Achieve Life Sciences (NASDAQ: ACHV) reported third-quarter 2025 results (quarter ended September 30, 2025), framing it as another significant quarter of regulatory and pre-launch momentum for cytisinicline, its sole product candidate for nicotine dependence. The quarter's headline milestones were the FDA's acceptance of the smoking-cessation NDA with a PDUFA target action date of June 20, 2026 (with the 120-day safety update submitted on time), and - announced shortly after quarter-end in October - the award of a Commissioner's National Priority Voucher (CNPV) for the vaping/e-cigarette cessation indication, one of only nine inaugural-year therapies, which management expects to compress the NDA review to 1-2 months and enable a launch roughly eight months earlier, potentially making cytisinicline the first FDA-approved treatment for the ~17 million U.S. e-cigarette users. The ORCA-OL open-label study wrapped strongly - its last participant completed in October with 334 finishing a full year, the fourth and final DSMC review found no treatment-related serious adverse events, and over 97% of exit-survey respondents felt the drug helped them quit - while a Thorax publication of pooled ORCA-2/ORCA-3 data showed cytisinicline worked as well in COPD smokers (odds ratio 5.3) as non-COPD smokers (5.2). Commercially, the team advanced availability, access, and awareness workstreams (3PL and Specialty Lite Hub partners selected, Washington State licensing accepted, payer/pricing research completed, Omnicom AI platform build-out) toward a U.S. launch expected in Q3 or Q4 2026. Financially, CFO Mark Oki reported $48.1 million in cash (after a recent raise) funding operations into the second half of 2026, total operating expenses of $14.7 million for the quarter ($40.1 million year-to-date), and a net loss of $14.4 million ($40.0 million year-to-date); management confirmed the ORCA vaping phase 3 (ORCA-V2), still in start-up, will require additional capital. In Q&A with Lake Street, Raymond James, and HC Wainwright, management detailed the vaping trial design (two-arm, 3 mg three times daily for 12 weeks, ~400 patients per arm, cotinine-based confirmation), the COPD opportunity of ~6 million smokers, a complementary specialty-plus-retail distribution plan, and its view that cytisinicline's superior tolerability differentiates it from a possibly returning Chantix in an ~8 million-script market.
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 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 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 priority of NDA submission, NDA acceptance, and ultimately NDA approval for cytisinicline 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 (CNPV), for the e-cigarette or vaping indication. This is a significant recognition of the importance of cytisinicline in addressing the emerging public health crisis caused by vaping. The CNPV is designed to provide enhanced FDA communications and an expedited NDA review timeline, reducing the potential NDA approval to 1-2 months from the standard 10-12 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 cytisinicline 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 cytisinicline for review and set a PDUFA or approval date of the June 20, 2026. Additionally, we submitted the one 20-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 U.S. 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 500,000 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 cytisinicline is designed to address. Smoking cessation is an immense addressable market that had 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 cytisinicline, 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 in 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 cytisinicline in smokers with COPD in Achieve's two phase 3 clinical trials. Our recent publication in Thorax highlighted cytisinicline's potential to help individuals with COPD who remain smokers.
As a reminder, approximately 6 million of the 16 million Americans diagnosed with COPD continue to smoke today. In our two phase 3 trials, we saw that smokers with COPD had higher quit rates on cytisinicline 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 cytisinicline'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 Xinos 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 Q3 or Q4 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 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 preventive 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 cytisinicline. With over 25 years in biopharma, his expertise will be key as we build the infrastructure to deliver cytisinicline to patients and move Achieve into a commercial-stage company. Lastly, in October, we welcomed Eric Atkinson as our new Chief Legal Officer, who will oversee our legal strategy, corporate governance, 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 cytisinicline 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.
Thank you, Rick, and good morning, everyone. As a clinician who has spent much of my career helping people overcome nicotine dependence, I'm honored to serve as Interim Chief Medical Officer during this pivotal time for the company. I'm also excited to continue to build on the solid foundation we have established thus far. Since last quarter, we have met several important milestones, and our regulatory process remains on track.
Most notably, the FDA has accepted our NDA for cytisinicline, initiating the review process and setting a PDUFA action date of June 20, 2026. All interactions with the FDA remain normal and on track. We submitted our 120-day safety update, ensuring that the most current and comprehensive long-term safety data are available for review from the Orca OL trial. In this submission, we included data on 411 individuals with at least six months of cumulative cytisinicline exposure and 214 with at least one year of cumulative cytisinicline through the submission cutoff date of June 4, 2025. In October, our Orca OL long-term exposure study received its fourth and final comprehensive safety review from the Data Safety Monitoring Committee (DSMC). The DSMC found that adverse events were mostly mild in severity, and no serious adverse events were deemed to be treatment-related. Additionally, there were no safety concerns with the drug.
