BTAI BioXcel Therapeutics Inc.

51.87
-1.55  -3%
Previous Close 53.42
Open 54.66
52 Week Low 3.76
52 Week High 61.5
Market Cap $1,048,359,924
Shares 20,211,296
Float 10,513,272
Enterprise Value $1,000,569,432
Volume 502,317
Av. Daily Volume 472,364
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Upcoming Catalysts

Drug Stage Catalyst Date
BXCL501 (SERENITY II)
Bipolar disorder - agitation
Phase 3
Phase 3
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BXCL501 (SERENITY I)
Schizophrenia - Agitation
Phase 3
Phase 3
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BXCL501
Agitation biomarkers in patients with schizophrenia
Phase 2
Phase 2
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BXCL501 (TRANQUILITY)
Alzheimer’s disease/dementia
Phase 1b
Phase 1b
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BXCL701 and Keytruda
Neuroendocrine Prostate Cancer (tNEPC)
Phase 2
Phase 2
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BXCL501
Opioid Withdrawal Symptoms
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
BXCL701 and pembrolizumab
Advanced solid tumors
Phase 2
Phase 2
Phase 2 open label basket trial has been initiated.
BXCL701, bempegaldesleukin and BAVENCIO
Pancreatic cancer
Phase 2
Phase 2
Phase 1/2 trial planned.

Latest News

  1. NEW HAVEN, Conn., July 09, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced that the Company has initiated an expanded access program at Massachusetts General Hospital ("MGH") to provide its investigational drug, BXCL501, the Company's proprietary sublingual thin-film formulation of dexmedetomidine ("Dex"), to critically ill patients diagnosed with COVID-19 in the intensive care unit ("ICU") that may require calming or arousable sedation.

    "We are pleased to support clinicians at MGH as they manage an in-flux of COVID-19…

    NEW HAVEN, Conn., July 09, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced that the Company has initiated an expanded access program at Massachusetts General Hospital ("MGH") to provide its investigational drug, BXCL501, the Company's proprietary sublingual thin-film formulation of dexmedetomidine ("Dex"), to critically ill patients diagnosed with COVID-19 in the intensive care unit ("ICU") that may require calming or arousable sedation.

    "We are pleased to support clinicians at MGH as they manage an in-flux of COVID-19 patients," commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. "COVID-19 primarily affects the respiratory system, with the severely ill often requiring mechanical ventilation. As a result of critical illness and the medical coma that is necessary for mechanical ventilation, patients frequently develop delirium and agitation, causing worse clinical outcomes and extended hospital stays. BXCL501 is being studied in advanced clinical trials to treat acute agitation, and we believe it has the potential, if approved, to help physicians treat patients that may be struggling with agitation or delirium."

    Facilitated by the U.S. Food and Drug Administration ("FDA"), expanded access, also known as compassionate use, provides an opportunity for patients to receive an investigational treatment prior to regulatory approval when there are no comparable or satisfactory therapeutic alternatives available.

    "Being on the frontlines of this pandemic, our intensivists have witnessed firsthand the high numbers of critically ill patients diagnosed with COVID-19 and ICU delirium," added Seun Johnson-Akeju, M.D., M.M.Sc., Anesthetist-in-Chief of the Department of Anesthesia, Critical Care and Pain Medicine at the Massachusetts General Hospital. "The COVID-19 surge caused an acute shortage of medications for managing agitation. We are hopeful that BXCL501 will improve the clinical outcomes of critically ill patients diagnosed with COVID-19 that are struggling with agitation and ICU delirium."

    About BXCL501

    BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in clinical studies across multiple neuropsychiatric indications. BXCL501 has also been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of mild to moderate agitation in schizophrenia, bipolar disorder, and dementia.

    A Phase 1b safety and efficacy study of BXCL501 yielded positive dose-response data. BXCL501 is being evaluated in the SERENITY program, consisting of two Phase 3 studies for the acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). BXCL501 is also being evaluated in the Phase 1b/2 TRANQUILITY trial for the treatment of agitation associated with dementia, as well as the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms.

    About BioXcel Therapeutics, Inc.:

    BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. For more information, please visit http://www.bioxceltherapeutics.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the evaluation of the Company's investigational drug, BXCL501, in the treatment of COVID-19 patients. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon BTI's current expectations and various assumptions. BTI believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.

