Press Release: Solid Biosciences Reports Second Quarter 2026 Financial Results and Provides Business Updates

Dow Jones
Aug 07

- Duchenne (SGT-003): SGT-003 has been generally well tolerated in the Phase 1/2 INSPIRE DUCHENNE clinical trial, with 53 participants dosed as of August 4, 2026 -

- Solid expects to meet with the FDA in late Q4 2026 to discuss the SGT-003 data package and to seek guidance on a potential accelerated approval pathway for SGT-003 -

- Initiation of dosing in the Phase 3 IMPACT DUCHENNE placebo-controlled, randomized, double-blind clinical trial commenced in Q2 2026 -

- Friedreich's Ataxia (SGT-212): Continued participant screening and enrollment is underway in the Phase 1b FALCON clinical trial; SGT-212 has been well tolerated in the two participants dosed as of August 4, 2026 -

- Capital Position: Cash, cash equivalents and available-for-sale securities of $377.7 million at June 30, 2026; the Company's cash runway is anticipated to support late-stage development and early pipeline opportunities into mid-2028 -

CHARLESTOWN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the "Company" or "Solid"), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update.

Bo Cumbo, President and CEO of Solid Biosciences, stated: "Our progress in the first half of 2026 positions us for continued momentum as we approach multiple key clinical and regulatory milestones across our Duchenne, Friedreich's ataxia and broader precision genetic medicine platform over the next several quarters. In Duchenne, we continue to have confidence in SGT-003's safety profile, which is achieved using a low-burden, steroid-only immunomodulation regimen. We are also highly encouraged by the strength of the biomarker data we have generated to date, which demonstrates promising biologic activity. As we prepare to analyze 12-month clinical data from initial participants in the INSPIRE DUCHENNE trial, we gain an important opportunity to evaluate the relationship between these biologic signals and clinical outcomes. We look forward to continued engagement with the FDA as we work with urgency to evaluate a potential accelerated approval pathway for SGT-003."

Mr. Cumbo continued, "In FA, we continue to progress SGT-212 with two participants dosed in the FALCON clinical trial, and we look forward to sharing initial data in the first quarter of 2027, which will help inform future development pathways as we aim to bring SGT-212 rapidly to the FA patient community."

Company Updates

Neuromuscular Pipeline

SGT-003 Next-Generation Duchenne Muscular Dystrophy (Duchenne) Program

   -- SGT-003 has been well tolerated in the 53 participants dosed in the Phase 
      1/2 INSPIRE DUCHENNE clinical trial as of August 4, 2026. Solid plans to 
      meet with the FDA late in the fourth quarter of 2026 to discuss the 
      INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential 
      accelerated approval pathway for SGT-003; the Company expects to provide 
      an update as discussions progress. 
 
   -- As announced on May 7, 2026, the Company reported that the first 
      participant was dosed in the Phase 3 IMPACT DUCHENNE placebo-controlled, 
      randomized, double-blind clinical trial. Clinical sites are currently 
      active in Australia and Canada, with additional clinical site activations 
      expected in the second half of 2026, subject to site initiation 
      activities and regulatory clearances. 

SGT-212 for Friedreich's ataxia $(FA)$

   -- SGT-212 has been well tolerated, with no treatment-related serious 
      adverse events (TRSAEs) observed in the two participants dosed in the 
      Phase 1b FALCON clinical trial as of August 4, 2026. 
 
   -- Participant screening and enrollment remains ongoing, and the Company 
      expects to report initial data in the first quarter of 2027, subject to 
      participant enrollment. 

Cardiac Pipeline

SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT)

   -- Solid has activated clinical trial sites and commenced participant 
      screening for the Phase 1b ARTEMIS clinical trial. 
 
   -- Solid expects to dose the first participant in the second half of 2026, 
      with initial safety data anticipated in the first half of 2027, subject 
      to participant enrollment. 

Platform Technologies

   -- Solid has executed more than 50 agreements, including licenses, with 
      corporations, institutions and academic labs for the use of 
      POLARIS-101$(TM)$, the Company's next-generation, muscle-tropic capsid used 
      in SGT-003. 
 
