Axsome Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the AXIM 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. Accompanying slides are available for this presentation on the company website at axim.com. 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. Our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2020 crossed the wire a short time ago and is available on our website at axiom.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 in the source of future clinical trials, regulatory plans, future research and development 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. Your caution 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, Dave Merrick, Chief Commercial Officer, and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Ariel will first provide an overview of the company, including reviewing recent developments and upcoming milestones. Following Ariel, Nick will review our financial results. We will then open the line for questions. I shall now turn over the call to Ariel.

Thank you, Mark. Good morning, everyone. And thank you all for joining Axome Therapeutics first quarter 2020 financial results and business update conference call. Over the past several months, we have accelerated our evolution into a leading CNS company. During this time, we continue to advance our broad and deep late stage portfolio of novel differentiated medicines targeting difficult-to-treat CNS indications that have limited or no treatment options and that affect significant patient populations. We now believe we have one of the most robust CNS pipelines in the industry. Our late-stage CNS pipeline is not only broad but also proven, as we have now generated or announced positive efficacy results from well-controlled clinical trials in five different indications, including depression, Alzheimer's disease agitation, migraine, narcolepsy, and fibromyalgia. Overall, these conditions affect more than 60 million patients in the U.S. alone. The prevalence, seriousness of, and high unmet needs represented by these conditions underscore the importance of our investigational medicines and the clinical data generated with them thus far. The resulting opportunities are significant. On this slide is a snapshot of select indications in our late stage pipeline for which we now have positive efficacy data from controlled clinical trials. For our XSO5 product candidate, we announced positive NDA enabling results in major depressive disorder in December, showing rapid and substantial improvement in depressive symptoms. And last week, we announced positive results from our pivotal Advance 1 trial of AXS05 in Alzheimer's disease agitation, which similarly demonstrated rapid and substantial symptom improvement in this condition. We have also announced positive NDA enabling results in migraine with our AXS07 product candidate demonstrating superior efficacy. And last month, we announced the positive results from our Infracept trial of AXS07 in the early treatment of migraine. Our AXS12 product candidate for narcolepsy has demonstrated in our CONSERV trial significant improvement in cataplexy and excessive daytime sleepiness, the key symptoms of narcolepsy. And our AXS14 product candidate for fibromyalgia has demonstrated a differentiated profile and positive results in both a phase two and a phase three trial. Overall, our product candidates have the potential to generate total peak sales of up to $9 billion in just these indications based on clinical data generated thus far. This robust portfolio highlights the potential to improve the lives of millions of patients and significantly increase shareholder value. With regards to our upcoming milestones, we remain on track to file our NDA for AXS05 in major depressive disorder in the fourth quarter. The NDA is supported by positive efficacy results from our Pivotal ASCEND and GEMINI trials. Of these three, open-label, long-term safety extension study of AXS05 to further support the NDE filing is ongoing. And to date, more than 800 patients have been dosed in this trial. We also remain on track to file our NDA for AXS07 in migraine in the fourth quarter. The NDA is supported by a positive efficacy result from our momentum and intercept trials. A phase three open-label long-term safety extension study of XSO7 to further support the NDA filing is ongoing. And to date, more than 700 patients have been dosed in this trial. As we move towards the filing of our NDAs in the fourth quarter for XSO5 and for XSO7, our commercial team is focused on launch readiness activities to ensure successful commercial execution. In parallel, we look to continue the momentum in our other late-stage development programs, including AXS05 and Alzheimer's disease agitation, a highly distressing and disabling condition for which there is no approved medicine. Following the recent announcement of positive top-line results from our pivotal Advance 1 trial in this indication, We intend to meet with the FDA as soon as possible to discuss these data. We expect these discussions to inform the design of our next study, which we anticipate initiating in the second half of this year. We also anticipate initiating phase three trials with AXS-12 in narcolepsy in the second half of this year, building on the strong results from our positive phase two concert trial. By focusing on commercial readiness to make our products available to patients starting as early as next year, and by advancing the rest of our development pipeline through innovation, we will continue to build an industry leading CNS company with an energetic culture that challenges the status quo to speed innovative therapies to patients. I would now like to turn the call over to Nick, who will provide a financial update.