- **LUCIDITY Trial Update**: Enrollment completion now expected in Q1 2026, with top-line data in Q3 2026. Avexitide remains on track for a 2027 launch pending FDA approval.
- **Financial Strength**: $344 million cash position supports a 2028 runway. Operating expenses down 53% YoY, driven by reduced pipeline spending.
- **Pipeline Progress**: Gubra collaboration for a long-acting GLP-1 antagonist nearing candidate nomination. AMX0035 pivotal trial initiation in H2 2026 pending FDA alignment.
- **Market Focus**: 160,000 PBH patients in the U.S., with unmet need driving avexitide's development and commercial readiness.

**【Management Opening Remarks】**
- Lindsey Allen provided an overview of the company's focus on avexitide for post-bariatric hypoglycemia (PBH) and the LUCIDITY Phase III trial. The call emphasized the unmet need in PBH and the company's strategic focus on avexitide's development and commercial readiness.

**【CEO Commentary】**
- Justin Klee highlighted the LUCIDITY trial's enrollment update, noting a steady rate and revised completion timeline to Q1 2026, with top-line data expected in Q3 2026. He emphasized avexitide's potential as the first FDA-approved therapy for PBH and the company's preparation for a 2027 launch pending FDA approval. Klee also discussed the pipeline, including the Gubra collaboration for a long-acting GLP-1 antagonist, with a decision on a development candidate expected in the next few months.

**【CFO Commentary】**
- James Frates reported a strong cash position of $344 million at quarter-end, supporting a 2028 cash runway. He noted a 53% year-over-year decline in operating expenses, driven by reduced spending on AMX0035 and AMX0114, and highlighted the company's focus on avexitide's clinical execution and commercial preparation.

**【Q&A Highlights】**
- Enrollment dynamics: Justin Klee and Joshua Cohen addressed the steady enrollment rate, revised timeline, and site activation challenges. Josh Cohen emphasized the importance of dietary adherence and CGM monitoring in trial execution. Questions on the addressable market for PBH (160,000 individuals) and pipeline updates on AMX0114 and AMX0035 were also key topics.

Amylyx Pharmaceuticals, Inc. (AMLX) Q3 2025 Earnings Call Transcript

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