FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501 NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the U.S. Food and Drug Administration (FDA) has concluded that the inspection of a single ...

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]

NEW HAVEN, Conn., Feb. 28, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum closing bid price requirement under Nasdaq Listing Rule 5550(a)(2). As previously disclosed, on September 16 ...

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]

Core Viewpoint - The upgrade of BioXcel Therapeutics to a Zacks Rank 2 (Buy) reflects an upward trend in earnings estimates, indicating a positive outlook for the company's stock price [2][8][11]. Earnings Estimates and Revisions - Analysts have raised their earnings estimates for BioXcel Therapeutics, with the Zacks Consensus Estimate increasing by 1.9% over the past three months [5]. - For the fiscal year ending December 2024, BioXcel is expected to report earnings of -$1.80 per share, representing a 70.7% change from the previous year's reported number [13]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [4]. - The Zacks rating system maintains an equal proportion of 'buy' and 'sell' ratings across its universe of over 4000 stocks, with only the top 5% receiving a 'Strong Buy' rating [6]. Market Implications - The correlation between earnings estimate revisions and near-term stock movements suggests that tracking these revisions can be beneficial for investment decisions [12]. - The upgrade positions BioXcel Therapeutics in the top 20% of Zacks-covered stocks, indicating its potential for market-beating returns in the near term [15][16].

Core Viewpoint - BioXcel Therapeutics, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $7.0 million before expenses [1][3]. Group 1: Offering Details - The company is offering 5,600,000 shares of common stock and accompanying warrants, with a public offering price of $0.48 per share [1]. - For certain investors, pre-funded warrants to purchase up to 9,000,000 shares are also available, priced at $0.479 per share [1]. - Each accompanying warrant will have an exercise price of $0.48 and will expire five years after issuance [2]. Group 2: Underwriting and Closing - Canaccord Genuity is acting as the sole book-running manager for the public offering [3]. - The offering is expected to close on or about November 25, 2024, subject to customary closing conditions [3]. Group 3: Regulatory Compliance - The securities are being offered under a shelf registration statement filed with the SEC, which became effective on November 13, 2023 [4]. - A preliminary prospectus supplement has been filed with the SEC and is available on their website [4].

Core Viewpoint - BioXcel Therapeutics, Inc. reported a quarterly loss of $0.32 per share, which was better than the Zacks Consensus Estimate of a loss of $0.50, and a significant improvement from a loss of $1.72 per share a year ago, indicating a 36% earnings surprise [1] Financial Performance - The company posted revenues of $0.21 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 82.17%, and a decline from $0.34 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - BioXcel Therapeutics shares have lost about 79% since the beginning of the year, contrasting with the S&P 500's gain of 25.5% [3] - The current Zacks Rank for the stock is 4 (Sell), indicating expectations of underperformance in the near future [6] Earnings Outlook - The current consensus EPS estimate for the coming quarter is -$0.49 on revenues of $1.24 million, and for the current fiscal year, it is -$1.97 on revenues of $4.12 million [7] - The trend for estimate revisions ahead of the earnings release has been unfavorable, which could impact future stock movements [6] Industry Context - The Medical - Biomedical and Genetics industry is currently in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

