Clearside Biomedical, Inc. (NASDAQ:CLSD) Q1 2019 Earnings Conference Call Transcript

May 08, 2019 • 08:30 am ET


Clearside Biomedical, Inc. (NASDAQ:CLSD) Q1 2019 Earnings Conference Call Transcript


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Good day, ladies and gentlemen and welcome to the Q1 2019 Clearside Biomedical, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Ms. Jenny Kobin, Clearside Investor Relations.

Jenny R. Kobin

Good morning, everyone, and thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. 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 our most recent annual report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 15, 2019, and our other SEC filings, all available on our website. In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as any subsequent date. While we may elect to update these forward-looking statements at some future point, we specifically disclaim any obligation to do so even if our views change.

On today's call, George Lasezkay, our interim Chief Executive Officer and member of the Board of Directors, will provide strategic updates. Dr. Tom Ciulla, our Chief Medical Officer, will highlight our recently presented data and current development plans. Brion Raymond, our Chief Commercial Officer, will review our plans for XIPERE. And Charlie Deignan, our Chief Financial Officer, will conclude the formal remarks with the financial summary. We will then open the call for your questions.

I would now like to turn the call over to George.

George M. Lasezkay

Thank you, Jenny. Good morning, everyone, and thank you for joining us on the call today. I'm pleased to join you today at this important stage in the evolution of Clearside. I joined the Board of Directors in 2017 with a very firm belief that our proprietary injection platform targeting the suprachoroidal space, or SCS, can have a profound impact on the treatment of patients suffering from vision-threatening eye diseases. Having worked with multiple biotechnology and pharmaceutical companies, I'm confident that Clearside is well positioned to bring our first product, XIPERE, to market if approved. Our new drug application for XIPERE, a suprachoroidal injection, is currently under review by the FDA for the treatment of macular edema associated with uveitis. This is a strategically focused indication for which there are currently no approved options. We can deploy a targeted approach to educating uveitis and retinal specialists on the potential benefits of XIPERE and our SCS injection platform. The PDUFA date for XIPERE is October 19, 2019. We are also planning