Core Insights - The discussion will focus on the high unmet need and lack of FDA-approved treatment options for acute agitation episodes in Alzheimer's dementia, affecting approximately 100 million episodes annually [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [6]. - The company is advancing preparations for the TRANQUILITY In-Care Phase 3 trial, which is a double-blind, placebo-controlled study evaluating BXCL501 for treating acute agitation episodes in Alzheimer's dementia [4][9]. Product Information - BXCL501 is a late-stage product candidate being evaluated for acute agitation episodes in Alzheimer's dementia, with no current FDA-approved therapies for this condition [3][8]. - 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 [8]. Clinical Trial Details - The TRANQUILITY In-Care trial aims to enroll approximately 200 patients aged 55 and older with mild to severe dementia, assessing the efficacy and safety of a 60 mcg dose of BXCL501 over a 12-week period [9]. - The primary endpoint of the trial is a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component total score at two hours post-first dose [9]. Event Information - A virtual key opinion leader (KOL) roundtable will be held on February 27, 2026, to discuss acute agitation episodes in Alzheimer's dementia and the potential role of BXCL501 [1][2][4]. - The event will be moderated by Anjalee Khemlani, an award-winning healthcare journalist [4]. Expert Panel - The roundtable will feature medical professionals specializing in geriatric psychiatry and Alzheimer's care, including George T. Grossberg, MD, and Anton P. Porsteinsson, MD [7].

Core Insights - BioXcel Therapeutics has completed an updated market opportunity assessment for IGALMI, indicating a larger than expected total addressable market for the treatment of acute agitation associated with bipolar disorders or schizophrenia in the at-home setting [1][2] - The assessment is based on the SERENITY At-Home clinical study and aims to inform the company's launch planning activities for IGALMI [1][3] Market Opportunity Assessment - The assessment involved interviews with 15 prescribers and 5 payers, along with survey responses from 180 prescribers, to gauge interest and potential market size for IGALMI [2] - Approximately 2.3 million treated bipolar disorder and schizophrenia patients in the U.S. experience frequent episodes of acute agitation at home, with up to 1.8 million potentially eligible for IGALMI treatment [5] - This translates to an estimated 86 million addressable annual episodes requiring treatment, a significant increase from previous estimates of 57-77 million [5] Prescriber and Payer Insights - Prescribers reported a moderate to high unmet need for at-home treatment options, noting that current treatments may be sedating or controlled substances [5] - There is strong prescriber interest in IGALMI, with expectations that it could be used in approximately 70% of their patients with schizophrenia and bipolar disorder [5] - Payers anticipate broad formulary coverage for IGALMI, indicating positive feedback on potential inclusion in treatment plans [5] Patient Demand and Advocacy - Patient interviews highlighted a high unmet need for effective at-home treatment options for acute agitation, reinforcing the urgency for IGALMI's availability [6] - Prior research indicated that patients with schizophrenia and bipolar disorder expect to use IGALMI in about 80% of their acute agitation episodes [5] Company Background - BioXcel Therapeutics is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [16] - The company is focused on re-innovating existing drugs and leveraging big data to identify new therapeutic indications [16]

Core Viewpoint - BioXcel Therapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for IGALMI, aiming to expand its use for the acute treatment of agitation associated with bipolar disorders or schizophrenia in outpatient settings, with potential approval by the end of 2026 [1][3]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop innovative medicines in neuroscience [11]. - The company focuses on drug re-innovation, leveraging existing approved drugs and machine learning to identify new therapeutic indications [11]. Product Information - IGALMI (dexmedetomidine) is the first orally dissolving sublingual film approved for treating agitation associated with schizophrenia and bipolar disorders under healthcare supervision [2][5]. - The sNDA submission seeks to allow treatment in outpatient settings without healthcare supervision, addressing a significant unmet medical need [2][3]. Clinical Trial Results - The sNDA is supported by the successful completion of the Phase 3 SERENITY At-Home safety trial, where IGALMI met its primary endpoint of being well-tolerated in the at-home setting [4]. - The safety profile of IGALMI in the trial was consistent with the approved label, indicating its potential for broader use [4]. Market Opportunity - There are approximately 7.3 million individuals in the U.S. diagnosed with schizophrenia or bipolar disorders, with an estimated 57 to 77 million annual agitation episodes occurring [3]. - The company is conducting a market opportunity assessment to evaluate commercialization strategies for IGALMI [3].

