Achieve Life Sciences, Inc. Aktie

Greetings, and welcome to the Achieve Life Sciences First Quarter 2026 Earnings Conference Call and Webcast. [Operator Instructions] 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. You may begin.

Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Dr. Andrew Goldberg, Chief Executive Officer, who will deliver the prepared remarks. Joining Dr. Goldberg for the Q&A will be Mark Oki, Chief Financial Officer. 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 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 risks, 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 Dr. Goldberg.

Thank you, Nicole, and good morning, everyone. I'm honored to step into the role of Chief Executive Officer at such an important time. I joined Achieve to lead a mission-driven company. We are developing a new treatment for cessation of smoking, the leading cause of preventable death, as well as vaping that is putting a new generation at risk. We are going to make sure the public and the people most directly affected get the help they deserve. Before turning to the quarter, a word about my background and why I'm here. For the last decade, I've been an investor and governance leader, serving as a director or observer on 19 health care boards, most recently at Veradermics and currently with Tarsus Pharmaceuticals through their national launch of XDEMVY.

My expertise is helping companies cross the chasm from late-stage development to commercial with disciplined execution, all in service of bringing next-generation therapies to market for patients. Improving patient care has been the focus of my career. I have spent nearly 20 years as a physician, dual board certified in critical care and emergency medicine. I trained in practice at the Mayo Clinic, Los Angeles General Medical Center, and the VA Health System. I published my first research on tobacco when I was 19. Through treating critically ill patients with respiratory failure, vascular events and complications of cancer, I've since seen firsthand the total nicotine dependence takes on patients and their families.

Today, in the United States, nearly 50 million adults use nicotine. Approximately 25 million are smokers, 18 million vape. And though the majority want to quit, most fail because current treatment options fall short. Despite the scale of this problem, there has not been a new FDA-approved smoking cessation therapy in more than 2 decades. And there has never been an approved therapy for vaping cessation. At Achieve, the strength of the clinical data and the favorable tolerability profile gave me conviction that we have an opportunity to fill that gap between patient need and available solutions and champion a category-defining public health intervention. Before I jump into this quarter's updates, I want to acknowledge Rick Stewart, our Co-Founder and former CEO. Rick was instrumental in building this company from recognizing cytisinicline's potential through NDA acceptance, and we are deeply grateful for his vision, leadership and unwavering dedication to this mission. We would not be where we are today without him.

We also recently appointed 3 new Board members: Chris Martin, most recently the Chief Commercial Officer of Verona Pharma; Dr. Lucian Iancovici, Managing Director at TPG; and Dr. Aaron Royston, Managing Partner at venBio. Chris recently led the launch of Ohtuvayre, widely regarded as one of the most successful pulmonary launches in industry history and brings exemplary commercial execution experience to our Board. Dr. Iancovici and Dr. Royston each bring deep expertise in company scaling, investing and board governance and have guided numerous companies through FDA approval. I'm pleased to welcome all 3 to the Board. And earlier this morning, we also announced 2 of Chris' prior colleagues from Verona joining us as key leaders in our commercial team, Mark Zappia as Senior Vice President of Commercial; and Jim Willis as Vice President of Sales and Enablement, where he will lead the field force. Together with Chris, this team brings deep experience from, Ohtuvayre, widely regarded as one of the best launches in industry history, and we are thrilled to have their leadership for what comes next.

Today, I'd like to touch on 3 key highlights from the quarter. First, we closed a transformational financing, which positions us for success. This private placement included $180 million in upfront capital, plus up to $174 million from milestone-based warrants that may be exercised at any time prior to and up to 20 trading days following FDA approval. This financing came together because a syndicate of leading specialist healthcare investors chose to support this company's next chapter. And I want to personally thank Frazier Life Sciences, TPG, venBio, Paradigm BioCapital, Marshall Wace and our other new and existing investors for the conviction they have placed in this team and this mission.

Second, we continue to make operational progress. As mentioned last quarter, the company has partnered with U.S.-based Adare Pharma Solutions to manufacture cytisinicline drug product for potential commercial supply. We expect this partnership will help decrease risk related to international importation of pharmaceuticals, including potential tariffs. In the first quarter, we produced our first cytisinicline engineering batch at their facility. In mid-April, the company announced it expects to receive a complete response letter from the FDA on or by our June 20 PDUFA date due to a separate third-party manufacturer having received an official action indicated classification. It is important to note that these observations relate to general cGMP matters at the facility and are not specific to cytisinicline manufacturing.

The company's plan, as previously stated, is to resubmit the NDA in the fourth quarter of 2026 naming Adare Pharma Solutions as our new and primary manufacturing partner for commercial supply. The company's stated expectation is for a commercial launch in the first half of 2027. I am now ensuring our readiness against that timeline. Third, let's now turn to the continued advancement of our scientific data. In March, we published mechanistic data in nicotine and tobacco research, providing evidence that cytisinicline selectively interacts with the alpha 4 beta 2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 serotonin receptor, a key mechanism potentially underlying its tolerability. These findings help explain the low nausea rates observed in clinical trials.

At the Society for Research on Nicotine and Tobacco Conference, our team presented an analysis of over 1,600 Phase III participants, demonstrating consistent efficacy regardless of prior treatment history or previous quit attempt patterns. Importantly, among participants with prior varenicline and bupropion use, those receiving 12 weeks of cytisinicline achieved continuous abstinence rates of 32.4% versus 6% on placebo with an odds ratio of 7.5. This is a particularly difficult-to-treat population, and these results highlight cytisinicline's potential to address a significant unmet need among patients who have failed existing therapies.

In closing, my focus now is on growing our team and executing the strategy required to launch this important medicine at the scale the opportunity deserves. We understand the stakes and with multiple physician officers and directors at Achieve, we have direct experience with the limited tools currently available to help patients. Our goal is to build a company that our shareholders, the public health community and every patient and family affected by nicotine dependence want to see succeed. That is what this company is for, and what I am here to do. Thank you for joining us this morning. I look forward to updating you on our continued progress in the months and years to come.

[Operator Instructions] Our first question comes from the line of Jason Butler with Citizens.

I really appreciate all the detail you provided this morning. Can you maybe just give us a few more comments on the commercial strategy and what you think really needs to be achieved in 2026 to be ready for launch next year?

Thank you. I appreciate asking that question. It's something we've obviously been thinking about carefully, especially since I've joined. If you look forward with me for a moment, now we have the capital after a meaningful financing. We're building our team. And fortunately, now we have the time and above all, the asset. And so my job right now is to make sure we have the right data-driven strategy to bring cytisinicline to patients. I think the team announcements this morning are some of the most visible evidence of that work, and we'll continue to build on that in the months and years to come.

