MITO - MITO STOCK NEWS

Stealth BioTherapeutics Corp (Nasdaq: MITO) has presented new data from the Phase 1 ReCLAIM study at the 2021 ARVO Annual Meeting, focusing on elamipretide for patients with geographic atrophy (GA) related to dry age-related macular degeneration (AMD). The study revealed significant correlations between improvements in low-light visual acuity (LLVA) and mitochondrial health assessments. CEO Reenie McCarthy expressed optimism about potential clinical trial enrichment strategies based on these findings. Elamipretide has Fast Track designation from the FDA for the treatment of dry AMD with GA.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a poster presentation at the 2021 ARVO Virtual Annual Meeting from May 1-7, 2021. The presentation highlights data supporting elamipretide's mechanism of action and backs the ReCLAIM-2 Phase 2 trial, focused on geographic atrophy in dry age-related macular degeneration. Enrollment for ReCLAIM-2, involving 176 patients, has been completed. Key outcomes will assess low-luminance best-corrected visual acuity over 48 weeks, along with secondary endpoints measuring disease progression.

Stealth BioTherapeutics (Nasdaq: MITO) announced that CEO Reenie McCarthy will deliver a keynote speech at the Mitochondria-Targeted Drug Development Digital Summit on April 28, 2021. The presentation will explore the advancements in mitochondrial medicine addressing rare genetic and common age-related diseases. Stealth will also present an abstract showcasing the significance of longitudinal natural history data in evaluating clinical trial outcomes for ultra-rare conditions. The content will be accessible to conference attendees through the event's website.

Stealth BioTherapeutics Corp (Nasdaq: MITO) reported its financial results for 2020, revealing a cash position of $32.8 million, down from $50.8 million in 2019. The company did not generate any revenue in 2020, compared to $21.1 million in 2019 due to the termination of an agreement with Alexion. R&D expenses decreased to $29.3 million, while G&A expenses fell to $19.4 million. Upcoming milestones include Phase 2 data from geographic atrophy trials expected in Q2 2022 and ongoing discussions with the FDA regarding its Barth syndrome NDA.

Stealth BioTherapeutics Corp (Nasdaq: MITO) will announce its full year 2020 financial results on April 6, 2021, before market opening. A conference call will follow at 8:30 am ET to discuss the results and provide a business update, accessible through dedicated phone lines and a live audio webcast. The company is focused on developing therapies for mitochondrial dysfunction, with key candidates including elamipretide for rare diseases and SBT-272 for neurodegenerative conditions. The firm aims to lead advancements in mitochondrial medicine.

Stealth BioTherapeutics (Nasdaq: MITO) announced the promotion of Marty Redmon, Ph.D., to Chief Research & Development Officer, effective immediately. Marty has over 25 years of experience in pharmaceutical R&D and has significantly contributed to the company's pipeline, notably in developing therapies for mitochondrial dysfunction and preparing for a New Drug Application submission. His leadership has generated promising preclinical data for candidates SBT-272 and SBT-550. This strategic move is expected to enhance the company’s development efforts and scientific excellence.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that CEO Reenie McCarthy will present at two virtual investor conferences in March 2021. The first is the H.C. Wainwright Global Life Sciences Conference on March 9 at 7:00 a.m. ET, followed by Oppenheimer's 31st Annual Healthcare Conference on March 17 at 10:40 a.m. ET. Live audio webcasts will be available on Stealth's website, with replays archived for 30 days. Stealth focuses on therapies for diseases related to mitochondrial dysfunction, with significant product candidates including elamipretide and SBT-272.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced the completion of patient enrollment for the ReCLAIM-2 clinical study. The study evaluates the efficacy of elamipretide in treating dry age-related macular degeneration (AMD) with geographic atrophy. Top-line data are expected in the first half of 2022. The trial enrolled 176 patients, with a primary endpoint focused on low-luminance visual acuity. Successful completion of enrollment also unlocks $10 million in additional funding for the company.

Stealth BioTherapeutics Corp (MITO) announced a registered direct offering of 2,339,000 American Depositary Shares (ADSs) at $2.00 each, aiming to raise approximately $4.7 million. The funds will support the clinical development of elamipretide and provide general corporate working capital. H.C. Wainwright & Co. is the exclusive placement agent for the offering. The ADSs are being offered under a previously filed shelf registration statement. The closing is expected on February 11, 2021, subject to customary conditions.