Achieve Life Sciences, Inc.

Greetings and welcome to the Achieve Life Sciences second quarter 2025 earnings conference call and webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones, Achieve Investor Relations. Thank you. You may begin.

Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Jamie Zenos, Chief Commercial Officer, and Mark Oakey, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks. A replay will be available later today using the information in the earnings press release or by visiting the Achieve website. Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risk, uncertainties, and other factors including but not limited to the factors set forth in the company's filings with the SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to Rick.

Thank you, Nicole, and good morning, everyone. We appreciate your time and participation in today's call. This quarter marks a defining moment in Achieve's progress toward the first new treatment for nicotine dependence in nearly 20 years. We achieved three transformative milestones. Firstly, the successful submission of our new drug application for cytosinicline as a treatment for nicotine dependence for smoking cessation to the FDA. Secondly, a strategic commercial partnership with the exceptional team at Omnicom. And thirdly, a $49 million capital raise that positions us to reach critical value inflection points in 2026, including potential product approval. The NDA submission starts the regulatory clock, and the PDUFA date will be defined on NDA acceptance, which we expect in mid-September. This is an exciting moment for Achieve after years of dedication to bring cytosinicline to FDA review and for patients and physicians who currently lack adequate tools to successfully quit. The opportunity to collaborate with Omnicom, a world-recognized leader in healthcare marketing, advertising, and technology, positions Achieve to quickly scale and leverage external expertise and infrastructure to execute our commercial launch strategy. Omnicom's deep experience and proven success with pharma and biotech clients includes successfully executing more than 100 product launches and new indications over the last three years. Finally, we're profoundly grateful to our stockholders whose continued investment support reflects an unwavering belief in our potential to create meaningful change in public health. The market opportunity is huge. 29 million Americans smoke. Every year, more than 15 million try to quit with poor success rates. The narrative needs to change to recognize nicotine dependence as a medical condition, much like how the GLP ones did for obesity. Patients and physicians currently lack adequate tools to be successful. For nearly a generation, innovation has stood still in nicotine dependence for smoking cessation, leaving patients frustrated, providers powerless, and public health carrying the burden of over $600 billion in annual costs in the US. Historically, individuals seeking to quit smoking have faced limited options, and we aim to change this. As we move forward, we will work with the FDA through the review process, and should we receive approval, be prepared to launch Cytosine Clean in late 2026. Before the team dives into the details, I want to express our gratitude to those who have been instrumental in supporting our progress. Firstly, the patients and physicians who participated in our clinical program, their engagement and commitment has been invaluable. Secondly, our entire Achieve team for their dedication in delivering the NDA submissions on time through a significant company-wide effort. And thirdly, our investors for their continued support, guidance, and belief in our mission. On today's call, Cindy will update you on regulatory timelines and progress on the Orca OL study. Jamie will provide an update on our commercial planning, and Mark will conclude the details on the recent financing and current cash runway. In short, our three announcements this quarter demonstrate that we are advancing confidently on three fronts, regulatory, commercial, and financial. Our path is clear, and we are committed to executing it to the fullest. With that, I'll turn it over to Cindy.

Thank you, Rick. Our regulatory accomplishment with the NDA submission during the second quarter was the result of years of focused development work. As Rick just mentioned, in June, we officially submitted our NDA for Cytosineclin as a treatment for nicotine dependence to achieve smoking cessation as our first indication. This is a comprehensive and well-supported application incorporating non-clinical data and manufacturing information, as well as the clinical trial results from two well-controlled Phase III studies, Orca II and Orca III, along with the long-term safety exposure data from our Orca OL clinical trial. The NDA submission is supported by data from over 2,000 clinical trial participants, providing a comprehensive foundation in characterizing cytosineclin's efficacy, safety, and tolerability. Regarding tolerability, and as requested by FDA, we included long-term exposure safety results in over 300 participants who had completed at least six months of commutative cytosineclin treatment. Also important to highlight this last quarter was reaching the second major milestone of the FDA's request for having over 100 participants completing one year of commutative cytosineclin treatment before approval. This safety data will be submitted in the standard 120-day safety update during the NDA review period. Meeting both critical thresholds for safety exposure data on schedule was essential in completing the NDA submission and for FDA's review toward market approval. As of the end of July, 290 participants have completed one year of cytosineclin treatment in the OL study, and the last participant is projected to complete treatment by early October. We are also in the process of collecting exit survey responses from participants when they complete the OL study, and so far we have survey responses from 40% of the 290. These responses and their comments have been encouraging. As to the impact cytosineclin has had on them and potentially could have on the lives of other people battling nicotine dependence. For example, 98% of the survey respondents stated they believe cytosineclin contributed to their ability to either stop or reduce their nicotine dependence, citing fewer cravings and less intense withdrawal symptoms compared to their previous quit attempts and with very few or manageable side effects. Impressively, 99% stated they would recommend cytosineclin to a friend or family member. Many also expressed their gratitude with specific comments, highlighting their extensive battle with nicotine for decades and that they finally feel that they have won. Although the final study results from this ORCA OL study is not required by FDA for market approval of cytosineclin, we plan on completing all trial activities to lock the final study database by the end of this year. We will look for future opportunities to publish and present the completed trial results in 2026. As we look ahead in the next few months, we expect to receive the 74-day letter from FDA in September and we will be submitting our 120-day safety update documents and data sets in October. The 74-day letter will also indicate that the NDA submission has been accepted for review and give target completion review dates, which will begin the official countdown to a potential approval decision. Now I'll turn the call over to Jamie to share more about our commercial launch preparations.

