Bioxcel Therapeutics 2025 Q3 Earnings Net Loss Widens 126.5%

Bioxcel Therapeutics (BTAI) reported Q3 2025 earnings that missed expectations, with revenue plummeting 54.2% and net losses more than doubling. The stock price has fallen sharply in the post-earnings period, reflecting investor concerns over the company’s financial trajectory and operational challenges.

Revenue

The company’s total revenue declined sharply to $98,000 in Q3 2025, a 54.2% drop from $214,000 in the same period in 2024. This significant contraction underscores ongoing pressure on revenue generation amid limited product offerings.

Earnings/Net Income

Bioxcel narrowed its per-share loss to $2.18 from $5.15 year-over-year (57.7% improvement), but the net loss ballooned to $30.91 million, a 126.5% increase from $13.65 million in 2024 Q3. Despite the EPS improvement, the widening net loss highlights structural financial challenges.

Post-Earnings Price Action Review

The stock price of Bioxcel Therapeutics has experienced a steep decline in the post-earnings period, dropping 6.56% during the latest trading day, 8.06% over the past week, and 34.48% month-to-date. This pronounced sell-off reflects investor skepticism about the company’s ability to reverse its financial trajectory, particularly given the widening net loss and stagnant revenue growth. The disconnect between the EPS improvement and the broader financial deterioration has amplified market concerns.

CEO Commentary

CEO Vimal Mehta emphasized progress in late-stage clinical trials, including the SERENITY At-Home Phase 3 safety trial, which demonstrated no drug-related serious adverse events. He highlighted plans to submit an sNDA for IGALMI® in Q1 2026 and advance the TRANQUILITY In-Care Phase 3 trial. Mehta stated, “BXCL501 has the potential to redefine the treatment of agitation, addressing a 57–77 million annual episode opportunity in the U.S. at-home market.”

Guidance

The company expects to maintain a disciplined approach to cash management to support its sNDA submission and key corporate milestones. However, the operating loss of $14.2 million and net loss of $30.9 million in Q3 2025 underscore the need for continued capital raising, with $37.3 million in cash and equivalents as of September 30, 2025.

Additional News

1. sNDA Submission: Bioxcel plans to file a supplemental New Drug Application (sNDA) for IGALMI® in Q1 2026, seeking FDA approval for at-home use based on SERENITY trial data.

2. SERENITY Trial Results: The trial enrolled 246 patients, with no drug-related serious adverse events and a favorable safety profile, supporting the sNDA pathway.

3. TRANQUILITY Trial Prep: The company is preparing for the TRANQUILITY In-Care Phase 3 trial for Alzheimer’s agitation, pending FDA feedback on its protocol.