Axsome Therapeutics, Inc.

Hello, and welcome to the Axon Therapeutics second quarter 2024 financial results conference call and webcast. At this time, all participants are in a listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. We ask that you please limit yourselves to one question, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Darren Open, Director of Corporate Communications at Axiom Therapeutics. Please go ahead, Darren.

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 second 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, among 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 CINOSI, Avaladi, and our 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 Tabuto, 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 comment on the progress we made in the second quarter of 2024 and review key upcoming milestones. Following Ariel, Nick will review our financial results, and then Ari will provide a commercial update. We will then open the line for questions. Questions will be taken in the order that they are received. And with that, I will turn the call over to Aria.

Thank you, Darren. Good morning, everyone, and thank you for joining Axiom Therapeutics' second quarter 2024 financial results and business update conference call. We had a very productive second quarter with all elements of our business advancing across our singular CNS-focused portfolio as we continue to build a leading neuroscience company. We delivered strong commercial performance with continued momentum for the launch of Avelity. In particular, we secured important improvements in both the quality and quantity of payer coverage, and we are clearly seeing the impact of our expanded sales representative team. We remain pleased with Synosi and remain excited by the opportunities we see and the currently improved indications alone. Nick and Ari will provide additional color on both products shortly. Adjacent to our commercial products, we made important progress on both our NDA stage product candidates. The NDA for AXS07 for the acute treatment of migraine has been resubmitted to the FDA, and we look forward to providing updates on the FDA review. We believe that AXS07, if approved, would be an important new treatment option that could provide differentiated outcomes for patients. With respect to AXS14 for the management of fibromyalgia, We made important progress on our NDE package, taking a steady approach to ensure a quality submission. And we expect to complete this NDE submission shortly in the third quarter. Fibromyalgia is a debilitating chronic CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment. With limited treatment options available, AXS14 has the potential to deliver much needed innovation to patients and HCPs alike. Moving on to the rest of our robust late stage development pipeline. We are making excellent progress on our numerous important clinical programs, a number of which have pivotal trial readouts later this year and next. AXS05 is Axome's novel oral investigational NMDA receptor antagonist and signal 1 receptor agonist that we are developing for Alzheimer's disease agitation. We continue to anticipate top-line results for the PIVOTL Advance 2 Phase 3 trial in the second half of the year. Additionally, the enrollment target in the PIVOTL Accord 2 Phase 3 trial has been reached. As a result, We now expect top-line results for both of these studies in the second half of 2024. Taurianfetol, our dopamine and norepinephrine reuptake inhibitor and par 1 agonist, is now in phase three trials in four new indications. The focus phase three trial in adults with ADHD remains on track for top-line results in the second half of the year. In addition, the Paradigm Phase III trial in major depressive disorder, and the Engage Phase III trial in binge eating disorder, also ongoing, with results from both trials anticipated in 2025. We also recently launched the Sustained Phase III trial in shift work disorder, for which we anticipate results in 2026. Each of these programs, if successful, has the potential to represent a significant commercial expansion opportunity for sorianfetol. Finally, we continue to anticipate results this year from the eMERGE phase three trial of AXS07 in patients with an inadequate response to oral CGRP therapy, as well as results from the phase three open label safety extension trial of AXS12 in narcolepsy. In total, we have five product candidates in late phase development for nine important indications each of which has key potentially value driving milestones on the horizon. We are incredibly excited by our work and the potential Axiom has to contribute to differentiated patient outcomes and to the advancement of medical practice in neuropsychiatry. Stay tuned for updates on our advancements as we continue to work every day to make a difference in the lives of the millions of people in the U.S. affected by central nervous system disorders. I will now turn the call to Nick, who will provide details of our financial performance.