And I think the main change in our strategy going forward is, yes, we plan to commercialize independently with our own field force, and we recruited a fantastic leader today. And so with this team, the asset, what we know about the category, we believe that Achieve is best positioned to bring cytisinicline to patients ourselves, and we'll share more specifics as our decisions firm up.

Great. And then just one follow-up. Just on the medical education side, where do you think awareness is with current CHANTIX prescribers of cytisinicline in the Phase III data? And again, what do you need to do in 2026 to keep building that awareness?

Thank you for that. So we're constrained about what we can communicate in a pre-approval environment, and we take those rules seriously. But what we can do is share our existing clinical data and any new data generated from our trials through the appropriate scientific channels. We expect to present some new data at conferences later that year, including some this month. And as we get closer to approval and the launch, our MedEd team will expand, and we'll continue to update throughout the course of the year.

Our next question comes from the line of Justin Walsh with JonesTrading.

It would be great if you could provide some color on what additional information will need to go into the NDA resubmission and how Adare is progressing in its manufacturing efforts? And related to this, also it would be great to hear your thoughts on capacity and if you expect Adare will be able to meet potential demand?

So we expect the -- any CRL that focus on the OAI classification of a prior third-party manufacturer, which is the basis of -- for the Adare transition. And so the three words I kind of want to use to characterize our position here are going forward are transparency, proactiveness and importantly, adaptability. So we'll continue to be transparent with our investors and analysts. What we know is that based on observations at that prior third-party manufacturing, they are unrelated to our drug. But although we haven't received that notification yet, the company has already been proactive. We've already moved our manufacturing to the U.S., and we've already produced our first batches this quarter.

And so our principal goal and my principal goal is completing that tech transfer to Adare on as fast a time line as possible while maintaining our completeness. And so I'm early in my tenure, but we're evaluating every strategy and expenditure as we do this right and we will not hesitate to adjust resourcing where it is needed, including ramping up where we believe that it's necessary. I am personally engaged in this process. I've already visited Adare headquarters in my first week to help ensure that we're ready, and we're committed to getting this done.

Importantly, now we have the resources to do so, and we recognize what's at stake. The patients waiting for this medicine can't afford for us to get this wrong. And so we will ramp up where it's needed to get this right. And we're confident that our current U.S. partner who has multiple FDA-approved products already can help us get there.

Our next question comes from the line of Gary Nachman with Canaccord Genuity.

Congrats on the next phase for the company. Andrew, before you led this last private placement and decided to take over as CEO, what sort of due diligence did you do on the IP for cytisinicline? And how comfortable you are with the durability of that product? And then just on the last question that you answered, how confident are you with the stated timeline given the transition to manufacturing, and it sounds like that's a fluid process.

So let me take the first question on IP. So I've looked at Achieve for -- I followed this company for a long time, both as a position and as an investor. And so we've done diligence on the intellectual property on several fold. And I would also add that was done by other investors who have come into this significant financing as well. And we're confident we have the IP to protect our franchise going forward well into the late 2030s and even the 2040s.

With respect to your question about the timeline, I'm, again, early in my tenure. We are trying to look under every nook and cranny to ensure that we can meet those timelines. Right now, I've not seen anything to suggest that we will not be able to meet them. And -- but I can assure you that we'll be transparent with the analysts and our investor community and the market and share any updates as they come forward.

Okay. Great. And then just a follow-up. With the likely change in leadership at FDA if Makary leaves, how are you thinking about the evolving dynamics in the vaping market if more vapes end up being approved? And also with respect to the priority voucher for vaping that you got last fall, if you think FDA will be committed to that as a priority?

Okay. So I won't speculate on the agency or comment on any of the internal dynamics that have been reported. What I can say is that our interactions with the FDA have been constructive and consistent with the standard submission process. What the CNPV means to us is that the agency is aligned with the public health need to get this therapy to patients as fast as possible. And so we're honored to be a part of the program. And remember, we also have breakthrough designation. So not only is this a public health imperative, it's also novel. It's the first ever for the indication, and that's important.

But I think what separates us from some of the other CNPV recipients is this. Smoking is our lead indication and vaping, the indication with the CNPV is a follow-on program. So the smoking NDA stands on its own 2 feet. We have 2 Phase III double-blind, placebo-controlled trials where not one, but both of our 6- and 12-week courses reached statistical significance. And so we're proud to be a recipient of the voucher, but we're not dependent on it to be successful. The voucher tells us that the agency understands the urgency, but it does not change the substance of what we're doing.

Okay. And then just lastly, how soon do you think it will be before you could start the vaping Phase III? Is there still a lot of work you want to do just going back to the FDA ensuring you just need that single Phase III? Is that something that could happen later this year?

Yes. So -- thank you for that. ORCA-V2 will be a randomized placebo-controlled multicenter trial, and we're finalizing that design and aligning on the criteria to ensure the highest probability of success. And so we hope to initiate the study this year, and we'll update the markets on timelines when we're able to do so.

Our next question comes from the line of Brandon Folkes with H.C. Wainwright.

Congratulations on all the progress. Three for me, if I may. The previous team had mentioned initially focusing on those smokers that need to stop smoking and may have comorbidities. Just given the capital you now have at your disposal, would you be willing to talk about if you contemplate a wider approach at launch? I'll ask my second one because it stays along those lines. How do you think about patient support programs for the launch, just things such as patient hotlines, et cetera. Can you just help us think about how large of an investment do you contemplate across the commercial organization at launch, I guess, especially in light of if we look back at the CHANTIX launch and sort of the importance of those programs as they were described?

Thank you for that. So, yes, after our financing, which we closed, we're in a very strong financial position to be able to execute on our goals and our launch preparation. So we have the resources now that we need to execute on a broader commercial strategy. I think the commercial model here matters as much as the budget. Nicotine dependence is uniquely well suited to a disease awareness and diagnosis approach. Patients already know they have the problem. We don't need a new diagnostic test. We don't need a long referral pathway, and we don't need extensive titration or monitoring. The vast majority of people with nicotine dependence are already in front of a healthcare provider for other reasons.

And so the barrier to treatment has not been awareness of the disease to date and with prior attempts. It's been with the lack of an effective and tolerable therapy that prescribers feel confident offering. And so that for us changes a bit of the commercial map. Launch efficacy -- launch efficiency in this category is not about saturating awareness. Patients already raised their hands. It's about where we're going to be focused is about giving prescribers a reason to treat, equipping them with the right therapy and removing that access friction. And that's what our commercial team, Mark, Jim and Chris, who were announced this morning has done before. And so with this team, this asset and category, we believe we can effectively launch at scale.

