Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom Therapeutics Second Quarter 2025 Financial Results Conference Call. Currently, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will be given at that time. Please note, this call is being recorded. I would now like to turn the call over to Darren Oplin, Director of Corporate Communications at Axiom Therapeutics. Please go ahead.

Thank you, and good morning, everyone. Thank you all for joining us for our second quarter 2025 earnings call. With me today are Dr. Ariel Tabuto, our Chief Executive Officer, Nick Pizzi, our Chief Financial Officer, and Ari Maizel, our Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdoch, our General Counsel, will join us for the Q&A portion of the call. This morning, we issued our earnings press release providing a business update and details of the company's financial results for the second quarter of 2025. I encourage everyone to visit the investor's page of our website to find our press release and the presentation related to today's call. Before we begin, please note that today's discussion includes certain forward-looking statements regarding, among other things, the efficacy, safety, and intended utilization of our investable 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 the possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations of future events that are subject to change and involve risks and uncertainties that may cause the 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 rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements. I'll now turn the call over to Ariel.

Thank you, Darren, and thank you all for joining us this morning. Axiom delivered a strong second quarter, reflecting focused execution across our commercial business and development pipeline. Demand for our in-market products saw robust growth, and we continue to advance multiple late-stage development programs targeting several important neuroscience indications with significant unmet needs and substantial market opportunities. We delivered total revenue of $150 million for the quarter, representing substantial double-digit year-over-year and sequential growth driven by outperformance for both Ovelity and Synose. Nick and Ari will provide additional details on the accelerating dynamics for these important, life-changing medicines. We are also excited to have recently launched Symbravo, our third approved product and our second product that has been developed wholly in-house. This launch represents a significant milestone for Axome and for the millions of patients with migraine who desire new treatment options to manage the burdensome symptoms of this condition. Ari will comment on the early feedback on the product thus far. All in all, we are encouraged by the accelerating trajectory of our commercial portfolio. In parallel with the commercial progress, we continue to advance our innovative late-stage neuroscience pipeline. Last month, we hosted our Frontiers in Brain Health R&D Day with expert clinicians and key opinion leaders. The event showcased the breadth and depth of Axone's potentially first-in-class or best-in-class pipeline, underscored the strengths of our clinical data, and highlighted our position at the forefront of neuroscience innovation. I will provide a brief update on the pipeline programs and upcoming milestones. Starting with AXS05 and Alzheimer's disease agitation. We are on track to submit the SMDA for AXS05 and Alzheimer's disease agitation this quarter. This is a key priority for the organization. and we look forward to keeping everyone updated on our progress for this program. We also continue to make progress on our development plans for AXS05 for the treatment of smoking cessation for the Phase 2-3 trial expected to initiate in the fourth quarter of this year. Moving on to AXS12, our novel product candidate for the treatment of narcolepsy with cataplexy. Progress continues in our NDA submission to the FDA, which is slated for the fourth quarter. In clinical trials to date, AXS-12 has demonstrated the potential to provide meaningful relief across multiple key symptoms of narcolepsy and to address a critical gap in care for this patient population. For AXS-14 and fibromyalgia, we look forward to initiating a phase three trial in the fourth quarter to address the FDA's feedback in the previously disclosed refusal to file letter. With more than 17 million people in the U.S. affected by this condition, and with a paucity of approved treatments, we see a substantial opportunity for AXS-14 to transform the standard of care for these patients. Our salt-reinfatol development programs continue to advance across four potentially high-value indications, ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. In ADHD, we previously reported phase three efficacy results in adults, and we plan to initiate a phase three trial in pediatric patients in the fourth quarter. In MDD with excessive daytime sleepiness, we are taking a precision medicine approach based on the clinical presentation and underlying pathophysiology of MDD. This approach is supported by pilot data from our paradigm study, and we expect to initiate a phase three trial in this patient population in the fourth quarter. Our engaged phase three trial of psoriambutol in binge eating disorder continues to enroll and remains on track to read out next year. Binge eating disorder is the most common eating disorder, estimated to afflict over 7 million individuals in the U.S. With only one agent approved for this condition, it represents a high unmet medical need. The sustained phase 3 trial of solvianfetol and excessive sleepiness associated with shift work disorder is also progressing, with top-line results also slated for 2026. With three innovative CNS medicines now on the market and multiple late-stage programs advancing toward registration, we continue to build a strong, durable foundation for continued growth and significant long-term value creation. With that, I'll hand the call over to Nick, who will provide details of our financial performance.