BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience and immuno-oncology, today announced
preliminary estimated unaudited net revenue results from sales of
IGALMI™ (dexmedetomidine) sublingual film for the second quarter
ended June 30, 2024. The Company expects unaudited revenue of
approximately $1.1 million for the three months ended June 30,
2024, representing an increase of approximately 90% quarter over
quarter and approximately 141% compared to the same period in 2023.
Revenue growth was driven by an increase in contracting with
psychiatric care clinics and behavioral health facilities using a
small commercial team.
“We are pleased with the positive feedback we continue to
receive from physicians, caregivers, and patients about
IGALMI™ for the acute treatment of agitation associated
with schizophrenia or bipolar I or II disorder,” said Vimal
Mehta, Ph.D., CEO of BioXcel Therapeutics. “Since our
commercial launch and deployment of focused market-access strategy,
we are continuing to build IGALMI brand equity. Our current
indication covers the institutional setting, where an estimated 16
million agitation episodes occur annually.1-3 We believe the
current market presence could also help drive our potential
expansion into the at-home setting, if BXCL501 is successfully
developed and approved for use at home, where we estimate an
additional 23 million annual agitation episodes occur. 1-3 We look
forward to advancing our SERENITY program with the goal of
addressing this at-home market, while remaining focused on
progressing our TRANQUILITY program to potentially reach an even
greater number of patients suffering from agitation associated with
Alzheimer’s dementia.”
The Company will discuss financial results and business updates
for the second quarter of 2024 during its upcoming earnings
conference call, the timing of which will be announced at a later
date.
About IGALMI™ (dexmedetomidine) sublingual film
INDICATION
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 in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
-
Decreased blood pressure, low blood pressure upon standing,
and slower than normal heart rate, which may be more likely in
patients with low blood volume, diabetes, chronic high blood
pressure, and older patients. IGALMI
is taken under the supervision of a healthcare provider who will
monitor vital signs (like blood pressure and heart rate) and
alertness after IGALMI is administered to help prevent falling or
fainting. Patients should be adequately hydrated and sit or lie
down after taking IGALMI and instructed to tell their healthcare
provider if they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT
interval prolongation). IGALMI should not be given to
patients with an abnormal heart rhythm, a history of an irregular
heartbeat, slow heart rate, low potassium, low magnesium, or taking
other drugs that could affect heart rhythm. Taking IGALMI with a
history of abnormal heart rhythm can increase the risk of torsades
de pointes and sudden death. Patients should be instructed to tell
their healthcare provider immediately if they feel faint or have
heart palpitations.
-
Sleepiness/drowsiness. Patients should not perform
activities requiring mental alertness, such as driving or operating
hazardous machinery, for at least 8 hours after taking IGALMI.
-
Withdrawal reactions, tolerance, and decreased response/efficacy.
IGALMI was not studied for longer than 24 hours after the first
dose. Physical dependence, withdrawal symptoms (e.g., nausea,
vomiting, agitation), and decreased response to IGALMI may occur if
IGALMI is used longer than 24 hours.
The 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.
Patients 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.
Everyone 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.
Please see full Prescribing Information.
About BXCL501Outside 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 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.
Industry and Other DataUnless otherwise
indicated, information contained in this press release concerning
our industry and the markets in which we operate, including our
general expectations, market position and market opportunity, is
based on our management’s estimates and research, as well as
industry and general publications and research, surveys and studies
conducted by third parties. While we believe the information from
these third-party publications, research, surveys and studies
included in this press release is reliable, we do not guarantee the
accuracy or completeness of such information, and we have not
independently verified this information. Management’s estimates are
derived from publicly available information, their knowledge of our
industry and their assumptions based on such information and
knowledge, which we believe to be reasonable. This data involves a
number of assumptions and limitations which are necessarily subject
to a high degree of uncertainty and risk due to a variety of
factors, including those described in the Company’s periodic
reports filed with the SEC under the captions “Forward Looking
Statements,” “Risk Factor Summary” and “Risk Factors” These and
other factors could cause our future performance and market
expectations to differ materially from these assumptions and
estimates.
Financial Disclosure AdvisoryThe estimated Q2
2024 net revenue included in this press release is unaudited and
preliminary and does not present all information necessary for an
understanding of the Company’s financial condition as of
June 30, 2024 and its results of operations for the quarterly
period ended June 30, 2024. This estimate represent the most
current information available to the Company’s management, as
financial closing procedures for the second quarter ended
June 30, 2024 are not yet complete. The Company expects that
its actual interim results to be reported in the earnings release
for the quarterly period ended June 30, 2024 will not differ
materially from the preliminary results presented in this press
release, however, these results are subject to change following the
completion of quarterly accounting procedures and adjustments.
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 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 estimated
financial results for the second quarter ended June 30, 2024; the
Company’s planned advancement of its TRANQUILITY and SERENITY
trials; the potential market opportunity for IGALMI in both the
in-care and at-home settings; the Company’s business strategy and
plans; and continued use of and feedback related to IGALMI by
physicians in medical settings. 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 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; the impact of the
reprioritization; its significant indebtedness, ability to comply
with covenant obligations and potential payment obligations related
to such indebtedness and other contractual obligations; the Company
has identified conditions and events that raise substantial doubt
about its ability to continue as a going concern; its limited
experience in drug discovery and drug development; risks related to
the TRANQUILITY program; its dependence on the success and
commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702
and other product candidates; the number of episodes of agitation
and the size of the Company’s total addressable market may be
overestimated, and approval that the Company may obtain may be
based on a narrower definition of the patient population; its lack
of experience in marketing and selling drug products; the risk that
IGALMI or the Company’s product candidates may not be accepted by
physicians or the medical community in general; the Company still
faces extensive and ongoing regulatory requirements and obligations
for IGALMI; 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 the Company’s product
candidates; its novel approach to the discovery and development of
product candidates based on EvolverAI; the significant influence of
and dependence on BioXcel LLC; its exposure to patent infringement
lawsuits; its reliance on third parties; its ability to comply with
the extensive regulations applicable to it; impacts from data
breaches or cyber-attacks, if any; risks associated with the
increased scrutiny relating to environmental, social and governance
(ESG) matters; risks associated with federal, state or foreign
health care “fraud and abuse” laws; and its ability to
commercialize its product candidates, as well as the important
factors discussed under the caption “Risk Factors” in its Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2024,
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 and the Investors section of the Company’s website at
www.bioxceltherapeutics.com.. 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 the Company
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 the Company’s views as of any date subsequent to
the date of this press release.
Contact Information
Corporate
BioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Media
Russo PartnersDavid
Schull1.858-717-2310David.schull@russopartnersllc.comScott
Stachowiak1.646-942-5630Scott.stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.
BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel
Therapeutics, Inc. All other trademarks are the properties of their
respective owners.Copyright © 2024, BioXcel Therapeutics, Inc. All
rights reserved.
References1. Data on file relating to agitation
episodes associated with schizophrenia or bipolar I or II disorder.
BioXcel Therapeutics, Inc. New Haven, CT December 2020. Actual
addressable market may be smaller.2. Data from Wu EQ, Shi L,
Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in
the USA: a claims data analysis approach. Psychol Med.
2006;36(11):1535-1540. Estimates based on whether indications are
approved for at-home use for the intended patient population and
such patients are treatable. Actual addressable market may be
smaller.3. National Institute of Mental Health. Prevalence of
bipolar disorder in adults. November 2017. Accessed December 16,
2022. https://www.nimh.nih.gov/health/statistics/bipolar-disorder.
Episode estimations may not reflect potential treatable episodes,
and actual addressable market may be smaller.
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