Stealth BioTherapeutics Corp - ADR

Stealth BioTherapeutics Corp. is a clinical-stage biotechnology company, which engages in the discovery, development, and commercialization of therapies for diseases involving mitochondrial dysfunction. The company was founded on April 3, 2006 and is headquartered in Needham, MA.

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Stealth is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction. Mitochondria, found in nearly every cell in the body, are the body's main source of energy production and are critical for normal organ function. The company was founded in 2007 and is based in Newton, Massachusetts, United States.

BOSTON , March 24, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the upcoming presentation of new data at The Association for Research in Vision and Ophthalmology (2022) Annual Meeting being held May 1-4, 2022 in Denver, Colorado. The poster presentation will showcase the potential effect of elamipretide and SBT-272 on complement gene expression and survival in a human iPSC-RPE cell model of dry age-related macular degeneration (AMD).

Stealth BioTherapeutics Announces New Data on Complement Gene Expression and Cell Survival in Dry AMD to be Presented at ARVO (2022)

BOSTON , March 17, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced it will host a virtual R&D event on the Company's lead candidate, elamipretide, for potential treatment of geographic atrophy (GA) in dry age-related macular degeneration (AMD) on Thursday, March 24th at 9:00 am ET. In addition to a brief overview of the development opportunities within the Stealth's pipeline, the event will feature renowned experts in the field presenting on elamipretide as a potential therapeutic option for patients with AMD with GA as well as a Q&A panel.

Stealth BioTherapeutics to Host Virtual Event on the Potential of Elamipretide in Treatment of Geographic Atrophy in Dry Age-Related Macular Degeneration

BOSTON, March 16, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today presented new data demonstrating the potential synergistic relationship between elamipretide and an exon skipping phosphorodiamidate morpholino oligomer (PMO) in the X-linked muscular dystrophy (mdx) mouse model.  The data were presented at the 2022 Muscular Dystrophy Association and Clinical and Scientific Conference, held in Nashville, TN.

Stealth BioTherapeutics Showcases New Duchenne Muscular Dystrophy Nonclinical Data at the 2022 Muscular Dystrophy Association and Clinical and Scientific Conference

BOSTON , March 9, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that Reenie McCarthy, CEO, will present at three upcoming investor conferences in March: Oppenheimer 32nd Annual Healthcare Conference. Pre-recorded presentation available for on-demand viewing starting on Tuesday, March 15 at 4:40 p.m.

Stealth BioTherapeutics to Present at Upcoming March Investor Conferences

BOSTON, Feb. 22, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that Reenie McCarthy, CEO, will present at the virtual Mitochondria-Targeted Drug Development Summit on Thursday, February 24, 2022 at 9:00 a.m. ET. Reenie McCarthy's presentation is titled, "Mitochondria as a Target for Ophthalmic Disease," which will focus on mitochondrial dysfunction as a key pathology in ophthalmic conditions such as dry age-related macular degeneration (AMD), glaucoma, diabetic retinopathy and Fuch's corneal endothelial dystrophy.

Stealth BioTherapeutics to Present at Mitochondria-Targeted Drug Development Summit

BOSTON, Feb. 15, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the final patient in its 176-subject, ReCLAIM-2 phase 2 clinical trial for extra-foveal geographic atrophy (GA) associated with dry age-related macular degeneration (AMD) has completed treatment.  The Company is developing elamipretide for treatment of extra-foveal GA under U.S. FDA Fast Track designation.

Last Patient Completes Treatment in Stealth BioTherapeutics' Phase 2 Geographic Atrophy Clinical Trial

BOSTON , Feb. 11, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that on February 11, 2022, it received a letter from The Nasdaq Stock Market LLC ("Nasdaq"), notifying the Company that it is currently not in compliance with the minimum Market Value of Publicly Held Shares (MVPHS) requirement based upon Nasdaq's review of the Company's MVPHS for the 30 consecutive business days through February 10, 2022.  This press release is issued pursuant to Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of deficiency notifications.

Stealth BioTherapeutics Receives Nasdaq Notification Regarding Minimum Market Value Of Publicly Held Shares Requirement

BOSTON, Feb. 8, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the company will have an oral presentation at the upcoming 2022 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, being held March 13-16, 2022 in Nashville, Tennessee. The presentation showcases data demonstrating a potential relationship between elamipretide and an exon skipping phosphorodiamidate morpholino oligomer (PMO) in the X-linked muscular dystrophy (mdx) mouse model.

Stealth BioTherapeutics Announces Oral Presentation of New Duchenne Muscular Dystrophy Data at the 2022 Muscular Dystrophy Association Clinical and Scientific Conference

BOSTON, Jan. 7, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that on January 4, 2022, it received a letter from The Nasdaq Stock Market LLC ("Nasdaq"), notifying the Company that it is currently not in compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule 5450(a)(1). It resulted from the fact that the closing bid price of the Company's American Depositary Shares ("ADSs") was below $1.00 per share for a period of 30 consecutive business days.

