BioXcel Therapeutics Reports Q2 2025 Financials, Topline Data Expected in August.

• BioXcel Therapeutics reports Q2 2025 financial results • Topline data from SERENITY Phase 3 trial expected in August • FDA meeting scheduled to support IGALMI label expansion • Non-clinical data published in Frontiers in Pharmacology • Cash position strengthened • BXCL501 has potential applications in chronic conditions

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, reported its financial results for the second quarter of 2025. The company announced that its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia was complete. Topline results from the study are expected in August.

The financial results showed IGALMI® revenue of $120,000 in Q2 2025, down from $1.1M in Q2 2024. The company reported an operating loss of $15.9M and a net loss of $19.2M. Cash position stood at $18.6M as of June 30, 2025, with additional post-quarter funding of $15.1M through ATM sales and warrant exercises.

The SERENITY At-Home Phase 3 trial enrolled over 200 patients across 22 sites, collecting data from more than 2,200 agitation episodes. The trial aims to expand IGALMI's label into the at-home setting, a market management now believes is substantially larger than their initial estimate of 23 million annual agitation episodes. Two favorable Data Safety Monitoring Board recommendations suggest a reasonable safety profile thus far.

The upcoming August data readout and FDA meeting represent binary events that could dramatically alter BioXcel's trajectory. Success could unlock substantial market opportunity and partnership potential, while failure would severely limit growth prospects given IGALMI's current commercial underperformance.

BioXcel's completion of the SERENITY At-Home Phase 3 trial represents a potentially transformative milestone in psychiatric care delivery. The trial's scope—capturing data from over 2,200 agitation episodes across both bipolar disorder and schizophrenia patients—provides an unprecedented dataset on agitation management outside institutional settings. The favorable Data Safety Monitoring Board recommendations suggest the sublingual dexmedetomidine formulation maintains its established safety profile in less controlled environments.

Beyond acute agitation, the publication in Frontiers in Pharmacology highlighting BXCL501's effects in stress-induced behavioral models opens intriguing potential applications for chronic stress-related conditions. This pharmacological profile could eventually position the medication for broader psychiatric applications beyond episodic agitation management.

The company's parallel pursuit of the TRANQUILITY program for Alzheimer's-related agitation, though currently in CRO evaluation phase, demonstrates a comprehensive approach to addressing agitation across multiple neuropsychiatric conditions. If successful across these programs, BXCL501 could establish a new paradigm in treating acute symptoms across the neuropsychiatric spectrum, potentially reducing emergency department visits and hospitalizations while improving quality of life for patients and caregivers.

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[1] https://www.stocktitan.net/news/BTAI/bio-xcel-therapeutics-reports-second-quarter-2025-financial-results-4lem1oavdnel.html