Mark Pavao to Join BioXcel Therapeutics as Interim Chief Commercial Officer Mr. Pavao Brings Deep Experience in Neuroscience Sales and Marketing to Support Potential Launch of IGALMI® in At-Home Setting as Early as Year-End 2026 BioXcel Therapeutics on Track to Submit a sNDA for IGALMI® this Month NEW HAVEN, Conn., Jan. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscienc ...

NEW HAVEN, Conn., Jan. 07, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced that it plans to submit a supplemental New Drug Application (sNDA) this month seeking the U.S. Food and Drug Administration’s (FDA) approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. “We are pleased with the ...

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].

Core Insights - BioXcel Therapeutics, Inc. released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, showing that BXCL501 has continued effects and consistent benefits with repeat dosing [1] - The trial evaluated a 120 mcg dose of BXCL501 for agitation associated with bipolar disorders or schizophrenia, demonstrating significant efficacy compared to placebo [2] Efficacy Results - Across 2,433 treated episodes, BXCL501 showed a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours [2] - Complete resolution of agitation symptoms was observed in 50% of patients in the BXCL501 arm compared to 33% in the placebo group [3] - Severe agitation episodes fully resolved in 61% of cases in the BXCL501 arm versus 18% on placebo, while moderate and mild episodes resolved in 43% and 60% of cases, respectively, compared to 34% and 40% on placebo [4] Dosage Impact - A mean reduction in mCGI-S score of 1.2 was noted after the first 12 doses, increasing to a mean reduction of 1.4 after 13 or more doses of BXCL501 [5] - Igalmi, the formulation of BXCL501, is currently FDA-approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings [5] Market Reaction - BioXcel Therapeutics shares increased by 3.07% to $3.69 at the time of publication, trading within a 52-week range of $1.17 to $13.36 [6]

SERENITY At-Home Trial Overview - The SERENITY At-Home trial evaluated the safety and tolerability of BXCL501 (120 mcg) for agitation associated with bipolar disorder or schizophrenia in the at-home setting[2, 27, 28] - The trial design was a double-blind, placebo-controlled study with a 1:1 randomization to BXCL501 (N=100) or placebo (N=100) over a 12-week period[27] - The study included patients aged 18-75 years with bipolar I or II disorder, schizophrenia, schizoaffective, or schizophreniform disorder on a stable psychotropic regimen[30] Key Results - The trial collected data from 2,628 agitation episodes in 215 patients, with 2,437 episodes treated in 208 patients[21, 22, 36] - 168 (81%) of treated patients completed the full 12-week study, with an average of 117 agitation episodes recorded per treated patient[36] - No drug-related serious adverse events (SAEs), falls, or syncopes were reported in the BXCL501 arm[23, 37] - The adverse event profile was consistent with the approved IGALMI® label and other clinical trials in institutional settings[23, 37] - Somnolence was the most common treatment-emergent adverse event (TEAE) in the BXCL501 group, occurring in 23 (225%) of patients after the first dose and 161 (139%) of all doses[38] Clinical Benefit - BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (P<005)[41] - Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (P<0001)[41] - For fully resolved episodes by baseline severity, BXCL501 showed higher percentages than placebo across mild, moderate, and severe agitation episodes[43] Next Steps - BioXcel Therapeutics plans to prepare and submit an sNDA (supplemental New Drug Application) in Q1 2026 for label expansion of IGALMI®[12, 23]

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, Inc. is leveraging artificial intelligence to develop transformative medicines in neuroscience and has a subsidiary focused on immuno-oncology [2] Group 1: Company Overview - BioXcel Therapeutics will present a company overview at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:30 p.m. Eastern Time [1] - The company utilizes a drug re-innovation approach, combining existing approved drugs with big data and proprietary machine learning algorithms to identify new therapeutic indications [2] Group 2: Upcoming Events - The presentation at the investment conference will be available via a live and archived webcast on the company's website [1]