Q4 2025 Achieve Life Sciences Inc Earnings Call

March 24, 2026

Speaker #1: Will be placed into questioning queue at any time by pressing star 1 on your telephone keypad. As a reminder, this conference is being recorded.

Speaker #1: If anyone should require operator assistance, please press star 0 on your telephone keypad. It's now my pleasure to turn the call over to Nicole Jones, Vice President, Strategic Communications.

Speaker #1: Nicole, please go ahead.

Speaker #2: Thank you, Operator. Good morning, everyone, and thank you for joining us today. From ACHIEVE LIFE SCIENCES, we are joined by Rick Stewart, President and Chief Executive Officer, Dr. Mark Rubinstein, Chief Medical Officer, Jaime Xinos, Chief Commercial Officer, and Mark Oki, Chief Financial Officer.

Speaker #2: The management team will be available for Q&A following the prepared remarks. Our replay will be available later today using the information in the earnings press release, or by visiting the ACHIEVE LIFE SCIENCES website.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: I'll now turn the call over to Rick.

Speaker #3: Thank you, Nicole. And good morning, everyone. The NDA submission in June 2025 started the transformation of ACHIEVE from a pure-play clinical development company into a commercially focused enterprise.

Speaker #3: Our primary objective now is to make cytosynthesin available to the 25 million patients who smoke and nearly 18 million who vape. The need for a new nicotine-dependence treatment like cytosynthesin has never been greater.

Speaker #3: ACHIEVE is committed to providing the new therapeutic tool to patients seeking to break free from a cycle of nicotine dependence. I'm incredibly impressed by the commitment and resilience of the entire ACHIEVE team and their dedication to addressing the nicotine dependence public health crisis in the US.

Speaker #3: Key highlights in 2025 include: firstly, the submission of the new drug application or NDA for the smoking cessation indication, and its acceptance by the FDA.

Speaker #3: Moving as one important step closer to becoming the first new FDA-approved treatment in 20 years. Secondly, ACHIEVE's vaping cessation indication was one of the first recipients of a Commissioner's National Priority Voucher.

Speaker #3: Recognition of cytosynthesin as a national priority is an incredible achievement of the work conducted by ACHIEVE and the importance of cytosynthesin in tackling a previously intractable problem of nicotine dependence.

Speaker #3: The Commissioner's Voucher gives us an accelerated pathway to be the first and only FDA-approved vaping cessation treatment. Thirdly, our clinical team delivered on all planned regulatory milestones and generated encouraging clinical data across our program during the year.

Speaker #3: This includes concluding the ORCA-OL long-term exposure trial which underlined cytosynthesin safety profile demonstrating strong tolerability and excellent patient satisfaction data. We should not underestimate the importance of the findings from the ORCA-OL safety study which demonstrated the tolerability of cytosynthesin over long-term 52-week exposure to treatment.

Operator: Greetings, and welcome to the Achieve Life Sciences Q4 and full year 2025 Earnings Conference Call and Webcast. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star zero on your telephone keypad. It's now my pleasure to turn the call over to Nicole Jones, Vice President, Strategic Communications. Nicole, please go ahead.

Speaker #1: Greetings and welcome to the Achieve Life Sciences Fourth Quarter and Full Year 2025 Earnings Conference Call and Webcast. At this time, all participants are in a listen-only mode.

Speaker #1: A question and answer session will follow the formal presentation . You may be placed in the question queue at any time by pressing star one on your telephone keypad As a reminder , this conference is being recorded .

Speaker #1: If any should require operator assistance , please press Star Zero on your telephone keypad It's now my pleasure to turn the call over to Nicole Jones vice President , Strategic Communications .

Speaker #3: Dr. Mark Rubinstein will elaborate in a minute. And lastly, post-hoc data published in Thorax are leading peer-reviewed medical journal demonstrated that cytosynthesin significantly improved smoking quit rates compared to placebo in adults with chronic obstructive pulmonary disease.

Speaker #1: Nicole, please go ahead.

Nicole Jones: Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Richard Stewart, President and Chief Executive Officer, Dr. Mark Rubinstein, Chief Medical Officer, Jaime Xinos, Chief Commercial Officer, and Mark Oki, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks. A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website. Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of Achieve. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay.

Speaker #2: Thank you . Operator . Good morning , everyone , and thank you for joining us today from a Chief Life Sciences . We are joined by Rick Stewart , President and Chief Executive Officer .

Speaker #2: Doctor Mark Rubinstein , chief Medical Officer . Jaime Xinos , chief commercial Officer . And Mark Oki chief financial officer . The management team will be available for Q&A following .

Speaker #3: There are 6 million COPD smokers in the US today with few options to help them quit. Their level of nicotine dependence must be high as continued smoking exacerbates COPD symptoms and impairs the efficacy of COPD drugs.

Speaker #2: Following the prepared remarks . A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website Today's conference call will contain certain forward looking statements , including statements regarding the goals , strategies , beliefs , expectations and future potential .

Speaker #3: The positive data on COPD patients highlight the expansive scope of opportunities for cytosynthesin in terms of a range of comorbidities that could potentially benefit from treatment and broad range of healthcare providers who would be interested in its benefits.

Speaker #2: 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 .

Speaker #3: Our commercial team has moved forward decisively towards building a scalable, data-driven commercial model that will position us to launch successfully. Our model is built to address the rapidly evolving healthcare environment where approximately 75% of primary care physicians will no longer meet with medical reps.

Speaker #2: 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 .

Nicole Jones: Actual results may differ materially as a result of risks, uncertainties, and other factors, including but not limited to the factors set forth in the company's filings with the SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company. I'll now turn the call over to Rick.

Speaker #2: 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 .

Speaker #3: ACHIEVE's omnichannel digital platform provides precision targeting of physicians and patients which will allow us to identify high-volume prescribers and the patients' motivated to quit.

Speaker #2: I'll now turn the call over to Rick.

Richard Stewart: Thank you, Nicole, and good morning, everyone. The NDA submission in June 2025 started the transformation of Achieve from a pure play clinical development company into a commercially focused enterprise. Our primary objective now is to make cytisinicline available to the 25 million patients who smoke and nearly 18 million who vape. The need for a new nicotine dependence treatment like cytisinicline has never been greater. Achieve is committed to providing the new therapeutic tool to patients seeking to break free from the cycle of nicotine dependence. I'm incredibly impressed by the commitment and resilience of the entire Achieve team and their dedication to addressing the nicotine dependence public health crisis in the US.

Rick Stewart: Thank you, Nicole, and good morning, everyone. The NDA submission in June 2025 started the transformation of Achieve from a pure play clinical development company into a commercially focused enterprise. Our primary objective now is to make cytisinicline available to the 25 million patients who smoke and nearly 18 million who vape. The need for a new nicotine dependence treatment like cytisinicline has never been greater. Achieve is committed to providing the new therapeutic tool to patients seeking to break free from the cycle of nicotine dependence. I'm incredibly impressed by the commitment and resilience of the entire Achieve team and their dedication to addressing the nicotine dependence public health crisis in the US.

Speaker #3: Deploying resources efficiently and maximizing impact per dollar spent. AI is a critical enabler in this evolution. We'll be using advanced analytics and machine learning to enhance decision-making and automate customer engagement and generate predictive insights about which messages will resonate most with target audiences.

Speaker #3: Thank you . Nicole , and good morning everyone The NDA submission in June 2025 started the transformation of achieve from a pure play clinical development company .

Speaker #3: Into a commercially focused enterprise. Our primary objective now is to make Cytisinicline available to the 25 million patients who smoke and nearly 18 million who vape.

Speaker #3: Positioning us to continue building an efficient commercial organization that punches well above its weight. We also just announced that we have selected ADEA Pharma Solutions—a US-based manufacturing organization—that will produce cytosynthesin drug product as we prepare for potential commercial launch and future demand.

Speaker #3: The need for a new nicotine dependence treatment like Cytisinicline has never been greater Achieve is committed to providing the new therapeutic tool to patients seeking to break free from the cycle of nicotine dependence I'm incredibly impressed by the commitment and resilience of the entire achieved team , and their dedication to addressing the nicotine dependence , public health crisis in the US Key highlights in 2025 include Firstly , the submission of the new drug application or NDA for the smoking cessation indication and its acceptance by the FDA Moving is one important step closer to becoming the first new FDA approved treatment in 20 years Secondly , achieves vaping cessation .

Speaker #3: We believe this partnership will secure our supply chain and reduce risks associated with international pharmaceutical importation and may lower overall costs including the risk and uncertainty for tariffs on international imports of drug product.

Richard Stewart: Key highlights in 2025 include firstly, the submission of a new drug application or NDA for the smoking cessation indication and its acceptance by the FDA, moving us one important step closer to becoming the first new FDA-approved treatment in 20 years. Secondly, Achieve's vaping cessation indication was one of the first recipients of a Commissioner's National Priority Voucher. Recognition of cytisinicline as a national priority is an incredible achievement of the work conducted by Achieve and the importance of cytisinicline in tackling a previously intractable problem of nicotine dependence. The Commissioner's voucher gives us an accelerated pathway to be the first and only FDA-approved vaping cessation treatment. Thirdly, our clinical team delivered on all planned regulatory milestones and generated encouraging clinical data across our program during the year.

