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Stealth BioTherapeutics Announces Elamipretide Clinical Data to be Presented at the 13th International Conference on Cachexia, Sarcopenia and Wasting Diseases

Date : December 9, 2020

BOSTON, Dec. 9, 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 that two abstracts have been selected for virtual presentations including a poster presentation and a late breaking research oral presentation at the upcoming 13th International Conference on Cachexia, Sarcopenia and Wasting Diseases being held online from December 11-13, 2020. The abstracts will feature encouraging findings from key elamipretide trials, including MMPOWER-3, highlighting improvements in the six minute walk test in genetic subgroups with mtDNA replisome disorders, and TAZPOWER, showing improvement in key biomarkers of mitochondrial dysfunction to potentially treat skeletal muscle wasting and cardiomyopathies. The presentations will be available to conference attendees via the conference website.

Details for the presentations are as follows:

Title: MMPOWER-3 Phase 3 Clinical Trial Results: Elamipretide improved six-minute walk test in individuals with mtDNA replisome disorders
Presenter: Michelangelo Mancuso, MD, PhD, University of Pisa
Session: Late breaking research/trials
Date and Time: Sunday, December 13th, 10:30-11:40 a.m. ET

Title: Changes in Plasma and Urinary Metabolites After Elamipretide in Barth Syndrome Patients: Analyses from the TAZPOWER Study
Presenter: Hilary Vernon, MD, PhD, Johns Hopkins University
Abstract #: 8-02
Session: 9. Therapeutic development (clinical) + Therapeutic development (pre-clinical) I 
Date and Time: Saturday, December 12th, 1:55-2:45 p.m. ET

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 and Becker muscular dystrophies 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, including SBT-259, the SBT-550 series of compounds, and other 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 include statements about the anticipated completion of the registered direct offering. 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 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.

Media Relations

Amelia Stetler, 617-762-2562
media@stealthbt.com

Investor Inquiries
Stern IR
Janhavi Mohite, 212-362-1200
IR@stealthbt.com
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