BioXcel Therapeutics, Inc. Q3 FY2024 earnings call

• Announced pivotal Phase 3 trials with BXCL501 for agitation in bipolar disorder, schizophrenia, and Alzheimer's dementia.
• SERENITY at home trial initiated, first patient randomized, expected duration 9-12 months from September initiation.
• TRANQUILITY In-Care trial planning, received FDA feedback on protocol.
• Externally funded studies for BXCL501, including Department of Defense grant for acute stress disorder.
• Maintaining IGALMI in the market with minimal resources.
• Working to strengthen balance sheet and evaluating strategic financing alternatives.

Net revenue for IGALMI was $214,000 in the third quarter of 2024, compared to $341,000 in the same period in 2023. For the nine months ended September 30, 2024, net revenue was $1.9 million, an 89% increase from $1 million in the same period in 2023. Cost of goods sold for the three months ended September 30, 2024 was $1.2 million, compared to $512,000 in the same period in 2023, due to higher non-cash charges for reserves for excess or obsolete inventory. Research and development expenses were $5.1 million in the third quarter of 2024, compared to $19.6 million in the same period in 2023. Selling, general, and administrative expenses were $7.7 million in the third quarter of 2024, compared to $24.3 million in the same period in 2023. BioXcel Therapeutics had a net loss of $13.7 million in the third quarter of 2024, compared to a net loss of $50.5 million in the same period in 2023. Cash and cash equivalents totaled $40.4 million as of September 30, 2024.

• The SERENITY trial is expected to last 9 to 12 months from September initiation.
• Focus on advancing the SERENITY and TRANQUILITY trials and strengthening the balance sheet.

Q: How has the launch of the SERENITY study gone so far?

A: Vince O’Neill stated the study has kicked off, first patient randomized recently, in ramp up phase, with anticipated slowdown in holiday season but rebound in January, and 26 active sites. Rob Risinger added they're on track and ramping up across multiple sites.

Q: What was the specific feedback from FDA on the TRANQUILITY trial protocol?

A: Vince O’Neill said feedback was direct, actionable, and concise, and they're happy with the feedback.

Q: How important is the successful completion of SERENITY At-Home to the company?

A: Vimal Mehta said the company is advanced in trials, and progressing them can be huge value drivers for stakeholders.

Q: Was the cohort of 20 patients in the At-Home setting still part of the TRANQUILITY In-Care trial following FDA feedback?

A: Vince O’Neill said the pilot cohort was taken out of the protocol.

Q: Any progress on BXCL701?

A: Vince O’Neill said it's still an ongoing process with the firm working on potential partners and diligence.

Q: Confirmation on inventory write-down?

A: Richard Steinhart said they're in good shape with inventory, enough to sustain for next couple of years, non-cash charge, and sales pick-up would have plenty of inventory to sell.