BioXcel Therapeutics Advances Clinical Trials Amid Financial Adjustments

Bioxcel Therapeutics ( (BTAI) ) has released its Q1 earnings. Here is a breakdown of the information Bioxcel Therapeutics presented to its investors.

BioXcel Therapeutics, Inc. is a biopharmaceutical company leveraging artificial intelligence to develop transformative medicines in neuroscience, with a focus on drug re-innovation and the use of big data and machine learning algorithms to identify new therapeutic indications. The company also has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology medicines.

In its first quarter of 2025 financial report, BioXcel Therapeutics announced the completion of enrollment in its SERENITY At-Home pivotal Phase 3 safety trial for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The company anticipates topline data in the second half of 2025, which could support a potential sNDA submission for label expansion of IGALMI in the at-home setting.

Key financial metrics for the first quarter of 2025 include net revenue from IGALMI at $168,000, a decrease from $582,000 in the same period of 2024. The company reported a net loss of $7.3 million, a significant improvement from the $26.8 million loss in the previous year. This reduction in net loss is attributed to decreased R&D and SG&A expenses, reflecting a reprioritization of resources.

Strategically, BioXcel is advancing its TRANQUILITY In-Care Phase 3 trial for agitation associated with Alzheimer’s dementia and continues to build brand awareness for IGALMI with minimal commercial resources. The company maintains a cash position of $31 million as of March 31, 2025, ensuring operational stability as it progresses its clinical programs.

Looking forward, BioXcel Therapeutics remains focused on expanding the market potential of its lead candidate, BXCL501, and is poised to deliver significant advancements in its clinical trials, potentially bringing new treatment options to patients with agitation associated with neurological conditions.