Stealth BioTherapeutics Corp (NASDAQ:MITO) Q4 2019 Earnings Conference Call - Final Transcript

Apr 01, 2020 • 08:30 am ET

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Stealth BioTherapeutics Corp (NASDAQ:MITO) Q4 2019 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Greetings and welcome to the Stealth BioTherapeutics Fiscal Year 2019 Financial Results and Recent Business Highlights Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Henry Hess, Chief Legal Counsel for Stealth BioTherapeutics. Thank you. You may begin.

Executive
Henry Hess

Good morning. I'd like to remind listeners that management will be making forward-looking statements on today's call, including, for example, expected timeline and plans for development of Elamipretide and other pipeline programs, expectations for discussions and possible opportunities with potential partners and collaborators, and discussions related to the company's financial position. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of Stealth's Form 20-F filed with the SEC on April 4, 2019. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so if our views change.

Now, I'd like to turn over the call to Reenie McCarthy, Stealth's CEO. Reenie?

Executive
Reenie McCarthy

Thank you, Henry, and thank you to everyone who has joined us this morning to review our full year financial results and recent corporate progress. With me today is Rob Weiskopf, our CFO; as well as Jim Carr, our Chief Clinical Development Officer; and Brian Blakey, our Chief Commercial Officer, in addition to Henry; and all of us will be available for question-and-answers.

I want to premise today's call by saying we're all working virtually, as I assume you are all as well. I hope everyone is faring well during these challenging times. Obviously, very challenging for some of the patient populations that we service as well.

We are off to a strong start in 2020 with a clear focus on advancing Elamipretide towards potential approval on Barth syndrome, an ultra-rare genetic condition characterized by cardiac abnormalities, often leading to heart failure, muscle weakness, recurrent infections, delayed growth and reduced life expectancy as a result of mitochondrial dysfunction.

We presented very strong data from our ongoing open label extension study early in the first quarter of last year at the American Society of Human Genetics 2019 Annual Meeting. That data demonstrated that treatment with Elamipretide resulted in a significant increase in average cardiac stroke volume. And more recently, we announced additional cardiac data at the American College of Cardiology 2020 Virtual Meeting, demonstrating significant improvements in left ventricular end-diastolic and end-systolic volumes, as well as trends in other cardiac parameters.

We also recently announced results from our SPIBA-001 natural history comparative control efficacy study in Barth patients, demonstrating a greater than 80 meter improvement in the primary endpoint of six-minute walk test at one year, compared to natural history controls with a p-value of 0.0005, as well as significant improvements in secondary endpoints of muscle strength by the time