ACHIEVE LIFE SCIENCES, INC. Q2 2025 earnings call

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. Cindy Jacobs, President and Chief Medical Officer, Jaime Xinos, Chief Commercial Officer, and Mark Oki, 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 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. We appreciate your time and participation in today's call. This quarter marks a defining moment in Achieve Life Sciences' progress toward the first new treatment for nicotine dependence in nearly 20 years. We achieved three transformative milestones. Firstly, the successful submission of our New Drug Application for cytisinicline as a treatment for nicotine dependence for smoking cessation to the FDA. Secondly, a strategic commercial partnership with the exceptional team at Omnicom. Thirdly, a $49 million capital raise that positions us to reach critical value inflection points in 2026, including potential product approval. The NDA submission starts the regulatory clock, and the PDUFA date will be defined on NDA acceptance, which we expect in mid-September.

This is an exciting moment for Achieve after years of dedication to bring cytisinicline to FDA review and for patients and physicians who currently lack adequate tools to successfully quit. The opportunity to collaborate with Omnicom, a world-recognized leader in healthcare marketing, advertising, and technology, positions Achieve Life Sciences to quickly scale and leverage external expertise and infrastructure to execute our commercial launch strategy. Omnicom's deep experience and proven success with pharma and biotech clients include successfully executing more than 100 product launches and new indications over the last three years. Finally, we're profoundly grateful to our stockholders whose continued investment support reflects an unwavering belief in our potential to create meaningful change in public health. The market opportunity is huge. 29 million Americans smoke. Every year, more than 15 million try to quit with poor success rates.

The narrative needs to change to recognize nicotine dependence as a medical condition, much like how the GLP-1s did for obesity. Patients and physicians currently lack adequate tools to be successful. For nearly a generation, innovation has stood still in nicotine dependence for smoking cessation, leaving patients frustrated, providers powerless, and public health carrying the burden of over $600 billion in annual costs in the U.S. Historically, individuals seeking to quit smoking have faced limited options, and we aim to change this. As we move forward, we will work with the FDA through the review process, and should we receive approval, be prepared to launch cytisinicline in late 2026. Before the team dives into the details, I want to express our gratitude to those who have been instrumental in supporting our progress. Firstly, the patients and physicians who participated in our clinical program, their engagement and commitment has been invaluable.

Secondly, our entire Achieve team for their dedication in delivering the NDA submission on time through a significant company-wide effort. Thirdly, our investors for their continued support, guidance, and belief in our mission. On today's call, Cindy will update you on regulatory timelines and progress on the ORCA-OL study. Jaime will provide an update on our commercial planning, and Mark will conclude the details on the recent financing and current cash runway. In short, our three announcements this quarter demonstrate that we are advancing confidently on three fronts: regulatory, commercial, and financial. Our path is clear, and we are committed to executing it to the fullest. With that, I'll turn it over to Cindy.

Thank you, Rick. Our regulatory accomplishment with the NDA submission during the second quarter was the result of years of focused development work. As Rick just mentioned, in June, we officially submitted our NDA for cytisinicline as a treatment for nicotine dependence to achieve smoking cessation as our first indication. This is a comprehensive and well-supported application incorporating non-clinical data and manufacturing information, as well as the clinical trial results from two well-controlled phase III studies, ORCA-2 and ORCA-3, along with the long-term safety exposure data from our ORCA-OL clinical trial. The NDA submission is supported by data from over 2,000 clinical trial participants, providing a comprehensive foundation and characterizing cytisinicline efficacy, safety, and tolerability. Regarding tolerability, and as requested by the FDA, we included long-term exposure safety results in over 300 participants who had completed at least six months of cumulative cytisinicline treatment.

Also important to highlight this last quarter was reaching the second major milestone of the FDA's request for having over 100 participants completing one year of cumulative cytisinicline treatment before approval. This safety data will be submitted in the standard 120-day safety update during the NDA review period. Meeting both critical thresholds for safety exposure data on schedule is essential in completing the NDA submission and for the FDA's review toward market approval. As of the end of July, 290 participants have completed one year of cytisinicline treatment in the OL study, and the last participant is projected to complete treatment by early October. We are also in the process of collecting exit survey responses from participants when they complete the OL study, and so far we have survey responses from 40% of the 290.

