MITO Stealth BioTherapeutics Corp.

1.46
+0.05  (+4%)
Previous Close 1.41
Open 1.41
52 Week Low 1.06
52 Week High 2.58
Market Cap $84,070,910
Shares 57,582,815
Float 57,582,815
Enterprise Value $50,695,316
Volume 152,704
Av. Daily Volume 336,697
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Upcoming Catalysts

Drug Stage Catalyst Date
Elamipretide (ReCLAIM-2)
Geographic atrophy / Age-related macular degeneration (AMD)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Elamipretide
Barth
NDA Filing
NDA Filing
Phase 2/3 trial did not meet primary endpoint December 2018. NDA filed August 24, 2021.
Elamipretide
Friedreich's ataxia
Phase 2a
Phase 2a
Phase 2a trial to commence 2H 2021.
Elamipretide
Mitochondrial disease associated with pathogenic nDNA mutations (nPMD)
Phase 3
Phase 3
Phase 3 trial to be initiated by end of 2021.
SBT-272
Rare neurodegenerative diseases
Phase 1
Phase 1
Phase 1 trial initiation announced January 21, 2020.

Latest News

  1. 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. These abstracts feature novel clinical findings from the positive ReCLAIM trial, which evaluated elamipretide in patients with dry age-related macular degeneration (AMD), as well as clinical updates from the ongoing ReCLAIM-2 study in patients with extrafoveal, or non-central, geographic atrophy (GA) due to dry AMD. The design and inclusion criteria for ReCLAIM-2 were…

    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. These abstracts feature novel clinical findings from the positive ReCLAIM trial, which evaluated elamipretide in patients with dry age-related macular degeneration (AMD), as well as clinical updates from the ongoing ReCLAIM-2 study in patients with extrafoveal, or non-central, geographic atrophy (GA) due to dry AMD. The design and inclusion criteria for ReCLAIM-2 were informed by the positive signals in patients with extrafoveal GA enrolled in the ReCLAIM study, which also demonstrated that patients with better baseline mitochondrial health experienced greater improvements in visual function following six months of elamipretide therapy. 

    "GA is a progressively blinding disease which contributes to a loss of independence for affected individuals," said Chief Executive Officer Reenie McCarthy. "Our mitochondria-targeted therapeutic approach offers the potential to not only slow the progression of retinal cell death, but to possibly reclaim visual function and associated visual quality of life. We believe that mitochondrial health is central to the bioenergetic deficit that drives downstream pathology in this devastating disease, and these data continue to support elamipretide's potential to improve visual health for patients suffering from GA."

    Details of the presentations are as follows:

    EURETINA 2021 Virtual Congress: September 9-12, 2021

    Title: Subcutaneous Elamipretide for non-central geographic atrophy: Findings from the ReCLAIM study

    Details: The pre-recorded presentation can be found on the Presentation section of Stealth's website at https://www.stealthbt.com/presentations/ 

    Presenter: David Boyer, M.D.

    Annual Scientific Session of The Retina Society: September 29-October 2, 2021

    Title: Low-Luminance Visual Acuity and the Association of Ellipsoid Zone Integrity in Dry AMD Patients Treated with Subcutaneous Elamipretide: Post Hoc Analysis of the Phase 1 ReCLAIM-1 Study

    Details: Thursday, September 30, 9:27-9:31 AM Central Daylight Time

    Presenter: Dante Pieramici, M.D.

    American Society of Retina Specialist (ASRS) Annual Scientific Meeting: October 8-12, 2021

    Title: Safety and Efficacy of SC Elamipretide to Treat Noncentral Geographic Atrophy: ReCLAIM-1 Results and Phase II ReCLAIM-2 Baseline Characteristics

    Details: Monday, October 11, 10:28–10:34 AM Central Daylight Time

    Presenter: David Lally, M.D.

    Title: Advanced OCT Analysis for Treatment Response Assessment for Non-neovascular AMD Treated with Subcutaneous Elamipretide from the Phase 1 ReCLAIM Study

    Author: Hasan Cetin MD, Justis Ehlers MD, et. al.

    American Academy of Ophthalmology (AAO) 2021: November 12-15, 2021

    Title: Subcutaneous Elamipretide to Treat Non-Central Geographic Atrophy: Findings from ReCLAIM-1

    Details: Presentation will be available on demand for conference attendees

    Presenter: Mark Barakat, M.D.

