ACHV

Closed a private placement of up to $354 million, with $180 million upfront and up to $174 million from warrants exercisable prior to and up to 20 trading days following FDA approval Strengthened organization with new Chief Executive Officer, experienced commercial, CMC, and quality leaders, along with six new appointments to the Board of Directors Anticipates potential FDA approval in the first half of 2027, followed by U.S. commercial launch SEATTLE and VANCOUVER, British Columbia, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the second quarter of 2026 and provided business updates. “This quarter was about building Achieve to match the significant opportunity of cytisinicline,” said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. “We added a commercial team, senior CMC and quality leadership, six new directors, and advanced the finished drug product manufacturing transition to the United States. The Complete Response Letter raised no question about the efficacy or clinical safety of cytisinicline. With the team and financing in place, our focus turns to resubmission and commercial readiness. Behind that work are millions of adults still looking for help to quit.” Key Highlights: Regulatory Update On June 20, 2026, Achieve received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline, an outcome the Company disclosed it anticipated in April 2026. The CRL relates to outstanding current Good Manufacturing Practice (cGMP) observations from an inspection of the Company’s prior third-party manufacturing facility, which received an Official Action Indicated classification, and to final product labeling that was not completed by the FDA’s action date. The FDA identified no deficiencies related to the clinical efficacy or safety of cytisinicline. Announced the transition of finished drug product manufacturing of cytisinicline to U.S.-based Adare Pharma Solutions (Adare). The Company has completed analytical method technology transfer, manufactured its first cytisinicline engineering batch, and fully qualified testing procedures at Adare’s facility. The Company intends to resubmit its NDA naming Adare as its finished drug product manufacturer for commercial supply in the fourth quarter of 2026 and anticipates potential FDA approval in the first half of 2027, with U.S. commercial launch to follow. Leadership and Board Updates Strengthened the Board of Directors with the appointments of Lucian Iancovici, MD (Managing Director, TPG), Aaron E. Royston, MD (Managing Partner, venBio), Christopher Martin (former Chief Commercial Officer, Verona Pharma), Jeffrey Farrow (CFO and CSO, Tarsus Pharmaceuticals), and Reid Waldman, MD (Founder and CEO, Veradermics), bringing combined expertise across healthcare investing, biopharmaceutical finance, and clinical-stage leadership. Dr. Goldberg also joined the Board in connection with his appointment as Chief Executive Officer. Announced commercial buildout with Mark Zappia and Jim Willis joining as Senior Vice President, Commercial, and Vice President of Sales and Sales Enablement, respectively, both previously part of the commercial launch team for Ohtuvayre® (ensifentrine) at Verona Pharma. Continued the finished drug product manufacturing transition with the appointments of Ronald Dadino as Senior Vice President, CMC and Supply Chain, and Gloria Cosgrove as Senior Vice President, Global Quality, each bringing significant U.S.-based pharmaceutical manufacturing and quality experience. Scientific Data Advancement Presented 52-week safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting, completing the anticipated clinical evidence package supporting the cytisinicline NDA. Among 475 participants dosed for up to 52 weeks (median cumulative exposure of 361 days), no new safety signals were identified by the independent Data Safety Monitoring Committee. Presented analysis of ORCA-2 and ORCA-3 Phase 3 RCTs evaluating cytisinicline in participants with a baseline history of cancer at the American Society of Clinical Oncology (ASCO) 2026 annual meeting. Cytisinicline was well tolerated and showed numerically higher abstinence rates than placebo in this population (24.4% with 12 weeks of cytisinicline versus 15.8% with placebo). Capital Raise Closed a private placement of up to $354 million ($180 million upfront; up to $174 million from milestone-based warrants exercisable prior to, and up to 20 trading days following, FDA approval of cytisinicline). Proceeds are expected to fund the ORCA-V2 Phase 3 trial, the commercialization of cytisinicline, and working capital and general corporate purposes. Financial ResultsAs of June 30, 2026, the Company’s cash, cash equivalents, and marketable securities were $187.3 million. Total operating expenses for the three and six months ended June 30, 2026, were $18.4 million and $28.9 million, respectively. Total net loss for the three and six months ended June 30, 2026, was $74.8 million and $84.9 million, respectively. Net loss for the quarter includes a non-cash charge of $48.7 million related to the change in fair value of the warrant liabilities issued in connection with the Company’s private placement. Investor CommunicationsAchieve will host conference calls in connection with significant clinical, regulatory, and commercial milestones, including the planned resubmission of the NDA for cytisinicline. Management will continue to participate in investor meetings and industry conferences. About Achieve Life Sciences, Inc.Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence. Achieve’s New Drug Application (NDA) for cytisinicline for smoking cessation in adults is supported by two successfully completed Phase 3 studies and an open-label long-term safety study. Achieve has also completed a Phase 2 study of cytisinicline in nicotine e-cigarette cessation, conducted an end-of-Phase 2 meeting with the FDA, and has received Breakthrough Therapy designation for the vaping cessation indication. About CytisiniclineThere are approximately 25 million adults in the United States who smoke combustible cigarettes, and tobacco use is currently the leading cause of preventable death.¹,² In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.¹ In 2025, approximately 1.4 million middle and high school students in the United States reported using e-cigarettes.3 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of Achieve’s third-party manufacturing partners, the successful launch and commercialization of cytisinicline, the use of proceeds from Achieve’s private placement, and statements concerning Achieve Life Sciences’ future plans and prospects. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including those described in Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. Achieve ContactNicole JonesVP, Strategic Communications and Stakeholder [email protected] References¹Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM Evidence, doi: 10.1056/EVIDpha2500339.²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2019.3Eunice Park-Lee, Lauren M Dutra, Hannah Cowan, et al. Tobacco Product Use Among Middle and High School Students in the United States: National Youth Tobacco Survey, 2025, Nicotine & Tobacco Research, 2026; ntag116, doi.org/10.1093/ntr/ntag116.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Appointed Dr. Andrew Goldberg as CEO to lead the transition from late-stage development to commercial execution, supported by a new board and commercial leadership team with successful pulmonary launch experience. Secured a transformational $180 million private placement, providing the capital necessary to build an independent commercial infrastructure and scale operations. Strategically shifted manufacturing to U.S.