Full Press Release Details
Therapeutics Reports Third Quarter 2024 Financial Results
two pivotal Phase 3 trials of BXCL501 for acute treatment of agitation associated with bipolar disorders,
schizophrenia, and Alzheimer's dementia
call set for 8:00 a.m. ET today
HAVEN, Conn., Nov. 14, 2024 - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial
intelligence to develop transformative medicines in neuroscience, today announced its financial
results for the third quarter of 2024.
focus continues to be the clinical development of BXCL501," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We
are advancing our SERENITY At-Home trial to pursue the near-term growth opportunity for treating acute agitation associated with bipolar
disorders or schizophrenia in the outpatient setting. At the same time, we are progressing with our TRANQUILITY In-Care trial planning
for Alzheimer's-associated agitation. We are driven by the needs of patients, caregivers, and healthcare providers, as well as the
market-expansion potential of our lead neuroscience asset."
BXCL501 Pivotal Phase 3 Trials
BXCL501 Investigator-Sponsored Trials
Company continues to strengthen its intellectual property portfolio for IGALMI (dexmedetomidine) sublingual film.
Third Quarter 2024 Financial Results
Revenue: Net revenue from IGALMI was $214 thousand for the third quarter of 2024, compared to $341
thousand for the same period in 2023. The decrease in sales was primarily due to the timing of re-orders from existing customers.
Net revenue of $1.9 million for the nine months ended September 30, 2024 increased 89% compared to $1.0 million for same period in 2023.
The increase in new customer acquisitions and increased sales activity reflects rising utilization.
of Goods Sold: Cost of goods sold for the three months ended September 30, 2024 and 2023, were $1.2 million and $512 thousand,
respectively. Cost of goods sold is related to the costs to produce, package, and deliver IGALMITM to customers, as well as
costs related to excess or obsolete inventory. The increase in Cost of goods sold for the three months ended September 30, 2024 is the
result of higher charges for reserves for excess or obsolete inventory compared to the same period in 2023. Charges for reserves for excess
or obsolete inventory were $1.2 million and $495 thousand in the three months ended September 30, 2024 and 2023, respectively.
and Development (R&D) Expenses: R&D expenses were $5.1 million for the third quarter of 2024, compared to $19.6 million for
the same period in 2023. The decreased expenses were primarily due to decreased clinical trial expenses, professional fees, as well as
personnel and related costs resulting from the Company's reprioritization in August 2023 and reduction in force in May 2024.
General and Administrative (SG&A) Expenses: SG&A expenses were $7.7 million for the third quarter of 2024, compared
to $24.3 million for the same period in 2023. The decreased expenses were primarily due to decreased personnel and related costs resulting
from the Company's reprioritization in August 2023 and reduction in force in May 2024, as well as decreased professional fees and
commercial expenses.
Loss: BioXcel Therapeutics had a net loss of $13.7 million for the third quarter of 2024, compared to a net loss of $50.5 million
for the same period in 2023. The Company used $16.3 million in operating cash during the third quarter of 2024.
and cash equivalents totaled $40.4 million as of September 30, 2024.
Conference Call and Webcast
Therapeutics will host a conference call and webcast today, November 14, 2024, at 8:00 a.m. ET to discuss its third quarter 2024 financial
results. To access the call, please dial 877-407-5795 or 201-689-8722. A live webcast
will be available on the Investors section of the corporate website, bioxceltherapeutics.com and a replay will be available for
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 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 your email address.
IGALMI (dexmedetomidine) sublingual film
(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.
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.
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.
Outside of its approved indication by the
U.S. Food and Drug Administration as IGALMI (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally
dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel
Therapeutics for the acute treatment of agitation associated with Alzheimer's dementia and for the acute treatment of agitation
associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational
uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation
associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders,
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative
medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in 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. For more information, please visit bioxceltherapeutics.com.
Forward-Looking Statements
press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of
1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained
in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements
contained in this press release other than statements of historical fact should be considered forward-looking statements, including,
without limitation, statements related to: the Company's planned advancement of its TRANQUILITY and SERENITY trials and the trial
designs thereof; potential market opportunity for BXCL501; the potential for the results from the Company's completed, ongoing
and proposed clinical trials to support regulatory approvals for its product candidates; the Company's current patent applications
and potential Orange Book listings. When used herein, words including "anticipate," "believe," "can,"
"continue," "could," "designed," "estimate," "expect," "forecast,"
"goal," "intend," "may," "might," "plan," "possible," "potential,"
"predict," "project," "should," "target," "will," "would" and
similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or
expressions. 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; the impact of the reprioritization; its significant
indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual
obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern;
its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success
and commercialization of IGALMI , BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of
agitation and the size of the Company's total addressable market may be overestimated, and approval that the Company may obtain
may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk
that IGALMI or the Company's product candidates may not be accepted by physicians or the medical community in general; the Company
still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical