Bioxcel Therapeutics 2025 Q3 Earnings Substantial Loss Widens Despite Strategic Advances

Bioxcel Therapeutics (BTAI) reported Q3 2025 results that fell short of expectations, with revenue declining sharply and net losses expanding. The company highlighted progress toward its sNDA submission for BXCL501’s at-home use, but financial challenges persist.

Revenue

The total revenue of Bioxcel Therapeutics decreased by 54.2% to $98,000 in 2025 Q3, down from $214,000 in 2024 Q3.

Earnings/Net Income

Bioxcel narrowed losses to $2.18 per share in 2025 Q3 from $5.15 in 2024 Q3 (57.7% improvement), but the net loss widened to $-30.91 million, a 126.5% increase from $-13.65 million in the prior year. The EPS and net loss reflect deteriorating financial performance despite reduced per-share losses.

Post-Earnings Price Action Review

The stock price of Bioxcel Therapeutics dropped 6.56% during the latest trading day, tumbled 8.06% during the most recent full trading week, and plummeted 34.48% month-to-date.

CEO Commentary

Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, emphasized the company’s focus on preparing for the sNDA submission for BXCL501’s at-home use in treating agitation linked to bipolar disorders and schizophrenia, targeting a U.S. market of 57–77 million annual episodes. He highlighted BXCL501’s potential to redefine agitation treatment and drive long-term growth, alongside disciplined cash management to support milestones. Mehta noted the SERENITY At-Home trial’s positive safety profile, with no serious adverse events or tolerability issues, reinforcing confidence in the program. The tone reflects optimism about BXCL501’s commercial potential and the company’s strategic readiness for regulatory and market challenges.

Guidance

BioXcel expects to submit the sNDA for BXCL501’s at-home use in early Q1 2026, following positive SERENITY At-Home trial data. The TRANQUILITY In-Care Phase 3 trial for Alzheimer’s agitation is in preparation, with FDA feedback incorporated into the protocol. The company anticipates initiating this trial after evaluating CRO proposals. It also raised $4.9 million post-Q3 via its ATM program, maintaining a $37.3 million cash balance as of September 30, 2025. Management expects to advance pre-launch initiatives while managing cash to support key regulatory and commercial milestones.

Additional News

Bioxcel Therapeutics announced plans to submit a supplemental New Drug Application (sNDA) for BXCL501’s at-home use in early Q1 2026, following positive safety data from the SERENITY At-Home trial. The company also disclosed a $4.9 million capital raise via its ATM program post-Q3, bolstering its $37.3 million cash reserves. Additionally, the TRANQUILITY In-Care Phase 3 trial for Alzheimer’s agitation is being prepared, with regulatory feedback integrated into the protocol. These developments underscore BioXcel’s focus on advancing BXCL501’s regulatory pathway while addressing cash constraints.