BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q3 2019 Earnings Conference Call - Final Transcript
Nov 14, 2019 • 08:30 am ET
Good morning, and welcome to BioXcel Therapeutics Third Quarter 2019 Earnings Conference Call and Audio Webcast. [Operator Instructions]
Just to remind everyone, certain matters discussed in today's conference call or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties relating to future events and/or the future financial performance of the Company. Actual results could differ materially from those anticipated in these forward-looking statements. These risk factors that may affect results are detailed in the Company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended September 30, 2019, which can be found on its website, www.bioxceltherapeutics.com, or on www.sec.gov.
I would now like to turn the call over to Vimal Mehta, Chief Executive Officer for BioXcel Therapeutics. Please go ahead, sir.
Thank you, operator. Good morning, everyone, and thank you for joining our conference call to discuss BioXcel Therapeutics' financial results and business highlights for the third quarter of 2019.
We appreciate everyone's time and attention today as we discuss our third quarter results. We are very pleased with the tremendous clinical advances and strategic initiatives we have made in progressing our pipeline this quarter. To begin, I would like to discuss our lead neuroscience clinical program, BXCL501, and the major milestones we have achieved over the past months. Just to remind everyone, BXCL501 is our proprietary thin film formulation of dexmedetomidine or Dex for the treatment of acute agitation. This candidate is designed to be easily administered and have a rapid onset of action that produces a calming effect without excessive sedation.
In July, we announced positive top line data from our Phase 1b trial of BXCL501 for the treatment of acute agitation in 135 patients with schizophrenia. The study met its primary endpoint with a rapid and durable reduction impact score. We believe that the outcome of this trial demonstrated that BXCL501 is differentiated from current treatment options, which can often cause unwanted side effects like excessive sedation and, therefore, result in their limited use. With this successful data readout, we plan to initiate a pivotal Phase 3 study in schizophrenia and bipolar patient with acute agitation during the fourth quarter of this year. We are fortunate that these studies are short in duration with a two-hour endpoint. And as a result, we currently believe we will report top line results in the first half of 2020.
Following our Phase 3 trials, we expect to be able to submit our first NDA for BXCL501 during the second half of 2020. We are confident that our initial BXCL501 NDA filing will lay a solid foundation for follow-on indications in dementia and opioid withdrawal and other indications.
In addition, with limited treatment options for acute agitation, we continue to examine the potential of BXCL501 for the treatment of agitation and other neuropsychiatric disorders. In parallel with Phase 3 studies for the acute treatment of agitation in schizophrenia and bipolar