Amylyx Pharmaceuticals, Inc.

Good morning. My name is Camille, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals Second Quarter 2024 Earnings Conference Call. All participants will be on 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, please press star 2. 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 second 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 Avexatide, AMX 35, and AMX 114, 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, and thank you all for joining us today. As an organization, we have made significant progress over the past few months as part of our continued mission and our goal to deliver important treatment options to the neurodegenerative, neuroendocrine, and endocrine communities we serve. Most notably, last month, we expanded our late-stage pipeline with our acquisition of Avexotide and now have three assets targeting orphan indications. Avexatide is a Phase III-ready asset with FDA breakthrough therapy designation in diseases with no approved treatment options. Avexatide is a GLP-1 receptor antagonist with orphan drug designation in hyperinsulinemic hypoglycemia. The GLP-1 receptor is one of the key regulators of the glucose insulin response. and an imbalance in this response leads to hyperinsulinemic hypoglycemia, which underlies several conditions and diseases. So far, Avexetide has been studied in two indications characterized by hyperinsulinemic hypoglycemia, post-bariatric hypoglycemia, or PBH, and congenital hyperinsulinism. The first indication, PBH, is a significant but orphaned condition that affects the subpopulation of people who have undergone bariatric surgery. Now, let me elaborate a little further on the market opportunity ahead. Despite the introduction of GLP-1 receptor agonists for weight loss, more than 200,000 new bariatric procedures are performed every year, and this number has continued to grow on an annual basis. Over the past 10 years, approximately 2 million people in the United States have undergone the two most common types for weight loss, Roux-en-Y gastric bypass and sleeve gastrectomy. Experts expect surgery to remain a cornerstone of weight loss therapy given the procedure is highly effective and results in substantial and sustained weight loss, particularly for people with higher BMIs. Evidence also suggests that bariatric surgery reduces the risk of cardiovascular events, and the severity of metabolic dysfunction-associated liver disease. Turning to PBH, this persistent condition can develop in people who had received bariatric surgery one to three years prior, and in some cases, even longer post-surgery. We estimate that approximately 8% of the 2 million people I referenced, or 160,000 people in the U.S. today, have symptomatic PBH. Symptomatic PBH is characterized by hypoglycemic events associated with brain glucose starvation, known as neuroglycopenia, including impaired cognition, loss of consciousness, and seizures, as well as activation of the autonomic nervous system, presenting as hunger, sweating, tingling, tremors, palpitations, and anxiety. People living with PBH could benefit from a treatment that helps stabilize glucose levels, particularly the dangerously low crashes in blood glucose associated with PBH. Camille will discuss our plans for the Phase III development program for Avexatide, which we expect to initiate in the first quarter of next year. There is agreement with FDA on the primary outcome for the pivotal Phase III study for PBH. The outcome, reduction in the composite of level 2 and level 3 hypoglycemia events, is clearly linked to GLP-1 receptor antagonism and was already met in the phase 2 and phase 2B clinical trials of avexatide and PBH with high significance. Camille will also recap the key data, including the statistically significant and clinically meaningful reductions in hypoglycemic events. We are highly encouraged by the greater than 50% reductions in level 1, 2, and 3 hypoglycemic events that have been demonstrated by Avexatide. Avexatide has the potential to be the first-in-class GLP-1 receptor antagonist. Before I turn it over to Camille, I would like to quickly touch on our cash runway. In the second quarter, we largely completed our restructuring. We expect our cash runway to take us into 2026. Jim will provide additional context. I will now turn the call over to Camille.