Achieve Life Sciences Q1 2026 Earnings Call - Cytisinicline NDA Resubmission Pushed to Q4 2026 Following Manufacturing CRL, $180M Financing Secured

Operator: 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.

Nicole Jones, Vice President, Strategic Communications and Stakeholder Relations, Achieve Life Sciences: 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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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 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. 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 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.

Operator: 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.

Jason Butler, Analyst, Citizens: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Jason Butler, Analyst, Citizens: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Jason Butler, Analyst, Citizens: Great. Thanks for taking questions.

Operator: Thank you. Our next question comes from the line of Justin Walsh with Jones Trading. Please proceed with your question.

Justin Walsh, Analyst, Jones Trading: 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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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 3 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, we 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.

Justin Walsh, Analyst, Jones Trading: Thanks for taking the question.

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

Gary Nachman, Analyst, Canaccord Genuity: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Gary Nachman, Analyst, Canaccord Genuity: Okay, great. And then just a follow-up. You know, with the likely change in leadership at FDA if Marty Makary leaves, 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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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. 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.

Gary Nachman, Analyst, Canaccord Genuity: 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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Gary Nachman, Analyst, Canaccord Genuity: Okay, great. Thank you.

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

Brandon Folkes, Analyst, H.C. Wainwright: 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, et cetera. 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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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 Oki, Jim Willis, and Chris Martin, 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.

Brandon Folkes, Analyst, H.C. Wainwright: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Brandon Folkes, Analyst, H.C. Wainwright: Great. Thank you very much, and congrats on all the progress.

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

Nelson Cox, Analyst, Lake Street Capital: 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 2-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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

John Vandermosten, Analyst, Zacks: Thank you.

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

John Vandermosten, Analyst, Zacks: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

John Vandermosten, Analyst, Zacks: Okay. With respect to the European manufacturer, have you completely severed ties with them? Is that all the way in the past now? Is that something that may continue as a alternative supply source or manufacturing source?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

John Vandermosten, Analyst, Zacks: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

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

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: I think the company’s had some fantastic partners to get to where they are today. 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.

John Vandermosten, Analyst, Zacks: Great. Thank you.

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

Boris Vilkov, Analyst, Freedom Broker: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: If I heard the question correctly, it was about manufacturing readiness for the clinical trial supply?

Boris Vilkov, Analyst, Freedom Broker: Yep.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Boris Vilkov, Analyst, Freedom Broker: 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?

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: 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.

Boris Vilkov, Analyst, Freedom Broker: Okay. Thanks. Appreciate the answers.

Operator: 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.

Dr. Andrew Goldberg, Chief Executive Officer, Achieve Life Sciences: Thank you. In closing, I think there are 3 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.

Operator: Thank you. This concludes today’s conference. You may disconnect your lines at this time. We thank you for your participation.