With respect to your second question around investment in patient support programs, the world now is very different than it was 20 years ago. And with a digital and tele-infrastructure and now everyone with a cellphone in their pocket, the ability to provide support programs for our patients has really never been easier. And so I can see -- I can foresee a potential future where we're able to offer not just that therapy, but also some of those support programs going forward in order to help our patients and the clinicians meet the goals.

Great. And one more, if I may. Given your focus on the data, do you anticipate doing any additional small clinical work or any clinical work you would like to do before refiling should you get the CRL?

So as a physician and a prior researcher, I'm always considering and thinking about new unique studies we can run. I do think that there are unique subsets within the smoking community that are well positioned to study. We've already shared some unique information today and over the last quarter around patients, the success rates in patients who have tried prior therapies before and the impressive efficacy and tolerability in those cohorts. We're also sharing some information later this year on patients with cancer and how this drug improves smoking in that cohort.

We've already described how we work pretty effectively in patients with COPD. I think there's additional subsets, some small and some, frankly, very large that we can also continue to highlight. The focus will be right now getting the drug approved through our primarily completed clinical program and ramping up our vaping study to get that follow-on indication. But I think you can expect that we will be thorough in generating data going forward. And I think we have an excited and committed research community that's going to help support us in that.

Our next question comes from the line of Nelson Cox with Lake Street Capital.

This is Nelson on for Thomas. I'll ask kind of, both mine upfront, which are follow-ups to previous questions. But on the CNPV, can you kind of walk us through your understanding of the 2-year clock? And specifically, does it start at receipt of the voucher or at the initiation of the pivotal vaping study? Or what's kind of the -- what's the -- how does that work there? And then how large of a field team would you anticipate needing to meet your commercial expectations?

I don't want to comment on the exact specifications around the voucher. We've received it. We plan on initiating the ORCA-V2 trial as fast as we can, and we will work with the agency in order to try and stay on any needed timelines. With respect to the size of our field force, I think we're going to be smart about how we scale that up. I could see us starting with a reasonable sized field force. I don't want to commit to any specific numbers right now, but I'm confident that we have both the capital and the team to help lead that. And as we branch out into a broader nationwide distribution, we -- our field force will scale in accordance with that. I think the main thing is we want to build both the company and the field force to scale with the magnitude of the opportunity, but we're going to be disciplined about when we start and how we do it.

Our next question comes from the line of John Vandermosten with Zacks.

Dr. Goldberg, with respect to the fourth quarter resubmission of the NDA, do you expect a Class I or Class II type of resubmission?

I think we'll wait for -- we're trying to be proactive here in what we plan. I think right now, we'll wait for the information from the agency and then plan our resubmission at that time, and we'll update the market when we do that.

Okay. And with respect to the European manufacturer, have you completely severed ties with them? Is that all the way in the past now? Or is that something that may continue as an alternative supply source?

Yes. So the manufacturer that received the OAI, we plan on no longer using them as part of our path forward. We've replaced them with our new U.S. partner as our primary supplier.

Got it. And it seems like there's been a lot of messaging recently around new aids for smoking cessation. GLP-1s, mentioned digital tools on your phone, and the FDA approved some flavored vapes, which I assume they're using that for nicotine -- they're intending that for nicotine cessation and then the psilocybin discussions as well going on about that. Does that drown out or potentially drown out the messaging that you guys will have about smoking cessation and using cytisinicline?

So I think that the area of smoking cessation has been undercovered for the last 20 years, and that's been because there has not been adequate therapies to meet the needs of patients -- and there's never been one, as we've discussed for vaping. I think some of the new resurgence in some of these other therapies is frankly helpful. We're going to get more attention to the condition. It's going to help more patients. Ultimately, we have a pretty robust and far along program with our Phase III clinical trials, and we have 52-week data that should be released on safety and both efficacy later this year.

And so we're confident that our asset has an extremely easy to tolerate profile. We're an oral pill, easy to take, standard dosing, no titration, no injections. And so we're confident that we have a strong position in that future landscape.

Okay. And then finally, with the new team, is your relationship or objectives with Omnicom going to change at all?

I think the company has had some fantastic partners to get to where they are today. And we are in full transparency, evaluating every partner as to how we've done on manufacturing to commercial to future data-driven infrastructures. And so we'll continue to evaluate our partners and pick the best ones for the time where we are and the ones that will align us best for the strategy going forward.

Our next question will be from the line of Boris Tolkachev with Freedom Broker.

Just a quick one for me. Should we assume that the drug batches for the ORCA-V trial will be already manufactured by Adare Pharma? And should we think that the readiness of this facility is the key to really start the trial?

Sorry, if I heard the question correctly, it was about manufacturing readiness for the clinical trial supply?

Yes.

Okay. So the company has manufactured clinical trial supply before. We've manufactured it for multiple Phase III programs, 52-week programs, including trial supply for our randomized controlled trial for vaping, which we've already completed and published. And so we have the ability to generate clinical trial supply. We have also already ramped up manufacturing. We've done our batches already last quarter at our U.S. manufacturer. And so we're working now with our clinical development teams and our CMC teams to source this next trial with appropriate supply, and we're making those decisions right now.

And just a last quick one. Maybe you could reiterate what is the -- what is driving the decision to push the resubmission exactly to Q4? Is it like something conservative? Or is it like a real assumption that you will be ready up to the point?

Yes. So it really just comes down to doing the technology transfer completely, doing the analytical method transfer, which we've already completed and all the necessary milestones to build up for a resubmission. We're trying to be accurate in how we portray the timelines.

And we have reached the end of the question-and-answer session. Therefore, I would like to turn the floor back over to Dr. Andrew Goldberg for closing remarks.

Thank you. In closing, I think there are three main things to take away this quarter, and thank you for the questions. First is that we have a strong capital position to execute our strategy of approval and launch. Second is that we have a U.S.-based supply chain that derisks our manufacturing and our launch timing. And third, we have new commercial leadership with directly relevant launch experience joining a team and company that has already done the hard work of getting to NDA acceptance. Achieve is positioned to address one of the largest preventable public health problems we know, and we're building the company to deliver on that opportunity.

Thank you for joining us today, and I look forward to speaking again soon.

Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

Greetings, and welcome to the Achieve Life Sciences Fourth Quarter and Full Year 2025 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. [Operator Instructions] 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 Rubinstein, 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 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 risks, 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 NDA submission in June 2025 started the transformation of Achieve from a pure-play clinical development company and to commercially focused enterprise. Our primary objective now is to make statistically and available to the 25 million patients who smoke and nearly 18 million who vape. The need for a new nicotine dependence treatment like cytosinocline 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 prices in the U.S. The highlights in 2025 include: firstly, the submission of the new drug action 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, these vaping cessation indication was one of the first recipients of the Commissioner's national priority voucher. Recognition of cytisinicline is a national priority is an incredible achievement of the work conducted by Achieve and the importance of sitecynically in tackling a previously intractable problem of nicotine dependence.

The commissioners 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 cytisinicline 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 cytisinicline over a long-term 52-week exposure to treatment Dr. Mark Rubinstein will elaborate in a minute. And lastly, post-hoc data published in Thorax a leading peer review medical journal demonstrated that psychosine 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 quick. Their level of nicotine dependence must be high as continued smoking exacerbate COPD symptoms and impairs the efficacy of COPD drugs. The positive data on COPD patients highlights the expansive scope of opportunities for psythocynically in terms of the range of comorbidities that could potentially benefit from treatment and broad range of health care 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 health care environment, where approximately 75% of primary care physicians will no longer meet with medical reps. -- achieves 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 customer 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 Adea Pharma Solutions a U.S. based manufacturing organization that will produce science cynical in 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 Ader is already underway. Their partnership provides redundancy in our supply chain, allowing contingency capacity in the U.S. The manufacturer named in the Science NDA recently had an FDA good manufacturing practices inspection with 2 observations related to solid oral dose manufacturer, which are being addressed through an ongoing communication of its remedial action plan with the FDA.

By establishing U.S. manufacturing with Adaire, we increased confidence in our supply chain security as we advance towards a planned commercial launch of cytocynicillin expected in the first half of 2027. We remain focused on bringing cytocynically into patients as quickly as possible, and our decision to work with Ader positions us to launch with the manufacturing reliability and operational readiness or patients and stakeholders expect.

Now let me take a moment to remind you why our team is so passionate in bringing cytocyline into market. recent data issued by CDC estimated that in 2024, approximately 25 million adults in the United States, smoke 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 health care 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. once equate 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 independence needs to change. We've seen this transformation happen with obesity. When GLP-1s emerged, they help 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 will power alone and an effective treatment exists. The bottom line is that achieve is not quitting on people who smoke. The parallels between obesity and nicotine dependents 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 Rubinstein, who will detail our regulatory progress and the data that continue to reinforce sizes in the claim across patient populations.

Thank you, Rick, and good morning, everyone. We have made tremendous progress in 2025 for citoseniclin from a clinical and regulatory standpoint. Since our last earnings call, we've continued to validate citosineclin's clinical profile through peer review publications and scientific conference presentations. We were pleased to present findings from a pooled analysis of over 1,600 participants from our Phase III trials at the orientation to nicotine and tobacco or SR&T Conference a few weeks ago. This analysis examines cytoclinicin efficacy across participants with different prior treatment histories and attempt patterns. -- regardless of whether the participants had previously tried varenicline, bupropion or nicotine replacement therapy or whether they had made 4 or fewer quit attempts versus many more we saw consistent efficacy.

These data show that if approved, cytisinicline will offer a new quitoption for patients, including those for whom medications have failed. This consistent efficacy across patient subgroups shows that past setbacks should not discourage people from trying again for millions of people who have tried and failed cytisinicline offers real hope. We also presented late-breaking survey data from our year-long ORCA OL study that demonstrated voluntary self-reported patient experiences with extended cytisinicline up to 52 weeks.

This survey of data from people who chose to continue treatment beyond the 6- or 12-week standard courses offers insight into long-term tolerability and impact. Patient experience is hugely important for those trying to quit smoking and it is encouraging to see trial participants describing meaningful benefits including successful quitting and improvements in physical health. We have also been accepted to present research at the 2026 American Thoracic Society Conference in May, and look forward to updating you in the coming months. On the e-cigarette front, we received the FDA Commissioner's National Priority Voucher for cytisinicline in e-cigarette or vaping pecan a significant recognition of the public health urgency.

The CNTV is designed to provide enhanced FDA communications and an expedited NDA review time line to 1 to 2 months compared to a typical 10 to 12 months. We are now laying the groundwork for our Orca V2 Phase III file for vaping cessation, including selecting trial sites and identifying principal investigators. In summary, 2025 has strengthened our clinical and regulatory position significantly. We're advancing through the FDA's review process with an active dialogue with the agency. We remain confident that cytisinicline has the potential to deliver the first FDA-approved treatment for nicotine dependence in 2 decades. With that, let me turn it over to Jaime.

Thank you, Mark. When I look back at where we started at the beginning of 2025 and where we stand today, I'm struck by the incredible progress our commercial team has made in just over a year. We've built the foundation for a launch-ready infrastructure from the ground up while we in lean and rightsized for our current stage requirements. We've established partnerships, deployed advanced analytics, created an AI-powered asset factory and are positioning ourselves to execute at scale. I'm deeply grateful to the entire team who have been instrumental in bringing this vision to life.

As a reminder, our commercial execution rests on 3 critical priorities: availability or ensuring supply chain readiness so that cytosenacline can reach the patients who need it, access to secure coverage and affordability, and awareness, which is educating the right patients and health care professionals at the right time about this transformative new option.

Every initiative is data-driven and every decision is tied to measurable impact with the goal of making cytisinicline accessible to the millions of Americans struggling with nicotine dependence. Now I'll provide updates on each of our 3 priorities. First, let's look at availability. Implementation with our third-party logistics provider is well underway. We are on track with our state licensing and have secured more than half of the required licenses to date.

Additionally, we have now completed the administrative and logistical setup with our specialty pharmacy hub partner. We believe these foundational steps will be critical to ensure patients can obtain cytisinicline and that prescriptions written are prescriptions filled. On the access front, our focus remains on securing rapid, broad and affordable coverage for citositaclene. In Q1, we continued discussions with prioritized payers to share our clinical data. Feedback from these ongoing discussions will be critical in finalizing our pricing, access and contracting strategy as we move closer to launch.

On awareness, our focus is establishing achieved reputation as a trusted, science-driven partner and shifting how patients and providers think about nicotine dependence. As Rick mentioned, we launched our willpower campaign which directly challenges the outdated narrative that clotting smoking is simply a matter of personal determination. The campaign featured visuals that reimagine vintage cigarette advertising, but instead of selling cigarettes, they're selling will power as a miracle product. It is deliberately provocative because the message is clear. will power alone is not enough.

