BioXcel Therapeutics (BTAI) Q2 2026 earnings summary

Executive summary

• Continued commercialization of IGALMI® for acute agitation in schizophrenia and bipolar disorder, with a focus on hospital/IDN contracting and minimal commercial resources following workforce reductions.

• SERENITY At-Home Phase 3 trial met its primary safety endpoint, supporting an sNDA for at-home use; FDA accepted the sNDA with a PDUFA date of November 14, 2026.

• Ongoing financial distress with substantial doubt about ability to continue as a going concern; active pursuit of strategic alternatives, including sale, merger, or additional financing.

• Significant legal proceedings and an SEC investigation are ongoing, with a major class action settlement pending court approval.

Financial highlights

• Net loss of $14.7 million for Q2 2026, compared to $19.2 million in Q2 2025; net loss of $27.4 million for the six months ended June 30, 2026, versus $26.4 million in the prior year period.

• Product revenue, net was $182,000 for Q2 2026, up from $120,000 in Q2 2025; six-month revenue was $388,000, up from $288,000 year-over-year.

• Cash, cash equivalents, and restricted cash totaled $13.8 million as of June 30, 2026; negative working capital of $108.4 million and stockholders' deficit of $115.5 million.

• Net cash used in operating activities was $17.9 million for the first half of 2026.

Outlook and guidance

• Management expects continued operating losses and negative cash flows; current cash is insufficient to fund operations beyond August 2026.

• Additional funding or a strategic transaction is required to avoid bankruptcy; failure to secure capital or a transaction may result in filing for protection under the U.S. Bankruptcy Code.

• FDA review of the sNDA for IGALMI® at-home use is ongoing, with a decision expected by November 2026.