Full Press Release Details
BioXcel Therapeutics Reports First Quarter
2024 Financial Results
Advancing TRANQUILITY and SERENITY program plans
for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation
Strengthened intellectual property portfolio
for BXCL501 with grant of two new patents, in Japan and the U.S.
Completed $25 million registered direct offering
Conference call set for 8:00 a.m. ET today
HAVEN, Conn., May 9, 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 first quarter of 2024.
"The fundamentals of our business are strong as we look to continue
advancing and expanding our agitation portfolio," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We have designed
two Phase 3 registrational programs for BXCL501 in addition to strengthening our balance sheet and intellectual property. We are intensely
focused on the BXCL501 journey into the at-home setting and expansion into Alzheimer's-related agitation with the goal of bringing
new treatment options to larger numbers of patients while expanding the market potential of our lead neuroscience asset."
TRANQUILITY and SERENITY Clinical Programs
IGALMI Post-Marketing Requirement (PMR) Study
IGALMI Commercialization
The Company continues to strengthen its intellectual
property portfolio with over 30 granted or allowed patents and more than 140 additional patent applications
in prosecution as of April 2024.
OnkosXcel Therapeutics
First Quarter 2024 Financial Results
Revenue: Net revenue from IGALMI was $582,000 for the first quarter of 2024, compared to $206,000 for the same period in 2023,
representing a 182% increase. Sequential quarterly revenue increased 55% in Q1
2024 from the fourth quarter of 2023. The increased revenue for both periods was primarily attributable to increasing
demand with existing customers, new customer orders, and volume-based contracting.
and Development (R&D) Expenses: R&D expenses were $11.4 million
for the first quarter of 2024, compared to $27.8 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 $13.3 million for the first quarter of 2024, compared
to $23.6 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 first quarter of 2023. The reduced expenses
were partially offset by increased professional fees in the first quarter of 2024.
Loss: BioXcel Therapeutics had a net loss of $26.8 million for the first quarter of 2024, compared to a net loss of $52.8 million
for the same period in 2023. The Company used $17.7 million in operating cash during the first quarter of 2024.
Cash and cash equivalents totaled $74.1
million as of March 31, 2024. This includes the $25 million from the registered direct offering announced on
Conference Call and Webcast
Therapeutics will host a conference call and webcast today, May 9, 2024, at 8:00 a.m. ET to discuss its first 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
through August 9, 2024.
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 your email address.
*SERENITY At-Home represents the redesigned SERENITY III trial.
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.
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.
In indications other than those approved by the U.S. Food and Drug
Administration (FDA) as IGALMI (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving
film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially
targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical trials across several
neuropsychiatric disorders. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with
dementia due to probable Alzheimer's disease 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, and dementia.
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 currently
being developed as 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 U.S. Food and Drug Administration
in four indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. The U.S. Food and
Drug Administration (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.
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