BioXcel Therapeutics, Inc. (NASDAQ: BTAI) reported fourth quarter and full year ended December 31st, 2019 financial results.  BXCL501 is designed for the treatment of acute agitation.  The company initiated phase 3 trials for acute treatment of agitation in patients in schizophrenia and bipolar disorder.  Data from both trials are expected by mid-2020.

The company reported a net loss of USD 8.3 Million for the fourth quarter of 2019, compared to USD 7.1 Million for the same period a year ago.  R&D research reached USD 6.5 Million, an increase from USD 6 Million a year prior.

“2019 has been a tremendous year for BTI. We have made significant growth in our two programs – BXCL501 and BXCL701 – laying the groundwork to achieve key milestones in the coming years,” stated Vimal Mehta, Chief Executive Officer of BTAI. “In neuroscience, we have made momentous advancements in the clinical development of BXCL501 and look forward to announcing topline results from our SERENITY program and our Phase 1b/2 TRANQUILITY trial in dementia-related agitation in mid-2020. Additionally, we have been dedicated to expanding the potential therapeutic use of BXCL501, announcing a fourth indication last month as well as examining biomarkers that may have relevance for a range of hyperarousal disorders. We believe these therapeutic opportunities, along with our plans to investigate BXCL501 for the treatment of all types of agitation, are crucial steps to building out a leading neuroscience franchise.”

Dr. Mehta added, “In addition to our ongoing studies with BXCL701 in prostate and pancreatic cancers, we are also evaluating this immuno-oncology candidate, in combination with KEYTRUDA®, in multiple advanced solid tumors with the goal of improving treatment responses to this PD-1 inhibitor. We believe this basket trial, led by researchers at MD Anderson, will help to accelerate the evaluation of BXCL701 and help to explore its full potential.”