Achieve Life Sciences (ACHV) Corporate presentation summary

Market opportunity and public health impact

• Nicotine dependence affects up to 50 million Americans, with 29 million smokers and 17 million vape users, representing a significant unmet need and $11 billion estimated prescription opportunity annually.

• Smoking-related healthcare costs in the U.S. exceed $600 billion annually, with profound co-morbidity including cardiovascular, respiratory, and neurodegenerative diseases.

• 53% of smokers attempt to quit each year, but less than 10% succeed, highlighting the need for new treatment options.

• E-cigarette use is rising, especially among young adults, with 60% of adult users wanting to quit.

• Cytisinicline addresses both smoking and vaping cessation, targeting a broad and underserved population.

Product profile and clinical efficacy

• Cytisinicline is the first potential new FDA-approved nicotine dependence treatment in nearly 20 years, offering a differentiated and well-tolerated profile.

• Demonstrated robust efficacy in Phase 3 trials (ORCA-2 and ORCA-3), with significantly higher quit rates than placebo and strong results in both 6- and 12-week regimens.

• Excellent tolerability with lower rates of nausea, insomnia, and abnormal dreams compared to varenicline (Chantix®).

• Efficacy and safety extend to high-risk groups, including COPD patients and heavily pre-treated smokers.

• Dual-acting mechanism helps normalize brain chemistry, reducing cravings and withdrawal symptoms.

Regulatory and development milestones

• PDUFA date for smoking cessation indication expected June 20, 2026; product launch anticipated in 2H 2026.

• Vaping cessation program awarded Commissioner's National Priority Voucher (CNPV) and Breakthrough Therapy designation, enabling accelerated FDA review.

• Phase 3 ORCA-V2 trial for vaping cessation underway, following strong Phase 2 results showing 2.6x increased quit likelihood.

• Synthetic cytisinicline manufacturing and expanded indications (e.g., relapse prevention) are in development.