Stealth BioTherapeutics Files for $86 Million IPO to Advance Mitochondrial Dysfunction Therapies

Recently, VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on December 28, 2018, local time, U.S. biopharmaceutical company Stealth BioTherapeutics filed an IPO application with Nasdaq, aiming to raise $86 million.

Stealth BioTherapeutics is an innovative biopharmaceutical company dedicated to the treatment of mitochondrial dysfunction, which is often associated with genetic mitochondrial diseases and many common age-related conditions. Stealth BioTherapeutics is committed to advancing the field of mitochondrial medicine and improving the lives of patients affected by mitochondrial dysfunction. The company is developing therapies targeting mitochondrial dysfunction related to age-related diseases and genetic mitochondrial disorders.

It is reported that the funding will support the use of Elamipretide in treating primary mitochondrial diseases and age-related dry macular degeneration. Elamipretide is a peptide that can readily cross cell membranes to reach cardiolipin located within the inner mitochondrial membrane. Stealth BioTherapeutics stated that this phospholipid is generated in the inner mitochondrial membrane and is “almost exclusively” present in this membrane.

Clinical studies have demonstrated that elamipretide can increase the rate of mitochondrial respiration and boost adenosine triphosphate (ATP) production, with ATP serving as the energy source for cellular functions. According to a filing with the U.S. Securities and Exchange Commission (SEC), the company will complete the development of the drug in the pivotal Phase 3 trial for the former indication and initiate a Phase 2b clinical trial in the pivotal Phase 3 trial for the latter indication.

Stealth BioTherapeutics stated that the binding of this elastin to cardiolipin has been demonstrated to normalize the structure of the mitochondrial inner membrane, thereby improving mitochondrial function. The company is also developing elamipretide for the treatment of Barth syndrome, a rare disorder characterized by cardiomegaly, cardiac weakness, and muscle weakness, and Leber hereditary optic neuropathy, a form of inherited blindness.

Stealth BioTherapeutics stated in its filing with the SEC (U.S. Securities and Exchange Commission) that the funding will also advance SBT-272, a preclinical drug candidate for the treatment of neurodegenerative diseases, into Phase I clinical trials and accelerate the development of its discovery-stage compounds.

Stealth BioTherapeutics stated in its filings that the company’s internal platform has generated more than 100 precisely categorized compounds, which could significantly benefit clinical research on diseases associated with mitochondrial dysfunction. The company plans to select the most promising candidates and also leverage certain compounds as integral components of its platform, serving as potential scaffolds to deliver other therapeutic agents into mitochondria.

Stealth BioTherapeutics is not the only company researching diseases related to mitochondrial dysfunction. Just over a year ago, Astellas acquired its partner MitoBridge in a deal with potential value of up to $450 million. The centerpiece of the acquisition was MA-2011, a PPAR-delta modulator designed to address the mitochondrial defects underlying Duchenne muscular dystrophy.

Astellas Pharma Inc. is a Japanese company primarily engaged in the business of pharmaceuticals and related products. The company operates two business segments: the first is the Pharmaceuticals and Related Products segment, which is mainly involved in the development, manufacturing, and sales of pharmaceuticals for markets including Japan, North America, Europe, and Asia; the second is the Real Estate segment. Astellas established a subsidiary in Brazil in July 2010. In 2017, the company completed its acquisition of MitoBridge, Inc., and developed a PPAR-delta modulator.