Full Press Release Details
BioXcel Therapeutics Reports Third Quarter 2022
Financial Results and Recent Operational Highlights
IGALMI (dexmedetomidine) well-positioned
for growth in 2023 based on increasing market access, efficient targeting, favorable market drivers, and sales force expansion in all
major U.S. geographies
Top-line pivotal data for TRANQUILITY II trial
investigating BXCL501 for Alzheimer's-related agitation expected in 1H 2023
Top-line pivotal data for SERENITY III trial
investigating at-home use of BXCL501 for acute treatment of bipolar and schizophrenia-related agitation expected in 1H 2023
Completed multiple, seven-day daily dosing regimen
cohorts in ongoing Phase 1 dose-selection trial in healthy volunteers to assess Major Depressive Disorder (MDD) program for at-home use;
top-line results expected in 1H 2023
To host conference call today, November 10,
2022, at 8:30 a.m. ET
HAVEN, Conn., Nov. 10, 2022 -- 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 third quarter ended September 30, 2022 and provided an update on key strategic initiatives.
"In the four months since IGALMI's trade launch, BioXcel
Therapeutics is advancing its leadership position in the agitation-treatment market," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics.
"In parallel, we are anticipating pivotal trial data readouts investigating BXCL501 for the treatment of Alzheimer's-related
agitation, and bipolar and schizophrenia-related agitation in an at-home setting. We are well-positioned to potentially capture 139 million
annual agitation episodes in the U.S.1-5 Our company is rooted in AI-driven innovation, and we are proud to be at the forefront
of developing transformative medicines in neuroscience."
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.6 Up to 16 million institutional episodes occur annually within these two patient
populations in the U.S.1-3
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:
SERENITY III is expected to utilize similar investigators
and clinical sites as the SERENITY I and II trials, which formed the basis for the FDA's approval of IGALMI.
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, orally administered, systemic innate immune activator in development for the combination treatment of aggressive
forms of prostate cancer.
Enhanced Intellectual Property:
Third Quarter 2022 Financial Results
Revenue: Net revenue of $137,000 for the quarter resulted from early product trial with limited market access. Due to
the Company's direct shipping model to hospitals, no wholesaler stocking was expected.
and Development (R&D) Expenses: R&D expenses were $22.1 million for the third quarter of 2022, compared to $11.9
million for the same period in 2021. The increased expenses were primarily attributable to an increase in clinical trial costs as the
Company expanded its BXCL501 clinical program for Alzheimer's-related agitation, at-home use, and MDD.
General and Administrative (SG&A) Expenses: SG&A expenses were $17.1 million for the third quarter of 2022, as
compared to $14.9 million for the same period in 2021. The increase was primarily due to personnel and costs related to the launch of
Loss: BioXcel Therapeutics reported a net loss of $41.8 million for the third quarter of 2022, compared to a net loss
of $26.8 million for the same period in 2021. The Company used $31.5 million in operating cash during the third quarter.
As of September 30, 2022, cash and cash equivalents totaled approximately
BioXcel Therapeutics will host a conference call and webcast November 10,
2022, at 8:30 a.m., ET, to discuss its third quarter 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 of the call will be available on
the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through February 10,
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 TRANQUILITY II and III
TRANQUILITY II and III are pivotal Phase 3 trials evaluating BXCL501
for the acute treatment of agitation in patients with probable Alzheimer's disease (AD). The trials include patients who experience
agitation across diverse medical settings and across the range of dementia severity. On days when an acute episode of agitation arises,
and pharmacological treatment is necessary, the efficacy and safety of dosing is assessed. TRANQUILITY II and III are designed to evaluate
the safety and efficacy of BXCL501 for the potential treatment of the full spectrum of agitation associated with AD. Each trial will enroll
approximately 150 dementia patients 65 years and older who will self-administer 40mcg or 60mcg of BXCL501 or placebo whenever agitation
episodes occur over a three-month period. TRANQUILITY II initiated in December 2021, and will assess patients in assisted living
or residential facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will assess patients residing
in nursing homes with moderate to severe dementia and require moderate or greater assistance with activities of daily living. The studies
will assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC)
total score, and include Pittsburgh Agitation Scale (PAS) scores and Clinical Global Impression (CGI). The primary efficacy endpoint for
both studies is change in PEC total score from baseline measured at two hours after the initial dose.
SERENITY III is a double-blinded, placebo-controlled, pivotal study
designed to evaluate BXCL501 60mcg dose for at-home use. This strategic trial decision follows a Type B meeting with the U.S. FDA and
observed dose-dependent responses in a prior Phase 1/2b study assessing 20mcg, 60mcg, 80mcg, 120mcg, and 180mcg doses. The first part
of SERENITY III is similar to the SERENITY I and II pivotal trials and is designed to assess the efficacy and safety in acutely agitated
patients with bipolar disorder or schizophrenia. The primary efficacy endpoint is change from baseline in Positive and Negative Syndrome
Scale-Excitatory Component (PEC) total score at two hours after dosing compared to placebo. The second part of SERENITY III is designed
to assess safety of 60 mcg doses compared to placebo when self-administered at home. SERENITY III is expected to utilize many of the same
investigators and clinical sites as SERENITY I and II.