Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom Therapeutics conference call. Currently, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will follow at that time. If you have any need to require operator assistance during the conference, please press star zero from 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. Please go ahead.

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 full year and the fourth quarter of 2022. The release crossed the wire a short time ago and is available on our website at axiom.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 synoviality 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 needed 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 Tibuto, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, Lori Engelberg, Executive Vice President of Commercial and Business Development. Ariel will first provide an overview of the company and then review progress made during 2022 and in the fourth quarter, as well as upcoming milestones. Following Ariel, Nick will review our financial results, and then Lori will provide a commercial update, including details on the first quarter of legality, sales, and our second quarter with Synozy. 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.

Well, thank you, Mark. Good morning, everyone, and thank you all for joining Axone Therapeutics' year-end and fourth quarter 2022 financial results and business update conference call. 2022 was a transformative year for Axone as we successfully transitioned to commercial stage and delivered on our goal to become a leading CNS-focused biopharmaceutical company. Now, with two differentiated products, Availability and Synology Commercialized, encouraging early launch metrics for Availability, a broad and advancing late-stage pipeline, and a strong financial position, Axel is well-positioned to continue to deliver significant value to patients and shareholders. The fourth quarter was an important milestone for Axel, as it is the first quarter with sales for both Obele and Senosi. Total net product sales in the quarter were strong at $24.4 million. Later, Nick and Lori will provide further details on our financial and commercial performance. To preview some of these updates, I'd like to start by talking about the topic that brings us all here, which is making a difference for patients. In just more than a quarter, Ability has already been prescribed to thousands of patients, and we have seen repeat prescribing by HTPs and refills by patients. Lori will provide additional perspective later. suggest that the unique mechanistic and clinical profile of Abelzi is having a positive impact on the treatment landscape for major depressive disorder and making a meaningful difference in the lives of MDD patients. Furthermore, with just half a year of snowy sales after the Axon relaunch efforts, we've seen steady growth both in the U.S. and overseas. We view the potential for Synose in the current indication as largely contact, leaving room for significant potential future growth. Just last week, we announced an important licensing deal for Synose, providing our new partner Forminovia commercial rights to Synose in Europe and certain countries from the Middle East and North Africa. Forminovia shares our excitement and commitment to maximize the potential of Synose for patients worldwide. Their strong commercial platform is well-suited to expand the availability of and access for this important treatment in the licensed region. In addition to our commercial progress, our broad late-stage CMS pipeline continues to advance, positioning us to drive further significant value creation in 2023 and beyond. Our leading CMS pipeline includes SS07 for migraine, SS05 for Alzheimer's disease agitation and for smoking cessation, ASF-12 from ALK-MFC, ASF-14 for phytomyalgia, and solar amphetol for ADHD. In the fourth quarter and subsequently, we made significant progress in our Alzheimer's disease agitation program with ASF-05, including the announcement of positive top-line results for the ACCORD trial, advancement of the ADVANCE-2 trial, and obtaining FDA feedback on our development plan for ASF-05 in dissemination. With regards to ADVANCE-2, our parallel group trial, based on recent and older trends, we now anticipate completion of this trial in the first half of 2024 versus our prior guidance of mid-2025. Given all the progress in the Alzheimer's Disease Vegetation Program, we recently sought and received feedback from the FDA on the registration file. The FDA requested generation of additional safe elderly population, including placebo-controlled safety information from the OnDone Advanced 2 trial, as well as long-term safety data in the target patient population consistent with ICH E1 guidelines. Based on this feedback, the company intends to submit an MDA for AXS05 after completion of the OnDone Advanced 2 and open-labeled safety extension trials. In parallel, we expect to initiate a Phase II free trial of FS-05 in smoking cessation in the fourth quarter of 2023. With regards to FS-07 for the acute treatment of migraine, manufacturing activities related to the planned resubmission of the NDA for this product candidate are ongoing, and we expect a resubmission to occur in the second half of this year. For AXS-12, our product candidate for the treatment of narcolepsy, enrollment in the Pivotal Phase III Symphony Trial is progressing, and top-line results are expected in the first half of 2023. As a reminder, AXS-12 has been granted orphan drug designation by the FDA for the treatment of narcolepsy. Our AXS-14 product candidate for fibromyalgia is also progressing, with manufacturing and other activities related to the preparation of the plan and the submission ongoing, and we expect to submit the MD for this product candidate in 2023. With regards to Solvianfetol or Synose for the treatment of ADHD, we are preparing to initiate a stage 3 trial in this indication in the first half of 2023. In the fourth quarter, we also shared positive top-line results from the SHARP trial, demonstrating improvement of cognitive function with Solvianfetol treatment, and highlighted new mechanistic data for Solvianfetol 1.1. These results further highlight the clinical potential and differentiated pharmacology of this molecule. As you can see, the Axon team is busy and continues to be excited as we prepare to deliver ongoing commercial success and potentially hit on multiple pipeline milestones, including clinical trial readouts and initiations and the filing within the next 12 to 18 months. I will now turn the call over to Nick who will review our financial results.