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Jun 30, 2020
Bioxcel Therapeutics Q2 2020 Earnings Report
Reported positive results from SERENITY trials, strengthened balance sheet, and advanced clinical programs.
Key Takeaways
BioXcel Therapeutics reported positive results from its SERENITY trials for BXCL501, plans to submit an NDA to the FDA in Q1 2021, and strengthened its balance sheet through a follow-on offering. The company is also advancing its TRANQUILITY and RELEASE trials and exploring alternative indications for BXCL501. Additionally, the immuno-oncology program is progressing with the Phase 2 efficacy trial of BXCL701 and KEYTRUDA®.
SERENITY I & II Phase 3 trials of BXCL501 achieved all primary and secondary endpoints; NDA submission to FDA planned for Q1 2021.
Initiating the third dose cohort, 90 mcg, of the TRANQUILITY trial in elderly dementia patients.
Initiated a separate efficacy cohort in the Phase 2 trial of BXCL701 in combination with pembrolizumab to include patients with castrate-resistant prostate cancer.
Strengthened balance sheet through follow-on offering raising approximately $200 million in gross proceeds.
Bioxcel Therapeutics
Bioxcel Therapeutics
Forward Guidance
The company is focused on submitting an NDA for BXCL501 to the FDA in the first quarter of 2021 and advancing its clinical programs.