Achieve Life Sciences, Inc.

Good day and thank you for standing by. Welcome to Achieve Life Sciences first quarter 2021 earnings call. At this time, all participants are in a listen-only 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 keypad. 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 Janie Sinas, Executive Vice President of Commercial. Thank you. Please go ahead.

Thank you, Charlotte, 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, 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. On today's call, we will review the progress we've made on the Phase III trial and other NDA-enabling activities. and provide an update on our Q1 financial results. Let's begin with ORCA-2. As a reminder, ORCA-2 is a double-blind, randomized, placebo-controlled Phase III trial that is currently enrolling 750 adult smokers across 17 locations in the United States. The trial is designed to evaluate the safety and efficacy of 3 milligrams cytosinicline dosed three times a day over a period of six and 12 weeks versus placebo. 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. After the 12-week treatment period, subjects are followed monthly out to 24 weeks. Behavioral support is being provided to all subjects throughout the study. 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. We are pleased to share that ORCA2 has reached over 80% of the 750 subject enrollment target and we look forward to completion of enrollment by the middle of the year. As we discussed on our last call, we experienced slower than anticipated enrollment during the initial months of the study, which was primarily due to the pandemic and participants' reluctancy for in-person site visits. In response, we implemented numerous recruitment initiatives to increase the pipeline of potential subjects to be screened and successfully assisted the sites in finding qualified subjects for the trial. We also onboarded two new clinical sites in Atlanta, Georgia, and Evansville, Indiana, bringing the total number of sites in the study to 17. We are pleased to see the additional recruitment support and new sites have resulted in increased randomizations, and we remain on track to completing enrollment by the middle of this year. Additionally, regarding ORCA2, we have completed two data safety monitoring committee meetings. The committee reviews general safety data and oversees the conduct of the trial. In both meetings, they did not identify any safety concerns nor any study conduct issues and recommended that the study continue as planned. Overall, we are pleased with the progress of the trial to date and the efforts being made by our clinical trial sites across the U.S. As a reminder, the company will remain blinded until the completion of all study follow-up evaluations and until the database has been finalized and locked. We look forward to providing further updates on ORCID II when enrollment is completed. Additionally, we have continued to make great progress on numerous non-clinical NDA-enabling regulatory requirements. We have completed and submitted to FDA both of the required long-term chronic toxicology studies. In addition, we are also near completion of one of the two required carcinogenicity studies and have completed a special protocol assessment with the FDA for the second required study. By next year, we expect that all required non-clinical toxicology studies for an NDA will be completed. Also, in the first quarter, we had two important cytosinicline studies published in leading peer-reviewed scientific journals. First, the results from ACHIE's phase two ORCA1 trial demonstrating superior quit rates for cytosinicline compared to placebo and impressive safety responses, was published in Nicotine and Tobacco Research. As a reminder, this study was instrumental in the selection of the three milligram dose and three times a day administration that we have taken forward into Phase III development. Additionally, the New Zealand RAURA study, showing improved efficacy and lower rates of adverse events when comparing cytosinicline to Chantix was published in the journal Addiction. We expect additional efficacy analyses from Raura in the coming months and look forward to sharing that with you when available. Finally, this quarter, we announced the appointment of two new directors to Achieve's board, Dr. Bridget Martel and Dr. Cindy Jacobs. Dr. Martel is board certified in both internal and addiction medicine and is an experienced executive leader in the pharmaceutical industry. Dr. Jacobs serves as Achieve's president and chief medical officer, and in addition to her board duties, will continue in her current role leading Achieve's regulatory and clinical development efforts. The appointment of Drs. Martell and Jacobs strengthens both our board diversity as well as our clinical and regulatory expertise. At this time, I'd like to turn the call over to Jerry to discuss our recent financial results. Maybe having an issue with Jerry's connection, so let me jump in. I'd like to provide an update on our cash balance as of March 31st, 2021, and our operating expenses for the first quarter of 2021. As of March 31st, the company's cash, cash equivalents, short-term investments, and restricted cash were $29.6 million compared to $35.9 million as of December 31st, 2020. We believe our cash balance is sufficient to provide runway into the middle of 2022. Turning to the statement of operations, the company incurred a net loss of $8 million for the quarter ended March 31st, 2021 as compared to a net loss of $3.3 million for the same quarter of 2020. Total operating expenses in the first quarter of 2021 increased to $8 million as compared to $3.4 million for the same quarter of 2020. As expected and highlighted during our call in March, operating expenses were elevated in the first quarter as enrollment in the ORCA2 trial increased. We anticipate our operating expenses to remain elevated during 2021 as we continue to execute on the ORCA2 trial. In closing, we continue to make excellent progress on advancing cytosinicline through the required clinical and regulatory development process. In the first quarter, we saw significantly increased interest and momentum in ORCA2 and look forward to the completion of enrollment in the middle of this year. Additionally, we continue to execute on the required NDA-enabling activities and publication of key data to expand awareness of cytosine acclaim's potential across new audiences. That concludes our prepared remarks. Thank you again for joining us. We will now open the line to questions. Operator?