Stealth BioTherapeutics Corp (MITO) stock prices were up by a colossal 35% as of the market closing on May 6th, 2021, bringing the price per share up to USD$1.62. Subsequent pre-market fluctuations saw the price fall by 11.11%, bringing it down to USD$1.44.
Collaboration with DCN
The company reported having convened with the Division of Cardiology and Nephrology (DCN) to discuss the forecasted submission of a New Drug Application (NDA). Having discussed MITO’s Barth development program for the treatment of cardiomyopathy in Barth syndrome, the two entities met again in February 2021 and early April 2021 to further explore the program and its NDA submission.
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NDA Rejection
As it stands the FDA deemed the existing clinical date available to be inadequate in the demonstration of substantial evidence of the effectiveness of MITO’s program, and, therefore, do not warrant an NDA review. The U.S. Food and Drug Administration did, however, suggest options for the company to pursue in the generation of additional data that could support MITO’s push for NDA approval.
ReCLAIM-2 Trial Milestone
February 2021 saw the announcement of the completion of enrollment of ReCLAIM-2 Phase 2b trial patients, culminating with 176 patients with geographic atrophy. MITO presented the design and preliminary baseline demographics for the ReCALIM-2 trial in February 2021.
Development Funding Agreement
The achievement of this milestone resulted in an addition USD$10 million tranche of development funding as per the Development Funding Agreement announced in November 2020. The Agreement to support the clinical trial of elamipretide was first closed in November 2020. In total, the company has collected USD$30 million to date and is qualified to be granted an additional USD$5 million following the NDA submission for the treatment of cardiomyopathy in Barth syndrome.
Solid Liquidity Position
Also in November of the fiscal year 2020, the company closed a registered direct offering that saw the company generate USD$3.2 million. The proceeds came from the sale of 2,844,446 American Depositary Shares (ADSs). Another registered direct offering was conducted in February 2021, with the company offering 2,339,000 ADSs to facilitate the generation of gross proceeds amounting to USD$4.7 million. As of December 31st, 2020, MITO reported USD$32.8 million in cash and cash equivalents.
Future Outlook for MITO
Having been given direction by the FDA, MITO is strategizing its next steps to facilitate the commercialization of its treatment for cardiomyopathy in Barth syndrome. Armed with a solid liquidity position, current and potential investors are hopeful that MITO can effectively leverage its resources to facilitate further growth and increases in shareholder value.