Furthermore, we were pleased to report that our last Orca OL participant completed the study in October, marking 334 participants who completed one full year of the trial. The final site closeout visit took place at the end of October, representing an important milestone in our long-term development program. We are thrilled with the outcomes from Orca OL. Long-term studies can be challenging when it comes to retention of participants for one-year treatment requirements, so it is encouraging to see so many participants choosing to stay on treatment well in excess of what the FDA requested. As someone who's treated countless patients struggling with nicotine dependence, I know firsthand how difficult it is for people to remain engaged in any quit attempt. Seeing participants stay committed for a full year truly underscores the tolerability and appeal of cytisinicline.
We believe their willingness to remain on cytisinicline speaks to its favorable side effect profile and possible efficacy benefit, and is a strong signal of the potential impact cytisinicline could have in clinical practice. In terms of patient experience in the OL trial, we collected exit survey responses from participants and are encouraged by their feedback. Over 97% of respondents believe cytisinicline helped them quit or reduce their nicotine use. In addition to reduced cravings, our respondents reported that they believe the lack of side effects and withdrawal symptoms helped them quit. Many described the treatment as the added push they needed and something that gave them the confidence to quit. Nearly all respondents indicated they would recommend cytisinicline to a friend or family member trying to quit. We remain on track to lock the Orca OL database by year-end and are preparing for presentations and further publications in 2026.
Our entire team is energized by the progress and the real-world impact we are poised to deliver. As Rick mentioned, new post-hoc data from an analysis of the Orca 2 and Orca 3 trials were published in Thorax, demonstrating that cytisinicline significantly improved quit rates compared to placebo in adults with COPD. Despite having more severe tobacco use histories and greater prior prescription treatment exposure, participants with COPD achieved quit rates with cytisinicline comparable to those without COPD. These findings support cytisinicline as a potential new pharmacologic option for people with COPD who continue to smoke despite their progressive disease. Lastly, we are thrilled to have received the Commissioner's National Priority Voucher (CNPV) for cytisinicline and vaping cessation. This is a significant recognition of the public health importance of our work and positions us well to advance cytisinicline as the potential first FDA-approved treatment for nicotine vaping dependence.
We are now preparing to initiate our Orca V2 phase 3 trial for vaping cessation, including finalizing the study protocol, selecting trial sites, and identifying the principal investigator. The CNPV allows us to have enhanced engagement with the FDA to shorten the timeframe for NDA submission and approval. That concludes my remarks, and I'll now turn the call over to Jamie to provide updates on our commercial strategy.
Thank you, Dr. Mark. This quarter, our team continued to make great progress in preparation for the U.S. commercial launch of cytisinicline. Our mission is to deliver this transformative therapy to the millions of Americans who want to overcome their nicotine dependence using the most advanced tools and strategies available. Our team remains focused on three strategic imperatives: availability, access, and awareness, each underpinned by a rigorous, data-driven approach and a commitment to maximizing efficiency and measurable impact.
Starting with availability, our first priority is ensuring cytisinicline will be available to patients nationwide. To this end, we have made progress on several key fronts. We've selected our third-party logistics (3PL) provider and will begin the implementation process in Q4 2025 well ahead of potential approval. I'm pleased to report that our home state licensing application was accepted in Washington State. We are now in the process of working on licenses for states that will allow us to submit prior to product approval. Additionally, we have further evaluated specialty distribution options and have selected our Specialty Light Hub partner. Administrative and logistical initiatives will begin this quarter and continue through launch. We believe these foundational steps will be critical to ensure patients can access cytisinicline and that prescriptions written are prescriptions filled. On the access front, our focus remains on securing rapid, broad, and affordable coverage for cytisinicline.
Our pricing and payer research accelerated significantly in Q3 2025, culminating in a comprehensive segmentation of payer organizations. The work identified distinct payer profiles, which will guide the alignment of our target lists and inform tailored engagement strategies. We have also completed both the quantitative and qualitative phases of our pricing and contracting research. This effort provides critical insights into market access dynamics, optimal price positioning, and payer expectations, laying out the foundation for a strategy designed to maximize reimbursement potential at launch. Importantly, payers continue to recognize cytisinicline's differentiated profile and the importance of having a new treatment to help people overcome nicotine dependence. Beginning in Q1 2026, we will start proactive engagement with prioritized payers to deliver pre-approval information exchange communications. Feedback from these interactions will be critical in finalizing our access and contracting strategy as we move closer to launch.
