MITO - MITO STOCK NEWS

Stealth BioTherapeutics (Nasdaq: MITO) announced plans for a meeting with the FDA's Division of Cardiology and Nephrology regarding the NDA submission for elamipretide, aimed at treating cardiomyopathy in Barth syndrome. The company received prior feedback indicating that additional clinical data was needed, but believes its existing data, along with new analyses, could meet NDA requirements. A short-term withdrawal protocol is proposed to assess durable effects. CEO Reenie McCarthy highlighted the urgent need for treatment in the Barth syndrome community, supported by over 4,000 petitioners.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced the selection of two abstracts for virtual presentation at the 13th International Conference on Cachexia, Sarcopenia, and Wasting Diseases from December 11-13, 2020. The presentations will showcase positive findings from elamipretide trials, particularly the MMPOWER-3 trial, which demonstrated improvements in the six-minute walk test for patients with mtDNA replisome disorders. The TAZPOWER study highlighted progress in key biomarkers related to mitochondrial dysfunction, which may impact treatment approaches for muscle wasting and cardiomyopathies.

Stealth BioTherapeutics Corp (Nasdaq: MITO) appointed Dr. Eve E. Slater to its Board of Directors. Dr. Slater, an experienced cardiovascular expert, previously held senior roles at Pfizer and Merck, where she contributed to numerous successful drug approvals. Her extensive background in medicine and regulatory policy is expected to enhance Stealth's focus on mitochondrial-targeted therapies, including elamipretide for rare metabolic disorders. The company's leadership expressed enthusiasm about Dr. Slater's potential impact on product development and patient care.

Stealth BioTherapeutics Corp (Nasdaq: MITO) has successfully closed a registered direct offering of 2,844,446 American Depositary Shares (ADSs) at $1.125 each, raising approximately $3.2 million. The offering was facilitated by H.C. Wainwright & Co. The ADSs were issued under a shelf registration statement filed with the SEC. This funding aims to support the company's development of therapies for mitochondrial dysfunction, a key area of focus for the clinical-stage biotechnology firm.

Stealth BioTherapeutics Corp (Nasdaq: MITO) has initiated a registered direct offering, entering into securities purchase agreements with institutional investors for 2,844,446 American Depositary Shares (ADSs) priced at $1.125 each. This transaction is projected to generate gross proceeds of approximately $3.2 million, expected to close around November 24, 2020. The ADSs are offered under an effective registration statement filed with the SEC. H.C. Wainwright & Co. serves as the exclusive placement agent for this offering.

Stealth BioTherapeutics Corp (MITO) reported third-quarter results on Nov. 5, 2020, highlighting progress in clinical trials and financial support. Key achievements include 90% enrollment in the ReCLAIM-2 trial for geographic atrophy. The company is committed to submitting a New Drug Application for elamipretide for Barth syndrome by year-end 2020. Financially, cash and equivalents dropped to $19.9 million from $50.8 million in December 2019, but a recent $20 million funding agreement with Morningside ensures continued development. The net loss was $11.2 million, down from $16.5 million in the previous year.

Stealth BioTherapeutics Corp (MITO) announced a $20 million initial closing under a Development Funding Agreement to advance the clinical development of elamipretide, with potential total funding up to $70 million contingent on clinical milestones. This financing aims to support the ongoing Phase 2b study for geographic atrophy and the upcoming NDA submission for Barth syndrome. Stealth retains exclusive global rights to elamipretide and plans to enhance its development efforts for rare cardiovascular and mitochondrial disorders.

Stealth BioTherapeutics (Nasdaq: MITO) will report its third quarter 2020 financial results on November 5, 2020, before markets open. Management will host a conference call at 8:30 am ET the same day to discuss the results and provide a business update. The event will be accessible via phone and a live webcast. Stealth BioTherapeutics focuses on developing therapies for mitochondrial dysfunction, with its lead candidate, elamipretide, targeting various mitochondrial diseases. Additionally, they are working on SBT-272 for rare neurodegenerative diseases like ALS.

Stealth BioTherapeutics (Nasdaq: MITO) announced its participation in the 2020 American Society of Human Genetics (ASHG) Meeting, presenting a poster that received a "Reviewers' Choice" award for its significance. The poster highlights the TAZPOWER trial results, demonstrating that elamipretide significantly improves functional parameters in Barth syndrome compared to natural history controls. The interventional study showed statistically significant enhancements in exercise endurance and cardiac function in patients receiving elamipretide, highlighting its potential to address unmet medical needs in ultra-rare diseases.