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Mar 31
Bioxcel Therapeutics Q1 2025 Earnings Report
BioXcel Therapeutics reported its financial results for the first quarter of 2025, with a net loss of $7.3 million and a decrease in revenue compared to the previous year, while also announcing the full enrollment of its SERENITY At-Home pivotal Phase 3 safety trial.
Key Takeaways
BioXcel Therapeutics reported a net loss of $7.3 million for the first quarter of 2025, a significant improvement from the $26.8 million net loss in the same period of 2024. Revenue from IGALMI® decreased to $168,000 from $582,000 year-over-year. The company also announced the full enrollment of its SERENITY At-Home pivotal Phase 3 safety trial, with topline data expected in the second half of 2025.
Net loss significantly improved to $7.3 million in Q1 2025 from $26.8 million in Q1 2024.
Product revenue from IGALMI® decreased to $168,000 in Q1 2025 from $582,000 in Q1 2024.
Research and Development expenses decreased to $4.6 million in Q1 2025 from $11.4 million in Q1 2024, primarily due to reduced clinical trial activity and personnel costs.
Selling, General and Administrative expenses decreased to $5.7 million in Q1 2025 from $13.3 million in Q1 2024, driven by lower personnel, professional fees, and marketing costs.
SERENITY At-Home pivotal Phase 3 safety trial is fully enrolled, with topline data anticipated in the second half of 2025.
Bioxcel Therapeutics
Bioxcel Therapeutics
Bioxcel Therapeutics Revenue by Segment
Revenue by Segment
IGALMI Revenue
CapyFin.com Forward Guidance
The company anticipates topline data from the SERENITY At-Home Phase 3 trial in the second half of 2025, which is intended to support a potential sNDA submission for label expansion of IGALMI® in the at-home setting. The TRANQUILITY In-Care Phase 3 trial remains part of the development strategy, with plans for trial initiation advancing.
Positive Outlook
- Topline data for SERENITY At-Home Phase 3 trial expected in second half of 2025.
- Potential sNDA submission for label expansion of IGALMI® in the at-home setting.
- Advancing plans for TRANQUILITY In-Care Phase 3 trial initiation.
- Opportunity to expand the market potential of IGALMI® to millions of additional patients.
- Continuing to supply IGALMI® to patients and providers and build brand awareness with minimal commercial resources.
Challenges Ahead
- The safety and effectiveness of BXCL501 for investigational uses have not been established.
- The Company's ability to realize its expectations and beliefs is inherently uncertain.
- Actual results could differ materially due to factors like limited operating history and need for additional funding.
- Risk of not receiving regulatory approval for product candidates.
- Potential for undesirable side effects caused by the Company's product candidates.