NASDAQ-NMS:MITO

Stealth BioTherapeutics Announces Departure of Chief Financial Officer

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Friday, September 30, 2022
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BOSTON, Sept. 30, 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 Robert Weiskopf, Stealth's chief financial officer, is leaving the company effective September 30, 2022.

Key Points: 
  • BOSTON, Sept. 30, 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 Robert Weiskopf, Stealth's chief financial officer, is leaving the company effective September 30, 2022.
  • Mr. Weiskopf joined Stealth in 2019 following the company's initial public offering to spearhead its public financial reporting activities and grow the Company's financial team.
  • "Rob has played a key role in building the infrastructure to support Stealth as a public company and developing its accounting and reporting capabilities.
  • Rob leaves the company with a strong accounting and financial reporting foundation as well as a talented finance and accounting team," Ms. McCarthy said.

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Wednesday, June 8, 2022
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Stealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration Symposium

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Wednesday, June 8, 2022

BOSTON, June 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, announced today the presentation of new SBT-272 preclinical data demonstrating functional improvement in upper motor neurons with TDP-43 pathology, which plays a significant role in both amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The data were presented at the Keystone Neurodegeneration Symposium in Keystone, CO held June 5-9, 2022. A Phase 1 study to evaluate the safety and tolerability of SBT-272 in healthy volunteers is underway.

Key Points: 
  • The data were presented at the Keystone Neurodegeneration Symposium in Keystone, CO held June 5-9,2022.
  • Chronic in vivo administration of SBT-272 reduced upper motor neuron degeneration and neuroinflammation in the motor cortex of the prphTDP43A315TUeGFP mouse model of ALS.
  • "Therefore, to build effective treatment strategies for ALS, it is necessary for therapeutics to demonstrate efficacy on upper motor neuron health and function.
  • "ALS is a devastating progressive neuromuscular disease with a significant unmet medical need," said Reenie McCarthy, Chief Executive Officer of Stealth BioTherapeutics.

Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Myopathic Mitochondrial DNA Depletion Syndrome

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Tuesday, May 31, 2022
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BOSTON, May 31, 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 European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of myopathic mitochondrial DNA depletion syndrome (M-MDS), a designation which applies to patients with nPMM eligible for enrollment in the NuPOWER Phase 3 clinical trial, which is currently enrolling patients at multiple clinical trial sites in the United States and Europe.

Key Points: 
  • "Orphan drug designation for M-MDS marks an important step toward advancing our regulatory initiatives in Europe.
  • M-MDS is caused by mutations in nuclear DNA genes encoding for enzymes responsible for maintenance and replication of mitochondrial DNA.
  • Mitochondrial DNA replication, which is critical to support muscular energy demands, can be impaired as a result of these mutations, leading to signs and symptoms of M-MDS.
  • These patients are also considered to have primary mitochondrial myopathy, or PMM, for which the Company has previously received orphan drug designation from the US FDA.

Stealth BioTherapeutics Announces Data from the Phase 2 ReCLAIM-2 Study of Elamipretide in Geographic Atrophy at the Clinical Trials at the Summit Meeting 2022

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Monday, May 23, 2022
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BOSTON, May 23, 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 new data from the ReCLAIM-2 study of elamipretide in geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD) at the Clinical Trials at the Summit meeting in Lake Tahoe, Nevada.

Key Points: 
  • Additional analyses show that, consistent with prior findings from the ReCLAIM Phase 1 study, changes in LLVA correlated with baseline EZ attenuation in ReCLAIM-2.
  • Such forward-looking statements include those regarding Stealth BioTherapeutics' expectations for its clinical development of elamipretide for GA associated with dryAMDand other indications, the potential benefits of elamipretide and potential regulatory interactions.
  • Statements that are not historical facts, including statements about Stealth BioTherapeutics' beliefs, plans and expectations, are forward-looking statements.
  • Except as required by law, Stealth BioTherapeutics does not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

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Thursday, May 12, 2022
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  • Each of those scores is then combined into an overall score that determines a stock's overall suitability for investment.
  • InvestorsObserver provides patented technology to some of the biggest names on Wall Street and creates world-class investing tools for the self-directed investor on Main Street.
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Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, May 12, 2022
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BOSTON, May 12, 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 US Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of patients with Duchenne muscular dystrophy (DMD). 

Key Points: 
  • The company has previously presented data demonstrating that administration of elamipretide in combination with a PMO significantly improves dystrophin expression levels in the X-linked muscular dystrophy (mdx) mouse model.
  • "We are pleased that the FDA has recognized the high unmet need for innovative treatments for DMD," said Chief Executive Officer Reenie McCarthy.
  • Once granted, Orphan Drug Designation provides various development benefits for an investigational drug, including seven-year exclusivity after marketing approval is received.
  • Such forward-looking statements include those regardingStealth BioTherapeutics'expectations for elamipretide preclinical data and development efforts for Duchenne muscular dystrophy.

STEALTH BIOTHERAPEUTICS ANNOUNCES DATA FROM RECLAIM-2 PHASE 2 TRIAL OF ELAMIPRETIDE IN GEOGRAPHIC ATROPHY

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Monday, May 2, 2022
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BOSTON, May 2, 2022 /PRNewswire/ -- Stealth BioTherapeutics (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced top-line data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration.  Although the trial did not meet its primary endpoints assessing mean changes in LLVA and GA, a key secondary endpoint showed however that elamipretide categorically improved visual function for patients with GA.  Additionally, elamipretide demonstrated proof of mechanism by reducing progressive ellipsoid zone loss, a key biomarker of retinal mitochondrial health which has been shown to be predictive of long-term GA growth and development.  Based on these data, the Company currently plans to progress development initiatives intended to better position this indication for potential partnering consistent with previous guidance.

Key Points: 
  • ET
    BOSTON, May 2, 2022 /PRNewswire/ -- Stealth BioTherapeutics (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced top-line data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration.
  • Administration of elamipretide resulted in a 2 or more line gain in LLVA for greater than 15% of patients completing the 48-week trial (p=0.04).
  • Stealth will host a conference call and webcast today at 8:30 am ET to discuss the ReCLAIM-2 trial.
  • Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration (AMD), a leading cause of blindness.

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

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Thursday, March 24, 2022
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The poster presentation will showcase the potential effect of elamipretide and SBT-272 oncomplement gene expression and survival in a human iPSC-RPE cell model of dry age-related macular degeneration (AMD).

Key Points: 
  • The poster presentation will showcase the potential effect of elamipretide and SBT-272 oncomplement gene expression and survival in a human iPSC-RPE cell model of dry age-related macular degeneration (AMD).
  • Excessive activation of the complement system, which is a part of the body's immune system, is thought to drive the destruction of retinal cells leading to progressive visual decline and blindness in dry AMD.
  • 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.
  • Except as required by law, Stealth BioTherapeuticsdoes not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

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

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Wednesday, March 16, 2022
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The data were presented at the 2022 Muscular Dystrophy Association and Clinical and Scientific Conference, held in Nashville, TN.

Key Points: 
  • The data were presented at the 2022 Muscular Dystrophy Association and Clinical and Scientific Conference, held in Nashville, TN.
  • Mitochondrial dysfunction has been observed early in the progression of Duchenne muscular dystrophy (DMD) and contributes to impaired energy homeostasis and inflammatory signaling in DMD.
  • These data highlight combination therapy of a PMO and elamipretide as a potential treatment for patients with DMD.
  • Except as required by law,Stealth BioTherapeuticsdoes not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.