Thank you, Cindy, and good morning, everyone. This quarter we made meaningful progress toward executing our core commercial objective, delivering cytosineclin to patients who are ready to quit using the most advanced tools and strategies available. Over the next several months, we will be building our brand, driving stakeholder engagement, and finalizing our -to-market activities in preparation for potential launch in 2026. Our path to launch is on track and full of momentum, as evidenced by the selection of Omnicom to provide a diverse range of critical launch capabilities. Our partnership brings together seven specialized Omnicom agencies operating as a single unified team across brand development, provider and patient initiatives, market access, public relations, media and marketing technology. This partnership gives us access to the scale, speed, and capabilities of a much larger organization and allows us to maintain a lean internal team who will lead key functional areas. This collaboration also supports our commitment to a modern data-driven approach to launch. We are building and will leverage a proprietary AI-enabled commercial platform and tool that will enable precision, agility, and measurable outcomes to support smarter decision-making across the entire organization. From targeting and engagement to performance optimization, our tech-focused strategy will help us to reduce costs, mitigate risk, and remain highly adaptive to real-world signals. Our strategy is intentional, insight-led, and focused on driving both commercial value and improved patient outcomes. As we look ahead to a potential launch in 26, we are confident in our ability to execute efficiently, scale effectively, and deliver long-term value for patients, providers, and shareholders alike. Our launch readiness efforts are anchored in three strategic imperatives. Availability, access, and awareness all underpinned by a commitment to measurable impact to ensure the efficiency and effectiveness of our investments. I'll provide a brief update on our recent progress and near-term priorities across each of these pillars. Starting with availability, this workstream encompasses trade and distribution activities to ensure product readiness at launch. We've made meaningful progress in this area, supported by external expert consultants and now guided by an internal achieve lead. We've contracted with a leading third-party logistics provider, or 3PL, named in our NDA and plan to begin implementation in the fourth quarter. Our home state licensing application has been submitted and once accepted will trigger the sequential submission of additional state applications. Following a comprehensive evaluation, we have shortlisted potential partners for specialty light distribution services. We believe this capability will be especially important in the early phase of launch to help ensure that prescriptions written are prescription filled. On the access front, we've built a strong foundation and are now accelerating our efforts. Our new Vice President of Market Access has joined the team and we've engaged a -in-class access agency to expand upon the foundational work we've already completed, including extensive payer research and market assessments to ensure the value of cytosinexcline is clearly reflected in our pricing, contracting, and coverage strategies. Our key priorities in the coming quarter include finalizing our pricing strategy, refining our value message, and completing payer segmentation and communication plans. We anticipate beginning the pre-approval information exchange with payers in Q4, with outsourced account managers beginning field work in Q1 of next year. We are laser-focused on clearly defining and communicating the differentiated value of favorable coverage decisions. Early engagement with payers is critical to building the relationships and understanding required to enable rapid access following approval. Securing access and insurance coverage for our patients is a top priority. Turning to awareness, our efforts are focused on building product-specific awareness and establishing achieved reputation as a trusted, science-driven partner. Unlike therapeutic categories that require broad disease education, the need in smoking cessation is well understood. Our strategy centers on reframing nicotine dependence as a medical condition, not a lifestyle choice, and one that warrants the use of effective and well-tolerated treatments like cytosinexcline. We are taking a focused, data-driven approach, engaging two high-impact audiences, motivated patients who are ready to quit and most likely to succeed with cytosinexcline, and healthcare providers who are already prescribing high volumes of smoking cessation therapies. Our goal is to activate these patients to initiate conversations with their providers and ensure those providers are informed, equipped, and ready to prescribe. To support this strategy, we are now triangulating multiple data sources, including prescribing patient behavioral signals and public health data sets to identify and prioritize the highest impact targets. In parallel, we're developing advanced analytics and machine learning capabilities that will continuously evaluate and optimize how we reach and convert these targets. This includes building dynamic audience models and segmentation strategies that allow us to personalize messaging based on where both patients and providers are in their decision-making journey. Whether it's raising initial awareness, addressing clinical questions, or prompting action, our content and channels will be designed to meet each stakeholder with the right message at the right time. This precision-targeted approach not only enhances effectiveness, it also improves efficiency and return on investment, ensuring that every dollar spent contributes to measurable outcomes and long-term value creation. As we look ahead, we are energized by the opportunity in front of us. We know that launching a drug, especially as a small company and for the first time, is often seen as a high-risk endeavor. But we are not doing this alone. We have built deep strategic relationships with experienced partners, including OPCOMP and others, who are not just vendors but believers in our mission and co-architects of our path forward. These partners bring a wealth of experience across every critical function, and they are fully aligned with our vision for Citus and Accline to become a powerful, life-changing option for the millions of people still struggling with nicotine dependence. Their investment in our success, both operationally and philosophically, adds strength, stability, and confidence as we move towards launch. We are guided by data, driven by purpose, and supported by a team, both internal and external, that is all in on delivering something truly transformative. The work ahead is substantial, but our focus is clear. We believe Citus and Accline can change the way the world approaches smoking cessation, and we are ready to lead that change. I'll now turn the call over to Mark to review the financials.

