Amylyx Pharmaceuticals, Inc. Q1 FY2026 earnings call

Good morning. Welcome to the AMELIST Pharmaceuticals first quarter 2026 earnings conference call. Justin Klee, co-CEO, discussed progress on the pivotal Phase III Lucidity Trial of Avexatide, advancing NDA readiness and launch readiness. Dan Monahan, Chief Commercial Officer, talked about refining launch strategies, disease state education, and market opportunity for PBH. Camille Bedrosian, Chief Medical Officer, provided update on clinical and medical affairs, including progress on the Lucidity Trial and launch of U.S. expanded access program. Jim Freydes, Chief Financial Officer, reviewed financials, noting operating expenses, R&D and SG&A expenses, and cash runway.

The pivotal Phase III Lucidity Trial of Avexatide is on track for top-line readout next quarter. For AMX318, IMD-enabling studies are underway with target 2027 IMD filing. For AMX35, longer term week 96 data from phase two open label helios clinical trial to be presented at upcoming scientific meeting. For AMX114, fully enrolled cohort two of phase one lumen trial in March, expecting to present early biomarker data from cohort one at NCALS annual meeting this June.

Q: About initiation of EAP and NDA preparation; A: Camille explained EAP is to ensure continuity for lucidity study participants, and working on NDA preparations to be efficient.

Q: Baseline of enrolled Phase III population vs Phase II; A: Study is ongoing and blinded, will share top-line data next quarter.

Q: Steps to ensure patient quality and protocol adherence in Lucidity study; A: Extensive training of clinical sites, materials for participants, and quality checks.

Q: Top line disclosure of Lucidity and NDA preparation; A: Primary outcome is level two and three hypoglycemic events, NDA work in progress.

Q: Claims data adjudication and patient population; A: Identifying patients with bariatric surgery, hypoglycemia, and associated symptoms, confident in 160,000 patient population.

Q: Level two/three events in Lucidity and commercial prescriber base; A: Primary endpoint is composite, commercial Salesforce sizing in progress.

Q: Natural variability in level 2 and 3 events and patient targeting; A: Powering analysis accounts for variability, targeting centers of excellence first.

Q: Placebo effect and implications for AMX114 trial; A: No read-through between studies.

Q: Biomarkers for AMX114 trial; A: Reporting biomarker data in June at NCALS.

Q: ICD-10 code impact and persistence in commercial plan; A: ICD-10 code helps track patients, early to comment on persistence.

Q: OLE setup and enrollment; A: Lucidity proceeding well, open label extension allows continuation.

Q: Ex-U.S. opportunities for Avexatide and Lumina biomarkers; A: Considerable global unmet need, biomarkers aim to see impacts of CalPain2 and ALS.