    About ReCLAIM and ReCLAIM-2

    ReCLAIM-2 is a phase 2 randomized, double-masked, placebo-controlled study to evaluate the efficacy and pharmacokinetics of elamipretide in patients with dry age-related macular degeneration (AMD) with extrafoveal, or non-central, geographic atrophy (GA). The ReCLAIM-2 study completed enrollment with 176 patients. The primary endpoint of the 48-week study will measure low-luminance best-corrected visual acuity (LLVA), which assesses visual function under low light conditions meant to represent dusk or indoor (artificial) lighting. Secondary functional endpoints are change in low-luminance reading acuity and best-corrected visual acuity (BCVA), as well as patient-reported assessments of visual quality of life. Secondary imaging endpoints assessing the rate of progression of the disease include GA area as measured by fundus autofluorescence and optical coherence tomography (OCT).

    ReCLAIM was a Phase 1 clinical trial which enrolled 40 patients with dry AMD with either extrafoveal, or non-central, GA or high-risk drusen to receive elamipretide therapy for 24 weeks.  The data showed improvements from baseline in LLVA and BCVA for patients with GA and drusen who completed the trial. Visual quality of life improvement under both low light and ordinary light conditions were also reported. Additionally, the rate of progression of GA was reduced relative to both the reported natural history of the disease and the six-month results reported by other agents in late-stage development.

    About Stealth

    We are 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. Dysfunctional mitochondria characterize a number of rare genetic diseases and are involved in many common age-related diseases, typically involving organ systems with high energy demands such as the heart, the eye, and the brain. We believe our lead product candidate, elamipretide, has the potential to treat both rare metabolic cardiomyopathies, such as Barth syndrome, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber's hereditary optic neuropathy. We are evaluating our second-generation clinical-stage candidate, SBT-272, and our new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data. We have optimized our discovery platform to identify novel mitochondria-targeted compounds which may be nominated as therapeutic product candidates or utilized as mitochondria-targeted vectors to deliver other compounds to mitochondria.

    Investor Relations

    Stern Investor Relations

    Janhavi Mohite, 212-362-1200

    IR@StealthBT.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/stealth-biotherapeutics-to-showcase-leadership-in-retinal-mitochondrial-health-with-clinical-updates-at-ophthalmic-conferences-301375841.html

    SOURCE Stealth BioTherapeutics Corp

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  2. 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. Wainwright 23rd Annual Global Investment Conference. Pre-recorded presentation available for on-demand viewing starting on Monday, September 13 at 7:00 a.m. ET.
    • Cantor Global Healthcare Conference. Fireside chat on Thursday, September 30 at 11:20 a.m. ET.

    A live audio webcast of the presentations will be available on the Investors & News section of Stealth's website at https://investor.stealthbt.com/. A replay of the webcasts will be archived on Stealth's website for 30 days following the event.

    About Stealth

    We are 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. Dysfunctional mitochondria characterize a number of rare genetic diseases and are involved in many common age-related diseases, typically involving organ systems with high energy demands such as the heart, the eye, and the brain. We believe our lead product candidate, elamipretide, has the potential to treat both rare metabolic cardiomyopathies, such as Barth syndrome, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber's hereditary optic neuropathy. We are evaluating our second-generation clinical-stage candidate, SBT-272, and our new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data. We have optimized our discovery platform to identify novel mitochondria-targeted compounds which may be nominated as therapeutic product candidates or utilized as mitochondria-targeted vectors to deliver other compounds to mitochondria.

    Investor Relations

    Stern Investor Relations

    Janhavi Mohite, 212-362-1200

    IR@StealthBT.com 

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/stealth-biotherapeutics-to-present-at-upcoming-september-virtual-investor-conferences-301370687.html

    SOURCE Stealth BioTherapeutics Inc.

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  3. BOSTON, Aug. 24, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Adminstration (FDA) for elamipretide, the company's lead product candidate, for the treatment of Barth syndrome, an ultra-rare genetic condition with no FDA- or EMA-approved therapies.

    "Children and young adults affected by Barth syndrome are suffering from life limiting, progressive cardiomyopathy, exercise intolerance, and debilitating fatigue for which there are no approved treatment options," said Chief Executive Officer Reenie McCarthy. "We initiated our Barth syndrome development efforts at the request of the Barth syndrome community. We respect the patient community's perspective regarding its tolerance for some uncertainty of benefit in considering therapies for this ultra rare disease, and with our NDA submission, have answered its petition that we submit our application. We know that the FDA has similarly heard the voice of these patients, and we look forward to continued dialogue with the FDA as it evaluates our submission for filing and review."

