Achieve Life Sciences, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Achieve Life Sciences fourth quarter and year-end 2020 earnings conference call. At this time, all participant lines are in a listening mode. After the speaker's 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 0. I would now like to hand the conference over to your speaker today, Jamie Venus, Executive Vice President of Commercial at Achieve. Thank you. Please go ahead, ma'am.

Thank you, Shannon, and thanks, everyone, for joining us. On the call today from Achieve, we have John Bensage, 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'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, Jamie. Despite all of its unique challenges, 2020 was a pivotal year for Achieve. While navigating the new normal of conducting business virtually, we accomplished several key milestones, including multiple data announcements supporting Cytosynaclean's differentiated product profile, made significant progress on NDA-supporting studies and regulatory activities required by FDA, and initiated the Phase III ORCA II study in U.S. smokers. Notably, we ended the year in the best capitalized position since the company's inception. Today, we will provide an update on the cytosinicline development program and discuss our key priorities for the coming months and year ahead. Let's begin with ORCA II. As a reminder, ORCA-2 is a double-blind, randomized, placebo-controlled Phase III trial that is currently enrolling 750 adult smokers across 15 locations in the U.S. The trial is designed to evaluate the safety and efficacy of 3 mg cytosinicline dosed three times a day over a period of 6 and 12 weeks versus placebo. This trial was launched during the fourth quarter of last year. Participants are being randomly assigned to one of three arms and receiving either 12 weeks of placebo, 12 weeks of cytosinicline, or a combination of six weeks of cytosinicline followed by six weeks of placebo. Behavioral support is being provided throughout the study, and after the 12-week treatment period, subjects are followed monthly out to 24 weeks. There are 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. Importantly, and unlike the design of our previous ORCA1 trial, smoking abstinence here is defined as continuous abstinence during the last four weeks of treatment. One of the primary changes we made going into ORCA II was to extend the treatment period from 25 days to 6 and 12 weeks. This now allows us to measure the FDA-approvable endpoint of four weeks' continuous abstinence while patients are still on therapy. This was not possible with the prior administration over 25 days, and we know that quit rates are highest while subjects remain on treatment. We believe these changes have the ability to improve on quit rates that we have seen historically. Regarding enrollment, we initially estimated our projections based on the rapid enrollment of ORCA1, which completed ahead of schedule. In this case, given the ongoing pandemic and more recently the winter storms that impacted numerous trial sites across the U.S., we are seeing slower weekly randomizations than originally projected by our clinical sites. We have implemented numerous recruitment initiatives to increase the pipeline of potential subjects to be screened and assist the centers in finding qualified subjects for the trial. Based on the current rate of randomizations, we expect enrollment of ORCA2 to be completed by the middle of this year, rather than by the end of March, as we previously anticipated. Our entry criteria and pre-randomization screening process clearly outlines the trial's six-month commitment and frequent in-clinic visits so that we enroll subjects who are motivated quitters, willing to comply with study requirements, and who are otherwise healthy. Ensuring these entry criteria are met and enrolling the most appropriate and motivated subjects remains our first priority over speed of enrollment. Overall, we are pleased with the conduct of the trial to date and the efforts being made by our clinical research centers across the U.S. As a reminder, the company will remain blinded until the completion of the trial and results have been analyzed. We look forward to providing further updates on ORCA II as we move forward, including on our next quarterly earnings call. As you may recall, the Society for Research on Nicotine and Tobacco annual meeting was held last month, where we had the opportunity to present findings on smoker and e-cigarette user attitudes and perceptions on quitting. The data collected from recent surveys of over 1,100 smokers and 500 nicotine e-cigarette users further reinforced the need for effective new cessation treatment options. In the smoking population specifically, overall satisfaction and perceived efficacy of available treatments was low. Of the smokers who had previously tried using a prescription medication, such as Chantix or Bupropion, only 26 percent stated they completed one month of treatment. This is consistent with prescription claims data we have reviewed that show 76 percent of Chantix users do not complete the full three-month course of therapy. The survey also showed that side effects, risk of suicidal thoughts, and perceptions about low treatment efficacy were among the stated reasons for discontinuation or lack of initiation of currently available medications. These insights are incredibly relevant as we think about the future product positioning of cytosinicline. We believe our tolerability profile with low levels of adverse events, a shorter course of treatment, and a more selective mechanism of action will increase the number of quitters willing to try prescription therapy. We expect these product features will lead to improved compliance and potentially better outcomes. Moving on to the results of the data presented from vaping or e-cigarette users, we conducted an analysis from over 500 users of nicotine vape products, including roughly half of whom were former smokers and half considered dual users who both vape and continue to smoke. The key findings that were reported indicate that regardless of current vaping behavior, both segments expressed an interest in quitting. In total, 73% stated that they intend to quit vaping within the next three to 12 months. Of those who plan to quit within the next three months, more than half stated that they would be interested in trying a new prescription treatment to help them do so. These data are of particular interest given our desire to initiate a vaping cessation trial of cytosinicline in the future. As we have previously stated, we have applied for non-dilutive grant funding for a Phase II vaping study and expect to hear more on our application status in the second quarter. Also at SR&T, Dr. Natalie Walker provided a review of the previously presented Rauora data. As a reminder, Rauora was the first ever head-to-head trial of cytosinicline compared to Chantix that enrolled a total of 679 smokers in New Zealand. The RAUERA results showed that cytosinicline not only met the pre-specified non-inferiority endpoint, but was trending towards superior efficacy with numerically higher quit rates for cytosinicline. In addition, the trial showed that subjects on cytosinicline had significantly lower rates of adverse events compared to those subjects on Chantix. Dr. Walker commented that RAUERA results would be published in the near future. At this time, I'd like to turn the call over to Jerry to discuss our recent financial results. Jerry?