Full Press Release Details
BioXcel Therapeutics Reports First Quarter 2025
Financial Results and Provides Business Update
Enrollment complete in SERENITY At-Home pivotal
Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders
data expected in second half of 2025 intended to support potential sNDA submission for label expansion of IGALMI
in the at-home setting
Conn., May 12, 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 first quarter of 2025 and announced that its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment
of agitation associated with bipolar disorders or schizophrenia is fully enrolled.
"We are pleased to have achieved this major milestone in our first
trial of BXCL501 in the at-home setting," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "An estimated 23 million
episodes of bipolar or schizophrenia-related agitation occur annually1-3 at home, yet there are no FDA-approved acute
treatment options for patients in this setting. We look forward to a data readout expected in the second half of this year and are excited
by the opportunity to expand the market potential of IGALMI and bring this drug to millions of additional patients."
BXCL501 Late-Stage Clinical
| The program remains part of the Company's broader development strategy. | ||
| The Company is advancing plans for trial initiation. |
IGALMI Market Presence
First Quarter 2025 Financial Results
from IGALMI was $168,000 for the first quarter of 2025, compared to $582,000 for the same period in 2024.
Goods Sold for the first quarter of 2025 was $14,000, compared to $80,000 for the same period in 2024. 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. There
were no charges for reserves for excess or obsolete inventory in the three months ended March 31, 2025.
and Development (R&D) expenses were $4.6 million for the first quarter of 2025, compared to $11.4 million for the same
period in 2024. The decreased expenses were primarily attributable to a decrease in clinical trial activity associated with previously
completed Phase 3 studies and a decrease in personnel related to the company's reprioritization.
General and Administrative (SG&A) expenses were $5.7 million for the first quarter of 2025, compared to $13.3 million for
the same period in 2024. The decreased expenses were attributable to a decrease in personnel and related costs, lower professional fees,
and lower commercial and marketing costs resulting from reprioritization actions taken in 2024.
BioXcel Therapeutics had a net loss of $7.3 million for the first quarter of 2025, compared to a net loss of $26.8 million for the same
period in 2024. The Company used $12.0 million in operating cash during the first quarter of 2025.
cash equivalents totaled $31 million as of March 31, 2025.
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 designed to evaluate 200 patients with a history of agitation episodes residing
at home either alone or with caregivers/informants. Patients are self-administering 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. In addition, 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.
the 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.
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.
full prescribing information at Igalmi.com.
About BioXcel Therapeutics, Inc.
BioXcel 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.
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 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained
in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation,
statements related to: the Company's planned advancement of its TRANQUILITY and SERENITY trials and the trial designs thereof;
potential market opportunity for BXCL501; completing enrollment and release of topline data from the ongoing SERENITY trial; the DSMB
meeting for the ongoing SERENITY trial; the supply of IGALMI through existing distribution channels; the potential for the results
from the Company's completed, ongoing and proposed clinical trials to support regulatory approvals for 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