Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): May 13, 2019



Solid Biosciences Inc.

(Exact Name of Registrant as Specified in Charter)




Delaware   001-38360   90-0943402

(State or Other Jurisdiction

of Incorporation)



File Number)


(IRS Employer

Identification No.)

141 Portland Street, Fifth Floor

Cambridge, MA 02139

(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))

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.  ☒

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


Title of each class





Name of exchange

on which registered

Common Stock $0.001 par value per share   SLDB   The Nasdaq Global Select Market




Item 2.02.

Results of Operations and Financial Condition.

On May 13, 2019, Solid Biosciences Inc. announced its financial results for the first quarter ended March 31, 2019. 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits:


99.1    Press Release of Solid Biosciences Inc., dated May 13, 2019


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: May 13, 2019     By:  

/s/ Jennifer Ziolkowski

      Name: Jennifer Ziolkowski
      Title: Chief Financial Officer



Exhibit 99.1

Solid Biosciences Reports First Quarter 2019 Financial Results and Provides Business Update

– Dosing of SGT-001 initiated in second cohort of patients in the IGNITE DMD clinical trial at 2E14 vg/kg –

– Clinical activities underway at additional study sites–

Cambridge, MA – May 13, 2019 – Solid Biosciences Inc. (Nasdaq: SLDB) today reported financial results for the first quarter ended March 31, 2019 and provided a business update.

“We have continued to advance our programs for Duchenne muscular dystrophy over the last few months, particularly our lead microdystrophin gene therapy candidate, SGT-001. Building on our findings from the preliminary Phase I/II clinical data that we announced in February, we initiated dosing at 2E14 vg/kg in the second cohort of patients,” said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. “Now, we are working to progress as quickly as possible, and we look forward to providing additional data later this year.”

Recent Developments



Today, Solid announced that two patients have been randomized in the second cohort of the Phase I/II IGNITE DMD study, including one patient dosed with 2E14 vg/kg of SGT-001 and another added to the control group. Shortly after dosing, the patient in the treatment group was diagnosed with a gastrointestinal infection that was classified as a serious adverse event unrelated to study drug, as well as a transient decline in platelet count that was considered a non-serious adverse event related to study drug; these events have fully resolved. In addition, the patient experienced a transient elevation of transaminases, as well as a transient increase in bilirubin higher than two times the upper limit of normal, which was rapidly resolved with an increase in oral glucocorticoids. This was reported to the FDA as a serious adverse event related to study drug. The patient is doing well and has resumed normal activities. Solid continues to enroll patients in IGNITE DMD per the study protocol and anticipates providing additional data later this year.



Solid recently initiated clinical trial activities for IGNITE DMD at additional sites, including the University of Massachusetts Memorial Medical Center. Screening continues at the University of Florida, the first clinical site for the study.


In late April, the Company presented additional preclinical data for SGT-001 at the 22nd Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT), which reinforce its potential to promote unique microdystrophin expression and rescue muscle function. Solid also presented new preclinical data at the meeting supporting its next generation gene therapy programs.

Financial Highlights

Research and development expenses for the first quarter of 2019 were $23.3 million, compared to $11.9 million for the prior year period. The increase was primarily attributable to research and development personnel and related facility costs, manufacturing costs, and clinical development costs for SGT-001.

General and administrative expenses for the first quarter of 2019 were $7.0 million, compared to $4.0 million for the prior year period. The increase was primarily attributable to increased personnel costs and other corporate expenses associated with being a public company.

Net loss for the first quarter of 2019 was $29.6 million, compared to $15.9 million for the first quarter of 2018.

Solid had $94.7 million in cash, cash equivalents and available-for-sale securities as of March 31, 2019, compared to $122.5 million as of December 31, 2018.

About SGT-001

Solid’s lead candidate, SGT-001, is a novel adeno-associated viral (AAV) vector-mediated gene transfer under investigation for its ability to address the underlying genetic cause of Duchenne muscular dystrophy (DMD), mutations in the dystrophin gene that result in the absence or near-absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin transgene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including neuronal nitric oxide synthase (nNOS). SGT-001 utilizes AAV9, which has an affinity for muscle and is currently being evaluated in multiple clinical programs in other indications. Data from Solid’s preclinical program suggest that SGT-001 has the potential to slow or stop the progression of DMD, regardless of genetic mutation or disease stage.

SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, and Fast Track Designation in the United States and Orphan Drug Designations in both the United States and European Union.

About Solid Biosciences

Solid Biosciences is a life science company focused solely on finding meaningful therapies for Duchenne muscular dystrophy (DMD). Founded by those touched by the disease, Solid is a center of excellence for DMD, bringing together experts in science, technology and care to drive forward a portfolio of candidates that have life-changing potential. Solid is progressing programs across four scientific platforms: Corrective Therapies, Disease-Modifying Therapies, Disease Understanding and Assistive Devices. For more information, please visit www.solidbio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our expectations regarding the IGNITE DMD clinical trial, the safety or potential efficacy of SGT-001, the sufficiency of our cash, cash equivalents and investments to fund our operation and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Solid’s ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities and investigational review boards at clinical trial sites; enroll patients in its clinical trials; continue to advance SGT-001 in clinical trials, including to proceed with dose escalation of IGNITE DMD; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop DMD treatments and gene therapies; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the

Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Solid Biosciences Inc.

Condensed Consolidated Statements of Operations

(unaudited, in thousands, except share and per share data)


     Three Months Ended March 31,  
     2019     2018  


   $ —       $ —    

Operating expenses:


Research and development

     23,269       11,929  

General and administrative

     7,033       4,044  







Total operating expenses

     30,302       15,973  







Loss from operations

     (30,302     (15,973







Other income (expense):


Interest income

     508       65  

Other income

     212       31  







Total other income (expense), net

     720       96  







Net loss

   $ (29,582   $ (15,877







Net loss per share attributable to common stockholders, basic and diluted

   $ (0.85   $ (0.54







Weighted average shares of common stock outstanding, basic and diluted

     34,776,488       29,354,650  







Solid Biosciences Inc.

Condensed Consolidated Balance Sheets

(unaudited, in thousands, except share and per share data)


     March 31,
    December 31,



Current assets:


Cash and cash equivalents

   $ 53,994     $ 86,366  

Available-for-sale securities

     40,750       36,098  

Prepaid expenses and other current assets

     7,043       6,175  







Total current assets

     101,787       128,639  

Property and equipment, net

     11,995       10,422  

Operating lease, right-of-use assets

     5,916       —    

Other non-current assets

     209       209  

Restricted cash

     327       327  







Total assets

   $ 120,234     $ 139,597  







Liabilities and Stockholders’ Equity


Current liabilities:


Accounts payable

   $ 5,352     $ 3,691  

Accrued expenses

     7,409       8,235  

Operating lease liabilities

     1,278       —    

Finance lease liabilities

     178       173  

Other current liabilities

     355       382  







Total current liabilities

     14,572       12,481  







Operating lease liabilities, excluding current portion

     5,736       —    

Finance lease obligations, excluding current portion

     813       859  

Other non-current liabilities

     —         1,074  







Total liabilities

     21,121       14,414  







Common Stock

     35       35  

Additional paid-in capital

     327,709       324,209  

Accumulated other comprehensive gain (loss)

     7       (5

Accumulated deficit

     (228,638     (199,056







Total stockholders’ equity

     99,113       125,183  







Total liabilities and stockholders’ equity

   $ 120,234     $ 139,597  









Media Contact:

Kate Niazi-Sai

+1 617-337-4680


Investor Contact:

Geoffrey M. Grande, CFA

+1 617-766-3398