Business
Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results
Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist, in post-bariatric hypoglycemia underway; completion of
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nPivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist, in post-bariatric hypoglycemia underway; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026\n\n\n\nCompleted a public offering of common stock with net proceeds of approximately $65.5 million, extending the company’s cash runway through the end of 2026\n\n\n\nManagement to host conference call and webcast today at 8:00 a.m. Eastern Time\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2024.\n\n“We made significant progress in 2024 across our pipeline, setting the stage for important milestones in the year ahead in orphan markets with high unmet need. We advanced our lead investigational asset avexitide into a pivotal Phase 3 trial and expect topline results in the first half of 2026. This year, we anticipate Week 48 data from our AMX0035 program in Wolfram syndrome, interim analysis data from our AMX0035 program in PSP, and early cohort data from our AMX0114 program in ALS,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “With a strong balance sheet, strengthened by our recent financing that extended our expected cash runway through the end of 2026, we believe we are well positioned to achieve our goals.”\n\nFourth Quarter and Recent Updates:\n\n\nAmylyx began the pivotal Phase 3 LUCIDITY clinical trial of avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, for the treatment of post-bariatric hypoglycemia (PBH). In February 2025, the Company started recruiting for LUCIDITY, an approximately 75-participant, randomized, double-blind, placebo-controlled trial designed to evaluate efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery at approximately 20 sites in the U.S. Dosing is expected to begin in March or April of 2025. Amylyx presented the design of LUCIDITY in December 2024, and the poster is available on the “Publications” page of the Amylyx website. The initiation of LUCIDITY follows five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant reductions in hypoglycemic events and improved glucose...