Amylyx Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Justin Klee discussed progress on avexitide in post-bariatric hypoglycemia (PBH), noting the pivotal Phase III LUCIDITY trial update with recruitment now expected to complete in Q1 2026 and top line data in Q3 2026. He also mentioned launch preparations for avexitide. - Camille Bedrosian emphasized PBH's impact and avexitide's mechanism as an inhibitor of GLP-1 receptor activity. - Jim Frates reviewed financials, highlighting strong cash position and expense decreases. - Joshua Cohen talked about the Gubra collaboration and ALS program updates, including AMX0114's Phase I LUMINA trial fully enrolling Cohort 1.

Total operating expenses for Q3 were $36 million, down 53% from Q3 2024. Research and development expenses were $19.9 million compared to $21.2 million in Q3 2024, primarily due to decreases in spending on AMX0035 for PSP and ALS but offset by increased spending on avexitide's clinical development. Selling, general and administrative expenses were $16.2 million compared to $17.8 million in Q3 2024, mainly due to a decrease in consulting and professional services. Noncash stock-based compensation expense was $7.1 million for the quarter, compared to $6.8 million in Q3 2024.

• Revised LUCIDITY trial recruitment completion to Q1 2026 and top line data to Q3 2026. - Plan to initiate pivotal Phase III trial for AMX0035 in Wolfram syndrome in the second half of 2026. - AMX0114 Phase I LUMINA trial fully enrolled Cohort 1, with early cohort data expected later in 2025 and biomarker data in the first half of 2026.

Q: What are the operational dynamics impacting the LUCIDITY trial enrollment timeline?

A: Justin Klee mentioned steady enrollment rate, updating projections to Q1 2026 completion, emphasizing focus on quality and participant engagement.

Q: What's the timeline for Gubra's DC development candidate selection to IND?

A: Joshua Cohen said they expect to make a decision on a potential development candidate in the next few months and prepare IND-enabling studies pending nomination.

Q: How is diet adherence measured in the LUCIDITY trial?

A: Justin Klee stated that the team uses blinded CGM and monitors to ensure diet adherence, with retraining if necessary.

Q: What's the addressable market for PBH and patient eligibility for the Phase III trial?

A: Joshua Cohen said the addressable market is ~160,000 PBH patients not controlled on diet, and eligibility for the Phase III is based on medically important PBH significantly impacting daily life.

Q: What about the Wolfram syndrome trial parameters and FDA discussions?

A: Camille Bedrosian said they plan to initiate the pivotal Phase III trial for AMX0035 in Wolfram syndrome in the second half of 2026, actively seeking FDA alignment and engaging stakeholders.