Solid Biosciences Reports Third Quarter 2026 Financial Results and Provides Business Updates

- Duchenne (SGT-003): SGT-003 has been generally well tolerated in the 53 participants dosed in the Phase 1/2 INSPIRE DUCHENNE clinical trial as of November 3, 2026 -

- Solid has scheduled a Type C meeting with the FDA in late Q4 2026 to discuss the preliminary INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway for SGT-003 -

- IMPACT DUCHENNE, a Phase 3 placebo-controlled, randomized, double-blind clinical trial, commenced dosing in Q2 2026 and is ongoing -

- Friedreich’s Ataxia (SGT-212): Five participants have been dosed in the Phase 1b FALCON clinical trial and SGT-212 has been well tolerated as of November 3, 2026 -

- Capital Position: Cash, cash equivalents and available-for-sale securities of $348.9 million as of September 30, 2026; the Company’s cash runway is anticipated to support late-stage development and early pipeline opportunities into H1 2028 -

CHARLESTOWN, Mass., Nov. 04, 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 third quarter ended September 30, 2026, and provided a business update.

Bo Cumbo, President and CEO of Solid Biosciences, stated: “As we approach key regulatory and clinical catalysts in our Duchenne and Friedreich’s ataxia programs, our progress this quarter reflects the dedication of our team, the differentiated nature of our clinical programs and the strength of our delivery technologies. In Duchenne, we look forward to meeting with the FDA late in the fourth quarter of 2026 to discuss a potential accelerated approval pathway for SGT-003. Our clearly differentiated safety data are central to those discussions. Across 53 participants dosed in INSPIRE DUCHENNE, SGT-003 has demonstrated an encouraging safety profile using a low-burden, steroid-only immunomodulation regimen. The Duchenne community deserves continued progress on both efficacy and safety, and that is what we are working to deliver.

"In Friedreich's ataxia, we have dosed five participants in the FALCON trial, and SGT-212 recently received Orphan designation from the European Commission. While cardiac disease remains the leading cause of mortality in FA, the FA patient community has consistently told us that slowing the relentless neurologic decline is their top priority. SGT-212 is designed to address both manifestations of the disease, and we believe its dual-route administration is what may uniquely enable SGT-212 to address the full scope of the disease. We anticipate reporting initial data in the first quarter of 2027,” Mr. Cumbo concluded.

Company Updates

Neuromuscular Pipeline

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

• SGT-003 has been generally well tolerated in the 53 participants dosed in the Phase 1/2 INSPIRE DUCHENNE clinical trial as of November 3, 2026. Solid 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 for SGT-003; Solid expects to provide an update following receipt of formal meeting minutes.
• Dosing in the Phase 3 IMPACT DUCHENNE placebo-controlled, randomized, double-blind clinical trial commenced in the second quarter of 2026; participant screening and enrollment remain ongoing.
  

SGT-212 for Friedreich’s ataxia (FA)

• Five participants have been dosed with SGT-212 in the Phase 1b FALCON clinical trial, with no treatment-related serious adverse events observed as of November 3, 2026.
• Participant screening and enrollment remain ongoing, and Solid expects to report initial data in the first quarter of 2027, subject to participant enrollment.
• In October, SGT-212 received Orphan designation for the treatment of Friedreich’s ataxia from the European Commission, acting upon the positive opinion of the European Medicines Agency’s Committee for Orphan Medicinal Products.
  

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 by the end 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.
  

Third Quarter 2026 Financial Highlights

• Cash Position: Solid had $348.9 million in cash, cash equivalents and available-for-sale securities as of September 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 the first half of 2028.
• At-the-Market (ATM) Proceeds: Solid generated $15.7 million in net proceeds from ATM sales for the third quarter of 2026.
• Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $43.6 million, compared to $38.9 million for the third quarter of 2025. The increase of $4.7 million was primarily due to a $2.8 million increase in personnel related expenses, a $2.6 million increase in costs for SGT-212 related to manufacturing and clinical costs, a $2.0 million increase in costs for SGT-003 related to manufacturing and research costs, and a $0.6 million increase in other development programs related to internal research costs, partially offset by a $1.6 million decrease in costs for SGT-601 due to lower manufacturing and internal research costs, a $1.1 million decrease in external expenses related to lower lab and professional service costs, and a $0.7 million decrease in costs for SGT-501 due to lower clinical and internal research costs.
• General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were $14.1 million, compared to $9.2 million for the third quarter of 2025. The increase of $4.9 million was primarily due to a $2.8 million increase in personnel related costs, a $0.8 million increase in costs related to commercial readiness, a $0.5 million increase in consulting and professional services, a $0.4 million increase in information technology and equipment related costs, and a $0.3 million increase in finance and legal expenses.
• Net Loss: Net loss for the third quarter of 2026 was $53.9 million, compared to a net loss of $45.8 million for the third 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 (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 (NCT06138639) and the Phase 3 IMPACT DUCHENNE trial (NCT07160634) – 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. The trial is expected to be conducted in Canada, Australia, the United States and multiple countries in Europe.

