Summary of Amylyx Pharmaceuticals FY Conference Call Company Overview - **Company**: Amylyx Pharmaceuticals (NasdaqGS:AMLX) - **Event**: FY Conference on November 10, 2025 - **Key Speakers**: Co-CEOs Josh Cohen and Justin Klee Key Points Drug Candidates and Clinical Programs - Amylyx has three drug candidates in clinical development, with Evexetide as the lead candidate targeting post-bariatric hypoglycemia (PBH) [2][3] - Evexetide is a GLP-1 receptor competitive inhibitor, currently in a pivotal phase three study for PBH, which affects approximately 160,000 people in the U.S. [2][3][14] - No FDA-approved treatments exist for PBH, highlighting a significant unmet medical need [3][15] - Other candidates include a small molecule for Wolfram syndrome and Amylyx 114, an antisense oligonucleotide for ALS [3][4] Clinical Trial Details - The phase three study for Evexetide is expected to complete enrollment in Q1 2026, with top-line results anticipated in Q3 2026 [3][38] - Previous studies have shown positive results, including FDA Breakthrough Therapy Designation [3][8] - The phase three trial aims to replicate the success of earlier trials, focusing on reducing level two and level three hypoglycemic events [21][29] Market Opportunity and Unmet Need - PBH is a rare complication following bariatric surgery, with an estimated 8% of patients developing the condition [14] - The condition leads to severe hypoglycemia, which can result in medical emergencies, emphasizing the need for effective treatment [12][13] - The majority of PBH cases are linked to Roux-en-Y gastric bypass surgery, with an estimated 120,000 cases from this procedure [15] Regulatory and Market Considerations - An ICD-10 code for PBH is being considered, which could aid in tracking and diagnosing patients, but is not deemed essential for Evexetide's success [17][19] - The treating community is actively working to elevate awareness of PBH, with recent discussions at medical conferences [18] Financial Position - As of Q3 2025, Amylyx reported $344 million in cash, providing a runway into 2028 [38] - The company anticipates completing enrollment in the lucidity trial in Q1 2026, with potential data release in Q3 2026 and a possible product launch in 2027 [38] Conclusion - Amylyx Pharmaceuticals is focused on addressing significant unmet needs in the treatment of PBH through its lead candidate Evexetide, with ongoing clinical trials and a strong financial position to support its initiatives [4][38]