Full Press Release Details
BioXcel Therapeutics Reports Second Quarter
2024 Financial Results
Planning initiation of SERENITY At-Home pivotal
Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia
Advancing plans for TRANQUILITY In-Care pivotal
Phase 3 trial with BXCL501 for agitation associated with Alzheimer's dementia
topline results from IGALMI post-marketing requirement (PMR) study
Conference call set for 8:00 a.m. ET today
HAVEN, Conn., August 6, 2024 - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing
artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results
for the second quarter of 2024.
"We are on track with our business priorities as we focus on
bringing BXCL501 to the greatest number of patients in need," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are
pleased with the progress with our SERENITY and TRANQUILITY programs and our focused market-access strategy for IGALMI . Our confidence
in our lead neuroscience asset is underpinned by its broad therapeutic potential across multiple neuropsychiatric conditions and its
growing intellectual property portfolio."
Late-Stage Clinical Programs
IGALMI (dexmedetomidine) Sublingual film
Post-marketing Requirement (PMR) Study
The Company continues to strengthen its intellectual
property portfolio for IGALMI .
OnkosXcel Therapeutics
Second Quarter 2024 Financial Results
Revenue: Net revenue from IGALMI was $1.1 million for the second quarter of 2024, compared to $457 thousand for the same period
in 2023, representing a 141% increase. Sequential
quarterly revenue increased 90% in Q2 2024 from Q1 2024. The increased revenue for both periods was primarily driven
by an increase in contracting with psychiatric care clinics and behavioral health facilities.
and Development (R&D) Expenses: R&D expenses were $8.0 million
for the second quarter of 2024, compared to $27.0 million for the same period in 2023. The decreased expenses were primarily attributable
to the wind-down of the SERENITY III and TRANQUILITY II and III trials, as well
as decreased professional fees, personnel, and related costs.
General and Administrative (SG&A) Expenses: SG&A expenses were $9.5 million for the second quarter of 2024, compared
to $25.9 million for the same period in 2023. The reduced expenses were primarily attributable to a
decrease in personnel and costs associated with the commercialization of IGALMI compared to the second quarter of 2023, driven by the
Company's strategic reprioritization announced in August 2023.
Loss: BioXcel Therapeutics had a net loss of $8.3 million for the second quarter of 2024**, compared to a net loss of $53.5
million for the same period in 2023. The Company used $23.2 million in operating cash during the second quarter of 2024.
Cash and cash equivalents totaled $56.3 million as of June 30,
*SERENITY At-Home represents the redesigned SERENITY III trial.
**In the second quarter of 2024, the loss from operations of $17.3
million was offset by unrealized gains related to derivative liabilities.
Conference Call and Webcast
Therapeutics will host a conference call and webcast today, August 6, 2024, at 8:00 a.m. ET to discuss its second quarter 2024
financial results. To access the call, please dial 877-407-5795 or +1 201-689-8722. A live webcast will be available on the Investors
section of the corporate website, bioxceltherapeutics.com and a replay will be available for 90 days.
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.
About 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.
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.
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
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,
BXCL701 is an investigational, oral innate immune activator designed to initiate inflammation in the tumor
microenvironment. Approved and experimental immunotherapies often fail to address cancers that appear "cold." Therefore,
BXCL701 is being evaluated to determine if it can render "cold" tumors "hot," making them more detectable by
the adaptive immune system and thereby facilitating the development of a strong anticancer immune response. OnkosXcel Therapeutics'
preclinical data support BXCL701's potential synergy with both current checkpoint inhibitors and emerging immunotherapies directed
to activate T-cells. BXCL701 is a potential therapy for the treatment of aggressive forms of prostate cancer and advanced solid tumors
that are refractory or treatment na ve to checkpoint inhibitors. BXCL701 has received Orphan Drug Designation from the FDA in four
indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. The FDA designated as
a Fast Track development program the investigation of BXCL701 in combination with a checkpoint inhibitor for treatment of patients with
metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability.
An 800+-subject clinical database, with data collected by the Company and others, supports the ongoing development of BXCL701.
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
This 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