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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, Inc. (Nasdaq: BTAI) will release its second quarter 2022 financial results on August 9, 2022, before U.S. market opening. A conference call and webcast will take place at 8:30 AM ET to discuss the results and provide business updates. BioXcel utilizes artificial intelligence for drug re-innovation in neuroscience and immuno-oncology. Its product, IGALMI™, is approved for treating agitation in schizophrenia and bipolar disorders. The company is also pursuing treatments for Alzheimer's-related agitation and prostate cancer.
BioXcel Therapeutics (BTAI) announced the appointment of Michael P. Miller to its Board of Directors, effective July 1, 2022. Miller has nearly 40 years of experience in the pharmaceutical industry, previously serving as EVP, U.S. Commercial at Jazz Pharmaceuticals. His leadership is expected to enhance BioXcel's commercial capabilities as the company launches its product IGALMI, a sublingual film for treating agitation linked to Alzheimer's disease. Miller's extensive background in product launches and market access is viewed as crucial for the company's growth trajectory.
BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta, Ph.D., will participate in fireside chats at the Jefferies Global Healthcare Conference on June 10, 2022, and the BofA Securities Napa Forum on June 22, 2022. Mehta will discuss the company’s neuroscience and immuno-oncology programs and its AI platform, which enhances drug discovery. The discussions will also cover the commercial readiness of IGALMI™ (dexmedetomidine) sublingual film, FDA-approved for treating agitation in adults.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on May 24 at 9:00 a.m. ET. The discussion will focus on the company's neuroscience and immuno-oncology programs, along with its AI platform for drug discovery and development. Dr. Mehta will also address the launch plans for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in patients with schizophrenia and bipolar disorders. A live webcast will be available for attendees.
BioXcel Therapeutics has received FDA approval for IGALMI™, a sublingual film for treating agitation in adults with schizophrenia or bipolar disorder. The expected cash runway extends to 2025, supported by a $260 million strategic financing. The company is optimizing its commercial launch efforts with a national salesforce beginning deployment on May 23, 2022. Clinical trials for BXCL501 are ongoing, with top-line results anticipated in Q4 2022.
BioXcel Therapeutics (Nasdaq: BTAI) announced that its CEO, Vimal Mehta, will speak at three investor conferences to showcase the company's neuroscience and immuno-oncology programs. The discussions will also highlight their artificial intelligence platform aimed at enhancing drug discovery. Key events include the BofA Securities 2022 Healthcare Conference on May 12, UBS Global Healthcare Conference on May 23, and H.C. Wainwright Global Investment Conference on May 25. The company’s product, IGALMI™, is FDA-approved for treating agitation in adults with schizophrenia or bipolar disorder.
BioXcel Therapeutics (BTAI) has dosed the first patient in the Phase 3 TRANQUILITY II trial of BXCL501 for treating agitation associated with Alzheimer’s disease. This pivotal study is part of a broader program that includes TRANQUILITY III, aiming to evaluate BXCL501’s safety and efficacy in patients aged 65 and older. The company plans to expand clinical sites and assesses both 40 and 60 mcg dosing regimens. BXCL501, recently FDA-approved for schizophrenia-related agitation, has shown promising results in reducing agitation in preliminary studies.
BioXcel Therapeutics (BTAI) will announce its first quarter 2022 financial results on May 9, 2022, before U.S. market opening. The management team will host a conference call at 8:30 AM ET to discuss the results and provide a business update. The call details, including domestic and international dial-in numbers, are provided. BioXcel leverages AI to develop medicines, with its product IGALMI™ approved for treating agitation in certain psychiatric disorders. For further information, the webcast and related materials will be available on their website.
On April 19, 2022, BioXcel Therapeutics (Nasdaq: BTAI) announced the formation of its subsidiary, OnkosXcel Therapeutics, to advance therapies targeting challenging cancers with high unmet needs. The lead asset, BXCL701, is currently in Phase 2 trials for aggressive prostate cancer and has shown promising data. OnkosXcel aims to optimize the oncology franchise and leverage AI for drug development. BXCL701, designed to activate innate immunity, has received Orphan Drug Designation in four indications, suggesting significant potential in treating both 'cold' and 'hot' tumors.
BioXcel Therapeutics (BTAI) announced strategic financing agreements with Oaktree Capital Management and Qatar Investment Authority, providing up to $260 million to support the U.S. commercial launch of IGALMI™ and clinical development of BXCL501. This financing includes a credit agreement of up to $135 million, revenue interest financing of up to $120 million, and a potential equity investment of up to $5 million. The arrangements are expected to extend the company’s cash runway into 2025 and support a pivotal Phase 3 program for treating agitation in Alzheimer’s patients.