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EX - 99.1 2 tm2132359d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 BioXcel Therapeutics Reports Third Quarter 2021 Financial Results and Recent Operational Highlights Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film , for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II , ahead of January 5 , 2022 PDUFA date On track to initiate Phase 3 program for acute treatment of agitation in patients with Alzheimer's disease in Q4 2021 Strengthened neuroscience franchise with indication expansion for BXCL501 in major depressive disorder ( MDD ) Introduced BXCL502 candidate for chronic agitation in dementia , identified through Company's artificial intelligence platform Demonstrated encouraging anti - tumor activity and favorable safety profile for BXCL701 in combination with KEYTRUDA® in mCRPC patients with adenocarcinoma ; expansion of Phase 2 trial in SCNC cohort To host conference call today , Nov. 10 , 2021 , at 8:30 a.m. EDT NEW HAVEN , Conn . , Nov. 10 , 2021 -- BioXcel Therapeutics , Inc. ( 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 third quarter ended September 30 , 2021 and provided an update on key strategic initiatives . " We have made tremendous progress advancing our neuroscience and immuno - oncology franchises , " said Vimal Mehta , Ph.D. , CEO of BioXcel Therapeutics . “ With our PDUFA date for BXCL501 less than two months away , we are excited that our commercial and launch readiness planning is progressing well . We are equally excited about initiating our Phase 3 program for BXCL501 for acute treatment of agitation associated with dementia in Alzheimer's patients , the most prevalent type of dementia in the United States , which has a high unmet medical need and we believe would mark the first orally available FDA - approved therapy . Furthermore , adding major depressive disorder as a potential indication for BXCL501 and introducing BXCL502 as a candidate for chronic treatment of agitation in dementia strengthens our pipeline and expands our market opportunity . " Dr. Mehta added , “ Our immuno - oncology program is also advancing , with positive interim results from our Phase 2 trial of BXCL701 in heavily pre - treated metastatic castration - resistant prostate cancer ( mCRPC ) demonstrating encouraging efficacy and a favorable safety profile . We believe BXCL701 shows considerable potential as an investigational , orally administered , systemic innate immune activator . ”