Amylyx Pharmaceuticals (AMLX) Q4 2025 earnings summary

Executive summary

• Advanced pipeline with Avexitide for PBH, completed pivotal Phase III LUCIDITY trial recruitment, and extended cash runway into 2028.

• Top-line data from LUCIDITY expected Q3 2026; commercial and regulatory preparations underway for potential 2027 launch.

• Expanded pipeline with nomination of AMX0318 and progress in ALS program AMX0114, including favorable Phase I safety data.

• AMX0318 selected as a development candidate for PBH and rare diseases after robust preclinical results; IND-enabling studies ongoing.

• Early safety and tolerability data from Phase I LUMINA trial of AMX0114 in ALS showed good tolerability and no treatment-related serious adverse events.

Financial highlights

• Ended Q4 with $317 million in cash and marketable securities, down from $344 million in Q3.

• Total operating expenses for Q4 were $36.6 million, an 8% decrease year-over-year.

• R&D expenses for Q4 were $21.2 million, down from $22.9 million in Q4 2024; full-year R&D expenses were $90.4 million, down from $104.1 million in 2024.

• SG&A expenses for Q4 were $15.4 million, down from $17.1 million in Q4 2024; full-year SG&A expenses were $62.9 million, down from $114.3 million in 2024.

• Net loss for Q4 was $33.0 million ($0.30/share), compared to $37.5 million ($0.55/share) in Q4 2024; full-year net loss was $144.7 million ($1.53/share), compared to $301.7 million ($4.43/share) in 2024.

Outlook and guidance

• Cash runway expected to fund operations through key milestones and potential Avexitide commercialization into 2028.

• LUCIDITY top-line data anticipated in Q3 2026; NDA submission and potential FDA approval targeted soon after.

• Commercial launch of Avexitide targeted for 2027, pending approval.

• IND filing for AMX0318 targeted for 2027; IND-enabling studies underway.

• Completion of enrollment for Cohort 2 of Phase I LUMINA trial of AMX0114 in ALS expected in March 2026; biomarker data from Cohort 1 expected in first half of 2026.