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EX - 99.1 2 tm2122742d2_99-1.htm EXHIBIT 99.1 Exhibit 99.1 BioXcel Therapeutics Reports Second Quarter 2021 Financial Results and Recent Operational Highlights Phase 3 study of BXCL501 for the acute treatment of agitation associated with dementia expected to begin in Q4 2021 PDUFA date of January 5 , 2022 assigned to BXCL501 NDA for the acute treatment of agitation associated with schizophrenia and bipolar disorders I & II Data from adenocarcinoma cohort of Phase 1b / 2 study of BXCL701 and KEYTRUDA® in aggressive forms of prostate cancer anticipated in Q3 2021 Raised gross proceeds of approximately $ 100 million with a common stock offering in June to further fund ongoing clinical development studies and commercialization readiness preparations Company to host a conference call today , August 10 , 2021 at 8:30 a.m. EDT -- NEW HAVEN , Conn . , August 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 financial results for the second quarter ended June 30 , 2021 and provided an update on key strategic initiatives . " During the second quarter , we continued to successfully execute across our clinical , regulatory and commercial objectives for our neuroscience candidate , BXCL501 , including furthering our plans for the pivotal Phase 3 program in dementia , executing on our global expansion strategy , and advancing through the regulatory review process , ” said Vimal Mehta , Ph.D. , CEO of BioXcel . " With acceptance of our NDA by the FDA , we are one step closer to our first - ever product approval and making this innovative therapy available to patients suffering from acute agitation associated with schizophrenia and bipolar disorders . We continue to advance our commercial readiness strategy , if approved , and in parallel are advancing our strategic plans for geographic expansion . " Dr. Mehta added , “ Looking ahead , we remain confident in the broad potential of BXCL501 across multiple indications where there is significant need for innovative treatments . We remain on track to commence our Phase 3 program for the acute treatment of agitation associated with dementia in the fourth quarter of this year and are exploring additional pipeline opportunities as growth drivers for this business . Looking beyond our neuroscience program , our Phase 1 / 2b study of BXCL701 for castrate resistant prostate cancer is advancing well , with additional efficacy data from the adenocarcinoma cohort expected in the third quarter 2021. We look forward to building on these successes during the second half of this year . " 1