ACHIEVE LIFE SCIENCES, INC.

Achieve Life Sciences, Inc. (NASDAQ: ACHV) is a late-stage clinical specialty pharmaceutical company focused on addressing the global nicotine dependence epidemic through the development and commercialization of cytisinicline. The company's website is www.achievelifesciences.com.

Cytisinicline is a naturally occurring alkaloid with a dual-acting mechanism of action that functions as both a receptor agonist and antagonist. The compound works by interacting with nicotine receptors in the brain to reduce craving and withdrawal symptoms while diminishing the reward associated with nicotine products. Cytisinicline has been approved and marketed in Central and Eastern Europe for over two decades, with an estimated twenty million people having used the treatment for nicotine dependence.

Achieve holds an exclusive license and supply agreement with Sopharma AD for development and commercialization of cytisinicline outside of Sopharma's territories, which include Central and Eastern Europe, Scandinavia, North Africa, the Middle East, Central Asia, and Vietnam. The company is developing cytisinicline for two primary indications: smoking cessation and nicotine e-cigarette cessation. In June 2025, Achieve submitted a New Drug Application to the FDA for cytisinicline as a smoking cessation treatment, with a PDUFA targeted action date of June 20, 2026. The company received Breakthrough Therapy designation for the vaping cessation indication in July 2024 and was awarded the Commissioner's National Priority Voucher in October 2025 for the same indication.

The company's clinical development program includes completed Phase 3 trials for smoking cessation, designated ORCA-2 and ORCA-3, which demonstrated statistically significant efficacy compared to placebo. A Phase 2 trial for vaping cessation, ORCA-V1, showed positive results, and an open-label long-term safety trial, ORCA-OL, was completed in September 2025. Achieve has partnered with U.S.-based manufacturer Adare Pharma Solutions to establish domestic manufacturing capacity and supply chain redundancy, with commercial launch anticipated in the first half of 2027. The company positions cytisinicline as differentiated from existing smoking cessation treatments through its combination of efficacy, well-tolerated safety profile, and flexible dosing regimens of six or twelve weeks.