Amylyx Pharmaceuticals, Inc.

Good morning. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the AMELIST Pharmaceuticals first quarter 2026 earnings conference call. All participants will be in a 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 2. Please limit yourselves to one question 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 first quarter 2026 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, Jim Freydes, our Chief Financial Officer, and Dan Monahan, our Chief Commercial 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 Avexatide, AMX 35, AMX 114, and AMX 318, statements regarding regulatory and clinical developments and 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 statements. You are cautioned not to place any undue reliance on these forward-looking statements, and AMOX 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. The first quarter of 2026 was marked by execution across our pipelines. Most notably, we continue to progress the pivotal Phase III Lucidity Trial of Avexatide, our investigational first-in-class GLP-1 receptor antagonist with the FDA Breakthrough Therapy designation in post-bariatric hypoglycemia, or PBH. We are executing on the three strategic imperatives for Avexatide that we outlined earlier this year. First, we are advancing the pivotal Phase III Lucidity Trial toward top-line data. Randomizing and dosing the last participant in late March was a significant milestone. We have a clear line of sight toward the completion of the 16-week trial, and we remain on track for a top-line readout next quarter. Second, we are advancing NDA readiness and regulatory preparations. We are already drafting NDA sections to support a potential submission. And third, we continue to strengthen our launch readiness We are executing against a comprehensive commercial readiness roadmap to help ensure we are fully prepared for commercialization of Avexatide if approved in 2027. In addition to Avexatide, we continue to make progress across our broader pipeline. For AMX318, our long-acting GLP-1 receptor antagonist, IMD-enabling studies are underway. We are targeting a 2027 IMD filing. For AMX35 and Wolfram syndrome, we anticipate presenting longer term week 96 data from the phase two open label helios clinical trial at an upcoming scientific meeting. And for AMX114 and ALS, we fully enrolled cohort two of the phase one lumen trial in March. At the NCALS annual meeting this June, we expect to present early biomarker data from cohort one, the first and lowest of four doses being evaluated in the trial. We expect these data will provide initial information about the levels of the ALS biomarkers being assessed in the Lumina trial from the first cohort. As we continue to advance our pipeline, we are simultaneously preparing for the potential commercial launch of Avexatide. To discuss our launch readiness efforts, Dan Monaghan, our Chief Commercial Officer, is with us on the call today. Dan joined AMLEX in January 2024, bringing more than two decades of experience. He was instrumental in the commercialization of Otsuka's Rixulti, Novartis' Cosentix, and Sanofi's Lantus and Actinil, among others. With that, Dan, I'll turn the call over to you.