ACHIEVE LIFE SCIENCES, INC.

Item 1. Legal Proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Other than as described below, we are not currently a party to any material pending legal proceedings, and we are not currently a party to any pending administrative or judicial proceeding to which a governmental authority is a party that involves potential monetary sanctions. Any such ordinary routine litigation incidental to our business, and any proceeding in which the amount involved does not exceed 10% of our current assets on a consolidated basis, is not required to be described and is not described below.

Achieve is party to the Sopharma Supply Agreement with Sopharma AD, or Sopharma. As we approached the submission of our NDA, we communicated to Sopharma that we had concerns regarding their ability to pass an FDA pre-approval inspection and that if those concerns were not resolved, we planned to utilize third-party manufacturers, and include such manufacturers in our NDA, until such time that Sopharma is able to pass an FDA inspection. In June 2025, we submitted our NDA, which included third-party manufacturers. Sopharma has alleged that our planned utilization of third-party manufacturers is a breach of the Sopharma Supply Agreement, which we have disputed. On July 17, 2026, Sopharma filed a demand for arbitration in New York with the American Arbitration Association, also known as AAA, pursuant to the dispute resolution provisions in the Sopharma Supply Agreements. Sopharma seeks actual, compensatory, incidental, and consequential damages; costs and attorneys’ fees; restitution; declaratory relief; and an order requiring us to include Sopharma as our designated manufacturer in any future NDA submission. We dispute these claims and intend to defend the matter vigorously. For additional information regarding this matter, see Note 4 “License Agreements” in the notes to the unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.