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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.
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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