Zevra Therapeutics, Inc.

Good afternoon, and thank you for joining Zephyr's first quarter 2026 financial results and corporate update conference call. Today's call is being recorded and will be available via the investor relations section of the company's website later today. The host for today's call is Nicole Oshner, Zephyr's vice president of investor relations and corporate communications.

Thank you. And welcome to those who are joining us. Today, we will provide an overview of our recent accomplishments, followed by a review of our first quarter 2026 financial results. I encourage you to read our financial results news release, which was distributed this afternoon and is available in the investor section of our website. Before we begin the call, please note that certain information shared today will include forward-looking statements. Actual results may differ materially from those stated or implied in any forward-looking statements due to risks and uncertainties associated with ZEVR's business. Forward-looking statements are not promises or guarantees and are inherently subject to risks, uncertainties, and other important factors that may lead to actual results differing materially from projections made. and should be evaluated together with the risk factor section in our most recent quarterly report on Form 10-Q, our annual report on Form 10-K, and our filings with the SEC. I am pleased to welcome ZEVRA's management team members participating in today's call. Neal McFarling, SEVRA's President and Chief Executive Officer, Josh Schaefer, our Chief Commercial Officer, and Justin Renz, our Chief Financial Officer. Our Chief Medical Officer, Adrian Cortell, will also be available for today's question and answer session. Now, it's my pleasure to hand the call over to Neal.

Thank you, Nicole, and welcome to everyone joining our quarterly call this afternoon. We are building a durable rare disease company grounded in disciplined execution, financial strength, and a commitment to patients. We continue to advance our strategic plan, delivering strong performance and positioning ourselves for long-term growth. We made substantial progress in establishing MyPlypha as a foundational treatment for Niemann-Pick disease type C, or NPC, in the U.S. by delivering meaningful clinical impact to patients and pursuing multiple pathways to expand patient access globally. We are also advancing our late-stage asset, Soliprolol, through a Phase III study for the treatment of vascular Ehlers-Danlos syndrome, or VEDS, and executing several approaches to accelerate its development. To sharpen our focus on high-impact activities and remove operational distractions, we optimized the portfolio by divesting non-core assets with the sale of the FDX portfolio to ComAv Therapeutics for $50 million and concurrently resolve the legal dispute. Our balance sheet is strong with a cash position of $236.8 million and no outstanding debt, providing financial flexibility to drive growth. In the first quarter, total net revenue was $36.2 million, which is a 78% increase over Q1 2025. We've now reached a total of 170 prescription enrollment forms for MyPlypha from launch through March 31st, nine of which were received in the first quarter. Recall, the estimated prevalence of NPC patients in the U.S. is approximately 900, of whom 300 to 350 are currently diagnosed. Thus, we have successfully reached roughly half of this patient population and continue to have traction in newly diagnosed patients. This is a significant early launch achievement and remains consistent with the meaningful opportunity ahead for continued growth. As a reminder, we've established a solid patent position for MyPlypha. It received orphan drug designation in the U.S., enabling marketing exclusivity through 2031. Consistent with our strategy to maximize the potential growth drivers for our business, we're pursuing a patent term extension through the U.S. Patent Office and await their decision, which could provide coverage beyond 2031. Through our Global Expanded Access Program, or EAP, we are able to deliver a much needed treatment to patients with MPC in certain European countries and select territories outside of Europe, including the U.K. As of the end of the quarter, we have a total of 122 patients enrolled in the EAP across geographies. Our global EAP is comprised of multiple access programs, including compassionate use and named patient reimbursement. Within each, we expect variability in enrollment and reimbursement over the first few years until the patient base has stabilized, consistent with our experience in the French EAP program. In Europe, there are an estimated 1,100 individuals with NPC. Diagnosis rates exceed those in the U.S., largely because the earlier approval of Miglestat established physician awareness and enabled patient identification. To support the geographic expansion with a potential approval of Aramacamol in Europe, we have a marketing authorization application under review by the European Medicines Agency, or EMA. We submitted our responses to the EMA's 120-day list of questions within the 90-day clock stop period and are progressing along the standard review process to make Arumacomal available to the European NPC community. As a reminder, we have also received orphan medicinal product designation in Europe for the treatment of NPCs. According to our late-stage pipeline, our Phase III DISCOVER trial is evaluating salipolol for the treatment of VEDS, a rare inherited connective tissue disorder caused by COL3A1 gene mutations that weaken the walls of blood vessels and hollow organs and can cause arterial rupture or dissection, among other complications. Approximately 90% of patients experience an event by the age of 40. There are roughly 7,500 individuals living with VEDS in the U.S. Soliprolol is a selective adrenoseptor modulator that works by inducing vascular dilation and smooth muscle relaxation, and thereby reducing mechanical stress on tissues of the arterial wall and hollow organs. Currently, there are no approved therapies for VEDS. Our commercialization strategy for Soliprolol is focused exclusively in the U.S., where there's a clear opportunity to fill an unmet need. While not approved in Europe for vets, Soliparol is the primary off-label treatment in several European countries. This use is supported by the results of several studies, including long-term European cohorts. We've enrolled a total of 62 patients in the DISCOVER trial, with 10 patients enrolled in the first quarter. This is an event-driven study, and we have two confirmed events out of the 28 events required to trigger the interim analysis. We continue to implement activities aimed at driving enrollment, including building a network of genetic testing centers to improve diagnosis, as well as strengthening connections with key specialists who manage these patients. In parallel, following the FDA Type C meeting, we had in the first quarter, we are preparing for a follow-up meeting in the second half of the year to explore pathways to accelerate its clinical development. In summary, we have a clear vision to become a leading rare disease therapeutics company, and we're motivated by the momentum and the opportunity that this phase of growth brings. I'll now turn the call over to Josh to review our commercial performance in more detail.