Full Press Release Details
Solid Biosciences Reports First Quarter 2018 Financial Results and Provides Business Update
- Company Finalizing Response to FDA Regarding Clinical Hold
on SGT-001 Phase I/II Clinical Trial -
Cambridge, MA - May 10, 2018 - Solid Biosciences Inc. (NASDAQ:SLDB) today reported financial results for the first quarter ended March 31, 2018
and provided a business update.
The first quarter of 2018 marked Solid s entry into public markets with the completion of our initial public
offering, which we believe helps position us to achieve our mission to provide meaningful new therapies to patients with Duchenne muscular dystrophy, said Ilan Ganot, Chief Executive Officer of Solid Biosciences. We are pleased with the
resolution of the manufacturing-related partial clinical hold on the high dose of our lead gene transfer candidate, SGT-001, in our Phase I/II clinical trial. Working with the FDA to resolve the full clinical
hold on the clinical trial is currently our top priority.
Anticipated Milestones
Financial Highlights
Solid Biosciences reported a net
loss of $15.9 million for the first quarter of 2018 as compared to $13.9 million for the first quarter of 2017. The increase in net loss for the year was due to increased research and development expenses, as well as investments in the
Company s infrastructure.
Research and development expenses for the first quarter of 2018 were $11.9 million as compared to $8.7 million
for the prior year period. The increase in research and development expenses was primarily driven by increased compensation, headcount and facility costs, as well as increased costs related to the clinical development and manufacturing activities
for SGT-001, which were offset by a reduction in the preclinical costs associated with SGT-001.
General and administrative expenses were $4.0 million for the first quarter of 2018 as compared to $5.4 million for the prior year period. The
decrease in general and administrative expenses was primarily due to a decrease in equity-based compensation offset by an increase in salary and benefit related costs due to the increase in employee related expenses, as well as an increase in other
Solid ended the first quarter of 2018 with $182.4 million in cash, cash equivalents and available-for-sale securities as 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
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. Currently, 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 Solid s intentions and expectations regarding the full clinical hold on its IGNITE DMD clinical trial and its anticipated achievement of milestones. 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: satisfactorily respond to requests from the FDA for information and data regarding IGNITE DMD; successfully resolve the clinical hold with regard
to IGNITE DMD; 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; replicate in later clinical trials positive results found in preclinical studies and earlier stage clinical trials of SGT-001 and its other product
candidates; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; 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.
Consolidated Statements of Operations
Solid Biosciences Inc.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenue | $ | $ | ||||||
| Operating expenses: | ||||||||
| Research and development | 11,929 | 8,733 | ||||||
| General and administrative | 4,044 | 5,380 | ||||||
| Total operating expenses | 15,973 | 14,113 | ||||||
| Loss from operations | (15,973 | ) | (14,113 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 65 | 62 | ||||||
| Other income | 31 | 176 | ||||||
| Total other income (expense), net | 96 | 238 | ||||||
| Net loss | (15,877 | ) | (13,875 | ) | ||||
| Net loss attributable to non-controlling interest | (1,060 | ) | ||||||
| Net loss attributable to Solid Biosciences Inc. | (15,877 | ) | (12,815 | ) | ||||
| Accretion of preferred units to redemption value | (959 | ) | ||||||
| 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 | $ | (15,877 | ) | $ | (14 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.54 | ) | $ | (0.01 | ) | ||
| Weighted average shares of common stock outstanding, basic and diluted | 29,354,650 | 3,047,759 |
Consolidated Balance Sheets
Solid Biosciences Inc.
Consolidated Balance Sheets
(unaudited, in thousands, except share and per share data)
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 164,773 | $ | 52,080 | ||||
| Available-for-sale securities | 17,609 | 17,014 | ||||||
| Prepaid expenses and other current assets | 1,931 | 1,499 | ||||||
| Restricted cash | 65 | 65 | ||||||
| Total current assets | 184,378 | 70,658 | ||||||
| Property and equipment, net | 4,418 | 2,429 | ||||||
| Other non-current assets | 209 | |||||||
| Restricted cash | 237 | |||||||
| Deferred offering costs | 3,106 | |||||||
| Total assets | $ | 189,242 | $ | 76,193 | ||||
| Liabilities, Preferred Units and Stockholders / Members Equity / (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 5,835 | 5,066 | ||||||
| Accrued expenses and other current liabilities | 4,092 | 6,205 | ||||||
| Total current liabilities | 9,927 | 11,271 | ||||||
| Other non-current liabilities | 365 | |||||||
| Total liabilities | 10,292 | 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 | 319,073 | |||||||
| Accumulated other comprehensive loss | (23 | ) | (13 | ) | ||||
| Accumulated deficit | (140,135 | ) | (124,258 | ) | ||||
| Total stockholders / members equity (deficit) | 178,950 | (59,257 | ) | |||||
| Total liabilities, preferred units and stockholders / members equity | 189,242 | 76,193 |