Stoke Therapeutics, Inc.

Hello and welcome to the Stoke Therapeutics Second Quarter 2026 Business and Financial Update. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand has been raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce CFO Thomas Leggett.

Good evening and welcome to Stoke Therapeutics second quarter 2026 business update conference call. I'm Thomas Leggett, the Chief Financial Officer of Stoke Therapeutics. Joining me on today's call are 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 Investors 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 with the SEC for additional information. On today's call, we will review recent progress across the breadth of our business. Ian will start with an overview and share an update on the ongoing Phase III EMPEROR study. This study is progressing nicely toward a data readout in the third quarter of 2027. Barry will then provide additional detail on EMPEROR in our longitudinal data set from our ongoing open-label extension studies, also known as our OLEs. He will also review the advancement of other pipeline opportunities that we are progressing, including our investigational medicine for autosomal dominant optic atrophy, or ADOA. We'll then hear from Jason on our commercial planning activities for the livers of RevaNurson to all patients who may benefit in the U.S. following a potential FDA approval by early 2028. I will review our financials and specifically the strength of our balance sheet, and then we will open for Q&A. I will now hand the call over to Ian.

Thank you, Tommy, and thank you to those joining us on the call tonight. Starting with our Phase III emperor study, the recent completion of enrollment of 162 patients in just 10 months speaks to the awareness and enthusiasm of vasorepanosin and its potential to change the course of Dravet syndrome by addressing the underlying genetic cause of this disease. Patients in the study are advancing through key study milestones, and importantly, there have been no treatment discontinuations. We are now within a year of our phase three readout to data that would support the completion of our NDA. We continue our discussions with the FDA and have scheduled a pre-NDA meeting later this year as we prepare to initiate our rolling NDA submission in the first quarter of 2027. The meeting will focus on further educating the agency on the long-term safety and efficacy of zarivinersen using prior and ongoing analyses from our Phase I, II and OLE studies. We'll also cover The details of our NDA submission included the data to be included, the statistical analysis plan, and the timing of each module. Beyond DRAVE, we have a unique opportunity with our platform in additional disease areas. We continue to advance STK002, our investigational medicine for ADOA. Our phase one study recently completed dosing of the first cohort of patients, and we have moved into a higher dose and a second cohort of patients. While continuing our work in SYNGAP1-related disorders, we are also expanding our early research efforts with new targets in haploinsufficient diseases, mainly focused in CNS, given our expertise in the field. Consistent with our investment in other pipeline opportunities, in July, we strengthened our leadership team with the addition of Tom McCauley, our Chief Scientific Officer, who will help guide the next phase of platform expansion and translational research. And from financial perspective, our business investment is well supported by our pro forma cash position of approximately $420 million, providing a runway through to potential U.S. launch of Cerevonursin by early 2028. We've entered a period where execution is increasingly important We remain focused on delivering the data and completing the regulatory and commercial readiness activities necessary to bring zuriva-nursin to patients as quickly as possible. With that, I now pass you to Barry, who can provide more detail as to our progress.