    BTI may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption "Risk Factors" in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as supplemented by its Current Report on Form 8-K filed on April 14, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at www.sec.gov and the Investors page of its website at www.bioxceltherapeutics.com.

    These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing BTI's views as of any date subsequent to the date of this press release.

    Contact Information:

    BioXcel Therapeutics, Inc.

    www.bioxceltherapeutics.com

    Investor Relations:

    John Graziano



    1.646.378.2942

    Media:

    Julia Deutsch



    1.646.378.2967

     

    Primary Logo

    View Full Article Hide Full Article
  2. NEW HAVEN, Conn., July 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for patent application No. 16/453,679 related to BXCL501, the Company's proprietary sublingual thin-film formulation of dexmedetomidine ("Dex"). The patent is expected to cover film formulations containing Dex and methods of treating agitation using such film formulations.

    "The allowance of this patent substantially strengthens our intellectual property position, an important…

    NEW HAVEN, Conn., July 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for patent application No. 16/453,679 related to BXCL501, the Company's proprietary sublingual thin-film formulation of dexmedetomidine ("Dex"). The patent is expected to cover film formulations containing Dex and methods of treating agitation using such film formulations.

    "The allowance of this patent substantially strengthens our intellectual property position, an important milestone for BXCL501's development and potential commercialization," commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. "With a significant need for an effective therapy that addresses the underlying cause of agitation, BXCL501 has the potential to fill this gap, while also providing a unique and favorable delivery method for treating patients. As we prepare to report topline data from our pivotal SERENITY trials this month, we are thrilled to have received this patent allowance for film formulations containing Dex, an essential step in creating value for our shareholders."

    A Notice of Allowance is issued after the USPTO makes a determination that a patent should be granted from an application. The patent, which is expected to be issued in the third quarter of 2020, will have a term that expires no earlier than 2039. After issuance, BioXcel plans to list the U.S. patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

    About BXCL501

    BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in clinical studies across multiple neuropsychiatric indications. BXCL501 has also been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of mild to moderate agitation in schizophrenia, bipolar disorder, and dementia.

    A Phase 1b safety and efficacy study of BXCL501 yielded positive dose-response data. BXCL501 is being evaluated in the SERENITY program, consisting of two Phase 3 studies for the acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). BXCL501 is also being evaluated in the Phase 1b/2 TRANQUILITY trial for the treatment of agitation associated with dementia, as well as the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms.

    About BioXcel Therapeutics, Inc.

    BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. For more information, please visit www.bioxceltherapeutics.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to receipt of patent approval for BXCL501, the Company's intellectual property strategy, the timing and data from clinical development initiatives and trials for BXCL501, the potential commercialization of BXCL501 and BTI's corporate strategy. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

    These forward-looking statements are based on management's current expectations and beliefs. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause BTI's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BTI's product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption "Risk Factors" in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at www.sec.gov and Investors sections of our website at www.bioxceltherapeutics.com.

    These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing BTI's views as of any date subsequent to the date of this press release.

    Contact Information:

    BioXcel Therapeutics, Inc.

    www.bioxceltherapeutics.com

    Investor Relations:

    John Graziano



    1.646.378.2942

    Media:

    Julia Deutsch



    1.646.378.2967

    Primary Logo

    View Full Article Hide Full Article
  3. NEW HAVEN, Conn., June 23, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced the appointment of Reina Benabou, M.D., Ph.D., as Senior Vice President and Chief Development Officer (CDO). Dr. Benabou has over 20 years of experience in directing drug development programs and implementing medical affairs strategies for product commercialization in neurology and psychiatry.

    "We couldn't be more pleased to welcome Reina to BTI, as her addition will significantly strengthen our leadership structure," commented Vimal Mehta, Ph.D., Chief Executive Officer…

    NEW HAVEN, Conn., June 23, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced the appointment of Reina Benabou, M.D., Ph.D., as Senior Vice President and Chief Development Officer (CDO). Dr. Benabou has over 20 years of experience in directing drug development programs and implementing medical affairs strategies for product commercialization in neurology and psychiatry.