    The NDA submission is based on results from the SPIBA-001 Phase 3 Retrospective Natural History Control Trial, which compared data from the open-label portion of the TAZPOWER Phase 2/3 clinical trial to matched natural history controls. SPIBA-001 met its primary and most secondary endpoints, demonstrating elamipretide-mediated improvements in assessments of exercise tolerance, strength and cardiac function that are unexpected in the natural course of this progressively debilitating disease. In addition, improvements were observed during the TAZPOWER Phase 2/3 clinical trial and open label extension in several surrogate and intermediate clinical endpoints that may be reasonably likely to predict clinical benefit for patients suffering from this serious disease, potentially supporting an accelerated approval pathway. Although the FDA has recommended that additional controlled data be generated to support NDA review, neither the FDA nor the Company has identified a feasible trial design due to the ultra-rare nature of this disease. In light of FDA's view that the existing clinical data are insufficient to demonstrate substantial evidence of effectiveness and would not support NDA review, there is no assurance that the FDA will file the NDA. Stealth believes, however, that the data could support an NDA review, and has accordingly submitted the NDA as requested by the Barth syndrome patient community.

    Elamipretide was previously granted rare pediatric designation, fast track designation, and orphan drug designation by the FDA, and orphan drug designation by the EMA, for the treatment of Barth Syndrome.  

    About 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. Barth syndrome occurs almost exclusively in males and is estimated to affect one in 200,000 to 400,000 individuals worldwide. There are currently no FDA- or EMA-approved therapies for patients with Barth syndrome.

    About Stealth

    We are 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. Dysfunctional mitochondria characterize a number of rare genetic diseases and are involved in many common age-related diseases, typically involving organ systems with high energy demands such as the heart, the eye, and the brain. We believe our lead product candidate, elamipretide, has the potential to treat both rare metabolic cardiomyopathies, such as Barth, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber's hereditary optic neuropathy. We are evaluating our second-generation clinical-stage candidate, SBT-272, and our new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data. We have optimized our discovery platform to identify novel mitochondria-targeted compounds which may be nominated as therapeutic product candidates or utilized as mitochondria-targeted vectors to deliver other compounds to mitochondria.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Stealth BioTherapeutics' plans, strategies and expectations for its preclinical and clinical advancement of its drug development programs; its expectations regarding regulatory interactions, including its belief that the existing data may provide sufficient evidence to support NDA review; and the potential benefits of Stealth BioTherapeutics' product candidates. Statements that are not historical facts, including statements about Stealth BioTherapeutics' beliefs, plans and expectations, are forward-looking statements. The words "anticipate," "expect," "hope," "plan," "potential," "possible," "will," "believe," "estimate," "intend," "may," "predict," "project," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Stealth BioTherapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of known and unknown risks, uncertainties and other important factors, including: Stealth BioTherapeutics' ability to obtain additional funding and to continue as a going concern; the impact of the COVID-19 pandemic; the ability to successfully demonstrate the efficacy and safety of Stealth BioTherapeutics' product candidates and future product candidates; the preclinical and clinical results for Stealth BioTherapeutics' product candidates, which may not support further development and marketing approval; the potential advantages of Stealth BioTherapeutics' product candidates; the content and timing of decisions made by the FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Stealth BioTherapeutics product candidates;  the possibility that the FDA will not file the Barth NDA for review; Stealth BioTherapeutics' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Stealth BioTherapeutics' ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in the Stealth BioTherapeutics' most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC"), as well as in any future filings with the SEC. Forward-looking statements represent management's current expectations and are inherently uncertain. 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.

    Investor Relations

    Stern Investor Relations

    Janhavi Mohite, 212-362-1200

    IR@StealthBT.com 

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/stealth-biotherapeutics-submits-elamipretide-new-drug-application-to-fda-for-treatment-of-barth-syndrome-301361153.html

    SOURCE Stealth BioTherapeutics Inc.

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  4. BOSTON, Aug. 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, today announced that the United States Patent and Trademark Office has issued patents for Stealth's lead product candidate, elamipretide, in the U.S. covering the treatment of Barth syndrome and Barth syndrome-related cardiomyopathy until February 2034.

    U.S. Patent Numbers 11,083,771 and 11,083,772, were granted on August 10, 2021, and include claims for the administration of elamipretide for treating Barth syndrome and Barth syndrome-related cardiomyopathy, respectively.

    "This expansion of the breadth and depth of our intellectual property portfolio further demonstrates our commitment to developing elamipretide for the treatment of Barth syndrome," said Chief Executive Officer Reenie McCarthy. "We look forward to working with the FDA as it evaluates our August NDA submission. We are also excited about the potential of elamipretide to address unmet needs for patients living with other rare metabolic cardiomyopathies."

