Achieve Life Sciences(ACHV) - 2025 Q3 - Quarterly Results

Financial Performance - As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $48.1 million, an increase from $34.4 million at the end of 2024[11][24] - Total operating expenses for the three months ended September 30, 2025, were $14.7 million, compared to $12.5 million for the same period in 2024, representing a 17.7% increase[11][22] - The net loss for the three months ended September 30, 2025, was $14.4 million, compared to a net loss of $12.5 million for the same period in 2024, indicating a 15.4% increase in losses[11][22] - The total net loss for the nine months ended September 30, 2025, was $40.0 million, compared to a net loss of $27.5 million for the same period in 2024, reflecting a 45.4% increase in losses[11][22] Drug Development and Regulatory Updates - The FDA has accepted the New Drug Application (NDA) for cytisinicline for smoking cessation, with a Prescription Drug User Fee Act (PDUFA) targeted action date set for June 20, 2026[3][5] - Cytisinicline demonstrated significantly higher smoking abstinence rates compared to placebo in Phase 3 trials involving over 2,000 participants[5][11] - Achieve Life Sciences was awarded the FDA Commissioner's National Priority Voucher for cytisinicline for vaping cessation, one of only nine therapies to receive this designation[6][3] - New post hoc data published in Thorax showed that cytisinicline improved smoking quit rates in adults with chronic obstructive pulmonary disease (COPD), based on over 1,600 participants[7][8] - The ORCA-OL long-term safety trial concluded with all 334 participants completing one year of treatment, exceeding FDA's requested thresholds for patient exposure prior to approval[9][11] Leadership Changes - The company appointed Erik Atkisson as Chief Legal Officer, bringing over 25 years of legal experience in the pharmaceutical and biotechnology industries[10][8]