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Amylyx Pharmaceuticals (AMLX) investor relations material

Amylyx Pharmaceuticals Corporate Presentation summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Corporate Presentation summary12 Sep, 2025

Pipeline and development focus

  • Advancing three novel therapies: Avexitide for post-bariatric hypoglycemia (PBH), AMX0035 for Wolfram syndrome, and AMX0114 for ALS, all targeting diseases with high unmet needs.

  • All programs have received FDA designations (Breakthrough, Orphan, or Fast Track) and are supported by robust intellectual property portfolios.

  • Clinical development is led by an experienced team with a strong track record in rare disease commercialization.

Avexitide for post-bariatric hypoglycemia (PBH)

  • Avexitide is a first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations.

  • Phase 3 LUCIDITY trial began dosing in April 2025, with topline data expected in 1H 2026 and potential commercial launch in 2027.

  • Prior Phase 2 trials showed >50% reduction in hypoglycemic events, with consistent, dose-dependent effects and favorable safety profile.

  • PBH affects ~160,000 people in the U.S., is life-altering, and currently has no approved treatments.

  • Avexitide demonstrated significant improvement in glucose stabilization and reduction of insulin hypersecretion in both clinical and preclinical studies.

AMX0035 for Wolfram syndrome

  • AMX0035 is a fixed-dose combination targeting ER stress and mitochondrial dysfunction, central to Wolfram syndrome pathology.

  • Phase 2 HELIOS trial met its primary endpoint of improved pancreatic function at Week 24, with continued stabilization or improvement at Week 48.

  • Long-term data suggest benefit across multiple outcomes, including glycemic control, vision, and symptom burden, with a favorable safety profile.

  • Orphan Drug Designation granted in both the U.S. and EU; Phase 3 trial design to be informed by ongoing FDA discussions.

  • Wolfram syndrome is a rare, fatal disorder with no approved therapies, affecting ~3,000 people in the U.S.

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Frequently asked questions

Amylyx Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing treatments for neurodegenerative diseases. The company's research and product development primarily target conditions such as amyotrophic lateral sclerosis (ALS) and other neurodegenerative disorders, aiming to slow disease progression and improve patient outcomes. Amylyx leverages its scientific expertise in neurobiology to create therapies that address the underlying mechanisms of these diseases. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.

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