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 reported financial results for the three and six months ended June 30, 2019 and provided a corporate update, including the announcement of a new Board member, Dr. Louis G. Lange.
| BOSTON, Aug. 14, 2019 /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 reported financial results for the three and six months ended June 30, 2019 and provided a corporate update, including the announcement of a new Board member, Dr. Louis G. Lange. “As we move into the second half of 2019, we look forward to achieving key near-term milestones including completion of our Phase 3 study of elamipretide in primary mitochondrial myopathy, clarification around the path to registration for our Barth program, and progression of our next product candidate, SBT-272, into the clinic,” said Reenie McCarthy, Chief Executive Officer. “We’re also delighted to welcome Lou Lange to our Board of Directors, where his extensive scientific, industry, operating and investment experience will augment our efforts to bring first-in-class therapies to patients with rare mitochondrial diseases.” Recent Highlights
Other posters included presentations on the TAZPOWER design, TAZPOWER data, primary mitochondrial myopathy natural history, primary mitochondrial myopathy open-label extension data, and MMPOWER primary mitochondrial myopathy Phase 1/2 metabolomics data.
Key Upcoming Milestones
Financial Results for the Six Months Ended June 30, 2019 Cash Position: Cash and cash equivalents were $53.2 million at June 30, 2019, compared to $10.9 million at December 31, 2018. In February 2019, the Company raised $76.9 million in net proceeds from its initial public offering (IPO). Research and Development (R&D) Expenses: R&D expenses were $23.7 million for the six months ended June 30, 2019, compared to $25.5 million for the six months ended June 30, 2018. The decrease was primarily due to a $5.4 million decrease in clinical trial costs due to timing of trials that ended in 2018 and a $0.5 million decrease in discovery related expenses due to timing of activities, offset in part by increases of $1.6 million in headcount, $1.4 million in consulting related expenses related to the continued build-out of clinical, medical affairs and regulatory functions, and a $1.1 million increase in contract manufacturing expenses for NDA-enabling activities. General and Administrative (G&A) Expenses: G&A expenses were $10.2 million for the six months ended June 30, 2019, compared to $7.8 million for the six months ended June 30, 2018. The increase in administrative expenses was primarily attributable to an increase of $1.3 million in pre-commercial activities including market awareness and payer reimbursement activities, a $0.7 million increase in professional services for activities attributable to operating as a public company, and a net $0.4 million increase in headcount and consulting related expenses. Other Expense, Net: Other expense for the six months ended June 30, 2019 was $25.0 million, compared to $14.1 million for the six months ended June 30, 2018. The increase in other expense is primary attributable to a $22.7 million loss on extinguishment of debt recorded in conjunction with the IPO, offset by an $8.8 million change period over period in the fair value adjustments of the derivative liability associated with the convertible debt and a decrease in interest expense mostly related to the convertible debt of $2.9 million. Net Loss: Net loss for the six months ended June 30, 2019 was $58.9 million, or $0.18 basic and diluted net loss per ordinary share, as compared to $47.4 million for the comparable period of 2018, or $0.69 basic and diluted net loss per ordinary share. 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, collectively known as primary mitochondrial diseases, and are also involved in many common age-related diseases. We believe our lead product candidate, elamipretide, has the potential to treat both rare genetic and common age-related mitochondrial diseases. We are studying elamipretide in the following primary mitochondrial diseases: primary mitochondrial myopathy, Barth syndrome and Leber’s hereditary optic neuropathy. We are also studying elamipretide in dry age-related macular degeneration. Our other pipeline candidates include SBT-272, which we are evaluating for rare neurodegenerative disease indications, and SBT-20, which we are evaluating for rare peripheral neuropathies. We have optimized our discovery platform to identify novel mitochondrial-targeted compounds, which may be nominated as therapeutic product candidates or utilized as scaffolds to deliver other compounds to mitochondria. We have assembled a highly experienced management team, board of directors and group of scientific advisors to help us achieve our mission of leading mitochondrial medicine. 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, including its ongoing clinical trials of elamipretide and planned clinical trial of SBT-272; the potential benefits of Stealth BioTherapeutics’ product candidates; its key milestones for 2019; and its plans regarding future data presentations and regulatory interactions. 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; 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 U.S. 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; 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 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. Media Relations Investor Relations
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