Full Press Release Details
BioXcel Therapeutics Reports First Quarter 2022
Financial Results and Recent Operational Highlights
FDA approval of IGALMI (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia
or bipolar I or II disorder in adults
Top-line data readout in Q4 2022/early Q1 2023
for TRANQUILITY II Phase 3 trial evaluating BXCL501 in acute treatment of agitation associated with Alzheimer's disease
Extended cash runway into 2025 with $260 million
strategic financing for IGALMI commercial launch and clinical and regulatory milestones
U.S. national salesforce deployment to commence
To host conference call today, May 9, 2022,
HAVEN, Conn., May 9, 2022 -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a
commercial-stage 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, 2022 and provided an update
on key strategic initiatives.
"2022 has already been a transformative year during which we
have made monumental progress on our journey to become the leading AI-enabled neuroscience company. Our recent achievements across our
clinical, business, and commercial priorities, highlighted by our first FDA approval of IGALMI, have positioned us to realize our 2022
goals and beyond," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "Building on this momentum, we are excited to launch
IGALMI, advance our proven technology, and continue delivering innovative medicines to patients and caregivers."
Neuroscience Franchise
IGALMI Approval and Commercial Launch
was approved by the FDA on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder
in adults.1 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each
The Company is focused on the following key commercial launch activities
to provide access to patients and caregivers:
BXCL501, a proprietary, sublingual film formulation of dexmedetomidine,
is being investigated in multiple neuropsychiatric conditions. BXCL501 has received Breakthrough Therapy and Fast Track designation for
the acute treatment of agitation associated with dementia.
Indication Expansion
Geographic Expansion
OnkosXcel Therapeutics
Established OnkosXcel Therapeutics as a wholly owned subsidiary
to focus on the sustained expansion and optimization of the Company's immuno-oncology (I-O) franchise, including its most advanced
I-O program, BXCL701. BXCL701 is an investigational, orally administered, systemic innate immune activator in development for the treatment
of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment na ve to checkpoint inhibitors.
First Quarter 2022 Financial Results
and Development Expenses: Research and development expenses were $18.6 million for the first quarter of 2022, compared to $14.7
million for the same period in 2021. The increased expenses were primarily attributable to clinical trial costs related to the Company's
TRANQUILITY program.
and Administrative Expenses: General and administrative expenses were $12.9
million for the first quarter of 2022, as compared to $11.6 million for the same period in 2021. The increase was primarily due to personnel
and costs related to the commercial launch readiness efforts for IGALMI in the U.S.
Loss: BioXcel Therapeutics reported a net loss of $31.5 million for the first
quarter of 2022, compared to a net loss of $26.4 million for the same period in 2021.
As of March 31, 2022, cash and cash equivalents totaled approximately
$200 million. This excludes contributions from the $260 million strategic financing announced in April. To date the Company has drawn
$70M of the loan agreement and has met the milestone to receive $30M of the royalty financing which is expected to be drawn in the second
Therapeutics will host a conference call and webcast May 9, 2022, at 8:30 a.m., ET, to discuss its first 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 BioXcel website, www.bioxceltherapeutics.com,
and a replay of the call will be available through August 9, 2022.
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 TRANQUILITY II and III
Initiated in December of 2021, TRANQUILITY
II and III are pivotal Phase 3 trials evaluating BXCL501 for the acute treatment of agitation in patients with Alzheimer's disease.
The trials expand the evaluation of patients who experience agitation across diverse medical settings and across the range of dementia
severity. TRANQUILITY II and III are designed to maximize the opportunity of BXCL501 for the 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 40 mcg or 60
mcg of BXCL501 or placebo whenever agitation episodes occur over a three-month period. TRANQUILITY II 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)
and Pittsburgh Agitation Scale (PAS) total scores. The primary efficacy endpoint for both studies is change in PEC score from baseline
measured at two hours after the initial dose and subsequent doses.
About BioXcel Therapeutics, Inc.
Therapeutics, Inc. is a commercial-stage 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
indices. The Company's commercial product, IGALMI (developed as BXCL501) is a proprietary, sublingual film formulation
of dexmedetomidine approved by the FDA 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. BXCL501 is also being
evaluated for the acute treatment of agitation associated with Alzheimer's disease, and as an adjunctive treatment for major depressive
disorder. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia and, under its subsidiary OnkosXcel
Therapeutics, BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms
of prostate cancer and advanced solid tumors that are refractory or treatment na ve to checkpoint inhibitors. For more information,
please visit www.bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but
are not limited to the commercialization and medical affairs plans for IGALMI, timing and data from clinical trials for BXCL501 and BXCL701,
the timing of the Company's MAA application for BXCL501, and future financial and operational results. When used herein, words including
"anticipate," "will," "plan," "may," "continue," "intend," "designed,"
"goal" and similar expressions are intended to identify forward-looking statements. 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; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI ,
BXCL501, BXCL502 and BXCL701 and other product candidates; the Company has no experience in marketing and selling drug products; IGALMI
or the Company's product candidates may not be accepted by physicians or the medical community in general; 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; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations