SLDB

8-K

false 0001707502 0001707502 2025-11-03 2025-11-03

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 3, 2025

Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter)

Delaware

001-38360

90-0943402

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

500 Rutherford Avenue, Third Floor Charlestown, Massachusetts 02129 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (617) 337-4680

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock $0.001 par value per share

SLDB

The Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On November 3, 2025, Solid Biosciences Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2025. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information provided under Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 7.01. Regulation FD Disclosure.

On November 3, 2025, the Company announced positive new interim data from its Phase 1/2 INSPIRE DUCHENNE clinical trial. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Also on November 3, 2025, the Company made available an updated corporate presentation on its website. The corporate presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The information provided under Item 7.01 of this Current Report on Form 8-K (including Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On November 3, 2025, the Company announced positive new interim data from its Phase 1/2 INSPIRE DUCHENNE clinical trial, a Phase 1/2 first-in-human, open-label, single-dose, multicenter trial designed to evaluate the safety, tolerability and efficacy of SGT-003 in pediatric participants with Duchenne muscular dystrophy at a dose level of 1E14vg/kg. SGT-003 is administered as a one-time intravenous infusion, and a regulatory update.

INSPIRE DUCHENNE

Interim Clinical Data Update The interim clinical data is reported as of a September 29, 2025 data cutoff date, with additional safety data reported as of October 31, 2025. As of October 31, 2025, 23 participants have been dosed in the trial. Enrollment in INSPIRE DUCHENNE is ongoing at 15 clinical trial sites across the United States, Canada, Italy and the United Kingdom. The Company expects to dose a total of 30 participants by early 2026. Statistical correlations, as measured by the Pearson correlation coefficient, were observed between Day 90 SGT-003

8-K

false 0001707502 0001707502 2025-02-18 2025-02-18

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 18, 2025

Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter)

Delaware

001-38360

90-0943402

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

500 Rutherford Avenue, Third Floor

Charlestown, Massachusetts 02129

(Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (617) 337-4680 (Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock $0.001 par value per share

SLDB

The Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

The information disclosed under the heading “Cash, Cash Equivalents and Available-for-Sale Securities as of December 31, 2024” under Item 8.01 of this Current Report on Form 8-K is herein incorporated by reference.

Item 8.01 Other Events.

Initial Clinical Data from INSPIRE DUCHENNE Trial of SGT-003

On February 18, 2025, Solid Biosciences Inc. (the “Company”) announced positive initial data from the Phase 1/2 INSPIRE DUCHENNE trial evaluating SGT-003, a next-generation gene therapy product candidate intended for the treatment of Duchenne muscular dystrophy (“Duchenne”). The INSPIRE DUCHENNE trial is a Phase 1/2 first-in-human, open-label, single-dose, multicenter trial designed to evaluate the safety, tolerability and efficacy of SGT-003 in pediatric patients with Duchenne at a dose of 1E14vg/kg. SGT-003 is administered as a one-time intravenous infusion. Interim 90-day biopsy data reported in the first three participants showed an average microdystrophin expression of 110%, as measured by western blot, and improvements in multiple biomarkers that are indicators of muscle health and resilience. The 90-day data reported of the data cutoff date of February 11, 2025 includes: microdystrophin expression, measures of restoration and activation of key elements of the dystrophin-associated protein complex, key muscle integrity biomarker evaluation, in each case, from the first three participants dosed in the INSPIRE DUCHENNE trial, and interim safety findings from the first six participants dosed in the INSPIRE DUCHENNE trial. The first three participants are two 5-year-old boys and one 7-year-old boy at the time of dosing. The second three participants are a 6-year-old boy and two 7-year-old boys at the time of dosing. Microdystrophin Expression and Other Measures at Day 90 (N=3)

Mean (N=3)

Participant 1

Participant 2

Participant 3

Microdystrophin Expression % Normal (Western Blot)

110 %

135 %

112 %

84 %

Microdystrophin Expression % Normal (Mass Spectrometry)

108 %

119 %

152 %

53 %

% Dystrophin Positive Fibers (Immunofluorescence)

78 %

77 %

88 %

70 %

Vector Copies/Nucleus

18.7

19.8

28.6

7.6

nNOS (neuronal nitric oxide synthase) % Positive Fibers

42 %

48 %

53 %

25 %

Beta Sarcoglycan % Positive Fibers

70 %

60 %

88 %

63 %

Muscle Integrity Biomarker Evaluation at Day 90 (N=3)

•

Mean reductions observed in markers of muscle injury and stress:

•

Serum creatine kinase (CK) (IU/L): -57%

•

Serum aspartate aminotransferase (AST) (IU/L): -45%

•

Serum alanine transaminase (ALT) (IU/L): -54%

•

Serum lactate dehydrogenase (LDH) (IU/L): -60%

•

Mean reductions observed in markers of muscle breakdown and dystrophic regeneration:

•

Serum titin (pmol/L): -42%

•

Embryonic myosin heavy chain (eMHC) positive fibers: -59%

Measure of Potential Cardiac B

8-K

false 0001707502 0001707502 2024-01-08 2024-01-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 8, 2024

Solid Biosciences Inc. (Exact Name of Registrant as Specified in its Charter)

Delaware

001-38360

90-0943402

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

500 Rutherford Avenue, Third Floor Charlestown, Massachusetts 02129 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (617) 337-4680

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock $0.001 par value per share

SLDB

The Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company  ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 1.01 Entry into a Material Definitive Agreement.

Securities Purchase Agreement On January 8, 2024, Solid Biosciences Inc., a Delaware corporation (the “Company”), entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company agreed to issue and sell to the Investors in a private placement an aggregate of 16,973,103 shares of the Company’s common stock, par value $0.001 per share (the “Shares”), at a price of $5.53 per share, and, to one Investor in lieu of Shares, pre-funded warrants to purchase 2,712,478 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a price of $5.529 per Pre-Funded Warrant (the “Private Placement”). The Private Placement is expected to close on or about January 11, 2024, subject to the satisfaction of certain customary closing conditions. The Company expects to receive aggregate gross proceeds from the Private Placement of approximately $108.9 million, before deducting placement agent fees and offering expenses, and aggregate net proceeds from the Private Placement of approximately $104.1 million, after deducting placement agent fees. Citigroup Global Markets Inc. and Cantor Fitzgerald & Co. acted as joint lead placement agents for the Private Placement. The Company has granted the Investors indemnification rights with respect to its representations, warranties, covenants and agreements under the Securities Purchase Agreement. The Private Placement includes new and existing investors, including Perceptive Advisors, Adage Capital Partners LP, Deerfield Management Company, Invus, Janus Henderson Investors, Vestal Point Capital, LP, Bain Capital Life Sciences, RA Capital Management and an undisclosed life sciences investor, among others. Pre-Funded Warrants Each Pre-Funded Warrant to be issued in the Private Placement will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until the Pre-Funded Warrant is exercised in full. Under the terms of the Pre-Funded Warrants, the Company may not effect the exercise of any such warrant, and a holder will not be entitled to exercise any portion of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) would exceed 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determ