Solid Biosciences Reports First Quarter 2018 Financial Results and Provides 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
Recent Developments
- Completed its initial public offering, in which the Company issued and sold 8,984,375 shares of common stock, including 1,171,875 shares of common stock pursuant to the underwriters’ overallotment, at a public offering price of
$16.00 per share. The Company received total net proceeds of approximately$129.1 million from the offering after discounts, commissions and offering expenses.
- Announced the receipt of a full clinical hold letter from the
U.S. Food and Drug Administration (FDA ) relating to IGNITE DMD, the Company’s Phase I/II clinical trial for its investigational gene therapy, SGT-001, for the treatment of Duchenne muscular dystrophy (DMD). The clinical hold is in response to an unexpected Serious Adverse Event (SAE) reported in the first patient dosed with SGT-001. In its clinical hold letter, theFDA requested additional information, including an assessment of the underlying etiology of the event, the patient’s clinical status and laboratory parameters, and any additional measures to address patient safety. Solid is finalizing its response to theFDA letter.
- Announced that the earlier partial clinical hold on IGNITE DMD related to manufacturing processes for the high dose of SGT-001 had been resolved. To lift the hold, Solid submitted additional data to the
FDA demonstrating that its current manufacturing process and product attributes for SGT-001 could support the high-dose group, enabling the use of a single lot for dose administration and limiting the number of vials of product required to treat each patient.
- Continued to build the Company’s gene therapy pipeline through an expanded collaboration with
Synpromics Ltd to further evaluate next generation promoters and an exclusive option agreement with Lonza to explore the use of a novel capsid library developed at Massachusetts Eye and Ear and for a potential license.
- Expanded its footprint in
Cambridge, Massachusetts with the opening of its new corporate headquarters and 9,500 sq. ft. of custom-built research and process development laboratory space inKendall Square .
Anticipated Milestones
- Work with the
FDA to resolve the full clinical hold on IGNITE DMD and resume the clinical trial as soon as possible.
- Present two platform presentations and five posters at the 21st Annual Meeting of the
American Association of Gene and Cell Therapy (ASGCT) in May inChicago . These presentations include data from several studies that expand upon the preclinical safety and efficacy of SGT-001 for the treatment of DMD, as well as studies supporting the Company’s growing next generation gene therapy portfolio.
Financial Highlights
Research and development expenses for the first quarter of 2018 were
General and administrative expenses were
Solid ended the first quarter of 2018 with
About
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.
| Solid Biosciences Inc. | ||||||||||
| Condensed 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 | ||||||||
| Solid Biosciences Inc. | |||||||||||
| Condensed 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 | |||||||||
Contact:
Kate Niazi-Sai
617-337-4680
media@solidbio.com
investors@solidbio.com
Source: Solid Biosciences Inc.