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. Now I'd 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 second quarter of 2020 across 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, 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. 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. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, Dave Merrick, Chief Commercial Officer, and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Herriot will first provide an overview of the company and then review recent developments and upcoming milestones. Following Herriot, Nick will review our financial results. He will then open the line for questions. I shall now turn the call over to Herriot.

Thank you, Mark. Good morning, everyone, and thank you all for joining Axon Therapeutics' second quarter and Tony Horny Financial Results and Business Update Conference Call. Over the past several months, we continue to advance our AXS05 and AXS07 product candidates towards NDE submissions in major depressive disorder and migraine, respectively. Across our broad development pipeline, we achieved several important clinical and regulatory milestones, including two FDA breakthrough therapy designations, I will provide a pipeline update, highlight the achievements in the quarter, and will then review our upcoming milestones. Starting with AXS05 and depression, this morning, in addition to our regular quarterly financial results press release, we issued a separate press release focused solely on the progress in our depression program, including the generation of new clinical data. We remain on track to submit the NDEA for AXS05 in the treatment of Major Depressive Disorder, or MDD, in the fourth quarter. To that end, we have completed a successful pre-NDEA meeting with the FDA for AXS05 and MDD. In addition, we have completed enrollment in the Phase III Open Label Safety Trial of AXS05 in MDD, which we call a CONIT study, to support the planned NDEA filings. We are also conducting three Phase II open-label efficacy sub-studies of the COMET trial, which will evaluate the efficacy and safety of XSO5 in three clinically pertinent MDD patient populations. The COMET TRD trial in treatment-resistant major depressive disorder, or TRD, the COMET AU trial in antidepressant unresponsive MDD, defined as patients who continue to have depressive symptoms and the Common SI Trial in Patients with Suicidal Aviation. Efficacy results from these studies are expected in the fourth quarter of this year and will further inform the antidepressant profile of AXS05. We also initiated a Phase II double-blind, placebo-controlled, randomized withdrawal study in patients with TRD which we call the MERIT Trial. Results from MERIT Trial are expected in the first half of 2021. The MERIT and COMET TRD trials are being conducted in lieu of the previously planned Phase III Trial TRD. This approach will more quickly generate clinically useful information with AXS05 in this treatment-resistant NBD population starting as early as the fourth quarter of 2020. Overall, These new trials will generate additional data on AXS05 across a broad spectrum of NDD patient types by the time of commercialization. We believe that this information will be helpful to prescribers and patients, especially given the new mechanism of action of AXS05. Moving on to our program in Alzheimer's disease agitation with AXS05. In June, we received breakthrough therapy designation from the FDA for AXS05 in the treatment of Alzheimer's disease agitation. This designation is supported by the positive results from our advance one pivotal trial, which demonstrated a substantial reduction in agitation in Alzheimer's disease patients as compared to placebo. We are on track to initiate the second phase three trial of AXS05 in this important indication in the fourth quarter of this year. Switching now to our migraine program with AXS07, we remain on track to submit the NDA for AXS07 for the acute treatment of migraine in the fourth quarter. To that end, we have completed enrollment in the phase three open label safety extension trial of AXS07 in migraine, which we call the movement study, to support the planned NDA filing. As we move towards the filing of our NDAs in the fourth quarter, for AXS05 and for AXS07, our commercial team is focused on launch readiness activities to ensure successful commercial execution. Moving next to our narcolepsy program with AXS12. Last week, we received FDA breakthrough therapy designation for AXS12 for the treatment of cataplexy in patients with narcolepsy. The designation was supported by the positive results from the Phase II Concert Study, which demonstrated substantial and rapid improvements in cataplexy and excessive daytime sleepiness with AXS-12 as compared to placebo. We are on track to initiate Phase III trials of AXS-12 in the treatment of narcolepsy in the fourth quarter of 2020. Our industry-leading late-stage CNS pipeline has now been granted three FDU Breakthrough Therapy Designations, AXS05 in MDD, AXS05 in Alzheimer's disease agitation, and AXS12 in cataplexy in narcolepsy. These designations exemplify our commitment to developing potentially life-changing medicines for patients with difficult to treat CNS conditions and highlight our innovative approach to clinical development and the potential for products to provide significant advances in patient care. With regards to major upcoming milestones, the rest of the year promises to be a busy time. We remain on track to submit our NDAs for AXS05 in major depressive disorder and for AXS07 in the acute treatment of migraine, both in the fourth quarter. We anticipate efficacy results with AXS05 from Comet TRD trial in treatment-resistant depression The Comet AU Trial, an Antidepressant Unresponsive MDD, and the Comet SI Trial, an MDD with Suicidal Ideation, all in the fourth quarter. And we expect to launch our second Phase 3 Trial of AXS05 in Alzheimer's Disease Education, and our Phase 3 Trials of AXS12 in Narcolepsy, all in the fourth quarter. I would now like to turn the call over to Nick, who will provide a financial update.