Rick Stewart: Key highlights in 2025 include firstly, the submission of a new drug application or NDA for the smoking cessation indication and its acceptance by the FDA, moving us one important step closer to becoming the first new FDA-approved treatment in 20 years. Secondly, Achieve's vaping cessation indication was one of the first recipients of a Commissioner's National Priority Voucher. Recognition of cytisinicline as a national priority is an incredible achievement of the work conducted by Achieve and the importance of cytisinicline in tackling a previously intractable problem of nicotine dependence. The Commissioner's voucher gives us an accelerated pathway to be the first and only FDA-approved vaping cessation treatment. Thirdly, our clinical team delivered on all planned regulatory milestones and generated encouraging clinical data across our program during the year.

Speaker #3: I'm pleased to report that work has commenced and our technology transfer to ADEA is already underway. The ADEA partnership provides redundancy in our supply chain allowing contingency capacity in the US.

Speaker #3: Indication was one of the first recipients of a commissioner's national priority voucher . Recognition of Cytisinicline as a national priority is an incredible achievement of the work conducted by Achieve , and the importance of Cytisinicline in tackling a previously intractable problem of nicotine dependence The commissioners voucher gives us an accelerated pathway to be the first and only FDA approved vaping cessation treatment Thirdly , our clinical team delivered on all planned regulatory milestones and generated encouraging clinical data across our program during the year .

Speaker #3: The manufacturer named in the cytosynthesin NDA recently had an FDA good manufacturing practices inspection with two observations related to solid oral dose manufacture. Which are being addressed through an ongoing communication of its remedial action plan with the FDA.

Speaker #3: By establishing US manufacturing with ADEA, we increase confidence in our supply chain security as we advance towards a planned commercial launch of cytosynthesin expected in the first half of 2027.

Speaker #3: We remain focused on bringing cytosynthesin to patients as quickly as possible and our decision to work with ADEA positions us to launch with a manufacturing reliability and the operational readiness of patients and stakeholders expect.

Richard Stewart: This includes concluding the ORCA-OL long-term exposure trial, which underlined cytisinicline safety profile, demonstrating strong tolerability and excellent patient satisfaction data. We should not underestimate the importance of the findings from the ORCA-OL safety study, which demonstrated the tolerability of cytisinicline over long-term 52-week exposure to treatment. Dr. Mark Rubinstein will elaborate in a minute. Lastly, post-hoc data published in Thorax, a leading peer-reviewed medical journal, demonstrated that cytisinicline significantly improved smoking quit rates compared to placebo in adults with chronic obstructive pulmonary disease. There are 6 million COPD smokers in the US today with few options to help them quit. Their level of nicotine dependence must be high as continued smoking exacerbates COPD symptoms and impairs the efficacy of COPD drugs.

Rick Stewart: This includes concluding the ORCA-OL long-term exposure trial, which underlined cytisinicline safety profile, demonstrating strong tolerability and excellent patient satisfaction data. We should not underestimate the importance of the findings from the ORCA-OL safety study, which demonstrated the tolerability of cytisinicline over long-term 52-week exposure to treatment. Dr. Mark Rubinstein will elaborate in a minute. Lastly, post-hoc data published in Thorax, a leading peer-reviewed medical journal, demonstrated that cytisinicline significantly improved smoking quit rates compared to placebo in adults with chronic obstructive pulmonary disease. There are 6 million COPD smokers in the US today with few options to help them quit. Their level of nicotine dependence must be high as continued smoking exacerbates COPD symptoms and impairs the efficacy of COPD drugs.

Speaker #3: This includes concluding the orca ol long term exposure trial , which underlined Cytisinicline safety profile , demonstrating strong tolerability and excellent patient satisfaction data We should not underestimate the importance of the findings from the orca Ol safety study , which demonstrated the tolerability of Cytisinicline over long term 52 week exposure to treatment .

Speaker #3: Now let me take a moment to remind you why our team is so passionate about bringing cytosynthesin to market. Recent data issued by CDC estimated that in 2024, approximately 25 million adults in the United States smoked cigarettes.

Speaker #3: Doctor Mark Rubinstein will elaborate in a minute . And lastly , post hoc data published in thorax , a leading peer reviewed medical journal , demonstrated that Cytisinicline significantly improved smoking , quit rates compared to placebo in adults with chronic obstructive pulmonary disease There are 6 million COPD smokers in the US today , with few options to help them quit Their level of nicotine dependence must be high , as continued smoking exacerbates COPD symptoms and impairs the efficacy of COPD drugs .

Speaker #3: It's estimated that more than 15 year. Smoking remains the leading cause of preventable death in the US claiming approximately 500,000 lives annually and costing over $600 billion each year in healthcare costs and loss productivity.

Speaker #3: The comorbidities are devastating. To name a few: respiratory disease, cardiovascular disease, metabolic disease, and cancer. We also know that 60% of the nearly 18 million adult e-cigarette users in the US want to quit and adult nicotine e-cigarette use is on the rise.

Richard Stewart: The positive data on COPD patients highlights the expansive scope of opportunities for cytisinicline in terms of the range of comorbidities that could potentially benefit from treatment, and broad range of healthcare providers who would be interested in its benefits. Our commercial team has moved forward decisively towards building a scalable, data-driven commercial model that will position us to launch successfully. Our model is built to address the rapidly evolving healthcare environment, where approximately 75% of primary care physicians will no longer meet with medical reps. Achieve's omni-channel digital platform provides precision targeting of physicians and patients, which will allow us to identify high-volume prescribers and the patients motivated to quit, deploying resources efficiently and maximizing impact per dollar spent. AI is a critical enabler in this evolution.

Rick Stewart: The positive data on COPD patients highlights the expansive scope of opportunities for cytisinicline in terms of the range of comorbidities that could potentially benefit from treatment, and broad range of healthcare providers who would be interested in its benefits. Our commercial team has moved forward decisively towards building a scalable, data-driven commercial model that will position us to launch successfully. Our model is built to address the rapidly evolving healthcare environment, where approximately 75% of primary care physicians will no longer meet with medical reps. Achieve's omni-channel digital platform provides precision targeting of physicians and patients, which will allow us to identify high-volume prescribers and the patients motivated to quit, deploying resources efficiently and maximizing impact per dollar spent. AI is a critical enabler in this evolution.

Speaker #3: The positive data on COPD patients highlights the expansive scope of opportunities for psychosis decline in terms of the range of comorbidities that could potentially benefit from treatment, and the broad range of healthcare providers who would be interested in its benefits.

Speaker #3: However, there is no FDA-approved treatment for e-cigarette cessation. Patients are frustrated. Physicians are frustrated. The narrative around nicotine dependence needs to change. We've seen this transformation happen with obesity.

Speaker #3: Our commercial team has moved forward decisively towards building a scalable, data-driven commercial model that will position us to launch successfully. Our model is built to address the rapidly evolving healthcare environment, where approximately 75% of primary care physicians will no longer meet with medical reps.

Speaker #3: When GLP-1s emerged, they helped society recognize obesity for what it truly is: a medical condition, not a personal failure. Nicotine dependence deserves the same recognition.

Speaker #3: It's a neurobiological condition rooted in how nicotine alters brain chemistry and creates physical dependence. It's a medical condition and it demands medical treatment. That's why we launched our willpower awareness campaign in January.

Speaker #3: Achieves omnichannel digital platform . Provides precision targeting of physicians and patients , which will allow us to identify high volume prescribers and the patient's motivated to quit deploying resources efficiently and maximizing impact per dollar spent AI is a critical enabler in this evolution .

Speaker #3: This is the beginning of us reframing the conversation to help people understand that quitting takes more than willpower alone and that effective treatment exists.

Richard Stewart: We'll be using advanced analytics and machine learning to enhance decision-making, automate custom engagement, and generate predictive insights about which messages will resonate most with target audiences, positioning us to continue building an efficient commercial organization that punches well above its weight. We also just announced that we have selected Adare Pharma Solutions, a US-based manufacturing organization that will produce cytisinicline drug product as we prepare for potential commercial launch and future demand. We believe this partnership will secure our supply chain, reduce risks associated with international pharmaceutical importation, and may lower overall costs, including the risk and uncertainty for tariffs on international imports of drug product. I'm pleased to report that work has commenced and our technology transfer to Adare is already underway. The Adare partnership provides redundancy in our supply chain, allowing contingency capacity in the US.

Rick Stewart: We'll be using advanced analytics and machine learning to enhance decision-making, automate custom engagement, and generate predictive insights about which messages will resonate most with target audiences, positioning us to continue building an efficient commercial organization that punches well above its weight. We also just announced that we have selected Adare Pharma Solutions, a US-based manufacturing organization that will produce cytisinicline drug product as we prepare for potential commercial launch and future demand. We believe this partnership will secure our supply chain, reduce risks associated with international pharmaceutical importation, and may lower overall costs, including the risk and uncertainty for tariffs on international imports of drug product. I'm pleased to report that work has commenced and our technology transfer to Adare is already underway. The Adare partnership provides redundancy in our supply chain, allowing contingency capacity in the US.

Speaker #3: The bottom line is that ACHIEVE is not quitting on people who smoke. The parallels between obesity and nicotine dependence are not lost on many investors.

