ACHIEVE LIFE SCIENCES, INC.

We are a late-stage clinical specialty pharmaceutical company focused on developing and selling cytisinicline to address the global nicotine dependence epidemic. In the United States, an estimated 29 million adults smoke combustible cigarettes and 17 million adults use e-cigarettes. Tobacco use causes over eight million deaths worldwide and nearly half a million deaths in the United States annually. Over 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are linked to smoking and secondhand smoke. While e-cigarettes are considered less harmful than combustible cigarettes, they are highly addictive and can deliver harmful chemicals. In 2024, 1.6 million high school and middle school students reported using e-cigarettes, and research indicates adolescents who have used e-cigarettes are seven times more likely to become smokers one year later. In 2024, the FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. This designation expedites the development and review of new drugs for serious or life-threatening conditions with evidence of substantial improvement over existing therapies. In October 2025, the FDA awarded cytisinicline for nicotine e-cigarette, or vaping, cessation the Commissioner's National Priority Voucher (CNPV) as part of a pilot program. A CNPV is given to product candidates with significant potential to address a major national priority, such as a large unmet medical need, reducing healthcare utilization, or addressing a public health crisis.