Cytisinicline

Brings 15 years of pharma launch, health system, and direct-to-patient engagement experience as Achieve prepares for potential commercialization of cytisinicline SEATTLE and VANCOUVER, British Columbia, Oct. 07, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve and 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 the appointment of Kaitlyn (Kait) Tuson as Senior Vice President, Marketing and Communications. Tuson joins Achieve’s executive team and will lead its marketing, brand strategy, and corporate communications as the Company prepares for the potential commercialization of cytisinicline. Tuson has spent 15 years building, launching, and scaling brands across the healthcare industry, with go-to-market leadership spanning dozens of launches, six of them in pharma, including three blockbuster therapies. She specializes in designing high-engagement, direct-to-patient experiences and has led campaigns, both for healthcare providers and consumers, from strategy through execution across more than 40 therapeutic areas and conditions globally. “We are delighted to welcome Kait to Achieve at this important time. Her experience across brand building, product launch strategy, patient engagement, and health systems will be invaluable as we advance toward our planned NDA resubmission and prepare for the potential commercialization of cytisinicline,” said Andrew D. Goldberg, MD, Chief Executive Officer, Achieve. “Kait will lead our efforts to build understanding of nicotine dependence as a treatable condition among patients, healthcare professionals, and other key stakeholders.” “Smoking remains the leading cause of preventable death in the world, and the tools available to help people quit haven’t meaningfully changed in two decades,” said Tuson. “I’ve spent my career building healthcare brands that turn science into something patients can act on, meeting them where they are and earning the trust of the clinicians who guide them. I’m honored to bring that experience to Achieve at a moment when cytisinicline has the potential to change what’s possible for millions of people who want and need to quit smoking and vaping.” Tuson’s appointment builds on a series of steps Achieve has made in 2026 to prepare for potential commercialization, including the appointment of Andrew D. Goldberg, MD as Chief Executive Officer, a financing of up to $354 million, and the additions of senior commercial, manufacturing, and quality leadership. 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 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, responsible for more than seven 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 2025, approximately 1.4 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 Achieve 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 dependence 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 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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements regarding the timing and outcome of Achieve’s planned NDA resubmission for cytisinicline, the timing of any FDA decision, the potential benefits of cytisinicline, the potential market for cytisinicline, the Company’s commercialization plans and readiness, and the anticipated benefits of new executive leadership. Achieve may not achieve its plans, projections, or other expectations and may not be able to successfully complete its NDA resubmission or obtain regulatory approval for cytisinicline on the anticipated timeline or at all. These statements are based on management’s current expectations and beliefs and are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including those detailed in Achieve’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Achieve undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. CONTACT Nicole Jones VP, Strategic Communications and Stakeholder Relations ir@achievelifesciences.com media@achievelifesciences.com 425-686-1510 REFERENCES ¹Agaku 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, 2025. Geneva: World Health Organization; 2025. ³U.S. Department of Health and Human Services. The Health Consequences of Smoking, 50 Years of Progress. A Report of the Surgeon General. Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. ⁴Eunice 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.

Brings public company CFO experience across commercial pharma and business development as Achieve prepares for potential commercialization of cytisiniclineSEATTLE and VANCOUVER, British Columbia, Oct. 01, 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 the appointment of Benjamin Halladay, CPA, as Chief Financial Officer, effective October 5, 2026. He will be responsible for the Company’s financial strategy, accounting, investor relations, information technology, and other key administrative functions. Mr. Halladay joins Achieve from Esperion Therapeutics, a commercial-stage pharmaceutical company with more than $400 million in annual revenue, where he served as Chief Financial Officer from November 2022 until July 2026. During his tenure, Esperion deleveraged its balance sheet and acquired Corstasis Therapeutics and its product Enbumyst. He led the finance workstream through the company’s sale to ARCHIMED for up to $1.1 billion. As announced by Esperion, the upfront cash consideration represented a premium of 58% to its closing share price on April 30, 2026. Mr. Halladay brings more than 15 years of financial management experience across commercial and launch environments, with earlier positions at Pfizer Inc., where he worked on Lipitor and Chantix in the Primary Care business unit, and at National Oilwell Varco, a Fortune 500 global industrial company. “Ben has helped scale a commercial pharma organization and expand its portfolio through business development within its existing capital structure,” said Andrew D. Goldberg, MD, Chief Executive Officer, Achieve. “He has run the finance function as a public company CFO, and began his biopharma finance career in large-cap pharma. As we move toward potential commercialization of cytisinicline, that combination of capital efficiency and operating experience is exactly what this stage demands.” “The discipline that determines how a launch goes is put in place long before the first prescription is written,” said Mr. Halladay. “That is the work I’m excited to do. Achieve is developing a medicine that could change what quitting looks like for millions of people, and my job is to build the financial and operating foundation that supports it, on schedule and on plan.” Mr. Halladay holds an MBA from Fordham University and a BA from Syracuse University, and is a Certified Public Accountant (inactive). Mark Oki will step down as Chief Financial Officer of Achieve, effective October 5, 2026, and Mr. Halladay succeeds him in the role. Mr. Oki served as Chief Financial Officer through Achieve’s Phase 3 program and NDA submission, and the Company thanks him for his contributions. 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.¹ Tobacco use is currently the leading cause of preventable death, responsible for more than seven 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 2025, approximately 1.4 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 Achieve 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 dependence 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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements regarding the timing and outcome of Achieve’s planned NDA resubmission for cytisinicline, the timing of any FDA decision, the potential benefits of cytisinicline, the potential market for cytisinicline, the Company’s commercialization plans and readiness, and the anticipated benefits of new executive leadership. Achieve may not achieve its plans, projections, or other expectations and may not be able to successfully complete its NDA resubmission or obtain regulatory approval for cytisinicline on the anticipated timeline or at all. These statements are based on management’s current expectations and beliefs and are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including those detailed in Achieve’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Achieve undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. CONTACTNicole JonesVP, Strategic Communications and Stakeholder Relationsir@achievelifesciences.commedia@achievelifesciences.com425-686-1510 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, 2025. Geneva: World Health Organization; 2025.³U.S. Department of Health and Human Services. The Health Consequences of Smoking, 50 Years of Progress. A Report of the Surgeon General. Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.⁴Eunice 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.