PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited condensed consolidated financial statements, including balance sheets, operations, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20at%20June%2030,%202023%20and%20December%2031,%202022) Total assets and stockholders' equity decreased from December 2022 to June 2023, driven by reduced cash and increased accumulated deficit Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | Change (in thousands) | % Change | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | :------- | | Cash and cash equivalents | $91,569 | $155,384 | $(63,815) | -41.07% | | Available-for-sale securities | $68,623 | $58,338 | $10,285 | 17.63% | | Total current assets | $167,475 | $219,638 | $(52,163) | -23.75% | | Total assets | $204,721 | $260,252 | $(55,531) | -21.34% | | Total current liabilities | $15,866 | $22,508 | $(6,642) | -29.51% | | Total liabilities | $40,993 | $48,586 | $(7,593) | -15.63% | | Total stockholders' equity | $163,728 | $211,666 | $(47,938) | -22.65% | | Accumulated deficit | $(617,437) | $(562,738) | $(54,699) | 9.72% | [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030,%202023%20and%202022) No collaboration revenue for Q2 and H1 2023; net losses remained substantial, driven by reduced collaboration revenue and increased interest income Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $0 | $6,169 | $0 | $8,094 | | R&D expenses | $19,777 | $23,180 | $44,408 | $43,125 | | G&A expenses | $7,129 | $6,851 | $14,528 | $14,203 | | Restructuring Charges | $(63) | $1,520 | $(63) | $1,520 | | Total operating expenses | $26,843 | $31,551 | $58,873 | $58,848 | | Loss from operations | $(26,843) | $(25,382) | $(58,873) | $(50,754) | | Interest income, net | $1,949 | $293 | $3,627 | $347 | | Net loss | $(24,629) | $(25,092) | $(54,699) | $(50,420) | | Net loss per share | $(1.25) | $(3.33) | $(2.79) | $(6.71) | - Collaboration revenue decreased to **$0** for both the three and six months ended June 30, 2023, from **$6,169 thousand** and **$8,094 thousand** respectively in the prior year, due to the completion of research and development services under the Ultragenyx Collaboration Agreement[10](index=10&type=chunk)[52](index=52&type=chunk) - Net loss per share significantly improved from **$(3.33)** to **$(1.25)** for the three months ended June 30, 2023, and from **$(6.71)** to **$(2.79)** for the six months ended June 30, 2023, despite increased net loss, primarily due to a substantial increase in weighted average shares outstanding[10](index=10&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030,%202023%20and%202022) Comprehensive loss for Q2 and H1 2023 was primarily driven by net loss, with minor impact from unrealized gains on securities Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(24,629) | $(25,092) | $(54,699) | $(50,420) | | Unrealized gain (loss) on available-for-sale securities | $9 | $(71) | $82 | $(77) | | Comprehensive loss | $(24,620) | $(25,163) | $(54,617) | $(50,497) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030,%202023%20and%202022) Stockholders' equity decreased from December 2022 to June 2023, driven by net loss, partially offset by equity compensation and common stock sales Condensed Consolidated Statements of Changes in Stockholders' Equity | Metric | Balance at December 31, 2022 | Six Months Ended June 30, 2023 | Balance at June 30, 2023 | | :-------------------- | :--------------------------- | :----------------------------- | :----------------------- | | Common Stock (shares) | 19,556,732 | 487,657 | 20,044,389 | | Common Stock (amount in thousands) | $20 | $0 | $20 | | Additional paid-in capital (in thousands) | $774,452 | $6,679 | $781,131 | | Accumulated other comprehensive income (loss) (in thousands) | $(68) | $82 | $14 | | Accumulated deficit (in thousands) | $(562,738) | $(54,699) | $(617,437) | | Total stockholders' equity (in thousands) | $211,666 | $(47,938) | $163,728 | - During the six months ended June 30, 2023, the company issued **420,000 shares** of common stock through an 'at-the-market offering' sales agreement, generating net proceeds of **$2,539 thousand**[14](index=14&type=chunk)[73](index=73&type=chunk) - Equity-based compensation contributed **$4,062 thousand** to additional paid-in capital for the six months ended June 30, 2023[14](index=14&type=chunk)[78](index=78&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030,%202023%20and%202022) Operating cash usage increased, investing cash usage decreased, and financing activities provided more cash, mainly from common stock issuance Cash Flow Activity (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(55,460) | $(43,068) | | Net cash used in investing activities | $(10,972) | $(21,852) | | Net cash provided by financing activities | $2,617 | $95 | | Net decrease in cash, cash equivalents and restricted cash | $(63,815) | $(64,825)

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 ...

