Axsome Therapeutics, Inc.

Good morning and welcome to Axiom Therapeutics third quarter 2023 financial results conference call. Currently, all participants are on a listen-only mode. Later, there will be a question and answer session and instructions will follow at that time. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, today's conference is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Axiom Therapeutics. Thank you. Please go ahead.

Good morning and thank you all for joining us on today's conference call. This morning we issued our earnings press release, providing a corporate update and details of the company's financial results for the third quarter of 2023. The release crossed 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, our commercial plans regarding finosy, ovality, and our pipeline products, revenue projections, 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. You 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. Ariel Tabuto, Chief Executive Officer, Nick Peavy, Chief Financial Officer, and Lori Engelbert, Executive Vice President, Product Strategy. Ariel will provide an overview of the company and progress made in the third quarter of 2023, as well as key upcoming milestones. Following Ariel, Nick will review our financial results, then Lori will provide a commercial update. 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 for joining Axiom Therapeutics' third quarter 2023 financial results and business update conference call. In the third quarter, we advanced our differentiated commercial products as well as our broad late-stage neuroscience pipeline. The strong progress in the quarter positions us well to continue delivering potentially life-changing new medicines to patients with serious brain disorders and to their healthcare providers. Total net product revenue in the quarter was $57.8 million, representing significant year-over-year and quarter-over-quarter sequential growth. The quarter's strong showing reflects contributions from both Obelity and Synose. Obelity, our first-in-class oral NMDA receptor antagonist and Sigma-1 receptor agonist, has now been on the market for one year. Its commercial performance to date reflects its fast onset and lasting efficacy as demonstrated in clinical trials. Later in the call, Nick will provide additional details on our quarterly financials and Laurie will go into more detail on our commercial performance. While we are proud of the positive market reception for Velody to date and the progress we have made with Synosi, we believe that we have barely scratched the surface of these opportunities. We look forward to continued commercial execution to realize the tremendous potential for these two differentiated medicines. Our commercial success to date has been enabled by strong clinical profiles for Ovelity and Synose and by our efficient, effective, and innovative digital centric commercialization or DCC approach. We will continue to deploy this platform with our expanded Ovelity sales force to further drive business performance. In addition, we intend to fully leverage the DCC platform for the potential commercialization of our broad late stage pipeline. I will provide a brief update on the pipeline progress, including some anticipated upcoming clinical and regulatory milestones. Starting with our two NDA stage products. For AXS07, for the acute treatment of migraine, we are on track to resubmit the NDA for this product candidate in the first half of 2024. In parallel, we're also working on the NDA submission for AXS14 for the management of fibromyalgia, which is on track for submission in the first quarter of 2024. Moving on to our phase three clinical programs, the phase three Symphony trial of AXS12 for the treatment of narcolepsy is on track to complete enrollment this year, with announcement of top line results expected in the first quarter of 2024. The phase three advanced two trial of XSO5 for the treatment of Alzheimer's disease agitation is on track for completion in the first half of 2024. In July, we initiated the focus phase three trial of solvary amphetol in ADHD, and we anticipate completion of this trial in the second half of 2024. We previously announced that we intend to develop solvary amphetol for the treatment of binge eating disorder, and for the treatment of excessive sleepiness associated with shift work disorder. These are two new potential indications with significant patient populations and limited treatment options. We are on track to initiate phase three trials of Sol re-amphitol in binge eating disorder by the end of this year and in shift work disorder in the first quarter of 2024. Further details about these clinical programs will be provided at a Sol re-amphitol investor day planned to be held before year's end. Overall, the third quarter saw us make significant progress with our commercial performance and development pipeline. We expect to close out this year with continued strong execution, setting the stage for productive 2024. I will now turn the call to Nick, who will provide details of our financial performance.