Financial Performance - Total revenues for the three months ended September 30, 2023, were $214,000, compared to $341,000 for the same period in 2022, representing a decrease of 37.3%[33]. - Operating expenses for the three months ended September 30, 2023, totaled $15,507,000, a decrease from $48,638,000 in the prior year, reflecting a reduction of 68.1%[33]. - The net loss for the three months ended September 30, 2023, was $13,650,000, compared to a net loss of $50,486,000 for the same period in 2022, indicating a 72.9% improvement[33]. - For the nine months ended September 30, 2024, the company reported a net loss of $48,740, a significant improvement compared to a net loss of $156,797 for the same period in 2023, representing a reduction of approximately 69%[46]. - The company recognized net losses of $13,650 and $50,486 for the three months ended September 30, 2024, and 2023, respectively, showing a 73% improvement in quarterly performance[46]. - Basic and diluted net loss per share for the nine months ended September 30, 2024, was $(1.29), an improvement from $(5.40) in the prior year[195]. Cash and Liquidity - As of September 30, 2024, cash and cash equivalents decreased to $40.387 million from $65.221 million as of December 31, 2023, indicating a decline of approximately 38.1%[30]. - The net cash used in operating activities for the nine months ended September 30, 2024, was $57,218, down from $128,143 in the prior year, indicating a decrease of about 55%[46]. - The company has significant indebtedness, with long-term debt amounting to $104.440 million as of September 30, 2024[31]. - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern[10]. - The Company must maintain a minimum liquidity amount of $15,000, which can increase to $25,000 if certain gross proceeds from stock issuance are not met by September 30, 2024[133]. Debt and Financing - Total liabilities increased to $134.525 million from $130.210 million, reflecting an increase of approximately 3.4%[31]. - The Company entered into two strategic financing agreements providing up to $260,000 in gross funding to support commercial activities and clinical development efforts[115]. - The Company entered into a Second Amendment to the Credit Agreement, providing up to $202,319 in senior secured term loans, including an initial Tranche A of $70,000 funded on April 28, 2022[117]. - The remaining tranches available under the Credit Agreement include Tranche B of $20,000, Tranche C of $30,000, and Tranche D of $50,000, contingent upon meeting specific regulatory and financial milestones[120]. - The Company received $25,000 in gross proceeds from stock issuance on March 27, 2024, satisfying the April 15, 2024 covenant requirement[133]. Research and Development - The company is dependent on the success of IGALMITM and four product candidates: BXCL501, BXCL502, BXCL701, and BXCL702 for future growth[13]. - The company’s most advanced neuroscience clinical development program, BXCL501, is aimed at treating agitation associated with psychiatric and neurological disorders[42]. - The company’s immuno-oncology asset, BXCL701, is under investigation for treating a rare form of prostate cancer and advanced solid tumors[43]. - The Company recognizes research and development expenses as incurred, which include wages, benefits, and costs related to clinical trials[90]. Operational Challenges - The company has incurred significant operating losses since inception and anticipates continuing to incur substantial losses for the foreseeable future[8]. - The regulatory approval processes for product candidates are lengthy and unpredictable, which could substantially harm the business if approvals are not obtained[14]. - The company relies on third parties for the manufacture of clinical supplies and commercial supplies, which poses risks to its operations[22]. - Management has expressed substantial doubt about the company's ability to continue as a going concern for at least 12 months from the issuance date of the financial statements due to significant losses and negative cash flows[48]. Stock and Equity - The Company raised $32,687 from the issuance of common stock and warrants during the nine months ended September 30, 2024, compared to $24,657 in the same period of 2023, marking an increase of approximately 32%[46]. - The Company amended and restated the Original Warrants, reducing the exercise price from $20.04 to $3.6452 per share, and granted new warrants for 70 shares at the same exercise price[136]. - The Company recorded a fair value adjustment resulting in an unrealized gain of $16,412 for the nine months ended September 30, 2024, related to derivative liabilities[144]. - The Company had common stock equivalents outstanding of 16,222 shares as of September 30, 2024, compared to 5,688 shares in 2023[194]. Cost Management - Operating expenses for the three months ended September 30, 2023, totaled $15,507,000, a decrease from $48,638,000 in the prior year, reflecting a reduction of 68.1%[33]. - The total stock-based compensation expense recognized for the three months ended September 30, 2024, was $1,865, down from $4,014 in the same period of 2023[173]. - The Company recorded total restructuring costs of $4,163 for the year ended December 31, 2023, which included severance and benefit costs of $4,063 and contract termination costs of $100[104]. Strategic Focus - The company is focused on utilizing AI approaches to develop transformative medicines, aiming to reduce therapeutic development costs and accelerate timelines[39]. - BioXcel Therapeutics, Inc. focuses on developing transformative medicines in neuroscience and immuno-oncology using artificial intelligence[204]. - The company employs AI platforms to reduce therapeutic development costs and potentially accelerate development timelines[204]. - BioXcel aims to leverage existing approved drugs and big data to identify new therapeutic indications, addressing substantial unmet medical needs[204].

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q3 2024 Earnings Conference Call November 14, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer Richard Steinhart - Chief Financial Officer Vincent O'Neill - Executive Vice President, Chief of Product Development and Medical Officer Rob Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Matt Wiley - Senior Vice President and Chief Commercial Officer Frank Yocca - Chief Scientific Officer Operator Good morning, and wel ...