Speaker #3: We'll be using advanced analytics and machine learning to enhance decision making, automate customer engagement, and generate predictive insights about which messages will resonate most with target audiences, positioning us to continue building an efficient commercial organization.

Speaker #3: Unmet medical needs, same physician call points, same cost to society. In summary, our science is strong. We're advancing through the regulatory review process with the FDA working constructively towards approval.

Speaker #3: That punches well above its weight. We also just announced that we have selected Dairy Farmer Solutions, a US-based manufacturing organization that will produce Cytisinicline drug product.

Speaker #3: Our commercial infrastructure is taking shape with real progress in 2025 and we're actively building for launch. With that, let me turn it over to Dr. Mark Rubinstein who will detail our regulatory progress and the data that continue to reinforce cytosynthesin across patient populations.

Speaker #3: As we prepare for potential commercial launch and future demand, we believe this partnership will secure our supply chain and reduce risks associated with international pharmaceutical importation.

Speaker #3: And may lower overall costs , including the risk and uncertainty for tariffs on international imports of drug product I'm pleased to report that work has commenced and our technology transfer to Adair is already underway The Adair partnership provides redundancy in our supply chain , allowing contingency capacity in the US .

Speaker #1: Thank you, Rick, and good morning, everyone. We have made tremendous progress in 2025 for cytosynthesin from a clinical and regulatory standpoint. Since our last earnings call, we've continued to validate cytosynthesin's clinical profile through peer-reviewed publications and scientific conference presentations.

Richard Stewart: The manufacturer named in the cytisinicline NDA recently had an FDA good manufacturing practices inspection with 2 observations related to solid oral dose manufacture, which are being addressed through an ongoing communication of its remedial action plan with the FDA. By establishing US manufacturing with Adare, we increase confidence in our supply chain security as we advance towards a planned commercial launch of cytisinicline expected in the H1 2027. We remain focused on bringing cytisinicline to patients as quickly as possible, and our decision to work with Adare positions us to launch with the manufacturing reliability and the operational readiness our patients and stakeholders expect. Now let me take a moment to remind you why our team is so passionate about bringing cytisinicline to market. Recent data issued by CDC estimated that in 2024, approximately 25 million adults in the United States smoked cigarettes.

Rick Stewart: The manufacturer named in the cytisinicline NDA recently had an FDA good manufacturing practices inspection with 2 observations related to solid oral dose manufacture, which are being addressed through an ongoing communication of its remedial action plan with the FDA. By establishing US manufacturing with Adare, we increase confidence in our supply chain security as we advance towards a planned commercial launch of cytisinicline expected in the H1 2027. We remain focused on bringing cytisinicline to patients as quickly as possible, and our decision to work with Adare positions us to launch with the manufacturing reliability and the operational readiness our patients and stakeholders expect. Now let me take a moment to remind you why our team is so passionate about bringing cytisinicline to market. Recent data issued by CDC estimated that in 2024, approximately 25 million adults in the United States smoked cigarettes.

Speaker #1: We were pleased to present findings from a pooled analysis of over 1,600 participants from our Phase III trials at the Society for Research on Nicotine and Tobacco or SRNT conference a few weeks ago.

Speaker #3: The manufacturer , named in the NDA recently had an FDA good manufacturing practices inspection , with two observations related to solid oral dose manufacture , which are being addressed through an ongoing communication of its remedial action plan with the FDA By establishing US manufacturing with Adair , we increase confidence in our supply chain security as we advance towards a planned commercial launch of Cytisinicline , expected in the first half of 2027 .

Speaker #1: This analysis examined cytosynthesin's efficacy across participants with different prior treatment histories and quit attempt patterns. Regardless of whether the participants had previously tried varenicline, bupropion, or nicotine replacement therapy, or whether they had made four or fewer quit attempts versus many more, we saw consistent efficacy.

Speaker #3: We remain focused on bringing Cytisinicline to patients as quickly as possible, and our decision to work with Adair positions us to launch with manufacturing reliability and operational readiness.

Speaker #1: These data show that if approved, cytosynthesin will offer a new quit option for patients including those for whom medications have failed. This consistent efficacy across patient subgroups shows that past setbacks should not discourage people from trying again.

Speaker #3: Our patients and stakeholders expect— Now, let me take a moment to remind you why our team is so passionate about bringing Cytisinicline to market. Recent data issued by the CDC estimated that in 2024, approximately 25 million adults in the United States smoked cigarettes.

Speaker #1: For millions of people who have tried and failed, cytosynthesin offers real hope. We also presented late-breaking survey data from our year-long ORCA OL study that demonstrated voluntary self-reported patient experiences with extended cytosynthesin use up to 52 weeks.

Richard Stewart: It's estimated that more than 15 million attempt to quit every year. Smoking remains the leading cause of preventable death in the US, claiming approximately 500,000 lives annually and costing over $600 billion each year in healthcare costs and lost productivity. The comorbidities are devastating. To name a few, respiratory disease, cardiovascular disease, metabolic disease, and cancer. We also know that 60% of the nearly 18 million adult e-cigarette users in the US want to quit, and adult nicotine e-cigarette use is on the rise. However, there is no FDA-approved treatment for e-cigarette cessation. Patients are frustrated. Physicians are frustrated. The narrative around nicotine dependence needs to change. We've seen this transformation happen with obesity. When GLP-1s emerged, they helped society recognize obesity for what it truly is, a medical condition, not a personal failure. Nicotine dependence deserves the same recognition.

Rick Stewart: It's estimated that more than 15 million attempt to quit every year. Smoking remains the leading cause of preventable death in the US, claiming approximately 500,000 lives annually and costing over $600 billion each year in healthcare costs and lost productivity. The comorbidities are devastating. To name a few, respiratory disease, cardiovascular disease, metabolic disease, and cancer. We also know that 60% of the nearly 18 million adult e-cigarette users in the US want to quit, and adult nicotine e-cigarette use is on the rise. However, there is no FDA-approved treatment for e-cigarette cessation. Patients are frustrated. Physicians are frustrated. The narrative around nicotine dependence needs to change. We've seen this transformation happen with obesity. When GLP-1s emerged, they helped society recognize obesity for what it truly is, a medical condition, not a personal failure. Nicotine dependence deserves the same recognition.

Speaker #3: It's estimated that more than 15 million attempt to quit every year. Smoking remains the leading cause of preventable death in the U.S., claiming approximately 500,000 lives annually and costing over $600 billion each year in healthcare costs and lost productivity.

Speaker #1: This survey of data from people who chose to continue treatment beyond the 6 or 12-week standard courses offers insight into long-term tolerability and impact.

Speaker #3: The comorbidities are devastating , to name a few . Respiratory disease , cardiovascular disease , metabolic disease , and cancer We also know that 60% of the nearly 18 million adult e-cigarette users in the US want to quit , and adult nicotine e-cigarette use is on the rise However , there is no FDA approved treatment for e-cigarette cessation .

Speaker #1: Patient experiences hugely important for those trying to quit smoking and is encouraging to see trial participants describing meaningful benefits including successful quitting and improvements in physical health.

Speaker #1: We have also been accepted to present research at the 2026 American Thoracic Society conference in May and look forward to updating you in the coming months.

Speaker #3: Patients are frustrated . Physicians are frustrated . The narrative around nicotine dependence needs to change We've seen this transformation happen with obesity . When GLP one emerged , they helped society recognize obesity for what it truly is a medical condition , not a personal failure Nicotine dependence deserves the same recognition .

Speaker #1: On the e-cigarette front, we received the FDA Commissioner's National Priority Voucher for cytosynthesin in e-cigarette or vaping cessation. A significant recognition of the public health urgency.

Speaker #1: The CMPV is designed to provide enhanced FDA communications and an expedited NDA review timeline to one to two months compared to a typical 10 to 12 months.

Richard Stewart: It's a neurobiological condition rooted in how nicotine alters brain chemistry and creates physical dependence. It's a medical condition, and it demands medical treatment. That's why we launched our willpower awareness campaign in January. This is the beginning of us reframing the conversation to help people understand that quitting takes more than willpower alone and that effective treatment exists. The bottom line is that Achieve is not quitting on people who smoke. The parallels between obesity and nicotine dependence are not lost on many investors. Unmet medical needs, same physician call points, same cost to society. In summary, our science is strong. We're advancing through the regulatory review process with the FDA, working constructively towards approval. Our commercial infrastructure is taking shape with real progress in 2025, and we're actively building for launch. With that, let me turn it over to Dr.

Rick Stewart: It's a neurobiological condition rooted in how nicotine alters brain chemistry and creates physical dependence. It's a medical condition, and it demands medical treatment. That's why we launched our willpower awareness campaign in January. This is the beginning of us reframing the conversation to help people understand that quitting takes more than willpower alone and that effective treatment exists. The bottom line is that Achieve is not quitting on people who smoke. The parallels between obesity and nicotine dependence are not lost on many investors. Unmet medical needs, same physician call points, same cost to society. In summary, our science is strong. We're advancing through the regulatory review process with the FDA, working constructively towards approval. Our commercial infrastructure is taking shape with real progress in 2025, and we're actively building for launch. With that, let me turn it over to Dr.

Speaker #3: It's a neurobiological condition rooted in how nicotine alters brain chemistry and creates physical dependence It's a medical condition , and it demands medical treatment That's why we launched our willpower Awareness campaign in January .