We will continue to strategically deploy this campaign throughout 2026 to drive ongoing conversation and awareness around nicotine dependence as a medical condition requiring a medical solution. Beyond this, we are leveraging technology and AI tools to generate rapid evidence-based and regulatory compliant content that will fuel our launch. To use a bit less marking jargon, this means we were able to build things faster using fewer resources. Through our partnership with Omnicom, we developed a marketing engine designed to shave weeks off the development review and approval of brand messaging, promotional and educational -- this is just 1 example of how modern second data are improving our ways of working at Achieve.

We've also established our unified data ecosystem and our custom-built marketing technology foundation to support hyper-targeted personalized customer engagement and measurement. Finally, we've completed detailed customer segmentation to better understand how to reach and meet the needs of our future patients and prescribers. As we look ahead, we are building plans for optimizing sales deployment and nonpersonal promotion to key audiences at launch and beyond. We will look to deploy the Will Power campaign in select audiences, complete our data and performance measurement capabilities and finalize media channels and plans. We are confident in our ability to execute and scale effectively and deliver long-term value for patients, providers and shareholders.

I'll now turn it over to Mark Oki for financial updates.

Thank you, Jamie. Let me walk through our financial position and results. As of December 31, 2025, cash, cash equivalents and marketable securities totaled $36.4 million. Total operating expenses for the 3 and 12 months ended December 31, 2025, were $14.7 million and $54.9 million, respectively. Reflecting our ongoing investment in regulatory, clinical, pre-commercial and commercial infrastructure activities. Our total net loss for the 3 and 12 months ended December 31, 2025, was $14.7 million and $54.7 million, respectively. As always, we continue to evaluate financing options and cash management strategies, and we will provide updates if and when appropriate.

I'll turn it back to Rick for closing remarks.

Thank you, Mark. In closing, I'm pleased with our regulatory, clinical and go-to-market efforts, which underscores the momentum behind Achieve Life Sciences and our unwavering commitment to addressing the critical unmet needs of nicotine dependence. As we look ahead, I want to highlight 3 critical value drivers for our company. first, receiving NDA approval and successfully launching Cytocinigine for smoking cessation. This is our near-term priority and the team is executing with discipline and purpose. Discipline is important to ensure there is a controlled and successful launch.

Second, the growing recognition of the significant opportunity represented by our vaping indication with the commissioner's national priority voucher and the urgent public health need around e-cigarettes cessation, we have the opportunity to be first to market with a treatment for an indication where no approved options currently exist. Finally, both of these are underpinned by our digital commercial platform, the AI-powered data-driven infrastructure we built that positions us to launch efficiently and scale rapidly with precision targeting and measurable impact.

To the millions of Americans who are ready to break free from nicotine dependence, Achieve Life Sciences is not quitting on new. We are dedicated to this urgent need. The standard of care in smoking cessation has not evolved in 2 decades, and we're about to change that. I'm grateful to our patience clinical investigators, regulatory partners, investors and our incredible achieve team for their unwavering dedication to this mission. Together, we're building something meaningful. We're not putting on you. We will not quite until we deliver treatment that changes the standard of care for nicotine dependence and helps people live free of nicotine.

Lastly, we're limited in what we can say about our interactions with the FDA, while the NDA is under review. And as I said earlier, the communications are normal for this stage of the review process. I look forward to updating you on our progress. Thank you for your time, attention and continued confidence in Achieve Life Sciences.

[Operator Instructions] First question is coming from Thomas Flaten from Lake Street.

Perhaps for Jamie, the launch timing for the first half of '27 , can you talk a little bit about the critical path between a late June NDA approval in the first half launch, is this primarily scale up on the commercial side? Is it potentially product supply? Can you just talk a little bit about that gap that's created there.

Sure. Thanks for the question, Thomas. So obviously, we need drugs in order to be able to the market. And so that is our first consideration is when can we get drug into the supply chain to get it out. into the hands of patients. So everything that we need to do on the trade and distribution side we'll be ready to go as soon as have drugs. So we have our 3PL set up, as I mentioned during the call, serialization, our specialty pharmacy vendor, all of those requirements for co-pay and access, all of those will be aligned and ready to go at launch. .

The rest of the time that we'll be spending over the next 6 months with a little bit of -- or the additional 6 months gives us an opportunity to get some additional data into the marketplace to the scientific community and also work towards additional partnerships with advocacy and potentially policymakers. So it does afford us a bit more time to get a few other operational things activated as well.

If I can add to that, if you look at it from a strategic standpoint, given the scale of the market that we're actually addressing we took a decision that we need to make sure that we've got all of the processes in place to maximize or optimize the product launch. So I think Jamie and the team are doing a terrific job on that front. Craig and the manufacturing side are doing an excellent job. So I think taking time to get right is critically important for the success of the launch.

And then with respect to manufacturing, you did mention the observations during the GMP inspection. And did you imply -- maybe perhaps I'm reading too much into it, that the manufacturer in the NDA will not be supplying commercial product rather a darwill? And then what indications does that have for holding it there into the process now during the NDA review.

The critical part of this is that the PDUFA date remains the 20th of June of this year. That is what the FDA has set and that's what we're working to. But of course, any time that there's any observations, we'd already made the decision to transfer manufacturing to the U.S. given the geopolitical situation. So we basically just accelerated that. So at the moment, PDUFA date remains exactly the same. And I think given the scale of this opportunity, it's prudent to ensure that we have contingency supply. It's prudent to ensure that we've got onshore manufacturers here in the U.S.

Our next question today is coming from Jason Butler from Citizens Bank.

On all the progress 2 for me. Can you just talk a little bit more about where you believe awareness currently is with health care providers? And what additional work you'll be doing in 2026 to continue to build awareness of similar and the data? And then second, is there anything you can say about FDA dialogue on the vaping indications since you've got the CPV Jamie, do you want to address the commercialization

Sure. Thanks for the question. So regarding ACC awareness, I would say it's not been a priority to date to do broad spread awareness about the product. A lot of that has to do with what you are allowed to say in a pre-approval environment. So obviously, disease state education is 1 channel that we can provide information in a regulatory compliant way, but 1 of the decisions that we've made is that we understand that -- everyone knows that smoking is bad for you.

And there's really not a huge need to go out and spread that message. And so what we've been doing is conserving our resources so that when we get closer to launch, we can do a stronger push from an educational perspective that is specific to data about the product and when the product is going to be in the hands of physicians that they can use it with their patients. So we're scaling it adequately based on the need to do disease awareness education or lack thereof in a smoking cessation indication. I think as we get closer to launch, we will be ramping up more opportunities. And you're already seeing us do that around some of the conferences where we will be presenting data and where we have.

