ACHV

Greetings, welcome to the Achieve Life Sciences first quarter 2026 earnings conference call and webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the phone presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones, Achieve's Vice President, Strategic Communications and Stakeholder Relations. 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, 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 have been an investor and governance leader, serving as a director or observer on 19 healthcare 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 and practiced 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 toll 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 two 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. 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 three 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 three to the Board.

Earlier this morning, we also announced two of Chris's 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 three 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.

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 20th 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 & 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 & 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.

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys. One moment please while we poll for questions. Our first question comes from the line of Jason Butler with Citizens. Please proceed with your question.

Hi. Thanks for taking the questions and 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. Fortunately, now we have the time and above all, the asset. 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.

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. 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. Just one follow-up. Just on the medical education side, where do you think awareness is with current Chantix prescribers of cytisinicline and the phase III data and again, what do you need to do in 2026 to keep building that awareness?

Yeah. Thank you for that. We're constrained about what we can communicate in a pre-approval environment and we take those rules seriously. 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. As we get closer to approval and in the launch, our med ed team will expand, and we'll continue to update throughout the course of the year.

Great. Thanks for taking questions.

Thank you. Our next question comes from the line of Justin Walsh with JonesTrading. Please proceed with your question.

Hi. Thanks for taking the question. 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. 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.

We expect the, you know, any CRL to focus on the OAI classification at the prior third-party manufacturer, which is the basis for the Adare transition. The three words I kinda wanna use to characterize our position here are going forward are transparency, proactiveness, and importantly, adaptability. 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. Although we haven't received that notification yet, the company's already been proactive.

We've already moved our manufacturing to the U.S., and we've already produced our first batches this quarter. Our principal goal and my principal goal is completing that tech transfer to Adare on as fast a timeline as possible while maintaining our completeness. I'm early in my tenure, but we're evaluating every strategy and expenditure as we do this right, and will not hesitate to adjust resourcing where is needed, including ramping up where we believe that it's necessary.

I am personally engaged in this process. I've already visited Adare's 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 sowe will ramp up where is needed to get this right. We're confident that our current U.S. partner, who has multiple FDA-approved products already, can help us get there.

Thanks for taking the question.

Thank you. Our next question comes from the line of Gary Nachman with Canaccord Genuity. Please proceed with your question.

Thanks. 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? 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?

Let me take the first question on IP. I've looked at it at Achieve for I've followed this company for a long time, both as a physician and as an investor. We've done diligence on the intellectual property on several folds, and I would also add that was done by other investors who have come into this significant financing as well. 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 am, 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, I can assure you that we'll be transparent with the 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. You know, with the likely change in leadership at FDA if Makary leads, how are you thinking about the evolving dynamics in the vaping market, if more vapes end up being approved? 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.

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 we're honored to be a part of the program.

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. 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.

The smoking NDA stands on its own two feet. We have two phase III double-blind placebo-controlled trials where not one, but both of our six and 12-week courses reached statistical significance. 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. Just lastly, how soon do you think it'll 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? Thanks.

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

Okay, great. Thank you.

Thank you. Our next question comes from the line of Brandon Folkes with H.C. Wainwright. Please proceed with your question.

Hi. Thanks for taking my questions, and congratulations on all the progress. Three from me, if I may. The previous team had mentioned initially focusing on those smokers that need to stop smoking and, you know, may have comorbidities. Just given the capital you now have at your disposal, you know, would you be willing to talk about if you contemplate a wider approach at launch?

I'll ask my second one 'cause it stays along those lines. You know, how do you think about patient support programs for the launch? Just things such as patient hotlines, etc. Can you just help us think about how large of an investment do you contemplate across the commercial organization at launch? You know, I guess especially in light of, you know, if we look back at the Chantix launch and sort of the importance of those programs as they were described. Thank you.

Thanks. Thank you for that. 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. 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. The barrier to treatment has not been awareness of the disease to date and with prior attempts. It's been the lack of an effective and tolerable therapy that prescribers feel confident offering. That, for us, changes a bit of the commercial math. The launch efficacy, launch efficiency in this category is not about saturating awareness. Patients already raised their hand. It's about where we're gonna be focused is about giving prescribers a reason to treat, equipping them with the right therapy, and removing that access friction. That's what our commercial team, Mark, Jim, and Chris who were announced this morning, has done before.

