Stealth Biotherapeutics has filed an F-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing details were mentioned in the filing, although the offering is valued up to $86.25 million. The company intends to list its American depositary shares on the Nasdaq under the symbol MITO.
The underwriters for the offering are Jefferies, Evercore ISI, BMO Capital Markets and Nomura Securities.
This is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction. Dysfunctional mitochondria characterize a number of rare genetic diseases, collectively known as primary mitochondrial diseases, and they are also involved in many common age-related diseases. Management believes its lead product candidate, elamipretide, has the potential to treat both rare genetic and common age-related mitochondrial diseases.
The firm’s mission is to be the leader in mitochondrial medicine, and the company has assembled a highly experienced management team, board of directors and group of scientific advisors to help it achieve this mission.
Essentially, primary mitochondrial myopathy, characterized by debilitating skeletal muscle weakness, exercise intolerance and fatigue, which is believed to affect an estimated 40,000 diagnosed individuals in the United States. There are no therapies approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency or the National Medical Products Association of China for the treatment of this indication.
The firm has received Fast Track and Orphan Drug designations from the FDA for the development of elamipretide in this indication. It is conducting a Phase 3 pivotal trial in North America and Europe and expects to have data from that trial by the end of 2019.
Stealth Bio intends to use the net proceeds from this offering to further its pipeline, as well as for working capital and other general corporate purposes, including advancement of its pipeline of discovery compounds.
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