BOSTON, Nov. 4, 2020 /PRNewswire/ -- Stealth
BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology
company focused on the discovery, development and commercialization
of novel therapies for diseases involving mitochondrial
dysfunction, today announced the first closing under a Development
Funding Agreement to support the clinical development of
elamipretide.
Stealth received $20 million and
is expected to receive up to an additional $15 million from Morningside Ventures contingent
on near-term clinical milestones associated with Stealth's
geographic atrophy and Barth syndrome development
programs. Additional investors may participate in subsequent
closings of up to an additional $35
million of near-term funding commitments. In addition, the
agreement contemplates that Stealth may receive up to an additional
$35 million upon meeting certain
pre-defined future milestones and subject to the agreement of the
parties. Funds are intended to support the continued clinical
development of elamipretide.
Under the terms of the agreement, Stealth will pay participating
investors regulatory approval milestone payments in annual
increments on a pre-determined payment schedule over seven years,
with the majority of payments due in years 5-7 following regulatory
approval. No approval payments are owed should regulatory approval
not be achieved for elamipretide in the indications currently under
or planned for near-term development. Stealth has an option to buy
out all future, unpaid milestone payments at any time following
certain regulatory approvals at a discounted rate. Stealth will
retain exclusive worldwide commercial rights to elamipretide in all
indications.
"This provides Stealth with critical funding to develop
elamipretide in diseases of mitochondrial dysfunction with serious
unmet need," said Reenie McCarthy,
CEO of Stealth. "We are incredibly fortunate to have the continued
support of Morningside during this pivotal time, as we complete
enrollment in our Phase 2b study in
geographic atrophy, prepare to file our first NDA for elamipretide
for the treatment of Barth syndrome, and expand our development
efforts to other rare cardiomyopathies and mitochondrial
diseases. The terms of the agreement maximize our financial
flexibility ahead of anticipated near-term regulatory, clinical,
and, potentially, commercial milestones."
About Stealth
We are a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel therapies for
diseases involving mitochondrial dysfunction. Mitochondria, found
in nearly every cell in the body, are the body's main source of
energy production and are critical for normal organ function.
Dysfunctional mitochondria characterize a number of rare genetic
diseases and are involved in many common age-related diseases,
typically involving organ systems with high energy demands such as
the heart, the eye, and the brain. We believe our lead product
candidate, elamipretide, has the potential to treat both rare
metabolic cardiomyopathies, such as Barth, Duchenne muscular
dystrophy and Friedreich's ataxia, rare mitochondrial diseases
entailing nuclear DNA mutations, such as POLG-related disorders, as
well as ophthalmic diseases entailing mitochondrial dysfunction,
such as dry age-related macular degeneration and Leber's hereditary
optic neuropathy. We are evaluating our second-generation
clinical-stage candidate, SBT-272, and our new series of small
molecules, SBT-550, for rare neurological disease indications
following promising preclinical data. We have optimized our
discovery platform to identify novel mitochondria-targeted
compounds which may be nominated as therapeutic product candidates
or utilized as scaffolds to deliver other compounds to
mitochondria.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding
Stealth BioTherapeutics' plans, anticipated milestones, potential
additional funding, strategies and expectations for its preclinical
and clinical advancement of its drug development programs, and
regulatory interactions and filings related to elamipretide.
Statements that are not historical facts, including statements
about Stealth BioTherapeutics' beliefs, plans and expectations, are
forward-looking statements. The words "anticipate," "expect,"
"hope," "plan," "potential," "possible," "will," "believe,"
"estimate," "intend," "may," "predict," "project," "would" and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Stealth BioTherapeutics may not
actually achieve the plans, intentions or expectations disclosed in
these forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results
or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements as a
result of known and unknown risks, uncertainties and other
important factors, including: Stealth BioTherapeutics'
ability to obtain additional funding and to continue as a going
concern; the impact of the COVID-19 pandemic; the ability to
successfully demonstrate the efficacy and safety of Stealth
BioTherapeutics' product candidates and future product
candidates; the preclinical and clinical results for Stealth
BioTherapeutics' product candidates, which may not support further
development and marketing approval; the potential advantages of
Stealth BioTherapeutics' product candidates; the content and timing
of decisions made by the U.S. FDA, the EMA or other regulatory
authorities, investigational review boards at clinical trial sites
and publication review bodies, which may affect the initiation,
timing and progress of preclinical studies and clinical trials of
Stealth BioTherapeutics product candidates; Stealth
BioTherapeutics' ability to obtain and maintain requisite
regulatory approvals and to enroll patients in its planned clinical
trials; unplanned cash requirements and expenditures; competitive
factors; Stealth BioTherapeutics' ability to obtain, maintain and
enforce patent and other intellectual property protection for any
product candidates it is developing; and general economic and
market conditions. These and other risks are described in
greater detail under the caption "Risk Factors" included in the
Stealth BioTherapeutics' most recent Annual Report on Form 20-F
filed with the Securities and Exchange Commission ("SEC"), as well
as in any future filings with the SEC. Forward-looking
statements represent management's current expectations and are
inherently uncertain. Except as required by law, Stealth
BioTherapeutics does not undertake any obligation to update
forward-looking statements made by us to reflect subsequent events
or circumstances.
Investor Relations
Stern Investor Relations
Janhavi Mohite, 212-362-1200
IR@StealthBT.com
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SOURCE Stealth BioTherapeutics Inc.