Achieve Life Sciences (ACHV) Corporate presentation summary

Addressing nicotine dependence and public health

• Nicotine dependence remains a major public health crisis, costing over $600B annually in U.S. healthcare costs and affecting millions of Americans, with high rates of co-morbidities such as cardiovascular and respiratory diseases.

• Approximately 25 million U.S. adults smoke, and 18 million use e-cigarettes, with a significant portion seeking to quit but lacking effective treatment options.

• Cytisinicline is positioned as the first new FDA-approved treatment for nicotine dependence in 20 years, targeting both smoking and vaping cessation.

Product profile and clinical efficacy

• Cytisinicline offers a highly differentiated, well-tolerated profile with once-daily oral dosing and potential for alternate administration routes.

• Phase 3 trials (ORCA-2 and ORCA-3) demonstrated significantly higher quit rates versus placebo, with strong efficacy and tolerability, including in COPD and heavier smokers.

• Adverse event rates for cytisinicline are notably lower than for varenicline (Chantix®), especially for nausea and sleep disturbances.

• The product’s dual-acting mechanism targets nicotine receptors to reduce cravings and withdrawal, helping restore normal brain chemistry.

Regulatory and commercialization strategy

• Cytisinicline’s PDUFA date for smoking cessation is June 20, 2026, with a U.S. launch expected in the first half of 2027.

• The vaping cessation indication has received the FDA Breakthrough Therapy Designation and a Commissioner's National Priority Voucher, expediting review.

• Launch strategy focuses on high-volume prescribers and highly motivated quitters, leveraging data-driven, omnichannel marketing and AI-enabled personalization.

• ACA coverage is anticipated, and the quiet promotional landscape offers a favorable environment for market entry.