Achieve Life Sciences, Inc.

Greetings. Welcome to the Achieve Life Sciences second quarter 2023 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. If anyone should require operator assistance during the call, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. At this time, I would like to hand the call over to Nicole Jones, investor relations. Thank you. You may begin.

Thank you, operator. And thank you to everyone for joining the call today. 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's 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 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 to everyone who has joined us this morning. The first half of 2023 has seen the culmination of our ambitions to bring the first smoking cessation product to market in nearly 20 years take a meaningful step forward. Several milestones were met in close proximity. all of which contributed substantial value to the Cytosinicline program and to shareholders. Firstly, the ORCA3 Phase 3 trial results in May validated and closely replicated those of the ORCA2 trial and demonstrated significant efficacy with a benign side effect profile. Secondly, just prior to the excellent ORCA3 results, Achieve announced positive results from the ORCA V1 Phase 2 clinical trial in 160 e-cigarette users. Thirdly, Achieve renegotiated the terms of our convertible loan agreement, extending the maturity date. Fourthly, the Journal of American Medical Association, or JAMA, published our groundbreaking ORCA II study. And finally, we raised additional capital, providing cash runway well into 2024. Overall, significant progress was made on many fronts. We look forward to continuing the campaign to highlight the value of cytosinicline and and the underlying public health importance of cytosinicline in the U.S. and globally. With both Phase III smoking cessation clinical trials completed in over 1,500 subjects, the combined results confirm the compelling efficacy and safety evidence of cytosinicline necessary to pursue FDA approval for smoking cessation. We are aiming to make an NDA submission in the first half of 2024, and if approved, cytosinicline could be the first new prescription treatment made available to the roughly 28 million smokers in the U.S. in nearly two decades. In parallel with the regulatory activities, we continue to focus on commercial readiness with attention on CMC and supply chain, as well as partnering discussions with interested parties around the globe who also believe in the immense potential of cytosinicline. Additionally, we can now expand our ambitions beyond the smoking cessation market and into the broader nicotine addiction market. As you are aware, vaping is expanding in popularity and serious concerns are continuing to emerge about both the short and long-term safety of these products. Cytosinicline has the potential to be a first-in-class product for vaping cessation. Combined with the potential target market is nearly 40 million Americans who are currently either smoking or using e-cigarettes. Looking at the data from both trials, specifically the 12-week treatment duration, the efficacy rates have exceeded what has been demonstrated historically by Chantix, Bupropion, or NRT. The primary endpoint that measured cessation rates during weeks 9 through 12 were over 30%, with odds ratios confirming that participants who received cytosinicline were four to six times more likely to quit compared to subjects on placebo. At the 24-week follow-up, the quit rates remained above 20%, with odds ratios in the range of five to six. Although we did not include any head-to-head comparisons in our ORCA program, we can review previous trial results for reference. The most recent large-scale randomized trial of approved smoking cessation treatments was the 8,000-subject EAGLES trial conducted to better understand the neuropsychiatric effects of current agents. For the U.S. population, quit rates at 24 weeks were between 11 and 16%, with odds ratios ranging from 1.6 to 2.6. This is in line with the independent meta-analyses published by the Cochrane Group, which observed odds ratios roughly between 2 and 3 for currently available agents. In addition, our ORCA program has validated a novel six-week treatment arm, which is half the duration of existing medications. Importantly, even with this shorter course of therapy, we observed odds ratios that exceed those of existing treatments. We are very pleased with the efficacy observed to date with cytosinicline and its potential to make a meaningful impact for patients in this setting. Complementary to the efficacy profile, The safety and tolerability we observed for cytosinicline in the ORCA program continues to shine and is described by the authors of the recent JAMA publication as excellent. As stated in the paper, only 2.9% of ORCA2 participants discontinued cytosinicline due to an adverse event. Side effects have been reported as a major limitation to adoption and compliance of existing therapies. Ultimately, Lack of compliance leads to unsuccessful quit attempts and smoking relapse. We believe the side effect profile of cytosinicline will compel many patients to make a quit attempt using the product, aid in adherence to the regimen, and increase the likelihood of having a successful outcome. The safety should also be encouraging for prescribers who have long dealt with the management of treatment-related side effects, as well as concerns of the neuropsychiatric adverse events. Finishing off on the clinical trial updates, we also announced in the second quarter the results of the ORCAv1 trial, evaluating the safety and efficacy of cytosinicline for e-cigarette cessation in 160 adults. We are extremely pleased to report a statistically significant benefit with a cessation rate of 31.8% for cytosinicline compared to 15.1% for placebo. Ultimately, Cytosinicline treated participants at a 2.6 times higher odds of quitting vaping compared to the placebo group. Again, cytosinicline was very well tolerated with no treatment-related serious adverse events reported during the trial. Vaping continues to be a rapidly growing epidemic with over 11 million adults reporting nicotine vape use in 2021, a 22% increase over the prior year. In a survey published in JAMA of nearly 2,000 daily users of e-cigarettes, 61% endorsed future plans to quit. Unfortunately, there are currently no treatments specifically FDA approved for e-cigarette cessation, which is why we believe this is a unique opportunity to expand the utilization of cytosinicline and make a significant impact to overall public health. At this time, I'll hand it over to Jerry to review our financial highlights and results.