Achieve Life Sciences, Inc.

Company at a glance

• Structure and locations: Delaware corporation with principal executive offices in Bothell, WA, and Vancouver, BC.
• Mission: Late-stage specialty pharmaceutical company developing cytisinicline to address nicotine dependence.
• Public status and revenue: Public company; no revenue from product sales to date. Development and commercialization depend on licensing, partnerships, and regulatory approvals for cytisinicline.
• Employees: 28 as of December 31, 2025 (11 R&D; 17 general and administrative).
• Stock and ownership:
  • Outstanding shares: 53,239,988 (as of March 24, 2026).
  • Aggregate market value held by non-affiliates: $103,958,994 (as of June 30, 2025, based on last sale price).
• Debt and liquidity:
  • Outstanding debt: $15.0 million under the New Debt Agreement with Silicon Valley Bank/First Citizens Bank (as of December 31, 2025).
  • Debt terms: Floating rates tied to the prime rate; maturity December 1, 2027 (with potential extensions); secured by substantially all assets except intellectual property.
• Regulatory highlights:
  • FDA accepted the NDA for cytisinicline for smoking cessation in September 2025; PDUFA target date June 20, 2026.
  • Breakthrough Therapy designation for vaping cessation granted July 2024.
  • FDA Commissioner’s National Priority Voucher (CNPV) awarded for vaping cessation in October 2025.

Cytisinicline: product profile and intended uses

• Compound: Cytisinicline (cytisine) is a naturally occurring alkaloid, structurally similar to nicotine, acting as a partial agonist/antagonist at α4β2 nicotinic receptors.
• Primary indication targeted: Prescription smoking cessation in adults in the United States (first FDA indication sought).
• Secondary and expansion opportunities: Nicotine e-cigarette (vaping) cessation and potential future indications for other forms of nicotine dependence.
• Dosing and formulation:
  • 3 mg tablet administered three times daily (TID) with a 25-day downward titration regimen.
  • Alternative 6- or 12-week regimens were evaluated in clinical trials.
  • In Sopharma territories, a 25-day downward titration regimen has been marketed for over 20 years.

Regulatory progress and clinical program

• IND and development timeline:
  • IND filed with FDA in June 2017, supported by non-clinical toxicology studies.
  • Phase 3 development discussions with FDA began in 2018; Phase 3 program initiated in late 2020.
• Smoking cessation Phase 3 trials:
  • ORCA-2 (Phase 3): 810 adult smokers; evaluated 6-week and 12-week cytisinicline regimens versus placebo.
    • 12-week arm: weeks 9–12 abstinence 32.6% (cytisinicline) vs 7.0% (placebo); odds ratio (OR) 6.3; p<0.0001.
    • 6-week arm: weeks 3–6 abstinence 25.3% (cytisinicline) vs 4.4% (placebo); OR 8.0; p<0.0001.
    • Continuous abstinence weeks 9–24 favored both cytisinicline arms (12-week: 21.1%; 6-week: 8.9%) versus placebo.
  • ORCA-3 (Phase 3 confirmatory): 792 adult smokers; 12-week and 6-week cytisinicline arms versus placebo.
    • 12-week arm: weeks 9–12 abstinence 30.3% vs 9.4% (placebo); p<0.0001. Continuous abstinence weeks 9–24: 20.5% vs 4.2% (placebo); p<0.0001.
    • 6-week arm: weeks 3–6 abstinence 14.8% vs 6.0% (placebo); p=0.0008. Continuous abstinence weeks 3–24: 6.8% vs 1.1% (placebo); p=0.0006.
• Vaping cessation development:
  • NIH/NIDA grant awarded July 2021 to study vaping cessation with cytisinicline.
  • FDA accepted an IND for vaping cessation in November 2021.
  • Breakthrough Therapy designation for vaping cessation granted July 2024; CNPV awarded October 2025.
  • ORCA-V1 (Phase 2 for vaping cessation): 160 adults; 12-week cytisinicline 3 mg TID versus placebo.
    • Vaping abstinence weeks 9–12: 31.8% (cytisinicline) vs 15.1% (placebo).
    • Cytisinicline increased odds of vaping cessation versus placebo (OR 2.64; p=0.04).
    • No serious adverse events reported; overall adverse event rates were similar between arms.
    • Results presented at SRNT and published in JAMA Internal Medicine (May 2024).
• Long-term safety exposure:
  • ORCA-OL: Open-label study up to 12 months; 479 subjects enrolled; completed September 2025.
  • FDA-required long-term exposure data (6 months and 1 year) were included in the NDA submission and a 120-day safety update.
• NDA submission and review status:
  • NDA for smoking cessation submitted June 2025; FDA accepted the filing in September 2025.
  • PDUFA target date: June 20, 2026.
  • The company identified potential manufacturing-related deficiencies at a third-party site named in the NDA that could delay approval beyond the PDUFA date.
  • Adare Pharma Solutions has been engaged to provide U.S.-based manufacturing contingency capacity; technology transfer is underway.

