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EX - 99.1 2 tm216668d4_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 BioXcel Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update Granted FDA Breakthrough Therapy designation for BXCL501 for the acute treatment of agitation associated with dementia ; registrational program expected to begin in 2H 2021 Submitted NDA to FDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders Strategic geographic market extension plans for BXCL501 underway ; expects to submit MAA to EMA for the acute treatment of agitation associated with schizophrenia and bipolar disorders in 2H 2021 Commercial readiness preparations ramping - up for potential approval of BXCL501 in first two -- indications Company to host conference call today at 8:30 a.m. ET NEW HAVEN , Conn . , May 10 , 2021 BioXcel Therapeutics , Inc. ( " BioXcel " or the " Company " ) ( Nasdaq : BTAI ) , a clinical - stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno- oncology , today announced its quarterly results for the first quarter ended March 31 , 2021 and provided an update on key strategic and operational initiatives . " This quarter , we have remained committed to executing on our vision for our neuroscience franchise , as we continue to advance the development of BXCL501 for treatment of agitation associated with dementia and prepare for its potential approval in acute agitation associated with schizophrenia and bipolar disorders , " stated Vimal Mehta , Chief Executive Officer of BioXcel . " We are pleased to have recently received Breakthrough Therapy designation for BXCL501 in agitation associated with dementia , highlighting the urgent need for new therapy options , as well as this candidate's potential to provide a solution across treatment settings . While we solidify our plans for a pivotal program in this condition , we are committed to building the commercial infrastructure needed to successfully launch BXCL501 in the first two indications , in addition to follow - on indications in the future . " Dr. Mehta continued , “ Importantly , we are moving forward with our strategic geographic expansion strategy , with plans to file a Marketing Authorization Application to the European Medicines Agency for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders in the second half of 2021. As we continue to advance our innovative neuroscience program , we remain committed to delivering transformative medicines to patients , expanding our regulatory footprint and creating value for our stockholders . "