Speaker #1: We are now laying the groundwork for our ORCA V2 Phase III trial for vaping cessation including selecting trial sites and identifying principal investigators. In summary, 2025 has strengthened our clinical and regulatory positions significantly.

Speaker #3: This is the beginning of us reframing the conversation to help people understand that quitting takes more than willpower alone, and effective treatment exists.

Speaker #3: The bottom line is that Achieve is not quitting on people who smoke. The parallels between obesity and nicotine dependence are not lost on many investors. Unmet medical needs.

Speaker #1: We're advancing through the FDA's review process with an active dialogue with the agency. We remain confident that cytosynthesin has the potential to deliver the first FDA-approved treatment for nicotine dependence in two decades.

Speaker #3: Same physician call points . Same cost to society . In summary , our science is strong . We're advancing through the regulatory review process with the FDA working constructively towards approval .

Speaker #1: With that, let me turn it over to Jaime.

Speaker #2: Thank you, Mark. When I look back at where we started at the beginning of 2025 and where we stand today, I'm struck by the incredible progress our commercial team has made in just over a year.

Speaker #3: Our commercial infrastructure is taking shape with real progress in 2025, and we're actively building for launch. With that, let me turn it over to Dr. Mark Rubinstein, who will detail our regulatory progress and the data that continue to reinforce Cytisinicline across patient populations.

Speaker #2: We've built the foundation for a launch-ready infrastructure from the ground up while remaining lean and right-sized for our current stage requirements. We've established partnerships, deployed advanced analytics, created an AI-powered asset factory, and are positioning ourselves to execute at scale.

Richard Stewart: Mark Rubinstein, who will detail our regulatory progress and the data that continue to reinforce cytisinicline across patient populations.

Rick Stewart: Mark Rubinstein, who will detail our regulatory progress and the data that continue to reinforce cytisinicline across patient populations.

Mark Rubinstein: Thank you, Rick, and good morning, everyone. We have made tremendous progress in 2025 for cytisinicline from a clinical and regulatory standpoint. Since our last earnings call, we've continued to validate cytisinicline's clinical profile through peer-reviewed publications and scientific conference presentations. We were pleased to present findings from a pooled analysis of over 1,600 participants from our phase 3 trials at the Society for Research on Nicotine & Tobacco, or SRNT conference a few weeks ago. This analysis examined cytisinicline's efficacy across participants with different prior treatment histories and quit attempt patterns. Regardless of whether the participants had previously tried varenicline, bupropion, or nicotine replacement therapy, or whether they had made 4 or fewer quit attempts versus many more, we saw consistent efficacy. These data show that if approved, cytisinicline will offer a new quit option for patients, including those for whom medications have failed.

Speaker #2: I'm deeply grateful to the entire team who have been instrumental in bringing this vision to life. As a reminder, our commercial execution rests on three critical priorities: availability, or ensuring supply chain readiness so that cytosynthesin can reach the patients who need it; access to secure coverage and affordability; and awareness, which is educating the right patients and healthcare professionals at the right time about this transformative new option.

Speaker #4: Thank you , Rick , and good morning , everyone . We have made tremendous progress in 2025 for Cytisinicline from a clinical and regulatory standpoint Since our last earnings call , we've continued to validate Cytisinicline clinical profile through peer reviewed publications and scientific conference presentations .

Speaker #4: We were pleased to present findings from a pooled analysis of over 1,600 participants from our phase three trials at the Society for Research on Nicotine and Tobacco, or SRNT, conference.

Speaker #2: Every initiative is data-driven and every decision is tied to measurable impact with the goal of making cytosynthesin accessible to the millions of Americans struggling with nicotine dependence.

Speaker #4: A few weeks ago This analysis examines Cytisinicline efficacy across participants with different prior treatment histories and quit attempt patterns . Regardless of whether the participants had previously tried varenicline , bupropion , or nicotine replacement therapy , or whether they had made four or fewer quit attempts , versus many more .

Speaker #2: Now I'll provide updates on each of our three priorities. First, let's look at availability. Implementation with our third-party logistics provider is well underway. We are on track with our state licensing and have secured more than half of the required licenses to date.

Speaker #2: Additionally, we have now completed the administrative and logistical setup with our specialty pharmacy hub partner. We believe these foundational steps will be critical to ensure patients can obtain cytosynthesin and that prescriptions written are prescriptions filled.

Speaker #4: We saw consistent efficacy. These data show that if approved, cytisinicline will offer a new quit option for patients, including those for whom medications have failed. This consistent efficacy across patient subgroups shows that past setbacks should not discourage people from trying again.

Speaker #2: On the access front, our focus remains on securing rapid, broad, and affordable coverage for cytosynthesin. In Q1, we continued discussions with prioritized payers to share our clinical data.

Mark Rubinstein: This consistent efficacy across patient subgroups shows that past setbacks should not discourage people from trying again. For millions of people who have tried and failed, cytisinicline offers real hope. We also presented late-breaking survey data from our year-long ORCA-OL study that demonstrated voluntary self-reported patient experiences with extended cytisinicline use up to 52 weeks. This survey of data from people who chose to continue treatment beyond the 6 or 12-week standard courses offers insight into long-term tolerability and impact. Patient experience is hugely important for those trying to quit smoking, and is encouraging to see trial participants describing meaningful benefits, including successful quitting and improved.

Speaker #2: Feedback from these ongoing discussions will be critical in finalizing our pricing, access, and contracting strategy as we move closer to launch. On awareness, our focus is establishing achieved reputation as a trusted science-driven partner and shifting how patients and providers think about nicotine dependence.

Speaker #4: For millions of people who have tried and failed . Cytisinicline offers real hope . We also presented late breaking survey data from our year long orca Ol study that demonstrated voluntary , self-reported patient experiences with extended cytisinicline use up to 52 weeks .

Speaker #2: As Rick mentioned, we launched our willpower campaign, which directly challenges the outdated narrative that quitting smoking is simply a matter of personal determination. The campaign features visuals that reimagine vintage cigarette advertising, but instead of selling cigarettes, they're selling willpower as a miracle product.

Speaker #4: This survey of data from people who chose to continue treatment beyond the 6- or 12-week standard courses offers insight into long-term tolerability and the impact of patient experiences.

Speaker #2: It is deliberately provocative because the message is clear: willpower alone is not enough. We will continue to strategically deploy this campaign throughout 2026 to drive ongoing conversation and awareness around nicotine dependence as a medical condition requiring a medical solution.

Speaker #4: This is hugely important for those trying to quit smoking, and it is encouraging to see trial participants describing meaningful benefits, including successful quitting and improvements in physical health. We have also been accepted to present research at the 2026 American Thoracic Society Conference in May, and look forward to updating you in the coming months.

Speaker #2: Beyond this, we are leveraging technology and AI tools to generate rapid, evidence-based, and regulatory-compliant content that will fuel our launch. To use a bit less marketing jargon, this means we were able to build things faster using fewer resources.

Speaker #4: On the e-cigarette front . We received the FDA Commissioner's national Priority Voucher for Cytisinicline in e-cigarette or vaping cessation , a significant recognition of the public health urgency .

Speaker #2: Through our partnership with Omnicom, we developed a marketing engine designed to shave weeks off the development, review, and approval of brand messaging, promotional, and educational materials.

Speaker #4: The PV is designed to provide enhanced FDA communications and an expedited NDA review timeline to 1 to 2 months, compared to a typical 10 to 12 months.

Speaker #2: This is just one example of how modern tech and data are improving our ways of working at ACHIEVE. We've also established our unified data ecosystem and our custom-built marketing technology foundation to support hyper-targeted, personalized customer engagement and measurement.

Speaker #4: We are now laying the groundwork for our orca V2 phase three trial for vaping cessation , including selecting trial sites and identifying principal investigators .

Speaker #2: Finally, we've completed detailed customer segmentation to better understand how to reach and meet the needs of our future patients and prescribers. As we look ahead, we are building plans for optimizing sales deployment and non-personal promotion to key audiences at launch and beyond.

Speaker #4: In summary , 2025 has strengthened our clinical and regulatory position significantly With advancing through the FDA's review process with an active dialogue with the agency .

Speaker #2: We will look to deploy the willpower campaign in select audiences, complete our data and performance measurement capabilities, and finalize media channels and plans. We are confident in our ability to execute and scale effectively and deliver long-term value for patients, providers, and shareholders.

Speaker #4: We remain confident that cytisinicline has the potential to deliver the first FDA-approved treatment for nicotine dependence in two decades. With that, let me turn it over to Jaime.

Speaker #2: I'll now turn it over to Mark Oki for financial updates.

Speaker #5: Thank you . Mark . When I look back at where we started at the beginning of 2025 and where we stand today , I'm struck by the incredible progress our commercial team has made in just over a year .

Speaker #3: Thank you, Jaime. Let me walk through our financial position and results. As of December 31, 2025, cash, cash equivalents, and marketable securities totaled $36.4 million.

Speaker #5: We've built the foundation for a launch ready infrastructure from the ground up while remaining lean and right sized for our current stage requirements .

Speaker #3: Total operating expenses for the three and 12 months ended December 31, 2025, were $14.7 million and $54.9 million respectively. Reflecting our ongoing investment in regulatory, clinical, pre-commercial, and commercial infrastructure activities.

