Solid Biosciences Reports First Quarter 2019 Financial Results and Provides Business Update
May 13 2019 - 4:10PM
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 |
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
- |
|
|
|
|
|
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, |
|
|
2019 |
|
|
|
2018 |
|
|
|
Assets |
|
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 media@solidbio.com
Investor Contact:
Geoffrey M. Grande, CFA+1 617-766-3398investors@solidbio.com
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