BioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

Core Insights - BioXcel Therapeutics has completed enrollment in its SERENITY At-Home pivotal Phase 3 safety trial for BXCL501, aimed at treating agitation associated with bipolar disorders or schizophrenia, with topline data expected in the second half of 2025 to support a potential sNDA submission for label expansion of IGALMI in the at-home setting [1][2] Company Updates - The SERENITY trial is designed as a double-blind, placebo-controlled study involving 200 patients, with over 165 patients already dosed and more than 115 receiving multiple doses during the 12-week trial period [7] - The company continues to supply IGALMI to patients and providers while building brand awareness with minimal commercial resources [4] Financial Performance - For Q1 2025, net revenue from IGALMI was $168,000, a decrease from $582,000 in Q1 2024 [5] - Cost of Goods Sold for Q1 2025 was $14,000, down from $80,000 in the same period last year [6] - Research and Development (R&D) expenses were $4.6 million for Q1 2025, significantly lower than $11.4 million in Q1 2024, primarily due to reduced clinical trial activity [8] - Selling, General and Administrative (SG&A) expenses decreased to $5.7 million in Q1 2025 from $13.3 million in Q1 2024, reflecting cost-cutting measures [9] - The company reported a net loss of $7.3 million for Q1 2025, compared to a net loss of $26.8 million for the same period in 2024, with cash and cash equivalents totaling $31 million as of March 31, 2025 [10] Product Development - BXCL501 is under investigation for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in the at-home setting, with Breakthrough Therapy and Fast Track designations granted by the FDA [11] - The TRANQUILITY In-Care Phase 3 trial is also in progress, designed to evaluate the efficacy and safety of BXCL501 for agitation associated with Alzheimer's dementia [13]