-based Adare Pharma Solutions to mitigate international supply chain risks, including potential tariffs and importation delays. Attributed the anticipated June 2026 Complete Response Letter (CRL) to general cGMP issues at a third-party facility rather than any product-specific deficiencies for cytisinicline. Positioned cytisinicline as a category-defining intervention for nicotine dependence, targeting a market of 50 million U.S. adults with no new FDA-approved therapies in over 20 years. Reinforced the drug's competitive profile through mechanistic data showing selective receptor interaction, which explains the low nausea rates observed in clinical trials. Demonstrated significant efficacy in difficult-to-treat populations, including a 32.4% abstinence rate in participants who previously failed varenicline or bupropion. Targeting an NDA resubmission in Q4 2026, naming Adare Pharma Solutions as the primary manufacturing partner for commercial supply. Projecting a commercial launch in the first half of 2027, supported by an internal field force rather than a partnership model. Planning to initiate the ORCA-V2 Phase III trial for vaping cessation in late 2026, leveraging the FDA's Breakthrough Therapy designation and a priority voucher. Developing a commercial strategy focused on 'removing access friction' for prescribers rather than broad consumer awareness, given high existing patient motivation. Evaluating additional clinical studies in specific patient subsets, such as smokers with cancer or COPD, to broaden the evidence base post-approval. Confirmed the complete severance of ties with the prior European manufacturer following their Official Action Indicated (OAI) classification. Successfully produced the first engineering batch at the new Adare facility in Q1 2026, marking a key milestone in the technology transfer process. Noted that the $174 million in milestone-based warrants are tied to FDA approval, providing a secondary capital infusion upon successful regulatory clearance. Clarified that the smoking cessation NDA stands independently of the vaping program, reducing regulatory dependency on the newer vaping indication. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed they will commercialize independently with their own field force, led by newly recruited veterans from the Ohtuvayre launch. The strategy focuses on equipping prescribers with a tolerable alternative for patients who have already 'raised their hands' to quit. The CEO is personally overseeing the tech transfer to ensure the Q4 2026 resubmission timeline is met. Adare was selected for its track record with multiple FDA-approved products and its ability to scale to meet anticipated market demand. Management expressed high confidence in the IP portfolio, stating it provides protection for the cytisinicline franchise into the late 2030s and potentially the 2040s. Management declined to speculate on FDA leadership but emphasized that their Breakthrough Designation and priority voucher reflect the agency's alignment on public health urgency. Stated that while the voucher is valuable, the company’s success is not dependent on it as the smoking indication is the primary driver.

This article first appeared on GuruFocus. Financing: Closed a transformational financing with $180 million in upfront capital and up to $174 million from milestone-based warrants. Manufacturing Partnership: Partnered with Adare Pharma Solutions for cytisinicline drug product manufacturing. NDA Resubmission: Plan to resubmit the NDA in Q4 2026, with a commercial launch expected in H1 2027. Clinical Data: Cytisinicline showed continuous abstinence rates of 32.4% versus 6% on placebo in a difficult-to-treat population. Warning! GuruFocus has detected 4 Warning Signs with ACHV. Is ACHV fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Achieve Life Sciences Inc (NASDAQ:ACHV) closed a transformational financing deal, securing $180 million in upfront capital and up to $174 million from milestone-based warrants. The company has partnered with US-based Adare Pharma Solutions to manufacture cytisinicline, reducing risks related to international importation. Clinical data shows cytisinicline's potential efficacy in smoking cessation, with a favorable tolerability profile and low nausea rates. New Board members and commercial team leaders with significant industry experience have been appointed, strengthening the company's leadership. Achieve Life Sciences Inc (NASDAQ:ACHV) has a strong capital position to execute its strategy for approval and launch, with a US-based supply chain to support manufacturing and launch timing. The company expects to receive a complete response letter from the FDA due to issues with a third-party manufacturer, delaying the NDA resubmission to the fourth quarter of 2026. There is uncertainty regarding the timeline for the commercial launch, which is now expected in the first half of 2027. The transition to a new manufacturing partner, Adare Pharma Solutions, involves completing a tech transfer and ensuring readiness, which could pose challenges. Achieve Life Sciences Inc (NASDAQ:ACHV) faces competition from other smoking cessation aids and therapies, which could impact market positioning. The company is constrained in its communication about cytisinicline in a pre-approval environment, which may affect awareness and education efforts. Q: Can you provide more details on the commercial strategy and what needs to be achieved in 2026 for a successful launch next year? A: Andrew Goldberg, CEO, emphasized the importance of having a data-driven strategy to bring cytisinicline to patients. The company plans to commercialize independently with its own field force, leveraging the recent team announcements as evidence of their preparation. Achieve believes it is best positioned to bring cytisinicline to patients and will share more specifics as decisions firm up. Q: What is the current awareness among CHANTIX prescribers of cytisinicline and its Phase III data, and what needs to be done in 2026 to build that awareness? A: Goldberg noted that while they are constrained in what they can communicate pre-approval, they can share existing and new clinical data through scientific channels. The company plans to present new data at conferences and will expand their medical education team as they approach approval and launch. Q: What additional information is needed for the NDA resubmission, and how is Adare progressing in its manufacturing efforts? A: Goldberg stated that the focus is on the OAI classification of a prior third-party manufacturer, which led to the transition to Adare. The company is committed to transparency, proactiveness, and adaptability. They have already moved manufacturing to the US and produced initial batches. The goal is to complete the tech transfer to Adare quickly while ensuring thoroughness. Q: What due diligence was done on the IP for cytisinicline, and how confident are you with the stated timeline given the manufacturing transition? A: Goldberg expressed confidence in the IP, which has been evaluated by both Achieve and other investors. The IP is expected to protect the franchise into the late 2030s and 2040s. Regarding the timeline, Goldberg is committed to transparency and has not seen anything to suggest they won't meet the stated timelines. Q: How will the potential change in FDA leadership affect the vaping market dynamics, and what is the status of the priority voucher for vaping? A: Goldberg stated that interactions with the FDA have been constructive. The CNPV indicates the agency's alignment with the public health need for the therapy. Achieve is not dependent on the voucher for success, as the smoking NDA stands on its own with robust Phase III trial data. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Achieve Life Sciences, Inc.? Here are five stocks we like better. Achieve Life Sciences secured a major capital infusion, including $180 million upfront and up to $174 million more through milestone-based warrants, giving it resources to pursue an independent commercialization strategy for cytisinicline. The company expects an FDA complete response letter by its June 20 PDUFA date because of issues at a third-party manufacturer, and it now plans to resubmit the NDA in Q4 2026 with U.S.