Turning to awareness, building product-specific awareness, and establishing Achieve's reputation as a trusted, science-driven partner continues to be a cornerstone of our strategy. In Q3 2025, we significantly advanced our patient and HCP targeting initiatives. We have finalized patient journey mapping, communications frameworks, and decile segmentation to prioritize HCPs on a series of key treatment, prescribing, and engagement behaviors, allowing us to deeply understand and motivate our key targets. Our partnership with Omnicom remains highly productive. The MarTech and data workstreams have now an established foundation infrastructure, and we are progressing towards a unified data ecosystem to power our AI-enabled commercial platform. This will allow us to continuously optimize targeting, messaging, and performance across all channels. Turning to our team, we have continued to build out our internal commercial organization, which includes new talent leading commercial development, market access, supply chain, and communications.
While we have added key new hires, we are maintaining a lean, efficient internal team. Our collaborative approach with partners ensures we benefit from their deep expertise and scalable resources across every critical function. In summary, I want to emphasize that our progress is guided by a clear and focused commercial strategy centered on precisely targeting the highest impact audiences, both patients and providers, ensuring our efforts are concentrated where they will make the greatest difference. Reaching the right audiences at the right time with the right message to deliver adoption and successful quitting, and leveraging our partnership with Omnicom and deploying advanced AI-powered tools that will enable us to optimize segmentation, personalize messaging, and measure engagement in real time. As we look ahead to our potential launch in 2026, our path is clear.
We are committed to delivering cytisinicline to the millions of Americans seeking a better path to quit nicotine. We remain confident in our ability to execute efficiently, scale effectively, and deliver long-term value for patients, providers, and shareholders. I look forward to updating you on our continued progress as we move closer to launch, and I will now turn the call over to Mark.
Thank you, Jamie, and good morning, everyone. We ended the third quarter with a strong balance sheet supported by our recent capital raise and continued financial discipline. As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $48.1 million. As we noted last quarter, our current cash runway is expected to fund operations into the second half of 2026.
Total operating expenses for the three-and nine-months ended September 30, 2025, were $14.7 million and $40.1 million, respectively, reflecting our ongoing investment in regulatory, clinical, and pre-commercial activities. With respect to net loss for the three and nine months ended September 30, 2025, it was $14.4 million and $40 million, respectively. We remain focused on disciplined capital allocation as we advance toward key regulatory and commercial milestones. With that, I'll turn the call back to Rick for closing remarks.
Thanks, Mark. The progress discussed today underscores the momentum behind Achieve and our unwavering commitment to addressing the critical unmet needs of nicotine dependence. Our recent receipt of the FDA Commissioner's National Priority Voucher for cytisinicline for vaping cessation is truly a landmark event.
Being selected as one of only nine therapies in the program's inaugural year demonstrates the urgent national need for effective treatments and the FDA's recognition that nicotine dependence is a public health crisis. Cytisinicline is uniquely positioned to address both of these significant public health challenges. For smokers who want to quit, it represents a potential new standard in smoking cessation at a time when it's been nearly two decades since new trials have shown compelling results, with cytisinicline's potential efficacy and safety profile continuing to generate excitement among both patients and clinicians. For those who vape and want to quit, cytisinicline could become the first-ever FDA-approved treatment, opening a nicotine-free path to quitting for the 17 million adult e-cigarette users in the U.S., about 60% of whom want to quit but currently have no approved options. The CNPV designation.
Means we can accelerate our efforts to bring this life-changing therapy to those who vape. As we look at the three key value drivers for the company, we're focused on. Firstly, executing on the NDA approval and product launch, with a PDUFA date set for June 20, 2026 and a launch in the Q3 or Q4 of 2026. Secondly, driving the progress on our innovative, data-driven commercial platform to enable a successful launch, allowing us to precisely target both patients and physicians. Finally, the growing recognition of value in our second indication, vaping, where we recently were awarded the CNPV by the FDA. This highlights the urgency of the public health crisis in the U.S. and enables a shortened review process of just one to two months. At Achieve, our message is simple: we are not quitting on you.
We remain committed to providing evidence-based solutions to help you succeed. I'm grateful to our patients, partners, investors, and the entire Achieve team for their ongoing support and dedication. We are energized and excited about the opportunities that lie ahead and confident that our efforts will deliver meaningful benefits for patients and long-term value for our stockholders. I also want to thank Cindy Jacobs again for her many contributions and are pleased to have her as an ongoing consultant.
Thank you for joining us today, and we look forward to sharing more updates in the quarters ahead. With that, operator, we're now ready for Q&A.