CAMBRIDGE, Mass. — Amylyx Pharmaceuticals reported fourth-quarter and full-year 2025 financial results Tuesday, highlighting progress in its late-stage avexitide program for post-bariatric hypoglycemia (PBH) and projecting its cash runway into 2028.
Company leaders said recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide in PBH is complete, with final randomization and dosing of eligible participants expected in the first quarter of 2026. Topline data from the trial is anticipated in the third quarter of 2026.
“2025 was a year of meaningful advancement for Amylyx’s pivotal avexitide program in post-bariatric hypoglycemia, as well as progress across our broader pipeline,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “In 2026, our primary focus is on our Phase 3 LUCIDITY trial of avexitide in PBH. With recruitment of LUCIDITY complete, we are on track to complete enrollment this month and continue to expect topline data in Q3 2026.”
They added that the company designed LUCIDITY to build on prior studies showing statistically significant reductions in hypoglycemic events and said they remain encouraged by participant interest and engagement across trial sites.
Amylyx said it continues preparing for a potential regulatory submission and commercial launch of avexitide in 2027, if approved. The therapy has received FDA Breakthrough Therapy Designation and is being studied as a first-in-class GLP-1 receptor antagonist for PBH. LUCIDITY is a 16-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating approximately 75 participants who developed PBH following Roux-en-Y gastric bypass surgery. Participants may enroll in a 32-week open-label extension after completing the double-blind phase.
Beyond avexitide, Amylyx announced the selection of AMX0318 as a development candidate for PBH and other rare diseases. The long-acting GLP-1 receptor antagonist candidate demonstrated favorable preclinical characteristics, including pharmacokinetics, stability and tolerability. The program emerged from a collaboration with Gubra A/S. Investigational New Drug-enabling studies are underway, with a filing targeted for 2027.
The company also shared early safety and tolerability data from Cohort 1 of its Phase 1 LUMINA trial of AMX0114, an investigational antisense oligonucleotide targeting calpain-2 for amyotrophic lateral sclerosis. AMX0114 has received FDA Fast Track Designation. In the first cohort of 12 participants, the therapy was generally well tolerated, with no treatment-related serious adverse events reported. Enrollment of Cohort 2 is expected to be completed in March 2026, with biomarker data from Cohort 1 anticipated in the first half of 2026.
Financially, Amylyx reported research and development expenses of $21.2 million in the fourth quarter of 2025, compared to $22.9 million in the same period in 2024. Full-year R&D expenses were $90.4 million, down from $104.1 million in 2024. The company attributed the decrease primarily to reduced spending on AMX0035, partially offset by increased investment in avexitide’s clinical development.
Selling, general and administrative expenses totaled $15.4 million in the fourth quarter, down from $17.1 million a year earlier. For the full year, SG&A expenses fell to $62.9 million from $114.3 million in 2024, driven largely by lower consulting and professional services costs.
Net loss for the fourth quarter was $33.0 million, or $0.30 per share, compared with $37.5 million, or $0.55 per share, in the prior-year quarter. For the full year, Amylyx reported a net loss of $144.7 million, or $1.53 per share, compared with a net loss of $301.7 million, or $4.43 per share, in 2024.
Cash, cash equivalents and short-term investments totaled $317.0 million as of December 31, 2025, down from $344.0 million at the end of the third quarter. Based on current operating plans, the company said it expects its cash resources to fund operations through potential commercialization of avexitide and into 2028.
