Achieve Life Sciences (ACHV) investor relations material

Regulatory and clinical milestones

• FDA accepted the NDA for cytisinicline, marking the first new nicotine dependence treatment in nearly 20 years.

• ORCA clinical trials showed robust efficacy and safety, with no major regulatory review concerns anticipated.

• Manufacturing and supply chain preparations are robust, with FDA-inspected partners and readiness for a gated launch by late 2026.

• Phase 3 trial for vaping cessation will start mid-next year, mirroring the smoking cessation trial design.

Commercialization strategy and market opportunity

• Commercial infrastructure is being built from scratch, leveraging Omnicom's integrated platform for agile, targeted messaging.

• Focused on 7,000 high-prescribing physicians and well-defined patient segments, with digital and adaptive outreach.

• Monthly, 500,000–600,000 prescriptions are written for nicotine dependence; peak Chantix sales reached $880M with only 4% market penetration.

• The vaping cessation market adds 17 million potential patients, significantly expanding the opportunity.

Payer access and financial position

• Affordable Care Act mandates two free smoking cessation treatments; payer engagement is ongoing to ensure rapid access.

• Initial payer engagement may take 6–9 months post-launch, with interim processes to maximize patient access.

• Recent $49M fundraising extends runway into H2 2026, with future funding to focus on debt and royalty rather than equity.