These responses and their comments have been encouraging as to the impact cytisinicline has had on them and potentially could have on the lives of other people battling nicotine dependence. For example, 98% of the survey respondents stated they believe cytisinicline contributed to their ability to either stop or reduce their nicotine dependence, citing fewer cravings and less intense withdrawal symptoms compared to their previous quit attempts and with very few or manageable side effects. Impressively, 99% stated they would recommend cytisinicline to a friend or family member. Many also expressed their gratitude with specific comments, highlighting their extensive battle with nicotine for decades and that they finally feel that they have won.

Although the final study results from this ORCA-OL study are not required by FDA for market approval of cytisinicline, we plan on completing all trial activities to lock the final study database by the end of this year, and we will look for future opportunities to publish and present the completed trial results in 2026. As we look ahead in the next few months, we expect to receive the Day 74 acceptance letter from FDA in September, and we will be submitting our 120-day safety update documents and data sets in October. The 74 day letter will also indicate that the NDA submission has been accepted for review and give target completion review dates, which will begin the official countdown to a potential approval decision. Now I'll turn the call over to Jaime to share more about our commercial launch preparations.

Thank you, Cindy, and good morning, everyone. This quarter, we made meaningful progress toward executing our core commercial objective: delivering cytisinicline to patients who are ready to quit using the most advanced tools and strategies available. Over the next several months, we will be building our brand, driving stakeholder engagement, and finalizing our go-to-market activities in preparation for potential launch in 2026. Our path to launch is on track and full of momentum, as evidenced by the selection of Omnicom to provide a diverse range of critical launch capabilities. Our partnership brings together seven specialized Omnicom agencies operating as a single unified team across brand development, provider and patient initiatives, market access, public relations, media, and marketing technology. This partnership gives us access to the scale, speed, and capabilities of a much larger organization and allows us to maintain a lean internal team who will lead key functional areas.

This collaboration also supports our commitment to a modern, data-driven approach to launch. We are building and will leverage a proprietary AI-enabled commercial platform and tool that will enable precision, agility, and measurable outcomes to support smarter decision-making across the entire organization. From targeting and engagement to performance optimization, our tech-focused strategy will help us to reduce cost, mitigate risk, and remain highly adaptive to real-world signals. Our strategy is intentional, insight-led, and focused on driving both commercial value and improved patient outcomes. As we look ahead to a potential launch in 2026, we are confident in our ability to execute efficiently, scale effectively, and deliver long-term value for patients, providers, and shareholders alike. Our launch readiness efforts are anchored in three strategic imperatives: availability, access, and awareness, all underpinned by a commitment to measurable impact to ensure the efficiency and effectiveness of our investments.

I'll provide a brief update on our recent progress and near-term priorities across each of these pillars. Starting with availability, this work stream encompasses trade and distribution activities to ensure product readiness at launch. We've made meaningful progress in this area, supported by external expert consultants and now guided by an internal Achieve lead. We've contracted with a leading third-party logistics provider, Fourth 3PL, named in our NDA, and plan to begin implementation in the fourth quarter. Our home state licensing application has been submitted, and once accepted, we'll trigger the sequential submission of additional state applications. Following a comprehensive evaluation, we have shortlisted potential partners for specialty light distribution services. We believe this capability will be especially important in the early phase of launch to help ensure that prescriptions written are prescriptions filled. On the access front, we built a strong foundation and are now accelerating our efforts.

Our new Vice President of Market Access has joined the team, and we've engaged a best-in-class access agency to expand upon the foundational work we've already completed, including extensive payer research and market assessments to ensure the value of cytisinicline is clearly reflected in our pricing, contracting, and coverage strategies. Our key priorities in the coming quarter include finalizing our pricing strategy, refining our value message, and completing payer segmentation and communication plans. We anticipate beginning the pre-approval information exchange with payers in Q4, with outsourced account managers beginning field work in Q1 of next year. We are laser-focused on clearly defining and communicating the differentiated value of cytisinicline, backed by rigorous clinical evidence to support favorable coverage decisions. Early engagement with payers is critical to building the relationships and understanding required to enable rapid access following approval. Securing access and insurance coverage for our patients is a top priority.

