RARE Daily

Stealth Bio Completes $25 Million Debt Financing with Horizon Technology Finance

October 4, 2021

Stealth BioTherapeutics, a clinical-stage company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, completed a $25 million long-term debt facility led by Horizon Technology Finance.

Photo: Reenie McCarthy, CEO of Stealth BioTherapeutics

Stealth has drawn down $15 million under the facility with an additional $10 million available upon achievement of a predetermined milestone.

“This transaction strengthens and extends our financial resources as we plan to initiate several new clinical trials in the coming months, progress our commercial planning for Barth syndrome, for which we have recently submitted an NDA that is subject to FDA review, and prepare for Phase 2 data readout in extra-foveal geographic atrophy associated with dry AMD,” said Reenie McCarthy, CEO of Stealth BioTherapeutics.

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.

Stealth says its 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, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber’s hereditary optic neuropathy.

Stealth has received Rare Pediatric Disease, Fast Track, and Orphan Drug designation for elamipretide as a treatment for the ultra-rare condition Barth syndrome, which is characterized by cardiac abnormalities often leading to heart failure and reduced life expectancy, recurrent infections, muscle weakness, and delayed growth. It occurs almost exclusively in males there are currently no FDA- or EMA-approved therapies for patients with Barth syndrome.

The company is also evaluating its second-generation clinical-stage candidate, SBT-272, and a new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data.

Author: Rare Daily Staff

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