Chiasma, Inc. (NASDAQ:CHMA) Q1 2019 Earnings Conference Call Transcript
May 09, 2019 • 05:00 pm ET
Ladies and gentlemen, greetings and welcome to the Chiasma Inc. First Quarter 2019 Earnings Conference Call. At this time all participants are in a listen only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this program is being recorded. It is my pleasure to introduce your host, Glenn Garmont, of LifeSci Advisors. Thank you. You may begin.
Pardon me Glenn, perhaps your line is on mute.
Thank you, operator. Good afternoon, and welcome to the Chiasma First Quarter 2019 Financial and Operating Results Conference Call. Before we begin, today, we will be making certain forward-looking statements about events and circumstances, including, but not limited to, statements regarding development of octreotide capsules, our expectations on timing of release of clinical data and regulatory submissions, our plans to seek regulatory approval in the United States and European Union and our anticipated cash runway.
These statements are based on current expectations. Actual results may differ materially due to numerous risks and uncertainties, including those detailed in the risk factors section of our Form 10-K filed with the SEC for the year ended December 31, 2018, as well as our subsequent filings with the SEC. Chiasma disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events or otherwise.
And now, I would like to turn the call over to Chiasma's President and Chief Executive Officer, Mark Fitzpatrick. Mark?
Mark J. Fitzpatrick
Thank you, Glenn. And thank you, everyone, for joining our call this afternoon. This is our first quarterly update conference call since 2016, and we are excited to share an update on our clinical progress as we approach the anticipated release of important Phase III data and begin preparation to transition to a commercial stage company. Joining me today is Bill Ludlum, our Senior VP of Clinical Development and Medical Affairs, who will discuss our clinical progress; and Drew Enamait, our Vice President of Finance and Administration, who will review our financials. Following our prepared remarks, we will open the call for questions.
We are approaching a potentially transformational milestone for our company, which is the anticipated release of top line data from our ongoing international Phase III CHIASMA OPTIMAL clinical trial of our investigational oral octreotide capsule's product candidate, which we are developing for the maintenance treatment of adult suffering from acromegaly.
If the results of this trial, which we are conducting under a Special Protocol Assessment agreement, or SPA agreement, reached with the FDA are positive, we plan to resubmit our NDA by the end of this year. We would then anticipate a six month PDUFA review classification and possible FDA approval in mid-2020.
For those who may be new to this story, acromegaly is a rare but debilitating disorder caused by a benign tumor in the pituitary gland that causes the release of excessive growth hormone. Common features of acromegaly include altered facial features, intense headache, joint pain, impaired vision and enlargement of the hand, feet, tongue