News


BioXcel Therapeutics to Highlight Advances in the BXCL501 Program at 2019 Investor Event in New York City 

Management to unveil BXCL501 global development strategy and agitation franchise expansion 

Key Opinion Leaders to discuss acute agitation across multiple disease conditions 

Webcast scheduled from 9:00 am – 11:30 am ET 

NEW HAVEN, Conn; May 13, 2019-- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, today announced that the Company will host an Investor Event on Wednesday, May 22, 2019 beginning at 8:30 a.m. ET in New York City. 

Key opinion leaders and BTI management team will highlight the advances in the clinical development of BXCL501 and its potential as a treatment option for acute agitation and other indications. BXCL501, a sublingual thin film of dexmedetomidine (Dex), is the most advanced drug asset in the Company’s pipeline. 

BTI BXCL501 Investor Day Featured Discussion Topics: 

BXCL501 Strategy & Vision
Vimal Mehta, PhD, Founder & CEO

Acute Agitation Overview

• Schizophrenia/Bipolar Disorder 
Sheldon Preskorn, MD, Professor of Psychiatry, University of Kansas School of Medicine-Wichita 

Dementia
George Grossberg, MD, Professor and Director of Geriatric Psychiatry, Saint Louis University School of Medicine

Opioid Withdrawal
Ismene Petrakis, MD, Professor of Psychiatry at Yale University School of Medicine

Hyperactive Delirium
Maurizio Fava, MD, Executive Vice Chair of Department of Psychiatry and the Executive Director, MGH Research Institute

BXCL501 Clinical Program Update

Summary of Clinical Results
Rob Risinger, MD, VP of Clinical Development

Overview of Registration Trial Path
Rob Risinger, MD, VP of Clinical Development
Vince O'Neill, MD, CMO

Agitation Franchise Expansion 
Frank Yocca, PhD, CSO

KOL Panel & Q&A
Drs. Preskorn, Grossberg, Petrakis & Fava

If you would like to attend in-person, please reach out to Janhavi Mohite at The Ruth Group at jmohite@theruthgroup.com or (646) 536-7026. 

A live audio webcast of the event will be available through the “Investor Relations” page of the BTI website, http://www.bioxceltherapeutics.com/. A replay of the webcast will be archived on BTI’s website for 30 days following the event. 

About BXCL501:

BXCL501 is a 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 using IV (intravenous) Dex has demonstrated anti-agitation effects in multiple clinical studies. There is precedent for FDA approval and reimbursement of a non-invasive therapy for the acute treatment of agitation in patients with schizophrenia and bipolar disease, evidenced by regulatory approval of Adasuve, an inhaled version of the antipsychotic loxapine. 

About BioXcel Therapeutics, Inc. (BTI):

BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes novel artificial approaches to identify the next wave of medicines across neuroscience and immuno-oncology. BTI'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 indices. BTI's two most advanced clinical development programs are BXCL501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an orally administered systemic innate immunity activator designed 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, statements that relate to the advancement and development of BXCL501 and BXCL701, the commencement of clinical trials, the availability and results of data from clinical trials, BTI’s submission of its first New Drug Application with the FDA and other information that is not historical information. When used herein, words such as “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; it 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; 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 period ended March 31, 2019 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 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
The Ruth Group for BTI:
Janhavi Mohite
646-536-7026
jmohite@theruthgroup.com