Thanks, Jamie. We are excited to have closed the second quarter with a strength and balance sheet following the successful completion of a $45 million underwritten public offering in June. And just last week, the underwriters partially exercised their over-allotment option, generating additional growth proceeds of $4.3 million to the company. The offering included common stock and warrants and was met with strong support from current shareholders, as well as new institutional and retail investors. As of June 30, 2025, we had cash, cash equivalents, and marketable securities totaling $55.4 million. These funds are expected to support operations into the second half of 2026. Total operating expenses for the three and six months into June 30, 2025, were $12.6 million and $25.5 million, respectively, consistent with our expectations as we increased investment in regulatory, quality, and precommercial planning. With respect to net loss for the three and six months ended June 30, 2025, it was $12.7 million and $25.5 million, respectively. Our funding strategy has always been designed to support our highest priorities, and with recent capital raise, we believe we are well positioned to execute our regulatory and early commercial initiatives, while remaining committed to financial discipline. With that, I'll turn the call to Rick for closing remarks.

Thank you, Mark. This past quarter has been a defining one to achieve. We delivered three separate milestones with more to come in the next 12 months as we anticipate product approval and launch. In the near term, we expect to receive the FDA's Day 74 MBA acceptance letter in mid-September. We'll add the 100-plus subjects with one year's exposure from the ORCA OL Open Label Safety Study, the 120-day safety update, and we'll accelerate our commercial launch preparation. Achieve is disciplined in executing its strategy with a clear focus on financial prudency, on executing a clear regulatory strategy with the FDA, and also optimizing its product launch capabilities by collaborating with Omnicom and other external partners who are recognized leaders in the space. These accomplishments are the result of extraordinary determination by Achieve's dedicated team who have worked tirelessly to bring this vision to life, and by the over 2,000 patients who enrolled in our trials committing to quit smoking and vaping in pursuit of a better health and lifestyle. We are confident that our focused efforts will have a meaningful impact on patients and create long-term value for all stockholders. Again, thank you for your time, and we look forward to updating you on our continued progress in the coming quarters. With that, Operator, we're now ready for Q&A.

Thank you. And at this time, we'll conduct our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press the star key followed by the number 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. And our first question comes from Thomas Flatten with Lake Street Capital. Please see your question.

Good morning, everyone. Thanks for taking the questions. Cindy, just a quick one for you just to confirm. In the 120-day safety update, will you submit only 100 patients or the full 290 that you now have access to?

We'll be submitting all of the subjects at the time of the database cut that occurred in June, so it'll be more than 100, but not exactly the 290 or over the 200 that we have right now.

Got it. And Rick, you mentioned launch in late 26, and if we assume an approval in late June, how should we think about your ramp in commercial spending ahead of launch? Is it going to be completely approval dependent or will you begin ramping that spend, let's say, first half of next year?