-based Adare Pharma Solutions as its primary manufacturing partner. Clinical data continues to support cytisinicline, with new analyses showing efficacy across hard-to-treat patient groups and a strong response versus placebo in patients who previously used varenicline and bupropion; Achieve still expects a first-half 2027 launch. Achieve Life Sciences (NASDAQ:ACHV) used its first-quarter 2026 earnings call to outline a transition period marked by new leadership, a major financing, manufacturing changes tied to its cytisinicline regulatory timeline and preparations for a potential commercial launch in 2027. Dr. Andrew Goldberg, Achieve’s new chief executive officer, said he joined the company at “an important time” as it works to develop cytisinicline for smoking cessation and vaping cessation. Goldberg said nearly 50 million adults in the United States use nicotine, including approximately 25 million smokers and 18 million people who vape, and said current treatment options leave many patients unable to quit. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum “Despite the scale of this problem, there has not been a new FDA-approved smoking cessation therapy in more than 2 decades, and there has never been an approved therapy for vaping cessation,” Goldberg said. Goldberg highlighted Achieve’s recently completed private placement, which included $180 million in upfront capital and up to $174 million from milestone-based warrants. The warrants may be exercised at any time prior to and up to 20 trading days following FDA approval, he said. → MercadoLibre Boldly Invests in Growth: Discount Deepens Goldberg said the financing gives Achieve the resources to execute its strategy and prepare for launch. He said the company now plans to commercialize cytisinicline independently with its own field force, adding that Achieve believes it is “best positioned to bring cytisinicline to patients ourselves.” The company also announced additions to its board and commercial team. Goldberg said Achieve appointed Chris Martin, most recently chief commercial officer of Verona Pharma; Dr. Lucian Iancovici, managing director at TPG; and Dr. Aaron Royston, managing partner at venBio, to its board. Achieve also added two former Verona executives to its commercial organization: Mark Zappia as senior vice president of commercial and Jim Willis as vice president of sales and enablement. → 3 Ways to Target the Resources Powering AI and Data Centers Goldberg said the new commercial leaders bring experience from the launch of Verona’s Ohtuvayre, which he described as “widely regarded as one of the best launches in industry history.” Achieve said it expects to receive a complete response letter from the U.S. Food and Drug Administration on or by its June 20 PDUFA date because a separate third-party manufacturer received an Official Action Indicated classification. Goldberg said the observations relate to general current good manufacturing practice matters at the facility and are not specific to cytisinicline manufacturing. The company’s plan is to resubmit the new drug application in the fourth quarter of 2026, naming U.S.-based Adare Pharma Solutions as its new and primary manufacturing partner for potential commercial supply. Achieve continues to expect a commercial launch in the first half of 2027. Goldberg said Achieve has already produced its first cytisinicline engineering batch at Adare’s facility and has completed analytical method transfer. In response to analyst questions, he said the company no longer plans to use the manufacturer that received the OAI classification as part of its path forward. “Our principal goal and my principal goal is completing that tech transfer to Adare on as fast a timeline as possible while maintaining our completeness,” Goldberg said. He added that he had already visited Adare’s headquarters and said Achieve is confident its U.S. partner, which he said has multiple FDA-approved products, can support the company’s plans. Goldberg also reviewed recent scientific updates supporting cytisinicline. In March, Achieve published mechanistic data in Nicotine & Tobacco Research showing that cytisinicline selectively interacts with the alpha-4 beta-2 nicotinic receptor while showing minimal interaction with the 5-HT3 serotonin receptor. Goldberg said that mechanism may help explain the low nausea rates observed in clinical trials. At the Society for Research on Nicotine & Tobacco conference, Achieve presented an analysis of more than 1,600 Phase III participants. Goldberg said the analysis showed consistent efficacy regardless of prior treatment history or previous quit attempt patterns. Among participants with prior varenicline and bupropion use, those receiving 12 weeks of cytisinicline achieved continuous abstinence rates of 32.4%, compared with 6% for placebo, with an odds ratio of 7.5, Goldberg said. He described that group as a difficult-to-treat population and said the data highlight cytisinicline’s potential among patients who have not succeeded with existing therapies. Goldberg said Achieve expects to present additional data later this year, including information on patients with cancer, and noted that the company has previously described cytisinicline’s performance in patients with chronic obstructive pulmonary disease. During the question-and-answer session, Goldberg said the company now has the resources to pursue a broader commercial strategy. He said nicotine dependence differs from some other disease categories because patients often already know they have the condition and are already interacting with healthcare providers. “The barrier to treatment has not been awareness of the disease,” Goldberg said. “It’s been the lack of an effective and tolerable therapy that prescribers feel confident offering.” Goldberg said Achieve’s launch strategy will focus on giving prescribers a reason to treat, equipping them with the right therapy and reducing access friction. He declined to specify the expected size of the field force, saying the company intends to scale “in accordance” with broader distribution and remain disciplined in how it builds the team. He also said patient support programs could be part of the company’s future commercial approach, citing the availability of digital and telehealth infrastructure. Achieve also addressed its vaping cessation program. Goldberg said the company’s smoking cessation NDA “stands on its own two feet,” supported by two Phase III double-blind, placebo-controlled trials in which both six-week and 12-week courses reached statistical significance. Goldberg said the vaping indication is a follow-on program and noted that Achieve has received both a CNPV voucher and Breakthrough Designation. He said ORCA-V2, the company’s planned Phase III vaping study, will be a randomized, placebo-controlled, multicenter trial. Achieve is finalizing the design and hopes to initiate the study this year, he said. In closing remarks, Goldberg said investors should focus on three points from the quarter: Achieve’s strengthened capital position, its U.S.-based supply chain and the addition of commercial leadership with relevant launch experience. “Achieve is positioned to address one of the largest preventable public health problems we know,” he said. Achieve Life Sciences, Inc (NASDAQ: ACHV) is a clinical-stage biotechnology company dedicated to the development and commercialization of cytisinicline, a plant-derived alkaloid for smoking cessation. The company’s mission is to offer a novel, evidence-based therapy that addresses the global need for effective and well-tolerated smoking cessation options. Achieve focuses its efforts on advancing the clinical profile of cytisinicline through rigorous development programs and regulatory engagement. Cytisinicline (formerly marketed as Tabex® in Europe) acts as a nicotinic acetylcholine receptor partial agonist, helping reduce withdrawal symptoms and nicotine cravings. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Achieve Life Sciences Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Closed Private Placement of Up to $354 Million, Including $180 Million Upfront and $174 Million in Milestone-Driven Warrants Appoints New CEO and Expands Board of Directors Advances U.S.-based Manufacturing Transition & Partnership Conference Call Scheduled for 8:30 AM EDT Today, May 12, 2026 SEATTLE and VANCOUVER, British Columbia, May 12, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the first quarter of 2026 and provided corporate highlights, including the recent financing and leadership updates. “Achieve is a mission-driven company. Nicotine dependence is one of the largest preventable public health hazards we know, and smoking remains the leading cause of preventable death,” said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. “If approved, cytisinicline would be the first new FDA-approved smoking cessation therapy in more than two decades, and could also be the first ever for vaping cessation. My job is to ensure we have the team, the capital, and the strategy to bring cytisinicline to patients.” Dr. Goldberg continued, “This quarter reflects deliberate work to build the company for the launch ahead. We closed a transformational financing, strengthened our Board, and advanced our transition to U.S. manufacturing. The Company will provide additional commercial leadership updates today. We are building the foundation to execute fully, and that is what we intend to do.” Key Highlights: Capital Raise Closed a private placement of up to $354 million, including $180 million upfront and up to $174 million from milestone-based warrants that may be exercised at any time prior to, and up to 20 trading days following, FDA approval of cytisinicline. Backed by leading healthcare investors, the proceeds will be used to fund the ORCA-V2 Phase 3 trial for cytisinicline for e-cigarette cessation, the commercialization of cytisinicline, and for working capital and general corporate purposes. Leadership Transition Appointed Andrew D. Goldberg, MD as Chief Executive Officer and a Board member. New directors Christopher Martin, Lucian Iancovici, MD, and Aaron E. Royston, MD, add expertise in commercialization, company building, and corporate governance. Tom King has decided to step down from the Board, with his last day of service on June 8, 2026. Dr. Iancovici will assume the role of Chairman of the Board. Jaime Xinos will also transition from the role of Chief Commercial Officer, effective May 31, 2026, after nearly 9 years of dedicated service to Achieve. The Company expresses its gratitude for her contributions to advancing cytisinicline through clinical development. In connection with this transition, the Company has reorganized its commercial leadership for the launch ahead, which will be detailed in a separate announcement today. Manufacturing Partnership with Adare Pharma Solutions Announced Achieve partnered with U.S.-based Adare Pharma Solutions (Adare) to support its commercial manufacturing. Achieve also completed an analytical method technology transfer to the site, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the facility. Regulatory Milestone and Manufacturing Readiness Announced Achieve’s prior third-party manufacturer facility received an Official Action Indicated classification by the U.S. Food and Drug Administration (FDA) related to general current Good Manufacturing Practice matters, with observations not specific to cytisinicline. As a result, Achieve expects to receive a Complete Response Letter from the FDA on or before June 20, 2026, the Prescription Drug User Fee Act goal date. The Company intends to resubmit its New Drug Application in the fourth quarter of 2026, naming Adare as its new and primary manufacturing partner for commercial supply. The Company's stated expectation is for U.S. commercial launch in the first half of 2027. Scientific Data Advancement Published in Nicotine & Tobacco Research, which provided evidence that cytisinicline selectively interacts with the α4β2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 receptor, a key mechanism potentially underlying its gastrointestinal tolerability. These findings help explain the low nausea rates observed in clinical trials and support cytisinicline as a promising alternative for smoking cessation, particularly in individuals sensitive to medication-related side effects. Presented data at the Society for Research on Nicotine and Tobacco (SRNT) 2026 Annual Meeting from a pooled analysis of over 1,600 participants in the Phase 3 ORCA-2 and ORCA-3 trials. Cytisinicline for 12 weeks significantly increased continuous abstinence versus placebo in patients with prior varenicline and bupropion use (32.4% vs. 6.0%; OR 7.5), supporting its potential for patients who have failed existing therapies. Presented late-breaking ORCA-OL post-trial survey data at SRNT, which followed participants for up to 52 weeks of cytisinicline treatment. Among survey respondents, 98% reported they would recommend cytisinicline to others, 88% reported fewer cravings compared to prior quit attempts, and 76% reported physical health improvement compared to before the study. Financial Results As of March 31, 2026, the Company's cash, cash equivalents, and marketable securities were $29.3 million, not including estimated net proceeds of approximately $168.6 million from the private placement, after deducting estimated agent fees and other expenses. Total operating expenses and net loss for the three months ended March 31, 2026 were $10.5 million and $10.2 million, respectively Conference Call Details Achieve will host a conference call at 8:30 AM EDT today, Tuesday, May 12, 2026. To access the webcast, please use the following link: 1Q26 Earnings Webcast. Alternatively, you may join the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) and referencing conference ID 13759781. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days. About Achieve Life Sciences, Inc. Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About Cytisinicline There are approximately 25 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.4 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. The FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of Achieve’s third-party manufacturing partners, the successful launch and commercialization of cytisinicline, the use of proceeds from the private placement of our securities in April 2026, and statements concerning Achieve Life Sciences’ future plans and prospects. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. Achieve Contact Nicole Jones VP, Strategic Communications and Stakeholder Relations [email protected] 425-686-1510 References 1Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM, doi: 10.1056/EVIDpha2500339. 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

SEATTLE and VANCOUVER, British Columbia, May 05, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced it will report its first quarter 2026 financial results and provide a corporate update on Tuesday, May 12, 2026, at 8:30 AM EDT. To access the webcast, please use the following link: 1Q26 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or +1 201-689-7817 (International) and referencing conference ID 13759781. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days. About Achieve Life Sciences, Inc. Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About Cytisinicline There are approximately 25 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.4 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. The FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of Achieve’s third-party manufacturing partners, the successful launch and commercialization of cytisinicline, and statements concerning Achieve Life Sciences’ future plans and prospects. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. Achieve Contact Nicole Jones VP, Strategic Communications and Stakeholder Relations [email protected] 425-686-1510 References 1Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM, doi: 10.1056/EVIDpha2500339. 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

