Scholar Rock Holding Corporation

Good morning, ladies and gentlemen, and welcome to Scholar Rock's second quarter 2026 conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. To ask a question, please press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. If you would like to remove yourself from the queue, press star 11 again. We also ask that you limit yourself to one question. This call is being recorded. on Thursday, August 6th, 2026. I would now like to turn the conference over to Scala Rock. Please go ahead.

Good morning. I'm Lori Ikus, Vice President of Investor Relations at Scala Rock. With me today are David Hallal, Board Chair and Chief Executive Officer, Akshay Vaishnaw, President of R&D, Keith Woods, Chief Operating Officer, and Vikas Sinha, 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 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 in 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. David?

Thank you, Laura, and good morning. Thanks to everyone for joining our second quarter earnings call. Today, Scholar Rock is operating from a position of strength as we enter a defining period for our company and for the SMA community. Across the business, we are executing with focus, discipline, and urgency as we, Drive towards the U.S. launch of Epidermab this quarter. Advance our Epidermab MAA in Europe to approval and prepare for launch in Germany. Build momentum across our world-leading anti-myostatin platform and maintain the financial strength to support our ambitions. Most importantly, we are on the threshold of bringing the world's first Muscle Targeted Therapy to Children and Adults Living with SMA as we advance Epidogramab through the final stages of the FDA regulatory process. Let me now provide additional detail on the ongoing review of our Epidogramab BLA in the US. As a reminder, the sole approvability issue for Epidogramab noted in the complete response letter that we received on our priority review PDUFA date last September was related to observations identified at a routine general site inspection of the Catalan Indiana fill finish facility owned and operated by Novo Nordisk. Since our constructive and collaborative Type A meeting in November, the cadence of activities has reflected the shared understanding between us and the agency of the high unmet need in the SMA community and a shared sense of urgency to bring epidegromab to children and adults with SMA as rapidly as possible. We are grateful for the agency's sustained level of engagement and for our ongoing dialogue, including our March 3rd Type C meeting where we discussed the accelerated progress that we had made at our second fill-finish facility and the agreed-upon data package to facilitate the FDA review of the second fill-finish facility. In alignment with FDA guidance from this discussion, we submitted the Epidigromab BLA on March 30th with two fill-finish facilities, both Catalin, Indiana and our second fill-finish facility. Our BLA was accepted in April with a PDUFA date of September 30th. Agency review of our application is progressing well. Importantly, we have significant optionality with two independent paths to approval, either through Catalan Indiana or through our second fill finish facility, or both, whichever is determined to be the most rapid. As it relates to cattle in Indiana, the FDA inspection classification following the April 2026 general site inspection is pending. We continue to be very pleased by the progress made at our second fill finish facility. Importantly, the data package for the FDA's review of the second facility has been submitted and the review is progressing. underscoring our operational excellence at our second site. We now have more vials available from this facility than we do from Catalan, Indiana. Notably, vials from both Catalan, Indiana and our second facility are now on site at our third-party provider awaiting packaging and labeling upon approval. As we near the final step In the U.S. regulatory process, we are well aware that patients are awaiting the world's first muscle targeted therapy for this devastating disease. Turning now to our commercial readiness in the U.S., our team continues to advance our launch preparations across all key functions, ensuring we are prepared to support patients, caregivers, and prescribers from day one. Our team is ready to launch Epidigromab at any time prior to and including our September 30th to do for date. Keith will discuss our commercial preparations in greater detail shortly. In addition to the US, we continue to look forward to serving children and adults living with SMA in Europe. I would now like to provide an update on where we stand in the European regulatory process. The Epidigromab MAA includes only Catalan Indiana fill finish facility and the EMA is awaiting the FDA inspection classification for that facility. In parallel, we are engaging with European regulators with regards to potential inclusion of our second fill finish facility in the Epidigromab application. Importantly, this facility has had recent successful site inspections by the FDA and the EMA. We are grateful for the EMA's continued level of engagement and we look forward to providing updated guidance on the potential timing of a CHMP opinion upon alignment with the European regulators. Turning to our launch preparations in Europe, we are executing our commercial playbook, building momentum with launch readiness activities and engaging with the SMA community. We are planning for an initial launch in Germany with additional countries and regions to follow as we build out our planned 50 country operating platform. We know it is not a matter of if but when. Epidigromab will be approved for children and adults with SMA in both the US and Europe. And we continue to work with urgency to reach the 35,000 people with SMA around the world who have received an SMN targeted therapy. Turning now to our world-leading anti-myostatin pipeline. We continue to make meaningful progress with our key clinical programs. We have robust enrollment in our Phase II OPAL study evaluating epidicromab in infants and toddlers with SMA. We initiated our randomized Phase II FORGE study in patients with FSHD. We are ready to engage with U.S. and European regulators on the development path of our High Concentration Subcutaneous Formulation of Epidigromab, which we will do once we have regulatory approvals. And enrollment and dosing is proceeding very well in our Phase 1 Healthy Volunteer Study for SRK439, our novel high-potency anti-myostatin antibody. Akshay will discuss these programs in greater detail shortly. Turning now to the balance sheet. We were very pleased to have ended the second quarter of 2026 with $492 million in cash, cash equivalents, and marketable securities. This cash balance includes net proceeds of $63 million from our ATM program during the second quarter. Vikas will provide more detail later in the call. In June, we had the opportunity to be with the SMA physician and patient community at the CURE SMA annual meeting in Orlando. I was able to sit down with several SMA treating physicians and with a number of patients and their families. And during our time with them, we heard some very moving stories about the impact that Pitigram Abbas had on children and adults who are participating in our ONIX and EAP programs. Our team at Scholar Rock is so inspired by these patients and by their families and we look forward to ushering in the next phase of innovation for this community. With that, I'll now turn the call over to Akshay for a closer look at our R&D initiatives. Akshay?