Achieve Life Sciences, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Achieve Life Sciences second quarter 2020 earnings conference call. At this time, all participants are in 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 your first speaker for today, Ms. Jamie Xinos, Executive Vice President of Commercial at Achieve. Thank you. Please go ahead.

Thank you, 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 Bensich, 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, Jamie. On today's call, we will review the second quarter highlights. Firstly, the exciting top-line data from the New Zealand Rawora Phase III clinical trial led by Dr. Natalie Walker. Secondly, Dr. Cindy Jacobs will review the continuing momentum on initiating the Phase III ORCA II trial in the U.S. later this year. And thirdly, John Bensich will review our financial results plus the strengthening of our balance sheet facilitating the start of the ORCA II trial. At the end of June, we announced the successful top-line results from the investigator-led Phase III non-inferiority Rawora trial, comparing cytosinicline to Chantix in the Maori or indigenous people of New Zealand. Our congratulations to Dr. Natalie Walker of the University of Auckland for conducting this landmark trial. The Rawora trial evaluated the efficacy, safety, and cost effectiveness of cytosinicline compared to Chantix as a smoking cessation aid. In total, the study randomized 679 subjects. As a non-inferiority trial, it was designed to demonstrate whether cytosinicline was at least as good as Chantix for efficacy and safety. In fact, it showed that cytosinicline efficacy was similar to Chantix and that cytosinicline had a superior safety profile. Rauora compared cytosinicline administered on a modified schedule over 25 days of downward dosing titration followed by twice daily dosing for a total of 12 weeks against Chantix, which was administered on a standard dosing schedule of seven days of upward titration followed by twice daily dosing for a total of 12 weeks. The primary endpoint was a comparison of biochemically confirmed continuous abstinence rates at six months. The trial successfully achieved the primary endpoint for showing that cytosinicline plus behavioral support was at least as effective as Chantix plus behavioral support at six months. In addition, the trial showed that cytosinicline resulted in significantly fewer reported adverse events when compared to Chantix. The positive top line results of the Rawora Phase III trial which is the first direct head-to-head comparative study between cytosinicline and Chantix provides additional evidence that cytosinicline is at least as effective as Chantix while offering improved tolerability. We're excited about this outcome that further strengthens the potential for cytosinicline to help smokers quit. Importantly, these benefits were achieved using only the currently marketed one and a half milligram dose of cytosinicline and the downward titration schedule. The dosing duration was modified to 12 weeks in order to match the Chantix dosing schedule. Our upcoming US cytosinicline phase three clinical trials will use the higher three milligram dose at a simplified three times daily dosing schedule. Based on the results of the ORCA-1 Phase IIb trial, we are optimistic that this simplified dosing schedule in combination with a 3 mg dose will be easier for subjects and potentially result in better smoking cessation rates than what was observed in the Rawora trial. The final Rawora trial results have been submitted by Dr. Nathalie Walker, the Rawora primary investigator, for presentation at the Society for Research on Nicotine and Tobacco European Annual Meeting to be held this September. We look forward to sharing additional details on the RAORA trial results when presented. Turning to the upcoming ORCA2 double-blind placebo-controlled phase three trial, preparations are underway for the trial commencement in the fourth quarter. These preparations include careful risk management assessments for any potential impact of the COVID-19 pandemic. Our continuous risk assessment dialogue with clinical trial sites and our CRO still indicates that initiation of the ORCA II trial in the fourth quarter of this year remains feasible. The health and safety of our trial participants, healthcare providers, and employees will continue to be our number one priority. We continue to monitor the crisis in real time taking advice and precautions to minimize risk to all involved. I'll now turn the call over to Cindy to review the ORCA-2 trial design and provide a regulatory update.