BioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Core Insights - BioXcel Therapeutics, Inc. has successfully raised $14 million in equity financing, resulting in a cash position of approximately $35 million to support its clinical trials [1][2] - The company is advancing its SERENITY At-Home Phase 3 trial, which aims to evaluate the safety of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in a home setting [1][3] - Topline data from the trial is expected in the second half of 2025, which may support a supplemental New Drug Application (sNDA) for expanding the label of IGALMI for at-home use [2][3] Company Overview - BioXcel Therapeutics is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [1][13] - The company’s investigational product, BXCL501, is an orally dissolving film formulation of dexmedetomidine, currently under investigation for various indications including agitation associated with Alzheimer's dementia and bipolar disorders [12][13] - IGALMI (dexmedetomidine) is a prescription medicine used for the acute treatment of agitation in adults with schizophrenia and bipolar disorder [4][12] SERENITY At-Home Phase 3 Trial - The trial is a double-blind, placebo-controlled study enrolling 200 patients with a history of agitation episodes, who will self-administer BXCL501 or placebo during the trial [3] - Safety data will be collected throughout the 12-week trial period, with exploratory endpoints including modified global impression scales to assess treatment effectiveness [3] Financial Position - Following the recent equity financing, the company is well-positioned financially with $35 million in cash to support ongoing clinical trials and operational needs [1][2]