– Patients dosed in Phase 1/2 INSPIRE DUCHENNE trial of SGT-003 for the treatment of Duchenne muscular dystrophy (Duchenne); Dosing was well tolerated in all patients with initial data expected Q4 2024 – – Solid plans to expand patient dosing with additional clinical trial sites in the U.S., Canada and Europe and plans accelerated production of multiple GMP batches of SGT-003 to support trial expansion – – Targeting the submission of 3-4 INDs by the end of 2026, strategically selecting cardiac and neuromusc ...

CHARLESTOWN, Mass., July 01, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the "Company"), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced a grant of 11,847 restricted stock units ("RSUs") to one newly hired employee. Solid Biosciences is a life sciences company focused on advancing a portfolio of gene therapy candidates including SGT-003 for the treatment of Duchenne muscular dystrophy (Duchenne), SGT-501 for the treat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-38360 Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 90-0943402 (Stat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38360 Solid Biosciences Inc. (Exact name of Registrant as specified in its Charter) Delaware 90-0943402 (State or other jurisdiction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-38360 Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-38360 Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdicti ...

This presentation 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 priorities and achieve key clinical milestones; the company's plans to present data from its Friedreich's ataxia program, next-generation Duchenne muscular dystrophy program, novel capsid program, and process developme ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-38360 Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdict ...

Financial Performance - The company incurred a net loss of $86.0 million for the year ended December 31, 2022, with an accumulated deficit of $562.7 million as of the same date [237]. - The company expects to continue incurring significant operating losses for the foreseeable future as it focuses on research and development [237]. - The company has never generated revenue from product sales and does not expect to do so for the foreseeable future [244]. - The company will need to raise additional funds to continue operations beyond 2025, with no assurance that such funds will be available on acceptable terms [240]. Acquisition and Integration - The acquisition of AavantiBio was completed on December 2, 2022, and included pipeline programs for treating FA and BAG3 mediated dilated cardiomyopathy [230]. - There is a risk that the integration of AavantiBio may divert management's attention and disrupt ongoing business operations [231]. - The anticipated benefits of the acquisition may not be realized if integration challenges arise or if undisclosed liabilities surface [232]. - Future capital requirements will depend on the progress and costs associated with integrating AavantiBio and the results of clinical trials for SGT-003 and other candidates [241]. - The company may face increased litigation risks following the acquisition, which could adversely impact business operations [236]. Clinical Trials and Regulatory Challenges - The COVID-19 pandemic has caused disruptions in clinical trials, regulatory activities, and supply chains, impacting the ability to complete preclinical studies and clinical trials [247][248]. - Company has faced challenges in recruiting patients for clinical trials due to COVID-19, resulting in missed or postponed patient visits [249]. - Regulatory approvals may be delayed or impacted due to the redirection of resources by the FDA towards COVID-19 therapies, affecting the progress of the company's product candidates [250]. - The company has limited experience in regulatory submissions and has never completed a clinical trial, which poses risks for future product candidates [272]. - The company may face significant delays in clinical trials due to various factors, including patient recruitment and regulatory approvals [278]. - Regulatory approval for SGT-003, AVB-202-TT, and AVB-401 is uncertain, and even if trials are successful, approvals may be for narrower indications than sought [285]. Product Development and Safety Concerns - The regulatory approval process for gene transfer candidates is uncertain and can be more expensive and time-consuming compared to other products, with only a limited number of such products approved in the U.S. and EU [262]. - There is a risk of undesirable side effects from gene transfer candidates that could delay or prevent regulatory approval, impacting their commercial potential [263]. - Previous gene therapy treatments have reported significant adverse side effects, raising concerns about the safety and efficacy of the company's candidates [266]. - A serious adverse event related to SGT-001 occurred in a clinical trial, leading to a clinical hold by the FDA in November 2019, which was lifted in October 2020 [270]. - The anticipated dosing requirements for SGT-003 may increase the risk of adverse side effects, as seen in previous high-dose AAV vector administrations [268]. Manufacturing and Supply Chain Risks - The company currently relies on third-party manufacturers for SGT-003 and plans to do so for AVB-202-TT and AVB-401 programs, which exposes it to risks of delays and insufficient supply [351]. - The company does not have long-term supply arrangements for SGT-003, which may hinder its ability to scale production and meet future demand [353]. - There is a risk of significant disruption in supply due to factors such as equipment malfunctions, contamination, or public health issues like the COVID-19 pandemic [346]. - The company is at risk of contamination in its manufacturing processes, which could disrupt the supply of its product candidates and affect clinical development timelines [366]. Market and Competitive Landscape - The company faces significant competition from larger pharmaceutical and biotechnology firms, which may achieve regulatory approval before the company or develop more effective therapies [328]. - Competitors such as Pfizer and Sarepta Therapeutics are advancing in clinical trials for gene therapies, with Sarepta having submitted a BLA for its candidate with a PDUFA date of May 29, 2023 [329]. - The company's commercial opportunity may be diminished if competitors launch safer, more effective, or less expensive products first [330]. - The commercial success of gene therapy products may be limited by patients' immune responses, affecting the population amenable to treatment [360]. Regulatory Environment and Compliance - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) if SGT-003 or other candidates receive marketing approval, which could include a medication guide and communication plan [269]. - Compliance with ongoing regulatory requirements post-approval is necessary, and failure to do so could limit the ability to market future products [291]. - The company is subject to various stringent privacy laws and regulations, including HIPAA, which impose significant compliance costs and potential penalties for violations [405]. - The company faces risks related to anti-corruption laws, including the U.K. Bribery Act and the U.S. Foreign Corrupt Practices Act, which could lead to civil or criminal penalties if violated [416]. Financial and Operational Risks - The company faces potential pricing pressures from both federal and state healthcare reforms, which could limit revenue generation capabilities [396]. - The company has reduced its workforce by approximately 35% in April 2022 and 18% in December 2022 as part of a strategic plan to streamline operations, but may not realize the anticipated benefits from these reductions [381]. - The company is highly dependent on key employees, and the loss of these individuals could impede the achievement of its research and commercialization objectives [378]. - The company may engage in future acquisitions or strategic collaborations, which could increase capital requirements and introduce additional risks [376].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-38360 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Sec ...