Achieve Life Sciences, Inc.

Good morning, ladies and gentlemen, and welcome to the Achieve Life Sciences first quarter 2020 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, then zero on your touchstone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Ms. Jaime Xinos, Executive Vice President of Achieve.

Thank you, Ashley, and thanks everyone for joining us. On the call today from Achieve, we have Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, Chief Medical Officer, Dr. Anthony Clarke, Chief Scientific Officer, and John Bensage, Chief Financial and Operating Officer. 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 will now turn the call over to Rick.

Thank you, Jaime. Before we begin the discussion of our first quarter activities, Thank you very much. with friends, family, and colleagues. We're facing unprecedented times that truly test our resilience. We remain hopeful and we're also proud to be part of an industry that is working diligently to expedite the development of COVID-19 testing and treatments. Achieve is fortunate in that as a multinational organization, we're accustomed to working in a virtual environment with the exception of not being able to travel to meet and many of you were conducting business as normal. We are, of course, carefully evaluating the impact of COVID-19 on the initiation of our Phase III clinical development program. The health and safety of our trial participants, healthcare providers and employees will continue to be our number one priority. Given the impact of COVID-19 in individuals with pre-existing conditions, such as pulmonary disease, it is now more important than ever for smokers to quit. We believe in the potential of cytosine cleaning to help them to do so. In addition to our clinical trial sites and our CRO, we continue to anticipate initiation of our first phase three, the ORCA-Q trial in the second half of this year. This is of course subject to financing and confidence in our ability to conduct this trial in a manner that is safe to participants and healthcare providers. From a regulatory perspective, we have now submitted to the FDA all requested non-clinical data allowing for cytosinic treatment of both six and 12 weeks in the upcoming Phase III ORCA II trial. We did not observe any new safety or toxicology signals when evaluating either 13 or 26 of treatment in these non-clinical studies. Subject to final review by the FDA, the Phase III trial will be ready to initiate. As a reminder, the ORCA II trial will address three key factors. Number one, the evaluation of the higher three milligram dose of cytosinicline. Number two, the simplification of the dosing schedule given only three times daily leading to ease of use. And number three, the extension of the treatment duration to six and 12 weeks expected to yield better and more durable efficacy results. The extension of the dosing period to six weeks in the phase three trials could have significant benefits. It will allow us to measure the primary endpoint of four weeks of continuous abstinence while patients are still receiving cytosinicline. This was not possible with a 25-day treatment period in the ORCA1 trial. As documented in the literature, measuring efficacy while patients are on treatment typically results in higher quit rates. Shifting towards other opportunities for cytosinicline as a treatment for nicotine addiction, as previously discussed, we initiated an agreement with Freemind, an organization that assists life science companies with non-dilutive financing opportunities. Through this partnership, we recently submitted a grant application for funding of a phase two clinical study to evaluate the potential for cytosinicline as a nicotine cessation treatment for vapors and e-cigarette users. If this non-dilutive financing is granted, this study will be the first multi-center, double-blind, randomized, placebo-controlled phase two study conducted in daily nicotine e-cigarette users seeking to quit. This trial would enroll approximately 150 adult subjects at eight sites throughout the United States. The number of vapors and e-cigarette users continues to grow, and as reported in the Annals of Internal Medicine in 2018, has reached nearly 11 million users in the U.S. alone, of which nearly half are under the age of 35. While e-cigarettes and vapes have historically been viewed as safer than combustible cigarettes for harm reduction, their long-term safety remains controversial. Since these products also sustain addiction, many vapers are now seeking to quit nicotine completely. To further explore vapers' interest in quitting, we recently conducted a survey with IQVIA in approximately 500 users of nicotine vapes or e-cigarettes. looking specifically at individuals that only vape nicotine, approximately 74% indicated that they intend to quit vaping within the next three to 12 months. Of those who intended to quit even sooner within the next three months, roughly half stated that they will be extremely likely to try a new prescription product to help them do so. Pending grant approval and the outcomes of the study We believe that cytosinicline could be the first prescription drug offering a new option for nicotine vapors and e-cigarette users who are ready to quit for good. Now, before I turn the call over to John for our financial discussion, I want to give a brief update on the timing of the RAURA study. As you may recall, this is an investigator-led study being conducted by Assistant Professor Natalie Walker and the New Zealand National Institute of Health Innovation. The trial is a single-blind, randomized, controlled, non-inferiority trial to evaluate the safety, efficacy and cost effectiveness of cytosinicline compared to varenicline in the Maori indigenous population. The results of the Rauora trial are eagerly awaited as this is the first head-to-head evaluation to determine whether cytosinicline is at least as effective as Veronica Lane and will provide insights as to how the safety profiles compare in this population. We applaud Dr. Walker's efforts conducting this challenging real-world trial and expect the data to be submitted for presentation at a medical conference later in the year. I'll now turn the call over to John to discuss the recent financing on our first quarter results.