AMLX · Amylyx Pharmaceuticals, Inc.

Amylyx Pharmaceuticals' Q1 2026 results reflect intensified investment in its lead program, avexitide for post-bariatric hypoglycemia (PBH), with R&D expenses climbing 25% year-over-year to $27.6 million. This increase was driven primarily by clinical development costs for the Phase 3 LUCIDITY trial, now fully enrolled with 78 participants, and a $4.0 million milestone payment to Gubra for AMX0318 advancement. Offsetting some pressure, spending on AMX0035 for progressive supranuclear palsy declined. SG&A rose modestly to $16.2 million on higher consulting and professional services, signaling ramped commercial readiness activities ahead of potential avexitide approval. The resulting net loss expanded to $41.3 million, or $0.37 per share, from $35.9 million last year, though per-share loss improved slightly due to share count dynamics. Balance sheet remains robust with $279.8 million in cash, equivalents, and short-term investments as of March 31, 2026, down from $317.0 million at year-end but sufficient to fund through potential commercialization and into 2028 per management. Co-CEOs Joshua Cohen and Justin Klee emphasized urgency in advancing LUCIDITY, with topline data on track for Q3 2026 targeting FDA-agreed reduction in severe hypoglycemic events; prior trials showed consistent efficacy and tolerability. Additional catalysts include LUMINA ALS biomarker data in June 2026 and AMX0318 IND in 2027, underscoring a focused pipeline in endocrine and neurodegenerative areas.