Achieve Life Sciences Q2 2025 Earnings Report

Achieve Life Sciences EPS Results

• Actual EPS: -$0.37
• Consensus EPS: -$0.37
• Beat/Miss: Met Expectations
• One Year Ago EPS: N/A

Achieve Life Sciences Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Achieve Life Sciences Announcement Details

• Quarter: Q2 2025
• Date: 8/7/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, August 7, 2025
• Conference Call Time: 8:30AM ET

Achieve Life Sciences (NASDAQ:ACHV), a clinical-stage pharmaceutical company, develops and commercializes cytisinicline for smoking cessation and nicotine addiction. The company offers cytisinicline, a plant-based alkaloid that interacts with nicotine receptors in the brain that reduce the severity of nicotine withdrawal symptoms. It has license and supply agreement with Sopharma AD and University of Bristol Achieve Life Sciences, Inc. is based in Vancouver, Canada.

Achieve Life Sciences Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Achieve reached three key milestones this quarter: submission of its cytisinicline NDA, a strategic commercial partnership with Omnicom, and a $49 million capital raise.
• Positive Sentiment: The NDA for cytisinicline is supported by data from over 2,000 participants and includes long-term safety results from more than 100 subjects with one-year exposure.
• Neutral Sentiment: Achieve expects the FDA to accept the NDA in mid-September, triggering a PDUFA date and setting the potential for cytisinicline approval and a late-2026 launch.
• Positive Sentiment: Interim ORCA-OL survey results show 98% of respondents felt cytisinicline helped them quit or reduce dependence and 99% would recommend it, with manageable side effects.
• Positive Sentiment: The $49 million financing boosts Achieve’s cash runway into 2026, supporting regulatory and pre-commercial activities while maintaining disciplined spending.

Presentation

[Operator]

Greetings and welcome to Achieve Life Sciences Second Quarter twenty twenty five Earnings Conference Call and Webcast. A 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.

[Nicole Jones, Investor Relations at Achieve Life Sciences]

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 Doctor. Cindy Jacobs, President and Chief Medical Officer Jamie Zenos, Chief Commercial Officer and Mark Okie, Chief Financial Officer. The management team will be available for Q and A following the prepared remarks.

[Nicole Jones, Investor Relations at Achieve Life Sciences]

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 risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC.

[Nicole Jones, Investor Relations at Achieve Life Sciences]

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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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 twenty years. We achieved three transformative milestones. Firstly, the successful submission of our new drug application for cytisinicline 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 $49,000,000 capital raise that positions us to reach critical value inflection points in 2026, including potential product approval.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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 cytisinicline 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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

The market opportunity is huge. Twenty nine million Americans smoke. Every year, more than fifteen 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-1s did for obesity. Patients and physicians currently lack adequate tools to be successful.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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 $600,000,000,000 in annual costs in The U. S. 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 cytisinicline in late twenty twenty six. Before the team dives into the details, I want to express our gratitude to those who have been instrumental in supporting our progress.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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 submission 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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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 cytisinicline 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 three studies, ORCA-two and ORCA-three, 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 and characterizing cytisinicline's efficacy, safety and tolerability.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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 cumulative cytisinicline treatment. Also important to highlight this last quarter was reaching the second major milestone of FDA's request for having over 100 participants completing one year of communicative cytisinicline treatment before approval. This safety data will be submitted in the standard one hundred and twenty 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 July, two ninety participants have completed one year of cytisinicline treatment in the OL study and the last participant is projected to complete treatment by early October.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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 forty percent of the two ninety. These responses and their comments have been encouraging as to the impact cytisinicline has had on them and potentially could have on the lives of other people battling nicotine dependence. For example, ninety eight percent of the survey respondents stated they believe cytisinicline 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, ninety nine percent stated they would recommend cytisinicline to a friend or family member.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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 cytisinicline, we plan on completing all trial activities to lock the final study database by the end of this year. And 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 seventy four day letter from FDA in September and we will be submitting our one hundred and twenty day safety update documents and data sets in October. The seventy four 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.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

Now I'll turn the call over to Jamie to share more about our commercial launch preparations.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

Thank you, Cindy, and good morning, everyone. This quarter, we made meaningful progress toward executing our core commercial objective, delivering cytisinicline 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 go 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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

As we look ahead to a potential launch in 2026, 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 work stream 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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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 services. We believe this capability will be especially important in the early phase of launch to help ensure that prescriptions written are prescriptions filled. On the access front, we've built a strong foundation and are now accelerating our efforts.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

Our new Vice President of Market Access has joined the team and we've engaged a best 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 cytisinicline 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 preapproval information exchange with payers in Q4 with outsourced account managers beginning fieldwork in Q1 of next year. We are laser focused on clearly defining and communicating the differentiated value of cytisinicline backed by rigorous clinical evidence to support favorable coverage decisions. Early engagement with payers is critical to building the relationships and understanding required to enable rapid access following approval.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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 Achieve's 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 cytisinicline.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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 cytisinicline 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 patterns, 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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

We have built deep strategic relationships with experienced partners, including Optum 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 Cytisinicline 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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

We believe cytisinicline 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.

[Mark Oki, CFO at Achieve Life Sciences]

Thanks, Jamie. We're excited to have closed the second quarter with a strengthened balance sheet following the successful completion of a $45,000,000 underwritten public offering in June. And just lastly, the underwriters partially exercised their overallotment option generating additional gross proceeds of $4,300,000 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 06/30/2025, we had cash, cash equivalents and marketable securities totaling $55,400,000 These funds are expected to support operations into the 2026.

