Scholar Rock Holding Corporation

Good morning, ladies and gentlemen, and welcome to Scholar Rock's first quarter 2026 conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. To ask a question during the session, you would need to press star 11 on your telephone, and you will then hear an automated message advising your hand is raised. And to withdraw your question, you may press star 11 again. This call is being recorded on Thursday, May 7th, 2026. I would now like to turn the conference over to Scholarock. Please go ahead.

Good morning. I am Laura Ikus, Vice President of Investor Relations at Scholarock. With me today are David Hillel, Chairman and Chief Executive Officer, Akshay Vashna, President of R&D, Keith Woods, Chief Operating Officer, and Vikas Binha, Chief Financial Officer. During today's call, David will provide introductory remarks and a business update. Akshay will review our R&D progress. Keith will provide an update on our commercial readiness activities. And Vikas will provide a financial update. We will then open the call for questions. Before we begin, I'd like to remind you that during this call, we will be making various statements about Scholar Rock's expectations, plans, and prospects. that constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any future date. I encourage you to go to the Investors and Media section of our website for our most up-to-date SEC statements and filings. With that, I'd like to turn the call over to David.

Thank you, Laura, and good morning. Thanks to everyone for joining our first quarter earnings call. Scholarock is positioned for a pivotal year ahead. To that end, today, I am very pleased to announce that the FDA has accepted for review our biologics license application for epidegromab for the treatment of children and adults living with SMA. The agency has assigned a PDUFA action date of September 30th. Importantly, the accepted BLA includes two fill-finish facilities, Catalan, Indiana, and a second U.S.-based facility, providing Scholarock with two independent paths to a PitagorMap approval. As a reminder, The sole approvability issue for epidechromab noted in the complete response letter last September was related to observations identified during a routine general site inspection of the Catalan Indiana fill finish facility, which is owned and operated by Novo Nordisk. Since our in-person type A meeting with the FDA in Q4, We have continued to work constructively and collaboratively with the agency, and we have made steady and rapid progress. During the first quarter, we made meaningful advancements at Catalan Indiana and our second fill finish facility. And with our ongoing open communication with the agency, we resubmitted our Epidogram App VLA in late March in complete alignment with the FDA to include both facilities. This approach underscores the shared understanding between the FDA and Scholar Rock of the unmet need in the SMA community and the shared urgency to bring a Pinnacle Map to children and adults in the US as quickly as possible. I would like to now provide an update on the status of each of these two sites. As it relates to cattle in Indiana, we are pleased that Following acceptance of our BLA, the FDA completed an unannounced reinspection of the facility. This timing was in line with our expectations, as the FDA had noted, following multiple engagements with Novo and Q1, that they would conduct an unannounced inspection following routine manufacturing activities, which resumed in late February. We are pleased that the inspection was completed in early Q2, and in accordance with FDA guidelines, the agency has up to 90 days to classify the facility. As it relates to the second fill-finish facility, we continue to be pleased with our ongoing meaningful progress. Importantly, the entirety of the epitigromab drug product required for FDA review and potential approval has been vial. From a commercial supply standpoint, we are well positioned as we expect to have ample commercial epidegromab available from the second facility in early Q3, well ahead of the September PDUPA date. We remain committed to the SMA community and we are grateful that significant progress continues to be made at a rapid pace. Our U.S. commercial team continues to advance critical activities and capabilities required to deliver a seamless launch and support patients from day one. Importantly, the team stands ready to launch Epidicromab immediately upon approval at any time prior to and including the September 30th Paducah date. In addition to the U.S., we continue to look forward to serving children and adults with SMA in Europe. The review of our MAA is progressing very well, and we expect a CHMT opinion near mid-year. We are building momentum with launch readiness activities, and we continue to anticipate a launch in the second half of the year, beginning with Germany. We know it is not a matter of if but when. Epidermab will be approved for children and adults with SMA, and he will discuss the continued progress we are making with commercial preparations and our disease awareness initiatives shortly. We continue to advance our world-leading anti-myostatin pipeline with enrollment in our Phase II oval study, evaluating epitigromab in infants and toddlers with SMA, the anticipated initiation of our randomized Phase II study in patients with FSHD, and progress with subcutaneous epitigromab and a novel high-potency anti-myostatin antibody, SRK439, currently in Phase I. Ache will discuss these programs in greater detail shortly. Turning now to the balance sheet, we are pleased to have ended the first quarter of 2026 with $480 million in cash, cash equivalents, and marketable securities. This cash balance includes the drawdown of an additional $100 million from our debt facility, which we took in March. Our cash balance also reflects net cash proceeds of $98 million from our ATM program during the quarter. Because we'll provide more details later in the call. We are building on a solid foundation for our company's growth, which we believe will be steady and consistent through the end of this decade and well into the next as we prepare to serve up to 35,000 children and adults living with SMA around the world who have received at least one SMN-targeted therapy. Beginning with SMA, we are excited to be shaping the future of treatment for patients living with rare and devastating neuromuscular diseases. And with that, I'll now turn the call over to Akshay. Akshay?