BioXcel Therapeutics Inc
NASDAQ:BTAI
BioXcel Therapeutics Inc
BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company, which focuses on drug development. The company is headquartered in New Haven, Connecticut and currently employs 89 full-time employees. The company went IPO on 2018-03-08. The company is focused on utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. Its two advanced clinical development programs are BXCL501, which is an investigational, orally dissolving, sublingual thin film formulation of the adrenergic receptor agonist dexmedetomidine (Dex) for the treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, which is an investigational orally administered systemic innate immune activator for the treatment of castration resistant prostate cancer and advanced solid tumors that are refractory or treatment nave to checkpoint inhibitors. The company is conducting a Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA (pembrolizumab) for metastatic castration-resistant prostate cancer (mCRPC), in patients with adenocarcinoma and in patients with the aggressive variant small-cell neuroendocrine carcinoma.
BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company, which focuses on drug development. The company is headquartered in New Haven, Connecticut and currently employs 89 full-time employees. The company went IPO on 2018-03-08. The company is focused on utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. Its two advanced clinical development programs are BXCL501, which is an investigational, orally dissolving, sublingual thin film formulation of the adrenergic receptor agonist dexmedetomidine (Dex) for the treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, which is an investigational orally administered systemic innate immune activator for the treatment of castration resistant prostate cancer and advanced solid tumors that are refractory or treatment nave to checkpoint inhibitors. The company is conducting a Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA (pembrolizumab) for metastatic castration-resistant prostate cancer (mCRPC), in patients with adenocarcinoma and in patients with the aggressive variant small-cell neuroendocrine carcinoma.
BXCL501 Trials: BioXcel launched pivotal Phase III trials for BXCL501 in agitation associated with bipolar disorder, schizophrenia, and Alzheimer’s, with the SERENITY At-Home trial now enrolling.
Revenue Decline: IGALMI net revenue fell to $214,000 in Q3 2024 from $341,000 last year, due to timing of customer reorders.
Cost Cuts: R&D and SG&A expenses fell sharply year-on-year, reflecting reduced personnel and reprioritization of resources.
Narrowed Loss: Net loss dropped to $13.7 million from $50.5 million in the prior year’s quarter.
Cash Position: Cash and equivalents stood at $40.4 million at quarter end; company is exploring strategic financing options but gave no specific runway guidance.
Clinical Progress: The SERENITY At-Home study is on track with 26 sites active; enrollment timeline remains 9–12 months.
FDA Feedback: TRANQUILITY In-Care trial design received concise, actionable feedback from the FDA, and a planned at-home cohort was removed.
