Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company
developing genetic medicines for neuromuscular and cardiac
diseases, today reported financial results for the second quarter
ended June 30, 2023, and provided a business update.
“We made strong progress this quarter across
multiple programs in our pipeline of genetic medicines and remain
on track to submit an IND for SGT-003 in the fourth quarter of this
year,” said Bo Cumbo, President and CEO of Solid Biosciences. “We
also continued to advance and diversify our preclinical pipeline.
Most notably, executing a licensing agreement for two preclinical
cardiac programs further growing our pipeline of gene therapies to
treat fatal neuromuscular and cardiac diseases. This agreement
strengthens the existing work being done in our cardiac portfolio,
including our BAG3 program as it enters animal proof-of-concept
dose ranging studies in the second half of this year. With
anticipated cash runway into 2025, we continue to be well
positioned to create additional momentum from our leading-edge
technology platform and product development programs in the months
ahead.”
The Company is on track to submit an
Investigational New Drug (IND) for its Duchenne gene therapy
program, SGT-003, in the fourth quarter of 2023. Solid also
continues to advance preclinical programs in both cardiac and
neuromuscular indications as well as platform enabling capsids.
This includes AVB-401 for treatment of BAG3 mediated dilated
cardiomyopathy and AVB-202-TT for Friedreich’s Ataxia as well as
its capsid library which is now in a second round of
development.
Second Quarter 2023 Financial
Highlights
There were no collaboration revenues for the
second quarter of 2023, compared to $6.2 million, for the second
quarter of 2022. Collaboration revenue in the 2022 period was
related to research services and cost reimbursement from our
Collaboration Agreement with Ultragenyx, which the Company entered
into in the fourth quarter of 2020.
Research and development expenses for the three
months ended June 30, 2023, were $19.8 million, compared to $23.2
million for the three months ended June 30, 2022. The decrease of
$3.4 million in research and development expenses was primarily due
to a $12.0 million decrease in costs for SGT-001 due to our
decision to prioritize development of SGT-003, offset by a $4.5
million increase in SGT-003 for manufacturing and non-clinical
study costs, a $2.6 million increase in other development programs,
and a $1.8 million increase in external expenses.
General and administrative expenses for the
three months ended June 30, 2023, were $7.1 million, compared
to $6.9 million for the three months ended June 30, 2022. The
increase of $0.3 million was primarily related to a $0.3 million
increase in IT-related costs and a $0.2 million increase in
professional services costs, offset by a $0.2 million decrease in
insurance costs.
Net loss for the second quarter of 2023 was
$24.6 million, compared to $25.1 million for the second quarter of
2022. The decrease in net loss was the result of lower research and
development costs and higher increase in yields on cash equivalents
and available-for-sale securities.
Solid had $160.2 million in cash, cash
equivalents, and available-for-sale securities as of June 30, 2023,
compared to $213.7 million as of December 31, 2022. The Company
expects that its cash, cash equivalents, and available-for-sale
securities will enable it to fund key strategic priorities into
2025.
About Solid Biosciences
Solid Biosciences is a life science company
focused on advancing a portfolio of neuromuscular and cardiac
programs, including SGT-003, a differentiated gene transfer
candidate for the treatment of Duchenne muscular dystrophy
(Duchenne), AVB-401 a gene therapy program for the treatment of
BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy
program for the treatment of Friedreich’s Ataxia, and additional
assets for the treatment of undisclosed fatal cardiac diseases.
Solid aims to be the center of excellence across a given disease
spectrum bringing together those with expertise in science,
technology, disease management, and care. Patient-focused and
founded by those directly impacted, Solid’s mandate is to improve
the daily lives of patients living with these devastating diseases.
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 future
expectations, plans and prospects for the company; the ability to
successfully achieve and execute on the Company’s priorities and
achieve key clinical milestones; the cash runway of the company and
the sufficiency of the Company’s cash, cash equivalents, and
available for sale securities to fund its operations; the Company’s
SGT-003 program, including expectations for submitting an IND, and
the Company’s future development of preclinical and capsid
programs; and other statements containing the words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “would,” “working” 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 the ability
to recognize the anticipated benefits of Solid’s acquisition of
AavantiBio; the Company’s ability to advance SGT-003, AVB-202-TT,
AVB-401 and other preclinical programs and capsid libraries on the
timelines expected or at all; obtain and maintain necessary
approvals from the FDA and other regulatory authorities; replicate
in clinical trials positive results found in preclinical studies of
the Company’s product candidates; obtain, maintain or protect
intellectual property rights related to its product candidates;
compete successfully with other companies that are seeking to
develop Duchenne and other neuromuscular and cardiac treatments and
gene therapies; manage expenses; and raise the substantial
additional capital needed, on the timeline necessary, to continue
development of SGT-003, AVB-202-TT, AVB-401 and other candidates,
achieve its other business objectives and continue as a going
concern. 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 Contact:Leah MonteiroVP,
Investor Relations and
Communications617-821-4427lmonteiro@solidbio.com
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