Full Press Release Details
Solid Biosciences Reports Fourth Quarter and Fiscal Year 2018 Financial Results and Provides Business Update
Activities underway to commence dosing of second cohort of patients in the IGNITE DMD clinical trial at 2E14 vg/kg of SGT-001
Cambridge, MA March 13, 2019 - Solid Biosciences Inc. (NASDAQ: SLDB)
today reported financial results for the fourth quarter and fiscal year ended December 31, 2018 and provided a business update.
year as a public company, we have significantly advanced our innovative science for Duchenne muscular dystrophy, made meaningful progress towards commercial scale manufacturing and continued to add talent and capabilities to our team to prepare to
bring differentiated therapies to patients, said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. We are especially pleased to have received rapid approval to
begin evaluating a higher dose of our investigational microdystrophin gene therapy, SGT-001, in the IGNITE DMD clinical trial. We look forward to continuing to understand its full potential in the clinic and
to providing additional data from the study later this year.
We are encouraged to continue advancing
SGT-001 in the clinic, said Jorge Quiroz, M.D., Chief Medical Officer of Solid Biosciences. Based on our preclinical data, we expect that increased doses of
SGT-001 will achieve higher microdystrophin expression and, with agreement from the study s Data Safety Monitoring Board and the University of Florida Institutional Review Board, we have initiated the
appropriate activities to dose escalate.
Financial Highlights
Research and development expenses
for the fourth quarter of 2018 were $17.8 million, compared to $11.9 million for the prior year period. Research and development expenses for the year ended December 31, 2018 were $58.0 million, compared to $39.9 million for
the year ended December 31, 2017. The increases were primarily attributed to an increase in research and development personnel and related facility costs increased manufacturing costs and an increase in clinical development costs for SGT-001. These increases were offset by a reduction in preclinical costs associated with SGT-001.
General and administrative expenses for the fourth quarter of 2018 were $4.6 million, compared to
$3.2 million for the prior year period. General and administrative expenses for the year ended December 31, 2018 were $17.7 million, compared to $15.0 million for the year ended December 31, 2017. The increases were
primarily attributed to increased personnel and related facility costs, as well as other corporate expenses associated with being a public company.
loss for the fourth quarter of 2018 was $21.9 million, compared to $14.5 million for the fourth quarter of 2017. Net loss for the year ended December 31, 2018 was $74.8 million, compared to $53.2 million for the year ended
Solid had $122.5 million in cash, cash equivalents and
available-for-sale securities as of December 31, 2018, compared to $69.1 million as of December 31, 2017. The increase was primarily the result of the
completion of the Company s initial public offering on January 30, 2018.
Management is scheduled to present at the Alliance of Regenerative Medicine (ARM) Cell & Gene Therapy Investor Day on Thursday, March 21, 2019 at
9:25 am ET in New York City.
A live video webcast will be available at http://arminvestorday.com/webcast/ and will also be published there shortly
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, and the potential 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.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Year Ended December 31, | ||||||||||||
| 2018 | 2017 | 2016 | ||||||||||
| Revenue | $ | $ | $ | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | 57,965 | 39,905 | 20,116 | |||||||||
| General and administrative | 17,722 | 14,952 | 5,460 | |||||||||
| Total operating expenses | 75,687 | 54,857 | 25,576 | |||||||||
| Loss from operations | (75,687 | ) | (54,857 | ) | (25,576 | ) | ||||||
| Other income (expense): | ||||||||||||
| Revaluation of preferred unit tranche rights | 459 | 1,163 | ||||||||||
| Interest income | 619 | 219 | 369 | |||||||||
| Other income | 270 | 1,001 | 271 | |||||||||
| Total other income (expense), net | 889 | 1,679 | 1,803 | |||||||||
| Net loss | $ | (74,798 | ) | $ | (53,178 | ) | $ | (23,773 | ) | |||
| Net loss attributable to non-controlling interest | (1,060 | ) | (2,234 | ) | ||||||||
| Net loss attributable to Solid Biosciences Inc. | $ | (74,798 | ) | $ | (52,118 | ) | $ | (21,539 | ) | |||
| Decretion (accretion) of preferred units to redemption value | (959 | ) | 4,309 | |||||||||
| Redemption of preferred units | 15,685 | |||||||||||
| Redemption of redeemable interest from non-controlling interest in Solid GT | (1,925 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (74,798 | ) | $ | (39,317 | ) | $ | (17,230 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.25 | ) | $ | (2.88 | ) | $ | (10.14 | ) | |||
| Weighted average shares of common stock outstanding, basic and diluted | 33,262,597 | 13,649,485 | 1,698,904 |
Solid Biosciences Inc.
Consolidated Balance Sheets
(unaudited, in thousands, except share and per share data)
| December 31, | ||||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 86,366 | $ | 52,080 | ||||
| Available-for-sale securities | 36,098 | 17,014 | ||||||
| Prepaid expenses and other current assets | 6,175 | 1,499 | ||||||
| Restricted cash | 65 | |||||||
| Total current assets | 128,639 | 70,658 | ||||||
| Property and equipment, net | 10,422 | 2,429 | ||||||
| Other non-current assets | 209 | |||||||
| Restricted cash | 327 | |||||||
| Deferred offering costs | 3,106 | |||||||
| Total assets | $ | 139,597 | $ | 76,193 | ||||
| Liabilities, Preferred Units and Stockholders / Members Equity / (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,691 | $ | 5,066 | ||||
| Accrued expenses | 8,235 | 5,972 | ||||||
| Current portion of capital lease obligations | 173 | |||||||
| Other current liabilities | 382 | 233 | ||||||
| Total current liabilities | 12,481 | 11,271 | ||||||
| Capital lease obligations, net of current portion | 859 | |||||||
| Other non-current liabilities | 1,074 | |||||||
| Total liabilities | 14,414 | 11,271 | ||||||
| Series 2 Senior Preferred Units | 55,002 | |||||||
| Series 1 Senior Preferred Units | 25,000 | |||||||
| Junior Preferred Units | 44,177 | |||||||
| Stockholders / Members Equity / (Deficit) | ||||||||
| Series A, B, C and D Common Units | 65,014 | |||||||
| Common Stock | 35 | |||||||
| Additional paid-in capital | 324,209 | |||||||
| Accumulated other comprehensive loss | (5 | ) | (13 | ) | ||||
| Accumulated deficit | (199,056 | ) | (124,258 | ) | ||||
| Total stockholders / members equity (deficit) | 125,183 | (59,257 | ) | |||||
| Total liabilities, preferred units and stockholders / members equity | $ | 139,597 | $ | 76,193 |
Geoffrey M. Grande, CFA