Achieve Life Sciences(US:ACHV)2025-05-13 11:34Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities of $23.2 million, down from $34.4 million at the end of 2024[10][23] - Total operating expenses for Q1 2025 were $12.9 million, compared to $6.0 million in Q1 2024, reflecting a 115% increase year-over-year[21] - The net loss for Q1 2025 was $12.8 million, compared to a net loss of $6.5 million in the same quarter of the previous year, representing a 97% increase[21] - Achieve's stockholders' equity decreased to $10.3 million as of March 31, 2025, from $20.9 million at the end of 2024[23] Clinical Trials and Drug Development - Achieve Life Sciences plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025[1] - Approximately 75% of the 479 participants in the ORCA-OL trial remain on treatment, indicating strong tolerability of cytisinicline[4] - The Phase 3 ORCA-3 trial involved 792 U.S. adult smokers and demonstrated efficacy in reducing nicotine cravings and improving quit rates[6] - Achieve has met FDA long-term exposure requirements with safety data from over 300 participants completing six months of treatment and 100 participants completing one year[7] - The company completed its third safety review of the ORCA-OL trial, with no unexpected treatment-related adverse events reported[8] - The company conducted a Science Advisory Board meeting with leading experts to discuss clinical progress and NDA preparations for cytisinicline[9]