BioXcel Therapeutics Q3 Loss Wides, Shares Update On Clinical Development Programs

BioXcel Therapeutics, Inc. (BTAI), Wednesday announced financial results for the third quarter of 2025 and provided an update on its late-stage agitation clinical development programs.

During the quarter, net loss widened to $30.9 million, or $2.18 a share, from a net loss of $13.7 million, or $5.15 a share, last year.

Product revenues declined to $98,000 from $214,000 in the previous year.

Concurrently, the company stated that BXCL501 demonstrated a mean reduction in mCGI-S score from baseline compared to placebo at 2 hours during the SERENITY at-home phase 3 safety trial. Also, it showed continued effects and consistent benefit with repeat dosing.

Meanwhile, the SERENITY at-home supporting correlation study noted that high correlation between validated clinician assessments and the mCGI-S scale used in the trial provides strong support for mCGI-S as a measurement of exploratory efficacy outcomes.

In addition, the company has taken additional steps toward the initiation of the TRANQUILITY In-Care Phase 3 Trial evaluating BXCL501 in agitation associated with Alzheimer's dementia.

Notably, the company plans to submit early in the first quarter of 2026 a supplemental New Drug Application seeking FDA approval for the at-home use of IGALMI for the acute treatment of agitation associated with bipolar disorders or schizophrenia.

In the pre-market hours, BTAI is trading at $1.9, down 5.94 percent on the Nasdaq.

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