BioXcel Therapeutics, Inc.

For the third quarter of 2024, net revenue from IGALMI was $214,000 versus $341,000 in the same period of 2023. Net revenue for the nine months ended September 30, 2024 was $1.9 million, up 89% from $1.0 million a year ago. Cost of goods sold was $1.2 million versus $512,000, including $1.2 million of reserves for excess or obsolete inventory versus $495,000 last year. R&D expense was $5.1 million versus $19.6 million, SG&A was $7.7 million versus $24.3 million, and net loss was $13.7 million versus $50.5 million. The company used $16.3 million in operating cash during the quarter and ended with $40.4 million in cash and cash equivalents. Management did not provide formal next-quarter or full-year financial guidance, but said SERENITY At-Home is expected to take nine to 12 months from its September initiation, and reiterated that it is working to strengthen the balance sheet and pursue strategic financing alternatives.

Vimal Mehta framed the quarter around advancing BXCL501, calling SERENITY At-Home a near-term growth opportunity and the company’s immediate focus. He said the company believes BXCL501 could address major unmet need in agitation across bipolar disorder, schizophrenia, and Alzheimer’s disease, and emphasized that the platform is being supported by additional externally funded studies. His tone was constructive but cautious, repeatedly returning to the need to get to data readout while strengthening the balance sheet.

Richard Steinhart focused on the quarter’s financials and cost actions. He said IGALMI revenue was $214,000, nine-month revenue reached $1.9 million, gross-related inventory reserves were $1.2 million, and the company’s quarterly net loss improved to $13.7 million from $50.5 million, largely because of lower R&D and SG&A after reprioritization and reductions in force. He also noted $16.3 million of operating cash usage in the quarter and $40.4 million of cash and cash equivalents at September 30, 2024, while saying the company is working on “all options” to strengthen the balance sheet and has enough inventory to sustain operations for “the next couple of years.”

Analysts pressed on SERENITY At-Home enrollment, rescue medication use, FDA feedback on TRANQUILITY, cash runway, covenant pressure, and the status of BXCL701. Management said SERENITY is in the normal ramp-up phase, with a seasonal holiday slowdown possible and a rebound expected in January, and confirmed rescue medications are allowed. On TRANQUILITY, management declined to share detailed FDA comments but said the feedback was positive in tone, and later confirmed the 20-patient at-home pilot cohort had been removed from the protocol. On funding, they said they are talking with stakeholders and strategic partners, but gave no explicit runway guidance.