Solid Biosciences(SLDB)

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Solid Biosciences (SLDB) Investor Presentation - Slideshow
2022-10-06 17:12
© 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 ...
Solid Biosciences(SLDB) - 2022 Q2 - Quarterly Report
2022-08-11 11:30
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(SLDB) - 2022 Q1 - Earnings Call Transcript
2022-04-30 21:25
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 ...
Solid Biosciences(SLDB) - 2022 Q1 - Quarterly Report
2022-04-27 11:25
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)
Solid Biosciences(SLDB) - 2021 Q4 - Annual Report
2022-03-14 12:06
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 ...
Solid Biosciences(SLDB) - 2021 Q3 - Quarterly Report
2021-11-03 10:56
☐ 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 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, 2021 OR Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 90-0943402 (State or other juris ...
Solid Biosciences Investor Presentation - Slideshow
2021-10-08 22:20
© 2021 Solid Biosciences1 Solid Biosciences Corporate OverviewOctober 2021 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's IGNITE DMD clinical trial, ability of the Company to continue dosing patients in the IGNITE DMD trial, the implication of interim clinical data, the safety or potential treatment benefits of SGT-001 in patients with Duchenne, the Com ...
Solid Biosciences(SLDB) - 2021 Q2 - Quarterly Report
2021-08-16 20:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 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) WASHINGTON, DC 20549 Delaware 90-0943402 (State or other jurisdicti ...
Solid Biosciences(SLDB) - 2021 Q1 - Earnings Call Transcript
2021-05-14 18:52
Solid Biosciences Inc. (NASDAQ:SLDB) Q1 2021 Earnings Conference Call May 14, 2021 8:30 AM ET Company Participants Tim Palmer – Manager-Corporate Communications Ilan Ganot – Co-Founder, President and Chief Executive Officer Cathryn Clary – Acting Chief Medical Officer Carl Morris – Chief Scientific Officer Joel Schneider – Chief Operating Officer Conference Call Participants Joseph Schwartz – SVB Leerink Gena Wang – Barclays Salveen Richter – Goldman Sachs Gbola Amusa – Chardan Maneka Mirchandaney – Everco ...
Solid Biosciences(SLDB) - 2021 Q1 - Quarterly Report
2021-05-14 11:43
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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-38360 Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 90-0943402 (State or other jurisdict ...