Achieve Life Sciences Reports $39.8 Million Net Loss for 2024, Highlights Clinical Advancements

Achieve Life Sciences, Inc. reported a net loss of $39.8 million for the year ended December 31, 2024, compared to a loss of $29.8 million in the previous year. The company's total operating expenses increased to $39.1 million from $27.3 million in 2023, primarily driven by higher research and development costs associated with the initiation of the ORCA-OL open-label safety trial. Research and development expenses rose to $22.8 million from $15.8 million, while general and administrative expenses also increased to $16.3 million from $11.4 million, reflecting higher employee compensation and legal costs. As of December 31, 2024, Achieve had cash, cash equivalents, and marketable securities totaling $34.4 million, with a positive working capital balance of $29.8 million.

The company has made significant strides in its clinical development of cytisinicline, a treatment for nicotine dependence. In 2024, Achieve received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for cytisinicline aimed at e-cigarette cessation. The company plans to submit a New Drug Application (NDA) for cytisinicline for smoking cessation by the end of the second quarter of 2025. Achieve has completed two Phase 3 clinical trials, ORCA-2 and ORCA-3, which demonstrated significant efficacy in smoking cessation, and is currently conducting the ORCA-OL trial to gather long-term safety data.

Achieve's operational metrics indicate a focus on expanding its clinical trials and regulatory submissions. The company has engaged in strategic partnerships, including a supply agreement with Sopharma AD for the manufacturing of cytisinicline, which is critical for its clinical trials and potential commercialization. As of December 31, 2024, Achieve had 25 employees, with a majority involved in research and development functions. The company is also exploring additional indications for cytisinicline, including its use in treating nicotine dependence related to e-cigarettes.

Despite these advancements, Achieve faces substantial financial challenges, including a significant accumulated deficit of $205.6 million and ongoing operating losses. The company has expressed substantial doubt about its ability to continue as a going concern without additional financing. Achieve plans to raise further capital through equity offerings, debt financing, and potential collaborations to support its clinical development and commercialization efforts. The financial environment for biotechnology companies remains uncertain, which may impact Achieve's ability to secure necessary funding on favorable terms.