With this team, this asset and category, we believe we can effectively launch at scale. With respect to your second question around investment and patient support programs, you know, the world now is very different than it was 20 years ago. With a digital and tele infrastructure and now everyone with a cell phone in their pocket, the ability to provide support programs for our patients has really never been easier. 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. Thank you very much. One more, if I may. You know, 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?

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. I think you can expect that we will be thorough in generating data going forward, and I think we have a excited, and committed, research community that's gonna help support us in that.

Great. Thank you very much, and congrats on all the progress.

Thank you. Our next question comes from the line of Nelson Cox with Lake Street Capital. Please proceed with your question.

Yeah. Hey, this is Nelson on for Thomas. I'll ask kind of both mine upfront, which are follow-ups to previous questions. On the CNPV, can you kinda walk us through your understanding of the two-year clock? Specifically, does it start at receipt of the voucher or at the initiation of the pivotal vaping study? What's kind of the how does that work there? How large of a field team would you anticipate needing to meet your commercial expectations? Thank you.

I don't wanna comment on the exact specifications around the voucher. We've received it. We plan on initiating the, you know, ORCA-V2 trial as fast as we can. We will work with the agency in order to, you know, try and stay on any needed timelines. With respect to the size of our field force, I think we're gonna be smart about how we scale that up. I could see us starting with a reasonable sized field force.

I don't wanna commit to any specific numbers right now, but I'm confident that we have both the capital and the team to help lead that. As we branch out into a broader nationwide distribution, our field force will scale in accordance with that. I think the main thing is we wanna build both the company and the field force to scale with the magnitude of the opportunity. We're gonna be disciplined about when we start and how we do it.

Thank you.

Thank you. Our next question comes from the line of John Vandermosten with Zacks. Please proceed with your question.

Great. Thank you. Good morning, Dr. Goldberg. With respect to the 4th quarter resubmission of the NDA, do you expect a Class 1 or Class 2 type of resubmission?

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

Okay. 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 a alternative supply source or manufacturing source?

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

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, you know, adequate therapies to meet the needs of patients. 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 gonna get more attention to the condition, and it's gonna 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. We're confident that our asset has an extremely easy to tolerate profile. We're an oral pill, easy to take, standard dosing, no titrations, no injections. We're confident that we have a strong position in that future landscape.

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

I think the company's 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. We'll continue to evaluate our partners and pick the best ones for the time, where we are, and that ones that will align us best for the strategy going forward.

Great. Thank you.

Thank you. Our next question will be from the line of Boris Tolkachev with Freedom Broker. Please proceed with your question.

Good morning, and thanks for taking the question. Just a quick one from me. Should we assume that the drug batches for the ORCA-V2 trial will be already manufactured by Adare Pharma? Should we think that the readiness of this facility is the key to really start the trial?

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

Yep.

Okay. The company's manufactured clinical trial supplies 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. 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. We're working now with our clinical development teams and our CMC teams to source this next trial with appropriate supply. We're making those decisions right now.

Thanks. Just some last quick one. Maybe you could reiterate what is driving the decision to push the resubmission exactly to Q4? Is it, like, something conservative, or is it, like, your real assumption that you will be ready up to that point?

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.

Okay. Thanks. Appreciate the answers.

