Full Press Release Details
BioXcel Therapeutics Reports Fourth Quarter
and Full Year 2022 Financial Results and Recent Operational Highlights
IGALMI (dexmedetomidine) commercial
execution fully underway in 2023 with key focus on market access and demand generation through expanded field team
Multiple pivotal data readouts for BXCL501
expected in Q2 2023 in disease areas with 139 million agitation episodes,1-3*including Alzheimer's-related agitation
Positive data for BXCL701 in small cell neuroendocrine
metastatic castration-resistant prostate cancer (SCNC) further validates Company's AI drug discovery and development expertise;
Company exploring strategic options for OnkosXcel subsidiary
Company to host conference call at 8:30 a.m. ET
HAVEN, Conn., March 9, 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 fourth quarter and full year ended Dec. 31, 2022 and provided an update on key strategic initiatives.
year was a transformational period for the Company, highlighted by the launch of our first AI-discovered commercial product, IGALMI,
in under four years since initiating human trials. A new treatment option is now available for patients suffering from agitation associated
with schizophrenia or bipolar I or II disorder," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are building on
these achievements in 2023 and look to accelerate our growth through commercial execution of IGALMI. We are also on track for significant
data readouts for our overall neuropsychiatric program that has potential to address an estimated 139 million
agitation episodes in the U.S.1-3* We have two pivotal study readouts for BXCL501 expected in the second quarter of 2023.
Lastly, we plan to advance our lead immuno-oncology program, BXCL701, into a Phase 2b registrational trial, pending further discussion
with the FDA, in conjunction with exploring strategic options for our OnkosXcel subsidiary. These upcoming milestones, along with our
strong financial foundation and late-stage programs, position BioXcel Therapeutics to deliver significant value to our shareholders
while helping treat millions of patients."
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.4 Up to an estimated 16 million institutional episodes occur annually within these
two patient populations in the U.S.1-3*
Development Pipeline
BXCL501, a proprietary, sublingual film formulation of dexmedetomidine,
has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.
SERENITY III consists of two parts:
Research and Development Pipeline
BXCL502: Novel serotonergic receptor antagonist
being developed for chronic treatment of agitation in patients with dementia and other related neuro-psychiatric conditions.
Emerging Pipeline: Leveraging our proprietary
AI platform and deep multidisciplinary neuroscience and development expertise to identify novel pipeline candidates for neuropsychiatric
disorders and neuro-rare diseases.
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.
Patent Portfolio: The
company is developing a broad global intellectual property portfolio, with over 100 patent applications in prosecution and multiple patents
issued as of January 31, 2023.
Fourth Quarter and Full Year 2022 Financial Results
Revenue: Net revenue was approximately $238,000 for the quarter and $375,000 for the
full year 2022, which resulted from early product trials and reflects limited market access. Due to the Company's direct shipping
model to hospitals, wholesaler stocking was neither expected nor occurred.
and Development (R&D) Expenses: R&D expenses were $32.5 million for the fourth quarter of 2022, compared to $12.5
million for the same period in 2021.
R&D expenses were $91.2 million for the full year 2022, compared
to $52.7 million for the same period in 2021. The increased expenses for both the fourth quarter and the full year were primarily attributable
to an increase in clinical trial costs related to multiple major pivotal BXCL501 clinical programs.
General and Administrative (SG&A) Expenses: SG&A expenses were $20.7 million for the fourth quarter of 2022,
as compared to $13.6 million for the same period in 2021.
SG&A expenses were $68.8 million for the full year 2022, as compared
to $54.2 million for 2021. The increased costs for both the fourth quarter and full year were primarily due to personnel and costs related
to the launch of IGALMI in the U.S.
Loss: BioXcel Therapeutics had a net loss of $54.8 million for the fourth quarter of 2022, compared to a net loss of
$26.1 million for the same period in 2021. For the full year, BioXcel Therapeutics reported a net loss of $165.8 million, compared to
a net loss of $106.9 million for the same period in 2021. The loss for the year includes approximately $17.3 million in non-cash stock-based
compensation. Total cash expenditures for 2022 totaled approximately $135.3 million.
Cash and cash equivalents totaled $193.7 million at December 31,
2022, compared to $233.0 million at December 31, 2021. To date in the first quarter of 2023, the Company utilized its existing at-the-market
equity facility and received net proceeds of approximately $24 million.
The Company believes that full execution of our strategic financing
with Oaktree and Qatar Investment Authority would result in a cash runway into 2025 for the Company.
Anticipated Milestones
BioXcel Therapeutics will host a conference call and webcast at 8:30
a.m. ET on March 9 to discuss its fourth quarter and full-year 2022 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 June 9,
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 is indicated for the acute treatment of agitation associated
with schizophrenia or bipolar I or II disorder in adults. Limitations of Use: The safety and effectiveness of IGALMI have
not been established beyond 24 hours from the first dose.
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
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 BioXcel Therapeutics, Inc.