The following is a summary of the Amylyx Pharmaceuticals, Inc. (AMLX) Q3 2024 Earnings Call Transcript:

Financial Performance:

• Ended Q3 with $234.4 million in cash and investments.

• Net product revenues for the quarter were $400,000 with cost of sales reported at $800,000.

• R&D expenses for the quarter were $21.2 million, down from $30 million compared to the same period in 2023.

• Recorded $36.2 million of expense related to the acquisition of Avexitide.

• Operating leverage expected with Q3 net loss at $72.7 million or $1.07 per share.

Business Progress:

• Reported positive topline data from open-label Phase II HELIOS trial of AMX0035 showing improvements in pancreatic function.

• Preparing to initiate a pivotal Phase III program in PBH in Q1 2025 with topline data expected in 2026.

• Clearance received from Health Canada to start a Phase I trial of AMX0114 in ALS; plan to commence in the coming months.

• ORION trial of AMX0035 in PSP is recruiting well with interim analysis expected mid next year.

Opportunities:

• Avexitide, with FDA breakthrough therapy and orphan drug designations, leading to Phase III development in PBH by Q1 2025.

• Potential expansion of AMX0035 into progressive supranuclear palsy.

Risks:

• Clinical hold by the FDA on AMX0114, requiring lower dosing understanding and more information.

• Gradual growth expected from AI services in neurodegenerative diseases.

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