Speaker #5: We've established partnerships , deployed advanced analytics , created an AI powered asset factory , and are positioning ourselves to execute at scale . I'm deeply grateful to the entire team who have been instrumental in bringing this vision to life .

Speaker #3: Our total net loss for the three and 12 months ended December 31, 2025, was $14.7 million and $54.7 million respectively. As always, we continue to evaluate financing options and cash management strategies and we will provide updates if and when appropriate.

Speaker #5: As a reminder , our commercial execution rests on three critical priorities availability or ensuring supply chain readiness so that Cytisinicline can reach the patients who need it .

Speaker #5: Access to secure coverage and affordability, and awareness, which is educating the right patients and healthcare professionals at the right time about this transformative new option. Every initiative is data-driven, and every decision is tied to measurable impact, with the goal of making Cytisinicline accessible to the millions of Americans struggling with nicotine dependence. Now, I'll provide updates on each of our three priorities.

Speaker #3: I'll turn it back to Rick for closing remarks.

Speaker #4: Thank you, Mark. In closing, I'm pleased with our regulatory, clinical, and go-to-market efforts. Which underscores the momentum behind ACHIEVE LIFE SCIENCES and our unwavering commitment to addressing the critical unmet needs of nicotine dependence.

Speaker #4: As we look ahead, I want to highlight three critical value drivers for our company. First, receiving NDA approval and successfully launching cytosynthesin for smoking cessation.

Speaker #5: First , let's look at availability implementation with our third party logistics provider is well underway . We are on track with our state licensing and have secured more than half of the required licenses to date .

Speaker #4: This is our near-term priority and the team is executing with discipline and purpose. Discipline is important to ensure there is a controlled and successful launch.

Speaker #5: Additionally , we have now completed the administrative and logistical setup with our specialty pharmacy hub partner . We believe these foundational steps will be critical to ensure patients can obtain cytisinicline , and that prescriptions written are prescriptions filled On the access front , our focus remains on securing rapid , broad and affordable coverage for Cytisinicline in Q1 , we continued discussions with prioritized payers to share our clinical data .

Speaker #4: Second, the growing recognition of the significant opportunity represented by our vaping indication. With a commissioner's national priority voucher and the urgent public health need around e-cigarette cessation, we have the opportunity to be first to market with a treatment for an indication where no approved options currently exist.

Speaker #5: Feedback from these ongoing discussions will be critical in finalizing our pricing . Access and contracting strategy as we move closer to launch On awareness , our focus is establishing a reputation as a trusted , science driven partner and shifting how patients and providers think about nicotine dependence .

Speaker #4: Finally, both of these are underpinned by our digital commercial platform. The AI-powered data-driven infrastructure we built that positions us to launch efficiently and scale rapidly with precision targeting and measurable impact.

Speaker #5: As Rick mentioned, we launched our Willpower Campaign, which directly challenges the outdated narrative that quitting smoking is simply a matter of personal determination.

Speaker #4: To the millions of Americans who are ready to break free from nicotine dependence, ACHIEVE LIFE SCIENCES is not quitting on you. We are dedicated to this urgent need.

Speaker #5: The campaign features visuals that reimagine vintage cigarette advertising, but instead of selling cigarettes, they're selling willpower as a miracle product. It is deliberately provocative because the message is clear.

Speaker #4: The standard of care in smoking cessation has not evolved in two decades and we're about to change that. I'm grateful to our patients, clinical investigators, regulatory partners, investors, and our incredible ACHIEVE team for their unwavering dedication to this mission.

Speaker #5: Willpower alone is not enough . We will continue to strategically deploy this campaign throughout 2026 to drive ongoing conversation and awareness around nicotine dependence as a medical condition requiring a medical solution Beyond this , we are leveraging technology and AI tools to generate rapid , evidence based and regulatory compliant content that will fuel our launch .

Speaker #4: Together, we're building something meaningful. We're not quitting on you. We will not quit until we deliver a treatment that changes the standard of care for nicotine dependence and helps people live free of nicotine.

Speaker #5: To use a bit less marketing jargon , this means we are able to build things faster using fewer resources . Through our partnership with Omnicom , we developed a marketing engine designed to shave weeks off the development review and approval of brand messaging , promotional and educational materials .

Speaker #4: Lastly, we're limited in what we can say about our interactions with the FDA, while the NDA is under review. And as I said earlier, the communications are normal for this stage of the review process.

Speaker #5: This is just one example of how modern tech and data are improving our ways of working at achieve . We've also established our unified data ecosystem and our custom built marketing technology Foundation to support hyper targeted , personalized customer engagement and measurement .

Speaker #4: I look forward to updating you on our progress. Thank you for your time, attention, and continued confidence in ACHIEVE LIFE SCIENCES. Thank you. We'll now be conducting a question-and-answer session.

Speaker #4: If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker #5: Finally , we've completed detailed customer segmentation to better understand how to reach and meet the needs of our future patients and prescribers . As we look ahead , we are building plans for optimizing sales , deployment , and non-personal promotion to key audiences at launch and beyond .

Speaker #4: You may press star two if you'd like to remove your question from the queue. For participants choosing speaker equipment, it may be necessary to pick up your handset before pressing star one.

Speaker #5: We will look to deploy the campaign and select audiences , complete our data and performance measurement capabilities , and finalize media channels and plans .

Speaker #4: One moment, please, while we pull for questions. Our first question is coming from Thomas Flaten from Lakestreet. Your line is now live.

Speaker #5: We are confident in our ability to execute and scale effectively and deliver long term value for patients , providers , and shareholders . I'll now turn it over to Mark Oki for financial updates .

Speaker #5: Hey, good morning. I appreciate you guys taking the questions. Perhaps for Jaime, the launch timing for the first half of '27, can you talk a little bit about the critical path between a late June NDA approval and a first-half launch?

Speaker #6: Thank you Jamie . Let me walk through our financial position and results . As of December 31st , 2025 . Cash , cash equivalents and marketable securities totaled $36.4 million .

Speaker #5: Is this primarily scale-up on the commercial side? Is it potentially product supply? Can you just talk a little bit about that gap that's created there?

Speaker #6: Sure. Thanks for the question, Thomas. So obviously, we need drugs in order to be able to go to market, and so that is our first consideration: when can we get drugs into the supply chain to get it out?

Speaker #6: Total operating expenses for the three and 12 months ended December 31st , 2025 were $14.7 million and $54.9 million , respectively . Reflecting our ongoing investment in regulatory , clinical , pre-commercial and commercial infrastructure activities , our total net loss for the three and 12 months ended December 31st , 2025 was $14.7 million and $54.7 million , respectively .

Speaker #6: Into the hands of patients. So everything that we need to do on the trade and distribution side will be ready to go as soon as we have drugs.

Speaker #6: So we have our three PLs set up, as I mentioned during the call: serialization, our specialty pharmacy vendor. All of those requirements for copay and access, all of those will be aligned and ready to go at launch.

Speaker #6: As always, we continue to evaluate financing options and cash management strategies, and we will provide updates if and when appropriate. I'll turn it back to Rick for closing remarks.

Speaker #6: The rest of the time that we'll be spending over the next six months with a little bit of or the additional six months gives us an opportunity to get some additional data into the marketplace, into the scientific community.

Speaker #3: Thank you , Mark . In closing , I'm pleased with our regulatory clinical and go to market efforts , which underscores the momentum behind Achieve Life and our unwavering commitment to addressing the critical unmet needs of nicotine dependence .

Speaker #6: And also work on work towards additional partnerships with advocacy and potentially policymakers. So it does afford us a bit more time to get a few other operational things activated as well.

Speaker #3: As we look ahead, I want to highlight three critical value drivers for our company. First, receiving NDA approval. And second, successfully launching Cytisinicline for smoking cessation. This is our near-term priority, and the team is executing with discipline and purpose.

Speaker #5: That's great. And then speaking of drugs oh, yeah. Sorry, Rick. Go ahead.

Speaker #4: Yes. If I can add to that, if you look at it from a strategic standpoint, given the scale of the market that we're actually addressing, we took a decision that we need to make sure that we have got all of the processes in place to maximize or optimize the product launch.

Speaker #3: Discipline is important to ensure there is a controlled and successful launch. Second, the growing recognition of the significant opportunity represented by our vaping indication with Commissioner's national priority voucher, and the urgent public health need around e-cigarette cessation.

Speaker #4: So I think Jaime and the team are doing a terrific job on that front. Craig and the manufacturing side are doing an excellent job.

Speaker #4: So I think taking time to get it right is critically important. For a success of the launch.

Speaker #3: We have the opportunity to be first to market with a treatment for an indication where no approved options currently exist. Finally, both of these are underpinned by our digital commercial platform.

Speaker #5: Got it. Understood. And then with respect to manufacturing, you did mention the observations during the GMP inspection. Did you imply maybe perhaps I'm reading too

Speaker #3: The AI powered , data driven infrastructure we built that positions us to launch efficiently and scale rapidly with precision targeting and measurable impact to the millions of Americans who are ready to break free from nicotine dependence Achieve life sciences is not quitting on you .

Speaker #1: Into it that that the manufacturer in the NDA will not be supplying commercial product . Rather , Adair will . And then what implications does that have for folding Adair into the process now ?

