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 Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9][10] Business Line Data and Key Metrics Changes - The drug Serenity was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Market Data and Key Metrics Changes - There is no specific market data or key metrics changes mentioned in the provided content Company Strategy and Development Direction and Industry Competition - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8][13] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook in the provided content Other Important Information - The company has approved the appointment of Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025 [13] - The advisory vote on the compensation of named executive officers has been approved [13] Q&A Session Summary Question: What was the average cost per share traded, and how many shares did the company sell? - The 14.4 million shares in Q2 were as of the filing date, not the end of the quarter, and the 21.8 million shares in Q3 were also as of the filing date, which is mid-November [9][10] Question: When was the drug Serenity approved, and how many doses have been issued? - The drug was originally approved in April 2022, with two doses approved, and there is no black box warning on the current label [10]

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9] - The low trade price during this period was $1.18, which would have returned over $8 million [9] Business Line Data and Key Metrics Changes - The drug SERENITY was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Company Strategy and Development Direction - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's current compliance status and the strategic measures being taken to ensure future flexibility in operations [8] Other Important Information - The company has appointed Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025, which has been ratified by stockholders [13] - The advisory vote on the compensation of named executive officers has also been approved [13] Q&A Session Summary Question: Average cost per share traded and number of shares sold - The average cost per share traded was not disclosed, but the company clarified that the share counts reported were as of the filing dates, not the end of the quarters [9] Question: Approval and dosage information for the drug SERENITY - The drug SERENITY was approved in April 2022, with no black box warning on the current label, and two doses are available [10]

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9][10] Business Line Data and Key Metrics Changes - The drug Serenity was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Market Data and Key Metrics Changes - There is no mention of specific market data or key metrics changes in the provided content Company Strategy and Development Direction and Industry Competition - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8] Management's Comments on Operating Environment and Future Outlook - Management has indicated that they are open to communication with shareholders and are willing to address any questions through their investor relations [10] Other Important Information - The company has approved several proposals during the meeting, including the election of directors and the ratification of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2025 [13] Q&A Session Summary Question: What was the average cost per share traded, and how many shares did the company sell? - The company clarified that the 14.4 million shares in Q2 were as of the filing date, not the end of the quarter, and that the 21.8 million shares in Q3 were also as of the filing date [9][10] Question: When was the drug Serenity approved, and does it have a black box warning? - The drug Serenity was approved in April 2022, with no black box warning on the current label [10]

Core Viewpoint - The discussion focuses on addressing acute agitation associated with schizophrenia and bipolar disorders, emphasizing the need for patient-centered innovations in non-clinical settings [1][3]. Group 1: Company Mission and Commitment - BioXcel Therapeutics aims to transform patient care by advancing solutions that alleviate the burden of acute agitation on patients, caregivers, and the healthcare system [3]. - The company recognizes the significant challenges posed by episodes of acute agitation, particularly outside clinical environments, highlighting the urgency for practical innovations [3]. Group 2: Event Structure and Participants - The event features a roundtable discussion moderated by Anjalee Khemlani, an award-winning journalist known for her in-depth reporting on healthcare [2]. - The participation of clinical experts is intended to provide valuable insights into the management of agitation in real-world settings [2].