Achieve Life Sciences, Inc.

Please go ahead.

Thank you, Tiffany, and thanks, everyone, for joining us today. On the call, we have John Bences, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Jerry Wan, Principal Accounting Officer, and Rick Stewart, Executive Chairman of the Board of Directors. I would 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 would now like to turn the call over to John.

Thank you, Jamie. On today's call, we will discuss the exciting progress we have made on the Sinus Center Clean Development Program, including key milestones that we have reached so far in 2021, and provide an update on our second quarter financial results. Let's begin with our phase three ORCA2 trial that is evaluating the efficacy and safety of three milligrams cytosinicline dosed three times daily over a period of six and 12 weeks versus placebo. ORCA2 is being conducted at 17 clinical sites in the United States. And as announced in June, we have reached the key milestone of enrollment completion. As you may recall, the original enrollment target was 750 smokers. However, we allowed additional subjects that were in screening at the time of our cutoff date to participate in the study, resulting in a total of 810 subjects randomized. All subjects have now been assigned to one of three arms to receive either 12 weeks of placebo, 12 weeks of cytosinicline, or a combination of six weeks of cytosinicline followed by six weeks of placebo. Following the 12-week treatment period, subjects are being followed monthly out to 24 weeks. The study has two independent primary endpoints that will evaluate the rate of smoking abstinence of cytosinicline compared to placebo at the end of both six weeks and 12 weeks of treatment. ORCA2 will be successful if either or both of the cytosinicline arms show an efficacy benefit over placebo. ACHIEVE will remain blinded until the completion of all study follow-up evaluations, and the database has been finalized and locked. We expect last patient, last visit in the ORCA2 study to occur at the end of 2021, and top-line data results to be announced in the first half of 2022. We also recently announced an update regarding our plans to expand the evaluation of cytosinicline into nicotine, e-cigarette, or vaping cessation. In July, we were notified that we received a federal grant award from the NIH to begin preparations for the Phase 2 ORCAv1 study. As part of this process to secure non-dilutive funding to offset costs related to this important trial, we applied for the maximum allowable funding of $2.8 million under the NIH Small Business Technology Transfer Grant. The NIH grant is awarded in two phases and requires that it achieve meet specific milestones in order to receive the second tranche. The first approved grant amount of $320,000 commenced on August 1st and is being used to complete critical regulatory and clinical operational activities such as protocol finalization, clinical trial site identification, and the submission of a new IND to FDA for this specific population. Upon completion of these milestones, as assessed by NIH, a chief expects to receive the next stage of the grant award of approximately $2.5 million that will enable execution of the Phase II ORCAv1 clinical study in approximately 150 adult nicotine e-cigarette users in the United States. The NIH funding is expected to cover approximately 50 percent of the total ORCAv1 trial costs. We are delighted to have Dr. Nancy Rigotti, professor of medicine at Harvard Medical School and director of the Tobacco Research and Treatment Center at Massachusetts General Hospital, along with the Chief's President and Chief Medical Officer, Dr. Cindy Jacobs, leading the efforts on the ORCA V1 trial as co-primary investigators. Dr. Rigotti is also the primary investigator in our ORCA II Phase III study. Recent data indicate there are more than 11 million adult users of nicotine e-cigarettes in the United States alone. While e-cigarettes have historically been viewed as less harmful than combustible cigarettes, their long-term safety remains controversial. Since these products also sustain addiction, many vapers are now seeking to quit nicotine completely. In research conducted by Achieve, roughly 73% of e-cigarette users expressed a desire to quit within 12 months. Of those with a more urgent interest in quitting, more than half indicated they would be interested in a new prescription cessation therapy. Currently, there are no treatments specifically indicated to help e-cigarette users quit. so we see this as an unmet commercial opportunity. If our development efforts prove to be successful, cytosinicline may offer a new cessation option for this growing population of e-cigarette users who seek to quit nicotine for good. Moving on to another important milestone that we just announced yesterday, the issuance of two new patents by the U.S. Patent and Trademark Office. These patents include claims covering the expected three milligram commercial dose of cytosinicline administered three times daily. The claims that have been granted under these patents stem from the results we obtained in our ORCA-1 clinical study that evaluated various doses and administrations of cytosinicline. Not including any patent term extensions to which we may be entitled, these patents will expire in the third quarter of 2040. With this new issuance, we now have seven granted patents, five patent families, and 34 pending patent applications. We expect to continue to expand our patent portfolio in the future as we seek additional ways to protect our cytosinicline franchise. Aggressively protecting the IP for cytosinicline in the U.S. and beyond is key to our commercial success, and we continue to make excellent progress on this front. That concludes the overview of our recent highlights. Now I'd like to turn the call over to Jerry to discuss our financial results.