Thank you. 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 de-risks our manufacturing and our launch timing. Third, we have new commercial leadership with the 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. 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 into a commercially focused enterprise. Our primary objective now is to make cytisinicline available to the 25 million patients who smoke and nearly 18 million who vape. The need for a new nicotine dependence treatment like cytisinicline has never been greater. Achieve is committed to providing the new therapeutic tool to patients seeking to break free from the cycle of nicotine dependence. I'm incredibly impressed by the commitment and resilience of the entire Achieve team and their dedication to addressing the nicotine dependence public health crisis in the U.S. Key highlights in 2025 include: firstly, the submission of the New Drug Application or NDA for the smoking cessation indication and its acceptance by the FDA, moving us one important step closer to becoming the first new FDA-approved treatment in 20 years. Secondly, Achieve's vaping cessation indication was one of the first recipients of the Commissioner's National Priority Voucher. Recognition of cytisinicline as a national priority is an incredible achievement of the work conducted by Achieve and the importance of cytisinicline in tackling the previously intractable problem of nicotine dependence. The Commissioner's voucher gives us an accelerated pathway to be the first and only FDA-approved vaping cessation treatment. Thirdly, our clinical team delivered on all planned regulatory milestones and generated encouraging clinical data across our program during the year. This includes concluding the ORCA-OL long-term exposure trial, which underlined 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 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-reviewed medical journal, demonstrated that cytisinicline significantly improved smoking quit rates compared to placebo in adults with chronic obstructive pulmonary disease. There are 6 million COPD smokers in the U.S. today with few options to help them quit. Their level of nicotine dependence must be high, as continued smoking exacerbates COPD symptoms and impairs the efficacy of COPD drugs. The positive data on COPD patients highlights the expansive scope of opportunities for cytisinicline 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. Achieve's omnichannel digital platform provides precision targeting of physicians and patients, which will allow us to identify high-volume prescribers and the patients motivated to quit, deploying resources efficiently and maximizing impact per dollar spent. AI is a critical enabler in this evolution. We'll be using advanced analytics and machine learning to enhance decision-making, automate 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 Adare Pharma Solutions, a U.S.-based manufacturing organization that will produce cytisinicline 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 Adare is already underway. The Adare partnership provides redundancy in our supply chain, allowing contingency capacity in the U.S. The manufacturer named in the cytisinicline NDA recently had an FDA Good Manufacturing Practices inspection with 2 observations related to solid oral dose manufacture, which are being addressed through an ongoing communication of its remedial action plan with the FDA. By establishing U.S.-manufacturing with Adare, we increase confidence in our supply-chain security as we advance towards a planned commercial launch of cytisinicline expected in the first half of 2027. We remain focused on bringing cytisinicline to patients as quickly as possible, and our decision to work with Adare positions us to launch with the manufacturing reliability and the operational readiness our patients and stakeholders expect. Now, let me take a moment to remind you why our team is so passionate about bringing cytisinicline to market. Recent data issued by CDC estimated that in 2024, approximately 25 million adults in the United States smoked cigarettes. It's estimated that more than 15 million attempt to quit every year. Smoking remains the leading cause of preventable death in the U.S., claiming approximately 500,000 lives annually and costing over $600 billion each year in health care cost and loss productivity. The comorbidities are devastating. To name a few, respiratory disease, cardiovascular disease, metabolic disease and cancer. We also know that 60% of the nearly 18 million adult e-cigarette users in the U.S. want to quit, and adult nicotine e-cigarette use is on the rise. However, there is no FDA-approved treatment for e-cigarette cessation. Patients are frustrated, physicians are frustrated. The narrative around nicotine dependence needs to change. We've seen this transformation happen with obesity. When GLP-1s emerged, they helped society recognize obesity for what it truly is, a medical condition, not a personal failure. Nicotine dependence deserves the same recognition. It's a neurobiological condition rooted in how nicotine alters brain chemistry and creates physical dependence. It's a medical condition and it demands medical treatment. That's why we launched our Will Power 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 dependence are not lost on many investors. unmet medical needs, same physician call points, same cost to society. In summary, our science is strong. We're advancing through the regulatory review process with the FDA, working constructively towards approval. Our commercial infrastructure is taking shape with real progress in 2025, and we're actively building for launch. With that, let me turn it over to Dr. Mark Rubinstein, who will detail our regulatory progress and the data that continue to reinforce cytisinicline across patient populations.

Thank you, Rick, and good morning, everyone. We have made tremendous progress in 2025 for cytisinicline from a clinical and regulatory standpoint. Since our last earnings call, we've continued to validate cytisinicline's clinical profile through peer-reviewed 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 Society for Research on Nicotine and Tobacco or SRNT conference a few weeks ago. This analysis examines cytisinicline's efficacy across participants with different prior treatment histories and quit-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 quit option 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 use 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 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 cessation, a significant recognition of the public health urgency. The CNPV 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 trial 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 remaining lean and right-sized 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 cytisinicline 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 cytisinicline. 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 Achieve's reputation as a trusted, science-driven partner and shifting how patients and providers think about nicotine dependence. As Rick mentioned, we launched our Will Power campaign, which directly challenges the outdated narrative that quitting 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 marketing jargon, this means we are 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 materials. This is just one example of how modern tech and 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 non-personal 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, Jaime. 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 cytisinicline 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-cigarette 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 you. We are dedicated to this urgent need. The standard of care in smoking cessation has not evolved in 2 decades, and we are about to change that. I'm grateful to our patients, 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 quitting on you. We will not quit until we deliver a 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] Our first question is coming from Thomas Flaten from Lake Street.

