Welcome to our dedicated page for Stealth Biotherapeutics news (Ticker: MITO), a resource for investors and traders seeking the latest updates and insights on Stealth Biotherapeutics stock.
Stealth BioTherapeutics Corp (MITO) has been the subject of news coverage centered on its mitochondria-targeted drug pipeline, regulatory milestones, and corporate transactions. Historically described as a clinical-stage biotechnology company, Stealth has focused on developing therapies for diseases involving mitochondrial dysfunction in high-energy organs such as the heart, eye, neuromuscular system, and brain.
News about Stealth has included clinical and regulatory updates for its lead candidate elamipretide, including interactions with the U.S. Food & Drug Administration (FDA) regarding Barth syndrome and other indications. Earlier releases detailed pre-NDA discussions and long-term clinical data in Barth syndrome, while a later announcement from Stealth BioTherapeutics Inc. reported that FORZINITY (elamipretide) injection received accelerated approval from the FDA as the first treatment for Barth syndrome and the first FDA-approved mitochondria-targeted therapeutic.
Coverage has also highlighted the company’s second-generation candidate SBT-272, with Phase 1 safety and tolerability results and preclinical data in amyotrophic lateral sclerosis (ALS) and other neurodegenerative disease models. Stealth has reported Orphan Drug Designation for SBT-272 for the treatment of ALS and presented data at scientific conferences focused on ALS and neurodegenerative disease research.
Corporate and capital markets developments are another recurring theme. In 2022, Stealth issued multiple releases about a preliminary non-binding proposal, a definitive agreement for a going-private transaction, and the subsequent completion of a merger that resulted in the company becoming privately held and its ADSs being delisted from the Nasdaq Global Market. Earlier communications also addressed a Nasdaq non-compliance notice related to listing requirements.
Investors and researchers using this news page can review historical announcements on clinical progress, FDA designations and meetings, ultra-rare disease engagement, and the steps leading to Stealth’s transition from a Nasdaq-listed issuer under the MITO symbol to a privately held biotechnology company.
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.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that it will report its third quarter 2021 financial results on November 11 before the market opens. A conference call will take place at 8:30 am ET to discuss the results and provide a business update. Investors can listen to the call by dialing (877)-407-0989 or accessing a live audio webcast on the company's investor website. Stealth is focused on therapies for mitochondrial dysfunction, with its lead product candidate, elamipretide, targeting rare diseases linked to this condition.
Stealth BioTherapeutics Corp (Nasdaq: MITO) received a Refusal to File letter from the FDA concerning its New Drug Application for elamipretide, a treatment for Barth syndrome. The FDA noted that the NDA lacked adequate evidence of effectiveness, citing negative results from the SPIBA-201 Phase 2 trial. While the FDA is open to discussing pathways for demonstrating elamipretide's benefits, the company is evaluating its next steps and plans to provide updates in November. Elamipretide holds various designations from the FDA and EMA for Barth syndrome, which affects fewer than 130 individuals in the U.S.
Stealth BioTherapeutics Corp (Nasdaq: MITO) presented promising data on SBT-272 at the 2021 NEALS Meeting. The study evaluated its effects on mitochondrial function in a murine model of ALS, revealing that SBT-272 crosses the blood-brain barrier and mitigates ischemic stress. The preclinical results showed improved mitochondrial motility and morphology, which correlated with enhanced axon outgrowth in neurons. CEO Reenie McCarthy expressed optimism about advancing SBT-272 towards Phase 1 clinical studies in the coming year, further supporting its potential as a therapy for neurodegenerative diseases.
Horizon Technology Finance Corporation (NASDAQ: HRZN) reported strong performance for Q3 2021, achieving a record $141 million in loan originations, with $99 million attributed to HRZN. The portfolio ended with a committed backlog of $123 million, reflecting robust demand for venture loans. During the quarter, HRZN received $50 million in loan prepayments, boosting fee and interest income. The company closed new loan commitments totaling $91 million, with a significant pipeline of opportunities, suggesting ongoing growth potential for shareholders.
Stealth BioTherapeutics (Nasdaq: MITO) completed a $25 million long-term debt facility with Horizon Technology Finance (Nasdaq: HRZN), drawing down $15 million initially. An additional $10 million is contingent on achieving a predetermined milestone. This financing aims to support ongoing clinical trials, including a recent NDA submission for Barth syndrome under FDA review. The facility includes terms for monthly repayments over 48 months, with a potential extension for the interest-only period. Stealth has issued warrants for 13,636,364 shares to Horizon at $0.11 per share.
Stealth BioTherapeutics (Nasdaq: MITO) announced promising preclinical data for SBT-272, a novel therapy for Parkinson's disease (PD), presented at the International Parkinson and Movement Disorder Society Virtual Congress 2021. In a murine model, SBT-272 protected against dopaminergic neuron loss and reduced neuroinflammation markers. Additionally, a collaborative study showed that SBT-272 safeguarded brain mitochondria following ischemic stroke. These findings support advancing SBT-272 into Phase 1 clinical trials in 2022, reinforcing its potential as a treatment for neurodegenerative diseases.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced the acceptance of multiple abstracts at leading ophthalmic conferences this fall, showcasing positive outcomes from the ReCLAIM trial. This trial evaluated elamipretide for patients with dry age-related macular degeneration (AMD) and highlighted its potential to improve visual function in patients with good mitochondrial health. The ReCLAIM-2 study, involving 176 patients, aims to assess elamipretide's efficacy in treating extrafoveal geographic atrophy (GA). The CEO emphasized the importance of mitochondrial health in combating retinal cell death.
Stealth BioTherapeutics Corp (MITO) announced that CEO Reenie McCarthy will present at two virtual investor conferences in September 2021. The presentations will include a pre-recorded segment at the H.C. Wainwright 23rd Annual Global Investment Conference, available on-demand starting September 13, and a live fireside chat at the Cantor Global Healthcare Conference on September 30.
Stealth focuses on developing therapies for mitochondrial dysfunction, with candidates like elamipretide targeting rare diseases and ophthalmic conditions.
Stealth BioTherapeutics Corp (Nasdaq: MITO) has submitted a New Drug Application (NDA) to the FDA for its lead product candidate, elamipretide, to treat Barth syndrome, an ultra-rare genetic disorder with no existing FDA- or EMA-approved options. This submission follows positive results from the SPIBA-001 clinical trial, which showed significant improvements in exercise tolerance and cardiac function. The company aims for dialogue with the FDA, acknowledging the existing data may not meet all the requirements for approval, but believes in its potential.
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