AMX0114

May 7, 2026 — Amylyx Pharmaceuticals (Nasdaq: AMLX) reported Q1 2026 financial and business updates and reiterated key upcoming clinical milestones. The company completed enrollment in its pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia (PBH) in March 2026; the 16‑week, randomized, double-blind, placebo-controlled study enrolled 78 adults with PBH after Roux‑en‑Y gastric bypass, with a 32‑week open-label extension. Topline results remain on track for Q3 2026, with the FDA-agreed primary endpoint being reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16; potential launch is targeted for 2027 if approved. Amylyx also initiated a U.S. Expanded Access Program for avexitide (May 2026). In ALS, the company completed Cohort 2 enrollment (n=12) in the Phase 1 LUMINA trial of AMX0114, with early Cohort 1 biomarker data expected June 2026.

Financially, Q1 2026 R&D was $27.6M (vs $22.1M in Q1 2025), SG&A $16.2M (vs $15.7M), and net loss $41.3M ($0.37/share). Cash/cash equivalents/short-term investments were $279.8M at March 31, 2026, and management expects runway into 2028, intended to support operations through potential avexitide commercialization.