Axsome Therapeutics, Inc.

Good morning and welcome to the Axon 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, Mr. Mark Jacobson, Chief Operating Officer at Axon 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 2021 across the wire a short time ago 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 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 statement. These and other risks are described in our periodic filings made with the Security and Exchange Commission, including our quarterly and annual reports. We are cautioned not to place undue reliance on these foreign business 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 DiVito, Chief Executive Officer, Nick Peasy, Chief Financial Officer, Dr. Kevin Liberty, Executive Vice President, Product Strategy, Lori Engelbert, Senior Vice President of Commercial and Business Development, and Dr. Amanda Jones, Senior Vice President of Clinical 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 Axome Therapeutics' second quarter 2021 financial results and business update conference call. Since our last update, we continue to make significant strides toward becoming a premier CNS biopharmaceutical company focused on delivering potentially life-changing medicines to people living with serious CNS conditions. I will provide an update on our development pipeline before turning it to Lori, who will provide a commercial update. starting with our first lead product candidate, XSO5, which is undergoing an NDA review for the treatment of major depressive disorder with a PDUFA date of August 22nd, 2021. On July 30th, we received a letter from the FDA stating that as part of their ongoing review of our NDA, they have identified deficiencies that preclude discussion of labeling at this time. The letter did not state what the deficiencies are. Immediately upon receipt of the letter and continuing through today, we have been in communication with the FDA to attempt to learn the nature of these deficiencies so that we can address them. In response, the FDA has informed the company that their review is ongoing and that they have no specific questions for the company at this time. Although the letter stated that the notification does not reflect a final decision on the information under review, this development may lead to a delay in the potential approval of AXS05. We will keep you informed as we learn more. This morning, in a separate release, we announced positive top-line results for the Phase II merit trial of AXS05 in treatment-resistant depression. XSO5 met the primary endpoint by substantially and statistically significantly delaying the time to relapse of depressive symptoms as compared to placebo with a p-value of 0.002. XSO5 also met a key secondary endpoint by significantly preventing relapse of depression over at least six months with relapse occurring in 36% of subjects receiving placebo compared to zero subjects receiving AXS05 with a p-value of 0.004. The robust results from this small trial add to the body of controlled data demonstrating the benefits of AXS05 in depression. AXS05 is also being developed for the treatment of Alzheimer's disease agitation. Enrollment in the Phase III accord trial for the syndication is progressing, with study completion anticipated in the fourth quarter of 2022. Moving on to our second lead product candidate, AXS07, a multi-mechanistic acute treatment for migraine. The NDA for AXS07 was filed at the end of the second quarter, and we expect to announce the FDA's decision regarding its acceptance of the filing this quarter. With two NDE filings, Axome is approaching commercialization stage for these programs. Laurie will provide some details on our pre-launch commercial activities to ensure successful launches, assuming FDA approval. The rest of our differentiated late-stage pipeline continues to advance. Our AXS-12 product candidate for narcolepsy is on track for initiation of the planned phase three trial this quarter. and we anticipate submitting an NDA for our AXS-14 product candidate for the management of fibromyalgia in the fourth quarter of 2022. I will now turn the call over to Lori, who will provide a commercial update.