Speaker #1: During the NDA review

Speaker #2: Yeah , I think the critical part of this is that the due date remains the 25th of June . Yeah . Of this year .

Speaker #3: We are dedicated to this urgent need. The standard of care in smoking cessation has not evolved in two decades, and we're about to change that.

Speaker #2: Yeah . That is what the FDA has set . And that's what we're working to . But of course , you know , any time that there is , you know , any observations , we'd already made the decision to transfer manufacturing to the US .

Speaker #3: I'm grateful to our patient's clinical investigators , regulatory partners , investors , and our incredible achieved team for their unwavering dedication to this mission Together , we're building something meaningful .

Speaker #2: You know , given the geopolitical situation . So , you know , we basically just accelerated that . So at the moment , the date remains exactly the same I think , you know , given the scale of this opportunity , it's prudent to ensure that we have contingency supply .

Speaker #3: We're not quitting on you . We will not quit until we deliver a treatment that changes the standard of care for nicotine dependence and helps people live free of nicotine Lastly , we're limited in what we can say about our interactions with the FDA While the NDA is under review and as I said earlier , the commission , the communications are normal for this stage of the review process .

Speaker #2: It's prudent to ensure that we've got , you know , onshore manufacturers here in the US

Speaker #1: Understood . Thanks for taking the questions .

Speaker #3: Thank you . Our next question today is coming from Jason Butler from citizens Bank . Your line is now live

Speaker #3: I look forward to updating you on our progress. Thank you for your time, attention, and continued confidence in Achieve Life Sciences, Inc.

Speaker #4: Hi . Thanks for taking the questions and congrats on all the progress in 2025 . Two from me . Can you just talk a little bit more about where you believe awareness currently is with healthcare providers ?

Speaker #1: Thank you . We'll now be conducting a question and answer session . If you'd like to be placed into question , queue , please press star one on your telephone keypad A confirmation tone will indicate your line is in the question queue .

Speaker #4: And what additional work you'll be doing in 2026 to continue to build awareness of , of . The data . And then second , is there anything you can say about FDA dialogue on the vaping indication since you got the CMV Thanks

Speaker #1: You may press star two if you'd like to remove your question from the queue . For participants using speaker equipment may be necessary to pick up your handset before pressing star one .

Speaker #1: One moment, please, while we poll for questions. Our first question is coming from Thomas Flaten from Lake Street. Your line is now live.

Speaker #2: Jamie , do you want to address the commercialization

Speaker #7: Hey . Good morning . I appreciate you guys taking the questions . Perhaps for Jamie , the launch timing for the first half of 27 .

Speaker #5: Sure . Thanks for the question . So regarding HCP awareness , I would say it's not been a priority to date to do broad spread awareness about the product .

Speaker #7: Can you talk a little bit about the critical path between a late June NDA approval and a first-half launch? Is this primarily scale-up on the commercial side?

Speaker #5: And a lot of that has to do with what you are allowed to say in a pre-approval environment . So obviously disease , state education is one channel that we can provide Information in a regulatory compliant way .

Speaker #7: Is it potentially product supply ? Can you just talk a little bit about that , that gap that's created there

Speaker #5: Sure . Thanks for the question , Thomas . Obviously , we need drugs in order to be able to go to market . And so that is our first consideration is when can we get drug into the supply chain to get it out into the hands of patients .

Speaker #5: But one of the decisions that we've made is that we understand that everyone knows that smoking is bad for you and that there's really not a huge need to go out and spread that message .

Speaker #5: So everything that we need to do on the trade and distribution side will be ready to go as soon as we have drugs.

Speaker #5: And so what we've been doing is conserving our resources so that when we get closer to launch , we can do a stronger push from an educational perspective , that is specific to data about the product .

Speaker #5: So we have our three PL set up mentioned during the call serialization , our specialty pharmacy vendor , all of those , all of those requirements for copay and access , all of those will be aligned and ready to go at launch .

Speaker #5: And when the product is going to be in the hands of physicians so that they can use it with their patients . So we're scaling it adequately based on the need to do disease awareness , education , or lack thereof in a smoking cessation indication .

Speaker #5: The rest of the time that we'll be spending over the next six months with the with a little bit of or the additional six months gives us an opportunity to get some additional data into the marketplace , and to the to the community and also work on work towards additional partnerships with advocacy and potentially potentially policy makers .

Speaker #5: I think as we get closer to launch , we will be ramping up more opportunities . And you're already seeing us do that around some of the conferences where we're where we will be presenting data and where we have .

Speaker #5: So ATS is a huge opportunity that Mark mentioned , where we're going to have some new data that we want to get out into the hands of , into the medical community and into the hands of physicians .

Speaker #5: So it does afford us a bit more time to get a few other operational things activated as well.

Speaker #5: So it's something that we are scaling up as we get closer to launch . But we've been very conservative in our efforts so far and how we spend money prior to them having the solution in their hands to give to their patients .

Speaker #7: That's great . And then speaking of . Oh , yeah . Sorry , go ahead

Speaker #3: If I can add to that , you know , if you look at it from a strategic standpoint , given the scale of the we're actually addressing , we took a decision that we need to make sure that we have got all of the processes in place to maximize or optimize the product launch .

Speaker #5: And then Rick or Mark , I'll turn it back over to discuss FDA dialogue on vaping

Speaker #2: Tomorrow .

Speaker #6: Oh , sure . So right now to date are discussions with FDA around vaping have largely been around approval for the protocol itself .

Speaker #3: So I think Jamie and the team are doing a terrific job on that front. Craig and the manufacturing side are doing an excellent job.

Speaker #6: And we hope to continue engagement as the study progresses

Speaker #3: So, I think taking time to get it right is critically important for the success of the launch.

Speaker #2: I think if I can answer that , we're already in site selection . So yeah , he's progressing at a pace . So I think the key is that we're anticipating a commencement , you know , in the first half of this year .

Speaker #7: Got it . Understood . And then with respect to manufacturing , you did mention the observations during the GMP inspection . And did you imply maybe perhaps I'm reading too much into it that that the manufacturer in the NDA will not be supplying commercial product , rather , Adair will .

Speaker #2: So yeah , it's moving along at a pace . And I noted also the the public forum that the FDA is putting together is in the 20th .

Speaker #7: And then, what implications does that have for folding Adair into the process now, during the NDA review?

Speaker #2: I think it's the 14th of June coming up . So I think there's some debate around the validity of the CMB . TPV , but for us , you know , we think that the opportunity is huge as being the first in market for a vaping cessation product .

Speaker #3: Yeah, I think the critical part of this is that the Purdue for date remains the 20th of June of this year. You know, that is what the FDA has set.

Speaker #3: And that's what we're working to . But of course , you know , any time that there is , you know , any observations we'd already made the decision to transfer manufacturing to the US .

Speaker #2: And that's clearly an underserved market as there are no treatments there . But so I think that's going to be a real area of focus and interest

Speaker #3: You know , given the geopolitical situation . So , you know , we basically just accelerated that . So at the moment , the date remains exactly the same .

Speaker #4: Great .

Speaker #7: Thank you

Speaker #3: Thank you . As a reminder that's star one to be placed into question . Q . Our next question is coming from Brandon Folkes from H.C.

Speaker #3: And I think , you know , given the scale of this opportunity , it's prudent to ensure that we have contingency supply It's prudent to ensure that we've got , you know , onshore manufacturers here in the US

Speaker #3: Wainwright . Your line is now live

Speaker #8: Hi . Thanks for taking my questions and congrats on all the progress So just coming back to the manufacturing , you know , does your US commercial launch timeline of one H 2027 does that assume a June 2026 approval or potential later approval ?

Speaker #7: Understood. Thanks for taking the questions.

Speaker #1: Thank you. Our next question today is coming from Jason Butler from Citizens Bank. Your line is now live.

Speaker #8: Hi . Thanks for taking the questions . And congrats on all the progress in 2025 . Two from me . Can you just talk a little bit more about where you believe awareness currently is with healthcare providers and what what additional work you'll be doing in 2026 to continue to build awareness of , of sort of , and , and the data .

Speaker #8: You know , what level of flexibility should we think about in terms of when one H 27 you may launch ? Anything to read into in that broad timeline .

Speaker #8: And then maybe on a similar vein , sort of , you know , are you looking to add Adair to the NDA before the June approval ?

Speaker #8: Or is this potentially something to qualify them ? Post approval

Speaker #8: And then second , is there anything you can say about FDA dialogue on the vaping Indication since you got the CMPD ? Thanks

Speaker #2: I'll take the answer in reverse order . Yeah , it's going to be post the June approval . I think the key now is to focus in on on the approval and also to ensure that we put a stake in the ground , frankly , in terms of the first half of 27 for the product launch , quite simply because of all of the , you know , the activities that need to go into it to ensure that we've got product to go into channel to make sure that all of the commercial operations have completed their activities .

Speaker #3: Jamie, do you want to address the commercialization?

Speaker #5: Sure. Thanks for the question. So, regarding HCP awareness, I would say it's not been a priority to date to do broad, spread awareness about the product.

Speaker #5: And a lot of that has to do with what you are allowed to say, in a pre-approval environment. So, obviously, disease state education is one channel that we can provide information.

