Axsome Therapeutics, Inc.

Good morning and welcome to Axon Therapeutics conference call. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Axon Therapeutics. Mark, 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 second 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, commercial plans, 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 Peasy, Chief Financial Officer, and Lori Engelbert, Senior 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, Lori will provide a commercial update and then Nick will review our financial results. 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 Axome Therapeutics second quarter 2022. financial results, and business update conference calls. We are proud to report our first commercial sales following the closing of the Synosi acquisition in the second quarter. This transition to commercial status is a milestone that few developmental stage companies reach, and we are positioned to potentially rapidly grow our commercial portfolio in the near to intermediate terms. This should happen with the two NDA stage product candidates that we have, as well as five additional phase three stage clinical programs. I will provide an update on our commercial and developmental portfolio before turning it to Lori for a commercial update and to Nick for the financial update. Starting with Synosi, we generated U.S. net sales of 8.8 million for the roughly two months from the close of the acquisition on May 9th to the end of the second quarter. We continue to be excited by the growth potential for this product. Moving on to our NDA stage products, AXS05 for MVD and AXS07 for migraine. With regards to our NDA for AXS05 and major depressive disorder, or MVD, we announced that we had entered into labeling discussions with the FDA in late June. We have been pleased with the progress of these discussions. And based on the interactions, we anticipate potential FDA action on the NDA in the third quarter and potentially as early as this month. With regards to XS07, following the complete response letter, we recently submitted for a type A meeting with the FDA to discuss our potential approach, our planned approach to the resubmission of the NDA. And we anticipate that this meeting will occur in the third quarter. The rest of our developmental pipeline continues to progress. With regards to our Alzheimer's disease agitation program, we have amended the relapse criteria for the accord phase three randomized withdrawal study of AXS05 in Alzheimer's disease agitation. The change was informed by results of an analysis requested by the FDA of data from the previously completed positive advance one trial. In order to generate additional data to support the efficacy of XSO5 in this indication, we're also initiating a new randomized placebo-controlled parallel group trial, the ADVANCE-2 trial, this quarter. Concurrent with the initiation of ADVANCE-2, we are concluding the ACCORD randomized withdrawal trial, and we expect top-line results from this study in the fourth quarter of 2022. For AXS12, our product candidate being developed for the treatment of narcolepsy. Enrollment in the Symphony Phase III trial is progressing, and top-line results are anticipated in the first half of 2023. For AXS14, our product candidate for the treatment of fibromyalgia, manufacturing, and other activities related to the planned submission of the NDA are ongoing, and we expect to submit the NDA for this product in 2023. With regards to a new indication for Synose, we recently announced our plans to develop Sorianfetol for the treatment of ADHD. We anticipate initiating a pivotal trial of Sorianfetol in adults with ADHD in the fourth quarter. I will now turn the call over to Lori, who will provide a commercial update.