The Tip Desk

Earnings

Solid Biosciences Widens Third-Quarter Loss

The gene-therapy company posted a $53.9 million net loss for the three months ended September 30, 2026, and said cash of $348.9 million will fund operations into the first half of 2028.

Solid Biosciences (SLDB), a life sciences company developing gene-therapy candidates for rare neuromuscular and cardiac diseases, reported a net loss of $53.9 million for the three months ended September 30, 2026, compared with $54.8 million in the three months ended June 30, 2026.

The company has not generated commercial product revenue and said it does not expect to do so for the foreseeable future. Total operating expenses were $57.7 million in the September quarter, versus $57.4 million in the June quarter.

Research and development expenses were $43.6 million, down from $44.3 million in the prior quarter. General and administrative expenses were $14.1 million, up from $13.1 million. The company said the year-over-year increase in research and development was primarily due to higher personnel-related costs, higher SGT-212 manufacturing and clinical costs, and higher SGT-003 manufacturing and research costs, partly offset by lower SGT-601, SGT-501 and external expenses. The year-over-year increase in general and administrative expenses was attributed primarily to personnel costs, commercial-readiness costs, consulting, information technology and finance and legal expenses.

Allocated research and development spend on SGT-003, the lead Duchenne candidate, was $20.2 million in the September quarter, down from $24.5 million in the June quarter. SGT-212 allocated spend was $4.4 million. SGT-501 allocated spend was $0.8 million. SGT-601 allocated spend was $0.5 million.

Interest income was $3.3 million in the September quarter. Other income, net was $3.7 million.

In the Phase 1/2 INSPIRE DUCHENNE trial of SGT-003, 53 participants had been dosed as of November 3, 2026, matching the count reported as of August 4, 2026. The company said SGT-003 had been generally well tolerated, with two previously disclosed treatment-related serious adverse events. One participant withdrew consent after the Day 60 follow-up visit, with no treatment-related adverse events seen in that participant. The trial is ongoing at sites in the United States, Canada, Italy and the United Kingdom.

The company said it has scheduled a Type C meeting with the FDA late in the fourth quarter of 2026 to discuss the preliminary INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway. It said it expects to provide an update after receiving formal meeting minutes. Process performance qualification manufacturing batches are expected to be completed by the end of 2026.

IMPACT DUCHENNE, a Phase 3 randomized, double-blind, placebo-controlled trial of SGT-003, had its first participant dosed in April 2026. Screening is underway. The trial is expected to be conducted in Canada, Australia, the United States and multiple countries in Europe.

In FALCON, an open-label Phase 1b trial of SGT-212 for Friedreich’s ataxia, five participants had been dosed as of November 3, 2026, up from two as of August 4, 2026. The company said SGT-212 had been well tolerated with no treatment-related serious adverse events. Initial data are anticipated in the first quarter of 2027, subject to enrollment.

For ARTEMIS, an open-label Phase 1b trial of SGT-501 for CPVT, the company said it anticipates dosing its first participant by the end of 2026, with initial safety data anticipated in the first half of 2027, subject to enrollment.

Cash, cash equivalents and available-for-sale securities were $348.9 million as of September 30, 2026, excluding restricted cash of $1.3 million, down from $377.7 million as of June 30, 2026. The company said that cash balance will enable it to fund operating expenses and capital expenditure requirements into the first half of 2028. The accumulated deficit was $1.1 billion.

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