Stamford, CT – BioXcel Therapeutics, Inc., a biopharmaceutical firm leveraging artificial intelligence for neuroscience drug development, has revealed a challenging financial quarter, balanced by significant progress in its clinical pipeline. The company’s Q2 2025 results show a decrease in revenue and a wider net loss, but all eyes are on the imminent data from its pivotal SERENITY At-Home trial, which could unlock a major new market for its flagship product, IGALMI®.
A Look at the Q2 2025 Financials
BioXcel Therapeutics reported a stark contrast in its financial performance compared to the previous year. Key financial highlights for the second quarter ending June 30, 2025, include:
Net Revenue: Revenue from its acute agitation treatment, IGALMI®, was $120 thousand, a significant decline from the $1.1 million generated in the same quarter of 2024.
Operating and Net Loss: The company posted an operating loss of $15.9 million and a net loss of $19.2 million. This compares to an operating loss of $17.3 million and a net loss of $8.3 million in Q2 2024.
Expenses: Research and Development (R&D) expenses increased to $10.3 million from $8.0 million, driven by heightened clinical trial activity. Conversely, Selling, General and Administrative (SG&A) expenses fell to $5.6 million from $9.5 million, a result of strategic personnel reductions and related cost-saving measures.
Cash Position: As of June 30, 2025, BioXcel held $18.6 million in cash and cash equivalents.
The financial results reflect a strategic shift, with the company minimizing commercial spending on IGALMI® in institutional settings to conserve resources for its high-stakes clinical development programs.
Pivotal Clinical Trial Data on the Horizon
The primary focus for BioXcel and its investors is the successful completion of its SERENITY At-Home pivotal Phase 3 trial. This landmark study evaluated the safety of BXCL501 (the active ingredient in IGALMI®) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home-use setting.
The trial was extensive, enrolling over 200 patients across 22 sites in the United States and collecting data from more than 2,200 agitation episodes. The company announced that topline results are expected in August 2025, a catalyst that could dramatically expand the drug’s market potential.
“We are incredibly excited about our upcoming topline data readout for the SERENITY At-Home Phase 3 trial,” said Dr. Vimal Mehta, CEO of BioXcel Therapeutics. He emphasized the significant unmet need, stating, “This represents an expanded market opportunity for IGALMI and could fundamentally change how these patients manage their agitation episodes.”
Advancing the Pipeline and Strategic Initiatives
Beyond the SERENITY trial, BioXcel continues to advance its neuroscience pipeline. The TRANQUILITY In-Care Phase 3 trial is moving forward, aiming to assess BXCL501 for treating agitation related to Alzheimer’s dementia in residential and assisted living facilities. This targets another major patient population with limited treatment options. Adding to its potential, recent research published in Frontiers in Pharmacology has suggested that BXCL501 may have applications in chronic conditions, hinting at future long-term value.
To support these ambitious programs, BioXcel has been actively strengthening its financial footing. The company raised an additional 3.6 million from the exercise of outstanding warrants.
The Path Forward
The coming weeks are critical for BioXcel Therapeutics. The company has an FDA meeting scheduled for August to discuss the SERENITY At-Home data. A positive outcome from both the trial and the FDA meeting would pave the way for a potential supplemental New Drug Application (sNDA) submission, seeking to expand IGALMI®’s label for at-home use.
While navigating current financial pressures through disciplined spending, BioXcel is strategically positioning itself for a transformative future. The upcoming clinical data will be a defining moment, determining whether its pivot towards at-home treatment can deliver the breakthrough the company and its patients are waiting for.
