Stoke Therapeutics, Inc.

Good day and thank you for standing by. Welcome to Stoke Therapeutics' third quarter 2026 Business Update 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 during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. Please be advised today's conference may be recorded. I will now hand the conference over to your first speaker for today. Thomas Leggett, Chief Financial Officer. Please go ahead, sir.

Good evening and welcome to Stoke Therapeutics' third quarter 2026 Business Update conference call. I'm Thomas Leggett, the Chief Financial Officer at Stoke Therapeutics. Join me on today's call with Ian Smith, our Chief Executive Officer, Dr. Barry Tico, Chief Medical Officer, and Jason Hoitt, Chief Patient Officer. As a reminder, today's webcast presentation is available in the investor section of our website. This webcast is being recorded and will be available for replay later this evening. Before we begin, please note that today's discussion includes forward-looking statements. These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially. Please refer to our filings at the SEC for additional information. With that, I'll turn the call over to Ian.

Thank you, Thomas, and thank you to everyone joining us this evening. It has been a busy quarter at Stowe. Tonight, we will discuss our recent progress, including an update on the advancement of patients through key time points in the EMPRA Phase 3 Registrational Study of Zareba Nursan, our recent discussion with the FDA related to our NDA planning, and the latest on our commercial readiness activities. I'll start with some highlights from our Phase 3 study. To date, approximately 110 of 162 enrolled patients have completed their Week 28 visit. This is the time point at which data for the primary endpoint of change in major motor seizure frequency is captured. Approximately 20 patients have also completed their Week 52 visit, marking the end of the study treatment period and the time point at which key secondary endpoint data will be captured. All of these patients are continuing into the open label portion of the study. Notably, There have been no treatment discontinuations to date. Barry will provide some additional metrics and context in a few moments. Next, I will highlight our recent interaction with the FDA that gave us the opportunity to discuss our five years of clinical data for Zeriva-Nurson, including our Phase I, II, and OLE studies, and to align on key aspects of our planned 2027 USMDA submission. We were pleased with the agency's engagement Responsiveness and Interest in Cerebral Nursing. An important outcome of our meeting was the FDA's willingness to accept a multi-component assessment of VINILIN3 data for purposes of evaluating the key secondary endpoint related to changes in cognition and behavior. This is a positive outcome because we believe a multi-component approach acknowledges the complexity of the disease and the fact that each patient's experience with Dravet syndrome is different. especially when it comes to impacts on cognition and behavior. Coming out to the discussion, we are reiterating our timelines for a data readout in Q3, 2027, followed by a planned NDA submission in the second half of next year. Clarity on these timelines is important as we scale our organization and capabilities to deliver Zoriba-Nersen to patients following a potential U.S. approval in early 2028. Our medical affairs team has done an incredible job over the past two years, establishing a foundation of awareness and understanding of Dravet syndrome and the data to support the disease-modifying potential of zarivinersen. We are continuing to expand our educational efforts, moving to reach more clinicians and other stakeholders, including payers, with the recent addition of our field market access team. We continue to learn as much as we can about Dravet syndrome and the opportunity through ongoing research. These efforts have given us additional confidence in the addressable patient population and are guiding our organizational build. At the same time, the field is continuing to evolve and we see growing awareness of the needs of patients with Dravet syndrome and other genetic epilepsies. We are encouraged by the actions of stakeholder organizations such as American Epilepsy Society's Presidential Task Force. on preparing for disease modifying therapies and education and advocacy related to the need for genetic testing. Jason will share more on these efforts in a few minutes. We see haploinsufficient diseases as a clear and unique opportunity for our platform, which is why we are excited to advance STK002. Autozomal dominant optic atrophy, or simply ADOA, is a rare genetic disease that is primarily caused by a haploid insufficiency that results in 50% of functional protein production. SDK002 is designed to increase naturally occurring, fully functional OPA1 protein production to address the underlying cause of this disease. In addition to our preclinical data, Recent data from the field supports the potential of the OPAL1 targeting hypothesis. Dosing is now underway in the third cohort of our Phase 1 Osprey study, and we expect to initiate the fourth dose cohort in early 2027. Initial safety and efficacy data are anticipated in the first half of next year, which will inform future development. As we expand our research efforts, we will continue to focus on severe genetic diseases. driven by haploid insufficiency with an emphasis on the CNS given our experience in Dravet syndrome. With that, I would summarize by saying that Stoke has made great progress throughout 2026 and we are well positioned heading into the end of this year. With that, I will turn the call over to Barry.