Achieve Life Sciences Reports $39.8M Loss, Plans NDA Submission for Cytisinicline

Achieve Life Sciences reported a net loss of $12.4 million for Q4 2024 and a total loss of $39.8 million for the year, reflecting increased research and development costs associated with its cytisinicline program aimed at nicotine dependence treatment. The company completed enrollment in the ORCA-OL long-term exposure trial and plans to submit a New Drug Application (NDA) to the FDA by the end of Q2 2025, aiming to introduce the first new FDA-approved treatment for smoking cessation in nearly two decades. Achieve's financial position remains strong with $34.4 million in cash, but it acknowledges the need for additional financing to support operations beyond 2025. Leadership changes were announced to strengthen the company's strategic initiatives, including the appointment of Dr. Kristen Slaoui and others to key positions. The potential market for cytisinicline is significant, with millions of Americans currently seeking effective smoking cessation solutions. Achieve remains optimistic about the future impact of its treatment on public health and shareholder value.