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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a pioneering clinical-stage biopharmaceutical company that harnesses the power of artificial intelligence (AI) to identify and develop the next generation of transformative medicines. Focusing on neuroscience and immuno-oncology, BioXcel re-innovates existing approved drugs and clinically validated candidates using proprietary machine learning algorithms and big data. This innovative approach allows the company to discover new therapeutic indications more efficiently.
BioXcel's two leading clinical programs are BXCL501 and BXCL701. BXCL501, marketed as IGALMI, is an FDA-approved sublingual film formulation of dexmedetomidine used for the acute treatment of agitation associated with schizophrenia or bipolar I and II disorder in adults. This product is undergoing further development to expand its use for agitation in dementia related to probable Alzheimer’s disease and for at-home use.
BXCL701 is an oral innate immune activator designed to inflame the tumor microenvironment, enhancing the efficacy of checkpoint inhibitors. It is currently being investigated for the treatment of rare forms of prostate cancer and pancreatic cancer. The company recently reported promising results from a Phase 2 trial of BXCL701 in combination with KEYTRUDA for metastatic pancreatic ductal adenocarcinoma (PDAC).
BioXcel also continues to strengthen its intellectual property portfolio, with over 100 patent applications in prosecution and multiple patents issued globally. The company's financial performance reflects a commitment to advancing its clinical pipeline; for example, net revenue from IGALMI increased significantly in the first quarter of 2024, driven by growing demand and new customer acquisitions.
The company maintains a strong focus on advancing its TRANQUILITY and SERENITY programs, designed to evaluate BXCL501 in treating agitation in various settings, including at home. Additionally, BioXcel's strategic collaborations with institutions like Georgetown University's Lombardi Comprehensive Cancer Center underline its dedication to innovative cancer therapies.
For ongoing updates, BioXcel engages with the investment community through regular conference calls and webcasts and actively participates in key industry conferences like the American Society of Clinical Oncology (ASCO) Annual Meeting. For more information and the latest news, please visit bioxceltherapeutics.com.
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.
BioXcel Therapeutics (Nasdaq: BTAI) reported its Q2 2024 financial results, highlighting progress in key clinical programs. The company is preparing to initiate the SERENITY At-Home pivotal Phase 3 trial for BXCL501 in acute agitation associated with bipolar disorders or schizophrenia. Plans for the TRANQUILITY In-Care pivotal Phase 3 trial for agitation in Alzheimer's dementia are advancing. Positive topline results were reported from the IGALMI™ post-marketing requirement study.
Financial highlights include:
- IGALMI™ net revenue grew 90% in Q2 2024 over Q1 2024
- Net revenue was $1.1 million, up 141% year-over-year
- R&D expenses decreased to $8.0 million from $27.0 million in Q2 2023
- SG&A expenses reduced to $9.5 million from $25.9 million in Q2 2023
- Net loss narrowed to $8.3 million from $53.5 million in Q2 2023
- Cash and cash equivalents totaled $56.3 million as of June 30, 2024
BioXcel Therapeutics (Nasdaq: BTAI), a biopharmaceutical company focused on AI-driven medicine development in neuroscience and immuno-oncology, has announced its plan to release second quarter 2024 financial results on August 6, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:00 AM ET on the same day to discuss the results and provide a business update.
Investors and interested parties can access the webcast link under the 'News/Events' section of BioXcel's website. For those unable to attend live, a replay will be available for 90 days following the event. This announcement highlights BioXcel's commitment to transparency and shareholder communication.
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