BioXcel Therapeutics Q1 2024 Financial Results

BioXcel Therapeutics, Inc., a biopharmaceutical company known for using artificial intelligence to develop drugs in neuroscience and immuno-oncology, has revealed its financial performance for the first quarter of 2024. Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, emphasized the company's robust business fundamentals and its focus on advancing its agitation portfolio, particularly the BXCL501 program.

BioXcel is progressing with two pivotal Phase 3 trials under its TRANQUILITY and SERENITY programs. The TRANQUILITY In-Care trial aims to test the efficacy and safety of a 60 mcg dose of BXCL501 for agitation related to Alzheimer's dementia. Meanwhile, the SERENITY At-Home safety trial will evaluate a 120 mcg dose of BXCL501 for agitation in patients with bipolar disorders or schizophrenia in a home setting, with the study protocol already submitted to the FDA.

In addition to clinical advancements, BioXcel has fortified its intellectual property portfolio, securing two new patents for BXCL501 in Japan and the U.S., providing protection until 2039 and 2043, respectively. IGALMI™, a commercial product for acute agitation treatment, saw a notable increase in net revenue by 55% in the first quarter of 2024 compared to the previous quarter. This growth was driven by new customer acquisition, increased use among existing customers, and a permanent J-Code for IGALMI effective from January 1, 2024.

The company also wrapped up a significant study to assess tolerance, tachyphylaxis, or withdrawal following repeated dosing of IGALMI™, enrolling about 20 patients in an open-label study. These patients self-administered 180 mcg of IGALMI for recurrent agitation episodes over a week, with data cleaning initiated to lock the database.

Further bolstering its patent portfolio, BioXcel now holds over 30 granted or allowed patents, along with more than 140 additional applications in prosecution as of April 2024. Additional patents have been recently granted for BXCL501 in Japan and the U.S.

On the financial front, BioXcel Therapeutics reported a net revenue of $582,000 for the first quarter of 2024, a significant rise from $206,000 in the same period of the previous year. This 182% increase was primarily driven by heightened demand from existing and new customers. Research and Development (R&D) expenses dropped to $11.4 million from $27.8 million year-over-year, reflecting the winding down of the SERENITY III and TRANQUILITY II and III trials as well as reduced professional fees and personnel costs.

Selling, General, and Administrative (SG&A) expenses also saw a decrease to $13.3 million from $23.6 million in the first quarter of 2023, mainly due to reduced personnel and commercialization costs for IGALMI™. These decreases were partially offset by higher professional fees in the first quarter of 2024.

The net loss for BioXcel Therapeutics narrowed to $26.8 million in the first quarter of 2024, compared to a $52.8 million net loss in the same period of 2023. The company used $17.7 million in operating cash during the first quarter of 2024, and cash and cash equivalents totaled $74.1 million as of March 31, 2024. This figure includes $25 million from a registered direct offering announced on March 25, 2024.

BioXcel Therapeutics will host a conference call and webcast to discuss its first-quarter financial results, reflecting on its strategic advancements and ongoing commitment to leveraging artificial intelligence in drug development for transformative patient outcomes.