Solid Biosciences(US:SLDB)2025-11-03 22:22Financial Performance - The company reported net losses of $45.8 million and $124.5 million for the three and nine months ended September 30, 2025, respectively, compared to $32.7 million and $82.1 million for the same periods in 2024[108]. - As of September 30, 2025, the company had an accumulated deficit of $908.0 million and expects to incur significant expenses and operating losses for the foreseeable future[108]. - The net loss for the nine months ended September 30, 2025, was $124.5 million, representing a 51.7% increase from a net loss of $82.1 million in the same period of 2024[131]. - Cash used in operating activities was $102.7 million for the nine months ended September 30, 2025, compared to $70.4 million in the same period of 2024[141]. - Other income, net decreased to $5.3 million, down 32.5% from $7.7 million in the previous year, primarily due to changes in the fair value of derivative liabilities[135]. Research and Development - The company has not generated any commercial product revenue to date and does not expect to do so in the foreseeable future[112]. - Research and development expenses for Q3 2025 were $38.9 million, a 42.2% increase from $27.3 million in Q3 2024[125]. - The allocated research and development expenses for SGT-003 increased by 242.8% to $18.1 million in Q3 2025 from $5.3 million in Q3 2024[126]. - Total research and development expenses for the nine months ended September 30, 2025, were $102.2 million, a 55.6% increase from $65.7 million in the same period of 2024[132]. - The total allocated research and development expenses increased by 88.2% to $62.0 million, driven primarily by a $30.1 million increase in costs for SGT-003[132]. Clinical Trials - The FDA has granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations for SGT-003 for the treatment of Duchenne muscular dystrophy[101]. - Interim data from the Phase 1/2 INSPIRE DUCHENNE trial showed a mean microdystrophin expression of 58% and mean microdystrophin positive fibers of 51%[96]. - As of October 31, 2025, 23 participants have been dosed in the INSPIRE DUCHENNE trial, with one treatment-related serious adverse event reported[97]. - The company anticipates that enrollment in the INSPIRE DUCHENNE trial will reach 30 participants by early 2026[98]. - The company activated the first clinical trial site for the Phase 3 IMPACT DUCHENNE trial in October 2025, which aims to support potential ex-U.S. regulatory authorizations[100]. Financial Position - The company had cash, cash equivalents, and available-for-sale securities of $236.1 million as of September 30, 2025, expected to fund operations into the first half of 2027[111]. - The company raised approximately $188.0 million in net proceeds from the February 2025 Offering, selling 35,739,810 shares at $4.03 per share[139]. - The company anticipates needing to raise additional funds to continue operations beyond the first half of 2027[149]. - As of September 30, 2025, the company had cash, cash equivalents, and available-for-sale securities totaling $236.1 million, excluding restricted cash of $1.9 million[140]. - Cash provided by financing activities increased to $189.3 million, up from $115.5 million in the prior year, reflecting successful capital raises[146]. Expenses - Total operating expenses for the nine months ended September 30, 2025, were $129.8 million, a 44.5% increase from $89.8 million in the same period of 2024[131]. - General and administrative expenses for Q3 2025 were $9.2 million, up 17.1% from $7.9 million in Q3 2024[129]. - General and administrative expenses rose to $27.6 million, a 14.1% increase from $24.2 million in the prior year[134]. - Personnel-related expenses in unallocated research and development increased by 43.8% to $9.0 million in Q3 2025 from $6.3 million in Q3 2024[126]. - The company expects general and administrative expenses to increase in the future to support ongoing clinical trials and commercialization efforts[119]. Market and Economic Conditions - Inflation has not had a material effect on the business in the last two years, but future operations may be adversely affected[161]. - An immediate 10% change in market interest rates would not have a material impact on the fair market value of the investment portfolio[160]. - Cash equivalents as of September 30, 2025, consisted of money market funds and treasury bills with maturities of less than 90 days[160]. - Investments as of September 30, 2025, included treasury bills and government bonds with maturities of less than one year[160]. - No material changes to contractual obligations and commitments during the nine months ended September 30, 2025[157].