Full Press Release Details
BioXcel Therapeutics Reports Financial Results
for the Fourth Quarter and Full Year 2024
Enrollment exceeds 60% of required number of
patients in SERENITY At-Home pivotal Phase 3 safety trial evaluating 200 patients for acute treatment of agitation associated with bipolar
disorders or schizophrenia
Topline data expected in second half of 2025
intended to support potential sNDA submission for label expansion of IGALMI in the at-home setting
Strengthened cash position to advance BXCL501
Conn., March 27, 2025 - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial
intelligence to develop transformative medicines in neuroscience, today reported its
financial results for the fourth quarter and full year 2024.
"We believe that our SERENITY program presents an exciting opportunity
to address a substantial unmet medical need - the 23 million episodes of bipolar and schizophrenia-related agitation that occur
annually in the United States at home1-3 - and expand the market potential for our lead neuroscience asset BXCL501,"
said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are pleased that patient enrollment in our SERENITY At-Home pivotal
Phase 3 trial is progressing well and that we have recently strengthened our cash position to further advance this important study."
BXCL501 Late-Stage Clinical
IGALMI Market Presence
Fourth Quarter and Full Year 2024 Financial Results
Net revenue from IGALMI was $366,000 for the
fourth quarter of 2024, compared to $376,000 for the same period in 2023.
Net revenue from IGALMI was $2.3 million for the full
year of 2024, compared to $1.4 million for 2023.
Cost of Goods Sold for the three months ended December 31,
2024 and 2023, were $832,000 and $714,000, respectively. Cost of goods sold is related to the costs to produce, package, and deliver IGALMI
to customers, as well as costs related to excess or obsolete inventory. The increase in Cost of goods sold for the three months ended
December 31, 2024 is the result of higher charges for reserves for excess or obsolete inventory compared to the same period in 2023.
Charges for reserves for excess or obsolete inventory were $778,000 and $696,000 in the three months ended December 31, 2024 and
Cost of Goods Sold was $2.1 million for the full year of 2024, compared
to $1.3 million for 2023. The increase in Cost of goods sold is the result of higher charges for reserves for excess or obsolete inventory
in 2024 compared to 2023. Charges for reserves for excess or obsolete inventory were $2.0 million and $1.2 million for 2024 and 2023,
Research and Development (R&D) expenses were $5.9 million
for the fourth quarter of 2024, compared to $9.9 million for the same period in 2023.
R&D expenses were $30.4 million for the full year of 2024, compared
to $84.3 million for the full year of 2023. The decreased expenses for both the fourth quarter and the full year were primarily attributable
to a decrease in clinical trial activity associated with previously completed Phase 3 studies, a decrease in chemical, manufacturing,
and control (CMC) costs, and a decrease in personnel related to the company's reprioritization.
Selling, General and Administrative (SG&A) expenses were
$4.1 million for the fourth quarter of 2024, compared to $9.6 million for the same period in 2023.
SG&A expenses were $34.5 million for the full year 2024, compared
to $83.4 million for 2023. The decreased costs for the fourth quarter and the full year 2024 were primarily attributable to a decrease
in personnel and related costs, lower non-cash stock compensation costs, lower legal and professional fees, and lower commercial and marketing
costs resulting from restructuring actions taken in 2024 and 2023.
Net Loss: BioXcel Therapeutics had a net loss of $10.9 million
for the fourth quarter of 2024, compared to a net loss of $22.3 million for the same period in 2023. For the full year of 2024, BioXcel
Therapeutics reported a net loss of $59.6 million, compared to a net loss of $179.1 million for the full year of 2023. The loss for the
2024 year includes approximately $6.2 million in non-cash stock-based compensation. Total cash used in operating activities for 2024 totaled
approximately $72.0 million, down $83.0 million from 2023 cash used in operating activities of approximately $155.0 million.
Cash and cash equivalents totaled $29.9 million on December 31,
2024, compared to $65.2 million on December 31, 2023.
Outside of its approved indication by the
U.S. Food and Drug Administration as IGALMI (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary,
orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation
by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer's dementia 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 SERENITY At-Home Phase 3 Trial
The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled
study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders
or schizophrenia in the at-home setting. The trial is evaluating 200 patients with a history of agitation episodes residing at home either
alone or with caregivers/informants. Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the
12-week trial period, with safety data (adverse events) collected during the trial. Patients or caregivers/informants will complete a
modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory
endpoint to evaluate use in the outpatient setting.
TRANQUILITY In-Care Phase 3 Trial
The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg
dose of BXCL501 over a 12-week period for agitation associated with Alzheimer's dementia in the care setting. The trial is
expected to enroll approximately 150 patients 55 years and older who have mild, moderate, or severe dementia with mini-mental state examination
scores of 0 to 25 and who reside in skilled nursing facilities, memory care units, or assisted living facilities. Patients will self-administer
60 mcg of BXCL501 or placebo when episodic agitation episodes occur over the trial period. The primary endpoint is expected to be a change
from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. Additional
PEC and Clinical Global Impressions - Improvement Scale measurements will also be obtained during the trial.
About IGALMI (dexmedetomidine) sublingual film
IGALMI (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
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
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.
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.
full prescribing information at Igalmi.com.
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
release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.