Axsome Therapeutics, Inc.

Good morning and welcome to the Axiom Therapeutics conference call. Currently all participants are in a listen only mode. Later we will conduct 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 our host, Mark Jacobson, Chief Operating Officer at Axiom Therapeutics. Please go ahead, sir.

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 2020 crossed the wire a short time ago and is available on our website at taxhomes.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 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 made only 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 and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Ariel will first provide an overview of the company and then review recent development and upcoming milestones. Following Ariel, Lori will comment on our commercialization approach and then 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' third quarter 2020 financial results and business update conference call. Over the past several months, we continued to advance our AXS05 and AXS07 product candidates towards NDE submissions in major depressive disorder and migraine, and we intensified our commercial launch readiness activities. Committed capital from our recently announced term loan facility combined with cash on hand approached $400 million, strengthening our balance sheet through these anticipated commercial launches. In the quarter, we also advanced the rest of our late-stage pipeline, including two positive FTA breakthrough therapy designation meetings for AXS05 in Alzheimer's disease agitation and AXS12 in narcolepsy. and we scheduled an FDA meeting for AXS14, our product candidate for the treatment of fibromyalgia. Our intellectual property portfolio continues to grow with recently issued and allowed patents for AXS05 in depression now extending to 2040. We anticipate an active next few months as we complete our NDA submissions for AXS05 and AXS07 release top-line efficacy data from open-label trials with these product candidates, initiate Phase III trials for AXS05 and AXS12 in Alzheimer's disease agitation and narcolepsy, and meet with the FDA on AXS14 for fibromyalgia. I will provide a brief pipeline update before handing it over to Laurie, who will discuss our commercialization strategy for AXS05 in depression. then Nick will discuss our financial results. Starting with AXS05, our novel oral and MDA receptor antagonist. Pre-submission activities for the MDA for AXS05 for the treatment of MDD are nearing completion. We expect to submit the MDA in January instead of by year end reflecting a COVID-19 related logistical delay from one vendor. We have completed the Phase 3 open-label long-term Comet Safety Trial of XSO5 in depression. The three Phase 2 open-label efficacy sub-studies of the Comet trial have also been completed, and we are on track to report top-line results from these efficacy studies by year-end. Our placebo-controlled MERIT trial in TRD, or treatment-resistant depression, is on track to report results in the first half of next year. Moving on to our program in Alzheimer's disease agitation with AXS05, which received FDA breakthrough therapy designation in June. Results of the subsequent breakthrough therapy meeting for the syndication confirmed the pivotal status of our positive completed ADVANCE-1 trial. Consequently, only one additional Phase III trial is needed to support the filing of an NDA for AXS05 in this indication, and we remain on track to initiate that study before year end. Switching now to our migraine program with AXS07. The major NDA-related items are on track for completion by year end. We now plan to submit the NDA in the first quarter of 2021 versus previous guidance of the fourth quarter of 2020 in order to allow for inclusion of supplemental manufacturing information. We believe that this approach will enhance the robustness of our submission. We have completed the movement phase three open label long-term safety trial of XSO7 in migraine. We now expect to announce efficacy results from this trial in the fourth quarter of 2020. Moving next to our NARCCL-FC program with AXS-12, which received FDA breakthrough therapy designation in August. We recently announced the expedited development status and plan for AXS-12 following a breakthrough therapy meeting. One phase three efficacy trial, which along with the previously completed phase two concert trial will be used to support the filing of an NDA for approval of AXS-12 for the treatment of cataplexy, and narcolepsy. We remain on track to initiate this phase three trial in the first quarter of 2021. Ahead of the potential launches of AXS05 and AXS07 starting next year, our commercial readiness activities have been accelerating. These activities include the build out of our proprietary digital centric commercialization or DCC platform, Our partnership with Viva Systems announced yesterday will provide digital technology that will be incorporated into the DCC platform. We are excited both by the clinical profile of our product candidates and our planned commercialization approach. I will now turn it over to Lori, who will provide some observations as it relates to the growing need in depression and some insights into our planned commercialization approach.