Amylyx Pharmaceuticals, Inc.

Good morning. My name is Carly, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals Third Quarter Earnings Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, please press star 1 on your telephone keypad. To withdraw your question, press star 1 again. Please limit your questions to one with one follow-up. If you have additional questions, you may rejoin the queue. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Lindsay Allen, Vice President, Investor Relations and Communications. Please proceed.

Good morning, and thank you all for joining us today to discuss our third quarter 2025 financial results and business updates. With me on the call today are Josh Cohen and Justin Klee, our co-CEOs, Dr. Camille Bedrosian, our chief medical officer, and Jim Fradies, our chief financial officer. Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans, and expectations and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our expectations with respect to a Vexatide AMX 35 and 114 statements regarding other development candidates, statements regarding regulatory and clinical developments, the impact thereof and the expected timing thereof, and statements regarding our cash runway. Actual events and results could differ materially from those expressed or implied by any forward-looking statement. You are cautioned not to place any undue reliance on these forward-looking statements, and AMLEX disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.

Good morning, everyone, and thank you for joining us. Q3 was a quarter of progress as we continue to focus on our lead program, Avexatide in Post-Bariatric Hypoglycemia, or PBH. Avexatide is our investigational, first-in-class inhibitor of GLP-1 receptor activity with FDA breakthrough therapy designation. PBH is a condition characterized by recurrent hypoglycemic events which can impose a significant and lasting burden on a person's quality of life. There is a robust body of data generated to date for vexatide, which includes five clinical trials demonstrating statistically significant and clinically meaningful reductions in hypoglycemic events. Based on those results, we designed our pivotal phase three lucidity trial with the goal of replication. We remain focused on enrolling a similar patient population collecting the data in a similar way, and executing lucidity with high quality. We continue to see high participant interest and broad engagement across clinical trial sites, which we believe supports the urgent need for an FDA-approved treatment. Our previous guidance for completion of recruitment was by the end of 2025, with top-line data in the first half of next year. Based on our most recent projections, we now expect to complete recruitment in Q1 2026, with top-line data expected in Q3 2026. We anticipated more of a ramp in the enrollment rate at this stage, but we have seen more of a steady enrollment rate in the last few weeks. Timing for potential launch remains unchanged. With early NEA preparation efforts underway, we continue to expect to be in a position to launch Avexatide in 2027, pending FDA approval. Having launched a commercial product in the past, we're focused on key areas required for successful launch. we are already laying the groundwork to be ready in 2027 if approved. We've been taking the initial steps towards building the medical affairs and commercial organizations with targeted investments in market research, insights, disease education, market access strategy, and commercial infrastructure. Our continued market research, claims analysis, and engagement in the field support our confidence in our estimate of 160,000 people with TBH in the U.S., and bolsters our understanding of the unmet need. Turning to our broader pipeline, in Wolfram syndrome, we are advancing the clinical development of AMX35, and pending alignment with FPA, we plan to initiate a focused pivotal phase 3 trial in the second half of 2026. For AMX114, our investigational antisense oligonucleotide targeting CalPain2 and ALS, We were pleased to share that in September, we fully enrolled cohort one in the phase one Lumina trial. We anticipate early cohort data later this year and plan to share the safety data at the 36th International Symposium on ALS and MND, which is being held from December 5th to the 7th. Based on biomarker collection and analysis timelines, we anticipate biomarker data will be available in the coming months and expect to present these at a medical meeting in the first half of 2026. We are excited by the potential of this novel mechanism and the fast track designation from the FDA. Across all of our programs, our team is focused on execution as we head toward a pivotal year in 2026 with top line data from Lucidity anticipated next year. Now, I'll turn the call over to Camille.