Solid Biosciences Reports $124.7 Million Net Loss for 2024, Increases R&D Spending

Solid Biosciences Inc. reported a net loss of $124.7 million for the year ended December 31, 2024, compared to a net loss of $96.0 million in 2023, representing a 29.9% increase. The company's research and development expenses increased by $19.8 million to $96.4 million, driven primarily by increased costs for SGT-501 ($14.0 million), SGT-212 ($4.6 million), and other development programs ($6.7 million), partially offset by a decrease in SGT-003 costs ($5.7 million). General and administrative expenses rose by $5.5 million to $33.3 million, mainly due to increased personnel costs and legal fees. The company had an accumulated deficit of $783.5 million as of December 31, 2024.

Significant developments during the year included the FDA clearance of the IND for SGT-212 in January 2025 and the commencement of patient dosing in the Phase 1/2 INSPIRE DUCHENNE trial for SGT-003 in the second quarter of 2024. The INSPIRE DUCHENNE protocol was amended in September 2024 to increase enrollment and expand age groups. Positive initial data from the INSPIRE DUCHENNE trial, released on February 18, 2025, showed an average microdystrophin expression of 110% in the first three participants and improvements in several muscle integrity biomarkers. The company also completed an asset purchase agreement with FA212 LLC in September 2024, acquiring intellectual property related to SGT-212, and a collaboration agreement with Mayo Clinic in December 2024.

The company's pipeline includes SGT-003 (Duchenne muscular dystrophy), SGT-212 (Friedreich's ataxia), SGT-501 (Catecholaminergic polymorphic ventricular tachycardia), and SGT-601 (TNNT2-mediated dilated cardiomyopathy), among others. As of December 31, 2024, Solid Biosciences employed 100 full-time employees, with 65 in research and development and 35 in general and administrative roles. The company's lead neuromuscular candidate, SGT-003, has received orphan drug designation, Fast Track designation, and Rare Pediatric Disease designation from the FDA. SGT-212 has received Fast Track designation, and SGT-501 has received orphan drug designation from both the FDA and EMA, as well as Rare Pediatric Disease designation from the FDA.

Solid Biosciences anticipates initiating a Phase 1b clinical trial for SGT-212 in the second half of 2025 and plans to submit an IND for SGT-501 in the first half of 2025. An IND for SGT-601 is anticipated in the second half of 2026. The company expects to request a meeting with the FDA in mid-2025 to discuss accelerated approval pathways for SGT-003. As of December 31, 2024, the company held $148.9 million in cash, cash equivalents, and available-for-sale securities, excluding restricted cash. A February 2025 underwritten offering generated net proceeds of approximately $187.5 million, which, along with existing resources, is expected to fund operations into the first half of 2027. The company acknowledges the need for additional funding beyond this period.