Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT) Q4 2018 Earnings Conference Call Transcript

Mar 04, 2019 • 10:00 am ET

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Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT) Q4 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Greetings, and welcome to the Innovate Biopharmaceuticals Corporate and Operational Progress Update Conference 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.

It is now my pleasure to introduce your host, Jennifer Zimmons, Investor Relations for Innovate Biopharmaceuticals. Please go ahead, Jennifer.

Executive
Jennifer K. Zimmons

Thank you, Kevin. Good morning, and thank you for joining us to discuss our recent business progress and Innovate's full year 2018 financial results and corporate highlights conference call. The press release containing the Company's financial results for 2018 was issued earlier.

Joining our call are Steve Laumas, Chief Executive Officer; Patrick -- and Patrick Griffin, Chief Medical Officer. Jay Madan, Chief Business Officer, will also be joining for the Q&A session.

Before we begin, I'd like to remind everyone that this conference call includes forward-looking statements. Each forward-looking statement contained in this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information regarding these factors are described in the Risk Factors and Management's Discussion and Analysis sections of our most recent quarterly and annual financial reports. The forward-looking statements on this call speak only as of the original date of this call, and we do not undertake any obligation to update or revise any of these statements.

With that, I'd like to turn the call over to our CEO, Dr. Laumas.

Executive
Sandeep Laumas

Thank you, Jennifer. Good morning, everyone, and thank you for joining us on this conference call, the first conference call of -- earnings conference call that we're having live with Q&A.

2018 was a transformative year for Innovative, as we became a public company last January. And throughout last year, we executed against multiple strategic initiatives, with the main focus on laying the groundwork for launching a successful Phase 3 trial, the first one so far for celiac disease, as well as launching the preclinical program for NASH, which we'll get into more detail. Both diseases, if you are aware of, are unmet needs without any approved drugs and both represent very large markets and significant patient populations globally.

We are very excited as well to announce this morning that as of yesterday, we closed an equity offering, which brought in gross proceeds of close to $10 million to help launch the first Phase 3 trial. We expect this raise, along with our current cash and potential for additional non-dilutive capital from our out-licensing activities and opportunities, to be able to fund the first Phase 3 trial to an interim look later at the end of the year.

Patrick, our Chief Medical Officer, will describe in more detail about the trial design and so on. We expect a positive interim look will generate an inflection point that will help us further derisk the clinical program for celiac disease and guide us towards a better trial design, a more efficient trial design for our second