Achieve Life Sciences(US:ACHV)2025-11-06 12:15Product Development - Cytisinicline is an investigational product candidate aimed at treating nicotine dependence, with a PDUFA targeted action date of June 20, 2026, for its NDA submission [131]. - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation in 2024, expediting its development process [129]. - The ORCA-OL trial, which evaluated long-term safety exposure of cytisinicline, enrolled 479 subjects and was completed in September 2025 [140]. - The company plans to commence commercial sales of cytisinicline in the U.S. in the second half of 2026, utilizing AI tools for targeted marketing [133]. Financial Performance - The company reported a net loss of $40.0 million for the nine months ended September 30, 2025, with an accumulated deficit of $245.6 million [134]. - The company has incurred operating losses in each year since inception and has no products approved for commercial sale to date [134]. - The company expects to incur substantial additional losses in the future as it continues its operations [157]. - The company has not generated any revenue from product sales to date and may not do so in the near future [158]. Expenses and Cash Flow - Research and development expenses for the three months ended September 30, 2025, decreased to $5.3 million from $7.6 million in the same period of 2024, while expenses for the nine months increased to $19.1 million from $15.5 million [151]. - General and administrative expenses increased to $9.4 million and $21.0 million for the three and nine months ended September 30, 2025, respectively, compared to $4.9 million and $11.4 million for the same periods in 2024, primarily due to higher commercial launch preparation and employee costs [152]. - Total interest income decreased to $0.6 million and $1.1 million for the three and nine months ended September 30, 2025, respectively, down from $0.7 million and $1.9 million in the same periods in 2024, attributed to lower average cash balances and interest rates [153]. - Total interest expense decreased to $0.2 million and $0.6 million for the three and nine months ended September 30, 2025, respectively, compared to $0.4 million and $2.0 million for the same periods in 2024, due to a lower principal balance on the New Convertible Term Loan [154]. Cash and Securities - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $48.1 million, with a positive working capital balance of $40.3 million [134]. - As of September 30, 2025, the company had $50.0 million available under the Open Market Sale Agreement with Jefferies LLC [180]. - Net cash used in operating activities was $31.5 million for the nine months ended September 30, 2025, an increase from $20.6 million for the same period in 2024, primarily due to higher R&D expenses [186]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $45.3 million, compared to $47.8 million for the same period in 2024 [187]. - Net cash provided by investing activities for the nine months ended September 30, 2025 was $5.4 million, a significant improvement from $33.3 million used in the same period in 2024 [188]. Stock Offerings - In February 2024, the company sold 13,086,151 shares of common stock at a price of $4.585 per share in a registered direct offering [176]. - Concurrently, the company issued unregistered warrants to purchase up to 13,086,151 shares of common stock at an exercise price of $4.906 per share [177]. - The registered direct offering raised total gross proceeds of approximately $60.0 million, with net proceeds of approximately $56.1 million after deducting fees and expenses [178]. - The June 2025 public offering of 15,000,000 shares and accompanying warrants raised total gross proceeds of approximately $45.0 million, resulting in net proceeds of approximately $41.2 million after underwriting discounts and expenses [185]. - The exercises of the Underwriters' option raised gross proceeds of $4.3 million, with net proceeds of approximately $4.0 million after underwriting discounts [185]. Debt and Financing - The New Convertible Term Loan has an original principal amount of $10.0 million, with an additional $5.0 million available upon certain conditions, maturing on December 1, 2027 [166][168]. - The increase in cash used in operations in 2025 was attributed to the ORCA-OL open-label safety trial initiated in May 2024 [186]. Accounting Standards - No new accounting standards were adopted in 2025, as noted in the company's financial statements [192].