Achieve Life Sciences Reports $12.8 Million Net Loss in Q1 2025, Faces Financial Challenges

Achieve Life Sciences, Inc. reported a net loss of $12.8 million for the first quarter of 2025, a significant increase from the $6.5 million loss recorded in the same period of 2024. The company's total operating expenses rose to $12.9 million, up from $6.0 million year-over-year, primarily driven by increased research and development costs associated with the ongoing ORCA-OL trial, which focuses on the long-term safety of its product candidate, cytisinicline. The company has not generated any revenue from product sales, maintaining an accumulated deficit of $218.4 million as of March 31, 2025.

In terms of financial position, Achieve Life Sciences reported cash, cash equivalents, and marketable securities totaling $23.2 million, down from $36.5 million at the end of 2024. The decrease in cash reserves is attributed to the higher operational costs and net cash used in operating activities, which amounted to $11.1 million for the quarter. The company has indicated substantial doubt regarding its ability to continue as a going concern, emphasizing the need for additional financing to support ongoing clinical development and operational activities.

Strategically, Achieve Life Sciences is focused on advancing cytisinicline, a plant-based alkaloid aimed at treating nicotine dependence. The company has received Breakthrough Therapy designation from the FDA for cytisinicline for vaping cessation, which is expected to expedite its development and review process. The company plans to submit a New Drug Application (NDA) to the FDA in June 2025, based on data from completed Phase 3 trials and the ongoing ORCA-OL trial. However, the company faces challenges, including potential disputes with its supplier, Sopharma, regarding manufacturing capabilities and compliance with FDA regulations.

Operationally, Achieve Life Sciences has been expanding its clinical trial efforts, with the ORCA-OL trial enrolling 479 subjects across 29 sites in the U.S. The trial aims to provide long-term safety data necessary for the NDA submission. The company has also indicated plans to explore additional indications for cytisinicline, including its use in e-cigarette cessation, contingent on securing adequate funding. As of March 31, 2025, Achieve Life Sciences had 34,685,072 shares of common stock outstanding, with no significant changes in employee headcount reported during the quarter.

Looking ahead, Achieve Life Sciences acknowledges the need for substantial additional capital to continue its clinical development and commercialization efforts. The company is exploring various financing options, including equity offerings and potential collaborations, to support its operations. However, the current macroeconomic environment poses challenges to raising funds, and the company has warned that failure to secure necessary financing could adversely impact its ability to achieve its development and commercialization goals.