BOSTON, May 17, 2021 /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 that it has reached
agreement with Morningside Ventures for Morningside to provide
$30 million of additional payments to
the Company during 2021 under its existing Development Funding
Agreement. The payments will be paid to the Company in three
tranches.
The additional payments were triggered by new positive analyses
of clinical data from the ReCLAIM Phase 1 trial, announced on
May 5, 2021, which associated
baseline mitochondrial viability with improvements in vision for
patients with geographic atrophy. The Company also previously
announced a new data analysis from its MMPOWER-3 Phase 3 clinical
trial, which identified responders among patients with primary
mitochondrial disease due to nuclear DNA mutations (nPMD), and
plans to initiate a Phase 3 clinical trial in patients with nPMD
based on these results.
"We are encouraged that Morningside shares our enthusiasm about
these recent findings from our geographic atrophy and nPMD
programs, which we believe will allow us to enrich our future
studies in these indications," said Reenie
McCarthy, CEO of Stealth. "This additional funding will
allow us to initiate a Phase 3 clinical trial evaluating the impact
of elamipretide in patients with nPMD as well as continue our work
on an intravitreal formulation to inform Phase 3 formulation
decisions as we await data from our ongoing ReCLAIM-2 trial in
geographic atrophy early next year."
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, for rare neurodegenerative disease
indications following promising preclinical data in amyotrophic
lateral sclerosis, or ALS. We have optimized our discovery platform
to identify novel mitochondria-targeted compounds which may be
nominated as therapeutic product candidates or utilized as
mitochondria-targeted vectors 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, but are not limited
to, statements relating to preliminary clinical data. 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: those regarding Stealth BioTherapeutics' plans,
strategies and expectations for its preclinical and clinical
advancement of its drug development programs, including its ongoing
clinical trials of elamipretide; whether results obtained in
preclinical studies and clinical trials will be indicative of
results that will be generated in future clinical trials;
whether elamipretide will successfully advance through
the clinical trial process on a timely basis, or at all; and
whether the results of the company's clinical trials will warrant
regulatory submissions and whether elamipretide will
receive approval from the FDA or equivalent foreign regulatory
agencies for GA, AMD, Barth syndrome or any other indication when
expected or at all. 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") on April 6, 2021, 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.