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Solid Biosciences(SLDB) - 2021 Q3 - Quarterly Report
2021-11-03 10:56
[PART I. FINANCIAL INFORMATION](index=2&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited financial statements reflecting increased equity from a public offering and new collaboration revenue [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a substantial increase in total assets and stockholders' equity, driven by a public offering Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $109,676 | $154,744 | | Available-for-sale securities | $120,084 | $— | | **Total current assets** | **$238,810** | **$158,901** | | **Total assets** | **$248,986** | **$171,169** | | **Liabilities & Equity** | | | | Total current liabilities | $22,542 | $24,480 | | **Total liabilities** | **$25,623** | **$39,083** | | **Total stockholders' equity** | **$223,363** | **$132,086** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Operations show new collaboration revenue and reduced R&D expenses, resulting in a lower net loss compared to the prior year Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | 9 Months 2021 | 9 Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $3,537 | $— | $10,466 | $— | | Research and development | $14,425 | $16,045 | $44,144 | $49,158 | | General and administrative | $7,143 | $5,181 | $19,924 | $15,957 | | Loss from operations | $(18,031) | $(21,226) | $(53,602) | $(67,059) | | **Net loss** | **$(17,983)** | **$(21,246)** | **$(53,578)** | **$(66,927)** | | Net loss per share | $(0.16) | $(0.44) | $(0.51) | $(1.39) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows indicate significant financing from a stock issuance, offset by cash used for investments and operations Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(56,890) | $(57,906) | | Net cash (used in) provided by investing activities | $(121,262) | $6,660 | | Net cash provided by financing activities | $134,919 | $— | | **Net decrease in cash, cash equivalents and restricted cash** | **$(43,233)** | **$(51,246)** | [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the IGNITE DMD trial status, the Ultragenyx collaboration, and the company's sufficient liquidity for the next twelve months - The company's lead product candidate, SGT-001, is in a Phase I/II clinical trial (IGNITE DMD) which was previously on clinical hold by the FDA and resumed patient treatment in February 2021[25](index=25&type=chunk) - The company believes its cash, cash equivalents, and available-for-sale securities of **$229.8 million** as of September 30, 2021, are sufficient to fund operations for at least twelve months[30](index=30&type=chunk) - The collaboration with Ultragenyx resulted in recognizing **$10.5 million** of related party collaboration revenue for the nine months ended September 30, 2021[61](index=61&type=chunk) - In March 2021, the company completed a public offering of 25,000,000 shares of common stock, receiving net proceeds of approximately **$134.9 million**[76](index=76&type=chunk)[109](index=109&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical progress of SGT-001, financial performance improvements, and a cash runway into Q2 2023 [Overview](index=20&type=section&id=MD%26A%20Overview) The company focuses on its SGT-001 trial for Duchenne, manages a recent adverse event, and advances its next-gen SGT-003 candidate - The eighth patient in the IGNITE DMD trial experienced a **serious adverse event**, which has since fully resolved, and a strengthened risk mitigation plan has been submitted to the FDA[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - Long-term biopsy data from patients 4-6 demonstrated **durable and widespread expression of microdystrophin protein** at 1 to 2 years post-dosing[95](index=95&type=chunk) - The company is advancing a next-generation program, SGT-003, and is targeting an **IND submission in early 2023**[99](index=99&type=chunk) - As of September 30, 2021, the company had cash, cash equivalents, and available-for-sale securities of **$229.8 million**, expected to fund operations into the second quarter of 2023[110](index=110&type=chunk) [Results of Operations](index=27&type=section&id=MD%26A%20Results%20of%20Operations) Financial results improved due to new collaboration revenue and lower R&D costs, despite an increase in G&A expenses Comparison of Results (in thousands) | Metric | 9 Months 2021 | 9 Months 2020 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $10,466 | $— | $10,466 | | Research & Development | $44,144 | $49,158 | $(5,014) | | General & Administrative | $19,924 | $15,957 | $3,967 | | **Net Loss** | **$(53,578)** | **$(66,927)** | **$13,349** | - The **$5.0 million decrease in R&D expenses** was primarily due to a $6.4 million decrease in SGT-001 manufacturing costs, partially offset by higher personnel expenses[137](index=137&type=chunk) - The **$3.9 million increase in G&A expenses** was due to a $2.2 million increase in corporate expenses and a $1.7 million increase in personnel-related expenses[138](index=138&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=MD%26A%20Liquidity%20and%20Capital%20Resources) The company's liquidity is strong following recent equity financing, providing a cash runway into the second quarter of 2023 - The company raised net proceeds of approximately **$134.9 million** from a public offering in March 2021[147](index=147&type=chunk) - As of September 30, 2021, the company had cash, cash equivalents and available-for-sale securities of **$229.8 million** and no debt outstanding[148](index=148&type=chunk) - The company expects its current cash position will be sufficient to fund operations into the **second quarter of 2023**, but will need to raise additional funds to operate beyond that time[155](index=155&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk from interest rate changes on its short-term investments is considered immaterial - The company's primary market risk is **interest rate sensitivity** on its cash equivalents and available-for-sale securities[165](index=165&type=chunk) - Due to the short-term nature of its investment portfolio, the company does not expect a 10% change in interest rates to have a **material impact** on its financial position[165](index=165&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - Management concluded that as of September 30, 2021, the company's disclosure controls and procedures were **effective at the reasonable assurance level**[166](index=166&type=chunk) - **No material changes** in internal control over financial reporting occurred during the three months ended September 30, 2021[167](index=167&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of