Achieve Life Sciences(US:ACHV)2024-11-07 21:15Financial Performance - The net loss for the nine months ended September 30, 2024, was $27.5 million, with an accumulated deficit of $193.2 million[119]. - The company has not generated any revenue from product sales to date and has incurred operating losses each year since inception[119]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development[120]. - The accumulated deficit through September 30, 2024 was $193.2 million, with expectations of incurring substantial additional losses in the future[170]. - For the nine months ended September 30, 2024, net cash used in operations was $20.6 million[170]. - The company incurred a loss on extinguishment of debt of $0.3 million for each of the three and nine months ended September 30, 2024[169]. - Substantial doubt exists regarding the company's ability to continue as a going concern without additional financing[173]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $42.9 million, and a positive working capital balance of $38.8 million[119]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $47.8 million, significantly higher than $15.3 million in the same period of 2023, driven by proceeds from the February 2024 offering and other financing activities[199]. - Net cash used in investing activities increased to $33.3 million for the nine months ended September 30, 2024, compared to only $15,000 in the same period of 2023, attributed to transactions involving marketable securities[200]. - As of September 30, 2024, the company had $50.0 million available under an Open Market Sale Agreement with Jefferies LLC, although no shares were sold under this agreement during the three and nine months ended September 30, 2024[197]. Clinical Trials and Drug Development - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation, which allows expedited development of the drug[125]. - The company initiated the ORCA-OL open label trial in May 2024, enrolling 479 subjects to provide long-term safety data for cytisinicline[127]. - In the Phase 2b ORCA-1 trial, cytisinicline treatment arms showed a 74-80% median reduction in the number of cigarettes smoked compared to a 62% reduction in placebo arms[133]. - The 3 mg TID cytisinicline arm demonstrated a 50% abstinence rate at week 4, compared to 10% for placebo (p<0.0001)[135]. - The ORCA-V1 trial showed a vaping cessation rate of 31.8% for cytisinicline compared to 15.1% for placebo during weeks 9 through 12 (p=0.04)[141]. - The Phase 3 ORCA-2 trial demonstrated that subjects receiving 12 weeks of cytisinicline had a 6.3 times higher likelihood of quitting smoking compared to placebo, with an abstinence rate of 32.6% versus 7.0%[144]. - The continuous abstinence rate from week 9 to 24 for the 12-week cytisinicline arm was 21.1%, compared to 4.8% for placebo, with an odds ratio of 5.3[145]. - The Phase 3 ORCA-3 trial showed that subjects receiving 12 weeks of cytisinicline had a 4.4 times higher likelihood of quitting smoking, with a cessation rate of 30.3% compared to 9.4% for placebo[150]. - Cytisinicline was well tolerated in both ORCA-2 and ORCA-3 trials, with no treatment-related serious adverse events reported[154]. Research and Development Expenses - R&D expenses for the three months ended September 30, 2024, increased to $7.6 million from $3.6 million in the same period in 2023, primarily due to the initiation of the ORCA-OL trial[162]. - The company initiated the ORCA-OL trial in May 2024, contributing to higher R&D expenses, while costs associated with completed trials (ORCA-3 and ORCA-V1) were reduced[198]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, rose to $4.9 million from $3.0 million in the same period in 2023, attributed to higher employee and consulting costs[164]. Financing Activities - In May 2023, the company sold 3,000,000 shares of common stock at $5.50 per share, raising approximately $15.3 million in net proceeds after fees and expenses[194]. - In February 2024, the company sold 13,086,151 shares of common stock at $4.585 per share, resulting in gross proceeds of approximately $60.0 million and net proceeds of about $56.1 million after deducting fees[197]. - The company issued unregistered warrants to purchase up to 13,086,151 shares at an exercise price of $4.906 per share, which are immediately exercisable and will expire under specific conditions[196]. Accounting Policies - There have been no material changes to the company's critical accounting policies since December 31, 2023, as disclosed in the Annual Report filed on March 28, 2024[202]. - The company has adopted new accounting standards in 2024, as detailed in the consolidated financial statements[203].