Financial Performance - The company reported net losses of $44.1 million for the six months ended June 30, 2024, compared to $23.8 million for the same period in 2023, with an accumulated deficit of $624.6 million[72]. - Total operating expenses for the six months ended June 30, 2024, were $52.95 million, an increase of 85% from $28.6 million in the same period in 2023[82]. - The net loss for the six months ended June 30, 2024, was $44.1 million, compared to a net loss of $23.8 million for the same period in 2023, representing an increase of 85%[82]. - General and administrative expenses rose by 44% to $16.5 million for the six months ended June 30, 2024, from $11.5 million in the same period in 2023[85]. - Net cash used in operating activities was $35.9 million for the six months ended June 30, 2024, compared to $23.9 million for the same period in 2023[93]. - As of June 30, 2024, the company had an accumulated deficit of $624.6 million, indicating ongoing operating losses since inception[96]. Cash and Financing - As of June 30, 2024, the company had $354.7 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2027[72]. - The gross proceeds from the October 2023 Financing were $64.0 million, and from the February 2024 Financing were $125.0 million[71]. - The company raised an aggregate of $823.4 million through equity financings from inception through June 30, 2024[86]. - The October 2023 Financing raised gross proceeds of $64.0 million, with net proceeds of $59.5 million[88]. - In February 2024, the company closed a financing round, selling 10,340,000 shares for gross proceeds of $125.0 million and net proceeds of $117.2 million[89]. - The company sold 2,945,806 shares under the 2021 ATM Program for gross proceeds of $20.6 million and net proceeds of $20.0 million in the six months ended June 30, 2024[90]. - Net cash provided by financing activities was $141.9 million for the six months ended June 30, 2024, mainly from net proceeds of $117.2 million from the February 2024 Financing[95]. - The company expects existing cash and short-term investments to fund operations into mid-2027, including activities related to the navenibart program and STAR-0310 OX40 program[96]. - The company may need to seek additional funds sooner than planned due to uncertainties in research and development[98]. Research and Development - Navenibart achieved a 92% reduction in monthly attack rate and a 96% reduction in moderate and severe attacks in the 450 mg dose cohort after 6 months of follow-up[65]. - In the 600 mg dose cohort, there was a 96% reduction in monthly attack rate and 100% of patients were attack-free in the first month after dosing[67]. - The company plans to initiate a Phase 3 pivotal trial for Navenibart in Q1 2025, with top-line results expected by year-end 2026[67]. - STAR-0310 demonstrated a long mean half-life of 26 days in preclinical studies, compared to 10-14 days for typical non-half-life extended IgG antibodies[68]. - The company anticipates submitting an IND for STAR-0310 by year-end 2024 and initiating a Phase 1a clinical trial in Q1 2025[70]. - The company expects to incur significant research and development expenses in 2024 related to navenibart and STAR-0310, with higher expenses anticipated in upcoming quarters[80]. - The company plans to report additional data from the ALPHA-STAR trial in Q4 2024 and initial data from the ALPHA-SOLAR trial in mid-2025[67]. Other Financial Information - Research and development expenses increased by 128% to $20.7 million for the three months ended June 30, 2024, compared to $9.1 million for the same period in 2023[80]. - Other income, net increased by 83% to $4.6 million for the three months ended June 30, 2024, from $2.5 million in the same period in 2023[81]. - Material cash requirements as of June 30, 2024, are primarily related to sublease agreements for office space[99]. - The company has not generated any product revenues and relies on public offerings and private placements for financing[72]. - The company has not made any changes in internal control over financial reporting that materially affected its financial reporting during the six months ended June 30, 2024[102]. - The company has filed various certifications pursuant to the Sarbanes-Oxley Act of 2002, including those from the principal executive and financial officers[105]. - The report includes Inline XBRL documents for detailed financial data presentation[105]. - The Chief Financial Officer, Noah C. Clauser, signed the report on August 12, 2024, confirming its accuracy[106].
Astria Therapeutics(ATXS) - 2024 Q2 - Quarterly Report