Annexon(US:ANNX)2024-11-14 21:10Financial Performance - The company reported a net loss of $34.8 million for the three months ended September 30, 2024, compared to a net loss of $32.5 million for the same period in 2023, representing a 7% increase in losses [76]. - Net loss for the nine months ended September 30, 2024, was $89.6 million, a decrease of $16.7 million, or 16%, compared to a net loss of $106.3 million in 2023 [89]. - Cash used in operating activities was $82.0 million for the nine months ended September 30, 2024, compared to $97.7 million in the same period in 2023 [93]. - Interest and other income, net, increased by 101% to $4.6 million for the three months ended September 30, 2024, compared to $2.3 million in 2023 [84]. - Interest and other income increased by $4.6 million, or 63%, for the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to higher average cash balances and favorable interest rates [91]. - Total operating expenses decreased by $12.1 million, or 11%, to $101.6 million for the nine months ended September 30, 2024, compared to $113.7 million in 2023 [89]. Research and Development - Research and development expenses increased by $2.2 million, or 8%, to $30.1 million for the three months ended September 30, 2024, primarily due to increased consulting and professional services costs [86]. - Research and development expenses decreased by $14.4 million, or 16%, to $76.1 million for the nine months ended September 30, 2024, primarily due to reduced costs in clinical services and contract manufacturing [89]. - ANX005, the lead candidate for Guillain-Barré Syndrome, showed positive results in a pivotal Phase 3 trial, with patients recovering faster and more completely [74]. - ANX007 for Geographic Atrophy has initiated patient dosing in a global pivotal Phase 3 trial, with topline data expected in the second half of 2026 [75]. - ANX1502, a novel oral small molecule inhibitor, is in a proof-of-concept study for cold agglutinin disease, with initial data expected in the first quarter of 2025 [75]. - The company expects future research and development expenses to increase as it advances product candidates through late-stage clinical trials and prepares for commercialization [100]. Cash and Financing Activities - Cash and cash equivalents and short-term investments totaled $340.1 million as of September 30, 2024 [76]. - The company raised net proceeds of approximately $116.8 million in June 2024 through the sale of common stock and pre-funded warrants [102]. - In July 2022, the company raised approximately $122.5 million through the sale of 9,013,834 shares of common stock and warrants [104]. - Cash provided by financing activities was $156.2 million for the nine months ended September 30, 2024, significantly up from $17.9 million in 2023 [98]. - 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 [108]. - The 2024 ATM program has a maximum offering of $100.0 million, with no sales made as of September 30, 2024, but 750,000 shares were sold post this date for net proceeds of approximately $4.5 million [107]. - The weighted-average exercise price for pre-funded warrants exercised during the nine months ended September 30, 2024 was $0.307 [105]. - The company issued 2,582,557 shares upon the cashless exercise of pre-funded warrants in March 2023 [104]. - The company had 22,113,062 pre-funded warrants outstanding as of September 30, 2023 [106]. - The 2021 ATM program registration expired on August 15, 2024, prohibiting further sales under this program [108]. Accumulated Deficit and Financial Position - The company has an accumulated deficit of $662.1 million as of September 30, 2024 [76]. - As of September 30, 2024, the company had available cash and cash equivalents of $340.1 million and an accumulated deficit of $662.1 million [92]. Accounting and Market Risk - The company has not made any material changes to its critical accounting policies as of September 30, 2024 [110]. - There were no quantitative and qualitative disclosures about market risk applicable for the company [112].