Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company
developing genetic medicines for neuromuscular and cardiac
diseases, today reported financial results for the first quarter
ended March 31, 2023, and provided a business update.
“In the first quarter of 2023, we made strong
progress across multiple programs in our diversified pipeline of
genetic medicines and remain on track to achieve important
milestones this year,” said Bo Cumbo, President, and CEO of Solid
Biosciences. “We look forward to presenting data from our
Friedreich’s ataxia program, next-generation Duchenne muscular
dystrophy program, novel capsid program, and our process
development activities as we participate in seven presentations
next week at the American Society of Gene and Cell Therapy Annual
Meeting. With cash runway into 2025, we are well positioned to
create additional momentum from our leading-edge technology
portfolio and multiple product development programs in the months
ahead.”
The Company is on track for an anticipated
Investigational New Drug (IND) submission for our Duchenne gene
therapy program, SGT-003 in the fourth quarter of 2023 and, subject
to IND clearance, the first patient dosing in late-2023. Solid also
continues to advance preclinical programs in its other
neuromuscular and cardiac indications, including AVB-202-TT for
Friedreich’s Ataxia, and AVB-401 for treatment of BAG3 mediated
dilated cardiomyopathy.
First Quarter 2023 Financial
Highlights
There were no collaboration revenues for the
first quarter of 2023, compared to $1.9 million, for the first
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 March 31, 2023, were $24.6 million, compared to
$20.0 million for the three months ended March 31, 2022. The
increase of $4.6 million in research and development expenses was
primarily due to a $7.0 million increase in costs for SGT-003 for
manufacturing and related costs and a $0.8 million increase in
costs for other development programs, offset by a $2.9 million
decrease in costs for SGT-001 due to a transition to SGT-003.
General and administrative expenses were $7.4
million for each of the three months ended March 31, 2023 and
2022.
Net loss for the first quarter of 2023 was $30.1
million, compared to $25.3 million for the first quarter of 2022.
The increase in net loss was the result of a greater investment in
research and development to progress DMD candidates.
Solid had $185.5 million in cash, cash
equivalents, and available-for-sale securities as of March 31,
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-202-TT, a gene therapy program for the treatment of
Friedreich’s Ataxia, AVB-401 a gene therapy program for the
treatment of BAG3 mediated dilated cardiomyopathy, and additional
assets for the treatment of undisclosed 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 company’s plans to present
data from its Friedreich’s ataxia program, next-generation Duchenne
muscular dystrophy program, novel capsid program, and process
development activities; the cash runway of the company and the
sufficiency of the company’s cash and investments to fund its
operations; the company’s SGT-003 program, including expectations
for filing an IND and initiating dosing, 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 Investor Contact:Leah
MonteiroVP, Investor Relations and
Communications617-821-4427lmonteiro@solidbio.com
Solid Biosciences Media Contact:Tim
PalmerAssociate Director, Corporate
Communications607-760-4223tim@solidbio.com
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