Scholar Rock Holding Corporation (NASDAQ:SRRK) Q3 2024 Earnings Conference Call November 12, 2024 8:15 AM ET

Company Participants

Jay Backstrom - President & CEO
Ted Myles - COO & CFO

Conference Call Participants

Jenna Lee - Jefferies
Etzer Darout - BMO Capital Markets
Gary Nachman - Raymond James
Alex Nugent - Truist Securities Limited

Operator

Good morning and welcome to Scholar Rock's Third Quarter 2024 Financial Results and Business Update Call. All participants will be in listen-only mode. After the company’s prepared remarks all participants will have an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded.

Before we begin, I’d like to point out that 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 on 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 sections of our website to find our most up to date SEC statements and filings. A recording of today's event will also be available on our website should you want to rewatch at a later date.

I would now like to turn the conference over to Jay Backstrom, President and CEO of Scholar Rock. Jay, please go ahead.

Jay Backstrom

Thank you, Carmen. Good morning, and welcome, everyone. Thank you for joining our third quarter business update. It's a very exciting time at Scholar Rock. With the success of SAPPHIRE, our Phase 3 registration study in spinal muscular atrophy and a successful financing, we have great momentum heading to the end of 2024.

I'm joined on today's call by Ted Myles, our Chief Operating Officer and Chief Financial Officer. For our call this morning, I will start with the company overview, Ted will provide a financial and business update and I'll provide a few closing remarks before opening the call up for questions.

As shown on Slide 6, we had another very successful quarter building on the momentum that we created throughout 2024. The dedication and commitment across the organization has been remarkable. The teams continue to execute and deliver all of our key milestones on time or ahead of schedule.

For our lead program with apitegromab in spinal muscular atrophy, the clinical team did an outstanding job delivering the SAPPHIRE data with great skill, speed and high quality, enabling us to report out the successful results in early October. This flawless execution allows us to advance toward the next important milestones of submitting the BLA and MAA in Q1 of 2025 and keeps us on track to have our first commercial launch in the U.S. in Q4 2025 with Europe to follow assuming regulatory approvals.