Annexon(US:ANNX)2025-11-10 21:10Financial Performance - The company reported a net loss of $54.9 million for the three months ended September 30, 2025, compared to a net loss of $34.8 million for the same period in 2024, representing a 58% increase in losses [116]. - The net loss for the nine months ended September 30, 2025, was $158.4 million, an increase of $68.8 million, or 77%, compared to the same period in 2024 [121]. - Cash used in operating activities for the nine months ended September 30, 2025, was $140.4 million, compared to $82.0 million for the same period in 2024 [129]. - Interest and other income decreased by 55% to $2.1 million for the three months ended September 30, 2025, compared to $4.6 million in 2024 [116]. - Interest and other income, net, decreased by $4.3 million, or 36%, for the nine months ended September 30, 2025, primarily due to lower average cash and investment balances [126]. Research and Development - Research and development expenses increased by $19.6 million, or 65%, for the three months ended September 30, 2025, primarily due to costs associated with the Phase 3 ARCHER II trial for vonaprument and the initiation of the FORWARD study for tanruprubart [118]. - Research and development expenses increased by $65.9 million, or 87%, to $142.0 million for the nine months ended September 30, 2025, driven by increased contract manufacturing and clinical service costs [123]. - The Phase 3 trial for vonaprument has enrolled 659 patients, with topline data expected in the second half of 2026 [110]. - Tanruprubart has shown approximately 90% improvement in GBS patients by week 1 in a Phase 3 trial, with more than twice as many patients achieving a normal state of health by week 26 [105]. - The company anticipates initial pharmacokinetics and pharmacodynamics data from the FORWARD study in 2026, with ongoing regulatory discussions for tanruprubart's BLA submission [105]. - The company expects future research and development expenses to increase as it pursues regulatory approval and advances product candidates through late-stage clinical trials [135]. Cash and Financing - The company has an accumulated deficit of $869.1 million as of September 30, 2025, with cash and cash equivalents and short-term investments totaling $188.7 million [106]. - The company believes its existing cash and cash equivalents will fund operations into late first quarter 2027, but substantial additional financing will be required to achieve its goals [136]. - The company raised net proceeds of approximately $116.8 million in June 2024 through the sale of common stock and pre-funded warrants [137]. - In July 2022, the company raised approximately $122.5 million through the sale of 9,013,834 shares of common stock and warrants [139]. - The company sold 5,235,959 shares under the 2024 ATM program for net proceeds of approximately $13.5 million during the nine months ended September 30, 2025 [143]. - Approximately $81.2 million remained available for the offer and sale of shares under the 2024 ATM program as of September 30, 2025 [143]. - The company sold 7,576,067 shares under the 2021 ATM program for net proceeds of approximately $38.4 million during the nine months ended September 30, 2024 [144]. - The modification of common warrants resulted in a deemed dividend of $1.9 million, recognized in additional paid-in capital [141]. - The common warrants' term was extended to June 30, 2026, with potential gross proceeds of approximately $39.9 million if fully exercised [140]. - The company issued an aggregate of 2,582,557 shares upon the cashless exercise of pre-funded warrants in March 2023 [139]. - The company had an accumulated deficit as of September 30, 2025, impacting the recognition of the deemed dividend [141]. Administrative Expenses - General and administrative expenses decreased by 22% to $7.3 million for the three months ended September 30, 2025, compared to $9.3 million in 2024 [116]. - General and administrative expenses decreased by $2.0 million, or 22%, to $7.3 million for the three months ended September 30, 2025, primarily due to a $1.9 million reduction in consulting and professional services costs [119]. Accounting Policies - No material changes were reported in critical accounting policies during the quarter ended September 30, 2025 [146].