© 2022 Solid Biosciences 1 Strategic Update: Acquisition of AavantiBio and $75M PIPE September 30, 2022 Forward-Looking Statements and Industry and Market Data This presentation and various remarks we make during this presentation contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding: future expectations, plans and prospects for Solid Biosciences Inc. (the "Company" or "Solid"), AavantiBio, Inc. ("AavantiBio") and the ...

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, 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 Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 90-0943402 (State ...

Solid Biosciences Inc. (NASDAQ:SLDB) Q1 2022 Results Conference Call April 27, 2022 8:00 AM ET Company Participants Caitlin Lowie - VP, Communications and IR Ilan Ganot - Co-Founder, President and CEO Dr. Joel Schneider - COO Dr. Carl Morris - Chief Scientific Officer Dr. Roxana Donisa Dreghici - SVP and Head, Clinical Development Conference Call Participants Gena Wang - Barclays Joseph Schwartz - SVB Securities Allison Bratzel - Piper Sandler Anupam Rama - JP Morgan Maury Raycroft - Jefferies Operator Ladi ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Q1 2022 net loss of $25.3 million, decreased assets, and April 2022 restructuring with 35% workforce reduction Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $129,711 | $119,136 | | Available-for-sale securities | $50,339 | $88,643 | | **Total Assets** | **$207,556** | **$232,380** | | Total current liabilities | $21,744 | $23,601 | | **Total Liabilities** | **$22,045** | **$24,169** | | **Total Stockholders' Equity** | **$185,511** | **$208,211** | Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Collaboration revenue - related party | $1,925 | $3,335 | | Research and development | $19,945 | $14,206 | | General and administrative | $7,352 | $6,015 | | **Loss from operations** | **($25,372)** | **($16,886)** | | **Net loss** | **($25,328)** | **($16,900)** | | **Net loss per share** | **($0.22)** | **($0.19)** | Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($27,190) | ($21,366) | | Net cash provided by (used in) investing activities | $37,743 | ($35) | | Net cash provided by financing activities | $22 | $135,154 | - In April 2022, the company implemented a corporate restructuring to prioritize its key programs, SGT-001 and SGT-003, involving a headcount reduction of approximately **35%**, with estimated restructuring costs of **$1.7 million** for severance and employee benefits[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic shifts, including a 35% workforce reduction to extend cash runway, and Q1 2022 net loss of $25.3 million from increased R&D - The company's lead product candidate is **SGT-001**, a gene transfer therapy for Duchenne, with enrollment in the Phase I/II **IGNITE DMD** trial complete and two-year data suggesting **durable benefit**[90](index=90&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) - In **April 2022**, the company announced a **strategic shift** to a commercially scaled, transient transfection-based manufacturing process for **SGT-001** and narrowed its R&D focus to **SGT-001**, **SGT-003**, and next-generation capsids[92](index=92&type=chunk) - As part of the **April 2022** reorganization, the company reduced its headcount by approximately **35%**, expected to extend the cash runway into the **second quarter of 2024**, based on **$180.1 million** in cash, cash equivalents, and available-for-sale securities as of March 31, 2022[93](index=93&type=chunk)[102](index=102&type=chunk) Comparison of Operating Results (in thousands) | Line Item | Q1 2022 | Q1 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $1,925 | $3,335 | ($1,410) | (42%) | | R&D Expenses | $19,945 | $14,206 | $5,739 | 40% | | G&A Expenses | $7,352 | $6,015 | $1,337 | 22% | | **Net Loss** | **($25,328)** | **($16,900)** | **($8,428)** | **50%** | Research & Development Expenses Breakdown (in thousands) | Program | Q1 2022 | Q1 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | SGT-001 | $5,422 | $6,173 | ($751) | (12)% | | SGT-003 and other programs | $3,364 | $192 | $3,172 | 1652% | | Unallocated R&D | $11,159 | $7,841 | $3,318 | 42% | | **Total R&D Expenses** | **$19,945** | **$14,206** | **$5,739** | **40%** | [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risk from interest rate changes on short-term investments, with a 10% change not materially impacting financial position - The company's primary market risk exposure is **interest income sensitivity** related to its cash equivalents and available-for-sale securities[145](index=145&type=chunk) - Due to the short-term nature of its investment