BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q1 2019 Earnings Conference Call Transcript
May 07, 2019 • 08:30 am ET
Good day, everyone, and welcome to the BioXcel Therapeutics' First Quarter 2019 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Brian Johnston at The Ruth Group. Please go ahead, sir.
Thank you, operator. 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. The risk factors that may affect results are detailed in the company's most recent public filings with the US Securities and Exchange Commission, including its annual report on Form 10-K for the fiscal year ended December 31, 2018, which can be found on its website, www.bioxceltherapeutics.com or on www.sec.gov.
With me today are Vimal Mehta, Chief Executive Officer of BioXcel Therapeutics; Richard Steinhart, Chief Financial Officer; Vince O'Neill, Chief Medical Officer; and Frank Yocca, Chief Scientific Officer.
With that said, it is my pleasure to turn the call over to the company CEO, Vimal Mehta. Vimal?
Vimal D. Mehta
Thanks, Brian. Good morning, everyone, and thank you for joining our conference call to discuss BioXcel Therapeutics' financial results and business highlights for the first quarter of 2019. In the first quarter of 2019, we achieved several key milestones, particularly related to the clinical development of our lead Neuroscience Program, BXCL501 and BXCL701 as we move toward transitioning into a commercial sales organization. Through our sound business strategy, we believe the company is well positioned to achieve further milestones in the coming quarters. We have built a strong team and world-class capabilities to lead the clinical advancement of our two drug therapies. We are executing according to our strategic plan and truly believe that 2019 will be a pivotal year for the company.
I would like to start by highlighting the exciting progress we have made in our lead neuroscience clinical development program, BXCL501. In December, we dosed the first cohort of subjects in our first-in-human study of BXCL501, our proprietary sublingual formulation of dexmedetomidine or Dex for the acute treatment of agitation. As of today, we have completed dosing of multiple patient cohorts and are on track to report top line data from the Phase I pharmacokinetic, bioavailability and safety study of BXCL501 in May 2019. We maintain our expectation that the result of this healthy voluntary study will enable us to launch registration trials in agitated patients in the second half of the year and we expect to provide more details on our specific plans for BXCL501 in the near future when we report the Phase I data. With FDA fast-track designation secured at the end of 2018, we remain on track for filing our first NDA drug application for BXCL501 in the second half of 2020.
On the technical front, we have finalized formulation development and transition to automated process for BXCL501, the