Core Insights - BioXcel Therapeutics is highlighted as a promising penny stock due to its late-stage pipeline progress, increasing market potential, and an upcoming FDA milestone, making it a company to watch for 2026 [1] Company Overview - BioXcel Therapeutics is a biopharmaceutical company that utilizes artificial intelligence (AI) and machine learning to discover and develop innovative treatments, particularly in neuroscience [2] - The company's lead product, IGALMI, is an FDA-approved sublingual film formulation of BXCL501 designed for the immediate treatment of severe agitation in individuals with schizophrenia and bipolar disorder [2] Regulatory Developments - BioXcel has conducted a Phase 3 SERENITY At-Home trial with 246 patients to evaluate the safety of BXCL501 in a home-use setting, collecting data on over 2,600 agitation episodes [3] - The trial results showed no discontinuations due to tolerability, no major adverse events related to the drug, and no new safety signals, prompting the company to submit a supplemental New Drug Application (sNDA) to the FDA for at-home use of IGALMI [3] - The company anticipates FDA approval within the year and is preparing for pre-launch and commercial activities [3] Market Potential - BioXcel is advancing its TRANQUILITY In-Care Phase 3 program to address agitation associated with Alzheimer's dementia, having received FDA feedback on the clinical protocol [4] - The company estimates that the at-home agitation market in the U.S. represents between 57 million and 77 million episodes annually, significantly higher than previous estimates of 23 million episodes [5] - If approved, at-home IGALMI could fulfill a substantial unmet need by transitioning treatment from institutional settings to patients' homes, benefiting the patients [5]

Core Insights - BioXcel Therapeutics is advancing its commercial planning for IGALMI, aiming for a supplemental New Drug Application (sNDA) submission this month for at-home use in treating agitation associated with bipolar disorders or schizophrenia [1][2] Company Developments - Mark Pavao has been appointed as Acting Chief Commercial Officer, bringing over 30 years of experience in CNS product commercialization to lead the development and execution of the company's commercial plans [1][2] - The company is focused on maximizing the value of the IGALMI franchise and improving patient access and convenience [2] Product Information - IGALMI (dexmedetomidine) is a sublingual film indicated for the acute treatment of agitation associated with schizophrenia and bipolar disorder in adults, with safety and effectiveness not studied beyond 24 hours from the first dose [3] - The product is administered under healthcare supervision, and its potential for at-home use addresses a significant unmet need in the treatment paradigm for these conditions [2][3] Market Positioning - The company aims to leverage strong clinical data and market feedback to position IGALMI as a unique treatment option, as there are currently no FDA-approved medicines for at-home use in this context [2] - Pavao's previous experience includes successful launches of multiple CNS therapies, which will be instrumental in the strategic planning for IGALMI's market entry [2]

Core Viewpoint - BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) for IGALMI® to the FDA for at-home use in treating agitation associated with bipolar disorders or schizophrenia, with potential approval as early as 2026 [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [10]. - The company’s approach involves leveraging existing approved drugs and big data to identify new therapeutic indications [10]. Product Information - IGALMI® (dexmedetomidine) is a sublingual film used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults, administered under healthcare supervision [4]. - BXCL501, the investigational formulation of dexmedetomidine, is being studied for treating agitation in Alzheimer's dementia and bipolar disorders in the at-home setting [3]. Regulatory Status - IGALMI has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [3]. - The safety and efficacy of IGALMI have not been established beyond 24 hours from the first dose, and its use in children is not known [4]. Market Potential - The company is focused on launch planning for IGALMI, aiming to provide a treatment option in the at-home setting where no FDA-approved alternatives currently exist [2].

Financial Performance - The company reported a net loss of $30.9 million, or $2.18 per share, for the third quarter of 2025, compared to a net loss of $13.7 million, or $5.15 per share, in the same quarter last year [1] - Product revenues decreased to $98,000 from $214,000 year-over-year [1] Clinical Development Updates - BXCL501 showed a mean reduction in mCGI-S score from baseline compared to placebo at 2 hours during the SERENITY at-home phase 3 safety trial, indicating positive efficacy [2] - The SERENITY at-home supporting correlation study demonstrated a high correlation between validated clinician assessments and the mCGI-S scale, reinforcing its use as a measurement for exploratory efficacy outcomes [3] Future Plans - The company is preparing to initiate the TRANQUILITY In-Care Phase 3 Trial to evaluate BXCL501 for agitation associated with Alzheimer's dementia [4] - A supplemental New Drug Application for at-home use of IGALMI for the acute treatment of agitation related to bipolar disorders or schizophrenia is planned for submission in early Q1 2026 [4] - As of pre-market hours, the company's stock is trading at $1.9, reflecting a decline of 5.94 percent on the Nasdaq [4]

