BioXcel Therapeutics Announces Q2 2024 Financial Results

BioXcel Therapeutics, Inc., a biopharmaceutical company leveraging artificial intelligence for drug development in neuroscience and immuno-oncology, has released its financial results for the second quarter of 2024, highlighting substantial progress in its clinical and commercial initiatives.

Dr. Vimal Mehta, CEO of BioXcel Therapeutics, expressed satisfaction with the company's progress, particularly with its SERENITY and TRANQUILITY programs aimed at treating agitation in patients with neuropsychiatric conditions. The company's lead product, BXCL501, shows significant therapeutic potential across various conditions, supported by a robust intellectual property portfolio.

Late-Stage Clinical Programs

SERENITY At-Home Pivotal Phase 3 Trial: This trial is designed to assess the safety of a 120 mcg dose of BXCL501 for at-home treatment of agitation associated with bipolar disorders or schizophrenia. The company has recently received feedback on the trial protocol from the FDA.

TRANQUILITY In-Care Pivotal Phase 3 Trial: This trial aims to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for agitation in Alzheimer's dementia. The protocol is being finalized for submission to the FDA.

IGALMI™ (dexmedetomidine) Sublingual Film

The company reported positive topline results from a post-marketing requirement (PMR) study for IGALMI™, which is used for treating agitation in bipolar disorders or schizophrenia. The study showed no evidence of tachyphylaxis, tolerance, or withdrawal at the highest approved dose of 180 mcg. Additionally, a reduction in agitation was observed during the study period, with no serious adverse events reported.

Commercialization

IGALMI™ has seen significant commercial success, with net revenue growing by 90% in Q2 2024 compared to Q1 2024. This growth is attributed to an effective market-access strategy and increased contracting with psychiatric care clinics and behavioral health facilities.

Patent Portfolio

BioXcel Therapeutics continues to fortify its intellectual property portfolio. The company has recently received a Notice of Allowance from the USPTO for a patent application related to IGALMI™, which, once issued, will extend the patent protection to January 12, 2043. This will be the 11th U.S. patent for IGALMI™ listed in the FDA’s Orange Book.

OnkosXcel Therapeutics

During the 2024 ASCO Annual Meeting, BioXcel presented a late-breaking abstract on preliminary findings from a Phase 2 trial of BXCL701 in combination with KEYTRUDA® for treating metastatic pancreatic ductal adenocarcinoma. The study was led by Dr. Benjamin Weinberg from Georgetown University Lombardi Comprehensive Cancer Center.

Financial Overview

For the second quarter of 2024, BioXcel Therapeutics reported net revenue of $1.1 million from IGALMI, reflecting a 141% increase compared to the same period in 2023. The company also noted a 90% sequential increase in quarterly revenue from Q1 2024. 

Research and Development (R&D) Expenses: R&D expenses were $8.0 million for Q2 2024, a significant decrease from $27.0 million in the same period in 2023. The reduction is attributed to the wind-down of certain clinical trials and decreased professional fees, personnel, and related costs.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for Q2 2024 were $9.5 million, down from $25.9 million in Q2 2023. The decrease is primarily due to reduced personnel and lower commercialization costs for IGALMI, aligned with the company's strategic reprioritization.

Net Loss: The company reported a net loss of $8.3 million for Q2 2024, compared to $53.5 million in Q2 2023. Operating cash usage totaled $23.2 million during the quarter, with cash and cash equivalents amounting to $56.3 million as of June 30, 2024.

BioXcel Therapeutics continues to advance its key clinical programs and commercial strategies, aiming to bring transformative treatments to patients in need.

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