BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. has completed the sale of substantially all of its neuroscience assets, including IGALMI® (dexmedetomidine) and BXCL501, to Teva Pharmaceuticals International GmbH for an upfront cash payment of $57.5 million. The company may also receive significant milestone payments based on the development and commercial success of IGALMI® for at-home use. Assets not included in the sale are BXCL701 and BXCL702. In connection with the sale and the wind-down of the company's affairs, the CEO and President, Vimal Mehta, Ph.D., and Senior Vice President Richard Steinhart have been terminated.

BioXcel Therapeutics reported substantial doubt about its ability to continue as a going concern, citing significant losses, negative cash flows, and current debt obligations. The company is actively pursuing strategic transactions or additional financing, warning of potential bankruptcy if unsuccessful. For Q2 2026, the company reported a net loss of $14.7 million on product revenue of $0.18 million, with an accumulated deficit reaching $747.5 million.

BioXcel Therapeutics, Inc. entered into the Twelfth Amendment to its Credit Agreement, extending the deadline for securing definitive agreements for debt repayment or alternative capital solutions to August 21, 2026. This amendment also reduced the minimum liquidity covenant from $6.25 million to $3.0 million. The required transactions must be acceptable to the company's lenders.

BioXcel Therapeutics, Inc. entered into the Eleventh Amendment to its Credit Agreement, deferring a principal and interest payment of $9,016,914.47 from July 31, 2026, to August 31, 2026. The amendment also reduced the minimum liquidity covenant from $7.5 million to $6.25 million. The company is now required to secure definitive agreements for full debt repayment or an alternative capital solution by August 10, 2026, and faces restrictions on modifying compensation arrangements until August 31, 2026.

BioXcel Therapeutics, Inc. entered into the Tenth Amendment to its Credit Agreement, deferring a $9.02 million principal and interest payment from June 30, 2026, to July 31, 2026. The amendment also reduced the minimum liquidity covenant to $7.5 million from $12.5 million. The company is now required to secure definitive agreements for full debt repayment or an alternative capital solution by July 31, 2026, and has established a Strategic Process Committee with broad authority over potential transactions. Additionally, the amendment imposes significant new reporting requirements and negative covenants, restricting various corporate actions and compensation changes.

BioXcel Therapeutics reported a Q1 2026 net loss of $12.7 million, an increase from $7.3 million in Q1 2025, while IGALMI net revenue grew to $206,000. The FDA accepted the supplemental New Drug Application for IGALMI for at-home use in acute agitation associated with bipolar disorders or schizophrenia, setting a PDUFA target action date of November 14, 2026. The company is also actively exploring strategic options with an advisor to maximize shareholder value for the IGALMI franchise and continues to advance its BXCL501 program for Alzheimer’s dementia.

BioXcel Therapeutics reported a net loss of $12.7 million for Q1 2026, a significant increase from $7.3 million in Q1 2025. The company's cash and cash equivalents decreased to $17.2 million from $28.4 million at year-end 2025. Management has identified substantial doubt about the company's ability to continue as a going concern due to significant losses, negative cash flows, and current debt obligations, despite ongoing efforts to raise additional capital and reduce expenses.

BioXcel Therapeutics announced that the FDA accepted its supplemental New Drug Application (sNDA) for IGALMI® for at-home use in acute agitation associated with bipolar disorders or schizophrenia, setting a PDUFA target action date of November 14, 2026. Concurrently, the company is evaluating strategic options with an advisor to maximize shareholder value for the IGALMI franchise. For Q1 2026, BioXcel reported a net loss of $12.7 million, an increase from $7.3 million in Q1 2025, with IGALMI® net revenue at $206,000 and cash reserves of $17.2 million.

BioXcel Therapeutics, Inc. granted warrants to its lenders to purchase up to 1,353,729 shares of common stock at an exercise price of $0.01 per share. This action was taken on April 15, 2026, pursuant to the Ninth Amendment to its Credit Agreement and Guaranty. The company also entered into a Fourth Amended and Restated Registration Rights Agreement, agreeing to register the shares issuable upon exercise of these warrants. The warrants were issued in reliance on an exemption from registration requirements under Section 4(a)(2) of the Securities Act.

BioXcel Therapeutics announced it will host a virtual event on April 23 to discuss the launch strategy for IGALMI, its treatment for acute agitation. The event will focus on commercial plans ahead of the November 14 PDUFA target action date. A recent market assessment identified up to 86 million addressable annual episodes of acute agitation in the at-home setting in the U.S., highlighting a significant market opportunity.