BioXcel Therapeutics(BTAI) - 2025 Q1 - Quarterly Results

Business Update and Clinical Program Highlights BioXcel completed SERENITY At-Home Phase 3 enrollment for BXCL501, expecting H2 2025 data to support at-home use - Enrollment is complete in the SERENITY At-Home pivotal Phase 3 safety trial for BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia[1] - Topline data from the SERENITY At-Home trial is expected in the second half of 2025, which is intended to support a potential supplemental New Drug Application (sNDA) for at-home use[1][6] - The company is continuing to supply its commercial product, IGALMI, and build brand awareness using minimal commercial resources[5] SERENITY Program (BXCL501 for Bipolar/Schizophrenia Agitation) SERENITY At-Home Phase 3 safety trial for BXCL501 completed enrollment, evaluating a 120 mcg dose for at-home agitation - The trial is a double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 in 200 patients in an at-home setting[6][14] - Trial enrollment is complete, with over 165 patients dosed and more than 115 patients having received multiple doses over the 12-week trial period[6] TRANQUILITY Program (BXCL501 for Alzheimer's Agitation) TRANQUILITY In-Care Phase 3 trial for BXCL501, assessing a 60 mcg dose for Alzheimer's agitation, is advancing - The TRANQUILITY program is designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for acute treatment of agitation associated with Alzheimer's dementia in a care setting[6][15] - The program remains part of the company's broader development strategy, and plans for trial initiation are being advanced[6] First Quarter 2025 Financial Results BioXcel's Q1 2025 net loss reduced to $7.3 million from $26.8 million in Q1 2024 Q1 2025 vs Q1 2024 Financial Performance (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | IGALMI Net Revenue | $168 | $582 | | R&D Expenses | $4,554 | $11,401 | | SG&A Expenses | $5,699 | $13,264 | | Net Loss | $(7,254) | $(26,791) | | Net Loss Per Share | $(1.50) | $(13.89) | Key Balance Sheet and Cash Flow Items | Metric | As of Mar 31, 2025 | | :--- | :--- | | Cash and cash equivalents | $31.0 million | | Operating cash used in Q1 2025 | $12.0 million | - The decrease in operating expenses was primarily attributable to reduced clinical trial activity, lower personnel costs, and reduced commercial and marketing expenses resulting from reprioritization actions taken in 2024[9][10] Product and Pipeline Overview This section outlines BioXcel's FDA-approved IGALMI and investigational BXCL501 for agitation treatment About BXCL501 BXCL501 is an investigational orally dissolving film for agitation, with FDA Breakthrough and Fast Track designations - BXCL501 is an investigational, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist[13] - It has received FDA Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for agitation associated with schizophrenia, bipolar disorders, and dementia[13] About IGALMI (Approved Indication) IGALMI is an FDA-approved sublingual film for acute agitation in schizophrenia and bipolar disorder - IGALMI is FDA-approved for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults, administered under medical supervision[16] - Serious side effects include decreased blood pressure, low blood pressure upon standing, slower heart rate, and heart rhythm changes (QT interval prolongation)[17] - Patients should not drive or operate hazardous machinery for at least 8 hours after taking IGALMI due to potential sleepiness/drowsiness[17] Forward-Looking Statements This section outlines forward-looking statements, subject to significant risks including limited operating history - The press release includes forward-looking statements regarding the advancement of TRANQUILITY and SERENITY trials, potential market opportunity for BXCL501, and timelines for data release and regulatory submissions[23] - The company highlights significant risks that could cause actual results to differ, including its limited operating history, significant losses, need for additional funding, significant indebtedness, and its ability to continue as a going concern[23]