Axsome Therapeutics, Inc.

Good morning, and welcome to the Axum Therapeutics conference call. Currently, all participants are in a listen-only mode. Later, there will be a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Darren Oppen, Director of Corporate Communications at Axome Therapeutics. Please go ahead.

Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2024. The release crossed the wire a short time ago and is available on our website at axome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, amongst other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding synopsis, ability, and our other pipeline products, revenue projections, and possible intended use of cash and investments. These forward-looking statements are based on current information assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today are Dr. Ariel Tabuteau, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, Mark Jacobson, Chief Operating Officer, and Ari Maisel, Executive Vice President and Head of Commercial. Ariel will provide an overview of the company and progress made in the first quarter of 2024, as well as key upcoming milestones. Following Ariel, Nick will review our financial results, then Ari will provide a commercial update. We will then open the line for questions. Questions will be taken in the order they are received. And with that, I will turn the call over to Ariel.

Thank you, Darren. Good morning, everyone, and thank you for joining Axon Therapeutics' first quarter 2024 financial results and business update conference call. The first quarter of 2024 was marked by strong financial performance for our on-market products, which are delivering important and differentiated treatment options for patients living with depression, narcolepsy, and obstructive sleep apnea. Total net product revenue in the quarter was $75 million. representing year-over-year growth of approximately 160%. We will share additional details on our financial and commercial performance later in the call. We also significantly advanced our innovative neuroscience pipeline in the quarter, including announcing positive top-line results for AXS-12 and narcolepsy, advancing AXS-07 and AXS-14 towards NDA submissions, initiating pivotal trials and new indications with sorianfetol, and advancing and expanding our Alzheimer's disease agitation program for AXS05. We expect to continue the commercial and pipeline momentum in the balance of 2024. I will now provide a brief update on our industry leading neuroscience pipeline and expected milestones. Starting with our two NDA stage products, AXS07 for the acute treatment of migraine is on track for an NDA resubmission this quarter. Additionally, we are conducting the eMERGE study, a multi-center phase three single group trial evaluating the efficacy and safety of AXS07 in adults with a prior inadequate response to an oral CGRP inhibitor. We anticipate top-line results from this trial in the second half of 2024. For AXS14, which we are developing for the treatment of fibromyalgia, pre-submission activities for the NDA for this product are nearing completion. continue to target submission later this quarter. In March, we announced that the Phase III symphony trial of AXS-12 and narcolepsy achieved its primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo. AXS-12 also reduced excessive daytime sleepiness severity, improved cognition, and reduced overall narcolepsy severity. An open-label safety extension trial for AXS-12 is ongoing. of 2024. We are excited about the potential of AXS-12 to provide a differentiated treatment option to patients and HCPs for this debilitating condition. Moving on to the AXS-05, we continue to anticipate completion of the Phase III Advanced II trial in the treatment of Alzheimer's disease agitation in the second half of 2024. Today, we announced that we launched the ACCORD II study a double-blind, placebo-controlled randomized withdrawal trial to evaluate the efficacy and safety of AXS05 in the treatment of Alzheimer's disease agitation. This study is similar in design to the completed positive ACCORD1 trial. With ACCORD2, the clinical development program will now include four controlled efficacy trials. Importantly, ACCORD2 further increases the robustness of our clinical program in Alzheimer's disease agitation without impacting our overall development timeline. Enrollment in Accord 2 is very far along, and we expect enrollment completion around mid-year. With respect to Sol-reampetol, our dopamine and norepinephrine reuptake inhibitor and colon agonist, in addition to continued commercial performance, we launched the Phase 3 paradigm trial in major depressive disorder and the Phase 3 engaged trial in binge eating disorder in the first quarter. Results from both trials are expected in 2025. We are on track to initiate a phase three clinical program in chip work disorder this quarter. Solvranfetol is also being evaluated in the FOCUS phase three trial in ADHD, for which we continue to anticipate top-line results in the second half of this year. Overall, our innovative neuroscience portfolio encompasses five late-stage patent-protected product candidates targeting 10 serious psychiatric and neurologic conditions with substantial market opportunities. Each body candidate has the potential to transform the treatment landscape for serious and difficult-to-treat CNS disorders, which affect more than 150 million people in the U.S. I will now turn the call to Nick, who will provide details of our financial performance.