Axsome Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the ATSOM third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mark Jacobs. Jacobson, Chief Operating Officer. 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 third quarter of 2021 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 four 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 four 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 four 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 Peavy, Chief Financial Officer, Dr. Kevin Merliberty, Executive Vice President, Product Strategy, Lori Engelberg, Senior Vice President of Commercial and Business Development, and Dr. Amanda Jones, Senior Vice President of Critical 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 Axon Therapeutics' third quarter 2021 financial results and business update conference call. Over the past several months, we have continued to advance our differentiated late-stage CNS product candidates aimed at meaningfully improving the lives of patients. I will provide an update on our development pipeline before turning it to Laurie, who will provide a commercial update. Starting with our first lead product candidate, the XSO5, which is undergoing an NDA review for the treatment of major depressive disorder. The FDA did not take action on the NDA by the August 22nd PDUFA date, as previously disclosed, and review of the application is ongoing. The agency recently informed us of two deficiencies related to analytical methods in the chemistry, manufacturing, and controls section of the NDA, which must be addressed prior to the FDA taking action on the NDA. We believe these deficiencies are addressable and are confirming the details of the request with the FDA. The XSO5 is also being developed for the treatment of Alzheimer's disease agitation. Enrollment in the Phase III Accord trial for the syndication is progressing. And based on current enrollment trends, we anticipate completion of the trial in the first half of 2023. With regards to the development of AXS05 in smoking cessation, we received positive pre-IND meeting written guidance from the FDA on a proposed clinical development plan. Based on this feedback, we plan to proceed to a pivotal Phase 2-3 trial in this indication and expect to provide timing on initiation of that trial next year. 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 has also informed us that due to COVID-19 pandemic-related travel restrictions, they may be unable to complete an inspection of one of the AXS07 manufacturing facilities prior to the PDUFA date. They will continue to monitor the public health situation as well as travel restrictions, and we will keep you informed of any developments on this front. With two NDAs under active review, Axome is in a position to potentially commercialize two new treatments in the near to intermediate term for patients living with depression and migraine. Laurie will provide details on our commercial launch readiness for AXS05 and our prelaunch commercial activities for AXS07. The rest of our rich pipeline continues to advance. For AXS12, our product candidate being developed for the treatment of narcolepsy, we initiated a symphony phase three trial in the third quarter. Enrollment in the 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 an NDA are ongoing. Based on the status of these activities, we now expect to submit the NDA in 2023. I will now turn the call over to Lori, who will provide a commercial update.