Stealth BioTherapeutics (MITO) Misses Q1 EPS by 1c

Stealth BioTherapeutics (NASDAQ: MITO) reported Q1 EPS of ($0.01), $0.01 worse than the analyst estimate of $0.00.

"Our team is energized by the potential of both elamipretide and our deep pipeline of novel mitochondrial-targeted compounds to address the devastating and typically progressive disease burden associated with diseases of mitochondrial dysfunction and we are thrilled to have secured additional financial resources to expand these development efforts," said Reenie McCarthy, Chief Executive Officer at Stealth. "We are pleased with our progress towards alignment with the Division of Cardiology and Nephrology at the FDA on a randomized withdrawal trial of the patients remaining in our open-label extension trial, which preserves a potential near-term path to NDA submission for Barth cardiomyopathy, and we are eager to engage with DRDMG regarding our Phase 3 protocol for the group of patients with nPMD who responded to therapy in our previous primary mitochondrial myopathy trial. As we complete dosing in our fully enrolled Phase 2 trial in geographic atrophy, we are encouraged by new data correlating visual improvement in our Phase 1 trial with mitochondrial function, which further supports our Phase 2 enrollment criteria. We are expanding our development efforts both clinically and preclinically, with continued progress toward initiating trials in Friedreich's ataxia and cardiomyopathy associated with Duchenne muscular dystrophy, to explore the full potential of our candidates, including several new pipeline compounds central to our burgeoning neurology franchise."

For earnings history and earnings-related data on Stealth BioTherapeutics (MITO) click here.

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