MITO - MITO STOCK NEWS

Stealth BioTherapeutics (Nasdaq: MITO) announced updates from the ReCLAIM-2 study of elamipretide for geographic atrophy due to dry age-related macular degeneration. While the primary endpoints were not met, the study indicated significant improvements in low luminance visual acuity (LLVA) and mitochondrial rich ellipsoid zone (EZ) preservation. The data suggest elamipretide could potentially benefit patients with dry AMD. The therapy was well tolerated, showing a lower rate of new-onset exudations compared to placebo. Future clinical development and strategic partnerships are being considered.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that the FDA has granted Orphan Drug Designation for elamipretide, aimed at treating Duchenne muscular dystrophy (DMD). The company has also secured a pre-IND meeting with the FDA's Division of Neurology I to discuss development strategies for elamipretide in combination with approved exon-skipping phosphorodiamidate morpholino oligomers. DMD leads to severe muscle dysfunction and current treatments have limited efficacy. The Orphan Drug Designation facilitates drug development for rare diseases, allowing seven-year exclusivity post-approval.

Stealth BioTherapeutics (Nasdaq: MITO) announced top-line results from its Phase 2 ReCLAIM-2 trial of elamipretide for geographic atrophy (GA) linked to dry age-related macular degeneration. Although the trial did not achieve its primary endpoints for mean change in low luminance visual acuity (LLVA) and GA progression, over 15% of elamipretide-treated patients showed significant improvement in vision at Week 48. Additionally, the treatment exhibited a reduction in ellipsoid zone loss, a biomarker of retinal health, suggesting potential for further development in GA.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a definitive agreement with an institutional investor for a registered direct offering of 5,583,028 American Depositary Shares (ADSs) at $0.6269 per ADS, generating approximately $3.5 million. Concurrently, a private placement with Morningside Venture raised $5 million through the sale of 95,712,096 ordinary shares at $0.05224 each, plus warrants. Both transactions are set to close around April 13, 2022. The offering will use a previously filed shelf registration statement with the SEC.

Stealth BioTherapeutics Corp (Nasdaq: MITO) has announced the presentation of new preclinical data on SBT-272 at the Mitochondrial Biochemistry in Health and Disease Symposium. Additionally, the company has begun dosing in its Phase 1 clinical trial for SBT-272, targeting mitochondrial dysfunction in neurodegenerative diseases. The preclinical study showed significant motor function improvements in Huntington's disease models with SBT-272 treatment. The trial aims to evaluate the safety and pharmacokinetics of SBT-272 in healthy subjects, progressing towards potential treatments for ALS and other diseases.

Stealth BioTherapeutics Corp (Nasdaq: MITO) has initiated a Phase 2a clinical trial for its drug elamipretide to treat Friedreich's ataxia, a rare genetic disorder affecting about 4,000 individuals in the U.S. The FDA has granted Orphan Drug Designation to elamipretide, which aims to address significant unmet medical needs associated with the disease, including visual and cardiac dysfunction. The trial will assess safety, visual function, and cardiac function in patients at the Children's Hospital of Philadelphia, directed by Dr. David Lynch.

Stealth BioTherapeutics (Nasdaq: MITO) announced the presentation of new data at the ARVO 2022 Annual Meeting in Denver, Colorado, from May 1-4, 2022. The presentation will focus on the effects of elamipretide and SBT-272 on complement gene expression and cell survival in a model of dry age-related macular degeneration (AMD). Dry AMD is a leading cause of blindness, affecting over 5 million people globally. The presentation is scheduled for May 4, 2022, with Mark Fields, MPH, PhD, from Yale University delivering the findings.

Stealth BioTherapeutics Corp (Nasdaq: MITO) will host a virtual R&D event on March 24, 2022, at 9:00 am ET, focusing on its lead candidate, elamipretide, for treating geographic atrophy (GA) related to dry age-related macular degeneration (AMD). The event will feature notable experts including Lucian Del Priore, David S. Boyer, and Mark Fields. It aims to present elamipretide as a potential therapeutic option for GA, a progressive eye condition affecting over five million globally, with no approved treatments available.

Stealth BioTherapeutics Corp (Nasdaq: MITO) presented promising data on elamipretide and its potential synergistic effects with a phosphorodiamidate morpholino oligomer (PMO) in Duchenne muscular dystrophy (DMD) at the 2022 Muscular Dystrophy Association conference. The 7-week study on mdx mice showed that combining PMO with elamipretide resulted in over double the dystrophin protein levels compared to PMO treatment alone. This suggests that improved mitochondrial function could enhance PMO efficacy, offering hope for better treatment outcomes for DMD patients.