Achieve Life Sciences, Inc.

Ladies and gentlemen, thank you for your patience. Please remain on the line. Your conference will begin momentarily. Again, we do appreciate your patience. Please remain on the line. Your conference will begin shortly. Thank you. Amen. Thank you. Good day, ladies and gentlemen, and welcome to Achieve Life Sciences third quarter 2022 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, CG Capital Investor Relations. Ma'am, the floor is yours.

Thank you, Operator. On today's call from Achieve, we have John Binsich, Chief Executive 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 ACHIEVA documents available on our website and filed 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. It was yet again a busy and exciting quarter for Achieve as we continue to advance cytosinicline through the clinic and closer to becoming the first new prescription treatment for nicotine dependence in nearly two decades. In September, we announced completion of target enrollment in our confirmatory phase three ORCA3 trial for smoking cessation. And just last week, we announced the earlier than expected completion of enrollment in our Phase II ORCAv1 trial for nicotine e-cigarette or vaping cessation. As a reminder, the ORCA III trial is the second and final randomized Phase III trial required for FDA submission and ultimately marketing authorization in the U.S. The design mirrors that of the previous ORCA II trial that read out with overwhelmingly positive results earlier this year. Both trials were designed to evaluate the smoking cessation efficacy, safety, and tolerability of three milligrams cytosinicline dosed three times daily over a period of either six or 12 weeks compared to placebo. The trials also share the same primary endpoint to evaluate smoking abstinence during the last four weeks of treatment, which is the FDA's approvable endpoint for smoking cessation medications. The outcome of ORCA2 further enhanced our belief that cytosinicline, if approved, has strong potential to become the new gold standard for the treatment of nicotine dependence. With single-digit rates of adverse events, cytosinicline's side effect profile is substantially better than what has been seen in currently available treatments. From an efficacy perspective, the odds ratios we observed in ORCA2 were unprecedented. With six to eight times higher odds of quitting, at the end of treatment compared to placebo. Additionally, our quit rates were impressive despite the highly addictive study population and the execution of the trial during a pandemic. We hope to see similar results from ORCA3 and look forward to sharing those with you in the second quarter of 2023. Vaping continues to be an important topic on a global scale. particularly with the alarming rate of adolescent users and new data reporting the potential harmful impacts to cardiovascular and respiratory health. The CDC released data last week indicating more than 2.5 million high school and middle school students were current users of e-cigarettes in the U.S. alone. There are also more than 11 million adult users of nicotine vape products in the U.S., and no treatments are currently approved specifically for vaping cessation. We pursued the ORCAv1 trial with the expectation that cytosinicline would be of interest to this growing and underserved population. The swift recruitment of ORCAv1 appears to reinforce our assumptions of the demand for treatment within this population. Recruiting at only five clinical trial sites, ORCAv1's target enrollment of 150 subjects was completed in roughly four months. Regarding the design, ORCAv1 will evaluate 12 weeks of cytosinicline versus placebo. As with the other ORCA trials, all participants will receive behavioral support throughout the study. The primary objective will be to evaluate for successful nicotine vaping cessation, defined as weekly abstinence for the last four weeks of treatment, with cotinine levels as biochemical confirmation of abstinence. Top-line data from ORCAv1 is also expected to be reported in the second quarter of 2023. With the two trial enrollment milestones behind us, we turn our attention to three key priorities over the coming months. First, continuous engagement with the ORCA III and ORCA V1 clinical trial sites and our third-party clinical research organization to ensure data reporting accuracy and adherence to timelines. Second, extensive preparations to support an NDA filing in the U.S. post-successful ORCA III trial results, including the completion of the remaining supportive trials required for filing. Third, commercial readiness, including launch preparedness activities and partnering discussions with interested parties who also believe in the immense potential of cytosinicline. Also, as part of our commercial readiness objective, we continue to work closely with our manufacturing partner, SoPharma, to ensure adequate commercial capacity at launch. As we announced today, SoPharma recently invested more than 3 million euros to complete the build-out of a new dedicated cytosinicline API purification suite at its primary manufacturing plant in Sophia. The new API suite complements SoFarm's capacity to produce nearly 3 billion tablets annually. I would now like to turn the call over to Jerry for the third quarter financial update.