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Sep 30, 2020
Bioxcel Therapeutics Q3 2020 Earnings Report
Reported third quarter results and provided a business update.
Key Takeaways
BioXcel Therapeutics reported a net loss of $24.8 million for the third quarter of 2020. The company's NDA submission for BXCL501 is on track for Q1 2021, and clinical trials for BXCL501 and BXCL701 are progressing. The company's cash position remains strong at $233.4 million.
Completed pre-NDA meeting with the FDA and initiated rolling submission of the NDA for BXCL501.
TRANQUILITY and RELEASE studies are on track; preparing to initiate a Phase 2 trial with BXCL501 in patients with agitation associated with delirium.
Presented encouraging data from the two ongoing combination trials of BXCL701 and KEYTRUDA® at SITC.
Cash and cash equivalents totaled approximately $233.4 million as of September 30, 2020.
Bioxcel Therapeutics
Bioxcel Therapeutics
Forward Guidance
The company is focused on advancing its BXCL501 and BXCL701 programs and expects to achieve key milestones well into 2022.
Positive Outlook
- Complete NDA submission for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders on track for Q1 2021.
- TRANQUILITY and RELEASE studies are on track.
- Preparing to initiate a Phase 2 trial with BXCL501 in patients with agitation associated with delirium.
- Encouraging data from the two ongoing combination trials of BXCL701 and KEYTRUDA® was presented at SITC.
- Strong cash position of $233 million to fund key milestones well into 2022.
Challenges Ahead
- Limited operating history.
- Incurrence of significant losses.
- Need for substantial additional funding and ability to raise capital when needed.
- Limited experience in drug discovery and drug development.
- Dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates.