Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom Therapeutics third quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. Later, there will be a question and answer session, and instructions will be given at that time. Please note that today's call is being recorded. I'll now turn the call over to Darren Oplin, Director of Corporate Communications. Please go ahead, sir.

Thank you. Good morning, everyone, and thank you for joining our third quarter 2024 financial results conference call. I'm joined today by Dr. Ariel Tabito, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, Mark Jacobson, Chief Operating Officer, and Ari Maizel, Chief Commercial Officer. Earlier this morning, we posted a new corporate presentation complementing today's call to the investor section of our website. Those joining by webcast may also advance through the slides at any time during the discussion. As a reminder, we will be making certain forward-looking 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 synopsis, availability, and our pipeline projects, revenue projections, and other financial forecasts, if any, and the possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations of future events and are subject to certain risks and uncertainties that may cause the company's actual performance and results to differ materially from those projected. Please refer to today's press release, presentation, and our SEC filings for additional details on these and important risk factors. You are cautioned not to rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update or revise these statements. With that, I'll hand it over to Ariel.

Thank you, Darren, and good morning, everyone. Thank you for joining us on today's financial results and business update conference call. At Axone, we are focused on developing and delivering novel, innovative medicines that can transform the lives of patients living with serious central nervous system conditions. We are pleased to report on the progress we've made in advancing this important mission in the quarter, articulate our long-term vision, and review potentially value-driving year and intermediate term milestones. The third quarter, was another strong quarter and represented a notable milestone as we delivered quarterly product revenue in excess of $100 million for the first time. This quarterly performance translates to an annual revenue run rate of approximately $420 million, just three quarters into our second full year as a commercial company. While this progress is tremendous, even more significant potential growth lies ahead. based on our current portfolio of innovative, marketed, and late-stage pipeline candidates. In addition to Avelity and Tenosi, our two FDA-approved treatments for major depressive disorder and excessive daytime sleepiness and narcolepsy and obstructive sleep apnea, respectively, our pipeline features five innovative late-stage product candidates currently in development for nine indications across psychiatry and neurology. Our late-stage pipeline positions us to continue to deliver important new medicines in therapeutic areas that impact more than 150 million patients in the US. If successfully developed, this portfolio has the potential to provide over $16 billion in peak sales. The diversity and depth of our pipeline also reflects Axiom's differentiated approach to scientific innovation. which we believe aligns with our patient-centered mission and expands the therapeutic possibilities for CNS conditions. Now, before turning it over to Megan Ari, who will provide greater detail on the strong performance in the quarter for availability and synopsis, I will provide an update on the pipeline and upcoming milestones. A key development in the quarter was the resubmission of our new drug application for AXS07, our novel multi-mechanistic product candidate for the acute treatment of migraine. The resubmission was acknowledged by the FDA and designated as a Class II resubmission with a PDUFA action goal date of January 31, 2025. Launch preparations are underway to ensure timely commercialization if approved. Our ongoing eMERGE Phase III trial evaluating AXS07 in patients with a prior inadequate response to oral CGRP antagonists is on track to read out in the fourth quarter of this year. Results from this trial will help inform the potential utility of AXS07 in different patient subgroups. With respect to AXS14 for the management of fibromyalgia, we are completing preparations for the NDE submission We expect to submit the NDA to the FDA this month. I'd now like to comment on our other late-stage pipeline products, starting with AXS05. Our comprehensive development program for AXS05 and Alzheimer's disease education consists of four pivotal Phase III placebo-controlled efficacy trials, the completed Positive Advance I and Accord I trials, and the ongoing ADVANCE-2 and ACCORD-2 trials. ADVANCE-2 is a parallel group trial, and ACCORD-2 uses a randomized withdrawal design. Given that target enrollment in both trials have been reached, we are on track to report top-line results from both ADVANCE-2 and ACCORD-2 simultaneously this quarter. We look forward to these readouts as we believe that a favorable outcome from one or both of these ongoing pivotal studies, in addition to the positive results from the two completed trials, would provide strong support for an ADA filing for AXS05 for Alzheimer's disease education. Turning now to AXS12, we are currently conducting two-period Phase III trial evaluating the long-term efficacy and safety of AXS-12 in narcolepsy called the ENCORE, or Evaluating Continued Treatment with Roboxetine Study. The trial consists of a 24-week open-label period, followed by a three-week double-blind randomized withdrawal period. Enrollment in the trial is complete, and we are on track to report top-line results this quarter. The UNCOR trial was conducted as a registration study to provide additional support for our planned MDA for AXS-12. Following completion of the trial, we plan to request a pre-MDA meeting with the FDA to discuss our planned submission. Rounding out our development pipeline, we continue to advance our four ongoing phase three trials of psoriasis at all in ADHD, major depressive disorder, or MDD, binge eating disorder, and shift work disorder, which we believe represent significant expansion opportunities for psoriasis. Enrollment in the FOCUS study, our phase three, double blind, placebo-controlled trial, evaluating the efficacy and safety of psoriasis in ADHD in adults, is expected to complete in December. And as a result, we now anticipate top-line results in the first quarter of 2025. The PARADIGM phase three trial in main depressive disorder is progressing nicely, with enrollment also expected to complete this quarter. PARADIGM will examine the effect of Solvangetol in MDT patients with and without excessive daytime sleepiness. We now anticipate top-line results from the trial in the first quarter of 2025. Lastly, the ENGAGE phase three trial in binge eating disorder and a sustained phase three trial in shift work disorder continue to enroll, with top-line results anticipated in 2025 and 2026, respectively. As we highlighted in previous calls, Solaran's unique pharmacology as a dopamine and norepinephrine reuptake inhibitor and a TAL1 and 5-HT1 agonist, along with preclinical and clinical evidence, support its potential a broad range of CNS conditions impacting over 80 million people in the U.S. With the potential new indications for Solvay-Avital under study, we have the potential to deliver multiple value-creating catalysts and drive long-term growth for Solvay-Avital alone. In closing, the path ahead for Axel includes a robust series of clinical, regulatory, and commercial milestones. With strategic focus, operational excellence, and a strong balance sheet, we are confident in our ability to deliver significant, near, and long-term value for patients and shareholders. With that, I'll hand it over to Nick.