• Company to review BXCL502 and other potential emerging pipeline candidates  
  
• Dr. Jeffrey Cummings to discuss agitation relief in Alzheimer’s disease and BXCL502 as a potential treatment
• Dr. Sandra Comer to discuss BXCL501 as a potential treatment for opioid withdrawal 

NEW HAVEN, Conn., Nov. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will host a virtual Neuroscience R&D Day from 1:00 to 2:30 p.m. ET on Tuesday, Dec. 12, 2023.

Vimal Mehta, Ph.D., Chief Executive Officer, Frank Yocca, Ph.D., Chief Scientific Officer, and other members of the Company’s R&D leadership team will discuss BioXcel Therapeutics’ R&D strategy and provide an overview of the proposed development program for BXCL502, a novel, investigational, non-antipsychotic anti-stress agent for the potential treatment of chronic agitation in dementia. Further, the Company will discuss its unique AI-driven approach to identify emerging development candidates, such as investigational BXCL503, to potentially treat Alzheimer’s disease-related symptoms unrelated to agitation.  

In addition, the presentation will feature two neuropsychiatry experts:

• Dr, Jeffrey Cummings, M.D. Sc.D.:_(HC): The Neuropsychiatric Inventory: Measuring Agitation Relief in Alzheimer’s Disease
  
  Dr. Jeffrey Cummings is Research Professor in the Department of Brain Health and Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas. He previously served as Founding Director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Director of the Mary S. Easton Center for Alzheimer’s Disease Research, and Director of the Deane F. Johnson Center for Neurotherapeutics, both at UCLA. A world-renowned Alzheimer’s researcher and leader of clinical trials, Dr. Cummings has been recognized with the American Geriatrics Society’s Henderson Award, the national Alzheimer’s Association’s Ronald and Nancy Reagan Research Award, and the American Association of Geriatric Psychiatry’s Distinguished Scientist Award. He has published nearly 900 articles and 44 books devoted to neuroscience, Alzheimer’s disease, and clinical trials.

• Dr. Sandra Comer, Ph.D.: BXCL501 as a Potential Treatment for Opioid Withdrawal
  
  Dr. Sandra Comer is Principal Investigator of the National Institute on Drug Abuse (NIDA)-funded trial of investigational BXCL501 for potential withdrawal treatment of patients diagnosed with opioid use disorder and Professor of Neurobiology in the Department of Psychiatry at Columbia University. She is also Director of the Opioid Laboratory in the Division on Substance Use Disorders. Her research focuses on the clinical testing of medications for treating opioid use disorders, devices for treating opioid overdose, methods to maximize the use of naloxone by opioid users, and evaluations of the comparative abuse liability of prescribed pain medications. Dr. Comer served as President of the College on Problems of Drug Dependence (CPDD), the longest-standing scholarly society in the U.S. devoted to research on substance use disorders, and is currently CPDD’s Public Policy Officer. She joined the Expert Advisory Panel on Drug Dependence for the World Health Organization and has 190 publications on substance use disorders.

Event Access

To access the virtual R&D Day presentation, please dial 877-407-5795 (domestic) or 201-689-8722 (international). A live webcast and presentation materials will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a webcast replay will be available through March 12, 2024.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information is routinely posted on and accessible through the Investors sections of its website at bioxceltherapeutics.com. In addition, you may sign up to automatically receive email alerts and other information about the Company by visiting the “Email Alerts” option under the News/Events section of the Investors & Media website section and submitting your email address.

About BXCL501

In indications other than those approved by the U.S. Food and Drug Administration (FDA) as IGALMI™ (dexmedetomidine) sublingual film, BXCL501 is an investigational, proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical trials across several neuropsychiatric disorders. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

About BioXcel Therapeutics, Inc.   

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications.  For more information, please visit bioxceltherapeutics.com. 

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, the date, time and content of the Company’s R&D Day, its proposed development programs, and the potential uses of its product candidates. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. 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 the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company 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, the important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, 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. 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 the Company 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 the Company’s views as of any date subsequent to the date of this press release.

Contact Information

Corporate

BioXcel Therapeutics
Erik Kopp
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Investor Relations

BioXcel Therapeutics
Brennan Doyle
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Media

Russo Partners  
David Schull  
T: 858-717-2310  
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Scott Stachowiak  
T: 646-942-5630  
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*IGALMI is a trademark of BioXcel Therapeutics, Inc. 
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