ACHIEVE LIFE SCIENCES, INC. Annual Report - How They Did This Year

I’ve put together this guide to help you understand Achieve Life Sciences’ performance. My goal is to turn complex filing data into simple information you can use to decide if this company fits your investment goals.

1. What does this company do?

Achieve Life Sciences is a drug developer focused on a single product: cytisinicline. This treatment is designed to help people quit smoking and vaping. The company is currently in the clinical trial phase and is working toward FDA approval. Their ORCA program aims to provide a faster, more effective alternative to current smoking cessation options.

2. Financial health: The "Going Concern" warning

The company’s auditors have raised "substantial doubt" about its ability to stay in business. They reported a loss of approximately $68.4 million last year and are currently burning through $4 million to $6 million per month on research and operations. With roughly $61.5 million in cash as of the end of 2025, the company has a limited runway and will need to secure additional funding within the next year to continue its trials and FDA application process.

3. Major wins and challenges

The company’s primary focus this year was securing the capital necessary to keep operations running:

• Capital Raises: They raised approximately $40 million through a stock sale in June 2025. Additionally, they secured a $125 million loan, though access to the full amount is contingent upon hitting specific FDA milestones.
• Manufacturing Risks: The company’s future is tied to a single product derived from plants grown outside the U.S. They rely on a third-party manufacturer in Bulgaria. Any supply chain disruptions, political instability, or failures to meet FDA quality standards could halt their progress.

4. Key risks for investors

Investing in Achieve is a high-stakes, "all-or-nothing" proposition. Consider these factors:

• Regulatory Hurdles: Because the company has no other products, their success rests entirely on FDA approval. If trials fail or the FDA identifies safety issues, the company lacks a secondary revenue stream, which would likely render the stock worthless.
• Dilution: Without product revenue, the company funds itself by issuing new shares. Last year, the total number of shares grew by 15%, which reduces the ownership percentage of existing shareholders.
• Debt Burden: The company carries significant debt with high interest rates. If they fail to reach the milestones required to unlock their loan facility, they may be forced to sell more shares at unfavorable prices to avoid defaulting.

5. Future outlook

The company’s immediate goal is to submit its application to the FDA for cytisinicline. They are also investigating the drug's potential for treating e-cigarette addiction. Success hinges on their ability to reach the finish line without exhausting their cash reserves or excessively diluting shareholders.

6. The Bottom Line

As of March 2026, the company had 53.2 million shares outstanding. With no product revenue, this is a speculative investment. You are not buying a business with steady sales; you are buying a position on a single regulatory outcome. If the FDA approves the drug, the company has the potential to transition into a commercial business. If the FDA rejects it, the company faces a severe cash crisis.

Before you invest: Ask yourself if you are comfortable with the binary nature of this stock. Since the company’s value is tied to one specific regulatory decision, ensure your position size reflects the high risk of a total loss versus the potential upside of a successful product launch.