Core Insights - BioXcel Therapeutics has completed enrollment in its SERENITY At-Home pivotal Phase 3 safety trial for BXCL501, aimed at treating agitation associated with bipolar disorders or schizophrenia, with topline data expected in the second half of 2025 to support a potential sNDA submission for label expansion of IGALMI in the at-home setting [1][2] Company Updates - The SERENITY trial is designed as a double-blind, placebo-controlled study involving 200 patients, with over 165 patients already dosed and more than 115 receiving multiple doses during the 12-week trial period [7] - The company continues to supply IGALMI to patients and providers while building brand awareness with minimal commercial resources [4] Financial Performance - For Q1 2025, net revenue from IGALMI was $168,000, a decrease from $582,000 in Q1 2024 [5] - Cost of Goods Sold for Q1 2025 was $14,000, down from $80,000 in the same period last year [6] - Research and Development (R&D) expenses were $4.6 million for Q1 2025, significantly lower than $11.4 million in Q1 2024, primarily due to reduced clinical trial activity [8] - Selling, General and Administrative (SG&A) expenses decreased to $5.7 million in Q1 2025 from $13.3 million in Q1 2024, reflecting cost-cutting measures [9] - The company reported a net loss of $7.3 million for Q1 2025, compared to a net loss of $26.8 million for the same period in 2024, with cash and cash equivalents totaling $31 million as of March 31, 2025 [10] Product Development - BXCL501 is under investigation for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in the at-home setting, with Breakthrough Therapy and Fast Track designations granted by the FDA [11] - The TRANQUILITY In-Care Phase 3 trial is also in progress, designed to evaluate the efficacy and safety of BXCL501 for agitation associated with Alzheimer's dementia [13]

Clinical Trial Progress - Patient enrollment in the SERENITY At-Home pivotal Phase 3 trial has exceeded 60%, with 127 out of 200 patients enrolled, representing 63% of the required enrollment[5] - Topline data from the SERENITY At-Home trial is expected in the second half of 2025, which may support a potential sNDA submission for label expansion of IGALMI[1][3] Financial Performance - Net revenue from IGALMI for Q4 2024 was $366,000, a slight decrease from $376,000 in Q4 2023; for the full year 2024, net revenue was $2.3 million, up from $1.4 million in 2023[8] - Product revenues for the year ended December 31, 2024, were $2,266,000, compared to $1,380,000 for the year ended December 31, 2023, representing a 64.3% increase[31] Cost and Expenses - Cost of Goods Sold (COGS) for Q4 2024 was $832,000, compared to $714,000 in Q4 2023; for the full year 2024, COGS was $2.1 million, up from $1.3 million in 2023[9][10] - Research and Development (R&D) expenses for Q4 2024 were $5.9 million, down from $9.9 million in Q4 2023; for the full year 2024, R&D expenses totaled $30.4 million, significantly lower than $84.3 million in 2023[11] - Selling, General and Administrative (SG&A) expenses for Q4 2024 were $4.1 million, down from $9.6 million in Q4 2023; for the full year 2024, SG&A expenses were $34.5 million, compared to $83.4 million in 2023[12][13] - Total operating expenses for the year ended December 31, 2024, were $69,511,000, down from $173,162,000 for the year ended December 31, 2023, indicating a 60.1% reduction[31] - Research and development expenses for the year ended December 31, 2024, were $30,435,000, down from $84,326,000 for the year ended December 31, 2023, a reduction of 64.1%[31] - Selling, general and administrative expenses decreased to $34,492,000 for the year ended December 31, 2024, from $83,413,000 for the year ended December 31, 2023, a decline of 58.6%[31] Net Loss and Financial Position - BioXcel Therapeutics reported a net loss of $10.9 million for Q4 2024, an improvement from a net loss of $22.3 million in Q4 2023; for the full year 2024, the net loss was $59.6 million, down from $179.1 million in 2023[14] - The net loss for the year ended December 31, 2024, was $59,599,000, compared to a net loss of $179,053,000 for the year ended December 31, 2023, reflecting a 66.7% improvement[31] - The net loss per share for the year ended December 31, 2024, was $23.51, compared to $98.33 for the year ended December 31, 2023, a 76.1% improvement[31] - The company reported a loss from operations of $67,245,000 for the year ended December 31, 2024, compared to a loss of $171,782,000 for the year ended December 31, 2023, a 60.8% decrease[31] Cash Position - Cash and cash equivalents totaled $29.9 million as of December 31, 2024, a decrease from $65.2 million on December 31, 2023[15] - Cash and cash equivalents decreased to $29,854,000 as of December 31, 2024, from $65,221,000 as of December 31, 2023, a decline of 54.2%[31] - The company closed a $14 million equity financing, strengthening its cash position to approximately $35 million as of March 4, 2025[7] Liabilities and Going Concern - Total liabilities increased slightly to $131,439,000 as of December 31, 2024, from $130,210,000 as of December 31, 2023[31] - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern[31]

Group 1: Earnings Performance - BioXcel Therapeutics reported a quarterly loss of $3.57 per share, which was better than the Zacks Consensus Estimate of a loss of $4.36, representing an earnings surprise of 18.12% [1] - The company has surpassed consensus EPS estimates three times over the last four quarters [2] - The revenue for the quarter ended December 2024 was $0.37 million, exceeding the Zacks Consensus Estimate by 144%, although it was slightly down from $0.38 million a year ago [2] Group 2: Stock Performance and Outlook - BioXcel Therapeutics shares have declined approximately 63.6% since the beginning of the year, contrasting with the S&P 500's decline of 2.9% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters [4] - The current consensus EPS estimate for the next quarter is -$2.72 on revenues of $0.3 million, and for the current fiscal year, it is -$16.32 on revenues of $3.51 million [7] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which BioXcel Therapeutics belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5][6]

