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Jun 30
Scholar Rock Q2 2025 Earnings Report
Scholar Rock reported its second quarter 2025 financial results and highlighted business progress, including the FDA's priority review acceptance for apitegromab BLA and positive Phase 2 EMBRAZE trial results.
Key Takeaways
Scholar Rock reported a net loss of $110 million for Q2 2025, an increase from $58.5 million in Q2 2024, primarily due to increased research and development and general and administrative expenses as the company prepares for the potential U.S. commercial launch of apitegromab. The company had no revenue for the quarter but maintained a strong cash position of $295 million, expected to fund operations into 2027.
Net loss for Q2 2025 was $110 million, significantly higher than $58.5 million in Q2 2024.
Research and development expenses increased by $20 million to $62.4 million, driven by drug supply manufacturing and employee-related costs.
General and administrative expenses surged by $32.6 million to $49.7 million, mainly due to stock-based compensation, employee expenses, and launch readiness infrastructure.
Cash, cash equivalents, and marketable securities stood at $295 million as of June 30, 2025, providing funding into 2027.
Scholar Rock
Scholar Rock
Forward Guidance
Scholar Rock is actively preparing for the U.S. commercial launch of apitegromab following the FDA's priority review with a PDUFA target action date of September 22, 2025. The company also anticipates a European launch in 2026 and plans to initiate the Phase 2 OPAL clinical trial for apitegromab in SMA in Q3 2025. Additionally, Scholar Rock expects to file an IND application for SRK-439 in the second half of 2025.
Positive Outlook
- FDA accepted apitegromab BLA under priority review with a PDUFA target action date of September 22, 2025.
- Finalizing U.S. commercial launch preparations for apitegromab, with customer-facing teams deployed.
- European Medicines Agency validated Marketing Authorisation Application (MAA) for apitegromab, with European launch anticipated in 2026.
- Positive topline results from Phase 2 EMBRAZE trial in obesity, demonstrating statistically significant preservation of lean mass with apitegromab.
- Expected to initiate Phase 2 OPAL clinical trial in SMA in Q3 2025 and file an IND for SRK-439 in H2 2025.
Challenges Ahead
- No revenue recorded for the current quarter, indicating reliance on existing cash reserves.
- Significant increase in operating expenses due to launch preparations and R&D, contributing to a larger net loss.
- European launch of apitegromab is not expected until 2026, delaying potential international revenue.
- The company's financial runway, while into 2027, is dependent on planned revenues which are not yet realized.
- Continued investment in clinical trials and regulatory processes without immediate product revenue.