Full Press Release Details
BioXcel Therapeutics Reports Financial
Results for the Fourth Quarter and Full Year 2023
Provides update on two late-stage clinical programs
for BXCL501 for potential treatment of agitation
Recently completed meetings with U.S. Food and
Drug Administration for TRANQUILITY and SERENITY programs
Conference call and webcast set for 8:00 a.m. ET
HAVEN, Conn., March 12, 2024 - BioXcel Therapeutics, Inc.
(Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and
immuno-oncology, today provided an update on its late-stage TRANQUILITY and SERENITY clinical programs. In addition, the Company reported
its financial results for the fourth quarter and full year 2023.
"We believe our late-stage programs evaluating BXCL501 for acute
agitation associated with Alzheimer's dementia, bipolar disorders, and schizophrenia represent groundbreaking opportunities to bring
much-needed treatment options to large numbers of patients and caregivers," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics.
"We are pleased to be advancing the clinical development paths for TRANQUILITY and SERENITY, and plan to focus our resources on
these high-priority programs."
TRANQUILITY Program:
Evaluating 60 mcg dose of BXCL501 for agitation associated with
Alzheimer's dementia (AAD)
Evaluating potential at-home use of 120 mcg of BXCL501 for agitation
associated with bipolar disorders or schizophrenia
IGALMI Commercialization
The Company continues to develop a broad global intellectual property
portfolio, with over 100 patent applications in prosecution and multiple patents issued as of February 29, 2024.
OnkosXcel Therapeutics
Fourth Quarter and Full Year 2023 Financial Results
Revenue: Net revenue from IGALMI was $376,000 for the fourth quarter of 2023, compared to $238,000 for the same period in 2022.
Net revenue from IGALMI was $1.4 million for the full year of 2023,
compared to $375,000 for 2022.
Research and Development (R&D)
Expenses: R&D expenses were $9.9 million for the fourth quarter of 2023, compared to $32.5 million for the same period
expenses were $84.3 million for the full year of 2023, compared to $91.2 million for the full year of 2022. The decreased expenses for
both the fourth quarter and the full year were primarily attributable to a decrease in clinical trial activity associated with
the wind down of the SERENITY III and TRANQUILITY II studies, a decrease in chemical, manufacturing, and control (CMC) costs, and a decrease
in personnel related to the Reprioritization.
General and Administrative (SG&A) Expenses: SG&A expenses were $9.6 million for the fourth quarter of 2023, compared
to $20.7 million for the same period in 2022.
SG&A expenses were $83.4 million for the full year 2023, compared
to $68.8 million for 2022. The increased costs for the full year were primarily attributable to
an increase in legal and professional fees, costs associated with increased personnel, and related costs to support the commercialization
of IGALMI in the U.S. prior to the Reprioritization.
Loss: BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8
million for the same period in 2022. For the full year of 2023, BioXcel Therapeutics reported a net loss of $179.0 million, compared to
a net loss of $165.8 million for the full year of 2022. The loss for the 2023 year includes approximately $18.6 million in non-cash stock-based
compensation. Total cash expenditures for 2023 totaled approximately $155.0 million.
Cash and cash equivalents totaled $65.2 million on December 31,
2023, compared to $193.7 million on December 31, 2022. The Company estimates that its current cash and cash equivalents will
fund its operations through mid-2024. This estimated cash runway does not include potential additional capital that may become available
under the amendments to the strategic financing agreements or resulting from any potential financing activities that may be undertaken
Conference Call and Webcast
Therapeutics will host a conference call and webcast on March 12, 2024, at 8:00 a.m. ET to provide an update on recent operational
highlights and to discuss its fourth quarter and full year 2023 financial results. To access the call, please dial 877-407-5795
(domestic) or 201-689-8722 (international). A live webcast will be available
on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through June 12, 2024.
Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information
regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.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 IGALMI (dexmedetomidine) sublingual film
(dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed
under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder
I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known
if IGALMI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or
numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients should
speak with their healthcare provider for medical advice about side effects.
should tell their healthcare provider about their medical history, including if they suffer from any known heart problems,
low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment.
They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any
drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088 or medinfo@bioxceltherapeutics.com.
see full Prescribing Information at igalmi.com.
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 the Positive and Negative Syndrome Scale-Excitatory
Component Score (PEC or PANSS-EC)
The PEC total score is a validated endpoint for
use in clinical research to quantify the severity of a patient's acute agitation. The PEC rating evaluates 5 elements associated
with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The
PEC total score is the sum of these 5 elements and thus ranges from 5 to 35.
About BioXcel Therapeutics, Inc.
Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines
in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in 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