So ATS is a huge opportunity that Mark mentioned where we're going to have some new data that we want to get out into the medical community and into the hands of physicians. So it's something that we are scaling up as we get closer to launch, but we've been very conservative in our ad so far and how we spend money prior to them having the solution in their hands to give to their patients. And then Rick or Mark, I'll turn it back over to you to discuss FDA dialogue on baking.

Sure. So right now, to date, our discussions with FDA around vaping have largely been around approval for the protocol itself. -- and we hope to continue engagement as the study progresses. I think I can add to that. We're already in site selection.

So yes, it is progressing at a pace -- so I think the key is that we're anticipating a commencement in the first half of this year. So yes, it's moving along to the pace. And I note it also the public forum that the FDA is putting together the 2 -- I think the 14th of June coming up. So I think there's some debate around the validity of the CNBV, but for us, we think that the opportunity is huge as being the first in market for a vaping cessation product. And that's clearly an underserved market as there are no treatments there. But so I think that's going to be a real area of focus and interest.

[Operator Instructions] Our next question is coming from Brandon Folkes.

Congrats on all the progress. So just coming back to the manufacturing. Does your U.S. commercial launch time line of 12 -- does that assume a June 2026 approval or potential later approval? What level of flexibility should we think about in terms of when in 127 you may launch -- anything to read into in that broad time line? And then maybe on the similar vein, sort of are you looking to add depth to the NDA before the June approval was this potentially something to qualify them post approval?

I'll take the answer in inverse order. It's going to be post the June approval. I think the key now is to focus in on the approval and also to ensure that we put a stake in the ground, frankly, in terms of first half of '27 for the product launch quite simple because of all of the activities that need to go into it to ensure that we've got product to go into channel to make sure that all of the commercial operations have completed their activities.

So I think there's nothing to read into it other than we got a couple of observations that our third-party manufacturer is currently addressing with the FDA. I mean there's a little bit of opacity around that, of course, because it's a discussion between the FDA and the manufacturer. But as far as we're concerned on the flip side, we're always in favor of transparency, so we'll keep you in the picture with respect to that as things move along.

That's very helpful. Lastly from me, just sort of given the lead time between a potential June approval and a 1227 launch, how should we think about insurance coverage at launch? Should we think about this similarly to normal launches? Or could we have better-than-normal insurance coverage at launch, obviously, given the indication, but also given that lead time to have those discussions.

I'll take that question, Rick. So regarding payers, yes, we have been out actively having conversations any regulatory compliance for approval information exchange. -- opportunities that we do have. So we've had about 40 touch points with payers in the first quarter. We've attended PCMA. We've actually had inbounds from payers who want to have conversations with us. So we are obviously on the radar -- they are very interested. They recognize the differentiated profile of cytisinicline and the clear unmet need.

Obviously, we know there's still 25 million people who smoke in those countries who need treatments that will help them stop. So -- the ongoing conversations are very encouraging. We also know that the Affordable Care Act requires coverage of smoking cessation treatments, so that certainly helps in our favor at launch and beyond. And regarding timing, the actual clock really starts building for the demand when the drug is in channel. So we will have more time to have more conversations, but we won't start building demand. So any initial restrictions to access such as new-to-market blocks. So it still will require a ramp period from time of drug being distributed in pans of patients to the timing of the bleed out that it takes in order to get on formulary for some of those plants. So we're still tracking a slow ramp for the initial 6 months of lodge.

Our next question is coming from Justin Walsh from Jones Trading.

I'm wondering if you can provide additional color on the robustness of the raw plant material supply chain. Are third-party suppliers able to meet expected demand if -- so pharma is unable to do so?

Excellent question, Justin. Yes, as I mentioned before, we have been stockpiling the starting material for some considerable time. And by the time we get to launch, we believe we'll have more than 3 years' supply of starting material for the amounts required for in-market sales. So -- and we will continue to add to that stockpile. So we don't really see the inventory going much below 3 years for foreseeable future. So we've been buying in for quite a few years now. And the starting material has a 3-year shelf life, but we basically will reprocess it as we -- as it's required to be used.

And 1 more for me. I'm wondering if you can comment on the cisasinaclen dosing schedule. If there's any concern that a potential pill burden could limit real-world compliance or commercial uptake? .

I'll have back whenever Dr. Mark Rumensin, Steve.

Sure. It's a great question. We actually have found just after completing our Orca OL where people actually use the pill 3 times a day for up to a year that not only did people not find it excessively burdensome, but our completion rate and the number of people who adhere to the protocol was incredibly high. A lot of participants reported that they felt that their highest ratings were around real time -- and so actually, even though you don't have to take cytosiniclin with meals, because it's TID, it's perfectly -- it can be perfectly timed around meals. And they found that it was reassuring to take something to address their cravings right around the time periods that they would have their highest cravings. And again, our adherence rates in all of our trials and our trial, which was 52 weeks was incredibly high, over 75%.

Great. Next question is coming from John Vandermosten from Zacks.

In December, there was a nice report that came out that calculated some prices for cytisinicline and I was wondering if you've seen that. And then wondering how that compares with your internal calculations and kind of what prices you're thinking about when that comes about next year.

We have John -- we've definitely seen a report on -- thanks for the question. Yes, we have seen the ISO report. We were involved in the process providing information when requested that was appropriate for their consideration. I think importantly, what did highlight is that they have a firm there is a substantial unmet need despite currently available treatments and that payers make cydosinaclen immediately available. And as far as pricing goes, we're not going to comment on our pricing because we've obviously not set that yet, and we're not ready to have those conversations with payers on an exact price. So we'll leave it at that, but we were pleased with the recommendation that ISR made.

Okay. And then a few questions on manufacturing. I guess I wanted to frame it first, where does it stand with a synthetic manufacturer of API? And then I believe there are 3 different entities, perhaps that you're working with. There's a dare. I believe there's a European manufacturer and then there's so pharma. How does that all fit together? .

Right. So some pieces of a jigsaw puzzle. Look, I think the key here is that the synthetic is in process, put it that way. It's not an easy process. And I think I've stressed this before, we're making substantial progress on that front. But I think in terms of the 3 manufacturers start off with a -- so Pharma was not included in the NDA because we had concerns over their FDA inspection readiness. I was down in Sofia about 3 weeks ago, and -- so Pharma have made substantial progress with respect to the inspection readiness, and we expect -- we're going to intend to add them to the NDA once it's approved.

