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Scholar Rock Holding (SRRK) investor relations material

Scholar Rock Holding Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary6 Aug, 2025

Executive summary

  • FDA accepted apitegromab BLA under priority review with a PDUFA date of September 22, 2025; U.S. commercial launch preparations underway and EU launch anticipated in 2026.

  • Positive Phase 3 SAPPHIRE and Phase 2 EMBRAZE trial results for apitegromab in SMA and obesity, showing significant motor function improvement and lean mass preservation.

  • Expanding apitegromab into additional neuromuscular diseases (DMD, FSHD) and advancing pipeline assets, including SRK-439.

  • Management transition with new CEO and executive team effective April 27, 2025.

  • Disciplined capital allocation and commercial buildout to support launch and pipeline expansion.

Financial highlights

  • Cash, cash equivalents, and marketable securities totaled $295 million as of June 30, 2025, expected to fund operations into 2027.

  • Net loss for Q2 2025 was $110 million ($0.98 per share), with no product revenue recorded.

  • R&D expenses rose to $62.4 million in Q2 2025, driven by drug supply, employee, and transition costs.

  • G&A expenses increased to $49.7 million in Q2 2025, mainly due to stock-based compensation and launch readiness.

  • $50 million drawn under Oxford loan facility; up to $150 million additional available upon milestones.

Outlook and guidance

  • U.S. commercial launch of apitegromab planned for 2025, pending FDA approval; European launch targeted for 2026.

  • Phase 2 OPAL trial in SMA infants and toddlers to begin in Q3 2025.

  • IND filing for SRK-439 expected in the second half of 2025.

  • Cash runway projected to support commercial and development programs into 2027.

  • Additional capital may be required for full program execution.

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Frequently asked questions

Scholar Rock Holding Corp is a biopharmaceutical company engaged in the discovery and development of innovative medicines for the treatment of serious diseases, with a focus on those in which signaling by protein growth factors plays a fundamental role. The company's research and development efforts include Apitegromab, an inhibitor of the activation of latent myostatin that has completed Phase 3 clinical trials for the treatment of spinal muscular atrophy, and SRK-181, which is in clinical trials for the treatment of cancers resistant to checkpoint inhibitor therapies. Scholar Rock is also developing a pipeline of novel product candidates aimed at transforming the lives of patients suffering from a range of serious diseases, including neuromuscular disorders, cancer, fibrosis, and iron-restricted anemia. cholar Rock Holding Corp is headquartered in Cambridge, Massachusetts, and its shares are listed on the Nasdaq.

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