portfolio, a **10%** change in interest rates is **not expected to materially impact** the company's financial condition[145](index=145&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2022, with no material changes to internal control over financial reporting - As of March 31, 2022, the President and Chief Executive Officer and the interim Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level**[146](index=146&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the first quarter of 2022[147](index=147&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not a party to any material legal proceedings - As of the filing date, the company states there are **no material legal proceedings**[150](index=150&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, developmental, manufacturing, commercial, and IP risks, including a history of losses and novel gene therapies - **Financial Risks:** The company has a history of significant net losses (**$25.3M** in Q1 2022) and an accumulated deficit of **$502.1M**, and will **require additional funding** to continue operations beyond its current cash runway[154](index=154&type=chunk)[158](index=158&type=chunk) - **Clinical Development Risks:** SGT-001 and SGT-003 are based on **novel gene transfer technology**, making development time and cost difficult to predict, and the IGNITE DMD trial was previously placed on **clinical hold** by the FDA[153](index=153&type=chunk)[172](index=172&type=chunk)[175](index=175&type=chunk) - **Manufacturing & Commercialization Risks:** The company has **limited gene transfer manufacturing experience** and **relies on third parties**, posing risks of performance, regulatory compliance, and **supply disruption**, with a planned shift to a new manufacturing process for SGT-001 potentially requiring additional studies[155](index=155&type=chunk)[249](index=249&type=chunk)[256](index=256&type=chunk) - **Intellectual Property Risks:** The business **heavily relies on in-licensed patents**, which the company may **not control the prosecution and enforcement** of, and they could be **challenged, invalidated, or circumvented** by competitors[155](index=155&type=chunk)[328](index=328&type=chunk)[334](index=334&type=chunk) - **Competition Risk:** The company faces **significant competition** from **larger, better-funded companies** like Pfizer and Sarepta Therapeutics, which have Duchenne gene therapy candidates in **later stages of clinical development (Phase III)**[235](index=235&type=chunk)[236](index=236&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On January 3, 2022, the company issued an inducement grant of 131,400 stock options and 65,700 restricted stock units - On **January 3, 2022**, the company granted a new employee an option for **131,400 shares** and **65,700 restricted stock units** as an **inducement award** under Nasdaq Listing Rule 5635(c)(4)[403](index=403&type=chunk) [Other Information](index=88&type=section&id=Item%205.%20Other%20Information) On April 25, 2022, the Board approved a restructuring plan with a 35% workforce reduction, costing $1.7 million, to extend cash runway into Q2 2024 - On **April 25, 2022**, the Board approved a restructuring plan to reduce the workforce by approximately **35%** to prioritize key programs and extend the cash runway into **Q2 2024**[405](index=405&type=chunk)[406](index=406&type=chunk) - The company estimates total restructuring costs of approximately **$1.7 million**, primarily for severance and employee termination benefits, to be paid mostly during 2022[407](index=407&type=chunk) - A **retention program** was approved for remaining key employees, including cash bonuses and stock option grants for the Chief Legal Officer and Chief Scientific Officer[408](index=408&type=chunk) [Exhibits](index=89&type=section&id=Item%206.%20Exhibits) The section lists exhibits filed with Form 10-Q, including CEO/CFO certifications and Inline XBRL documents for financial reporting - The filing includes **CEO and CFO certifications** pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[410](index=410&type=chunk) - **Inline XBRL** Instance, Schema, and other related taxonomy documents are included as exhibits for interactive data[410](index=410&type=chunk) [Signatures](index=90&type=section&id=Signatures) The report was signed on April 27, 2022, by Ilan Ganot (CEO) and Stephen DiPalma (Interim CFO) - The report was signed on **April 27, 2022**, by **Ilan Ganot (CEO)** and **Stephen DiPalma (Interim CFO)**[413](index=413&type=chunk)

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, 2021 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 jurisdiction of incorporation or ...