I think in terms of the third-party manufacturer, the key there is that, as I mentioned, we've got these observations that we're monitoring very, very carefully and they're collaborating with the FDA to rectify any kind of observations and the remedial action associated with it. And then ultimately, the transfer of manufacturers in the U.S. has largely been driven by a desire to have contingency and redundancy in our overall supply chain. And given the kind of uncertainty around tariffs, in particular and also MFM and that kind of stuff. We decided that some time ago to actually move manufacturing into the U.S. So timing-wise, we're anticipating that there should be available to be added to the NDA in the third quarter that comes time frame. So does that answer the question?

We reached the end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments.

Well, I'd just like to thank you all for your continued interest in Achieve Life Sciences. We've made terrific, terrific progress this year. And I just want to put it into context, 15 years ago, Tony Clark, who is the Co-Founder of Achieve and I have this idea that cytisinicline could do immense societal benefit. With a desperate need for a new treatment for nicotine dependence, the smoking cessation. And at that point, vaping didn't even exist. So over the years, we worked tremendously hard the initial 8 years with Tony Clark and I actually funding the company ourselves.

And since we -- over the last 7 years, we've made fantastic progress to address this huge unmet medical need. And we really do believe that we're at this -- on the brink of actually great success in having the ability to treat patients who have got very few options to -- so just like to say thank you for your continued interest in the company. We look forward to updating you.

Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.

Greetings, and welcome to the Achieve Life Sciences Third Quarter 2025 Earnings Conference Call and Webcast. [Operator Instructions] 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 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 risks, 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 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 or 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 CMPV is designed to provide enhanced FDA communications and an expedited NDA review time line, reducing the potential NDA approval to 1 to 2 months from a 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 the vaping indication means cytisinicline could be launched 8 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 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 0.5 million deaths annually are attributable directly to smoking, costing over $600 billion each year in smoking-related U.S. health care 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 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 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 dependent 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 2 Phase III 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 2 Phase III trials, we saw the 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 psytisinicline'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 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 health care professionals, patients and payers. By utilizing a unified HIPPA 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, e-mail, 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 to providing improved revenue outcomes. I'm sure you will share Achieve's excitement with the commercial buildup prior to launch in the third or fourth quarter next year.

Turning to updates on our team. We had 2 promotions and 1 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 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 Blick, where he spearheaded the company's strategy to help smokers and vapors 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 has 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 towards bringing a much needed new treatment to market. With that, I'll now turn it over to Dr. Rubinstein.

Thank you, Rick, and good morning, everyone. As a clinician who 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 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 6 months of cumulative cytisinicline exposure and 214 with at least 1 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. 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 1 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 1-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 help 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 PHLX, 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 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 III 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 FDA to shorten the time frame 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 3 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 provider and will begin the implementation process in Q4, 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, culminating in a comprehensive segmentation of payer organizations. The work identified distinct payer profiles, which will guide the alignment of our target list 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, 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, we significantly advanced our patient and HCP targeting initiatives. We have finalized patient journey mapping, communication 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 work streams 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, personalized 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 3 and 9 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 3 and 9 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 1 of only 9 therapies in the programs in inaugural year demonstrates the urgent national need for effective treatments and the FDA's recognition for nicotine dependence in the 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 2 decades since the new treat 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 CMPD design means we can accelerate our efforts to bring this life-changing therapy to those who vape.

As we look at the 3 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 the 20th of June 2026 and a launch in the third or fourth quarter 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. And finally, the growing recognition of value in our second indication, vaping, where we recently were awarded the CNBV by the FDA. This highlights the urgency of the public health crisis in the U.S. and enables a shortened review process of just 1 to 2 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 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.

[Operator Instructions] Your first question comes from the line of Thomas Flaten from Lake Street.

A couple of quick follow-ups from the call itself. Jamie, I know you mentioned a specialty distributor. Does that -- should I presume that you're going to go specialty only? Or is there a retail strategy in place as well?

Thomas, this is Rick here. Jamie has actually had to step away to address an urgent matter, and she's not going to be available for the Q&A. But the rest of our executive team are here, and we're happy to take your questions. I'll turn to Jerry for any questions you might have on the commercial front.

Okay. So could you just repeat your question, Thomas?

Yes. So in the prepared remarks, there was a comment made that you selected a specialty distributor. I was wondering if there was also a complementary retail strategy in place or are you going specialty?

No, no, there's going to be a complementary retail strategy in place as well. But the specialty route is one of the quickest and I think the optimal route at least in the initial stages, and then we'll build out from there.

Got it. And then a follow-up for Mark. The cash runway into the second half of next year, just to confirm, that does not contemplate funding the vaping study. Is that correct that we need separate funding?

Yes, to complete the vaping study, we'll need to raise additional capital. That's correct.

Got it. And then, Rick, anything that you can share with respect to the protocol you anticipate having for the vaping study? I don't know what conversations you've had with FDA or how far along that is, but any insight there would be great.

Yes. Thomas, it's a very similar protocol to the ones that we used for the smoking cessation trials. So it is a 2-arm study, placebo for 3 milligram 3 times daily for 12 weeks. And then it is active. It cytisinicline 3 milligrams 3 times daily for 12 weeks, roughly 400 patients in each arm. There is a difference between the smoking cessation trials and the vaping trials. And we believe that the vapors are actually more nicotine dependent than necessarily the smoking population was. So they are only treated for 12 weeks, whereas in the smoking cessation trial, we had the flexibility of 6 or 12 weeks. But other than that, they're very similar.

And the endpoint will be what because you can't do any kind of objective breath analysis, right?

Correct. So it's simple. It's going to be overall quit rates at end of 12 weeks of treatment and then with a 24-week follow-up.

Your next question comes from the line of Gary Nachman from Raymond James.

Congrats on all the progress. So first, with the priority voucher for vaping, you said you're preparing to initiate that Phase III. How are you looking for ways to accelerate it and maybe started on the earlier side of the first half of next year? Could you clarify that? And you mentioned the Phase III design. That's just going to be the same as what you've talked about previously. Just wanted to confirm that.

I'll take the first part of it, Gary, and then I'll hand over for a bit more detail to Dr. Mark Rubinstein. Yes, I mean, the CMPV allows us a once 2 months of approval. So the NPV or ROI on that 8 months that we're potentially benefiting from accelerating the product launch, that's substantial. And whereas the CNPV doesn't allow the transfer of the actual voucher itself. We strongly believe that the acceleration, both in the launch period, but you also got to launch -- look at the acceleration of peak revenues by 8 or 9 months. So yes, it's extremely valuable. And yes, we are going to go back to the agency because I think we need to take advantage of the benefits under the CNBV to see where we could streamline the agreed clinical trial design. You remember that we got breakthrough designation originally. Now that is reinforced by the CNBV. So we do see that there's potential for some kind of streamlining of it. I'll hand over to Dr. Mark.

