Stealth BioTherapeutics Presents Positive Elamipretide Data in Pediatric Cardiology at International Society for Heart Research North American Section Meeting 2021

Date : September 28, 2021

BOSTON, Sept. 28, 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, announced today the presentation of positive elamipretide data showing improvements in mitochondrial respiration and heart muscle function in tissue from failing human hearts at the International Society for Heart Research North American Section Meeting 2021.

Problems in energy production are well-characterized in pediatric and adult heart failure and postulated to be centrally involved in impaired cardiac function in these patients. In this study, mitochondria and muscle fibers from the explanted failing left ventricle were isolated from adult and pediatric patients undergoing cardiac transplant, post organ transplantation. The effects of elamipretide on mitochondrial respiration and muscle function were determined in the laboratory. Mitochondrial respiration was decreased in heart tissue from patients with pediatric cardiomyopathy compared to explanted tissue from non-failing hearts. Study findings showed that these impairments in respiration were significantly improved with elamipretide treatment in the pediatric hearts. The study also demonstrated that elamipretide treatment improved both contraction and relaxation in muscle fibers isolated from failing hearts of patients with dilated cardiomyopathy.

"This study builds upon our previously published findings that elamipretide improves mitochondrial and muscle fiber function in heart tissue isolated from the failing human heart. The observation of improved mitochondrial function from pediatric cardiomyopathy is very encouraging as there are currently no therapies that target mitochondrial dysfunction in this patient population. These data are consistent with our observed effects of elamipretide across other types of heart failure including idiopathic cardiomyopathy and metabolic (muscular dystrophy) cardiomyopathy" said Dr. Brian Stauffer, Chief of Cardiology at Denver Health Medical Center and Professor of Medicine/Cardiology at the University of Colorado Anschutz Medical Campus, who was the lead author on the study.

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 syndrome, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, 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 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, those regarding the implications of preliminary preclinical 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: 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; 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; and general economic and market conditions. These and other risks which 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.

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