By John Vandermosten, CFA NASDAQ: ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ: ACHV) reported 2025 results following the submission of a new drug application (NDA) to the FDA and the assignment of cytisinicline’s Prescription Drug User Fee Act (PDUFA) date of June 20th, 2026. While the FDA reviews the application, Achieve has been hard at work on pre-commercialization activities working with Omnicom to support the commercial launch of cytisinicline. Since the company’s previous quarterly update in November, Dr. Mark Rubinstein has been promoted to Chief Medical Officer, management held meetings during the JP Morgan Healthcare conference in January and team members presented data from the pivotal and safety trials at the Society for Research on Nicotine & Tobacco (SRNT) 2026 Annual Meeting. In its earnings release Achieve announced that it will be working with the domestic manufacturer Adare Pharma to provide cytisinicline drug product to support an anticipated 1H:27 product launch. Financial and Operational Results Achieve’s 2025 financial and operational results were detailed in a press release, Form 10-K filing and a webcast which provided analysts the opportunity to ask questions. No revenues were reported in 2025. Operating expense was $54.9 million producing a net loss of ($54.7) million or ($1.25) per share. For the year ending December 31st, 2025 versus the prior year: Research & development expense totaled $23.0 million, up 1% from $22.8 million, due to higher employee costs from increased headcount and higher manufacturing and supply chain costs associated with commercial launch preparation, including purchase of raw cytisinicline inventory expenses prior to regulatory approval. This was partially offset by lower clinical trial costs associated with the wind down of the ORCA-OL trial, which was completed last year; General & administrative expense was $31.9 million, up 96% from $16.3 million on higher employee expenses and commercial launch preparation; Net interest income was $0.7 million vs. $0.2 million as interest income offset interest expense on higher cash balances; Other expense of $0.4 million compares to $0.9 million. The amount is related to change in fair value of contingent consideration and other expense; Net loss was $54.7 million vs. $39.8 million or $1.25 and $1.24 per share, respectively. As of December 31st, 2025, cash and equivalents totaled $36.4 million. This compares to a $34.4 million balance held at the end of 2024. At year end, Achieve carried convertible debt of $14.9 million on the balance sheet which includes an additional $5 million drawn down in October 2025 upon achieving its milestone of NDA acceptance. Cash used in operations during 2025 was $49.5 million versus $29.8 million in the same prior year period. SRNT Presentation Achieve presented new data at the Society for Research on Nicotine & Tobacco (SRNT) 2026 Annual Meeting, held from March 4-7 in Baltimore, Maryland. Information was presented at two sessions drawing from participants in the ORCA-OL and the more than 1,600 participants in the ORCA-2 and ORCA-3 studies. Titles of the sessions and conclusions are included below. Cytisinicline in Adult Smokers: Post-Trial Survey from ORCA-OL Many individuals do not complete a smoking cessation course of therapy due to side effects and patient experience is important to success Participants reported better physical health while taking cytisinicline including improved breathing, increased stamina and greater vitality Participants were satisfied with cytisinicline reporting that the urge to smoke had lessened, and fewer psychological cravings Cytisinicline was well tolerated even with up to one year of use with no new safety signals during the open label phase Efficacy of Cytisinicline for Smoking Cessation in Adults with and without Multiple Prior Quit Attempts or Prior Pharmacotherapy Use: Pooled Analysis of Two Phase 3 Trials The presentation concluded that cytisinicline was effective and well-tolerated regardless of participants’ prior use of smoking cessation medications or number of previous quit attempts If approved in the US, cytisinicline will offer a new quit option for patients, including those who have failed other medications Cytisinicline was consistent across regimens with benefits observed for both the six- and twelve-week treatment courses, although the twelve-week course provided improved long-term outcomes Manufacturer Relationships Achieve raised concerns in its third quarter 10-Q filing regarding Sopharma’s ability to pass an FDA pre-approval inspection and has engaged other third-party manufacturers to produce tableted and packaged cytisinicline. In response, Sopharma has alleged that engagement of third-party manufacturers is a breach of the Sopharma License and Supply Agreement. The two parties are discussing a resolution. Achieve is sourcing its cytisinicline from a supplier in China who is extracting cytisine from the Thermopsis tree. If Achieve is not able to come to an agreement with Sopharma, it plans to source cytisinicline from China, formulate, tablet and package it at partners in India and France, and then have it shipped to the United States for commercialization. Additionally, the company has also disclosed that it has intellectual property rights pending for synthetic cytisinicline. This may play a role in the future and could provide further sourcing flexibility and efficiency. Due to observations by the FDA related to solid oral dose manufacturing with the manufacturer listed in the NDA and a desire to move production to the United States, Achieve announced that it had partnered with Adare Pharma Solutions to manufacture cytisinicline drug product for potential commercial launch. Achieve and Adare have begun a technology transfer following three development agreements that the two entities have signed with each other. We see multiple sources of cytisinicline manufacturing, especially one in the United States as a material positive for the company which provides flexibility and the ability to sidestep any future tariffs that may exist. Summary Achieve management confirmed the June 20th PDUFA date; however, issues at the company’s manufacturers have raised the risk of a potential delay, especially if the questions cannot be resolved sufficiently prior to the anticipated approval date. The status and disposition of the observations is between the manufacturer and the FDA, which gives Achieve limited visibility on the process. In an effort to execute a stronger launch, management has pushed back its anticipated launch of cytisinicline to 1H:27 which will allow sufficient supply to be available and give more time to contract with payors. The marketing team continues its efforts with Omnicom to communicate with stakeholders and implement its digital campaign. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

