SGT-003

- 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™, the Company’s next-generation, muscle-tropic capsid used in SGT-003. In July, Solid executed a license agreement with Addgene for POLARIS-101™. 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™ 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™ (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 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, multi-center 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 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 and other pre-clinical programs and technologies; strategies and expectations for the company’s SGT-003, SGT-212, SGT-501, SGT-601 and other pre-clinical programs and technologies; expectations for planned site activation, planned enrollment, planned regulatory interactions and the potential approval pathways for SGT-003, SGT-212 and SGT-501; 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 clinicals 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; and 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; 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. Solid Biosciences Investor Contact: Nicole Anderson Senior Director, Investor Relations and Corporate Communications Solid Biosciences Inc. investors@solidbio.com Source: Solid Biosciences Inc.