The lead underwriters on this IPO were Barclays, UBS, and BMO Capital Markets. Shares are slated to open later this morning on the Nasdaq.
BTAI is a clinical stage biopharmaceutical company focused on developing drugs utilizing artificial intelligence (AI) to identify the next wave of medicines in the field of neuroscience and immuo-oncology. The company is currently a 93% owned subsidiary of BioXcel. Assuming it sells the number of shares set forth in this IPO, BioXcel will own, in the aggregate, approximately 62% of the outstanding common shares.
Its drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices.
Its two most advanced clinical development programs are BXCL501, a sublingual thin film formulation of dexmedetomidine (Dex) designed for acute treatment of agitation resulting from neurological and psychiatric disorders, and BXCL701, an immuno-oncology agent designed for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer.
BTAI initiated a Phase 1b safety study using the IV formulation of Dex in mild probable Alzheimer's Disease in December 2017 and it plans to initiate a Phase 1b safety study using the IV formulation of Dex in schizophrenia patients in the first half of 2018.
Dex has been well tolerated, having been prescribed in millions of patients as the sedative and anesthetic Precedex and has been studied in over 130 clinical trials to date. BXCL501 is designed to be a non-invasive, easy to administer agent that has a rapid onset of action, which is critical for the acute treatment of agitation. BTAI estimates that over 500,000 patients who suffer from AD in the United States annually could be eligible for the acute treatment of agitation with BXCL501.
The company expects to report data from both studies by the second half of 2018. It also intends to commence Phase 2 proof of concept (PoC) open label clinical trials in 2018 for both programs.
It expects that a data readout from the planned Phase 2 PoC clinical trials for the BXCL501 program will be available by the end of 2018, potentially leading to the start of registration trials, and that preliminary data from the planned Phase 2 PoC clinical trial of BXCL701 will be available in the first half of 2019.