Company to host conference call at 8 a.m. ET, August 27, 2025NEW HAVEN, Conn., Aug. 26, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will host an investor call and live webcast at 8 a.m. ET, August 27, 2025 to review topline data from the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company’s proprietary, sublingual ...

Data from more than 2,600 agitation episodes collected Topline data readout is on track for August BXCL501 was granted Fast Track Designation for the acute treatment of agitation associated with bipolar disorders or schizophrenia. There are no FDA-approved therapies for the acute treatment of agitation in the at- home setting. About the SERENITY At-Home Phase 3 Trial The trial was designed to study 200 patients with a history of agitation episodes despite being on stable treatment for their underlying bipol ...

The primary purpose of the planned meeting was to gain alignment with the FDA regarding the content and format of the Company's planned supplemental New Drug Application (sNDA) submission for the at-home (outpatient) use of BXCL501, including the clinical, nonclinical, and chemistry and manufacturing and controls (CMC) requirements. The Company concludes that the objectives of the pre-sNDA meeting have been accomplished based on the FDA's written responses and has determined that the meeting, originally sch ...

Core Insights - BioXcel Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) recommended the continuation of the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 without modification, with topline data expected in Q3 2025 [2][9] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on utilizing artificial intelligence to develop transformative medicines in neuroscience [15] - The company is also involved in immuno-oncology through its subsidiary, OnkosXcel Therapeutics [15] Trial Details - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting [4][7] - The trial is fully enrolled with more than 205 patients dosed, and over 150 patients have received multiple doses during the 12-week trial period [3][9] Product Information - BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, which is under investigation for the acute treatment of agitation associated with Alzheimer's dementia, bipolar disorders, and schizophrenia [6] - BXCL501 has received Breakthrough Therapy designation from the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for agitation associated with schizophrenia and bipolar disorders [6] Future Prospects - The results from the SERENITY trial are intended to support a potential supplemental New Drug Application (sNDA) submission for label expansion of IGALMI in the at-home setting, addressing a significant unmet medical need [4]

Core Viewpoint - BioXcel Therapeutics, Inc. has received approval from the Nasdaq Hearings Panel to continue its listing on The Nasdaq Stock Market, with a deadline to regain compliance by September 16, 2025 [1][2]. Company Overview - BioXcel Therapeutics is a biopharmaceutical company that leverages artificial intelligence to develop innovative medicines in the field of neuroscience [12]. - The company is also focused on immuno-oncology through its subsidiary, OnkosXcel Therapeutics [12]. Compliance and Listing - The Nasdaq Panel reviewed BioXcel's compliance plan during a hearing on May 1, 2025, and granted an extension for compliance with the MVLS Rule [2]. - The company is committed to executing its compliance plan to meet the necessary requirements within the specified timeframe [2][3]. Product Development - BioXcel is advancing multiple strategic initiatives, including the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501, aimed at supporting a supplemental New Drug Application (sNDA) to expand the IGALMI label [3]. - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently under investigation for treating agitation associated with Alzheimer's dementia and bipolar disorders [4]. SERENITY At-Home Phase 3 Trial - The SERENITY At-Home trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation in patients with bipolar disorders or schizophrenia [5]. - The trial involves 200 patients self-administering BXCL501 or placebo during agitation episodes over a 12-week period, with safety data collected throughout [5]. IGALMI Overview - IGALMI (dexmedetomidine) is a prescription medicine used for the acute treatment of agitation associated with schizophrenia and bipolar disorder in adults [6]. - The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose [6]. Safety Information - IGALMI can cause serious side effects, including decreased blood pressure and slower heart rate, particularly in patients with certain pre-existing conditions [7][8]. - Common side effects reported in clinical studies include sleepiness, dizziness, and dry mouth [9].

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]

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]