Full Press Release Details
Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales
of IGALMI (dexmedetomidine) Sublingual Film
market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial
90% increase from the prior quarter and 141% increase from the second quarter of 2023
NEW HAVEN, Conn., July 16, 2024 -- 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
are pleased with the positive feedback we continue to receive from physicians, caregivers, and patients about IGALMITM 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
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
(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:
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.
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.
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.
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 Data
Unless 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 Advisory
The 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.
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