Amylyx Pharmaceuticals, Inc.

Good morning, everyone. My name is Jim, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals fourth quarter and full year 2025 earnings conference call. All participants will be in a listen-only mode, and after today's presentation, there will be the opportunity to ask questions. To place yourself into a queue, please press star and one on your telephone keypad. To withdraw your question, you can repeat the steps of star and one. Please limit yourself to one question with one follow-up today, and if you have additional questions, you are invited to rejoin the queue. Please be advised that this call is being recorded at the company's request, and it is now my pleasure to turn the floor over to Lindsay Allen, Vice President, Investor Relations and Communications. Welcome, Lindsay.

Good morning, and thank you all for joining us today to discuss our fourth quarter and full year 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 Avexatide, AMX 35, AMX 114, and AMX 318, 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 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'll turn the call over to Justin.

Good morning, everyone, and thank you for joining us. In 2025, we meaningfully advanced our pipeline, made important progress on our regulatory and commercial preparations for Avexotide, strengthened our financial position, which extended our cash runway into 2028, and positioned the company for what will be a transformative year in 2026. Importantly, in 2025, we initiated the pivotal phase three lucidity trial of our lead program of Exotide, a GLP-1 receptor antagonist in post-bariatric hypoglycemia, or PBH. In addition, our collaboration with Gubra progressed significantly, In January of this year, we announced the nomination of AMX318, a novel, long-acting GLP-1 receptor antagonist as a development candidate for PBH and other rare diseases. We also made strides in ALS. AMX114 received fast track designation and demonstrated a favorable safety and tolerability profile in cohort one of the phase one Lumina trial in people with ALS, allowing us to advance into the next cohort. As we look ahead, Our top priority is our work toward potentially delivering the first approved therapy for PVH. We are focused on three objectives for Avexatide in 2026. One, deliver top line data from the pivotal phase three lucidity trial expected in Q3 2026. We are excited to share that the recruitment phase of lucidity is complete, and we are on track to fully complete enrollment this quarter. With the final potential patients currently in screening, We continue to expect to randomize and dose the last eligible participants this month. Two, advance NDA readiness and regulatory preparations so we can move rapidly following top line data. We are already hard at work drafting NDA sections to support a potential submission. And three, strengthen launch readiness to support a potential 2027 commercialization of Avexatide if approved. We are actively building our commercial infrastructure and fine-tuning our launch strategies, drawing on our experience of successfully establishing a commercial organization in the past. As we prepare the organization and continue to understand the market, we're making key hires, conducting market research, including gathering insight from clinicians and people living with PBH, and building our disease education initiatives and market access strategies. We're acting with urgency, driven by the significant unmet need in PBH and our conviction in the opportunity we believe is ahead of us. When we assess the epidemiology of PBH, we benefit from a growing body of prospective and retrospective published literature, including large long-term cohort studies evaluating hypoglycemia in people who've undergone bariatric surgery. From these studies, we estimate that there are approximately 160,000 people living with PVH in the U.S. out of the more than 2 million people over the last decade who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass. Our independent claims analysis across multiple databases continues to help validate our view of the market opportunity and further our understanding of where people with PVH are being cared for. Additionally, we continue to hear from clinics and families about the difficulty in managing PBH and how the lives of patients are upended by this condition. With that, I'd like to now turn the call over to Camille to further discuss the unmet need in PBH, the lucidity trial, and some of the launch preparation underway in her organization.