Core Insights - BioXcel Therapeutics is advancing its SERENITY At-Home pivotal Phase 3 trial, with patient enrollment exceeding 60% of the required 200 patients for evaluating BXCL501 in treating agitation associated with bipolar disorders or schizophrenia [1][2][8] - The company has strengthened its cash position to approximately $35 million following a $14 million equity financing, which will support the SERENITY program [6][15] - Topline data from the SERENITY trial is expected in the second half of 2025, which may support a supplemental New Drug Application (sNDA) for label expansion of IGALMI in the at-home setting [1][2][8] Financial Performance - Net revenue from IGALMI for Q4 2024 was $366,000, a slight decrease from $376,000 in Q4 2023, while full-year revenue increased to $2.3 million from $1.4 million in 2023 [7][9] - Cost of Goods Sold (COGS) for Q4 2024 was $832,000, up from $714,000 in Q4 2023, primarily due to higher reserves for excess or obsolete inventory [10] - Research and Development (R&D) expenses decreased to $5.9 million in Q4 2024 from $9.9 million in Q4 2023, and full-year R&D expenses were $30.4 million, down from $84.3 million in 2023 [12] - Selling, General and Administrative (SG&A) expenses for Q4 2024 were $4.1 million, compared to $9.6 million in Q4 2023, with full-year SG&A expenses at $34.5 million, down from $83.4 million in 2023 [13][14] - The company reported a net loss of $10.9 million for Q4 2024, an improvement from a net loss of $22.3 million in Q4 2023, and a full-year net loss of $59.6 million compared to $179.1 million in 2023 [15] Clinical Programs - The SERENITY At-Home Phase 3 trial is designed as a double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation in patients with bipolar disorders or schizophrenia [8][18] - The TRANQUILITY In-Care Phase 3 trial is also underway, focusing on the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer's dementia [19] - A Data Safety Monitoring Board (DSMB) is planned to assess safety during the SERENITY trial [8] Market Potential - The SERENITY program aims to address a significant unmet medical need, with an estimated 23 million episodes of agitation related to bipolar and schizophrenia occurring annually in the U.S. [2] - The company continues to supply IGALMI through existing distribution channels with minimal commercial support, indicating a focus on expanding market presence [5]

Industry Overview - Artificial Intelligence (AI) and Machine Learning (ML) are crucial in precision oncology, enhancing decision-making through the analysis of large datasets and digital pathology [1] - The global AI in oncology market is valued at $1.92 billion in 2023, with a projected CAGR of 29.4%, reaching $11.52 billion by 2030, indicating rising investor interest [3] AI Initiatives and Developments - The National Institutes of Health (NIH) is evaluating the PRIMED-AI initiative to enhance disease diagnosis and treatment through coordinated AI/ML efforts [2] - AI models developed by NIH aim to predict cancer patients' responses to therapies, showcasing the growing integration of AI in healthcare [2] Key Players in AI-Driven Precision Oncology - NVIDIA is a significant player, providing powerful GPUs essential for AI models in imaging and drug development [5] - Palantir's Foundry platform enables comprehensive data analysis across laboratories, enhancing research capabilities [5] - Google's DeepMind, IBM Watson Health, and Microsoft's AI initiatives are also shaping the competitive landscape in healthcare [6] Investment Opportunities - BioXcel Therapeutics utilizes its proprietary AI platform, NovareAI, to expedite drug development, with a long-term expected earnings growth rate of 37.9% and projected revenue growth of 71.2% by 2025 [8][9] - Tempus AI enhances precision medicine through its algorithmic test platform, with a long-term expected earnings growth rate of 42% and projected revenue growth of 78.4% by 2025 [10][12] - Quest Diagnostics is integrating AI to improve operational efficiency and has acquired PathAI Diagnostics to advance digital pathology innovations, with a long-term expected earnings growth rate of 8.2% [13][14]

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]

Core Insights - BioXcel Therapeutics is progressing with its SERENITY At-Home trial, having reached 33% enrollment of the targeted 200 patients, aimed at evaluating the safety of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in a home setting [1][2][3] - Topline data results are anticipated in the second half of 2025, which will support a potential supplemental new drug application (sNDA) for expanding the label of IGALMI [1][3] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [13] - The company’s approach involves leveraging existing approved drugs and big data to identify new therapeutic indications [13] SERENITY At-Home Trial Details - The SERENITY At-Home trial is a double-blind, placebo-controlled study assessing the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation in home settings [4] - The trial will collect safety data over a 12-week period, with patients self-administering the drug during agitation episodes [4] Market Context - There are approximately 23 million annual episodes of agitation related to bipolar disorders or schizophrenia occurring in the U.S. home setting, with no FDA-approved therapies currently available for acute treatment in this context [3][4]

Core Insights - BioXcel Therapeutics is progressing with its SERENITY At-Home trial, which is pivotal for evaluating the safety of BXCL501 in treating agitation associated with bipolar disorders or schizophrenia in a home setting [1][2][4] - The trial aims to enroll 200 patients and has reached 33% enrollment, with topline data expected in the second half of 2025 to support a potential supplemental new drug application (sNDA) for IGALMI® [1][3][4] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [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] Trial Details - The SERENITY At-Home trial is a double-blind, placebo-controlled study assessing the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation [4] - The trial is designed for patients with a history of agitation episodes, allowing them to self-administer the treatment during episodes over a 12-week period [4] Market Context - There are an estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occurring in the home setting in the U.S., with no FDA-approved therapies currently available for acute treatment in this context [3][4] - The SERENITY At-Home trial represents a significant opportunity for BioXcel to address an unmet medical need in the treatment of agitation [3]

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].