Axsome Therapeutics, Inc.

Good morning and welcome to the Accent 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. As a reminder, today's conference call is being recorded. I will now turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Accent Therapeutics. Please go ahead.

Thank you, Operator. Good morning and thank you all for joining us on today's conference call. Our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2021 crossed the wire a short time ago and is available on our website at axom.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, are clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and 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 findings 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 when the company disclaims any obligation to update such statements. Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, Laurie Engelbert, Senior Vice President of Commercial and Business Development, Dr. Amanda Jones, Senior Vice President of Critical Development, and Dr. Cedric O'Gorman, Senior Vice President of Medical Affairs. Herriot will first provide an overview of the company and then review recent developments and upcoming milestones. Following Herriot, Lori will provide a commercial update and then Nick will review our financial results. He 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 Herriot.

Thank you, Mark. Good morning, everyone, and thank you all for joining Axome Therapeutics' first quarter 2021 financial results and business update conference call. The timing of this call coincides with Mental Health Month, and Axome is proud to observe May as Mental Health Month by partnering with advocacy groups and helping to raise awareness and support for people living with depression and other mental health conditions. In the first quarter, We continue to make significant strides towards becoming a premier CNS biopharmaceutical company focused on delivering potentially life-changing medicines to people living with serious CNS conditions. The dedicated work of the Axlum team resulted in the submission of our NDA for AXS05 for the treatment of major depressive disorder, or MDD. The NDA was granted priority review by the FDA, and the FDA has set up a Dufa target action date for the NDA of August 22, 2021. The NDA for our second lead product candidate, AXS07, for the acute treatment of migraine is on track for submission to the FDA this quarter. And we expect to announce the FDA's decision regarding its acceptance of the filing in the third quarter. With two NDA filings and a PDUFA target action date for AXS05 in late August, Axome is quickly approaching commercialization stage. Laurie will provide some details on our pre-commercial activities to ensure launch readiness assuming a successful NDE review. The rest of our differentiated late-stage pipeline continues to advance. AXS05 is also being developed for the treatment of Alzheimer's disease agitation and enrollment in the Phase III Accord trial is progressing. Our AXS12 product candidate for narcolepsy is progressing towards initiation of the planned Phase III trial early in the third quarter. For our AXS14 product candidate for the treatment of fibromyalgia, we recently met with the FDA to discuss its further clinical development plan, and we are awaiting written feedback from the meeting. Our portfolio comprises four late-stage product candidates under development for six distinct indications representing unmet medical needs that affect a large percentage of Americans We are energized by their potential to deliver significant benefit to patients and by our planned commercialization approach. I will now turn the call over to Lori, who will provide a commercial update.