About SGT-212

SGT-212 is a recombinant AAV-based gene replacement therapy for Friedreich’s ataxia (FA) designed to deliver full-length human frataxin (FXN) via a dual route of administration: intradentate nucleus (IDN) infusion, using an FDA-approved neurosurgical device in a stereotactic, precision MRI-guided technique, followed by an intravenous (IV) infusion, with the intent to increase therapeutic FXN levels in the cerebellar dentate nuclei, cardiomyocytes and other systemic tissues. Targeted delivery to the dentate nuclei will be confirmed in real time via MRI. Restoration of FXN levels is expected to repair the underlying mitochondrial dysfunction in neurons and cardiomyocytes to address neurologic, cardiac and systemic manifestations of the disease.

About the FALCON Clinical Trial

FALCON is a first-in-human, open-label, multicenter Phase 1b clinical trial designed to evaluate the safety and tolerability of SGT-212 in participants aged 18-40 who have been diagnosed with FA. FALCON is being conducted in the United States.

About POLARIS-101™ 

POLARIS-101 (formerly AAV-SLB101) is Solid’s proprietary, next-generation, rationally engineered capsid developed for enhanced skeletal and cardiac muscle tropism and reduced liver biodistribution. Preclinical studies have demonstrated increased transduction speed, enhanced skeletal and cardiac muscle delivery, decreased liver biodistribution and improved efficiency compared with first-generation capsid benchmarks. POLARIS-101 is being clinically evaluated as the delivery capsid for SGT-003, Solid’s investigational gene therapy for Duchenne muscular dystrophy, in the Phase 1/2 INSPIRE DUCHENNE clinical trial (NCT06138639) and the Phase 3 IMPACT DUCHENNE clinical trial (NCT07160634).

POLARIS-101 is part of Solid’s broader gene therapy technology platform that includes proprietary manufacturing and other enabling delivery technologies, such as additional capsids and promoters. This expanded platform has been developed to provide next-generation technologies to developers early in the research and development cycle when technology decisions can shape the long-term performance of a program.

About Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit www.solidbio.com and follow us on LinkedIn at Solid Biosciences and X at @Solid_Bio.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company’s goals; anticipated benefits of SGT-003, SGT-212, SGT-501, SGT-601 and other preclinical programs and technologies; strategies and expectations for the company’s SGT-003, SGT-212, SGT-501, SGT-601 and other preclinical programs and technologies; expectations for planned site activation, planned enrollment, planned regulatory interactions and the potential approval pathways for SGT-003, SGT-212, SGT-501 and SGT-601; the cash runway of the company and the sufficiency of the Company’s cash, cash equivalents and available-for-sale securities to fund its operations; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company’s ability to advance SGT-003, SGT-212, SGT-501, SGT-601 and other preclinical programs, capsid libraries and other enabling technologies on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company’s product candidates; manufacture sufficient quantities of our drug product in a timely manner and maintain adequate supply to support our clinical development and potential commercialization; obtain, maintain or protect intellectual property rights related to its product candidates; replicate preliminary or interim data from clinical trials in the final data of such trials; compete successfully with other companies that are seeking to develop Duchenne, FA, CPVT and other neuromuscular and cardiac treatments and gene therapies; manage expenses; raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, SGT-212, SGT-501, SGT-601 and other candidates; and achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.

Investor Contact

Nicole Anderson
Senior Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
investors@solidbio.com

Media Contact
Amir Khan
Corporate Affairs Practice
Syneos Health
amir.khan@syneoshealth.com
(347) 249-0230

SOLID BIOSCIENCES, INC
SELECTED FINANCIAL INFORMATION (UNAUDITED)
CONDENSED CONSOLIDATED BALANCE SHEETS		September 30,			December 31,
(in thousands, except share data)		2026			2025
Cash and cash equivalents		$	125,971		$	59,900
Available-for-sale securities			222,957			127,950
Prepaid expenses and other current assets			15,629			16,384
Restricted cash, current			638			1,222
Operating lease, right-of-use assets			20,020			21,924
Property and equipment, net			3,734			4,169
Other non-current assets			248			223
Restricted cash, net of current portion			708			768
Total assets		$	389,905		$	232,540
Accounts payable		$	3,230		$	3,224
Accrued expenses and other current liabilities			20,890			18,945
Operating lease liabilities, current			2,284			2,103
Derivative liabilities			4,050			9,200
Operating lease liabilities, net of current portion			17,340			19,058
Total stockholders’ equity			342,111			180,010
Total liabilities and stockholders’ equity		$	389,905		$	232,540
Common stock outstanding			111,555,073			78,967,888

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS		Three Months Ended September 30,								Nine Months Ended September 30,
(in thousands, except per share data)			2026				2025				2026				2025
Operating expenses:
Research and development		$	43,595			$	38,861			$	134,000			$	102,190
General and administrative			14,060				9,197				38,347				27,613
Total operating expenses			57,655				48,058				172,347				129,803
Loss from operations			(57,655	)			(48,058	)			(172,347	)			(129,803	)
Other income, net:
Interest income			3,343				2,586				8,628				7,852
Interest expense			—				336				—				208
Change in fair value of derivative liabilities			150				(850	)			(2,350	)			(3,400	)
Other income, net			214				210				585				605
Total other income, net			3,707				2,282				6,863				5,265
Net loss		$	(53,948	)		$	(45,776	)		$	(165,484	)		$	(124,538	)
Net loss per share, basic and diluted		$	(0.36	)		$	(0.48	)		$	(1.23	)		$	(1.46	)
Weighted average shares of common stock outstanding, basic and diluted			151,031,642				94,417,746				134,994,925				85,069,288