Axsome Therapeutics, Inc.

and welcome to today's AXA AXM fourth quarter and fall year 2021 financial results. My name is Candice and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for question and answer at the end. If you would like to ask a question, please press start followed by one on your telephone keypad. I would now like to pass the conference call over to our host, Mark Jacobson, Chief Operating Officer Mark, please.

Thank you, Operator. Good morning, and thank you all for joining us on today's conference call. Our earnings press release providing corporate update and details of the company's financial results for the fourth quarter and full year 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, 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 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 Tibuto, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, Lori Engelbert, Senior Vice President of Commercial and Business Development, and Dr. Amanda Jones, Senior Vice President of Clinical 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 Axiom Therapeutics' fourth quarter and year-end 2021 financial results and business update conference call. 2021 was a year of continued progress, which has put us in a position to potentially launch two new investigational medicines for patients living with depression and migraine. I will provide an update on our development pipeline before turning it to Lori, who will provide a commercial update. Starting with our first lead product candidate, AXS05, which is undergoing an NDA review for the treatment of major depressive disorder. The FDA previously informed us of two deficiencies related to analytical methods in the chemistry, manufacturing, and controls section of the NDA. We submitted a response addressing these deficiencies. The FDA has acknowledged receipt of the response, and to date, we have not been made aware of any other deficiencies related to the NDA by the FDA. AXS05 is also being developed for the treatment of Alzheimer's disease agitation. Enrollment in the Phase III ACCORD trial for this indication is progressing. Currently, blinded relapse events are below projections. This may imply a potentially greater than projected overall durability of effect in the study, which would have implications for the duration of the trial. In light of these observations, We are evaluating the design of this study and will provide an update following consultation with the FDA. With regards to the development of AXS05 in smoking cessation, we intend to provide timing on initiation of that trial in the coming months. Moving on to our second lead product candidate, AXS07, a multi-mechanistic acute treatment for migraine. The NDA for AXS07 was accepted for review by the FDA with a PDUFA target action date of April 30, 2022. The FDA previously notified us that due to COVID-related travel restrictions, they might be unable to complete a required inspection of a contract manufacturing facility prior to the PDUFA date. We have since been informed by the FDA that it does not anticipate any issues with completing this facility inspection prior to PDUFA. With the NDAs for AXS05 and AXS07 under active review, Axome launch preparations are underway, and Laurie will provide details on our commercial launch readiness. The rest of our rich pipeline continues to advance. 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 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 candidate in 2023. I will now turn the call over to Lori, who will provide a commercial update.