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. Our earnings press release providing a corporate update and details of the company's financial results for the fourth quarter and full year of 2020 crossed the wire a short time ago and is available on our website at axome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding Among other things, the advocacy, 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 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 firings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned 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 President of Commercial and Business Development, Dr. Amanda Jones, Senior Vice President of Clinical Development, and Dr. Cedric O'Gorman, Senior Vice President of Medical Affairs. Ariel will first provide an overview of the company and then review recent development and upcoming milestones. Following Ariel, Nick will review our financial results. We will then open the line for questions.

And with that, I will turn the call over to Ariel. Thank you, Mark. Good morning, everyone, and thank you all for joining Axome Therapeutics' one-quarter and full-year 2020 financial results and business update conference calls. This past year was one of focused execution for Axone as we advanced our industry leading CNS pipeline towards marketing application submissions. Our portfolio comprises four late stage product candidates under development for six distinct indications representing unmet medical needs that affect over 60 million patients in the U.S. alone. Our focus this year will be on the regulatory activities surrounding our NDA filings for AXS05 and AXS07, launch readiness to ensure a successful transition to commercialization assuming product approvals, and continued advancement of the rest of our late stage CNS pipeline. I will provide a brief update on our pipeline and pre-commercial activities before turning it over to Nick, who will provide a financial update. starting with our first lead product candidate, AXS05. The new drug application or NDA for AXS05 for the treatment of MDD has been submitted. We intend to issue a press release following the FDA's decision regarding its acceptance of the filing. This NDA submission is a major milestone for the company because it brings us closer to potentially making this innovative treatment available to the millions of patients who are living with depression. AXS05 is a novel oral NMDA receptor antagonist with multimodal activity. If approved, AXS05 has the potential to be the first new oral mechanism of action for depression in over 60 years. In the fourth quarter, we announced positive results from the long-term open-label days three common trial demonstrating rapid, substantial, and durable improvements in depressive symptoms and functional impairment that was sustained over the 12-month treatment period with AXS05. AXS05 was well-tolerated with long-term treatment, with a safety profile consistent with that observed in the previously reported controlled trials. We also announced positive results from a Phase II open-label, common sub-studies in patients failing one prior treatment, failing two prior treatments, and in patients with suicidal ideation. Moving on to our Alzheimer's disease agitation program with AXS05. Alzheimer's disease agitation is a serious and debilitating condition for which there is currently no approved treatment. Last year, we announced positive results from the Pivotal Advance One trial, which demonstrated rapid and substantial improvement of agitation in patients with Alzheimer's disease with AXS05 treatment. We subsequently received breakthrough therapy designation for AXS05 in this indication. In December, we launched our second pivotal trial, the ACCORD study, which is a double-blind, placebo-controlled, randomized withdrawal study. Turning now to our migraine program with AXS07. We are completing compilation of the NDA which we expect to submit to the FDA early in the second quarter. There is a significant unmet need for more efficacious treatments for migraine. The World Health Organization ranks the disability from severe migraine attacks on par with that from dementia, quadriplegia, or active psychosis. AXS07's novel oral multi-mechanistic approach may help to address this unmet need. In the fourth quarter, we announced positive results from the long-term open-label movement trial of AXS07, demonstrating rapid, substantial, and durable relief of migraine pain and associated symptoms over the 12-month treatment period. AXS07 was well-tolerated over long-term treatment with a safety profile consistent with that observed in the previously reported control trials. Moving next to our AXS12 product candidate for narcolepsy. Narcolepsy is a serious and debilitating condition with limited treatment options. Results from our Phase 2 trial demonstrated the potential for AXS12 to address a broad range of narcolepsy symptoms. We expect to initiate a Phase 3 trial of AXS12 in narcolepsy in the second quarter. For our AXS14 product candidate for the treatment of fibromyalgia, We're scheduled to meet with the FDA in the second quarter of this year to discuss the development plan for this program. AXS14 has previously met the primary endpoints in a phase three and in a phase two trial for the treatment of fibromyalgia. Our intellectual property portfolio continues to grow with recently issued and allowed patents for AXS05 and AXS07. The number of issued U.S. patents for these product candidates now total 50 for each. with protection extending to 2040 and 2036, respectively. With potential FDA decisions on two NDE filings over the coming year, preparations for potential commercial launch are well underway. All functional commercial leadership is in place, and the team continues to expand. Salesforce structure and design have been finalized, and the hiring of sales managers and representatives will begin shortly. The infrastructure for our proprietary DCC, or digital-centric commercialization platform, is in place, and payer engagement activities have started. We are excited by the differentiated clinical profile of our numerous product candidates, the potential of our investigational medicines to deliver significant benefit to patients, and our planned commercialization approach. I will now turn the call over to Nick, who will provide a financial update.