Solid Biosciences Inc. SEC 10-Q Report
Nov 3, 2025, 17:33 GMT-52 min read
 SLDB-15.29%
Solid Biosciences Inc., a biotechnology company focused on developing gene therapies for rare neuromuscular and cardiac diseases, has released its Form 10-Q report for the third quarter of 2025. The report highlights significant financial and operational developments, reflecting the company's ongoing commitment to advancing its clinical programs and expanding its research capabilities.
Financial Highlights
- Net Loss: $45.8 million, reflecting a 39.9% increase compared to the same period in 2024, primarily due to increased research and development expenses.
- Net Loss Per Share, Basic and Diluted: $(0.48), compared to $(0.79) in the same period in 2024, indicating a decrease in loss per share despite the increased net loss, due to a higher number of shares outstanding.
- Loss from Operations: $48.1 million, representing a 36.6% increase from the prior year, driven by higher operating expenses.
- Total Operating Expenses: $48.1 million, up 36.6% from the previous year, mainly due to increased research and development costs.
- Interest Income: $2.6 million, an increase of 11.1% from the previous year, reflecting higher interest earnings on cash and investments.
- Change in Fair Value of Derivative Liabilities: $(0.9) million, reflecting a loss due to changes in the fair value of derivative liabilities.
Business Highlights
- SGT-003 Clinical Trial Progress: The Phase 1/2 INSPIRE DUCHENNE trial for SGT-003 began participant dosing in Q2 2024. As of October 31, 2025, 23 participants have been dosed, with positive interim data showing significant microdystrophin expression and early signals of cardiac function normalization.
- SGT-003 Regulatory Designations: SGT-003 has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA, and an Innovation Passport from the UK Innovative Licensing and Access Pathway.
- SGT-212 Clinical Trial Initiation: The FDA cleared the IND for SGT-212 for the treatment of Friedreich's ataxia in January 2025. The FALCON trial, a Phase 1b clinical trial, began screening participants in October 2025.
- SGT-501 Clinical Trial Approval: The FDA and Health Canada have approved the IND and CTA for SGT-501 for the treatment of CPVT. The ARTEMIS trial is expected to begin in Q4 2025.
- SGT-601 Preclinical Development: SGT-601 is in preclinical development for TNNT2-mediated dilated cardiomyopathy, with studies showing promising results in mice.
- Capsid Development: Solid Biosciences is developing next-generation capsid and promoter libraries, with final capsid selection from the first cardiac capsid library anticipated in the first half of 2026.
- Geographical Expansion: The INSPIRE DUCHENNE trial has 15 active sites across the U.S., Canada, Italy, and the UK, with plans to expand the IMPACT DUCHENNE trial into additional countries.
- Future Outlook for SGT-003: A meeting with the FDA to discuss potential regulatory pathways for SGT-003 is anticipated in the first half of 2026, with 30 total participants expected to be dosed by early 2026.
- Operational Focus: The company is focused on advancing gene therapy candidates for rare neuromuscular and cardiac diseases, leveraging internal capabilities and collaborations with experts in the field.
SEC Filing: Solid Biosciences Inc. [ SLDB ] - 10-Q - Nov. 03, 2025 |