   -- In July, Solid executed a license agreement with Addgene for 
      POLARIS-101(TM). Addgene is one of the largest global plasmid 
      repositories and has been a pioneer in accelerating research and 
      discovery by improving access to high-quality scientific research 
      materials. Under the terms of the agreement, the Company has granted 
      Addgene a non-exclusive worldwide license to provide access to 
      POLARIS-101(TM) through Addgene's curated online catalog of materials. 

Second Quarter 2026 Financial Highlights

   -- Cash Position: Solid had $377.7 million in cash, cash equivalents and 
      available-for-sale securities as of June 30, 2026, compared to $187.9 
      million as of December 31, 2025. The Company expects that its existing 
      cash, cash equivalents, and available-for-sale securities will be 
      sufficient to fund its operational runway into mid-2028. 
 
   -- At-the-Market (ATM) Proceeds: The $377.7 million cash position at June 
      30, 2026, is inclusive of $60.8 million in net proceeds generated from 
      ATM sales during the six months ended June 30, 2026. The Company 
      generated an additional $15.7 million in net proceeds from ATM sales 
      after June 30, 2026. 
 
   -- Research and Development (R&D) Expenses: R&D expenses for the second 
      quarter of 2026 were $44.3 million, compared to $32.4 million for the 
      second quarter of 2025. The increase of $11.9 million in research and 
      development expenses was primarily due to a $12.2 million increase in 
      costs for SGT-003 primarily related to manufacturing and clinical costs, 
      a $3.2 million increase in personnel related expenses, and a $1.2 million 
      increase in costs for SGT-212 primarily related to clinical and research 
      costs, partially offset by a $2.2 million decrease in costs for SGT-601 
      related to lower manufacturing and research costs, a $1.4 million 
      decrease in external expenses primarily related to laboratory supplies, 
      and a $1.3 million decrease in costs for SGT-501 primarily related to 
      lower license payments and research costs. 
 
   -- General and Administrative (G&A) Expenses: G&A expenses for the second 
      quarter of 2026 were $13.1 million, compared to $9.3 million for the 
      second quarter of 2025. The increase of $3.8 million was primarily due 
      to a $2.6 million increase in personnel related costs, a $0.5 million 
      increase in business development costs, a $0.4 million increase in 
      equipment costs, and a $0.3 million increase in consulting services. 
 
   -- Net Loss: Net loss for the second quarter of 2026 was $54.8 million, 
      compared to a net loss of $39.5 million for the second quarter of 2025. 

About SGT-003

SGT-003 is an investigational gene therapy containing a novel microdystrophin construct and a proprietary, next-generation capsid, POLARIS-101(TM) (formerly known as AAV-SLB101), which was rationally designed to target integrin receptors, and has shown enhanced cardiac and skeletal muscle transduction with decreased liver targeting in data from the Phase 1/2 INSPIRE DUCHENNE clinical trial and in nonclinical studies. SGT-003's microdystrophin construct uniquely includes the R16/17 domains, which localize nNOS to the muscle. Nonclinical studies have shown that nNOS can improve blood flow to the muscle thereby reducing muscle breakdown from ischemia and muscle fatigue. Together, these design features suggest that SGT-003 could be a potential best-in-class investigational gene therapy for the treatment of Duchenne.

About the SGT-003 Development Program

The SGT-003 clinical development program consists of two multinational clinical trials -- the Phase 1/2 INSPIRE DUCHENNE trial and the Phase 3 IMPACT DUCHENNE trial -- which together were designed to generate a comprehensive data package to support potential global regulatory authorizations.

INSPIRE DUCHENNE is a first-in-human, open-label, single-dose, multicenter Phase 1/2 clinical trial evaluating the safety, tolerability and efficacy of a single dose of SGT-003 in pediatric participants with a genetically confirmed Duchenne diagnosis. The trial is being conducted at clinical sites in the United States, Canada, the United Kingdom and Italy.

IMPACT DUCHENNE is a Phase 3 placebo-controlled, randomized, double-blind clinical trial evaluating the efficacy of a single dose of SGT-003 in ambulatory participants with a genetically confirmed Duchenne diagnosis. Clinical trial sites are currently active in Australia and Canada, with additional clinical site activations expected in the second half of 2026, subject to site initiation activities and regulatory clearances.

About SGT-212

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