BioXcel Therapeutics (BTAI) Earnings Call Presentation

SERENITY At-Home Trial Overview - The SERENITY At-Home trial investigates IGALMI® for agitation associated with bipolar disorders or schizophrenia in the at-home setting[2] - The trial aims for sNDA submission for IGALMI® label expansion, as there are currently no FDA-approved therapies for this indication in the at-home setting[12] - The study design is a double-blind, placebo-controlled trial evaluating the safety of a 120 mcg dose of BXCL501 in the home setting[28] Safety and Tolerability Results - The trial collected data from 2,628 agitation episodes[22] - 2,437 episodes were treated in 208 patients, who self-administered the film[23] - No drug-related serious adverse events, syncopes, or falls were reported in the BXCL501 arm[24,38] - The adverse event profile was consistent with the approved IGALMI® label and previous clinical trials[24,38] - The most common treatment-emergent adverse event (TEAE) for the first dose of BXCL501 120 mcg was somnolence, occurring in 23 out of 102 patients (22.5%)[39] Efficacy and Future Steps - Preliminary results suggest continued treatment effect with repeat BXCL501 dosing across the trial[24,42] - A greater percentage of patients with mild, moderate, or severe agitation experienced full resolution of symptoms in the BXCL501 arm compared to placebo[42] - The company plans to submit an sNDA in Q1 2026[13,24]