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

(RTTNews) - 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.