Achieve Life Sciences(ACHV) - 2024 Q3 - Quarterly Results

Financial Performance - As of September 30, 2024, the company's cash, cash equivalents, restricted cash, and short-term investments totaled $42.9 million[8] - Total operating expenses for the three months ended September 30, 2024 were$12.5 million, compared to $6.6 million for the same period in 2023, representing an increase of 90$12.5 million, compared to a net loss of $7.1 million for the same period in 2023, indicating an increase of 76$27.5 million, compared to $24.3 million for the same period in 2023[15] - Achieve's total assets as of September 30, 2024 were$47.9 million, significantly up from $19.4 million as of December 31, 2023[16] Clinical Development - Achieve completed enrollment in the Phase 3 ORCA-OL clinical trial with 479 participants across 29 U.S. sites, evaluating a 3 mg cytisinicline regimen for smoking and vaping cessation[3] - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation, aimed at expediting development and review[6] - The company plans to submit a New Drug Application (NDA) in the second quarter of 2025[3] Leadership and Strategy - Achieve's leadership team has been enhanced with the appointment of Richard Stewart as CEO and Thomas King as Executive Chairman, focusing on strategic growth[7] - The company has initiated the formation of a dedicated U.S. product launch preparedness team to support the upcoming market entry of cytisinicline[3]