MITO - MITO STOCK NEWS

Stealth BioTherapeutics Corp (Nasdaq: MITO) reported financial results for Q2 2021, highlighting a net loss of $18.4 million, or $0.03 per share, compared to a loss of $12.4 million in Q2 2020. The company plans to submit its NDA for Barth syndrome in August 2021, hoping to leverage existing clinical data despite FDA concerns over data support. R&D expenses decreased to $5.9 million while G&A expenses rose to $5.1 million. Stealth has $30.8 million in cash as of June 30, 2021, expected to cover operations into Q2 2022. Upcoming milestones include anticipated data from several clinical trials in 2022.

Stealth BioTherapeutics Corp (Nasdaq: MITO) will release its second quarter 2021 financial results on August 5 before market opening. A conference call is scheduled for 8:30 am ET to discuss these results and provide a business update. Stealth BioTherapeutics focuses on developing therapies for mitochondrial dysfunction, with lead candidate elamipretide targeting rare diseases and age-related conditions. The company is also evaluating SBT-272 and SBT-550 for neurological diseases following promising preclinical outcomes.

On July 7, 2021, Stealth BioTherapeutics Corp (NASDAQ: MITO) announced its membership in the Rare Disease Company Coalition, aimed at developing therapies for rare diseases. CEO Reenie McCarthy expressed enthusiasm for collaborating with other companies to address challenges in rare disease treatment development. The coalition will advocate for favorable drug policies and regulations to support innovation while highlighting the unique difficulties faced in rare disease drug discovery. Stealth focuses on mitochondrial dysfunction therapies, with candidates like elamipretide targeting rare genetic disorders.

Stealth BioTherapeutics Corp (Nasdaq: MITO) has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its therapy elamipretide, targeting Barth syndrome, a rare genetic disorder. This designation recognizes the urgent need for treatments for conditions affecting fewer than 5 in 10,000 people. CEO Reenie McCarthy highlighted the potential for advancing regulatory initiatives in Europe and securing partnerships. Barth syndrome, impacting 1 in 200,000 to 400,000 individuals, currently has no approved therapies, emphasizing the significance of this designation.

Stealth BioTherapeutics Corp (Nasdaq: MITO), a biotechnology company, announced that CEO Reenie McCarthy will present at the Jefferies Healthcare Conference on June 1, 2021, at 3:00 p.m. ET. The presentation will focus on their novel therapies targeting mitochondrial dysfunction, particularly the lead candidate, elamipretide, which aims to treat rare metabolic cardiomyopathies and ophthalmic diseases. A live audio webcast will be available on their website, with a replay accessible for 30 days after the event.

Stealth BioTherapeutics Corp (Nasdaq: MITO) reported financial results for Q1 2021, showcasing a net loss of $7.7 million or $0.01 per share, reduced from $15.5 million in the same period of 2020. The company continues to advance its clinical pipeline, focusing on elamipretide for mitochondrial diseases, with a Phase 3 trial for Barth cardiomyopathy expected by Q3 2021. They also anticipate results from the Phase 2 ReCLAIM-2 trial in dry age-related macular degeneration by mid-2022. Cash and equivalents stood at $32.1 million as of March 31, 2021, projected to fund operations through Q2 2022.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a $30 million funding agreement with Morningside Ventures, which will be distributed in three tranches throughout 2021. This funding comes after positive results from the ReCLAIM Phase 1 trial, linking mitochondrial viability to vision improvements in patients with geographic atrophy. The company plans to initiate a Phase 3 trial for patients with nuclear DNA mutations and continue developing an intravitreal formulation of elamipretide. This financing supports further clinical studies and enhances the company's research capabilities.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a poster presentation at the 2021 American College of Cardiology meeting. The poster, titled 'Elamipretide Improves Functional Assessments when Compared to the Natural History Progression of Cardiomyopathy-related Disease Symptomatology in Patients with Barth Syndrome: A TAZPOWER Analysis,' showcases findings from a Phase 3 retrospective study. Results indicate that elamipretide treatment leads to significant improvements in left ventricular stroke volume and functional assessments over time, contrasting with expected declines in Barth syndrome patients.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that CEO Reenie McCarthy will present at two upcoming virtual investor conferences in May 2021. The conferences are: Oppenheimer's Rare & Orphan Disease Summit on May 21, 2021, from 9:55 to 10:35 a.m. ET, and UBS Global Healthcare Virtual Conference on May 26, 2021, from 10:00 to 10:45 a.m. ET. Live webcasts of the presentations will be available on Stealth's Investor Relations website, with replays archived for 30 days.