Chiasma, Inc. (NASDAQ:CHMA) Q2 2019 Earnings Conference Call - Final Transcript
Aug 08, 2019 • 05:00 pm ET
Good afternoon, ladies and gentlemen. And welcome to the conference call to discuss Chiasma's Second Quarter 2019 Operating and Financial Results. [Operator Instructions]
Thank you, operator. Please turn to Slide 1. Today we'll be making certain forward-looking statements about events and circumstances, including but not limited to statements regarding our development and potential commercialization of MYCAPSSA, our expectations on timing of release of clinical data and regulatory submissions and review periods, our plans to seek regulatory approval in the United States and European Union, 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. Chiasma's disclaims any obligation to update information contained in these false 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 Chief Executive Officer, Raj Kannan. Raj?
Thanks, Glenn. And thank you, everyone for joining our call this afternoon to review our Second Quarter Results. Joining me on this call is Bill Ludlam, our Senior Vice President of Clinical Development and Medical Affairs, who will review our exciting Chiasma optimal results. And Mark Fitzpatrick, our President, who will review our financial results.
This is my first quarterly update since joining the company in June, and I'm pleased to join the organization at such an exciting and transformational time. There are three key points, I want to highlight.
Please turn to Slide 2. First, the positive top line results, we recently announced from our OPTIMAL pivotal trial, which met its primary endpoint as well as all four secondary endpoints. It is important to note that we conducted this Phase 3 trial under a special protocol assessment agreement with the FDA in order to address the clinical concerns that the agency raised in 2016.
Second, we believe the capital that we raised following the optimal data relief, positions us to successfully execute our planned commercial launch of MYCAPSSA in the US, if approval is obtained and through the planned completion of our ongoing Phase 3 MPOWERED trial of MYCAPSSA in acromegaly, which is designed to support EU approval and the top line data is expected in the second half of 2020. We believe there is an attractive global acromegaly market opportunity for MYCAPSSA beyond the US. The global market for SSA, for all indications, is approximately $2.7 billion annually, and as a first step with MYCAPSSA, we plan to target the estimated $800 million global annual opportunity for acromegaly. And third, we believe now we are well-positioned with MYCAPSSA and our TPE technology platform to begin planning for a growth beyond acromegaly.
Let me add some context to the three points I highlighted. Injectable SSAs are currently considered the