Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom 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 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 two press releases. Our earnings press release, providing a corporate update and details of the company's financial results for the first quarter of 2022, and the release relating to the FBA's action on the AXS07 NDA. These cross the wire a short time ago and are 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 uncertainty 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. We 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 Cabuto, Chief Executive Officer, Nick Peavy, Chief Financial Officer, Lori Engelbert, Executive 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 Axone Therapeutics' first quarter 2022 financial results and business update conference call. The past few months have been incredibly busy and productive for Axone. We have made progress in the FDA reviews of both of our NDAs, announced the agreement to acquire Synosee, and continue to advance the rest of our rich late-stage pipeline, which includes AXS05 in Alzheimer's disease agitation, AXS12 in narcolepsy, and AXS14 in fibromyalgia. Axon is poised to transform into a commercial entity, potentially as early as this month, a direct result of our team's focused execution. I will provide an update on the status of our NDAs. the pending Synose acquisition, and the rest of our pipeline before turning it over to Laurie and Nick who will provide a commercial and financial update. With regards to AXS07, this morning we announced that we have received a complete response letter or CRL from the FDA for the AXS07 NDA for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS07. The principal reason given in the CRL relate to chemistry, manufacturing and controls, or CNC considerations. The CRL identified the need for additional CNC data pertaining to the drug product and manufacturing process. We believe that all the issues raised in the CRL are addressable. We are excited by the prospects for AXS07. This excitement is driven by the strong clinical data and product profile of AXS07. The approval of AXS07 would offer a much needed new multi-mechanistic treatment option for the millions of people living with migraine. It is our goal to work closely with the FDA to provide them with the information they need so that we can make this important new medicine available to patients as quickly as possible. We intend to provide potential timing for a resubmission following consultation with the FDA. With regards to XSO5, review of the FDA is progressing. Based on feedback from the FDA, we believe that the previously disclosed CMC deficiencies have been resolved. In addition, we recently received and agreed the post-marketing requirements and commitments proposed by the FDA for AXSOSIs. Based on this interaction, we anticipate potential FDA action on the NDA in the second quarter of 2022. With regards to our Alzheimer's disease agitation program, Enrollment in the Phase III Accord trial of AXS05 in the syndication continues to progress. As previously disclosed, we are evaluating the design of this study and will provide an update following consultation with the FDA. Moving on to the Synose acquisition. In March 2022, we entered into a definitive agreement to acquire Synose or Solvianfetol from Jazz Pharmaceuticals. Synose is a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. The Hart-Scott-Rodino waiting period for the acquisition has now expired, and so we expect the transaction to close this month. Between the pending FDA action on our NDA for AXS05 in depression and the expected closing of our acquisition of Synose, Axone is poised to potentially make two important new medicines available to patients living with serious CNS disorders in the coming months. The rest of our late stage pipeline continues to advance. For AXS12, our product candidate being developed for the treatment of narcolepsy, enrollment in the symphony phase three 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.