BioXcel Therapeutics Inc (BTAI) Reports Q3 2023 Financial Results and Strategic Updates

In this article:
  • BioXcel Therapeutics Inc (NASDAQ:BTAI) aligns with FDA for Phase 3 trial in TRANQUILITY program.

  • Strategic financing terms agreed with Oaktree Capital Management and Qatar Investment Authority.

  • Net revenue from IGALMI reported at approximately $341,000 for the quarter.

  • Company estimates current cash and cash equivalents to fund operations through mid-2024.

On November 14, 2023, BioXcel Therapeutics Inc (NASDAQ:BTAI) released its 8-K filing, announcing strategic advancements and financial results for the third quarter ended September 30, 2023. The company is at the forefront of utilizing artificial intelligence for the development of transformative medicines in neuroscience and immuno-oncology.

Strategic Clinical and Financial Highlights

BioXcel Therapeutics Inc (NASDAQ:BTAI) has aligned with FDA recommendations to conduct a Phase 3 trial for its TRANQUILITY program, which evaluates BXCL501 for the acute treatment of agitation associated with Alzheimer's dementia. The company also plans a Phase 3 trial for the SERENITY III program, focusing on the at-home treatment of agitation in bipolar disorders or schizophrenia. Additionally, BTAI has secured key financial terms with Oaktree Capital Management and Qatar Investment Authority, enhancing operational and financial flexibility.

Financial Performance Overview

The company reported net revenue of approximately $341,000 from IGALMI for the quarter. Research and Development (R&D) expenses decreased to $19.6 million compared to $22.1 million in the same period in 2022, primarily due to reduced expenses in BXCL501 clinical trials. Selling, General and Administrative (SG&A) expenses increased to $24.3 million, up from $17.1 million in the previous year, attributed to one-time legal and professional fees, costs associated with the OnkosXcel potential public offering, and personnel costs related to the commercialization of IGALMI in the U.S. The net loss for the quarter was $50.5 million, an increase from a net loss of $41.8 million in the same quarter of 2022.

Balance Sheet and Cash Flow

As of September 30, 2023, BioXcel Therapeutics Inc (NASDAQ:BTAI) had cash and cash equivalents totaling $90.0 million. The company has restructured key financial terms with strategic financing partners to provide greater flexibility, including the potential to access additional capital. The current cash position is estimated to support operations through mid-2024, not accounting for any additional capital that may become available under the amended strategic financing agreements or potential future financing activities.

Operational and Clinical Progress

Dr. Vimal Mehta, CEO of BioXcel Therapeutics, expressed optimism about the company's progress, particularly with the TRANQUILITY and SERENITY III programs.

This is a time of tremendous progress and excitement for our company and stakeholders, especially as we report a clinical development path forward for our TRANQUILITY program,"

said Dr. Mehta. He also highlighted the FDA's feedback, which provides a clear path for the development of BXCL501 for at-home use in treating agitation associated with schizophrenia and bipolar disorders.

Looking Ahead

BioXcel Therapeutics Inc (NASDAQ:BTAI) continues to focus on its late-stage clinical programs and the commercialization of IGALMI. The company will host a conference call and webcast to discuss the third quarter 2023 financial results and provide operational updates. Investors and stakeholders are keenly watching the company's strategic moves, clinical trial outcomes, and financial management as BTAI advances its pipeline and seeks to deliver on its mission of transforming patient care through innovative therapies.

For detailed financial tables and further information, readers are encouraged to view the full 8-K filing.

Explore the complete 8-K earnings release (here) from BioXcel Therapeutics Inc for further details.

This article first appeared on GuruFocus.

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