Speaker #2: So I think there's nothing to read into it other than , you know , we got a couple of observations that our third party manufacturer is currently addressing with the FDA .

Speaker #5: In a regulatory-compliant way. But one of the decisions that we've made is that we understand that everyone knows that smoking is bad for you and that there's really not a huge need to go out and spread that message.

Speaker #2: I mean , there's a little bit of opacity around that , of course , because it's a discussion between the FDA and the manufacturer .

Speaker #5: And so what we've been doing is conserving our resources so that when we get closer to launch , we can do a stronger push from an educational perspective that is specific to data about the product .

Speaker #2: But as far as we're concerned , on the flip side , we're always in favor of transparency . So we'll keep you in the picture with respect to that .

Speaker #2: As things move along

Speaker #8: Thank you . That's very helpful . Maybe lastly from me , just sort of given the lead time between a potential June approval and a one 2027 launch , how should we think about insurance coverage at launch ?

Speaker #5: And you're already seeing us do that around some of the conferences where we're where we will be presenting data and where we have so ATS is a huge opportunity that Mark mentioned , where we're going to have some new data that we want to get out into the hands of , into the medical community and into the hands of physicians .

Speaker #8: You know , should we think about this similarly to normal launches ? Or could we have , you know , better than normal insurance coverage at launch ?

Speaker #5: So, we are scaling up as we get closer to launch. But we've been very conservative in our efforts so far and in how we spend money prior to them having the solution in their hands to give to their patients.

Speaker #8: You know , obviously , given the indication , but also given that lead time to have those discussions . Thank you .

Speaker #5: Thanks . I'll take that question , Rick . So regarding payers , yes , we have been out actively having conversations in the regulatory compliance pre-approval information exchange opportunities that we do have .

Speaker #5: And then, Rick or Mark, I'll turn it back over to you to discuss FDA dialogue on vaping.

Speaker #4: Oh , sure . So right now , to date , are discussions with FDA around vaping , have largely been around approval for the protocol itself And we hope to continue engagement as the study progresses

Speaker #5: So we've had about 40 touchpoints with payers in the first quarter . We've attended Pcma . We've actually had inbound from payers who want to have conversations with us .

Speaker #5: So we are obviously on the radar . They are very interested . They recognize the differentiated profile of Cytisinicline and the clear unmet need .

Speaker #5: Obviously , we know there's still 25 million people who smoke in this country who need treatments that will help them stop . So the ongoing conversations are very encouraging .

Speaker #3: I think if I can answer that , we're already in site selection , so yeah , it is progressing at a pace . So I think the key is that we're anticipating a commencement , you know , in the first half of this year .

Speaker #5: We also know that the Affordable Care Act requires coverage of smoking cessation treatments . So that certainly helps in our favor at launch .

Speaker #3: So yeah , it's moving along at a pace . And I , I noted also the the public forum that the FDA is putting together is in the 20th .

Speaker #5: And beyond And regarding timing , the actual clock really starts building for the demand when the drug is in channel . So we will have more time to have more conversations , but we won't start building demand .

Speaker #3: I think it's the 14th of June, coming up. So, I think there's some debate around the validity of the CMB TPV.

Speaker #5: So any initial restrictions to access , such as new to market blocks , those still will require a ramp period from time of drug being distributed .

Speaker #3: But for us , you know , we think that the opportunity is huge as being the first in market for a vaping cessation product .

Speaker #5: And in pans of patients to the timing of , you know , the bleed out that it takes in order to get on formulary for some of those plans .

Speaker #5: So we're still tracking a slow ramp for the initial six months of launch

Speaker #3: That's clearly an underserved market, as there are no treatments there. So I think that's going to be a real area of focus and interest.

Speaker #8: Thanks very much . Very helpful . And congrats again on all the progress

Speaker #8: Great . Thank you

Speaker #5: Thanks .

Speaker #7: Brenda

Speaker #3: Thank you . Our next question is coming from Justin Walsh from Jones training . Your line is now live

Speaker #1: Thank you. As a reminder, that star one is to be placed into question queue. Our next question is coming from Brandon Fowlkes from H.C.

Speaker #1: Hi . Thanks for taking the question .

Speaker #1: Wainwright, your line is now live.

Speaker #9: I'm wondering if you can provide additional color on the robustness of the raw plant material supply chain Our third party suppliers are able to meet expected demand if so , is unable to do so

Speaker #9: Hi . Thanks for taking my questions . And congrats on all the progress . Yeah . So just coming back to the manufacturing , you know , does your US commercial launch timeline of one H 2027 does that assume a June 2026 approval or potential later approval You know , what level of flexibility should we think about in terms of when 27 you may launch anything to read into in that broad timeline ?

Speaker #2: Excellent question Justin . Yeah . As I mentioned before , we have been stockpiling the starting material for some considerable time . And , you know , by the time we get to launch , we believe we'll have more than three years supply of starting material for the amounts required for , for in-market sales .

Speaker #9: And then maybe on a similar vein , sort of , you know , are you looking to add Adair to the NDA before the June approval ?

Speaker #2: So and we will continue to add to that stockpile . So we don't really see the , the inventory going much below three years for the foreseeable future .

Speaker #9: Or does this potentially qualify them? Post approval?

Speaker #3: I'll take the answer in order . Yeah , it's going to be post the June approval . I think the key now is to focus in on on the approval and also to ensure that we put a stake in the ground , frankly , in terms of the first half of 27 for the product launch , quite simply because of all of the , you know , the activities that need to go into it to ensure that we've got product to go into channel to make sure that all of the commercial operations have completed their activities .

Speaker #2: So we're , we've been buying in for quite a few years now . And the starting material has a , you know , a three year shelf life .

Speaker #2: But we've basically will reprocess it as we , as it's required to be used .

Speaker #9: Got it . Thanks . And one more for me . I'm wondering if you can comment on the innerclean dosing schedule and if there's any concern that a potential pill burden could limit real world compliance or commercial uptake .

Speaker #2: I'll have that . Doctor Mark Rubinstein 16 .

Speaker #6: Sure . That is a great question . We actually have found just after completing our orca Ol where people actually used the pill three times a day for up to a year , that not only did people not find it excessively burdensome , but our completion rate and the number of people who adhere to the protocol was incredibly high .

Speaker #3: So I think there's nothing to read into it other than, you know, we got a couple of observations that our third-party manufacturer is currently addressing with the FDA.

Speaker #3: I mean , there's a little bit of opacity around that , of course . It's a discussion between the FDA and the manufacturer , but as far as we're concerned .

Speaker #3: On the flip side , we're always in favor of transparency . So , you know , we'll keep you in the picture with respect to that as things move along

Speaker #6: A lot of participants reported that they felt that their highest cravings were around meal time , and so actually , even though you don't have to take cytisinicline with meals because it's tid , it's perfectly it can be perfectly timed around meals .

Speaker #9: Thank you . That's that's very helpful . Maybe lastly from me , just sort of given the lead time between a potential June approval and a one 2027 launch , how should we think about insurance coverage at launch ?

Speaker #9: You know , should we think about this similarly to normal launches ? Or could we have , you know , better than normal insurance coverage at launch ?

Speaker #6: And they found that it was reassuring to take something to address their cravings . Right around the time periods that they would have their highest cravings .

Speaker #9: You know, obviously, given the indication, but also given that lead time to have those discussions. Thank you.

Speaker #6: And again , our adherence rates in all of our trials and our ol trial , which was 52 weeks , was incredibly high , over 75% .

Speaker #5: Thanks . I'll take that question . Rick . So regarding payers , yes , we have been out actively having conversations in the regulatory compliant pre-approval information exchange opportunities that we do have .

Speaker #9: Great . Thanks for taking the questions

Speaker #3: Thank you . Next question is coming from John Vandermosten from Zach's . Your line is now live .

Speaker #5: So, we've had about 40 touchpoints with payers in the first quarter. We've attended PCMA. We've actually had inbounds from payers who want to have conversations with us.

Speaker #10: Thank you and good morning . And in December , there was an Icer report that came out that calculated some prices for Cytisinicline .

Speaker #5: So, we are obviously on the radar. They are very interested. They recognize the differentiated profile of Cytisinicline and the clear unmet need.

Speaker #10: And I was wondering if you'd seen that . And then wondering how that how that compares with your internal calculations and kind .

Speaker #5: Obviously, we know there's still 25 million people who smoke in this country who need treatments that will help them stop. So the ongoing conversations are very encouraging.

Speaker #7: Of

Speaker #10: What prices you're thinking about when that comes about next .

Speaker #7: Year

Speaker #2: Amy , thanks .

Speaker #5: Yeah , we have . Hi , John . Good morning . We've definitely seen the reports . How are you doing ? Thanks for thanks for the question .

Speaker #5: We also know that the Affordable Care Act requires coverage of smoking cessation treatments, so that certainly helps in our favor at launch and beyond. And regarding timing, the actual clock really starts building for the demand when the drug is in channel.

Speaker #5: Yeah , we have seen the Icer report . We were involved in the process providing information . When requested . That was appropriate for their consideration .

Speaker #5: So we will have more time to have more conversations , but we won't start building demand . So any initial restrictions to access , such as new to market blocks .

Speaker #5: I think , importantly , what it did highlight is that they have a firm there is a substantial unmet need despite currently available treatments , and that payers should make cytisinicline immediately available .

