BioXcel Therapeutics, Inc. - BTAI STOCK NEWS

BioXcel Therapeutics (BTAI) has announced a public offering of its common stock and accompanying warrants, along with pre-funded warrants for certain investors. The company plans to use the proceeds to fund the SERENITY At-Home trial, prepare for the TRANQUILITY In-Care trial, and for working capital and general corporate purposes. Canaccord Genuity is acting as the sole book-running manager. The offering is being made through a shelf registration statement that became effective on November 13, 2023.

BioXcel Therapeutics (BTAI) reported Q3 2024 financial results, highlighting progress in two pivotal Phase 3 trials of BXCL501. Net revenue from IGALMI was $214,000 in Q3 2024, down from $341,000 in Q3 2023, though nine-month revenue increased 89% to $1.9 million. The company reported a net loss of $13.7 million, improved from $50.5 million in Q3 2023. R&D expenses decreased to $5.1 million from $19.6 million, while SG&A expenses reduced to $7.7 million from $24.3 million. Cash position stood at $40.4 million as of September 30, 2024.

BioXcel Therapeutics (BTAI) announced progress in two pivotal Phase 3 trials for BXCL501. The first patient has been randomized in the SERENITY At-Home trial, evaluating a 120 mcg dose for at-home treatment of agitation in bipolar disorders or schizophrenia. The company also received FDA feedback on the TRANQUILITY In-Care trial protocol, testing a 60 mcg dose for Alzheimer's-related agitation. The SERENITY trial aims to enroll 200 patients over 9-12 months, while TRANQUILITY targets 150 patients aged 55+ across various dementia severity levels. Both conditions currently lack FDA-approved acute therapies, with an estimated 140 million annual acute agitation episodes.

BioXcel Therapeutics (BTAI) has scheduled its third quarter 2024 financial results release for Thursday, November 14, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:00 AM ET the same day, featuring management's discussion of results and business updates. The webcast will be available on the company's website under the Investors & Media section, with a replay accessible for 90 days following the event.

BioXcel Therapeutics (Nasdaq: BTAI), an AI-focused biopharmaceutical company specializing in neuroscience medicines, has announced its upcoming presentation at the ThinkEquity Conference in New York City. CEO Vimal Mehta and Executive VP Vincent O'Neill will deliver the presentation on Wednesday, October 30 at 2 p.m. ET.

The presentation will be accessible via live webcast on the company's website under the Events & Presentations page in the Investors & Media section. The webcast recording will remain available for 90 days following the event.

BioXcel Therapeutics (Nasdaq: BTAI) announced a collaboration with the University of North Carolina at Chapel Hill (UNC) to evaluate BXCL501 as a potential treatment for acute stress disorder (ASD). The study is funded by a $2.8 million grant from the U.S. Department of Defense to UNC's Institute for Trauma Recovery.

The Phase 2a trial, expected to begin in H1 2025, will enroll 100 patients experiencing ASD after motor vehicle collisions. This double-blind, placebo-controlled study aims to assess BXCL501's efficacy in reducing ASD symptom severity and posttraumatic neuropsychiatric symptoms.

ASD affects millions annually, with an estimated 40 million Americans visiting emergency departments after traumatic experiences. This marks the second externally funded stress-related trial for BXCL501, following a study at Yale University for PTSD related to alcohol and substance abuse disorder.

BioXcel Therapeutics (Nasdaq: BTAI) announced a strategic shift, prioritizing late-stage clinical programs for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer's disease while deprioritizing sales efforts for its approved drug IGALMI™. The company has initiated the SERENITY At-Home pivotal Phase 3 trial for agitation in bipolar disorders or schizophrenia and submitted a protocol to the FDA for the TRANQUILITY In-Care pivotal Phase 3 trial for Alzheimer's dementia-related agitation. BioXcel will maintain IGALMI in the market without its current commercial infrastructure, focusing resources on developing BXCL501 for potential new markets. This strategic move aims to optimize resource allocation and advance the company's lead neuroscience asset into promising growth opportunities.

BioXcel Therapeutics (Nasdaq: BTAI) has initiated patient enrollment in its SERENITY At-Home pivotal Phase 3 trial. The study will evaluate the safety of BXCL501, an investigational orally dissolving film formulation of dexmedetomidine, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is expected to last 9-12 months and will enroll approximately 200 patients. Participants will self-administer 120 mcg of BXCL501 or placebo during agitation episodes over a 12-week period. The primary objective is safety, with an exploratory endpoint using a modified clinical global impression of change (mCGI-C) to evaluate patient and caregiver impressions. This trial addresses a significant unmet need, as there are currently no FDA-approved therapies for at-home treatment of agitation in these conditions.

BioXcel Therapeutics (Nasdaq: BTAI), a biopharmaceutical company focusing on AI-driven neuroscience and immuno-oncology medicines, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event will take place in Boston on August 13, 2024.

CEO Vimal Mehta, Ph.D., will engage in a fireside chat at 1 p.m. ET, accompanied by Vincent J. O'Neill, M.D., Executive VP and Chief of Product Development and Medical Officer. Interested parties can access a live webcast of the discussion through the company's website. The replay will be available for 90 days post-event.