicotine dependence. Furthermore, we are pleased with the recent refinancing, which will propel us towards our first NDA submission for smoking cessation, which remains on track for filing in the first half of 2025. We will go through each of our achievements in more detail, but briefly, in the last few months, we have received FDA breakthrough therapy designation for cytosinicline for treating e-cigarette or vaping nicotine dependence. We initiated and gained significant traction on the ORCA-OL trial, evaluating the long-term safety effects of cytosinicline. We were added to the U.S. Russell 3000 and Russell microcap indexes, and we refinanced our outstanding debt agreement with SVB. We are very pleased with this progress and the support we are receiving from the scientific, regulatory, and financial communities. that are setting up cytosinicline for great success. I'll now turn it over to Cindy, who will give an update on recent regulatory and clinical advances. Cindy?