NEW HAVEN, Conn., March 09, 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 its quarterly results for the fourth quarter and full year ended December 31, 2019 and provided an update on key strategic and operational initiatives.

2019 has been a tremendous year for BTI. We have made significant growth in our two programs BXCL501 and BXCL701 laying the groundwork to achieve key milestones in the coming years, stated Vimal Mehta, Chief Executive Officer of BTAI. In neuroscience, we have made momentous advancements in the clinical development of BXCL501 and look forward to announcing topline results from our SERENITY program and our Phase 1b/2 TRANQUILITY trial in dementia-related agitation in mid-2020. Additionally, we have been dedicated to expanding the potential therapeutic use of BXCL501, announcing a fourth indication last month as well as examining biomarkers that may have relevance for a range of hyperarousal disorders. We believe these therapeutic opportunities, along with our plans to investigate BXCL501 for the treatment of all types of agitation, are crucial steps to building out a leading neuroscience franchise.

Dr. Mehta added, In addition to our ongoing studies with BXCL701 in prostate and pancreatic cancers, we are also evaluating this immuno-oncology candidate, in combination with KEYTRUDA, in multiple advanced solid tumors with the goal of improving treatment responses to this PD-1 inhibitor. We believe this basket trial, led by researchers at MD Anderson, will help to accelerate the evaluation of BXCL701 and help to explore its full potential.

Fourth Quarter 2019 and Recent Highlights

BXCL501-Neuroscience Program BXCL501 is an investigational sublingual thin film of dexmedetomidine, a selective alpha-2A adrenergic receptor agonist, designed for the treatment of acute agitation. The Company believes BXCL501 may directly target a causal agitation mechanism.

BXCL701-Immuno-Oncology Program-BXCL701 is an orally-delivered small molecule, innate immunity activator designed to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). It has shown single agent activity in melanoma and safety has been evaluated in more than 700 healthy subjects and cancer patients.

Strengthened Balance Sheet

Fourth Quarter and Full Year 2019 Financial Results

BTI reported a net loss of $8.3 million for the fourth quarter of 2019, compared to a net loss of $7.1 million for the same period in 2018. The fourth quarter 2019 results include approximately $0.7 million in non-cash stock based compensation.

Research and development expenses were $6.5 million for the fourth quarter of 2019, as compared to $6.0 million for the same period in 2018. The increase was primarily due to an increase in professional research and related project costs, salary, and related payroll costs, manufacturing costs offset in part by a decrease in clinical trial expenses.

General and administrative expenses were $1.9 million for the fourth quarter of 2019, as compared to $1.3 million for the same period in 2018. The increase was primarily due to increases in salary, and related payroll costs and professional fees.

BTI reported a net loss of $33.0 million for the full year 2019, compared to a net loss of $19.3 million for the same period in 2018.

Research and development expenses were $25.8 million for full year 2019, as compared to $14.6 million for the same period in 2018. The increase was primarily due to clinical trial costs, salary and related payroll costs, professional research and project costs and manufacturing costs.

General and administrative expenses were $7.8 million for full year 2019, as compared to $5.4 million for the same period in 2018. The increase was primarily due to salary and related payroll costs and professional fees.

As of December 31, 2019, cash and cash equivalents totaled approximately $32.4 million.

Please note that these numbers do not include our recent financing, which secured $60 million in net proceeds.

Conference Call:BTI will host a conference call and webcast today at 8:30 a.m. ET. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors sections of the BTI website at http://www.bioxceltherapeutics.com. The replay will be available through March 23, 2020.

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 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 timing and data from clinical development initiatives and trials for BXCL501 and BXCL701, the Companys cash runway and the Companys future growth and position to execute on key milestones. 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; undesirable side effects caused by BTIs 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; 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 such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SECs website at http://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 managements 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 BTIs views as of any date subsequent to the date of this press release.

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Contact Information:

BioXcel Therapeutics, Inc.www.bioxceltherapeutics.com

Investor Relations:John Grazianojgraziano@troutgroup.com1.646.378.2942

Media:Julia Deutschjdeutsch@troutgroup.com1.646.378.2967

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BioXcel Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update - BioSpace