Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial. The pivotal Phase 3 trial is designed to evaluate the safety of BXCL501, t ...

Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial. The pivotal Phase 3 trial is designed to evaluate the safety of BXCL501, th ...

NEW HAVEN, Conn., March 04, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the closing of its previously announced registered direct offering of 4,000,000 shares (the “Shares”) of common stock, par value $0.001 per share (“Common Stock”) (or common stock equivalents in lieu thereof), and accompanying warrants (the “Accompanying Warrants”) to ...

Core Viewpoint - The market anticipates BioXcel Therapeutics, Inc. (BTAI) to report a year-over-year increase in earnings despite lower revenues for the quarter ended December 2024, with actual results being crucial for stock price movement [1][2]. Financial Expectations - The consensus EPS estimate for BioXcel Therapeutics is a loss of $4.36 per share, reflecting a year-over-year change of +64.1% [3]. - Expected revenues are projected at $0.15 million, which is a decrease of 60.5% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a stable outlook from covering analysts [4]. - The Most Accurate Estimate for BioXcel is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -15.50%, suggesting a bearish sentiment among analysts [10]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the likelihood of actual earnings deviating from consensus estimates, with a strong predictive power for positive readings [7][8]. - BioXcel's current Zacks Rank is 2 (Buy), but the negative Earnings ESP complicates predictions for an earnings beat [11]. Historical Performance - In the last reported quarter, BioXcel was expected to post a loss of $8 per share but delivered a loss of $5.12, resulting in a surprise of +36% [12]. - Over the past four quarters, BioXcel has beaten consensus EPS estimates three times [13]. Industry Comparison - Another company in the same industry, IGM Biosciences, Inc. (IGMS), is expected to report a loss of $0.72 per share, with revenues projected at $0.53 million, down 18.5% year-over-year [17]. - IGM has an Earnings ESP of 4.55% and a Zacks Rank of 2, indicating a higher likelihood of beating consensus EPS estimates [18].

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]

Core Viewpoint - The FDA has concluded the inspection of a site involved in BioXcel Therapeutics' TRANQUILITY II trial, indicating that the data from this trial is reliable and supports the company's potential sNDA submission for BXCL501 [1][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] BXCL501 Overview - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently approved as IGALMI by the FDA [3] - It is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in at-home settings [3] - BXCL501 has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [3] TRANQUILITY In-Care Phase 3 Trial - 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 with varying degrees of dementia [4] - The primary endpoint is a change in the Positive and Negative Syndrome Scale-Excitatory Component total score at two hours post-first dose [4]

Core Points - BioXcel Therapeutics, Inc. has regained compliance with Nasdaq's minimum closing bid price requirement [1][2] - The company was previously notified on September 16, 2024, for failing to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days [2] - To regain compliance, the company needed to maintain a minimum closing bid price of $1.00 per share for at least 12 consecutive trading days, which was achieved on February 26, 2025 [2] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that utilizes artificial intelligence to develop transformative medicines in neuroscience [3] - The company's subsidiary, OnkosXcel Therapeutics, focuses on developing medicines in immuno-oncology [3] - BioXcel employs a drug re-innovation approach, leveraging existing approved drugs and big data with proprietary machine learning algorithms to identify new therapeutic indications [3]

Core Viewpoint - BioXcel Therapeutics, Inc. announced a 1-for-16 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement, effective February 7, 2025 [1][2][5] Group 1: Reverse Stock Split Details - The reverse stock split will convert every 16 shares of common stock into one share, maintaining the par value of $0.001 per share [5] - The reverse stock split was approved by stockholders on January 28, 2025, with a ratio determined by the Board of Directors [5] - Fractional shares will not be issued; instead, stockholders entitled to fractional shares will receive a cash payment [3] Group 2: Trading Information - Post-split, the common stock will continue trading on the Nasdaq Capital Market under the symbol "BTAI" with a new CUSIP number [2] - The split-adjusted trading is expected to commence on February 10, 2025 [1] Group 3: Impact on Equity Securities - Proportionate adjustments will be made to the number of shares underlying outstanding stock options and equity incentive plans [4]

Core Insights - BioXcel Therapeutics is advancing its SERENITY and TRANQUILITY clinical programs aimed at treating acute agitation associated with bipolar disorders, schizophrenia, and Alzheimer's dementia, addressing an estimated 140 million annual agitation episodes [2][6] - The company has enhanced its operational and financial flexibility through an amendment to its existing credit agreement and successfully raised $7 million in equity funding [7] - Recent appointments to the Board of Directors have strengthened the company's leadership with expertise in clinical, financial, and legal areas [5][8] Clinical Programs - The SERENITY At-Home Phase 3 trial for BXCL501 is progressing with patient enrollment, focusing on acute treatment for agitation related to bipolar disorders and schizophrenia [1][6] - Plans for the TRANQUILITY In-Care Phase 3 trial of BXCL501 for agitation associated with Alzheimer's dementia have been developed [1][6] Financial and Operational Updates - The company has improved its financial position by amending its credit agreement, which was announced on November 25, 2024 [7] - The recent equity funding raised $7 million in gross proceeds, which closed on the same date [7] Leadership Enhancements - The Board of Directors has been strengthened with new members who bring significant operational and clinical expertise, including Dr. Rajiv Patni and David Mack [5][8] - Dr. Rajiv Patni has extensive experience in global product development across various therapeutic areas [5] - David Mack has over 25 years of experience in financial and legal leadership, aiding companies through transitions [8]