Achieve Life Sciences, Inc.

Good day, ladies and gentlemen, and welcome to the Achieve Life Sciences first quarter 2023 earnings conference call. All lines have been placed on a listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Nicole Jones, Investor Relations at CG Capital. Ma'am, the floor is yours.

Thank you, Operator, and thank you to everyone for joining the call. Today from Achieve, we have John Binsich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry Wan, Principal Accounting Officer. Achieve Management will be available for Q&A after the 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 achieved 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 thank you to all for joining us. Just a few weeks ago, we reported positive topline results from our groundbreaking Phase II ORCAv1 clinical trial, the first ever randomized placebo-controlled trial for vaping cessation. Cytosinicline treatment resulted in a statistically significant benefit for nicotine e-cigarette cessation compared to placebo. Results for the primary endpoint showed that study participants who received cytosinicline were approximately three times more likely to quit vaping compared to those who received placebo. Cytosinicline also continued to demonstrate exceptional safety and tolerability. We are very pleased with another win for cytosinicline and for people who are seeking options to overcome their nicotine dependence. Nicotine e-cigarette use continues to be a growing concern, with recent reports from CDC indicating vaping rates in the U.S. are increasing. Data recently published indicates that roughly 11 million adults and 2.5 million high school and middle school students use e-cigarettes to vape nicotine. The CDC indicated in recent weeks the percentage of use has increased by 2.5%. As this segment of nicotine use continues to grow, an increasing number of people who use e-cigarettes may start to look for solutions to quit, and currently there are no medications specifically indicated for vaping cessation. We completed a survey in people using e-cigarettes and found that 73% of participants desired to quit vaping in the next three to 12 months. And the overwhelming majority would be interested in using a naturally derived prescription treatment to help them do so. Based on this unmet need for treatments, the swift enrollment we observed in the ORCA V1 trial, and the statistically significant results from the recent top line data announcement, we believe that cytosinicline has a unique opportunity to become a solution to help address this growing vaping epidemic. To touch more on the recent clinical data, I will now hand the call over to Cindy to go through the ORCAv1 results in more detail.