Core Insights - BioXcel Therapeutics is set to release topline data from its SERENITY At-Home Phase 3 trial for the acute treatment of agitation associated with bipolar disorders or schizophrenia in August [1][2] - The company is preparing for a meeting with the FDA to support a potential supplemental New Drug Application (sNDA) for label expansion of IGALMI in the at-home setting [1][2] - Recent research indicates potential applications of BXCL501 in chronic conditions, enhancing its market prospects [1][4] Clinical Trials - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation in bipolar disorders or schizophrenia at home [4][15] - The trial enrolled over 200 patients across 22 sites, with a balanced distribution between bipolar disorder and schizophrenia populations [6] - The TRANQUILITY In-Care Phase 3 trial is also underway, focusing on agitation associated with Alzheimer's dementia [6][16] Financial Performance - For Q2 2025, net revenue from IGALMI was $120 thousand, a significant decrease from $1.1 million in Q2 2024 [8] - Cost of Goods Sold for Q2 2025 was $107 thousand, up from $62 thousand in the same period last year [9] - Research and Development (R&D) expenses rose to $10.3 million in Q2 2025, compared to $8.0 million in Q2 2024, primarily due to increased clinical trial activities [10] Losses and Cash Position - The company reported an operating loss of $15.9 million and a net loss of $19.2 million for Q2 2025, compared to an operating loss of $17.3 million and a net loss of $8.3 million in Q2 2024 [12] - As of June 30, 2025, cash and cash equivalents totaled $18.6 million, not including an additional $11.5 million from sales and $3.6 million from warrant exercises [13][30]