    About 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. Barth syndrome occurs almost exclusively in males and is estimated to affect one in 200,000 to 400,000 individuals worldwide. There are currently no FDA- or EMA-approved therapies for patients with Barth syndrome.

    About Stealth

    We are 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. Dysfunctional mitochondria characterize a number of rare genetic diseases and are involved in many common age-related diseases, typically involving organ systems with high energy demands such as the heart, the eye, and the brain. We believe our lead product candidate, elamipretide, has the potential to treat both rare metabolic cardiomyopathies, such as Barth, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber's hereditary optic neuropathy. We are evaluating our second-generation clinical-stage candidate, SBT-272, and our new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data. We have optimized our discovery platform to identify novel mitochondria-targeted compounds which may be nominated as therapeutic product candidates or utilized as mitochondria-targeted vectors to deliver other compounds to mitochondria.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Stealth BioTherapeutics' expectations for its preclinical and clinical advancement of its drug development programs; its expectations regarding regulatory interactions; and the potential benefits of Stealth BioTherapeutics' product candidates. Statements that are not historical facts, including statements about Stealth BioTherapeutics' beliefs, plans and expectations, are forward-looking statements. The words "anticipate," "expect," "hope," "plan," "potential," "possible," "will," "believe," "estimate," "intend," "may," "predict," "project," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Stealth BioTherapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of known and unknown risks, uncertainties and other important factors, including: Stealth BioTherapeutics' ability to obtain additional funding and to continue as a going concern; the impact of the COVID-19 pandemic; the ability to successfully demonstrate the efficacy and safety of Stealth BioTherapeutics' product candidates and future product candidates; the preclinical and clinical results for Stealth BioTherapeutics' product candidates, which may not support further development and marketing approval; the potential advantages of Stealth BioTherapeutics' product candidates; the content and timing of decisions made by the FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Stealth BioTherapeutics product candidates;  the possibility that the FDA will not file the Barth NDA following the Company's submission of it;  Stealth BioTherapeutics' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Stealth BioTherapeutics' ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in the Stealth BioTherapeutics' most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC"), as well as in any future filings with the SEC.  Forward-looking statements represent management's current expectations and are inherently uncertain. 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.

    Investor Relations

    Stern Investor Relations

    Janhavi Mohite, 212-362-1200

    IR@StealthBT.com 

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/stealth-biotherapeutics-strengthens-ip-portfolio-with-issuance-of-us-patents-covering-elamipretide-for-barth-syndrome-301360285.html

    SOURCE Stealth BioTherapeutics Inc.

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  5. BOSTON, Aug. 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 announced that Reenie McCarthy, CEO, will present at the H.C. Wainwright Ophthalmology Virtual Conference on Tuesday, August 17, 2021 at 7:00 a.m. ET. Additionally, Stealth's management will also participate in H.C. Wainwright's "Addressing Unmet Medical Needs in Macular Degeneration – Dry AMD and Stargardt Disease" panel at the event on August 17, 2021 at 11:00 a.m. ET.

    A live audio webcast of the presentation will be available on the Investors & News section of Stealth's website at https://investor.stealthbt.com/. A replay of the webcast will be archived on Stealth's website for 30 days following the event.

    About Stealth

    We are 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. Dysfunctional mitochondria characterize a number of rare genetic diseases and are involved in many common age-related diseases, typically involving organ systems with high energy demands such as the heart, the eye, and the brain. We believe our lead product candidate, elamipretide, has the potential to treat both rare metabolic cardiomyopathies, such as Barth, Duchenne muscular dystrophy and Friedreich's ataxia, rare mitochondrial diseases entailing nuclear DNA mutations, as well as ophthalmic diseases entailing mitochondrial dysfunction, such as dry age-related macular degeneration and Leber's hereditary optic neuropathy. We are evaluating our second-generation clinical-stage candidate, SBT-272, and our new series of small molecules, SBT-550, for rare neurological disease indications following promising preclinical data. We have optimized our discovery platform to identify novel mitochondria-targeted compounds which may be nominated as therapeutic product candidates or utilized as mitochondria-targeted vectors to deliver other compounds to mitochondria.

    Investor Relations

    Stern Investor Relations

    Janhavi Mohite, 212-362-1200

    IR@StealthBT.com 

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/stealth-biotherapeutics-to-present-at-hc-wainwright-ophthalmology-virtual-healthcare-conference-301352781.html

    SOURCE Stealth BioTherapeutics Inc.

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