Amylyx(US:AMLX)2025-11-06 12:03Financial Performance - The company reported a net loss of $34.4 million, or $0.37 per share, for Q3 2025, compared to a net loss of $72.7 million, or $1.07 per share, for the same period in 2024[11]. - Net loss for the three months ended September 30, 2025, was $34.386 million, an improvement from a net loss of $72.704 million in the same period of 2024[26]. - Loss before income taxes for the nine months ended September 30, 2025, was $111.736 million, compared to a loss of $263.955 million in the same period of 2024, indicating a reduction of 57.6%[26]. - The net loss per share for the three months ended September 30, 2025, was $0.37, an improvement from $1.07 in the same period of 2024[26]. Expenses - Research and development expenses for Q3 2025 were $19.9 million, a decrease from $21.2 million in Q3 2024, primarily due to reduced spending on AMX0035[9]. - Selling, general, and administrative expenses for Q3 2025 were $16.2 million, down from $17.8 million in Q3 2024, mainly due to lower consulting and professional service costs[10]. - Total operating expenses for the nine months ended September 30, 2025, were $116.686 million, a decrease of 67.7% compared to $362.113 million in the same period of 2024[26]. - Research and development expenses for the nine months ended September 30, 2025, totaled $69.191 million, down from $81.192 million in the same period of 2024, representing a decrease of 14.7%[26]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $344.0 million as of September 30, 2025, up from $180.8 million at June 30, 2025, reflecting net proceeds of approximately $191 million from a public offering[12]. - Cash, cash equivalents, and marketable securities increased significantly to $343.990 million as of September 30, 2025, compared to $176.501 million at the end of 2024, marking a growth of 94.8%[24]. - Total assets increased to $362.741 million as of September 30, 2025, compared to $193.634 million on December 31, 2024, reflecting a growth of 87.5%[24]. - Total liabilities increased slightly to $30.745 million as of September 30, 2025, from $28.869 million on December 31, 2024, reflecting a growth of 6.1%[24]. - Stockholders' equity rose to $331.996 million as of September 30, 2025, compared to $164.765 million at the end of 2024, representing an increase of 101.5%[24]. Clinical Trials and Development - Recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide is expected to be completed in Q1 2026, with topline data anticipated in Q3 2026[6]. - The company plans to initiate a pivotal Phase 3 trial for AMX0035 in Wolfram syndrome in the second half of 2026, pending FDA alignment[13]. - Avexitide demonstrated a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in the Phase 2b trial, with a p-value of 0.0031[7]. - Early cohort data from the Phase 1 LUMINA trial of AMX0114 in ALS will be presented at the 36th International Symposium on ALS/MND in December 2025[4]. - Amylyx is advancing a collaboration with Gubra A/S for a novel long-acting GLP-1 receptor antagonist, with a decision on a potential development candidate expected soon[13].