    "We couldn't be more pleased to welcome Reina to BTI, as her addition will significantly strengthen our leadership structure," commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. "Reina's expertise in bringing neuroscience products to market will be an important asset to our clinical, commercial and medical affairs teams, positioning us well as we prepare to report topline results from our pivotal SERENITY trials. Furthermore, as we look to pursue multiple follow-on indications with BXCL501 and continue to advance our neuroscience pipeline, her success in drug development and strategic planning will be essential to provide patients with potentially differentiated products that may have important benefits over the current standard of care."

    Prior to joining BTI, Dr. Benabou held numerous leadership roles at leading biopharma companies, including at Pfizer as Head of Global Medical Product Evaluation and in other principal medical affairs roles, at Novartis as VP & World Wide Medical Head for the Neuroscience Franchise, and most recently at Cognivue as Chief Medical Officer. She has built and led a variety of U.S. and global high performing development, medical, regulatory and safety teams responsible for the commercialization of multiple products, such as SUBOXONE ® for the treatment of opioid drug addiction, GEODON ® for the treatment of schizophrenia and manic symptoms of bipolar disorder, LYRICA ® for the treatment of neuropathic pain in diabetes, fibromyalgia and SCI and to control seizures, and GILENYA® for the treatment of relapsing forms of multiple sclerosis. Dr. Benabou held academic appointments in the Neurology Departments of Mount Sinai School of Medicine and Columbia University in New York. She holds an M.D. from the Universidade de São Paulo and a Ph.D. in Neurological Sciences from the University of Montreal, Canada.

    "I am thrilled to be joining BTI. Throughout my career, I have been committed to helping bring innovative neuroscience treatments to market that improve patients' lives," added Dr. Benabou. "BTI's lead neuroscience candidate, BXCL501, has the potential to be an effective treatment for acute agitation across multiple disorders, and I am honored to have the opportunity to lead the global development strategy for current and future indications. In addition, as BTI looks to transition to a significant commercial organization, I look forward to working with the team to educate clinicians, patients, and caregivers on the potential clinical benefits of BXCL501."

    About BXCL501

    BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in clinical studies across multiple neuropsychiatric indications. BXCL501 has also been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of mild to moderate agitation in schizophrenia, bipolar disorder, and dementia.

    A Phase 1b safety and efficacy study of BXCL501 yielded positive dose-response data. BXCL501 is being evaluated in the SERENITY program, consisting of two Phase 3 studies for the acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). BXCL501 is also being evaluated in the Phase 1b/2 TRANQUILITY trial for the treatment of agitation associated with dementia, as well as the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms.

    About BioXcel Therapeutics, Inc.

    BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. For more information, please visit www.bioxceltherapeutics.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the timing and data from clinical development initiatives and trials for BXCL501, the potential commercialization of BXCL501 and BTI's corporate strategy. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

    These forward-looking statements are based on management's current expectations and beliefs. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause BTI's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BTI's product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption "Risk Factors" in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at www.sec.gov and Investors sections of our website at www.bioxceltherapeutics.com.

    These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing BTI's views as of any date subsequent to the date of this press release.

    Contact Information:

    BioXcel Therapeutics, Inc.

    www.bioxceltherapeutics.com

    Investor Relations:

    John Graziano



    1.646.378.2942

    Media:

    Julia Deutsch



    1.646.378.2967

     

    Primary Logo

    View Full Article Hide Full Article
  4. NEW HAVEN, Conn., June 16, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced the appointment of Will Kane as Executive Vice President and Chief Commercial Officer (CCO). Mr. Kane brings over three decades of product commercialization experience in the pharmaceutical industry, most recently as the Head of the U.S. General Medicine business unit at Allergan.

    "We are delighted to welcome Will, a biopharma veteran with a proven track record in bringing neuropsychiatric drugs to market, to our team," commented Vimal Mehta, Ph.D., Chief Executive Officer…

    NEW HAVEN, Conn., June 16, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced the appointment of Will Kane as Executive Vice President and Chief Commercial Officer (CCO). Mr. Kane brings over three decades of product commercialization experience in the pharmaceutical industry, most recently as the Head of the U.S. General Medicine business unit at Allergan.

