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 Viewpoint - BioXcel Therapeutics, Inc. has regained compliance with Nasdaq's market value of listed securities requirement, indicating a positive development for the company's listing status [1][2]. Company Compliance - The company was previously notified on March 20, 2025, that it was not in compliance with Nasdaq Listing Rule 5550(b)(2) due to its market value being below $35.0 million for 30 consecutive business days [2]. - Following a hearing on May 1, 2025, the company received an exception to regain compliance, and on September 17, 2025, Nasdaq confirmed that the company has met all listing requirements [2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that utilizes artificial intelligence to develop transformative medicines in neuroscience [3]. - The company's subsidiary, OnkosXcel Therapeutics, focuses on immuno-oncology drug development [3]. - BioXcel employs a drug re-innovation approach, leveraging existing approved drugs and big data to identify new therapeutic indications [3].

Core Insights - BioXcel Therapeutics announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501, indicating significant benefits in treating agitation associated with bipolar disorders and schizophrenia [1][3][5] Efficacy Results - BXCL501 demonstrated a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) [6] - Complete resolution of agitation symptoms was significantly higher with BXCL501 compared to placebo, with an overall resolution of 50% in the BXCL501 arm versus 33% on placebo (p <.0001) [7] - The mean reduction in mCGI-S score was maintained across repeated dosing, with a mean reduction of 1.2 after the first 12 doses and 1.4 after 13 or more doses [8] - The reduction in agitation symptoms was consistent throughout the 12-week trial duration, with a mean reduction of 1.3 in mCGI-S scores across all weeks [9] Trial Design and Patient Insights - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients, with data collected on 2,628 agitation episodes over 12 weeks [4][16] - The trial included patients with bipolar disorders (45%) and schizophrenia (55%), allowing for concomitant interventions to manage agitation episodes [4] - Patients reported an average of 11.7 agitation episodes during the trial, with 81% completing the full 12-week study [4] Market Opportunity - The total addressable market for at-home agitation treatment is estimated to be significantly higher than previously anticipated, with 57-77 million agitation episodes annually compared to an earlier estimate of 23 million [12] - The lack of FDA-approved therapies for at-home agitation treatment highlights a substantial unmet need in the market [11][12] Future Plans - Based on the positive trial results and FDA feedback, the company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded usage of IGALMI® in outpatient settings [1][2][10]

Core Insights - BioXcel Therapeutics announced that BXCL501 achieved its primary endpoint in the SERENITY At-Home trial, demonstrating good tolerability for treating agitation in patients with bipolar disorders or schizophrenia at home [1][2][3] - The company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded use of BXCL501 in outpatient settings without healthcare provider supervision [1][2][3] - The SERENITY At-Home trial treated over 2400 episodes of agitation, indicating a significant market opportunity for BXCL501 [1][2][3] Company Overview - BioXcel Therapeutics is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [2][26] - BXCL501 is a proprietary sublingual film formulation of dexmedetomidine, currently FDA-approved for use in medically supervised settings [19][20] - The company aims to change the treatment paradigm for agitation associated with bipolar disorders and schizophrenia, addressing a significant unmet medical need in the at-home setting [3][14] Trial Details - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients over 12 weeks, evaluating the safety of a 120 mcg dose of BXCL501 [3][18] - The trial reported that 168 patients (81%) completed the full 12-week duration, with an average of 11.7 agitation episodes recorded per treated patient [6][9] - No discontinuations due to tolerability were reported in the BXCL501 arm, and the adverse event profile was consistent with the approved IGALMI® label [9][10] Market Insights - Previous estimates suggested 23 million annual episodes of agitation, but new data indicates the total addressable market could be significantly higher, with estimates of 57 million to 77 million episodes annually in the at-home setting [15][22] - Market research suggests that episodes may occur 3-4 times a month on average, with most being moderate or severe [15][22] - Physicians believe there is a significant unmet need for effective and fast-acting treatments for agitation in the community setting [22] Future Plans - BioXcel plans to leverage the positive results from the SERENITY At-Home trial to support its regulatory submission for BXCL501, aiming to provide patients with access to treatment in the home setting [3][13] - The company will continue to analyze the full dataset from the trial and present additional results at upcoming medical meetings and conferences [16][12]