Yeah, it'll be incremental. I mean, we have to invest in the pre-commercial activities prior to the approval, so I think you'll see an increase over the coming quarters, but as soon as we reach approval, then you'll see an increase. Well, I think the key message here is that we keep a very disciplined approach to that commercial investment. But again, I think you'll look at this. Once we've got the NDA acceptance, you'll start to see a ramp up, but not excessive.

And then one final one, if I may, for Jamie. I might be getting ahead of the pricing work you're already doing, but are you assuming that a premium price relative to the generic chantix will be available to you or should we be thinking about something closer to the generic pricing that we see today?

Well, I think, thanks to the question, we would view this as a branded product at a premium price and also I think that resonates based on the profile and what we are able to differentiate versus the current options. And that's what we've been going in and having discussions with payers about. They aren't in disagreement with that.

Excellent. I appreciate you taking the question. Thank you.

Your next question comes from John VanderMustin with Zax. Please, see your question.

Great. Thank you guys for taking my question. I had a question, also had a question for Jamie on just the initial contact method for reaching out to providers. I think in the presentation you mentioned email and social and perhaps you can walk us through all those initial contact methods and then I guess the flow chart based on the response, how you'd move to different levels in communicating with everyone.

Yeah, thanks for the question. So I think that's still yet to be determined because as we've noted in a lot of our conversations, we really want to identify the individual needs of the physicians that we are targeting and meet them where they are. And so I think there are obviously opportunities for engagement across all of those channels that you mentioned such as social and email, putting reps where it is appropriate, where they can get strong access and where they need to have those conversations in person. Virtual reps as well will be another option that we'll be looking at. But again, it's really going to depend on what we define further through our targeting exercise as where they want to have those engagements with pharma.

Okay, thank you.

Thank you.

And your next question comes from Gary Natchman with Raymond James. Please state your question.

Hi, good morning and congrats on all the progress. So back to the full safety data for the 290 patients at 12 months. Any commentary just on the overall safety profile if it was consistent with the six month data and how will you be releasing that assuming after you provide the updated safety data to FDA at 120 days? And then are there any communications with the FDA prior to the day 74 letter or is that the first time that you hear back from them that have a follow up?

Sure. For the 120 safety day update, we will be submitting it in October and the data currently right now and we've obviously made this public has been reviewed by the data safety monitoring committee throughout this process and there's been no different or unique safety signals that have been seen. So it is consistent with what we would expect at six months in one year. The next I think question was, sorry, what was the second question?

Yeah, just how you, well, in terms of your communications with the FDA at the day 74 letter, is that the next time you hear from them or is there any back and forth

prior to

that?

Normally at this time there's back and forth with the FDA and that's what we're experiencing and that's what's happening so it's all normal procedures in that regard. They're contacting us asking where various things are. We're very responsive, letting them know where they are in the NDA and so it is a back and forth process that's been and it's normal.

Okay. Any chance for a priority review or I guess you're anticipating a standard review? That's most likely scenario?

Well, at this point we are, however, we're always hopeful for a priority review. We have requested it. Also there is the new commissioners national priority voucher that they just published a couple of weeks ago, how to kind of request it and we have requested it. We don't view that that is a likely possibility but in all of our interactions we are trying as best as we can to highlight this submission and NDA review process for priority as best as we can.

Okay, great. And then Jamie, regarding the Omicron partnership, any specific work that you're doing together right now in the early days while you wait for the approval or certainly until you have better visibility on timelines, does it make sense to do any unbranded marketing to physicians to get them comfortable? Obviously they know the Omic need and nicotine dependence but you want to reframe the message. So what are you doing on that front to position you better for the launch?

Yeah, I'll start with the first part of that question. We have engaged all seven of our agencies and are fully operational with various workstreams that we view as high priority activities that need to be conducted now to better inform what we need to do at launch and how we will deploy resources going forward. So across all of the functional areas that I mentioned on the call as well as I think in the press release, we have teams who are activated and we are also working very aggressively towards building our launch roadmap and our AI-driven, our AI-enabled platform which will allow each of those functional areas to work as one team seamlessly in one ecosystem where all of the data are coming in, being analyzed and then helping us to inform decision making and then eventually performance metrics down the road. So all of that is underway and we are obviously working very hard as a lean team within Achieve. We have leadership all across all the workstreams and then we've got leadership within the Omnicom organizations moving this launch forward. So we are well underway. Regarding awareness activities, our early focus is going to be driving that message that the conversation needs to get started again because it's been so long, 20 years since something new has come to the market. So we think it's important that they know that there will be a new treatment and we also need to elevate the seriousness of those conversations. So that's the work that we'll be doing early on. The more product-specific work will come closer to launch because we want whatever efforts and whatever resources we dedicate towards that awareness to go directly to prescribing so we can track and monitor the effectiveness of those communications. So the early work will be more around elevating the conversation, making sure we have the right patient identified for physicians who should be, this product should be prescribed for and changing that medical conversation that this is not a moral or a lifestyle choice. This is actually a medical, this is a medical condition that needs to be treated with a medical solution.