This article first appeared on GuruFocus. Cash and Cash Equivalents: $36.4 million as of December 31, 2025. Total Operating Expenses: $14.7 million for Q4 2025; $54.9 million for the full year 2025. Net Loss: $14.7 million for Q4 2025; $54.7 million for the full year 2025. Release Date: March 24, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Achieve Life Sciences Inc (NASDAQ:ACHV) submitted a New Drug Application (NDA) for Cytisinicline, marking a significant step towards becoming the first new FDA-approved treatment for smoking cessation in 20 years. The company received a Commissioner's National Priority Voucher for its vaping cessation indication, providing an accelerated pathway for FDA approval. Clinical trials, including the ORCA-OL long-term exposure trial, demonstrated Cytisinicline's strong safety profile and patient satisfaction. Achieve Life Sciences Inc (NASDAQ:ACHV) is building a scalable, data-driven commercial model using AI to enhance decision-making and customer engagement. The company has secured a partnership with Adair Pharma Solutions for US-based manufacturing, enhancing supply chain security and reducing risks associated with international importation. Achieve Life Sciences Inc (NASDAQ:ACHV) reported a net loss of $54.7 million for the year, reflecting ongoing investments in regulatory, clinical, and commercial activities. There are concerns about manufacturing readiness, with observations noted during an FDA inspection of the current manufacturer, prompting a shift to US-based production. The timeline for the commercial launch of Cytisinicline is set for the first half of 2027, indicating a significant gap between potential NDA approval and market availability. The company faces challenges in raising awareness among healthcare providers due to regulatory constraints on pre-approval promotion. Insurance coverage at launch may face initial restrictions, requiring a ramp-up period to achieve broad payer acceptance and formulary inclusion. Warning! GuruFocus has detected 3 Warning Signs with ACHV. Is ACHV fairly valued? Test your thesis with our free DCF calculator. Q: Can you explain the critical path between a late June NDA approval and a first-half 2027 launch? Is it primarily about scaling up on the commercial side or product supply? A: Jaime Xinos, Chief Commercial Officer: The primary consideration is ensuring we have the drug in the supply chain to reach patients. Our trade and distribution side will be ready as soon as we have the drug. The additional time allows us to gather more data and work on partnerships with advocacy and policymakers. Richard Stewart, CEO: Strategically, given the market scale, it's crucial to have all processes in place to optimize the product launch. Q: Regarding manufacturing, will the manufacturer in the NDA supply commercial products, or will Adair take over? What are the implications for the NDA review? A: Richard Stewart, CEO: The PDUFA date remains June 23, 2026. We had already decided to transfer manufacturing to the US due to geopolitical concerns, which we accelerated. It's prudent to ensure supply contingencies and have US-based manufacturers. Q: What is the current awareness level among healthcare providers, and what are the plans to build awareness in 2026? A: Jaime Xinos, Chief Commercial Officer: Broad awareness hasn't been a priority due to pre-approval restrictions. We've focused on disease state education and conserving resources for a stronger educational push closer to launch. We plan to ramp up awareness efforts as we approach launch, particularly at conferences like ATS. Q: How should we think about insurance coverage at launch, given the lead time between potential approval and launch? A: Jaime Xinos, Chief Commercial Officer: We've had about 40 touchpoints with payers, and there's significant interest due to the unmet need. The Affordable Care Act requires coverage for smoking cessation treatments, which helps. However, initial restrictions may still apply, and we expect a slow ramp in the first six months post-launch. Q: Can you comment on the robustness of the raw plant material supply chain? A: Richard Stewart, CEO: We've been stockpiling starting material for some time and expect to have more than three years' supply by launch. We will continue to add to this stockpile, ensuring a stable supply chain. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Transitioned from a clinical development firm to a commercially focused enterprise following the June 2025 NDA submission for cytisinicline. Attributed strong clinical momentum to the ORCA-OL study, which demonstrated safety and tolerability over 52 weeks, addressing long-term treatment concerns. Identified a significant market opportunity in the 6 million COPD smokers in the U.S., where post-hoc data showed cytisinicline significantly improved quit rates. Pivoted to a lean, omnichannel commercial model to address the reality that 75% of primary care physicians no longer meet with traditional medical representatives. Integrated AI and machine learning into the 'asset factory' to automate customer engagement and generate predictive insights for precision marketing. Strategic selection of Adare Pharma Solutions for U.S. manufacturing aims to secure the supply chain and mitigate risks from international tariffs and importation uncertainties. Anticipates a commercial launch in the first half of 2027, allowing time for manufacturing scale-up and the establishment of a robust U.S. supply chain. Leveraging the Commissioner's National Priority Voucher to expedite the vaping cessation indication, targeting a review timeline of 1 to 2 months. Planning the ORCA-V2 Phase III trial for vaping cessation with site selection and principal investigator identification currently underway. Focusing 2026 efforts on the 'Will Power' awareness campaign to reframe nicotine dependence as a medical condition rather than a personal failure. Assumes a slow initial 6-month launch ramp due to standard 'new-to-market' payer blocks despite favorable Affordable Care Act coverage requirements. Disclosed two FDA GMP inspection observations at the current NDA-named manufacturer, prompting an accelerated technology transfer to Adare Pharma Solutions. Maintains a strategic stockpile of raw starting material sufficient for more than 3 years of market demand to ensure long-term supply continuity. Noted that while the PDUFA date remains June 20, 2026, the transition to U.S.-based manufacturing with Adare is intended to ensure supply reliability for the commercial launch expected in the first half of 2027. Highlighted the geopolitical rationale for onshoring manufacturing to the U.S. to provide redundancy and contingency capacity. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management explained the gap is primarily driven by the need to get drug product into the supply chain and finalize trade distribution logistics. The additional time allows for further engagement with advocacy groups and policymakers to optimize the launch environment. Management clarified that Adare will be added to the NDA post-approval, likely in Q3, as a contingency and long-term U.S. supplier. The current manufacturer is addressing FDA observations through a remedial action plan, but Achieve is prioritizing U.S. onshoring for security. Reported over 40 touchpoints with payers in Q1, noting high interest due to the differentiated clinical profile and unmet need. Management declined to provide specific pricing but noted the ICER report affirmed the need for immediate payer access. Management dismissed concerns over the three-times-daily (TID) dosing, citing a 75% adherence rate in the 52-week ORCA-OL trial. Patients reported that TID dosing aligned well with mealtime cravings, providing a psychological benefit during the quitting process. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Achieve also Announces Partnership with U.S.-based Adare Pharma Solutions for Cytisinicline Manufacturing Conference Call Scheduled for 8:30 AM EDT Today, March 24, 2026 SEATTLE and VANCOUVER, British Columbia, March 24, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced financial results for the fourth quarter and full year 2025 and provided updates on the cytisinicline development program, including the announcement of its partnership with Adare Pharma Solutions (Adare). “Achieve is fully committed to bringing cytisinicline to the millions of people who continue to struggle with nicotine dependence and need a new solution to help them quit. Much like GLP-1 therapies have transformed the way obesity is treated, shifting it from a lifestyle issue to a recognized medical condition, smoking cessation deserves the same evolution,” said Rick Stewart, President and Chief Executive Officer of Achieve. “Achieve is not quitting on smokers or people who want to quit vaping. We are relentlessly working towards the potential approval of cytisinicline, the initiation of the Phase 3 vaping trial, and a data-driven, highly targeted commercial launch approach.” Achieve has selected Adare, based in the U.S., to manufacture cytisinicline drug product for potential commercial launch and beyond. Achieve expects this partnership will help decrease risks related to international importation of pharmaceuticals and reduce costs, including potential tariffs. Achieve has commenced the technology transfer to Adare. In addition to potential cost-savings, the Adare partnership provides supply chain redundancy and U.S.