    "We are delighted to welcome Will, a biopharma veteran with a proven track record in bringing neuropsychiatric drugs to market, to our team," commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. "As we advance our late-stage pipeline, his extensive experience in developing both pre-launch plans and building commercial capabilities will lay the groundwork for our potential go-to-market strategy for BXCL501. Furthermore, Will's vast knowledge in commercializing drugs for diverse healthcare settings, including hospital-based products, will be key to navigating specific market environments. In only a few short weeks, our pivotal SERENITY trials will be reading out – a momentous time in our Company's history – and, assuming positive data, Mr. Kane will be instrumental in transitioning BTI from a research and development-focused business into a fully-integrated, commercial organization."

    Prior to joining BTI, Mr. Kane held senior level commercial positions at leading biopharma companies, including Allergan, Pfizer, and Sepracor (now Sunovion Pharmaceuticals), and was an integral part of launching numerous successful brands. These include CELEBREX® for the treatment of arthritis, NAMZARIC®‎ for Alzheimer's disease, VRAYLAR® for the treatment of schizophrenia and bipolar disorder, and UBRELVY™, the first oral calcitonin gene-related peptide (CGRP) for the acute treatment of migraine. Most recently, he was Senior Vice President and Head of the U.S. General Medicine business unit at Allergan, a multi-therapeutic portfolio with $5.8 billion in 2019 sales, where he oversaw more than 2,000 sales and marketing professionals. Mr. Kane holds a B.A. in Government from Connecticut College and an M.B.A. from the Wharton School at the University of Pennsylvania.

    "I am thrilled to be joining BTI at this important time for the Company," added Mr. Kane. "Using its innovative research and development platform, BTI has identified a potentially first-in-class treatment, BXCL501, for patients with acute agitation associated with neuropsychological disorders. Affecting approximately 10 million individuals in the U.S., agitation is widespread and lacks treatment options addressing the underlying condition, resulting in a significant healthcare burden. Together with the BTI team, I look forward to building a successful commercial organization that is capable of bringing new therapeutic options to physicians and caregivers, while improving the lives of millions of patients."

    About BioXcel Therapeutics, Inc.:

    BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. For more information, please visit www.bioxceltherapeutics.com.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the timing and data from clinical development initiatives and trials for BXCL501, the potential commercialization of BXCL501 and BTI's corporate strategy. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

    These forward-looking statements are based on management's current expectations and beliefs. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause BTI's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BTI's product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption "Risk Factors" in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at www.sec.gov and Investors sections of our website at www.bioxceltherapeutics.com.

    These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing BTI's views as of any date subsequent to the date of this press release.

    Contact Information:

    BioXcel Therapeutics, Inc.

    www.bioxceltherapeutics.com

    Investor Relations:

    John Graziano



    1.646.378.2942

    Media:

    Julia Deutsch



    1.646.378.2967

    Primary Logo

    View Full Article Hide Full Article
  5. NEW HAVEN, Conn., June 15, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or the "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will participate in fireside chats at two upcoming virtual investor conferences.

    Presentation Details:
    Event: BMO 2020 Prescriptions for Success Healthcare Conference
    Date: Tuesday, June 23, 2020
    Time: 8:30 AM ET

    Event: BofA Securities Napa Biopharma Conference
    Date: Wednesday, June 24, 2020
    Time: 7:30 AM PT/10:30 AM ET

    Live webcasts from the BMO and BofA fireside chats will be accessible through the…

    NEW HAVEN, Conn., June 15, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or the "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will participate in fireside chats at two upcoming virtual investor conferences.

    Presentation Details:

    Event: BMO 2020 Prescriptions for Success Healthcare Conference

    Date: Tuesday, June 23, 2020

    Time: 8:30 AM ET

    Event: BofA Securities Napa Biopharma Conference

    Date: Wednesday, June 24, 2020

    Time: 7:30 AM PT/10:30 AM ET

    Live webcasts from the BMO and BofA fireside chats will be accessible through the Investors section of the Company's website at www.bioxceltherapeutics.com. Following the conference, the webcast will be archived on the BioXcel Therapeutics, Inc. website for at least 30 days.

    About BioXcel Therapeutics, Inc.:

    BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. For more information, please visit www.bioxceltherapeutics.com.

    Contact Information:

    BioXcel Therapeutics, Inc.

    www.bioxceltherapeutics.com

    Investor Relations:

    John Graziano



    1.646.378.2942

    Media:

    Julia Deutsch



    1.646.378.2967

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