Praxis Precision Medicines, Inc.

Good day and thank you for standing by. Welcome to the Praxis Precision Medicines Second Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you will need to press star 11 on your phone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Daniel Ferry, Managing Director of LifeSci Advisors. Daniel, please go ahead.

Good morning, and welcome to the Praxis Precision Medicines second quarter 2026 financial results and business update conference call. This call is being webcast live and can be accessed on the investor section of Praxis' website at www.praxismedicines.com. Please note that remarks made during this call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about the company's future expectations and plans, clinical development timelines, and financial projections. While these forward-looking statements represent Praxis's views as of today, they should not be relied upon as representing the company's views in the future. Praxis may update these statements in the future, but is not taking on an obligation to do so. Please refer to Praxis' most recent filings with the Securities and Exchange Commission for discussion of certain risks and uncertainties associated with the company's business. Joining us on today's call are Marcio Souza, President and Chief Executive Officer of Praxis, and Tim Kelly, our Chief Financial Officer. After providing updates on our key programs, We'll move to a brief Q&A session where Marcio and Tim will be joined by Steve Petrou, President of Research and Development, and Megan Sniecinski, Chief Operating Officer. With that, it's my pleasure to turn the call over to Marcio. Marcio?

Thank you, Dan. Good morning, everyone. Thank you for joining Praxis' second quarter 2026 conference call. Three months ago, I told you this would be the year Praxis become a commercial company. This quarter is the one where that stopped being a plan and started materializing into the organization. We have two NDAs in late stage review with the FDA, with both approvals expected in about six months. It's extremely exciting to bring both Ulexacultamide to UT patients and RelutraGene to SCN2A and 8A patients. We have commercial leadership in place. a field force for the first launch hires and trains, and a distribution network established and inventory being built. I want to spend most of my time today on some key regulatory developments in what we have been building. Let me start with Ulexacalpamide. Essential tremor affects over 7 million Americans, and there is still no FDA-approved therapy developed specifically to treat the condition. With the potential approval coming up by January next year, ULIX account might is poised to change that. Speaking about the NDA review, the FDA completed its mid-cycle communications with us and are very pleased with the progress and discussions with the agency. In that meeting, the agents identified no efficacy-related significant issues and he stated that he does not plan to request an advisory committee meeting. I would characterize the discussion as expected and very forward-looking. On the commercial bill itself, leadership is in place and all core capabilities are where we expect it to be at this stage. We will be ready ahead of PDUFA to launch Ulexacautomide for DT patients. We're set up for a very successful launch and continue to think many years in the future as we intend to continue to serve patients with ET and other neurological conditions. As part of that, you should expect updates from us in the near future about life cycle opportunities for T-type calcium channel inhibitors. One of those steps is the collaboration we just announced with Reimagine, which would extend the reach of Ulexa further. Their work is about expanding the value for patients in praxis way beyond the initial launch year. Turning to relitrogen. SCN2A and SCN8A are amongst the most severe epilepsies we know of. Fissure onset in infancy, profound developmental delays, and no approved treatment. The addressable population is roughly 10,000 patients in the United States. As we disclosed last quarter, we submitted additional sensitivity analysis of existing clinical data, and the FDA deemed that submission a major amendment. And the review period was extended with a new PDUFA target now off December 27th this year. In the mid-cycle meeting for relutrigine, very similarly to Ulexacultimide, as I just discussed, the agents also confirmed they do not intend to hold an advisory committee meeting. If approved, relutrigine would be the first therapy for SEM2A and 8AD and would be eligible for a pediatric review voucher. Just like for ULIXA, launch preparation here is further along than the calendar might suggest. Commercial and medical teams are fully hired, the supply chains established, and you have to build a comprehensive patient support program, all pointing to a very structured and successful launch. The broader opportunity keeps getting clearer. Enrollment in Emeralds, our study in broad DEs, exceeded its target, with approximately 200 patients enrolled spanning more than 50 distinct genetically defined etiologies, amongst many others not genetically defined. There is a trial population that did not exist as a cohort even five years ago. Assuming the study will be positive and the initial review for relutrigine in 2A and 8A, also positive, Emerald would serve as the base for supplemental NDA approval in 2027. It's also worth mentioning a quick regular update that spans both programs. During the quarter, the FDA conducted a bimon inspection of Praxis as a sponsor for both ulexacalcmide and relutrigine applications. The scope was very comprehensive. including corporate and clinical operations, safety, reporting, data integrity, statistical analysis, and the interim analysis for both programs amongst other areas of the BiOMO program. We're incredibly pleased that the inspections concluded without any findings and therefore no Form 483 was issued. Considering how complex both programs are with multiple studies and the first-in-its-kind decentralized study for ET, as well as the interim analysis, we're extremely pleased with the outcome of the inspections. One note on how it communicates from now on. Given the stage of discussions on both applications, we do not intend to provide further regulatory updates until the expected action date. I'll ask you to read our silence between now and January as discipline rather than a signal of any kind. Let me turn to vermatrogen. In June, we reported top line results from Power One in a highly refractory focal onset seizure population. As you know, the study did not meet its primary endpoints of reduction in monthly focal seizures frequency from baseline to week 12. It did meet a key secondary endpoint with a significantly greater proportion of patients on vermatrogen achieving at least 50% reduction in seizure frequency. That result tells you something specific, and you have spent the last several weeks making sure we took the right lessons from it rather than the comfortable one. The responder findings say the drug is doing something real in a population where very little works. The primary endpoint myths say our dose and a few elements of our design were not matched to the question we're asking. Those are design problems and therefore fixable. We're finalizing the plans to amend and revamp both Power 2 and Power 3, informed directly by what Power 1 taught us about the dose and entry criteria, and we intend to have both studies up and running by the fourth quarter of this year. We will further describe the amendments and impact on the design once they are final in the very near future. Switching gears to Alzheimer's. In June, the FDA granted us BTD designation for Alzheimer's for seizures associated with SCN2A-DE caused by gain-of-function variant based on the results of the EMBRAVE Part A study. That's our third breakthrough designation since July last year. Three designations across three different assets on two different platforms. It's basically unheard of for a company like Praxis. We're taking advantage of the access to the FTA that the designation give us and discussing a comprehensive plan with the agents in the near future. Parallel to that, Embrave 3 continues to enroll well, with top-line results expected next year. We're incredibly pleased with all the progress made in all fronts this quarter, and we look forward for a successful rest of the year. Let me now turn the call to our CFO, Tim Kelly. Tim?