[Mark Oki, CFO at Achieve Life Sciences]

Total operating expenses for the three and six months ended 06/30/2025 were $12,600,000 and $25,500,000 respectively, consistent with our expectations as we increased investment in regulatory, quality and pre commercial planning. With respect to net loss for the three and six months ended 06/30/2025, it was $12,700,000 and $25,500,000 respectively. Our funding strategy has always been designed to support our highest priorities. And with this recent capital raise, we believe we are well positioned 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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

Thank you, Mark. This past quarter has been a defining one for Achieve. We delivered three separate milestones with more to come in the next twelve months as we anticipate product approval and launch. In the near term, we expect to receive the FDA's Day 74 NDA 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 at the one hundred twenty day safety update and will accelerate our commercial launch preparation.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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 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 and A.

[Operator]

Thank you. And at this time, we'll conduct our question and answer session. And our first question comes from Thomas Flaten with Lake Street Capital. Please state your question.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets]

Good morning, everyone. Thanks for taking the questions. Cindy, just a quick one for you just to confirm. In the one hundred and twenty day safety update, will you submit only 100 patients or the full two ninety that you don't have access to?

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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 two ninety or the over the 200 that we have right now.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets]

Got it. And Rick, you mentioned launch in late 'twenty six. 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, half of next year?

[Richard Stewart, CEO & Director at Achieve Life Sciences]

Yes. It will be incremental. I mean we have to invest in the precommercial 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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

But 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.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets]

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?

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

Well, I think thanks for the question. We would view this as a branded product at a premium price. And also, 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.

[Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets]

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

[Operator]

Your next question comes from Jon Vandermosten with Zacks. Please state your question.

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

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.

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

And then I guess the flowchart based on the response, how you'd move to different levels in communicating with everyone?

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

Yeah, thanks for the question.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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.

[John Vandermosten, Senior Analyst at Zacks Small Cap Research]

Okay. Thank you.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

You bet. Thank you.

[Operator]

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

[Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial]

Hi, good morning and congrats on all the progress. So back to the full safety data for the two ninety patients at twelve 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 one hundred and twenty 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? And then I have a follow-up.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

Sure. For the one hundred and twenty 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?

[Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial]

Yes. Just, how you're well, in terms of your communications with the FDA at the day 74 letters, that's the next time you hear from them? Or is there any back and forth prior to that?

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

Normally, at this time, there's back and forth with 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.

[Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial]

Okay. And any chance for a priority review or I guess you're anticipating a standard review, that's most likely scenario?

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

Well, at this point, we are. However, we're always hopeful for a priority review. We have requested it. And 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 as a likely possibility.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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.

[Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial]

Okay, great. And then Jamie, regarding the Omnicon 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 unmet need in nicotine dependence, but you want to reframe the message. So what are you doing on that front to position you better for the launch?

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

Yes. I'll start with the first part of that question. We have engaged all seven of our agencies and are fully operational with various work streams 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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

So all of that is underway, and we are obviously working very hard as a lean team within Achieve. We have leadership across all the work streams, 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, twenty 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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

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.

[Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial]

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

[Richard Stewart, CEO & Director at Achieve Life Sciences]

Yes. Thanks, Gary. Yes, 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 yes, we continue to work on it.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

In terms of partnering, I'd say exactly the same thing. Our focus has remained on a successful NDA submission. And I would suggest that once the NDA has now been submitted that we can start to have further discussions around that.

[Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial]

Okay, great. Thank you.

[Operator]

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

[Justin Walsh, Director & Research Analyst at Jones Trading]

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.

[Nicole Jones, Investor Relations at Achieve Life Sciences]

Do you want me to take that, Rick?

[Richard Stewart, CEO & Director at Achieve Life Sciences]

Yes. I think it's all complementary, right? As you build this out, at the center of all of this, we've got the Omnicom partnership, but there aren't 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. We'll bring in additional resources as required.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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.

[Jaime Xinos, Chief Commercial Officer at Achieve Life Sciences]

If I sorry, could just add to that 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 and 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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

One final thing, Justin. I think as you look at our kind of 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, it does offer the platform does offer opportunities to target what we internally called ifs, whether that's an oncologist, cardiologist, pulmonologist, etcetera. So I think the platform itself has got great value driving forward.

[Operator]

Thank you. And our next question comes from Boris Tokachev with Freedom. Please state your question.

[Boris Tolkachev, Analyst at Freedom]

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, the roadmap before the end of the year? And also do you plan to share any interim results from the ORCA-eleven trial ahead of full publication?

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

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.

[Cindy Jacobs, President & Chief Medical Officer at Achieve Life Sciences]

So obviously, our focus on that trial will allow us to hopefully proceed quickly with getting results in 2026 out to everyone.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

Boris, we see great value in the data from an 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 III trials. And of course, the secondary endpoint is efficacy.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

And we're really, really interested to see what that long term efficacy data will look like.

[Boris Tolkachev, Analyst at Freedom]

Okay. Got it. Appreciate your answers. Thank you.

[Operator]

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.

[Richard Stewart, CEO & Director at Achieve Life Sciences]

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

[Operator]

Thank you. That concludes today's call. All parties may disconnect. Have a good

Participants

Executives

• Nicole Jones, Investor Relations
• Richard Stewart, CEO & Director
• Cindy Jacobs, President & Chief Medical Officer
• Jaime Xinos, Chief Commercial Officer
• Mark Oki, CFO

Analysts

• Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets
• John Vandermosten, Senior Analyst at Zacks Small Cap Research
• Gary Nachman, MD - BioPharma/Biotech Equity Research Analyst at Raymond James Financial
• Justin Walsh, Director & Research Analyst at Jones Trading
• Boris Tolkachev, Analyst at Freedom