BioXcel Therapeutics, Inc. Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Quarterly Period Ended March 31, 2024

Press release · 05/10 10:21
BioXcel Therapeutics, Inc. Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Quarterly Period Ended March 31, 2024

BioXcel Therapeutics, Inc. Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Quarterly Period Ended March 31, 2024

BioXcel Therapeutics, Inc. has reported a net loss of $10.8 million for the quarter ended March 31, 2024, compared to a net loss of $8.7 million for the same period in 2023. The company’s cash and cash equivalents increased to $104.7 million as of March 31, 2024, from $91.4 million as of December 31, 2023. The company’s common stock outstanding was 37,530,821 as of May 7, 2024.

Overview

BioXcel Therapeutics is a biopharmaceutical company utilizing artificial intelligence to develop medicines for neurological and immuno-oncology diseases. In April 2022, the FDA approved IGALMITM for treating agitation in adults with schizophrenia or bipolar disorder. IGALMITM was commercially launched in July 2022.

The company is continuing to develop its lead neuroscience drug candidate BXCL501 for treating agitation associated with dementia and psychiatric disorders. The TRANQUILITY and SERENITY programs are evaluating BXCL501 for treating agitation in patients with Alzheimer’s disease and schizophrenia/bipolar disorder, respectively.

On the immuno-oncology front, BioXcel is developing BXCL701 as a potential therapy for aggressive prostate and pancreatic cancers.

In August 2023, BioXcel implemented a restructuring plan to reduce costs and prioritize the most promising R&D programs. This involved reducing the workforce by ~60% and refocusing the IGALMITM commercial strategy.

Financial Performance

In Q1 2024, BioXcel reported:

  • IGALMITM product revenue of $582,000
  • R&D expenses of $11.4 million
  • SG&A expenses of $13.3 million
  • Net loss of $26.8 million

At March 31, 2024, BioXcel had $74.1 million in cash.

Revenue and Profit Trends

  • IGALMITM product revenue was $582,000 in Q1 2024, up from $206,000 in Q1 2023, reflecting increased market penetration
  • R&D spending declined 59% year-over-year in Q1 2024 due to reduced clinical trial activities
  • SG&A spending fell 44% in Q1 2024 as a result of the restructuring plan
  • Net losses are expected to continue in the near term as BioXcel advances its R&D programs

Strengths and Weaknesses

Strengths:

  • Approved product IGALMITM on the market
  • Promising late-stage assets BXCL501 and BXCL701
  • Focus on high unmet need neurological and oncology indications
  • Utilizing AI and machine learning to enhance R&D productivity

Weaknesses:

  • Early commercial stage company with limited revenue
  • History of operating losses and negative cash flows
  • Requires substantial additional capital to fund operations

Outlook

Key upcoming milestones:

  • Report results from opioid withdrawal study of BXCL501 (H2 2024)
  • Initiate TRANQUILITY In-Care Phase 3 Alzheimer’s agitation trial (2024)
  • Report data from pancreatic cancer study of BXCL701 (H1 2024)
  • Advance development of second innate immuno-oncology candidate BXCL702 (2025)

BioXcel is targeting profitability longer-term based on IGALMITM sales growth and advancing the BXCL501 and BXCL701 programs. Further funding is needed in the near term to continue operations.