-based contingency capacity. One manufacturer named in the cytisinicline NDA recently underwent an FDA current Good Manufacturing Practices inspection, where two observations related to solid oral dose manufacturing were identified, which are being addressed through an ongoing communication with FDA of its remedial action plan. The company anticipates U.S. commercial launch in the first half of 2027. Mr. Stewart commented further, “Establishing U.S. manufacturing with Adare increases our confidence in our supply chain and continues our strong progress towards launch.” Key Highlights Made meaningful progress toward regulatory approval in smoking and vaping: FDA accepted the cytisinicline NDA for treatment of nicotine dependence for smoking cessation in adults, assigning a PDUFA targeted action date of June 20, 2026. Completed the ORCA-OL long-term exposure trial with 334 participants finishing the one-year study, providing comprehensive long-term safety data for cytisinicline and significantly exceeding the number of patients required for FDA review. Cytisinicline was selected as one of the first nine therapies chosen for the inaugural FDA Commissioner’s National Priority Voucher for e-cigarette or vaping cessation. The voucher is designed to provide enhanced FDA communications and expedited review, once complete materials are submitted to the FDA. Preparation for commercial readiness in anticipation of launch: Completed supply chain and market access readiness activities, including beginning implementation of third-party logistics provider and specialty pharmacy partner selection. Announced partnership with Omnicom across multiple, cross-functional agencies to create a data-driven commercial model designed to execute with precision, scale efficiently and accelerate meaningful engagement for patients and providers. Advanced scientific exchange surrounding nicotine dependence, including: Complete results from its ORCA-3 trial were published in the Journal of the American Medical Association (JAMA) Internal Medicine. The authors concluded that ORCA-3 reaffirms cytisinicline’s efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks. Publication of new data in Thorax demonstrated that cytisinicline significantly increased continuous smoking abstinence versus placebo in both chronic obstructive pulmonary disease (COPD) and non-COPD subgroups. Despite more severe tobacco use histories and greater prior treatment exposure, participants with COPD achieved quit rates comparable to those without COPD. Presented new data at the Society for Research on Nicotine and Tobacco (SRNT) 2026 Annual Meeting indicating that cytisinicline delivers meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts. Presented late-breaking survey data from ORCA-OL at SRNT, which followed participants for up to one year of treatment. The voluntary post-trial survey offered insights into patient-reported experiences with the extended use of cytisinicline beyond the 6- and 12-week courses previously studied. “Our comprehensive clinical program demonstrates cytisinicline's potential to address a persistent, public health challenge,” said Mark Rubinstein, MD, Chief Medical Officer of Achieve. “The SRNT findings are particularly encouraging because they indicate that cytisinicline helps people quit smoking regardless of their prior treatment history or number of prior attempts, and, if approved, could offer hope to those who have struggled to quit. Combined with our published research on cytisinicline's tolerability profile, we have a comprehensive body of evidence that could represent a potential new standard of care in nicotine dependence treatment.” Financial Results As of December 31, 2025, the company’s cash, cash equivalents, and marketable securities were $36.4 million. Total operating expenses for the three and twelve months ended December 31, 2025, were $14.7 million and $54.9 million, respectively. Total net loss for the three and twelve months ended December 31, 2025, was $14.7 million and $54.7 million, respectively. Conference Call Details Achieve will host a conference call at 8:30 AM EDT today, Tuesday, March 24, 2026. To access the webcast, please use the following link: 4Q25 Earnings Webcast. Alternatively, you may join the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) and referencing conference ID 13758715. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days. About Achieve Life Sciences, Inc. Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About Cytisinicline There are approximately 25 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3 In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.4 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of Achieve’s third-party manufacturing partners, and the successful launch and commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. Achieve Contact Nicole Jones VP, Strategic Communications and Stakeholder Relations [email protected] 425-686-1510 References 1National Center for Health Statistics. National Health Interview Survey, 2023 and 2024. 2026 (https://www.cdc.gov/nchs/nhis.htm). 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

FDA accepted Achieve's smoking cessation NDA and management says the FDA-set PDUFA date “remains the 20th of June,” with the company shifting to commercial readiness and targeting a potential U.S. launch in the first half of 2027 pending approval and supply readiness. Clinical results emphasize long-term tolerability and consistent efficacy: the ORCA-OL 52‑week trial showed strong safety and >75% adherence, a pooled analysis of >1,600 Phase 3 participants found efficacy across prior-treatment subgroups, and post‑hoc data in Thorax showed significantly improved quit rates in adults with COPD. Achieve has selected U.S. manufacturer Adare, is stockpiling raw material to cover more than three years of expected demand, and is building a digital‑first commercial infrastructure; the company had $36.4 million in cash as of Dec. 31, 2025 and is evaluating financing options given FY operating expenses of $54.9 million. Interested in Achieve Life Sciences, Inc.? Here are five stocks we like better. Achieve Life Sciences (NASDAQ:ACHV) used its fourth-quarter and full-year 2025 earnings call to outline progress toward a potential U.S. launch of cytisinicline, the company’s investigational therapy for nicotine dependence. Management emphasized that the June 2025 new drug application (NDA) submission for smoking cessation marked an inflection point, shifting the company from a “pure play clinical development” focus toward commercial readiness. President and CEO Rick Stewart said the company’s smoking cessation NDA was accepted by the FDA, and he described the review process as involving “normal” communications for this stage. In the Q&A, Stewart stated the FDA-set PDUFA date for the smoking cessation NDA “remains the 20th of June” (as discussed on the call) and said the company continues to work toward that date. → Active ETFs Surge Past Passive, and These Are in the Lead On the vaping cessation program, Chief Medical Officer Dr. Mark Rubinstein highlighted that cytisinicline was among the first recipients of an FDA Commissioner’s National Priority Voucher for e-cigarette or vaping cessation. Rubinstein said the voucher is designed to provide enhanced FDA communications and an expedited NDA review timeline of “1–2 months compared to a typical 10–12 months.” Management said Achieve is preparing to initiate ORCA-V2, its Phase 3 vaping cessation trial. Rubinstein said groundwork is underway, including selecting trial sites and