Achieve Life Sciences, Inc.

Greetings. Welcome to the Achieve Life Sciences first quarter 2024 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 our 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 Achieve's documents available on our website and files with the SEC 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 today. Today, we will review our first quarter 2024 financial performance and discuss key highlights, including reaching agreement with the FDA on the long-term cytosinicline exposure data necessary for our NDA filings. Critically for the timing of the NDA submission, we agreed on the number of subjects required with six months' exposure to enable the NDA filing. Cindy will provide an update on the ORCA-OL study and discuss the status of initiation in just a moment. Concurrently with the FDA decision, we successfully secured financing of up to $124 million, enabling Achieve to execute the ORCA-OL trial and provide cash runway through the NDA submission NDA approval, and beyond. The financing included participation from new fundamental healthcare investors, including our manufacturing partner, Sofarma. The investor demand for the financing demonstrates the importance of cytosinicline in battling nicotine dependence and a growing confidence in cytosinicline's market opportunity. The visibility of cytosinicline as a drug for nicotine dependence has been raised markedly during the quarter, and as many of you will have read, The results from the Phase II ORCAv1 trial of cytosinicline for vaping cessation were published in JAMA Internal Medicine earlier this week. The ORCAv1 study included 160 adults who used e-cigarettes daily and desired to quit. There was incredible interest in this trial, and it enrolled quickly in approximately four months. The results showed that cytosinicline more than doubled the odds of quitting e-cigarettes compared to placebo. with 31.8% of cytosinicline-treated participants achieving continuous vaping abstinence compared to just 15.1% of those receiving placebo. As seen in our other trials, cytosinicline was incredibly well-tolerated, and compliance with study treatment was exceptional. The prevalence rates of vaping continue to increase, and it is estimated that 11 million adults and 2 million middle and high school age students use e-cigarettes in the U.S. alone. More than half of adults who vape have reported interest in quitting, and many who've tried to quit struggled to do so successfully. If approved, cytosinicline would be the first FDA-approved treatment specifically evaluated and approved for e-cigarette cessation. We plan to further our discussions with the FDA on a label expansion for vaping cessation and expect to conduct an end-of-Phase II meeting later this year to discuss clinical requirements. Additionally, in the first quarter, we presented detailed trial results from our ORCA program at the Society for Research on Nicotine and Tobacco annual meeting. The ORCA II and ORCA III Phase III trials have consistently demonstrated cytosinicline's efficacy in achieving smoking cessation with favorable safety and tolerability profiles. For the first time, we presented survey results from participants in our phase three trials. Of the participants who responded, over 80% had been treated with cytosinicline. Of these cytosinicline-treated subjects, 69% of them had successfully quit smoking, and of those who did not quit completely, approximately one quarter cut their smoking in half. These respondents attributed their success in quitting to cytosinicline noting that amongst other things, it helped reduce cravings. Nearly all participants of the survey were willing to recommend cytosinicline to others, and notably, 86% of participants, including those who did not quit completely, showed interest in using cytosinicline again if needed. This is a great segue into Cindy's update on the ORCA-OL trial. Cindy?