Achieve Life Sciences(US:ACHV)2024-08-13 20:08Financial Performance - The net loss for the six months ended June 30, 2024, was $15.0 million, with an accumulated deficit of $180.7 million[110]. - The company has incurred an accumulated deficit of $180.7 million through June 30, 2024, and expects to incur substantial additional losses in the future[147]. - For the six months ended June 30, 2024, net cash used in operating activities decreased to $10.2 million from $15.0 million in the same period of 2023[164]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $56.0 million, significantly higher than $15.3 million in the same period of 2023[165]. - Net cash used in investing activities increased to $46.6 million for the six months ended June 30, 2024, compared to nil in the same period of 2023[166]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $61.3 million, with a positive working capital balance of $48.8 million as of June 30, 2024[110]. - As of June 30, 2024, the company had a cash balance of $61.3 million and a positive working capital of $48.8 million[147]. Research and Development - R&D expenses for the three months ended June 30, 2024, increased to $5.1 million from $4.6 million in the same period in 2023, while expenses for the six months decreased to $7.9 million from $10.1 million[143]. - The company anticipates an increase in R&D expenses as it continues ongoing non-clinical studies and initiates new clinical trials[138]. Clinical Trials and Efficacy - Cytisinicline demonstrated a 74-80% median reduction in the number of cigarettes smoked over a 25-day treatment period, compared to a 62% reduction in placebo arms[118]. - The 3 mg TID cytisinicline arm showed a 50% abstinence rate at week 4, compared to 10% for placebo (p<0.0001)[119]. - The Phase 3 ORCA-2 trial showed that subjects receiving 12 weeks of cytisinicline had a 32.6% abstinence rate compared to 7.0% for placebo (p<0.0001)[125]. - The Phase 2 ORCA-V1 trial reported a vaping cessation rate of 31.8% for cytisinicline compared to 15.1% for placebo (p=0.04)[123]. - The Phase 3 ORCA-3 trial showed that subjects receiving 12 weeks of cytisinicline had 4.4 times higher odds of quitting smoking compared to placebo, with a cessation rate of 30.3% versus 9.4% for placebo[130]. - The continuous smoking cessation rate from week 9 to week 24 was 20.5% for the 12-week cytisinicline arm compared to 4.2% for placebo, with an odds ratio of 5.79[131]. - Cytisinicline is differentiated from existing treatments due to its robust efficacy, minimal side effects, and optional shorter course of therapy[109]. Regulatory and Safety - Cytisinicline received Breakthrough Therapy designation from the FDA for nicotine e-cigarette cessation in Q3 2024[113]. - The FDA indicated that a single open-label study evaluating long-term safety effects of cytisinicline will be sufficient for NDA submission anticipated in the first half of 2025[112]. - The ongoing ORCA-OL trial aims to provide long-term safety exposure data from over 1,700 subjects, with results expected to support NDA submission[114]. Debt and Financing - The company entered into a contingent convertible debt agreement on May 15, 2023, providing term loans with an aggregate original principal amount of $16.6 million, refinancing previous convertible debt[150]. - The New Convertible Term Loan, initiated on July 25, 2024, has an original principal amount of $10.0 million, with additional loans of up to $10.0 million available upon certain events[151]. - The New Convertible Term Loan matures on December 1, 2027, with a potential extension to June 1, 2028, and features an interest rate of at least 7.0%[153]. - The company raised approximately $15.3 million in net proceeds from a registered direct offering of 3,000,000 shares at $5.50 per share in May 2023[161]. - In February 2024, the company raised approximately $56.1 million in net proceeds from a registered direct offering of 13,086,151 shares at $4.585 per share[163]. Accounting and Obligations - The company has contractual obligations and contingencies disclosed in its Annual Report on Form 10-K for the year ended December 31, 2023[167]. - There have been no material changes to the company's critical accounting policies since December 31, 2023[168]. Revenue Generation - The company has not generated any revenue from product sales to date and may not do so in the near future[147].