Speaker #5: Though, still will require a ramp period from time of drug being distributed and in hands of patients, to the timing of, you know, the bleed out that it takes in order to get on formulary for some of those plans.

Speaker #5: And as far as pricing goes , we're not going to comment on our pricing because we've obviously not set that yet , and we're not ready to have those conversations with payers on an exact price .

Speaker #5: So we're still tracking a slow ramp for the initial six months of launch.

Speaker #5: So we'll we'll leave it at that . But we were pleased with the recommendation that Icer .

Speaker #7: Made

Speaker #9: Thanks very much . Very helpful . And congrats again on all the progress .

Speaker #10: Okay . And then a few questions on , on manufacturing , I guess , I wanted to frame it first . Where does it stand with synthetic manufacturer of API and then I believe there are three different entities , perhaps that you're working with .

Speaker #5: Thanks , Brianna .

Speaker #1: Thank you. Our next question is coming from Justin Walsh from Jones Training. Your line is now live.

Speaker #7: Hi . Thanks for taking the question .

Speaker #10: I'm wondering if you can provide additional color on the robustness of the raw plant material supply chain. Are our third-party suppliers able to...

Speaker #10: There's Adair . I believe there's a European manufacturer . And then there's Sopharma . How does that all fit together

Speaker #10: Meet expected demand? If so, is unable to do so.

Speaker #2: Right . There's pieces of a jigsaw puzzle . Look , I think the key here is that the synthetic is a m process .

Speaker #3: Excellent question . Justin . Yeah . As I mentioned before , we had been stockpiling the the starting material for some considerable time .

Speaker #2: Put it that way . It's not an easy process . And I think I've stressed this before . You were making substantial progress on that front .

Speaker #3: And , you know , by the time we get to launch , we believe we'll have more than three years supply of starting material for the amounts required for , for in-market sales .

Speaker #2: But I think in terms of the three manufacturers and start off with Sopharma , you know , we . Sopharma was not included in the NDA because we had concerns over their FDA inspection readiness .

Speaker #3: So, and we will continue to add to that stockpile. So we don't really see the inventory going much below three years for the foreseeable future.

Speaker #2: I was down in Sofia about three weeks ago . You know , and soap opera made substantial progress with respect to their inspection readiness .

Speaker #3: So we're , we've been buying in for quite a few years now . And the starting material has a , you know , a three year shelf life .

Speaker #2: And we'd expect we're going to intend to add them to the NDA once it's approved . I think in terms of the third party manufacturer , the the key there is that , you know , as I mentioned , we've got these observations that we're monitoring very , very carefully .

Speaker #3: But we basically will reprocess it as we, as it's required to be used.

Speaker #10: Got it, thanks. And one more for me. I'm wondering if you can comment on the dosing schedule, and if there's any concern that a potential pill burden could limit real-world compliance or commercial uptake?

Speaker #2: And they're collaborating with the FDA to rectify any kind of observations . And the remedial action associated with it . And then ultimately , the transfer of manufacturers to the US .

Speaker #3: I'll have that . Doctor Mark Rubenstein .

Speaker #11: Sure .

Speaker #2: Has largely been driven by a desire to have contingency and redundancy in our overall supply chain . And give given the kind of uncertainty around tariffs , in particular , and also MFN and that kind of stuff , you know , we decided that it's some time ago to actually move manufacturing into the US .

Speaker #4: That is a great question . We actually have found just , you know , after completing our orca ol where people actually used the pill three times a day for up to a year , that not only did people not find it excessively burdensome , but are completion rate and the number of people who adhere to the protocol was incredibly high .

Speaker #2: So timing wise , we're anticipating that there should be , you know , available to be added to the NDA . You know , in the third quarter that timeframe .

Speaker #4: A lot of of participants reported that they felt that their highest cravings were around meal time . And so actually , even though you don't have to take cytisinicline with meals because it's tid , it's perfectly it can be perfectly timed around meals .

Speaker #2: So does that answer the question ?

Speaker #10: Yeah it does . Thanks , Rick . Appreciate it . That's all for me .

Speaker #3: Thank you . We reached out of our question and answer session . I'd like to turn the floor back over for any further closing comments .

Speaker #2: Well , I'd just like to thank you all for your continued interest in ACHIEVE LIFE SCIENCES, INC. . We've made terrific , terrific progress this year , and I just want to put it into context .

Speaker #4: And they found that it was reassuring to take something to address their cravings right around the time periods that they would have their highest cravings.

Speaker #2: 15 years ago , Tony Clark , who is the co-founder of achieve , and I had this idea that Cytisinicline could do immense societal benefit , you know , with desperate need for a new treatment for nicotine dependence , for smoking cessation .

Speaker #4: And again , our adherence rates in all of our trials and our ol trial , which was 52 weeks , was incredibly high .

Speaker #4: Over 75% .

Speaker #10: Great . Thanks for taking the questions

Speaker #2: And at that point , vaping didn't even exist . So over the years , we've worked tremendously hard . The initial eight years with Tony Clark and I actually funding the company ourselves .

Speaker #1: Thank you. Next question is coming from John Van Der from Zach's line, which is now live.

Speaker #12: Thank you and good morning . And in December . There was an Icer report that came out that calculated some prices for Cytisinicline .

Speaker #2: And since we over the last seven years , we made fantastic progress to address this huge unmet medical need . And we really do believe that we're at this brink , on the brink of actually great success and having the ability to treat patients who have got very few options to quit .

Speaker #12: And I was wondering if you'd seen that, and then wondering how that compares with your internal calculations, and kind of what prices you're thinking about when that comes about next year.

Speaker #11: Amy .

Speaker #5: Thanks . Yeah . We have . Hi , John . Good morning . We've definitely seen the reports . How are you doing ?

Speaker #2: So just like to say thank you for your continued interest in the company . And we look forward to updating you

Speaker #5: Thanks for thanks for the question . Yeah . We have seen the Icer report . We were involved in the process . Providing information .

Speaker #3: Thank you . That does conclude today's teleconference and webcast . You may disconnect your lines at this time and have a wonderful day .

Speaker #5: When requested . That was appropriate for their consideration . I think importantly , what it did highlight is that they have affirmed there is a substantial unmet need despite currently available treatments , and that payers should make Cytisinicline immediately available And as far as pricing goes , we're not going to comment on our pricing because we've obviously not set that yet , and we're not ready to have those conversations with payers on an exact price .

Speaker #5: So we'll leave it at that. But we were pleased with the recommendation that ICER made.

Speaker #12: Okay . And then a few questions on on manufacturing . I guess , you know , I wanted to frame it first . Where does it stand with synthetic manufacturer of API and then I believe there are three different entities , perhaps that you're working with .

Speaker #12: There’s Adair, I believe there’s a European manufacturer, and then there’s Sopharma. How does that all fit together?

Speaker #3: Right . There's pieces of a jigsaw puzzle . Look , I think the key here is that the synthetic is a it's an N process .

Speaker #3: Put it that way . It's not an easy process . And I think I've stressed this before . You were making substantial progress on that front , but I think in terms of the three manufacturers and start off with Sopharma , you know , we .

Speaker #3: Sopharma was not included in the NDA because we had concerns over their FDA inspection readiness. I was down in Sofia about three weeks ago.

Speaker #3: You know, and SOAP made some substantial progress with respect to their inspection readiness. And we'd expect, we're going to intend to add them to the NDA once it's approved.

Speaker #3: I think in terms of the third party manufacturer , you know , the key there is that , you know , as I mentioned , we've got these observations that we're monitoring very , very carefully .

Speaker #3: And they're collaborating with the FDA to rectify any kind of observations . And the remedial action associated with it . And then ultimately , the transfer of manufacture to the US has largely been driven by a desire to have contingency and redundancy in our overall supply chain .

Speaker #3: And give , given the kind of uncertainty around tariffs in particular , and also MFN and that kind of stuff , you know , we decided that it's some time ago to actually move manufacturing into the US .

Speaker #3: So timing wise , we're anticipating that there should be , you know , available to be added to the NDA . You know , in the third quarter that can time frame .

Speaker #3: So, does that answer the question?

Speaker #12: Yeah it does . Thanks , Rick . Appreciate it . That's all for me .

Speaker #1: Thank you. We've reached the end of the question and answer session. I'd like to turn the floor back over for any further closing comments.

Speaker #3: Well, I'd just like to thank you all for your continued interest in Achieve Life Sciences, Inc. We've made terrific, terrific progress.

Speaker #3: This year , and I just want to put it into context . 15 years ago , Tony Clark , who is the co-founder of achieve , and I had this idea that Cytisinicline could do immense societal benefit You know , with a desperate need for a new treatment for nicotine dependence , for smoking cessation .

Speaker #3: And at that point , vaping didn't even exist . So over the years , we've worked . Tremendously hard . The initial eight years was Tony Clark .

Speaker #3: And I actually funding the . Company ourselves . And since we over the last seven years , we've made fantastic progress to address this huge unmet medical need .

Speaker #3: And we really do believe that we're at this brink, on the brink of actually great success and having the ability to treat patients who have got very few options to correct.

Speaker #3: So, just like to say thank you for your continued interest in the company, and we look forward to updating you.

Speaker #1: Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time, and have a wonderful day.

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