Yes. So just to clarify, you wanted to hear a little bit more about the study design. And so as Rick has said, it will be a 12-week trial of cytisinicline with behavior versus placebo with behavioral treatment with follow-up at 12 weeks and 24 weeks. We will be biochemically confirming I understand the prior caller's question about confirmation with J B CO and he is correct that is only to detect cigarette smoke. However, we will also be employing blood analysis and/or saliva. We're looking to see which we can do more rapidly to look for coin, which is a biomarker of nicotine exposure so that we can confirm self-report. Does that answer your question?

Yes. And I guess just in terms of size, it sounds like you're going to try and streamline that the way that Rick described and will it be the same dosing as what you currently have for smoking.

Exactly. Same dosing.

Okay. And then I guess since I have you, Mark, maybe just regarding the benefits for cytisinicline in COPD patients that you just published. And this is also for Rick, but maybe just talk about a little bit more just about what you saw in those patients, like how much of a benefit there was? And then, Rick, are you still having conversations with potential partners to do a study in that patient group? So what's the status there?

Again, I'll kind of flip that one as well as Dr. Mark can answer part of it. Look, I think the key is that the effect that we saw, the benefit that we saw in COPD smokers was quite remarkable. We'd always suspected that those were potentially the highest beneficiaries because to be a COPD smoker, you have to be highly nicotine dependent when you have a progressive disease like COPD. And our belief was that they could well be the real beneficiaries.

By being COPD smokers, they are impairing the efficacy of the standard corticosteroid treatment. and the anti-IL-33 simply don't work in the smoking population. So we see that there are 6 million COPD smokers in the U.S. today. And we believe strongly that cytisinicline can have a significant impact on making sure that their current treatment actually works more effectively. So there's a kind of unique characteristic to this in terms of a 6 million population of patients with COPD who actually have the ability to benefit from cytisinicline. And that can parallel with other respiratory companies because we believe there should be an interest in ensuring that they can target that 6 million population. So over to you, Dr. Mark.

Sure. Thank you, Rick. So one of the things that we saw were that these patients with COPD were older, they were heavier smokers. They had higher levels of dependence and higher levels of depression, all of which we know are associated with poor outcomes. However, despite that, with cytisinicline, their quit rates were roughly the same as what we saw in smokers without COPD. For example, the odds ratio without COPD was 5.2 and with COPD was 5.3. So basically the same. And interestingly, and I think Rick had mentioned this earlier, patients on placebo were -- had a tremendously difficult time quitting. Really, when you have COPD, given those -- probably those other factors that you are heavier smoker and older, you couldn't really quit unless you use cytisinicline.

Okay. That's really helpful. And then just last one, Rick. Pfizer, I think, is bringing CHANTIX back to the market. So what are your thoughts on how that impacts the overall smoking cessation market? Will that potentially help it grow again? And I'm not sure if you've seen how Pfizer is pricing CHANTIX with generics available. So if you have any color on that.

Well I mean, I can take a kind of strategic view on it. Why reintroduce CHANTIX when the generics have basically taken over the market. There's no value in the promotional activity because it really drives them towards the generic rather than the brand. So it's going to take -- if they're going to promote it, then it's going to be an interesting kind of ROI on that investment. And regardless of whether CHANTIX varenicline is in the market, I think the differentiation between cytisinicline in terms of not just its efficacy, but also the superior overall side effect profile and particularly focusing on that nausea and vomiting experience in the first few days of taking varenicline or CHANTIX, -- we clearly believe we've got a much superior product.

I mean cytisinicline has 5x less incidence of nausea and vomiting than varenicline does and less than half of the other side effects, be sleep disturbances, abnormal dams and nightmares, headache, et cetera. So it's a huge market. There are about 8 million scripts for smoking cessation annually. At peak, CHANTIX had about 2.8 million scripts written, 75% of those were in the U.S. So regardless, I think that we have the benefits and the advantage over generic varenicline, and we see that as not being a necessary stumbling block.

Your next question comes from the line of Brandon Folkes from H.C. Wainwright.

Congratulations on all the progress. Maybe for me, can you just elaborate on the commercial infrastructure overlap you expect between smoking cessation and vaping? And then given that vaping now comes to the market earlier in the launch of the smoking cessation, which is probably not going to be at peak. Does that change your commercial infrastructure outlook or how you're looking at sort of launching these 2 products in tandem or I guess, not launching them in tandem, but I guess maximizing their potential in tandem. Just any changes to the go-to-market strategy? And then along the same lines, just with the priority voucher, how are you doing manufacturing just that vaping maybe earlier in the process than perhaps you had planned?

Brandon, thanks for the question. We are anticipating or estimating that the vaping indication will be launched around about 12 to 14 months after the smoking cessation indication. And I think that is really a really beneficial time because it allows us to effectively knock out any of the wrinkles that might be as a result, and we've got some learning to be done from the launch of the smoking cessation. Are we targeting different markets or different patients? The answer is yes. We're targeting a much younger patient population. The typical age of smokers in our clinical trials is around about 55 years old. They've been smoking for somewhere up to 30 years. And our key strategy here is a highly motivated quitters.

So of that -- of the 29 million smokers currently in the U.S., we're estimating that approximately 7 million are highly motivated quitters. On the vaping target population, it's different. So they are a much younger population. Again, average age in our Phase II trial was 33 to 35. On average, they've been vaping between 8 -- or 5 and 8 years, and we're already starting to experience some of the comorbidities associated with vaping. So I think that the fundamental approach to targeting the patients will remain the same. But I think that the younger population of vapors are more digitally inclined than the perhaps slightly older population for smoking cessation.

Again, we think that gives us a kind of an advantage because the ability to communicate directly to the patients digitally is a fundamental part of our overall strategy. From a physician standpoint, it won't make any difference. The physicians all we've got to do is make them aware of the benefits of cytisinicline in vapors because they will already be aware of the benefits in the smoking population. So I think that's the slight nuance between the 2 populations. In terms of manufacturing, it will be the same. It's 3 milligrams 3 times daily. But as far as is concerned, it's 3 milligrams 3 times daily over 12 weeks only. It won't have the flexibility that we've seen in the smoking cessation at 6 or 12 weeks.

[Operator Instructions] There are no further questions at this time. I will now turn the call back to Mr. Rick Stewart. Please continue.

I'd just like to thank you for your time and attention. We are progressing rapidly with both the smoking cessation indication. We're excited about the prospect of a PDUFA date in June and actually launching the product for smokers who have few treatment options at the current time. From a vaping standpoint, obviously, the CNBV is a real recognition of the value of cytisinicline in treating vapers who want to quit, and we look forward to…