Achieve Life Sciences, Inc.

Greetings and welcome to the Achieve Life Sciences third quarter 2025 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. As a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones, Achieve's Vice President, Strategic Communications and Stakeholder Relations. Thank you. You may begin.

Thank you, Operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer, Dr. Mark Rubenstein, Interim Chief Medical Officer, Jamie Zenos, Chief Commercial Officer, and Mark Oakey, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks. A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website. Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risk, uncertainties, and other factors including, but not limited to, the factors set forth in the company's filings with the SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. 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.

Thank you, Nicole, and good morning, everyone. This has been another truly significant quarter for Achieve in our mission to get a new treatment for nicotine dependence into the hands of patients. Our priorities of NDA submission, NDA acceptance, and ultimately NDA approval for cytosinicline as a treatment for nicotine dependence in smoking cessation have advanced significantly this quarter. These priorities have now been reinforced by the recent announcement that the FDA has awarded Achieve a Commissioner's National Priority Voucher, or CNPV, for the e-cigarette or vaping indication. This is a significant recognition of the importance of cytosinicline in addressing the emerging public health crisis caused by vaping. The CNPB is designed to provide enhanced FDA communications and an expedited NDA review timeline, reducing the potential NDA approval to one to two months from the standard 10 to 12 months. The implications are enormous for patients and physicians and are significantly value-enhancing for our stockholders. A rapid approval of a vaping indication means cytosinicline could be launched eight months earlier than expected. This would allow Achieve to potentially pioneer the first and only FDA-approved treatment for the 60% of people who want to quit vaping. During the quarter, we hit several regulatory milestones related to our smoking cessation indication. Most notably, the FDA acceptance of our new drug application for cytosinicline for review and set a producer or approval date of the 20th of June, 2026. Additionally, we submitted the 120-day safety review to the FDA on time. All interactions with the FDA remain normal and timely. To put our progress into perspective, nearly 29 million adults in the United States smoke cigarettes. and more than 15 million people attempt to quit every year. Smoking remains the leading cause of preventable death in the U.S. Approximately half a million deaths annually are attributable directly to smoking, costing over $600 billion each year in smoking-related U.S. healthcare costs and lost productivity. Numerous comorbidities including respiratory, cardiovascular and metabolic disease and of course cancer result from cigarette smoking and countless lives are impaired. This is the urgent need Achieve is focused on and cytosinicline is designed to address. Smoking cessation is an immense addressable market that has no new FDA-approved treatment options for nearly 20 years. Patients and physicians are frustrated by the lack of adequate tools to help drive success in their quit journey. The message is clear. Achieve is not quitting on you. With cytosinicline, Achieve is on the threshold of delivering a potential game changer for the millions hoping to quit. Fundamentally, it is clear that the narrative surrounding smoking and vaping has to change. Nicotine dependence has to be acknowledged as a medical condition in much the same way as obesity is now recognized with the advent of GLP-1s. There are clear similarities between the obesity and nicotine dependence market dynamics. Nicotine dependence is a neurobiological condition resulting from an overabundance and the number of nicotinic receptors in the brain and needs to be treated as such. As I mentioned in the introduction, comorbidities are a significant life impairment as a result of smoking, anything from COPD, asthma, cardiovascular disease, cancer, type 2 diabetes. The list is long. We decided to specifically investigate the impact of cytosinicline in smokers with COPD and achieves two phase three clinical trials. Our recent publication in Thorax highlighted cytosinicline's potential to help individuals with COPD who remain smokers. As a reminder, approximately six million of the 16 million Americans diagnosed with COPD continue to smoke today. In our two phase three trials, we saw the smokers with COPD had higher quit rates on cytosinicline compared to placebo. COPD smokers on placebo did not quit at all. We were thrilled to see this outcome within this subgroup as these patients are often amongst the most difficult to treat due to the severity of their progressive illness. We know that quitting smoking improves the effectiveness of COPD treatments and helps reduce exacerbations and hospitalizations. since smoking worsens symptoms and increases disease progression. These findings underscore cytosinicline's potential impact in offering meaningful benefits to one of the most vulnerable patient populations. Dr. Mark Rubenstein will discuss the findings in more detail in a minute. Jamie Zenos will also discuss Achieve's data-driven digital commercialization strategy and provide an update. I'd like to set the stage by noting that many large and specialty pharmaceutical companies have embraced AI as a powerful tool to advance precision targeting of both physicians and patients. What differentiates Achieve's commercial strategy is the integrated nature of our ecosystem and platform. Achieve leverages AI and machine learning to drive next best action orchestration, omnichannel marketing, and audience activation across healthcare professionals, patients, and payers. By utilizing a unified, HIPAA-compliant data warehouse and generative AI, Achieve is able to optimize campaigns, enhance engagement, and measure ROI across all channels. For Achieve Life Sciences, this represents a scalable model for deploying AI-powered commercialization at launch. while minimizing infrastructure investment. Without getting into too much technical jargon, the benefits of an AI or data-driven approach include channel sequencing, determining the next best action email, social ad, webinar invite, or rep visit for each audience. Message optimization, using AI-driven models to tailor messaging to behavioral and conceptual data. dynamic measurement, real-time KPI or performance monitoring, and tracking, allowing optimization mid-campaign. These powerful AI-driven tools allow integrated payer, HCP, and patient activation through a single HIPAA-compliant environment. The integrated platform is cost-efficient, ensuring resources are applied with targeted precision, providing improved revenue outcomes. I'm sure you will share Achieve's excitement with the commercial build-up prior to launch in the third or fourth quarter next year. Turning to updates on our team, we had two promotions and one new hire. Dr. Mark Rubenstein became our interim chief medical officer, and Craig Donnelly was promoted to chief operations officer. Eric Atkinson joined us recently as chief legal officer. Dr. Rubenstein joined is a seasoned physician and executive with deep experience in patient care, clinical development, scientific research, and medical affairs leadership, with a strong focus on nicotine cessation and preventative medicine. Having served as our head of medical affairs since 2024, he brings a strong understanding of our programs, pipeline, and strategic objectives, along with real-world experience treating patients who are eager to quit nicotine. Dr. Rubenstein is steeped in the world of smoking cessation and nicotine dependence. In his academic career, he led a clinical and translational research program focused on nicotine addiction and smoking cessation as a professor at UCSF. Prior to joining Achieve, Dr. Rubenstein served as the head of medical affairs at Blip, where he spearheaded the company's strategy to help smokers and vapers quit through FDA approved medications and digital support tools. His deep understanding of the nicotine dependence landscape positions him to seamlessly lead our clinical and medical efforts as we move toward potential approval and commercialization. It's been great to work with Dr. Rubenstein in his new role. We promoted Craig Donnelly to Chief Operations Officer since joining Achieve in 2022 Craig has shown outstanding leadership in manufacturing and regulatory. In his new role, he will align our supply chain and commercial strategy as we prepare to launch CytoCineClean. With over 25 years in biopharma, his expertise will be key as we build the infrastructure to deliver CytoCineClean to patients and move Achieve into a commercial stage company. Lastly, in October, we welcomed Eric Atkison, as our new chief legal officer who will oversee our legal strategy, corporate governments, compliance, and risk management. With over 25 years' experience in the pharmaceutical and biotech industries, specifically in legal, regulatory, and M&A, ERIC's already been a tremendous asset as we move cytosinicline through regulatory review and get ready for a potential launch. Thanks to our world-class team and relentless focus on execution, we continue to deliver on our milestones and move confidently toward bringing a much-needed new treatment to market. With that, I'll now turn it over to Dr. Rubenstein.