Scholar Rock Q2 2023 Earnings Report
Key Takeaways
Scholar Rock reported a net loss of $37.9 million for the second quarter of 2023. The company's cash, cash equivalents, and marketable securities were approximately $249 million as of June 30, 2023, expected to fund operations into 2025.
Presented 36-month apitegromab extension data from Phase 2 TOPAZ trial, demonstrating long-term improvement of motor function.
Pivotal Phase 3 SAPPHIRE trial evaluating apitegromab is on track to complete enrollment in Q3 2023, with top-line data expected in 2H 2024.
Clinical and biomarker update from the Part B portion of the Phase 1 DRAGON trial of SRK-181 in solid tumors is anticipated in 2H 2023.
Cash, cash equivalents, and marketable securities were approximately $249 million as of June 30, 2023, expected to fund operations into 2025.
Scholar Rock
Scholar Rock
Forward Guidance
Scholar Rock anticipates several important milestones with their current cash runway.
Positive Outlook
- Completion of enrollment for Phase 3 SAPPHIRE clinical trial expected in Q3 2023.
- Top-line data from SAPPHIRE trial expected in 2H 2024.
- Potential commercial product launch in 2025, if SAPPHIRE is successful and approved.
- Biomarker and clinical updates from Part B of the DRAGON trial in the second half of 2023.
- Cash runway is expected to fund operations into 2025.
Challenges Ahead
- Clinical trial data may be inconsistent with future trials.
- Dependence on third parties for development and manufacture of product candidates.
- Competition from third parties developing products for similar uses.
- Uncertainties regarding regulatory approval.
- Impacts of public health pandemics such as COVID-19 on business operations and expectations.