Achieve Life Sciences, Inc.

Ladies and gentlemen, welcome to the Achieve Life Sciences third quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star zero on your touchstone telephone. And as a reminder, this conference call is being recorded. I would now like to turn the conference over to your For today, Ms. Jamie Zinnes, ma'am, please go ahead.

Thank you, Ludi, and thanks, everyone, for joining us. On the call today from Achieve, we have John Bensich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Jerry Wan, Principal Accounting Officer, Rick Stewart, Executive Chairman of the Board of Directors, and Dr. Anthony Clark, Chief Scientific Officer. 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 will now turn the call over to John.

Thank you, Jamie. On today's call, we will provide an update on the cytosinicline development program, including our ongoing ORCA-2 study. the great progress we are making on our upcoming clinical trials, and provide an overview of our Q3 financial results. Let's begin with ORCA2, our current phase three trial evaluating cytosinicline in 810 adult cigarette smokers at 17 clinical trial sites in the United States. ORCA2 was initiated in October of 2020 and is evaluating the efficacy and safety of three milligrams cytosinicline dosed three times daily over a period of six and 12 weeks versus matched placebo. We reached the key milestone of completing our target enrollment in June of this year. All randomized subjects were assigned to one of three arms to receive either 12 weeks of placebo, 12 weeks of cytosinicline, or six weeks of cytosinicline followed by six weeks of placebo. All subjects are then followed monthly out to 24 weeks. The ORCA2 study has two independent primary efficacy endpoints that will evaluate the rate of smoking abstinence of cytosinicline during the last four weeks of treatment 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. All ORCA2 subjects have now completed study treatment and are in follow-up. We expect the last patient last visit to occur by end of December 2021 and top line data results to be announced in the first half of 2022. ACHIEV will remain blinded until the completion of all study follow-up evaluations and until the database has been finalized and locked. Additionally, planning is well underway for ORCA3, our proposed phase three clinical trial, which we anticipate could launch by early 2022. ORCA III will mirror the ORCA II trial and study design, safety and efficacy evaluations, and statistical criteria. ORCA III will serve as the second required Phase III trial to support the cytosine and clean regulatory submission in the U.S. Similar to ORCA II, approximately 750 subjects are expected to be enrolled into ORCA III and randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of cytosine and clean administered for either six or 12 weeks compared to placebo. To support the initiation of ORCID III, we have hired three new full-time clinical operations employees, completed the selection process for the CRO, finalized the packaging and study drug supply, and are currently undergoing clinical trial site selection. We look forward to providing you with additional updates in the coming months as we progress towards ORCID III initiation. We are also making excellent progress on our plans for expansion into nicotine e-cigarettes or vaping cessation. We announced just a few days ago that the FDA has completed their review and acceptance of our IND application to investigate cytosinicline as a cessation treatment for nicotine e-cigarette users. As previously discussed, we have secured non-diluted grant funding from the NIH to offset costs related to the Phase II ORCA V1 trial. which will enroll approximately 150 adult nicotine e-cigarette users in the US. The grant is awarded in two phases, with the initial amount of $320,000 used to complete regulatory and clinical operational activities, such as protocol finalization, clinical trial site identification, and the submission of a new IND for vaping cessation to FDA. Upon completion of these milestones, as assessed by NIH, Achieve expects to receive the next stage of grant award of approximately $2.5 million in early 2022, which will enable execution of the ORCAv1 study. The funding is subject to authorization by the NIH under the grant process and is expected to cover approximately 50% of the total ORCAv1 trial costs. We expect to initiate the ORCAv1 study in the second quarter of 2022. 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 can 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, cytosinically may offer a new cessation option for this growing population of e-cigarette users who seek to quit nicotine for good. Finally, In the third quarter, we had two cytosinicline data presentations at the Society for Research on Nicotine and Tobacco annual European meeting. The first data set evaluated the time to sustained abstinence with cytosinicline compared to placebo in our Phase II ORCA1 trial. This new analysis determined that smokers treated in the study with cytosinicline showed an earlier onset of sustained abstinence compared with placebo. In this cohort, It took smokers who were successful at quitting a median of seven days to achieve smoking abstinence compared to 18 days for placebo. We have seen this early onset of activity in earlier studies, including in our repeat dose PK-PD study, where we saw a greater than 75% reduction in cigarettes consumed within the first 48 hours of initiating treatment. Data were also presented from additional ORCA1 subgroup analysis, evaluating outcomes in smokers who previously failed treatment with Chantix. Smokers who received 3 mg cytosinicline three times daily demonstrated a week 4 abstinence rate of 51.3% compared with 15.8% for placebo-treated subjects. The cytosinicline three times a day regimen appeared to be more effective for smokers who had previously failed to quit on varenicline than the titration regimen. We believe both the speed of cessation and cytosinicline's efficacy in Chantix pre-treated smokers bodes well for the Phase III development program and for the commercial prospects of the product. That concludes the overview of our recent highlights. Now I'd like to turn the call over to Jerry to discuss our financial results.