Axsome Therapeutics, Inc.

Hello, and welcome to the Axiom Therapeutics second quarter results conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may press star one at any time to be placed in the question queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mark Jacobson, Chief Operating Officer at Axiom Therapeutics. Please go ahead, Mark.

Thank you, Operator. 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 second 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 investigation 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 synovi, ovality, and our other 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 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, and Lori Engelbert, Executive Vice President of Commercial and Business Development. Ariel will provide an overview of the company and progress made in the second 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 Axon Therapeutics second quarter, 2023 financial results in business update conference call. In the second quarter, we continue to execute across all areas of our business. We drove continued success in the commercialization of Avelity and Synosi, advanced our late stage product pipeline, and further solidified our financial foundation through a public equity offering that provided us significant operational flexibility and strength. Total net product sales in the quarter were 46.7 million, driven by strong performances from both Obelity and Synose. Based on the growing Obelity prescription trends to date and positive feedback from clinicians, we are increasing the Obelity field force by nearly 100 representatives. In conjunction, with our digital-centric commercialization or DCC platform, the expansion should nearly double the number of prescribers we are able to reach. Later in the call, Laurie will comment further on our commercial performance and Nick will provide additional details on our financials. In conjunction with the commercial performance, our first-in-class development pipeline continues to expand and advance. With respect to Sol Re-Invital, our dopamine and norepinephrine reuptake inhibitor, and TAR1 agonist, we recently initiated the FOCUS phase three trial in ADHD. Today, we are pleased to announce the launch of two new high-value potential indications for solar re-amphitol, binge eating disorder and excessive sleepiness associated with shift work disorder. Binge eating disorder is the most common eating disorder, affecting approximately 2.8% of U.S. adults. There is currently only one FDA approved product for this indication. We recently received positive pre-IND meeting feedback from the FDA for this program and are preparing to initiate a phase three trial in patients with binge eating disorder before the end of this year. Turning to shift work disorder. An estimated nearly one third of Americans perform shift work of whom 10 to 43% are diagnosed with shift work disorder. There are currently only two FDA approved products for the treatment of excessive sleeviness associated with shift work disorder. We also recently received positive pre-IND meeting feedback from the FDA for this program and are preparing to initiate a phase three trial in shift work disorder in the first quarter of 2024. The target indications of ADHD, binge eating disorder, and shift work disorder have the potential to dramatically increase the number of patients sorianfetol could help if successful in clinical testing, further growing our already first in class CNS pipeline. Stay tuned for more updates on these programs and the rest of our leading late stage CNS pipeline. We are excited by the number of value creating opportunities that lie ahead of us. We anticipate completion of the phase three symphony trial of AXS-12 for the treatment of narcolepsy in the fourth quarter of this year. We continue to see steady enrollment in the phase three, advanced two trial of AXS05 for the treatment of Alzheimer's disease agitation. And we remain on track to complete advanced two in the first half of 2024. We are making progress towards initiating a planned phase two, three trial of AXS05 in smoking cessation. which is scheduled to start in the fourth quarter of this year or the first quarter of 2024. Additionally, the team is nearing finalization of the work for the resubmission of the NDA for AXS07 in migraine. This work has moved at a slower pace than anticipated. And as a result, we now expect to resubmit the NDA in the first half of 2024. With respect to the plan NDA submission for AXS14 for the management of fibromyalgia, We are making good progress and are working to finalize the content and data sets that will complete the submission. We are tracking to an NDA submission in the fourth quarter of this year to the first quarter of next year. Each of these potential milestones builds value for our stakeholders, and we continue to make strategic decisions to maximize the potential for future growth. Lastly, we recently closed an underwritten public offering of common stock that resulted in $258.8 million in gross proceeds, fortifying our financial foundation and providing additional flexibility to execute on multiple fronts. Not only expanding commercial activities by strategically expanding our field force, but also by adding the aforementioned new indications for solar re-amphitol that may serve to maximize the product's potential. Laurie and Nick We'll each discuss in further detail how the financing amplifies our ability to read value across our portfolio. All in all, we expect a productive second half of 2023 that sets us up for multiple milestones over the next 12 months. I will now turn the call to Nick, who will provide details of our financial performance.