ACHV Achieve Life Sciences Inc

Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, is pleased to announce the promotion of Ms. Jaime Xinos to Chief Commercial Officer, effective immediately.

Ms. Xinos has been with Achieve Life Sciences since 2017, serving as Executive Vice President of Commercial. In her expanded role, she will oversee all commercial operations and lead the company’s strategic preparations for the anticipated U.S. launch of cytisinicline. This includes driving readiness across key stakeholders, including patients, healthcare providers, and payors. These efforts will help position cytisinicline for a successful launch upon FDA approval.

Rick Stewart, CEO of Achieve Life Sciences, commented, “We are thrilled to promote Jaime to Chief Commercial Officer, where she will continue to build upon her leadership in driving our commercial initiatives. Her focus on developing innovative, patient-first, digital strategies is critical to our efforts to successfully bring cytisinicline to market. Jaime’s leadership will not only enhance cytisinicline’s commercial readiness but will also be pivotal in helping millions of people struggling with smoking and vaping addiction who are seeking new solutions to quit following FDA approval.”

Ms. Xinos will spearhead Achieve’s efforts to forge strategic partnerships with partners and commercialization experts with proven experience that understand the unique challenges of small biotech companies launching their first product and offer value-driven, efficient solutions designed to ensure successful market entry.

“I’m honored to step into this expanded role as Chief Commercial Officer at such a pivotal time for Achieve Life Sciences,” said Ms. Xinos. “Cytisinicline’s potential to become the first new FDA-approved treatment for nicotine dependence in nearly two decades offers an unparalleled opportunity to make a meaningful impact on global public health. My focus will be on fostering strong collaborations with key stakeholders and executing a targeted, innovative strategy that can drive value while improving the lives of the patients we serve.”

Ms. Xinos brings nearly 25 years of commercial experience in the biotechnology and pharmaceutical industries, having held positions of increasing responsibility at companies including OncoGenex, Pfizer, Novartis, and Abbott Laboratories. She is recognized as an inspirational thought leader, adept at translating scientific advancements into business strategies and developing commercial frameworks for specialty products across all stages of the product lifecycle. Ms. Xinos holds a Bachelor of Arts (B.A.) in Liberal Arts and Sciences and a Master of Business Administration (MBA) both from the University of Illinois.

About Achieve and CytisiniclineAchieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are approximately 29 million adults in the United States alone 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 over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.5 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.

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 for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.

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 regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, the development and effectiveness of new treatments, and the successful 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, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including inflation, volatile interest rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, 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.

Investor Relations ContactRich Cockrellachv@cg.capital(404) 736-3838

Media ContactGlenn SilverGlenn.Silver@Finnpartners.com(646) 871-8485

References 1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641. 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. 4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 5Park-Lee E, Jamal A, Cowan H, et al. Notes from the Field: E-Cigarette and Nicotine Pouch Use Among Middle and High School Students — United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:774–778.