Achieve Life Sciences(US:ACHV)2024-08-13 20:06Financial Performance - Total operating expenses for Q2 2024 were $8.4 million, compared to $7.7 million in Q2 2023, representing an increase of approximately 9%[15] - The net loss for Q2 2024 was $8.5 million, compared to a net loss of $8.2 million in Q2 2023, indicating a year-over-year increase of about 3%[15] - The total net loss for the six months ended June 30, 2024, was $15.0 million, down from $17.2 million for the same period in 2023, reflecting a decrease of approximately 13%[15] - The weighted average number of basic and diluted common shares outstanding was 34,341,303 as of August 13, 2024[8] Cash and Debt Management - Achieve Life Sciences reported total cash, cash equivalents, restricted cash, and short-term investments of $61.3 million as of June 30, 2024[8] - The company refinanced up to $20 million in debt with Silicon Valley Bank, extending the maturity date from August 1, 2024, to December 1, 2027[4] Clinical Trials and Designations - The company initiated the ORCA-OL clinical trial with over half of the 650 participants already enrolled, aiming to support an NDA submission in the first half of 2025[6] - Achieve received FDA Breakthrough Therapy designation for cytisinicline for vaping cessation, which may accelerate the development and review process[2] - Data from the ORCA-V1 trial indicated that cytisinicline more than doubled the likelihood of quitting nicotine e-cigarettes compared to placebo[7] Market Presence - Achieve joined the U.S. Russell 3000® and Russell Microcap® Indexes effective July 1, 2024, enhancing visibility among investors[5]