Achieve Life Sciences, Inc.

Greetings, and welcome to the Achieve Life Sciences third quarter 2024 earnings conference call and webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. And as a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones, Achieve Investor Relations. Thank you, Nicole. You may begin.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Jerry Wan, Principal Accounting Officer, and Jamie Zenos, Chief Commercial Officer. Management will be available for a Q&A session following today's prepared remarks. Before we begin, 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 available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to Rick.

Thanks, Nicole. The third quarter was yet again eventful and productive for Achieve, with a change of management, new hires in key roles, the FDA granting breakthrough therapy designation for e-cigarettes or vaping cessation, and refinancing our SVB loan. Much of this activity reflects the rapidly maturing Achieve and reflects the increasing value to patients, physicians, and shareholders as the company transitions from a pure play clinical development company towards a more commercially focused company. As a result, the board decided that as Achieve swiftly approaches NDA submission, acceptance, and approval, the company needed to strengthen executive management with greater commercial and M&A expertise to enhance the future value of the company. The value proposition continues to increase. A target population of more than 40 million Americans with nicotine dependence is awe-inspiring to Big Pharma let alone a microbiotech. To continue value enhancement, we have carefully and thoughtfully assessed the future strategy of Achieve and cannot rely solely on a third-party exit or strategic partnering to commercialize cytosinicline. In fact, to do so would hold Achieve to ransom for unpalatable terms. We have to move forward from a position of strength with strong conviction about our ability to provide patients with a best-in-class smoking cessation therapy and a first-in-class vaping cessation treatment. As you will hear a little later, smoking does not only affect the health and life expectancy of the people who smoke, it has a profound impact on family, friends, and the wider community. The proliferation of smoking-related diseases, including respiratory, cardiovascular, cancer, diabetes, dementia, and so on, reverberates through society. For far too long, we've ignored the medical nature of nicotine dependence and solely focused on the $300 billion a year cost of the consequences of smoking-related diseases. Nicotine dependence is a disease, and it needs to be treated as such. Achieve has the unique privilege to change the health and well-being of millions of Americans, up to 40 million, plus the wider global population of more than 1 billion people suffering from nicotine dependence disease. That is our mission, our goal, and our commitment. Focusing on how Achieve can accomplish this is a priority, but does not preclude an exit, and we believe actually enhances the possibility. A traditional primary care sales force commercial strategy is no longer viable in today's world and must be combined with innovative digital execution. This is what many big pharma are currently grappling with. How do you reach primary care physicians when access is increasingly restricted? Our challenge will be how to target primary care physicians efficiently and raise awareness of our new treatment option in potential quitters. That is why we promoted Jamie Zinos to Chief Commercial Officer. Quietly and behind the scenes, Jamie has been working for more than two years to develop an innovative and highly focused digital commercial strategy. She has converged with experts in the field to create a cost-effective strategy which is importantly dynamic and scalable. Our goal is to build for growth, expand when appropriate, so that we can optimize value and patient benefit. Jane has been with Achieve since 2017, previously serving as our Executive VP of Marketing. She has nearly 25 years of pharma commercial experience, from initially carrying the bag as a sales rep to U.S. and global marketing and commercial development roles at Abbott, Novartis, and Pfizer. With respect to our commitment to smoking cessation, and treating nicotine dependence, Dr. Cindy Jacobs, a Chief President and Chief Medical Officer, presented at the FDA-NIH joint public meeting on advancing smoking cessation held on the 21st of October in D.C. This important meeting gave the opportunity to stakeholders to represent their views regarding the crucial need for future treatments in smoking cessation. The meeting crystallized the public health importance of providing solutions for nicotine dependence. There are 29 million Americans who smoke combustible cigarettes, and over 11 million adults in the US who vape nicotine. Approximately 65% of people who smoke attempt to quit annually, with fewer than 10% doing so successfully. Nicotine is immensely addictive, and options to help people quit its use are extremely limited. If approved, cytosinicline will be the first new prescription smoking cessation drug in nearly 20 years. At its peak, Chantix revenues exceeded $1 billion, with 75% of that attributed to the U.S. market. We believe cytosinicline with its excellent efficacy and tolerability profile is a significant opportunity to help the millions of people who want to quit smoking and vaping. Our phase three clinical trials demonstrated impressive efficacy while meeting the FDA gold standard endpoint of continuous abstinence. As a result, cytosinicline is poised to become the best in class option for smoking cessation and the first in class option for vaping cessation. Our focus is now looking at the future NDA submission, acceptance, and approval for smoking cessation. Additionally, we are targeting Q3 2025 to commence the Phase III clinical trial for vaping cessation. On today's call, Cindy will provide an update on the ORCA-OL Open Label Safety Study, timing and status for the NDA submission, and comment on her recent participation at the FDA-NIH joint meeting. Then Jamie will share a few thoughts on near-term NDA and launch readiness priorities and overall commercial strategy. Finally, Jerry will lead us through the financials before returning to me for closing comments. With that, I will turn the call over to Cindy.