MITO - MITO STOCK NEWS

Stealth BioTherapeutics Corp (MITO) reported encouraging Phase 1 results on the safety and tolerability of its drug candidate, SBT-272, for ALS treatment. The drug demonstrated neuroprotective effects in preclinical models and has been granted Orphan Drug Designation by the FDA, highlighting the urgent need for ALS therapies. The Phase 1 study indicates that SBT-272 could achieve therapeutic levels in the brain, supporting its further clinical development. The findings were discussed at the NEALS conference on November 1, 2022.

Stealth BioTherapeutics (MITO) announced an extraordinary general meeting (EGM) for shareholders on November 15, 2022, in New York City. The EGM will focus on approving a merger agreement dated July 31, 2022, which involves Stealth merging with Stealth Parent Limited. If approved, Stealth will become a privately-held subsidiary and its ADSs will be delisted from Nasdaq. Shareholders as of October 7, 2022, are entitled to vote. The board has recommended a vote in favor of the merger, deeming it fair and in the best interests of shareholders.

Stealth BioTherapeutics Corp (Nasdaq:MITO) announced that Chief Financial Officer Robert Weiskopf has left the company, effective September 30, 2022. Weiskopf joined Stealth in 2019 and has played a pivotal role in building the company's financial infrastructure. CEO Reenie McCarthy expressed gratitude for his contributions. On August 1, 2022, Stealth confirmed an agreement for acquisition by a consortium led by Morningside Venture in an all-cash transaction, signaling a transformative phase for the company.

Stealth BioTherapeutics (NASDAQ: MITO) announced its participation in significant events focused on ultra-rare disease drug development on September 15, 2022. CEO Reenie McCarthy will engage in discussions at the Rare Disease Research: A Prescription event and the Business of RARE Biotech Summit. These presentations will spotlight Stealth's clinical progress with elamipretide for Barth syndrome, showcasing over 40% improvement in cardiac function after 3.5 years. The company is also planning further talks with the FDA to clarify regulatory pathways.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a definitive merger agreement to be acquired by a consortium led by Morningside Venture Investments Ltd. for $0.03125 per share. The deal includes a premium of 34.4% over the closing price before the proposal and is expected to close in H2 2022, subject to shareholder approval. The consortium holds approximately 65% of shares. Following the merger, Stealth BioTherapeutics will become a privately-held entity and its shares will cease trading on NASDAQ.

Stealth BioTherapeutics (Nasdaq:MITO) announced it received a non-compliance notice from Nasdaq due to failure to meet minimum bid price and market value requirements. Unless an appeal is requested, trading will be suspended on July 18, 2022. The company plans to appeal and present a compliance plan to the Nasdaq Hearings Panel. Additionally, discussions are ongoing regarding a proposed acquisition by Morningside Venture, while no final decisions have been made. Stealth also aims to regain compliance and may seek an extension depending on the status of the acquisition.

Stealth BioTherapeutics Corp (Nasdaq: MITO) has received a non-binding proposal from Morningside Venture and J. Wood Capital to acquire all outstanding shares not currently owned by Morningside. The proposed acquisition price is $0.026 per share and $0.313 per American Depositary Share (ADS), representing premiums of 11.7% and 20% respectively. The company's Board has formed a Special Committee to evaluate this and other strategic alternatives, emphasizing no decisions have been made yet regarding the proposal.

Stealth BioTherapeutics (MITO) has scheduled a Type B meeting with the FDA's Division of Cardiology and Nephrology to discuss new clinical data concerning elamipretide for treating Barth Syndrome. This meeting follows the FDA's previous refusal to file an NDA for the treatment in October 2021. The company aims to present clinical data from the Phase 2 TAZPOWER study, which could support a future NDA submission. Barth Syndrome is a rare genetic condition with no FDA-approved therapies, affecting 1 in 200,000 to 400,000 individuals worldwide.

Stealth BioTherapeutics Corp (Nasdaq: MITO) presented promising preclinical data for SBT-272 at the Keystone Neurodegeneration Symposium. The data indicates significant enhancement in mitochondrial health and neuronal function, specifically in upper motor neurons linked to amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). A Phase 1 study assessing SBT-272's safety and tolerability in healthy volunteers is currently in progress. The drug showed superior effects over existing treatments like edaravone and AMX0035, marking a potential breakthrough in ALS therapies.