Amylyx Pharmaceuticals, Inc.

Good morning. My name is Alan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelinks Pharmaceuticals Third Quarter 2024 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 in your telephone keypad. To withdraw your question, please press star two. 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, Head, Investor Relations and Communications. Please proceed.

Good morning, and thank you all for joining us today to discuss our third quarter 2024 financial results. 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 Avexotide, AMX 35, and AMX 114, statements regarding regulatory 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 AMELEX disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.

Good morning, and thank you all for joining us. The last few months have been productive in advancing our late-stage pipeline in the effort to fulfill our mission to bring new potential treatments to communities with high unmet needs in neurodegenerative diseases and endocrine conditions. We continue to progress our lead asset of Exatide, a GLP-1 receptor antagonist with both FDA breakthrough therapy and orphan drug designations in diseases with no approved treatment options. We remain on track to initiate our Phase III trial in post-bariatric hypoglycemia, or PBH, in the first quarter of 2025. which Camille will discuss a little later. We have also significantly increased our interactions with the endocrine and PBH communities and are excited for the potential of this therapy. In mid-October, we reported positive top-line data from our open-label Phase II Helios trial of AMX35 in 12 participants living with Wolfram syndrome. People treated with AMX35 showed improvement in pancreatic function, as measured by the primary endpoint of C-peptide response at 24 weeks. We also saw similar overall improvements or stabilization across all secondary endpoints. Additionally, the longer-term data being collected demonstrated sustained improvement over time. With these positive data in hand, we plan to meet with the FDA and other stakeholders to inform a Phase III program. Our Orion trial of AMX35 in PSP is recruiting well, and we continue to expect data from an interim analysis mid next year. And we are looking forward to initiating our phase one clinical trial of AMX114, our antisense oligonucleotide targeting CalPain2 in people with ALS. We are in a strong financial position and continue to expect our cash runway to take us into 2026. Our pipeline strategy is focused on addressing orphan conditions and well-defined mechanistic rationales, clear and measurable biomarkers, and is built on rigorous preclinical data. Our progress this quarter, including the positive data we reported in Wolfram Syndrome, supports this strategy. Our team remains focused on progressing our pipeline and delivering on our key milestones ahead. I will now turn the call over to Camille.