Manufacturing, supply chain, and third-party relationships

• Primary supplier/manufacturer: Sopharma (supplies finished drug product for clinical trials and certain territories).
• U.S. manufacturing contingency: Adare Pharma Solutions engaged for potential commercial manufacturing; technology transfer ongoing to provide redundancy and reduce import reliance.
• Other contract manufacturers: Multiple CMOs used for clinical packaging and potential commercial supply.
• Supply chain considerations:
  • Cytisinicline is plant-derived; agricultural variability affects raw material supply and may require development of synthetic routes if plant supply is unstable.
  • Regulatory inspections of manufacturers and potential impurities (e.g., nitrosamines) are managed as part of pre-approval readiness.
  • Disputes with Sopharma related to third-party manufacturing engagements have been identified and are being addressed.

Intellectual property

• Patent and licensing position:
  • Cytisinicline is a naturally occurring compound and is not patentable as the compound itself in the U.S.; protection is pursued through method, formulation, derivative, and process patents.
  • Portfolio: Over 20 issued patents and more than 50 pending applications (as of December 31, 2025) covering dosing methods, derivatives, salts, extraction methods, and formulations across multiple jurisdictions.
  • Key arrangements: Exclusive licensing and supply arrangements with Sopharma, and licensed technology from the University of Bristol.
• Regulatory exclusivity: The company also plans to rely on Hatch-Waxman data exclusivity and EU competition/exclusivity provisions to extend market protection.

Market context and competitive landscape

• Market need: High prevalence of cigarette smoking and vaping with substantial relapse rates create demand for effective cessation therapies.
• Competitive environment:
  • Existing therapies in the U.S. include varenicline, bupropion, and nicotine replacement therapies.
  • Cytisinicline is positioned as a dual-acting agent with 6-week or 12-week regimens and an additional focus on vaping cessation.
• Reimbursement and pricing:
  • Pricing, coding, and reimbursement will be central to commercial success in the U.S. and internationally.
  • Pharmacoeconomic data and payer engagement will be needed to support coverage and formulary decisions.
  • Healthcare policy developments may affect pricing, rebates, and reimbursement dynamics.

Financial position and operating outlook

• Revenue and profitability: No product revenue to date; not profitable and has incurred losses since inception. The company expects continued losses during development and potential commercialization.
• Funding and liquidity:
  • Dependent on external financing (debt and equity) to support development, regulatory activities, and commercialization planning.
  • Existing secured debt carries floating interest and matures in 2027, with covenants and repayment obligations that may constrain cash resources.
• Personnel and operations:
  • 28 employees as of December 31, 2025.
  • Leadership team includes executives such as Richard Stewart, Craig Donnelly, Erik Atkisson, Jaime Xinos, Mark Oki, and Mark Rubinstein.
  • The company relies on CROs and external contractors for clinical development.
• Commercial timing:
  • NDA acceptance and a PDUFA date of June 20, 2026 are key near-term milestones.
  • The company anticipates a potential U.S. commercial launch in the first half of 2027, contingent on regulatory approval and successful scale-up with Adare and other CMOs.

Key agreements and partnerships

• Sopharma:
  • License and supply agreements covering cytisinicline outside Sopharma territories; collaboration on manufacturing and supply; royalties and milestone payments are part of the arrangements.
  • Agreements have been amended over time to adjust royalties, extend terms, and clarify termination provisions.
• University of Bristol:
  • License agreement for cytisinicline-related technology for human medicinal uses, with milestone payments and royalties on commercialization.
• Share Purchase Agreement with Sopharma (2015):
  • Acquisition of a majority interest in Extab Corporation with contingent consideration tied to regulatory approvals; fair value reflected in the company's financials.
• Omnicom:
  • Marketing support arrangement for potential U.S. commercialization (subject to terms and financial commitments).

Summary takeaways

• Focus: Developing and commercializing cytisinicline as a prescription treatment for nicotine dependence, targeting smoking cessation first and vaping cessation as an additional indication.
• Clinical evidence: Phase 2 and Phase 3 trials demonstrated favorable efficacy outcomes versus placebo for both 6-week and 12-week regimens in smoking cessation, and positive Phase 2 results in vaping cessation.
• Regulatory path: NDA accepted for smoking cessation with a PDUFA date of June 20, 2026; Breakthrough Therapy designation and a CNPV support the vaping cessation program.
• Supply strategy: Primary supply from Sopharma with a transition plan to include U.S.-based CMOs (Adare) to provide redundancy and reduce import reliance; manufacturing and regulatory readiness are ongoing priorities.
• IP and commercialization: A patent portfolio covering methods and formulations, plus licensing arrangements with Sopharma and Bristol, supports the company’s commercialization strategy.
• Financial posture: Pre-revenue and not profitable; dependent on external financing with existing secured debt; commercial launch timing contingent on regulatory approval and supply-chain scale-up.