Stealth BioTherapeutics Inc. announced their entry into an exclusive licensing agreement whereby Pharmanovia will commercialize elamipretide, Stealth's lead investigational product candidate, in Europe and other key global territories for the treatment of Barth syndrome, an ultra-rare life-threatening cardiac condition caused by mitochondrial cardiolipin deficiency for which there are currently no approved treatments. Elamipretide, an investigational mitochondrial protective agent which has been shown to improve mitochondrial structure and function through its interaction with cardiolipin, has completed Phase 3 development as a potential treatment for Barth syndrome. Under the terms of the agreement, Pharmanovia receives exclusive rights to commercialize elamipretides for the treatment of Barth syndrome in the European Union and other European countries (including Iceland, Norway, Switzerland, and the United Kingdom), the Middle East and Northern Africa (MENA, including Algeria, Bahrain,jibouti, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, the United Arab Emirates, Palestine, and Yemen).

In exchange, Stealth BioTherapeutics will receive upfront and future development, regulatory, and commercial milestone payments, plus tiered royalties on net sales of elamipretide in the licensed territories.