identifying principal investigators. In Q&A, management added that FDA dialogue has largely centered on protocol approval so far, with anticipated study commencement in the first half of the year (as referenced during the call). → Macy’s Beats Expectations Again, But Guidance Spooks Investors Stewart highlighted several clinical developments in 2025, including completion of the ORCA-OL long-term exposure trial. He said the study “underlined cytisinicline safety profile,” citing strong tolerability and “excellent patient satisfaction data,” and emphasized the significance of tolerability over 52 weeks of exposure. Rubinstein added that Achieve presented a pooled analysis of more than 1,600 participants from Phase 3 trials at the Society for Research on Nicotine and Tobacco (SRNT) conference. According to Rubinstein, efficacy was consistent across participants with different prior treatment histories—including those who previously tried varenicline, bupropion, or nicotine replacement therapy—and across differing quit-attempt patterns. → Super Micro's Plunge: An AI Deep Value Opportunity? The company also presented late-breaking survey data from ORCA-OL focused on voluntary, self-reported experiences among participants who continued cytisinicline beyond standard six- or 12-week courses, providing insight into long-term use up to 52 weeks. Rubinstein said participants described meaningful benefits, including successful quitting and improvements in physical health. Stewart also pointed to post-hoc data published in Thorax showing cytisinicline significantly improved quit rates versus placebo among adults with chronic obstructive pulmonary disease (COPD). He noted there are “6 million COPD smokers in the U.S.” and characterized the data as highlighting broader opportunity across comorbidities and provider types. During Q&A, Rubinstein addressed questions about dosing and adherence, noting that in ORCA-OL, participants took cytisinicline three times a day for up to a year. He said participants did not find the regimen excessively burdensome, adding that adherence and completion were high and that adherence in the 52-week trial was “over 75%.” He also said some participants aligned dosing with mealtimes, which they associated with higher cravings. Chief Commercial Officer Jaime Xinos said Achieve built “the foundation for a launch-ready infrastructure from the ground up” while remaining lean. She framed commercialization around three priorities: Availability: supply chain readiness, including progress with a third-party logistics provider, serialization, and state licensing (Xinos said the company had secured more than half of required licenses), plus administrative and logistical setup with a specialty pharmacy hub partner. Access: payer engagement to support coverage and affordability. Xinos said Achieve continued discussions with prioritized payers in Q1 to share clinical data and gather feedback to inform pricing, access, and contracting strategy. Awareness: education designed to reposition nicotine dependence as a medical condition. Stewart and Xinos highlighted the “Willpower” awareness campaign launched in January, intended to challenge the idea that quitting is only about personal determination. Xinos said the company is building an omni-channel, digital platform intended to reach physicians and patients as access to in-person detailing declines. Stewart stated that about 75% of primary care physicians “will no longer meet with medical reps,” and he described AI and machine learning as tools to enhance decision-making, automate engagement, and generate predictive insights. Xinos also described an “AI-powered asset factory” and a partnership with Omnicom to speed development and review of messaging and materials, while maintaining regulatory compliance. Asked about current healthcare provider awareness, Xinos said broad product awareness has not been a priority to date due in part to pre-approval communication limits. She said the company has focused on conserving resources for a stronger push closer to launch, including leveraging scientific meetings such as the American Thoracic Society (ATS) conference, where Achieve has been accepted to present in May 2026. Stewart said Achieve selected Adare Pharma Solutions, a U.S.-based manufacturer, to produce cytisinicline drug products ahead of potential commercial launch and future demand. He said work has begun and the technology transfer is underway, positioning the partnership as a way to secure supply, reduce risks tied to international importation, and potentially reduce costs, including tariff-related uncertainty. Stewart also disclosed that the manufacturer named in the NDA recently underwent an FDA good manufacturing practices inspection that resulted in “2 observations related to solid oral dose manufacture,” which are being addressed through ongoing communications with the FDA. In Q&A, management said the commercial launch is expected in the first half of 2027 and characterized the timeline as driven by the need to ensure product supply and operational readiness. Stewart said adding Adare to the NDA is expected to occur post-approval; he also indicated a goal of having Adare available to be added to the NDA in the third quarter timeframe discussed on the call. Stewart provided additional supply chain color regarding raw plant material, saying Achieve has been stockpiling starting material and expects to have more than three years of supply by launch for expected market needs. He said the company intends to maintain inventory at roughly that level and described reprocessing material as needed. He also discussed Sopharma AD, noting it was not included in the current NDA due to concerns about FDA inspection readiness, but said the company has seen progress and intends to add Sopharma after NDA approval. Chief Financial Officer Mark Oki reported that as of December 31, 2025, Achieve had $36.4 million in cash equivalents and marketable securities. Total operating expenses were $14.7 million for the fourth quarter and $54.9 million for the full year, reflecting investment in regulatory, clinical, and pre-commercial and commercial infrastructure. Net loss totaled $14.7 million for the quarter and $54.7 million for the year. Oki said the company continues evaluating financing options and cash management strategies. On payer strategy, Xinos said Achieve has been engaging payers through pre-approval information exchange, citing “about 40 touch points with payers” in the first quarter and participation at PCMA. She said some payers have proactively requested discussions, and she cited the Affordable Care Act requirement for coverage of smoking cessation treatment as supportive of access. Still, Xinos said the company expects a “slow ramp” in the first six months after launch as formulary placement expands and initial access restrictions are worked through. Management declined to discuss specific pricing. In response to a question about an ICER report, Xinos said Achieve participated in the process by providing information when requested and said the report affirmed substantial unmet need and recommended payers make cytisinicline immediately available, but she said the company has not set pricing yet. Achieve Life Sciences, Inc (NASDAQ: ACHV) is a clinical-stage biotechnology company dedicated to the development and commercialization of cytisinicline, a plant-derived alkaloid for smoking cessation. The company’s mission is to offer a novel, evidence-based therapy that addresses the global need for effective and well-tolerated smoking cessation options. Achieve focuses its efforts on advancing the clinical profile of cytisinicline through rigorous development programs and regulatory engagement. Cytisinicline (formerly marketed as Tabex® in Europe) acts as a nicotinic acetylcholine receptor partial agonist, helping reduce withdrawal symptoms and nicotine cravings. The article "Achieve Life Sciences Q4 Earnings Call Highlights" was originally published by MarketBeat.