Stealth BioTherapetuics Receives Nasdaq Notifications Regarding Minimum Bid And Market Value Requirements

BOSTON, Jan. 4, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that Reenie McCarthy, CEO, will present at the H.C. Wainwright BioConnect Virtual Conference taking place from January 10-13, 2022.

Stealth BioTherapeutics to Present at 2022 H.C. Wainwright BioConnect Virtual Conference

BOSTON, Dec. 20, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today reported an update on its pre-IND meeting with the FDA's Division of Cardiology and Nephrology (DCN) regarding its Duchenne muscular dystrophy (DMD) development program, including reaching alignment on Stealth's proposal to assess the progression of myocardial fibrosis as a surrogate endpoint for its planned clinical trial. "We applaud DCN for recognizing the importance of assessing myocardial fibrosis in DMD, where progressive fibro-fatty infiltration starting as early as middle childhood is associated with a loss of left ventricular function and adverse cardiovascular events," said Reenie McCarthy, Chief Executive Officer at Stealth.

Stealth BioTherapeutics Reports Positive Pre-IND Meeting for Duchenne Muscular Dystrophy

BOSTON, Dec. 13, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today reported an update on its clinical-stage rare disease programs. Duchenne muscular dystrophy (DMD).

Stealth BioTherapeutics Provides Update On Clinical Stage Rare Disease Programs

Stealth BioTherapeutics Corp (MITO) CEO Reenie McCarthy on Q3 2021 Results - Earnings Call Transcript

BOSTON, Nov. 11, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today reported financial results for the three months ended September 30, 2021 and announced recent business highlights. "We are excited to broaden our clinical development efforts with multiple new trial initiations expected over the coming months," said Reenie McCarthy, Chief Executive Officer at Stealth.

Stealth BioTherapeutics Reports Third Quarter 2021 Financial Results and Recent Business Highlights

BOSTON, Nov. 4, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that it will report third quarter 2021 financial results on Thursday, November 11, before the market opens. Management will host a conference call at 8:30 am ET that day to discuss the financial results and provide a general business update.

Stealth BioTherapeutics to Report Third Quarter Financial Results on Thursday, November 11

Stealth BioTherapeutics Corp (NASDAQ: MITO) has received a Refusal to File letter from the FDA regarding its marketing application for elamipretide, a mitochondria-targeted therapy for Barth syndrome. Barth syndrome is an ultra-rare genetic condition characterized by cardiac abnormalities often leading to heart failure and reduced life expectancy, recurrent infections, muscle weakness, and delayed growth.

Stealth Bio Stock Falls On FDA Refusal to File Letter For Barth Syndrome Candidate

BOSTON, Oct. 20, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that it received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding Stealth's New Drug Application (NDA) for elamipretide, a mitochondria-targeted therapy for the treatment of Barth syndrome. The FDA determined, upon its preliminary review, that the NDA was not sufficiently complete to permit a substantive review.

Stealth BioTherapeutics Receives Refusal to File Letter from the FDA

BOSTON, Oct. 7, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the presentation of new promising data from a study evaluating the effects of SBT-272 in a murine model of amyotrophic lateral sclerosis (ALS). The data were presented at the virtual 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting held October 6-7, 2021.

Stealth BioTherapeutics Presents Positive SBT-272 Preclinical Data at 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting

Horizon Technology Finance

BOSTON, Oct. 4, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced completion of a $25 million long-term debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon"). Stealth has drawn down $15 million under the facility with an additional $10 million available upon achievement of a predetermined milestone.

Stealth BioTherapeutics Completes a $25 Million Debt Financing with Horizon Technology Finance

Stealth BioTherapeutics Corp (NASDAQ: MITO) has presented new data from a study evaluating SBT-272 in a murine model of Parkinson's disease (PD).  SBT-272 is a mitochondria-targeted product candidate, which is known to cross the blood-brain barrier.

Stealth Bio Posts Encouraging Preclinical Data In Parkinson's Animal Studies

BOSTON, Sept. 23, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the presentation of new promising data from a study evaluating the effects of SBT-272 in a murine model of Parkinson's disease (PD).

Stealth BioTherapeutics Presents Positive SBT-272 Preclinical Data at International Parkinson and Movement Disorder Society Virtual Congress 2021

The stock price of Stealth BioTherapeutics Corp (Nasdaq: MITO) increased yesterday and pre-market today. This is why it happened.

MITO Stock: Why It Is Trading Higher

BOSTON, Sept. 14, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that multiple abstracts have been accepted for presentation at several leading ophthalmic conferences this fall.

Stealth BioTherapeutics to Showcase Leadership in Retinal Mitochondrial Health with Clinical Updates at Ophthalmic Conferences

BOSTON, Sept. 7, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that Reenie McCarthy, CEO, will present at two upcoming virtual investor conferences in September: H.C.

Stealth BioTherapeutics to Present at Upcoming September Virtual Investor Conferences

Stealth BioTherapeutics (MITO) files a new drug application for elamipretide to the FDA for the treatment of Barth syndrome, an ultra-rare genetic condition.

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