Achieve Life Sciences, Inc.

Today's conference is scheduled to begin shortly. Please continue to standby. Thank you for your patience. Thank you. Good day, and thank you for standing by. Welcome to the Achieve Life Sciences first quarter 2022 earnings conference call. At this time, all participants are on the listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your first speaker today, to Nicole Jones. Please go ahead.

Thank you, operator, and thanks, everyone, for joining us. On the call today from Achieve, we have John Bincich, 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 Achieve documents filed with the SEC concerning factors that could affect the company, copies of which are available on our website. I'll now turn the call over to John.

Thank you, Nicole, and thank you, everyone, for joining us today. As you've probably heard, last month we reported the highly successful outcome of the ORCA II Phase III clinical trial of cytosinicline for smoking cessation. Cytosinicline demonstrated impressive efficacy across the primary and secondary endpoints for both the 6- and 12-week cytosinicline treatment arms. The safety and tolerability profile remains best in class. with single-digit rates of adverse events reported. We could not be more excited that cytosinicline succeeded in the challenge of helping many long-term heavy smokers in whom previous treatments have failed successfully kick the habit. And the timing could not be better to bring a new cessation option forward. For the first time in over 20 years, cigarette sales increased during the COVID-19 pandemic, while calls to quit lines dropped by nearly 30%. There are still more than 30 million smokers in the U.S. alone and over a billion globally who have not been offered a new regulatory-approved treatment in nearly two decades. Smoking kills more people every year than alcohol, AIDS, car accidents, illegal drugs, and murders combined. In the U.S., it accounts for more than 480,000 deaths and billions in healthcare dollars spent each year. Yet despite these alarming statistics, there have been very few clinical advances aiding smokers and healthcare providers to treat nicotine addiction. Chantix, which was FDA approved in 2006 and withdrawn from the market last year, was the leader in the smoking cessation category, generating over 1 billion in peak sales before going generic, with roughly 75% of those sales attributed to the U.S. market. While it has been considered the most efficacious treatment currently available, it was never able to reach its full potential of helping more people quit successfully due to its side effect profile. In fact, when marketed, only 4% of the U.S. smoking population were prescribed Chantix each year, and in the ORCA2 trial, less than half of the participants had ever used Chantix in their multiple prior quit attempts. Insights from our research and from smoking cessation opinion leaders and prescribers suggests that the primary reason a majority of smokers avoid starting or completing a full 12-week course of Chantix is due to the high incidence of side effects, such as nausea, headaches, and sleep disturbances. Based on prior evidence, we have always believed that cytosinicline could offer a more tolerable alternative, and we now have proof from a randomized Phase III study of more than 800 smokers to support this belief. The adverse event profile appears to be best in class, with more headaches and nausea in the placebo arm than in the active treatment groups. In addition, the odds ratios we observed in ORCA2 are unprecedented, with six to eight times higher odds of quitting at the end of treatment compared to placebo. And our quit rates were impressive, despite the highly addicted study population and the execution of the trial during a pandemic. We are excited to see that both six- and 12-week courses of cytosinicline therapy appear to be highly effective for smokers. The six-week therapy option provides flexibility for a shorter treatment to achieve abstinence and is half the duration of current treatments. And finally, quite simply, it is a new option. Smokers and their doctors need new solutions. This is an indication that has not seen any new approved treatments in more than 15 years. We believe a new treatment option will provide hope to the millions of smokers who are ready to finally quit. We plan to offer that hope with cytosinicline. Turning to the top-line data readout, I'd like to hand it over to Cindy to review the key findings from the ORCA-2 trial. Cindy?