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Stealth BioTherapeutics Corp (Nasdaq:MITO), a biotechnology firm focused on therapies for mitochondrial dysfunction, announced CEO Reenie McCarthy will present at three investor conferences in March 2022. These include the Oppenheimer 32nd Annual Healthcare Conference on March 15, the 34th Annual Roth Conference also on March 15, and the Maxim Group 2022 Virtual Growth Conference from March 28 to March 30. Webcasts of the presentations will be available on Stealth's website for 30 days post-event, highlighting the company’s lead candidate, elamipretide, targeting mitochondrial-related diseases.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced that CEO Reenie McCarthy will present at the Mitochondria-Targeted Drug Development Summit on February 24, 2022, at 9:00 a.m. ET. The presentation will focus on mitochondrial dysfunction in ophthalmic diseases, including dry AMD and diabetic retinopathy, showcasing preclinical data on elamipretide's effects. Clinical data indicate a potential predictive relationship between baseline function and therapeutic response in dry AMD patients. More details are available at mitochondria-targets.com.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced the completion of treatment for the final patient in its ReCLAIM-2 phase 2 clinical trial targeting extra-foveal geographic atrophy (GA) due to dry age-related macular degeneration (AMD). The trial involved 176 subjects and assessed the efficacy and safety of elamipretide. Following positive results from a prior phase 1 trial, topline results are expected in Q2 2022. GA affects over five million people globally, with no approved treatments currently available.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced on February 11, 2022, that it is not in compliance with Nasdaq's minimum Market Value of Publicly Held Shares requirement. This notification follows a review of the company's MVPHS for the 30 consecutive business days leading up to February 10, 2022. The notice does not affect the trading of the company's ADSs, which will continue on Nasdaq. Stealth has a 180-day compliance period to regain compliance, requiring a minimum MVPHS of $15 million for ten consecutive days.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced an oral presentation at the 2022 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, scheduled for March 13-16, 2022, in Nashville, Tennessee. The presentation will discuss how elamipretide may enhance the therapeutic effects of an exon skipping PMO in a mouse model of X-linked muscular dystrophy. Reenie McCarthy, CEO, expressed optimism about advancing clinical development to improve treatments for Duchenne muscular dystrophy.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced on January 7, 2022, that it received notifications from Nasdaq regarding non-compliance with minimum bid price and market value requirements. The company's ADSs fell below $1.00 and $50 million respectively for over 30 consecutive business days. Stealth has a compliance period until July 5, 2022, to rectify these issues. If compliance is not achieved, the company may receive a notification for delisting. Despite these concerns, the company's shares will continue trading on Nasdaq under the ticker MITO.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that CEO Reenie McCarthy will present at the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. The presentation will be available for on-demand viewing starting January 10 at 7:00 a.m. ET on the company's website. Stealth focuses on therapies for mitochondrial dysfunction, with lead candidate elamipretide targeting conditions like Barth syndrome and age-related diseases. The company is also developing second-generation candidate SBT-272 and new compounds SBT-550 for neurological diseases.
Stealth BioTherapeutics (Nasdaq: MITO) announced a positive update from its pre-IND meeting with the FDA regarding its Duchenne muscular dystrophy (DMD) program. The FDA's Division of Cardiology and Nephrology approved Stealth's proposal to assess myocardial fibrosis as a surrogate endpoint for their upcoming clinical trial. This is critical as heart failure is a leading cause of mortality in DMD. The company aims to submit an IND in the first half of the year and initiate trials later, pending regulatory feedback. New preclinical data shows elamipretide may enhance dystrophin expression.
Stealth BioTherapeutics Corp (NASDAQ: MITO) recently updated investors on its clinical programs for rare diseases involving mitochondrial dysfunction. The early data indicates elamipretide, in combination with a PMO, significantly enhances dystrophin expression in a mouse model of Duchenne muscular dystrophy (DMD). The company is on track to initiate its Phase 3 NuPOWER trial for patients with nuclear DNA mutations causing mitochondrial myopathy. Discussions with DCN regarding the Barth syndrome development program are progressing positively, with expectations for regulatory feedback soon.
Stealth BioTherapeutics Corp (Nasdaq:MITO) reported third-quarter financial results for 2021, showing a net loss of $6.3 million, or $0.01 per share, an improvement from $11.2 million or $0.02 per share in Q3 2020. The company is optimistic about elamipretide's potential for treating geographic atrophy with ReCLAIM-2 data expected in early 2022. However, they faced a setback when the FDA declined to file their NDA for Barth syndrome. Stealth retains a cash position of $42.3 million, expected to fund operations into Q3 2022.
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