Chiasma, Inc. (NASDAQ:CHMA) Q3 2019 Earnings Conference Call - Final Transcript
Nov 05, 2019 • 05:00 pm ET
Good afternoon, ladies and gentlemen and welcome to the conference call to discuss Chiasma's Third Quarter 2019 Operating and Financial Results.
At this time, I'd like to introduce Dawn Schottlandt, Vice President of Investor Relations. Please go ahead ma'am.
Thank you, operator. Today we will be making certain forward-looking statements about events and circumstances, including but not limited to statements regarding our development and potential commercialization of MYCAPSSA, expectations on timing of regulatory submissions and review periods and release of clinical data. Our plans to seek regulatory approval in the United States and European Union, our plans and expectations for US commercial launch, our anticipated cash runway and the size and composition of potential markets for MYCAPSSA if approved. 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. Except as required by law, Chiasma disclaims any obligations of update information contained in these forward-looking statements whether as a result of new information, future events or otherwise.
Joining the call today is Raj Kannan, Chief Executive Officer; Bill Ludlam, Senior VP of Clinical Development & Medical Affairs; and Mark Fitzpatrick, our President, who will review our financial results. And now I would like to turn the call over to Chiasma's Chief Executive Officer, Raj Kannan. Raj?
Thank you, Dawn. I wanted to take an opportunity to welcome Dawn Schottlandt, as our newest addition to the Chiasma team, as a new Head of Investor Relations. And thank you everyone for joining our call this afternoon to discuss our third quarter operating highlights and financial results. The highlight of this quarter was the positive, statistically significant data that we reported in July from our pivotal Phase III CHIASMA OPTIMAL trial of our lead product candidate, oral octreotide capsules, conditionally trade named MYCAPSSA.
Bill Ludlam will briefly summarize the data in a moment, but suffice it to say, we were very pleased with the trial results and are working diligently to prepare our NDA for submission. We remain on track to submit our NDA by the end of this year. Following the top-line data release in July, we completed a successful financing. With the capital we raised, we believe we have sufficient cash resources to execute our planned commercial launch of MYCAPSSA in the US, if approval is obtained and through the planned completion of our ongoing Phase III MPOWERED trial of MYCAPSSA in acromegaly. As you know, with top-line data expected in the second half of 2020. The MPOWERED trial is designed to support an application for marketing approval of MYCAPSSA in the European Union. Mark Fitzpatrick will touch on the financing and our overall financial position in his remarks.
Turning now to our US commercial preparedness activities. We are finalizing our go-to-market plan and have made key commercial hires in