Okay, great. And then just last one quickly for Rick. Just any update on the synthetic version of cytosinequine, timing of that potentially and also if there are any partnership discussions that have progressed, you know, specifically with some comorbid conditions like COPD.

Yeah, thanks Gary. Yeah, we're continuing to work on the potential for the synthetic but frankly our focus really has been on the NDA submission and ensuring that that's been a success. So, yeah, we continue to work on it. In terms of partnering, I'd say exactly the same thing. You know, our focus has remained on a successful NDA submission and I would suggest that, you know, once the NDA has now been submitted that we can start to have further discussions around that.

Okay, great.

Thank

you.

Thank you. And your next question comes from Justin Walsh with Jones Trading. Please, do your question.

Hi, thanks for taking the question. Congrats on all the progress. I'm wondering if you expect your partnership with Omnicom to impact potential discussions with more traditional pharma partners.

Do you want me to take that,

Rick? Yeah, I think it's all complementary, right? You know, as you build this out, you know, at the center of all of this we've got the Omnicom partnership but there are going to be other opportunities to build out more traditional routes. But for now, again, we're focused very much on ensuring that the Omnicom platform is fully functional and we'll bring in additional resources as required. I think the market right now is pretty dynamic and we need to maintain our flexibility to ensure that we've got the right resources at the right time and ultimately targeting the right patients and physicians.

Great, thanks for taking the question. Sorry, if I could just add one quick note to that. I think as Rick mentioned in the prepared remarks, Omnicom is a well-known healthcare entity. In fact, they've launched over 100 products and new indications over the last three years with the likes of Merck, J&J, Novartis, AV, CMS. So they're not an unknown company to many of these large pharma players. So if anything, I think our relationship and the work that we're doing with them adds credibility that we will have a complete launch package and be able to drive value in the market.

One final thing, Justin, I think as you look at our launch platform and go forward platform, we are primarily focused on primary care physicians and addressing that market highly efficiently and in a very precise targeted manner. But as I've said in the past, the comorbidities associated with smoking, be that cardiovascular, hypertension, respiratory disease, the platform does offer opportunities to target what we internally call the ists, whether that's an oncologist, cardiologist, pulmonologist, etc. So I think the platform itself has got great value driving forward.

Thank you. And a reminder to the audience to ask a question at this time, press star 1 on your telephone keypad. To remove your question, you can press star 2. And our next question comes from Boris Tolkachev with Freedom. Please state your question.

Good morning and thanks for taking the question. It might be too early to ask. However, I was wondering if we could expect any updates on future clinical development roadmap before the end of the year. And also, do you plan to share any interim results from the ORCA-OL trial ahead of full publication?

I'm not sure I heard the first question, this is Cindy. But we are planning on completing the entire database for the ORCA-OL study and that's going to happen quickly actually by the end of this year. And we will be looking at conferences as well as getting publications ready early next year for hopefully a conference maybe by quarter two or during the 2026 year. A number of times that we can present the data because there will be a lot of safety as well as efficacy data for us to present. That is the only ongoing trial we have right now. So obviously our focus on that trial will allow us to hopefully proceed quickly with getting results in 2026. Out to everyone.

Boris, we see great value in the data from the open label safety study. I think with one year's exposure to the drug, so far we've seen an important element, which is the tolerability of the drug to patients during that period. And we think that's going to stand us in good stead in the future. So as Cindy said in her prepared remarks, the safety profile looks pretty much in line with what we've seen in the phase three trials. And of course, the secondary end point is efficacy. And we're really, really interested to see what that long term efficacy data will look like.

Okay, got it. I appreciate your answers. Thank you.

Thank you. And we have reached the end of the question and answer session. I'll hand it back to Rick Stewart for closing remarks.

Great. So thank you, everyone, for joining us today and for your questions. And thank you to the patients and the health care professionals who participated in our clinical program to date, enabling us to submit the new drug application for cytosinicline. We're very excited about the potential for cytosinicline, and we look forward to providing you with future updates. And finally, I'd like to thank our shareholders for their continued support and their dedicated and talented team and achieve for their commitment. Operator, that concludes today's call.

Thank you. That concludes today's call. I'll part with disconnect. Have a good day.