Core Insights - BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) in early Q1 2026 for the at-home use of IGALMI® based on positive results from the SERENITY At-Home trial [1][2] - The company is also preparing to initiate the TRANQUILITY In-Care Phase 3 Trial for BXCL501 targeting agitation associated with Alzheimer's dementia [1][6] Financial Performance - For Q3 2025, net revenue from IGALMI® was $98 thousand, a decrease from $214 thousand in Q3 2024 [9] - Cost of Goods Sold (COGS) for Q3 2025 was $11 thousand, significantly lower than $1.17 million in Q3 2024 [10] - Research and Development (R&D) expenses increased to $8.7 million in Q3 2025 from $5.1 million in Q3 2024, primarily due to heightened clinical trial activities [11] - Selling, General and Administrative (SG&A) expenses decreased to $5.4 million in Q3 2025 from $7.7 million in Q3 2024 [12] - The company reported a net loss of $30.9 million for Q3 2025, compared to a net loss of $13.7 million in Q3 2024 [13] Clinical Development Programs - The SERENITY At-Home Phase 3 trial involved 246 patients and evaluated the safety of a 120 mcg dose of BXCL501 for treating agitation in a home setting [6][19] - The TRANQUILITY In-Care Phase 3 trial is designed to assess the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer's dementia in care settings [6][20] - The SERENITY At-Home trial demonstrated a mean reduction in the modified Clinical Global Impression-Severity (mCGI-S) score at 2 hours post-treatment compared to placebo [6] Market Insights - The potential at-home market for agitation treatment is estimated to encompass 57 to 77 million annual episodes in the U.S., significantly higher than the previously estimated 23 million episodes [2][17] - The company continues to supply IGALMI® to patients and providers while building brand awareness with limited commercial resources [8] Cash Position - As of September 30, 2025, the company had cash and cash equivalents totaling $37.3 million, with an additional $4.9 million raised post-quarter-end [14]

Core Insights - BioXcel Therapeutics has completed clinical trials necessary for a supplemental New Drug Application (sNDA) submission, which is planned for the first quarter of 2026 [1] - The company reported positive results from the SERENITY At-Home trial, indicating a strong correlation between clinician assessments and patient/caregiver-rated outcomes [3][4] Group 1: Clinical Trial Results - The SERENITY At-Home trial showed a statistically significant correlation between the Positive and Negative Syndrome Scale – Excited Component (PEC) and the modified Clinical Global Impression – Severity Scale (mCGI-S), with correlation coefficients of ρ=0.89 for patients and ρ=0.88 for informants, both with p<0.0001 [3] - The mCGI-S scale was developed in consultation with the FDA to allow patients and caregivers to assess efficacy in an outpatient setting [2][6] Group 2: Safety and Efficacy - No serious adverse events were reported during the trials, and the safety profile of BXCL501 remains consistent with the existing IGALMI label [4] - BXCL501 is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders in the at-home setting, with Breakthrough Therapy and Fast Track designations from the FDA [8] Group 3: Future Plans - The findings from the SERENITY At-Home study will be included in the upcoming sNDA package [4] - Additional data and results from the trials are expected to be presented at future medical meetings and conferences [5]

Core Insights - BioXcel Therapeutics, Inc. is celebrating a significant milestone by ringing the Nasdaq Stock Market Closing Bell, highlighting its progress in addressing unmet needs in psychiatry, particularly in treating agitation associated with bipolar disorders and schizophrenia [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that leverages artificial intelligence to develop transformative medicines in neuroscience. The company also has a subsidiary, OnkosXcel Therapeutics, focused on immuno-oncology [3]. Recent Developments - The company has successfully completed its SERENITY At-Home pivotal trial, moving closer to its goal of redefining agitation management and bringing its product IGALMI® to patients in their homes [2]. - The Nasdaq Closing Bell ceremony is scheduled for October 14, 2025, and will be broadcast live [2]. Strategic Focus - BioXcel aims to transform the standard of care in neuropsychiatry by combining technology and compassion to deliver meaningful changes in patient care [2].