Full Press Release Details
BioXcel Therapeutics Reports First Quarter
2023 Financial Results and Recent Operational Highlights
IGALMI (dexmedetomidine) commercial
momentum accelerating with doubling of formulary wins, unlocking more than $55 million in targeted market opportunity, and an additional
$255 million scheduled to vote
Top-line data from pivotal SERENITY III Phase
3 trial (Part 1) for BXCL501 in bipolar or schizophrenia-associated agitation for at-home use expected in May 2023
Top-line data from repeat dosing of BXCL501
in Phase 1b trial for Major Depressive Disorder program in healthy volunteers expected in May 2023
Top-line data from pivotal TRANQUILITY II Phase
3 trial for BXCL501 for acute treatment of agitation associated with Alzheimer's disease expected in June 2023
Company to host conference call at 8:00 a.m.
HAVEN, Conn., May 8, 2023 -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence
approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first
quarter ended March 31, 2023, and provided an update on key strategic initiatives.
first quarter marked a strong start to the year with numerous advancements in our clinical programs and continued commercial focus
building the agitation market for our new therapeutic option in a historically underdiagnosed and underserved medical
condition," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are gearing up to announce top-line data readouts
in agitation from two Phase 3 pivotal trials as well as BXCL501 potential as an adjunctive treatment for chronic use in our MDD
program. In addition, IGALMI's launch momentum is expanding our reach into addressable market opportunities. We believe the
second quarter of 2023 represents a defining moment for the Company as we expand the full potential of BXCL501 in agitation for
at-home use and long-term care settings, and in depression. These upcoming catalysts may have a transformational impact for patients
in need and all our stakeholders."
Neuroscience Franchise
IGALMI (dexmedetomidine) sublingual film
is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with schizophrenia or bipolar
I or II disorder in adults.1 Up to an estimated 16 million institutional episodes occur annually within these
two patient populations in the U.S.2-4*
Key Commercial Parameters
Development Pipeline
BXCL501, an investigational proprietary, sublingual film formulation
of dexmedetomidine, has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with
SERENITY III consists of two parts:
OnkosXcel Therapeutics
OnkosXcel Therapeutics is a subsidiary of BioXcel Therapeutics
focused on the sustained growth of the Company's immuno-oncology (I-O) franchise, including BXCL701, its most advanced I-O program.
BXCL701 is an investigational, oral innate immune activator in development for the treatment of aggressive forms of prostate cancer and
other solid and liquid tumors.
First Quarter 2023 Financial Results
Revenue: Net revenue was approximately $206,000 for the quarter, in line with
the fourth quarter. The Company expects to see a notable uptick in revenues in the second half of the year in connection with additional
formulary approvals.
and Development (R&D) Expenses: R&D expenses were $27.8 million for the first quarter of 2023, compared to $18.6
million for the same period in 2022. The increased expenses were primarily attributable to multiple clinical trials and CMC costs related
to the upcoming three data readouts.
General and Administrative (SG&A) Expenses: SG&A expenses were $23.6 million for the first quarter of 2023, compared
to $12.9 million for the same period in 2022. The increased expenses were primarily attributable to personnel and sales, market access,
and marketing costs associated with the commercialization of IGALMI in the U.S.
Loss: BioXcel Therapeutics had a net loss of $52.8 million for the first quarter of 2023, compared to a net loss of $31.5
million for the same period in 2022.
Cash and cash equivalents totaled $165.5 million as of March 31,
2023. BioXcel Therapeutics believes that full execution of its strategic financing with Oaktree and Qatar Investment Authority, and IGALMI
revenues, would result in a cash runway into 2025.
Anticipated Milestones
BioXcel Therapeutics will host a conference call and webcast on May 8
at 8:00 a.m. ET to discuss its first quarter 2023 financial results and provide an update on recent operational highlights. To access
the call, please dial 877-407-5795 (domestic) and 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 August 8, 2023.
BioXcel 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 automatically receive
email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option
under the News/Events menu of the Investors & Media section of its website.
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 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.
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
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing
artificial intelligence approaches to develop transformative medicines in neuroscience and 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. The Company's commercial product, IGALMI (developed
as BXCL501), is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated
with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours
from the first dose. For more information, please visit igalmi.com and also see the IGALMI full Prescribing Information. BXCL501
is under evaluation for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for acute treatment of
agitation associated with probable Alzheimer's disease, and as an adjunctive treatment for major depressive disorder. The safety
and efficacy of BXCL501 for these uses have not been established. The Company is also developing BXCL502 as a potential therapy for chronic
agitation in dementia. Under its subsidiary, OnkosXcel Therapeutics, the Company is developing BXCL701, an investigational, oral systemic
innate immune activator for the treatment of aggressive forms of prostate cancer and other solid and liquid tumors. The safety and efficacy
of BXCL502 and BXCL701 have not been established. For more information, please visit bioxceltherapeutics.com.
Forward-Looking Statements