Achieve Life Sciences(US:ACHV)2025-05-13 11:38Financial Performance - The net loss for the three months ended March 31, 2025, was $12.8 million, with an accumulated deficit of $218.4 million as of the same date[121]. - The company incurred an accumulated deficit of $218.4 million through March 31, 2025, and expects to incur substantial additional losses in the future[149]. - For the three months ended March 31, 2025, net cash used in operations was $11.1 million, an increase from $5.3 million for the same period in 2024, primarily due to higher R&D expenses[170]. - The company has substantial doubt regarding its ability to continue as a going concern without additional financing, which may be impacted by macroeconomic conditions[152]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for its product candidate[154]. - The company has not generated any revenue from product sales to date and may not do so in the near future[149]. Research and Development - Research and development expenses increased to $7.1 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024, primarily due to costs from the ORCA-OL trial[141]. - The ORCA-OL trial completed enrollment of 479 subjects, with safety data from at least 300 subjects treated for six months to be included in the NDA submission[127][129]. - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation in 2024, expediting its development[124]. - The company plans to submit the NDA for cytisinicline to the FDA in June 2025, following the completion of a long-term safety study initiated in May 2024[122]. Expenses and Income - General and administrative expenses rose to $5.8 million for the three months ended March 31, 2025, up from $3.2 million in the same period in 2024, driven by higher employee expenses and commercial launch preparation costs[142]. - Interest income decreased to $0.3 million for the three months ended March 31, 2025, compared to $0.4 million for the same period in 2024, due to lower average cash balances[143]. - Interest expense decreased to $0.2 million for the three months ended March 31, 2025, down from $0.8 million in the same period in 2024, attributed to a lower principal balance on the New Convertible Term Loan[144]. Cash and Financing - As of March 31, 2025, the company had a cash, cash equivalents, and marketable securities balance of $23.2 million, with a positive working capital balance of $17.9 million[149]. - The company raised approximately $60.0 million in gross proceeds from a registered direct offering in February 2024, receiving net proceeds of approximately $56.1 million after fees[168]. - The company entered into a New Debt Agreement on July 25, 2024, providing term loans with an aggregate original principal amount of $10.0 million, with additional loans available upon certain events[157]. - The New Convertible Term Loan matures on December 1, 2027, with an option to extend to June 1, 2028, and has an interest rate of at least 7.0%[158]. - For the three months ended March 31, 2025, net cash provided by investing activities was $11.4 million, attributed to transactions involving marketable securities[174]. Accounting Standards - New accounting standards will be adopted in 2025, as detailed in Note 2 of the unaudited consolidated financial statements[177].