BioXcel Therapeutics, Inc. Q4 FY2023 earnings call

• TRANQUILITY is a top priority, with a Type B breakthrough therapy designation meeting with the FDA on Feb 20. Plan to generate additional Phase 3 efficacy and safety data in care facilities, reevaluating TRANQUILITY At Home timing. Need to generate long-term safety data for AD treatment.
• SERENITY: Evaluating at-home use of 501, completed Type C meeting with FDA, plan to evaluate 120 microgram dose in amended SERENITY 3 Part 2 protocol with safety as primary objective.
• Corporate updates: Permanent J Code for IGALMI effective, commercial efforts progress, IP portfolio building, fast track designation for BXCL701, exploring financial options to extend cash runway.

Net revenue from IGALMI was $376,000 in Q4 2023 compared to $238,000 in Q4 2022, and $1.4 million for full-year 2023 vs $375,000 in 2022. Research and development expenses were $9 million in Q4 2023 vs $32.5 million in Q4 2022, and $84.3 million for full-year 2023 vs $91.2 million in 2022. Selling, general and administrative expenses were $9.6 million in Q4 2023 vs $20.7 million in Q4 2022, and $83.4 million for full-year 2023 vs $68.8 million in 2022. Net loss was $22.3 million in Q4 2023 vs $54.8 million in Q4 2022, and $179 million for full-year 2023 vs $165.8 million in 2022. Cash and cash equivalents totaled $65.2 million as of Dec 31, 2023, vs $193.7 million in 2022, and are estimated to fund operations through mid-2024.

Estimates current cash and cash equivalents will fund operations through mid-2024. Plan to generate additional Phase 3 efficacy and safety data in care facilities for TRANQUILITY, reevaluating TRANQUILITY At Home timing. Plan to move forward with amended SERENITY 3 Part 2 protocol with safety as primary objective for SERENITY.

Forward-looking statements subject to risks and uncertainties. Need to generate long-term safety data for TRANQUILITY, lack of regulatory precedent for episodic treatment of AD, potential challenges in funding and clinical trial timelines.

Q: After recent FDA meetings, would there be two separate paths to sNDA in Alzheimer's (care setting and at home) and how is the company funding the programs?

A: Vince O'Neill said yes, they believe there are two paths, and Vimal Mehta mentioned exploring multiple financing options.

Q: Regarding the 120-microgram dose for SERENITY and funding the programs?

A: Vince O'Neill said 120-microgram dose is a good choice with established efficacy, and Vimal Mehta emphasized focus on TRANQUILITY first then SERENITY.

Q: What changed with TRANQUILITY at-home pivot and funding needs?

A: Vince O'Neill explained FDA feedback led to reevaluation of efficacy endpoints, and Vimal Mehta discussed financing based on FDA clarity.

Q: About paused study data and OnkosXcel?

A: Robert Risinger said safety data from paused study is in NDA package, and Vimal Mehta said focusing on Neuroscience business first then OnkosXcel.

Q: On TRANQUILITY timing, IGALMI sales, and credit agreement?

A: Vince O'Neill, Matt Wiley, and Vimal Mehta provided insights on timing, sales growth, and collaborative financing with partners.

Q: TRANQUILITY strategy and OpEx run rate?

A: Vince O'Neill said sensible approach for care setting first, and Richard Steinhart said Q4 OpEx is a good run rate marker.

Q: Commercial pricing of 501 in Alzheimer's and OpEx run rate?

A: Matt Wiley discussed pricing flexibility in the market, and Richard Steinhart confirmed Q4 OpEx is a good run rate for Q1.