Core Points - BioXcel Therapeutics, Inc. has entered into a securities purchase agreement for a registered direct offering of 4,000,000 shares of common stock at a price of $3.50 per share, aiming for gross proceeds of approximately $14 million [1][2] - The offering includes accompanying warrants to purchase an additional 4,000,000 shares at an exercise price of $4.20 per share, which are exercisable after issuance and expire five years from the date of issuance [1] - The offering is expected to close on March 4, 2025, and the net proceeds will be used for working capital and general corporate purposes [2] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that utilizes artificial intelligence to develop transformative medicines in neuroscience [5] - The company’s subsidiary, OnkosXcel Therapeutics, LLC, focuses on immuno-oncology drug development [5] - BioXcel employs a drug re-innovation approach, leveraging existing approved drugs and big data to identify new therapeutic indications [5]

Core Insights - The FDA has concluded the inspection of a site involved in the TRANQUILITY II Phase 3 trial of BXCL501, indicating "Voluntary Action Indicated," which supports the reliability of the trial data [1][2] - BioXcel Therapeutics is advancing its TRANQUILITY In-Care Phase 3 trial for BXCL501, having received FDA feedback on the trial protocol [2] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [5] - The company has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology [5] Product Information - BXCL501 is an investigational orally dissolving film formulation of dexmedetomidine, currently approved as IGALMI® for specific indications [3] - BXCL501 is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders, with Breakthrough Therapy and Fast Track designations from the FDA [3] Trial Details - The TRANQUILITY In-Care trial is a double-blind, placebo-controlled study evaluating the efficacy and safety of a 60 mcg dose of BXCL501 over 12 weeks for agitation in Alzheimer's dementia patients [4] - The trial aims to enroll approximately 150 patients aged 55 and older residing in care facilities, with the primary endpoint being a change in the Positive and Negative Syndrome Scale-Excitatory Component total score [4]