Overview

BioXcel Therapeutics, Inc. (BTI) is a biopharmaceutical company that uses artificial intelligence (AI) to develop transformative medicines in neuroscience and immuno-oncology. The company’s most advanced neuroscience candidate is BXCL501, an investigational oral dissolving film formulation of dexmedetomidine (Dex) for the treatment of agitation associated with psychiatric and neurological disorders. Its most advanced immuno-oncology asset is BXCL701, an investigational oral innate immune activator being developed as a potential therapy for aggressive forms of prostate cancer, pancreatic cancer, and other solid and liquid tumors.

On April 6, 2022, the FDA approved IGALMI® (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI® is approved to be self-administered by patients under the supervision of a healthcare provider. The company is continuing to develop BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting and for the acute treatment of agitation (non-daily) associated with dementia due to probable Alzheimer’s disease in the at-home setting and in care facilities.

IGALMI® Commercialization Strategy

In August 2023, the company announced a shift in commercial strategy for IGALMI® in the institutional setting, including a reduction of in-hospital commercialization expenses and a focus on the development of BXCL501 for use in the at-home and care facility settings. The company is currently seeking potential commercial partners for IGALMI®.

Recent Developments

The company received a Nasdaq delisting notice in September 2024 due to its market value of listed securities closing below the minimum requirement. The company has requested a hearing to appeal the delisting determination.

The company has also entered into several amendments to its Credit Agreement, including waivers, modifications to covenants, and new capital raising requirements. These amendments have provided the company with additional flexibility and funding to continue its operations.

Our Neuroscience Clinical Programs

The table below summarizes the status of the company’s major clinical development programs as of the date of the report:

Basis of Presentation

The company’s consolidated financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP).

Components of Our Results of Operations

The company’s key financial components include:

• Product Revenue, Net: Revenue from sales of IGALMI®
• Operating Costs and Expenses: Cost of goods sold, research and development, selling, general and administrative, and restructuring costs
• Other (Income) Expense: Interest expense, interest income, and changes in fair value of derivative financial instruments

Liquidity and Capital Resources

As of December 31, 2024, the company had $29,854 in cash and cash equivalents, but substantial doubt exists about its ability to continue as a going concern. The company is pursuing various options to raise additional capital, including equity financing, debt financing, partnerships, and asset sales. However, there is no guarantee the company will be successful in obtaining adequate funding to continue its operations.

Contractual Obligations and Commitments

The company has commitments related to its commercial supply agreement, distribution agreement, and office lease. It also has quarterly interest payment obligations under its Credit Agreement.

Critical Accounting Policies and Estimates

The company’s critical accounting policies include stock compensation and the estimation of research and development expenses.