Full Press Release Details
BioXcel Therapeutics Reports Second Quarter
2023 Financial Results and Announces Strategic Reprioritization
Business to prioritize high-potential agitation
market opportunities for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer's disease
Commercial reprioritization intended to reduce
related expenses by 80% with focus on market access through contracting with large hospital systems (IDNs)
Requested meeting with FDA to discuss TRANQUILITY
II, audit plan, and data package to support potential submission of sNDA for BXCL501 in patients with agitation associated with mild to
moderate dementia due to probable Alzheimer's disease
SERENITY III Phase 3 trial (part 2) protocol
amendment in process to evaluate BXCL501 80 mcg dose for at-home use in bipolar disorder or schizophrenia agitation
Cash runway post-strategic reprioritization,
expected through mid-2024; discussions underway with existing strategic finance partners
Company to host conference call at 8:00 a.m. ET
HAVEN, Conn., August 14, 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 second quarter ended June 30, 2023, and a strategic reprioritization to strengthen its focus and significantly reduce
Strategic Reprioritization and Clinical Development Initiatives
Following a comprehensive review of the
business, the Company has determined to focus on high-potential agitation-market opportunities using its innovative, AI-based clinical
drug development platforms. The Company intends to reduce more than 50% of its cash burn to approximately $80 million on a go-forward
annualized basis. The Company will also be reducing its workforce from approximately 190 to 80 employees. These actions include a shift
in commercial strategy for IGALMI in the institutional setting, a reduction of in-hospital commercialization expenses, a
suspension of programs no longer deemed core to the Company's business, and a shift in focus to develop BXCL501 for use in the at-home
setting in the treatment of agitation in schizophrenia, bipolar disorders, and in patients with mild to moderate dementia due to probable
Alzheimer's disease.
are shifting our primary focus to development in the at-home setting while maintaining our value-creating core capabilities ranging from
AI innovation to commercialization," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "Our AI-driven drug re-innovation
approach has led to the capital-efficient development of product candidates in underserved therapeutic areas. We intend to prioritize
our resources to develop BXCL501 for use in assisted living facility (ALF) and at-home settings and continue to advance our neuroscience
pipeline. Unfortunately, this reprioritization requires us to reduce
our workforce. We are grateful to all employees for their contributions and will support those who are impacted through their transitions."
Strengthened Focus on At-home Market Opportunities for BXCL501
TRANQUILITY Program: Alzheimer's Dementia Agitation
SERENITY Program: Agitation Associated with Bipolar Disorders or
Schizophrenia (At-Home Use)
Adjunctive treatment in Major Depressive Disorder (MDD)
Neuroscience Pipeline Development
IGALMI Commercialization
IGALMI continued to build on its momentum through the second quarter,
climbing to over 185 formulary approvals and unlocking up to $80 million in market potential. There are more than 650 additional
formulary reviews scheduled, representing up to an additional $275 million in bipolar and schizophrenia agitation market opportunity.
Recent substantial orders through the contracting process resulted in the doubling of Q2 revenues sequentially, a process which the Company
will emphasize moving forward.
OnkosXcel Therapeutics Immuno-oncology Subsidiary
Second Quarter 2023 Financial Results
Revenue: Net revenue of IGALMI was approximately $457 thousand for the quarter.
and Development (R&D) Expenses: R&D expenses were $27.0 million for the second quarter of 2023, compared to $17.9 million
for the same period in 2022. The increased expenses were primarily attributable to increased clinical trial expenses for SERENITY III
General and Administrative (SG&A) Expenses: SG&A expenses were $25.9 million for the second quarter of 2023, compared
to $18.4 million for the same period in 2022. The increased expenses were primarily attributable to an increase in personnel and related
costs to support the commercialization of IGALMI .
Loss: BioXcel Therapeutics had a net loss of $53.5 million for the second quarter of 2023, compared to a net loss of $37.7
million for the same period in 2022. The loss for the quarter included approximately $6.1 million in non-cash stock-based compensation.
and cash equivalents totaled $127.5 million as of June 30, 2023. As noted above, the Company is undertaking a strategic reprioritization,
which includes a reduction in force of more than 50%, that is expected to reduce expenses significantly. In
the absence of additional capital becoming available to the Company under the strategic financing agreements or otherwise, the Company
estimates that its current cash and cash equivalents will last through mid-2024.
The Company's previously disclosed cash runway projection assumed
the full utilization of its strategic financing agreements ($155 million of potential additional availability) with Oaktree Fund Administration
LLC and Qatar Investment Authority. Based on recent events, the Company is not likely to be in a position to meet the milestones
required to access additional capital under the financing agreements. The Company has initiated discussions with its strategic financing
partners to amend the agreements. Successful modification of these agreements could further extend the Company's cash runway.
Therapeutics will host a conference call and webcast on August 14, 2023 at 8:00 a.m. ET to discuss its second 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 November 14, 2023.
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 sign up to automatically receive email alerts and other information about the Company by visiting the
"Email Alerts" option under the News/Events section of the Investors & Media website section and submitting
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:
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.
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 at igalmi.com.
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
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 have 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
of agitation associated with Alzheimer's disease, and as an adjunctive treatment for major depressive disorder. The safety and efficacy