Amylyx Pharmaceuticals (AMLX) investor relations material

Executive summary

• Approaching pivotal Phase III LUCIDITY top-line data readout for avexitide in post-bariatric hypoglycemia (PBH), with results expected late August or early September 2026.

• NDA preparations and commercial launch readiness for avexitide are underway, targeting a 2027 launch if approved.

• Expanded Access Program for avexitide initiated for eligible PBH patients.

• Pipeline progress includes AMX0035 for Wolfram syndrome, AMX0114 for ALS, and AMX0318, a long-acting GLP-1 receptor antagonist, with IND-enabling studies ongoing.

• Research collaboration with Gubra expanded to identify candidates for rare endocrine diseases.

Financial highlights

• Ended Q2 2026 with $250.8 million in cash and marketable securities, down from $279.8 million in Q1.

• Net loss for Q2 2026 was $43.4 million ($0.39/share), compared to $41.4 million ($0.46/share) in Q2 2025.

• Total operating expenses were $45.7 million, up 7% year-over-year.

• R&D expenses were $23.8 million, down from $27.2 million in Q2 2025, mainly due to reduced spending on AMX0035.

• SG&A expenses rose to $21.9 million from $15.6 million, driven by legal and commercial investments.

Outlook and guidance

• Cash runway anticipated into 2028, supporting operations through key milestones including LUCIDITY data, potential FDA approval, and commercial launch.

• Topline LUCIDITY data expected late August or early September 2026; commercial launch of avexitide anticipated in 2027 if approved.

• IND-enabling studies for AMX0318 ongoing, with IND filing targeted for 2027.