Turning to awareness, our efforts are focused on building product-specific awareness and establishing Achieve Life Sciences' reputation as a trusted, science-driven partner. Unlike therapeutic categories that require broad disease education, the need in smoking cessation is well understood. Our strategy centers on reframing nicotine dependence as a medical condition, not a lifestyle choice, and one that warrants the use of effective and well-tolerated treatments like cytisinicline. We are taking a focused, data-driven approach, engaging two high-impact audiences: motivated patients who are ready to quit and most likely to succeed with cytisinicline, and healthcare providers who are already prescribing high volumes of smoking cessation therapies. Our goal is to activate these patients to initiate conversations with their providers and ensure those providers are informed, equipped, and ready to prescribe.

To support this strategy, we are now triangulating multiple data sources, including prescribing patterns, patient behavioral signals, and public health data sets to identify and prioritize the highest impact targets. In parallel, we're developing advanced analytics and machine learning capabilities that will continuously evaluate and optimize how we reach and convert these targets. This includes building dynamic audience models and segmentation strategies that allow us to personalize messaging based on where both patients and providers are in their decision-making journey. Whether it's raising initial awareness, addressing clinical questions, or prompting action, our content and channels will be designed to meet each stakeholder with the right message at the right time. This precision-targeted approach not only enhances effectiveness, it also improves efficiency and return on investment, ensuring that every dollar spent contributes to measurable outcomes and long-term value creation.

As we look ahead, we are energized by the opportunity in front of us. We know that launching a drug, especially as a small company and for the first time, is often seen as a high-risk endeavor. We are not doing this alone. We have built deep strategic relationships with experienced partners, including Omnicom and others, who are not just vendors but believers in our mission and co-architects of our path forward. These partners bring a wealth of experience across every critical function, and they are fully aligned with our vision for cytisinicline to become a powerful, life-changing option for the millions of people still struggling with nicotine dependence. Their investment in our success, both operationally and philosophically, adds strength, stability, and confidence as we move toward launch.

We are guided by data, driven by purpose, and supported by a team, both internal and external, that is all in on delivering something truly transformative. The work ahead is substantial, but our focus is clear. We believe cytisinicline can change the way the world approaches smoking cessation, and we are ready to lead that change. I'll now turn the call over to Mark to review the financials.

Thanks, Jaime. We're excited to have closed the second quarter with a strengthened balance sheet following the successful completion of a $45 million underwritten public offering in June. Just last week, the underwriters partially exercised their overall allotment option, generating additional gross proceeds of $4.3 million to the company. The offering included common stock and warrants and was met with strong support from current shareholders, as well as new institutional and retail investors. As of June 30th, 2025, we had cash, cash equivalents, and marketable securities totaling $55.4 million. These funds are expected to support operations into the second half of 2026. Total operating expenses for the three and six months ended June 30th, 2025, were $12.6 million and $25.5 million, respectively, consistent with our expectations as we increased investment in regulatory, quality, and pre-commercial planning.

With respect to net loss for the three and six months ended June 30, 2025, it was $12.7 million and $25.5 million, respectively. Our funding strategy has always been designed to support our highest priorities, and with this recent capital raise, we believe we are well positioned to execute our regulatory and early commercial initiatives while remaining committed to financial discipline. With that, I'll turn the call to Rick for closing remarks.

Thank you, Mark. This past quarter has been a defining one for Achieve Life Sciences. We delivered three separate milestones with more to come in the next 12 months as we anticipate product approval and launch. In the near term, we expect to receive the FDA's Day 74 NDA acceptance letter in mid-September. We'll add the 100+ paid subjects with one year's exposure from the ORCA-OL open-label safety study at the 120-day safety update, and we'll accelerate our commercial launch preparation. Achieve Life Sciences is disciplined in executing its strategy with a clear focus on financial prudency, on executing a clear regulatory strategy with the FDA, and also optimizing its product launch capabilities by collaborating with Omnicom and other external partners who are recognized leaders in the space.

These accomplishments are the result of extraordinary determination by Achieve Life Sciences' dedicated team who've worked tirelessly to bring this vision to life, and by the over 2,000 patients who enrolled in our trials, committing to quit smoking and vaping in pursuit of better health and lifestyle. We are confident that our focused efforts will have a meaningful impact on patients and create long-term value for all stockholders. Again, thank you for your time, and we look forward to updating you on our continued progress in the coming quarters. With that, operator, we're now ready for Q&A.