Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom Therapeutics conference call. Currently, all participants are in 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, 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, Mark Jacobson, Chief Operating Officer at Axiom Therapeutics. Please go ahead.

Thank you, Operator. 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 third quarter of 2022. The release crossed the wire a short time ago and is available on our website at axon.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 synosy, ovality, 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 Securities and Exchange Commission, including our quarterly and annual reports. Your caution 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 Peasy, Chief Financial Officer, and Lori Engelbert, Executive Vice President of Commercial and Business Development. Ariel will first provide an overview of the company and then review recent developments and upcoming milestones. Following Ariel, Nick will review our financial results, and Lori 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, Mark. Good morning, everyone, and thank you all for joining Axon Therapeutics' third quarter 2022 financial results and business update conference call. The past few months have been pivotal and exciting at Axon. Our transformation into a commercial stage, fully integrated, research and development-driven, CNS-focused biopharmaceutical company has accelerated. with the commercialization of Synose for EDS associated with narcolepsy and obstructive sleep apnea, and now with the launch of Abelity for the treatment of MDD in adults. In addition, our broad and differentiated CNS pipeline continues to progress. The third quarter was the first full quarter of sales for Synose, and the results demonstrate the efficiency of our commercial approach. Current and future initiatives and potential indication expansion for Synose bode well for the continued growth of this differentiated product with significant market potential. Nick will provide more details on our financial performance. We are thrilled to have recently launched Orvelity, making this important new treatment available to the millions of adult patients living with MDD in the US. Orvelity is now helping to address a major public health concern given the current mental health epidemic. While still very early days, with only 12 days on the market, Laurie will provide some comments on our initial experience. Complementing our commercial progress, our broad late-stage CNS pipeline continues to progress, setting the stage for potentially continued significant value creation over the near, intermediate, and long term. This pipeline includes AXS07 for migraine, AXS07, AXS05 for Alzheimer's disease agitation, AXS-12 for narcolepsy, AXS-14 for fibromyalgia, as well as ADHD, a potential new indication for sorianfetol or senosine. With regards to AXS-07 for the acute treatment of migraine, we completed a type A meeting with the FDA in the third quarter. Based on the meeting results, we intend to resubmit the AXS-07 NDA in the third quarter of 2023. As a reminder, no additional clinical efficacy or safety trials have been requested by the FDA for resubmission of the NDA. With regards to our Alzheimer's disease agitation program, we recently initiated the ADVANCE-II study, which is a Phase III randomized, double-blind, placebo-controlled, multi-centered trial to assess the efficacy and safety of AXS05 for the treatment of Alzheimer's disease agitation. Concurrent with the initiation of the ADVANCE-II trial, we have concluded the ACCORD randomized withdrawal trial as planned. Top-line results from the ACCORD trial are now on track for the fourth quarter of 2022. For AXS-12, our product candidate for the treatment of narcolepsy, enrollment in the Symphony Phase III trial is progressing, and top-line results continue to be anticipated in the first half of 2023. For AXS-14, our product candidate for the treatment of fibromyalgia Manufacturing and other activities related to the planned submission of an NDA are ongoing, and we expect to submit the NDA for this product in 2023. With regards to psori-amphetol, or Synose, for the treatment of ADHD, we are preparing to initiate a Phase 2-3 multicenter randomized double-blind placebo-controlled trial in the syndication in the fourth quarter of this year. The Axon team is therefore busy and excited as we prepare to deliver on continued ongoing commercial progress and near and intermediate term pipeline milestones, which include clinical trial readouts, clinical trial initiations, and NDA filings over the remainder of this year and through 2023. I will now turn the call over to Nick, who will provide a financial update.