Achieve Life Sciences(ACHV) - 2024 Q4 - Annual Results

Financial Performance - Achieve Life Sciences reported a total net loss of $12.4 million for Q4 2024 and$39.8 million for the full year 2024, compared to a net loss of $5.5 million and$29.8 million for the same periods in 2023, respectively[10][21]. - Operating expenses for Q4 2024 were $12.2 million, compared to$4.4 million in Q4 2023, while total operating expenses for the year were $39.1 million, up from$27.3 million in 2023[10][21]. - The company's cash, cash equivalents, and marketable securities as of December 31, 2024, were $34.4 million, an increase from$15.5 million at the end of 2023[10][23]. Clinical Trials and Drug Development - Achieve successfully completed enrollment in the ORCA-OL clinical trial with 479 participants across 29 U.S. sites, meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment[4][5]. - The company announced two positive data safety monitoring committee (DSMC) reviews for the ORCA-OL trial, with no safety concerns identified[6]. - Achieve plans to submit its New Drug Application (NDA) for cytisinicline at the end of Q2 2025, marking it as the first new FDA-approved nicotine dependence treatment in nearly 20 years[1][3]. - The FDA granted Breakthrough Therapy designation for cytisinicline for vaping cessation, aimed at accelerating development and review processes[9]. - The company has conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication, confirming alignment on the proposed Phase 3 study design[9]. Leadership and Management - Achieve appointed Mark Oki as Chief Financial Officer in December 2024 to oversee financial strategy and operational initiatives[8]. Share Information - Achieve's weighted average number of basic and diluted common shares outstanding as of March 11, 2025, was 34,685,072[10].