Perhaps for Jaime, 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 and 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 drug in order to be able to go to 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 will be ready to go as soon as we have drug. So we have our 3PL setup, as I mentioned during the call, serialization, our specialty-pharmacy vendor, all of those requirements for copay 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 and to the scientific community, and also work on -- 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 have got all of the processes in place to maximize or optimize the product launch. So, I think Jaime and the team are doing a terrific job on that front and Craig on the manufacturing side is doing an excellent job. So I think taking time to get it 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 Adare will? And then, what implications does that have for folding Adare into the process now during the NDA review?

Yes. I think 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 toward. But of course, any time that there's any observations, we've 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, the 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 onshored manufacturers here in the U.S.

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

On all the progress in 2025. Two from 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 cytisinicline and the data? And then second, is there anything you can say about FDA dialogue on the vaping indication since you got the CNPV?

Jaime, do you want to address the commercialization?

Sure. Thanks for the question. Regarding HCP awareness, I would say it's not been a priority to date to do broad-spread awareness about the product. And 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 one channel that we can provide information in a regulatory-compliant way, but one 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 so 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 hands of -- 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 efforts so far in 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 vaping.

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 if I can add to that, we're already in site-selection. So, 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 at the pace. And I noted also the public forum that the FDA is putting together the 20 -- I think it's the 14th of June coming up. So, I think there's some debate around the validity of the CNPV. 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 from H.C. Wainwright.

Congrats on all the progress. So, just coming back to the manufacturing, does your U.S. commercial launch time line of 1H 2027, does that assume a June 2026 approval or potential later approval? What level of flexibility should we think about in terms of when in 1H '27 you may launch? Anything to read into in that broad time line? And then, maybe on a similar vein, are you looking to add Adare to the NDA before the June approval? Or is this potentially something to qualify them post-approval?

I'll take the answer in reverse order. Yes, 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 the first half of '27 for the product launch quite simply 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. 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. Maybe lastly from me, just given the lead time between a potential June approval and a 1H 2027 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?

Thanks. I'll take that question, Rick. So regarding payers, yes, we have been out actively having conversations in the regulatory compliant pre-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 this country 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. Any initial restrictions to access, such as new-to-market blocks, those still will require a ramp period from time of drug being distributed and in hands of patients to the timing of the bleed out that it takes in order to get on formulary for some of those plans. So, we're still tracking a slow ramp for the initial 6 months of launch.

Our next question is coming from Justin Walsh from JonesTrading.

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 Sopharma 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. We don't really see the inventory going much below 3 years for the foreseeable future. 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 one more for me. I'm wondering if you can comment on the cytisinicline dosing schedule and if there's any concern that a potential pill burden could limit real-world compliance or commercial uptake.

I'll hand that one over to Dr. Mark Rubinstein stage.

Sure. That'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 adhered to the protocol was incredibly high. A lot of participants reported that they felt that their highest cravings were around mealtime. And so actually, even though you don't have to take cytisinicline 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 OL trial, which was 52 weeks was incredibly high, over 75%.

Next question is coming from John Vandermosten from Zacks.

In December, there was an ICER 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 what prices you're thinking about when that comes about next year.

Jaime?

We have definitely seen the report -- thanks for the question. Yes, we have seen the ICER report. We were involved in the process, providing information when requested that was appropriate for their consideration. I think, importantly, what it did highlight is that they have affirmed there is a substantial unmet need despite currently available treatments, and that payers should make cytisinicline 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 are pleased with the recommendation that ICER made.

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 Adare. I believe there's a European manufacturer and then there's Sopharma. 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 an end 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, we start off with Sopharma. Sopharma 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 Sopharma have made substantial progress with respect to their inspection-readiness. And we'd 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 manufacturer to the U.S. has largely been driven by a desire to have contingency and redundancy in our overall supply chain. And given the uncertainty around tariffs in particular, and also MFN and that kind of stuff, we decided some time ago to actually move manufacturing into the U.S. So, timing-wise, we're anticipating that Adare should be available to be added to the NDA in the third quarter, that kind of time frame. So does that answer the question?

Yes. 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 progress this year. And I just want to put it into context, 15 years ago, Tony Clarke, 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 for smoking cessation. At that point, vaping didn't even exist. Over the years, we've worked tremendously hard. The initial 8 years was Tony Clarke 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 brink -- on the brink of actually great success and having the ability to treat patients who have got very few options to quit. So, I'd just like to say thank you for your continued interest in the company, and 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.