Praxis Precision Medicines, Inc.

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Praxis Precision Medicine's first 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 telephone keypad. As a reminder, this conference call is being recorded. At this time, I would like to turn the conference over to Mr. Dan Ferry of LifeSci Advisors. Sir, please begin.

Good morning, and welcome to Praxis Precision Medicine's first 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 the call today are Marcio Souza, President and Chief Executive Officer of PRAXIS, and Tim Kelly, 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 Petra, President of Research and Development, and Megan Sinicinski, Chief Operating Officer. With that, it's my pleasure to turn the call over to Marcio.

Thank you, Dan, and good morning, everyone, and thanks for joining Praxis' first quarter 2026 conference call. Building on a remarkable 2025, we have continued executing across our portfolio in our journey to become a commercial company with strong momentum building across four late-stage assets representing more than $20 billion in peak sales potential. With the NDAs for elixir-cultamide and relutrigine accepted by the FDA, and Piduphidate-Seth, we're ramping up commercial efforts to support the two potential U.S. launch within the next eight months, while also making significant progress with our other clinical programs. It was incredibly exciting to announce that we have completed recruitment for the Emerald study in the broad DE population. with top-line results expected in the fourth quarter of this year, which we expect to support a potential supplemental NDA next year. We're also on track to report results from our PowerOne study for brometrogen later this quarter. We also made exciting progress with our SOLIDS ASO platform. with the positive results from the Embrave Part A showing a disease-modifying effect of halosinursin in SCN2A early onset GE and substantial reduction in monthly seizures, amongst many other results. With key hires made in our commercial organization and a strong financial foundation, we're accelerating the delivery of life-altering treatments to patients with CNS disorders. Let me provide a bit more detail on each one of our programs. Let's just start with Ulexa. The FDA acceptance for Ulexa's NGA marked a meaningful step forward for the 7 million Americans living with essential tremor, who currently have no ET-specifically developed treatments approved. We estimate that about 2 million of those people living with ET are in immediate need for therapy that can clinically improve their daily life. representing a potential for over $10 billion in peak sales. To unlock the benefit for patients and the value, we have been diligently preparing for a commercial launch based on the PDUFA date of January 29 next year. The commercial leadership team is in place with our field force plan to be higher and trained in advance of the launch. and we continue to expand and build the commercial infrastructure across multiple areas, like operations, marketing, access, and compliance. We have also successfully established a distribution network to ensure drug availability at launch at successful levels. Earlier this year, we conducted a very comprehensive observational study with physicians to understand their view of E.T. and elixir chalmides. We surveyed more than 2,300 U.S. physicians who collectively managed tens of thousands of patients. The results were beyond encouraging. They validated the Ulexacalpamide profile across efficacy, the breadth of benefits, and tolerability, reinforcing the more than $10 billion peak sale potential and the needs for a drug like Ulexa in the markets. Importantly, We also wanted to hear in more detail from patients and conduct a similar work with over 1,300 ET patients, which further validated the agreements between the needs of patients in terms of their functional benefits with the results of the Essential 3 program. It's truly exciting to be in a place of such alignment amongst treating physicians, patients, and the results of our program. We're also very pleased with a robust presence at the American Academy of Neurology Annual Meeting last month, with 15 scientific presentations, including a plenary presentation highlighting the Essential 3 program results, which received the AM's Abstract of Distinction in Movement Disorder Award, which underscore the strong interest and engagement of the medical community. To further enhance our engagement with healthcare professionals, we have launched the Essential to Me disease state campaign. Let's now move to our epilepsy programs. As we shared in March, in another pivotal moment for praxis and patients, the FDA has accepted, with priority review, the NDA for relitrigine for seizures associated with SCN2A and ADE. Those are severe patients. affected early in life and where the seizures are intractable from the very beginning. It's important to highlight that if approved, religion would be eligible for a pediatric review voucher. With the PDUFA date of September 27, preparation for launch are moving fully steam ahead. We've continued hiring of commercial roles, building sufficient inventory, establishing a comprehensive patient support program, and engaging with payers to ensure timely access upon potential approval. We remain confident on the clinical potential for LetroGene and the benefits to the broader DE population. With recruitment in Emerald study now completed in record time, it's clear that patients and investigators share our view. The potential launch in SCN2A and 8A will build the foundation, and the results of the emerald later this year, if positive, will significantly expand the commercial potential for lethargy by several folds, considering the broad DE population is comprised of over 200,000 patients in the United States. Let's now talk about vormetrogene. the most potent and selective sodium channel modulator ever developed for the three and a half million people living with epilepsy in the United States. We have three key milestones in the near future for the program. The first is the readouts of the Power One phase three study later this quarter. Then the initiation of the Power Three study, a milestone in the community using all the exciting features of vermatrogen to deliver on what the majority of the market really needs. And then, later in the year, the completion of the Power 2 Phase 3 study, which is evaluating those of 20, 30, and 40 milligrams once daily. Enrollment is progressing well in our own track to finalize the study this year and report early next year. Lastly, let's talk about alginersin, the first ASO in our platform. Alginersin also has a rare pediatric drug designation and is being developed for the treatment of early seizure onset patients with SCN2A mutations. We have recently reported the results of EMBRAVE Part A, which enrolls nine children aged 2 to 12 to randomize 3 to 1 to alginersin or SHEM over 24 weeks. We're thrilled with the impressive 77% placebo-adjusted reduction in monthly seizures and the disease-modifying components seen across multiple domains in those patients, while maintaining the generally safe and well-tolerated profile. The overall data from both the EMBRAVE program, Open Label Extension, and Emergency Use Program globally highlight durable seizure reduction and meaningful global gains, which further underscore the transformational potentials of this drug. In conclusion, we're off to a great start for momentum continuing to accelerate across our clinical portfolio, preparations for commercial launch of elixir-cultimide and erythrogen well underway, the completion of the Emerald study enrollments, Power One top-line readout coming up and many other achievements to come. Backed by a strong balance sheet and a long multilayer IP portfolio across the programs, we're focused on rigorous execution and driving progress across our innovative first and best in class portfolio of CNS therapies. And I'll hand over the call to our CFO, Tim Kelly.