Bioxcel Therapeutics Inc Stock Price, News & Analysis

BioXcel Therapeutics (BTAI) announced a successful expansion of its Phase 1b/2 trial for BXCL701, an investigational drug for small-cell neuroendocrine prostate cancer (SCNC). The trial met its efficacy threshold, showing three composite responses among ten evaluable patients, leading to cohort expansion. As SCNC currently lacks FDA-approved treatments, the study signifies a crucial step forward. Data from the trial, including the expanded cohort's findings, is expected by Q1 2022, with hopes for BXCL701 to generate immune responses in 'cold' tumors.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) hosted a virtual R&D Day on September 23, 2021, to showcase its AI-driven drug development initiatives, particularly focusing on neuropsychiatric disorders. The company introduced its new program, BXCL502, and discussed the expansion of BXCL501, which targets agitation associated with various neuropsychiatric disorders. BXCL501 has received Breakthrough Therapy designation and Fast Track designation for several indications. The event featured insights from leading neuroscience experts and emphasized the role of AI in building a sustainable pipeline for transformative medicines.

BioXcel Therapeutics (BTAI) reported promising data from its ongoing Phase 1b/2 trial of BXCL701, an oral innate immunity activator, in metastatic castration-resistant prostate carcinoma (mCRPC) patients at the ESMO Congress. The trial showed a 26% composite response rate among adenocarcinoma patients, with all responders experiencing a decrease in tumor size. The treatment exhibited a favorable safety profile, with low-grade adverse events. BXCL701 aims to enhance the efficacy of immunotherapies, representing a potential breakthrough in treating mCRPC.

BioXcel Therapeutics (Nasdaq: BTAI) announced updates from its Phase 1b/2 trial of BXCL701, an investigational oral innate immunity activator for aggressive prostate cancer. The findings will be presented at the ESMO Congress, taking place September 16-21, 2021. The poster, titled 'BXCL701—1st-in-class oral activator of systemic innate immunity—combined with pembrolizumab in men with mCRPC: Phase 2 results,' will be available from September 15 at 6:05 PM EST. BXCL701 aims to convert 'cold' tumors into 'hot' ones, enhancing immune response against mCRPC and other solid tumors.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) will host a virtual R&D Day on September 23, 2021, from 12:00 PM to 2:00 PM ET, titled Revolutionizing Drug Discovery and Development Through AI. The event will showcase BioXcel’s AI platform and emerging neuroscience pipeline, highlighting updates on its lead program, BXCL501. Key executives, including CEO Vimal Mehta and CSO Frank Yocca, will present, alongside Dr. Maurizio Fava from Massachusetts General Hospital. BXCL501 targets agitation in psychiatric disorders and has received Breakthrough Therapy and Fast Track designations.

BioXcel Therapeutics (BTAI) reported financial results for Q2 2021, including a net loss of $27.6 million. The company raised approximately $100 million through a stock offering in June, supporting ongoing clinical studies and commercialization efforts. BXCL501, aimed at treating agitation in schizophrenia and bipolar disorders, has received an FDA PDUFA date of January 5, 2022. The Phase 3 program for dementia-related agitation is anticipated to begin in Q4 2021. R&D expenses decreased to $13.5 million, while G&A expenses rose sharply to $14.1 million due to increased team expansion costs.

BioXcel Therapeutics, Inc. (BTAI) announced the release of its second quarter 2021 financial results scheduled for August 10, 2021, before U.S. market opening. A conference call will follow at 8:30 AM EDT to discuss the results and provide a business update. The company focuses on utilizing artificial intelligence to develop innovative treatments in neuroscience and immuno-oncology, with notable clinical advancements in BXCL501 and BXCL701, aimed at addressing agitation and aggressive prostate cancer, respectively.

BioXcel Therapeutics (BTAI) will participate in the Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 9:30 a.m. Eastern Time. The event will feature Dr. Vimal Mehta, the CEO and Founder of BioXcel. Investors and interested parties can access the live webcast on the Company’s website under the “Events” section. A replay will be available for 30 days post-event. BioXcel focuses on utilizing artificial intelligence to develop innovative medicines, including therapies for agitation and advanced prostate cancer.

BioXcel Therapeutics (BTAI) has priced an underwritten public offering of 3,155,000 shares at $31.70 each, aiming for gross proceeds of approximately $100 million. A related party, BioXcel LLC, has granted underwriters a 30-day option to purchase up to 473,250 additional shares. The offering is set to close around June 25, 2021, and is being managed by BofA Securities under a previously filed registration statement with the SEC. The company will not receive any proceeds from shares sold by BioXcel LLC.