Achieve Life Sciences, Inc.

Greetings and welcome to the Achieve Life Sciences fourth quarter and full year 2025 earnings conference call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. You will be placed into question queue at any time by pressing star 1 on your telephone keypad. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star 0 on your telephone keypad. It's now my pleasure to turn the call over to Nicole Jones, Vice President, Strategic Communications. Nicole, please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, President and Chief Executive Officer, Dr. Mark Rubenstein, 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. The MBA submission in June 2025 started the transformation of Achieve from a pure play clinical development company into a commercially focused enterprise. Our primary objective now is to make cytosine clean available to the 25 million patients who smoke and nearly 18 million who vape. The need for a new nicotine dependence treatment like cytosinicline has never been greater. Achieve is committed to providing the new therapeutic tool to patients seeking to break free from the cycle of nicotine dependence. I'm incredibly impressed by the commitment and resilience of the entire Achieve team and their dedication to addressing the nicotine dependence public health crisis in the U.S. Key highlights in 2025 include, firstly, the submission of the new drug application or NDA for the smoking cessation indication and its acceptance by the FDA, moving us one important step closer to becoming the first new FDA-approved treatment in 20 years. Secondly, Achieve's vaping cessation indication was one of the first recipients of a commissioner's national priority voucher. Recognition of cytosinicline as a national priority is an incredible achievement of the work conducted by Achieve and the importance of cytosinicline in tackling a previously intractable problem of nicotine dependence. The commissioner's voucher gives us an accelerated pathway to be the first and only FDA approved vaping cessation treatment. Thirdly, our clinical team delivered on all planned regulatory milestones and generated encouraging clinical data across our program during the year. This includes concluding the ORCA-OL long-term exposure trial, which underlined cytosinicline safety profile, demonstrating strong tolerability and excellent patient satisfaction data. We should not underestimate the importance of the findings from the ORCA-OL safety study, which demonstrated the tolerability of cytosinicline over long-term, 52-week exposure to treatment. Dr. Mark Rubenstein will elaborate in a minute. And lastly, post hoc data published in Thorax, a leading peer-reviewed medical journal, demonstrated that cytosinicline significantly improved smoking quit rates compared to placebo in adults with chronic obstructive pulmonary disease. There are 6 million COPD smokers in the U.S. today with few options to help them quit. Their level of nicotine dependence must be high as continued smoking exacerbates COPD symptoms and impairs the efficacy of COPD drugs. The positive data on COPD patients highlights the expansive scope of opportunities for cytosinicline in terms of the range of comorbidities that could potentially benefit from treatment and broad range of healthcare providers who would be interested in its benefits. Our commercial team has moved forward decisively towards building a scalable, data-driven commercial model that will position us to launch successfully. Our model is built to address the rapidly evolving healthcare environment where approximately 75% of primary care physicians will no longer meet with medical reps. Achieve's omnichannel digital platform provides precision targeting of physicians and patients, which will allow us to identify high volume prescribers and the patients motivated to quit, deploying resources efficiently and maximizing impact per dollar spent. AI is a critical enabler in this evolution. We'll be using advanced analytics and machine learning to enhance decision-making, automate custom engagement, and generate predictive insights about which messages will resonate most with target audiences, positioning us to continue building an efficient commercial organization that punches well above its weight. We also just announced that we have selected Adair Pharma Solutions, a U.S. based manufacturing organization that will produce cytosinicline drug product as we prepare for potential commercial launch and future demand. We believe this partnership will secure our supply chain, reduce risks associated with international pharmaceutical importation, and may lower overall costs, including the risk and uncertainty for tariffs on international imports of drug product. I'm pleased to report that work has commenced and our technology transfer to Adair is already underway. The Adair partnership provides redundancy in our supply chain, allowing contingency capacity in the U.S. The manufacturer named in the cytosinicline NDA recently had an FDA good manufacturing practices inspection with two observations related to solid oral dose manufacture. which are being addressed through an ongoing communication of its remedial action plan with the FDA. By establishing U.S. manufacturing with Adair, we increase confidence in our supply chain security as we advance towards a planned commercial launch of cytosinicline expected in the first half of 2027. We remain focused on bringing cytosinicline to patients as quickly as possible, and our decision to work with Adair positions us to launch with the manufacturing reliability and the operational readiness our patients and stakeholders expect. Now, let me take a moment to remind you why our team is so passionate about bringing cytosine and clean to market. Recent data issued by CDC estimated that in 2024, approximately 25 million adults in the United States smoked cigarettes. It's estimated that more than 15 million attempt to quit every year. Smoking remains the leading cause of preventable death in the U.S., claiming approximately 500,000 lives annually and costing over $600 billion each year in healthcare costs and lost productivity. The comorbidities are devastating. To name a few, respiratory disease, cardiovascular disease, metabolic disease, and cancer. We also know that 60% of the nearly 18 million adult e-cigarette users in the U.S. want to quit, and adult nicotine e-cigarette use is on the rise. However, there is no FDA-approved treatment for e-cigarette cessation. Patients are frustrated. Physicians are frustrated. The narrative around nicotine dependence needs to change. We've seen this transformation happen with obesity. When GLP-1s emerged, they helped society recognize obesity for what it truly is, a medical condition, not a personal failure. Nicotine dependence deserves the same recognition. It's a neurobiological condition rooted in how nicotine alters brain chemistry and creates physical dependence. It's a medical condition, and it demands medical treatment. That's why we launched our Willpower Awareness Campaign in January. This is the beginning of us reframing the conversation to help people understand that quitting takes more than willpower alone and that effective treatment exists. The bottom line is that Achieve is not quitting on people who smoke. The parallels between obesity and nicotine dependence are not lost on many investors. Unmet medical needs, Same physician call points, same cost to society. In summary, our science is strong. We're advancing through the regulatory review process with the FDA working constructively towards approval. Our commercial infrastructure is taking shape with real progress in 2025, and we're actively building for launch. With that, let me turn it over to Dr. Mark Rubenstein who will detail our regulatory progress and the data that continue to reinforce cytosinicline across patient populations.