September 30, 2021, the company is **not aware of any material legal proceedings**[82](index=82&type=chunk)[170](index=170&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of net losses, clinical development challenges, manufacturing reliance, and intellectual property dependencies - Financial risks include a history of significant net losses (**$458.1M accumulated deficit**) and the need for additional funding beyond Q2 2023[174](index=174&type=chunk)[177](index=177&type=chunk)[179](index=179&type=chunk) - **Clinical development risks are high**, highlighted by the previous FDA clinical hold on the IGNITE DMD trial for SGT-001 due to a serious adverse event[192](index=192&type=chunk) - The company has limited manufacturing experience and **relies on third parties**, facing risks of production problems, delays, and regulatory compliance issues[266](index=266&type=chunk) - The business is **heavily dependent on intellectual property licensed from universities**, which imposes diligence obligations and may be subject to government 'march-in' rights[347](index=347&type=chunk)[385](index=385&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) The company issued unregistered stock options as inducement awards to two new employees during the third quarter of 2021 - On July 1, 2021, granted an option to purchase **235,000 shares** at an exercise price of $3.77 per share to a new employee[424](index=424&type=chunk) - On August 16, 2021, granted an option to purchase **118,000 shares** at an exercise price of $2.51 per share to a new employee[425](index=425&type=chunk) [Exhibits](index=89&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including stock plans, agreements, and officer certifications [Signatures](index=90&type=section&id=Signatures) The report is formally signed and authorized by the company's CEO and interim CFO
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
Financial Data and Key Metrics Changes - In Q1 2021, the company closed a public offering resulting in gross proceeds of approximately $143.8 million before deductions, strengthening its balance sheet [33] - The company ended the quarter with $268.5 million in cash and cash equivalents, which is expected to fund operating expenses into Q4 2022 [34] Business Line Data and Key Metrics Changes - Two patients were dosed in the IGNITE DMD trial this quarter using SGT-001 produced with an improved manufacturing process [7] - Patient 8 experienced a serious adverse event (SAE) but has since been discharged, with lab values trending towards normal [7][13] Market Data and Key Metrics Changes - The company is advancing its preclinical pipeline with the nomination of SGT-003 as the next development candidate, which combines a novel capsid and proprietary microdystrophin construct [9][30] Company Strategy and Development Direction - The company is focused on expanding its pipeline with differentiated gene therapies, including SGT-003, which aims to enhance delivery to muscle cells [10][30] - Collaboration with Ultragenyx is ongoing to optimize candidate vectors for additional Duchenne gene therapies [31][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of SGT-001 based on encouraging long-term biopsy data and clinical biomarker trends [26][37] - The company remains committed to the Duchenne community and aims to advance therapies that improve patient lives [38] Other Important Information - The company is working closely with its Data Safety Monitoring Board (DSMB) to evaluate data and ensure patient safety before continuing dosing in the IGNITE DMD trial [12][14] Q&A Session Summary Question: Long-term expression data and its correlation with clinical benefits - Management acknowledged the correlation observed but emphasized the need for more data to establish specific relationships [42][44] Question: Dosing path for additional patients and details on SAE - Management confirmed that the SAE was an inflammatory response and that they are working with the DSMB to evaluate the situation before proceeding with further dosing [47][48] Question: Additional information on Patient 8's inflammatory response - Management indicated that they are still evaluating the specifics of Patient 8's response and have seen laboratory evidence of complement activation in all treated patients [51][53] Question: Timeline for additional functional data from Patients 7 and 8 - Management stated that functional data from Patient 7 will take time to analyze due to the influence of steroids and has not provided a specific timeline [63] Question: Factors influencing long-term data variability among patients - Management noted that variability is expected in biological assays and that they are investigating potential mechanisms behind the differences observed [65][66] Question: Potential changes to the protocol to reduce inflammatory events - Management is exploring various options for protocol modifications to enhance patient safety, but no specific changes have been determined yet [75] Question: Sharing of SAE details with FDA and DSMB - Management confirmed that they have shared details of the SAE with both the FDA and DSMB and are in ongoing discussions [77]
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 ...
Solid Biosciences (SLDB) Investor Presentation - Slideshow
2021-03-26 16:54
SGT-001 Interim Clinical Results From IGNITE-DMD Ilan Ganot, Co-founder, President, and CEO March 15, 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 ...
Solid Biosciences(SLDB) - 2020 Q4 - Annual Report
2021-03-15 20:11
FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the fiscal year ended December 31, 2020 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 ...
Solid Biosciences(SLDB) - 2020 Q3 - Earnings Call Transcript
2020-11-08 07:16
Solid Biosciences Inc (NASDAQ:SLDB) Q3 2020 Earnings Conference Call November 5, 2020 8:30 PM ET Company Participants Jennifer Ziolkowski – Chief Financial Officer Ilan Ganot – Co-Founder, President and Chief Executive Officer Joel Schneider – Chief Technology Officer Cathryn Clary – Acting Chief Medical Officer Conference Call Participants Mark Connolly – Credit Suisse Joseph Schwartz – SVB Leerink Operator Ladies and gentlemen, thank you for standing by and welcome to the Solid Biosciences Update Call. At ...
Solid Biosciences(SLDB) - 2020 Q3 - Quarterly Report
2020-11-05 12:35
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, 2020 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 juris ...
Solid Biosciences(SLDB) - 2020 Q2 - Quarterly Report
2020-08-06 10:36
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, 2020 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 jurisdicti ...