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
- Plans for two late-stage programs are advancing following
recently announced designs of pivotal Phase 3 trials:
- TRANQUILITY In-Care trial: designed
to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for
agitation associated with Alzheimer’s dementia (AAD).
- SERENITY At-Home* safety trial:
designed to evaluate the safety of a 120 mcg dose of BXCL501 in the
at-home setting for agitation associated with bipolar disorders or
schizophrenia.
- Study protocol submitted to
FDA.
IGALMI™ Post-Marketing Requirement (PMR)
Study
- Study was designed to evaluate
whether tolerance, tachyphylaxis, or withdrawal occur following
repeat dosing of IGALMI™ following seven days of repeated
treatment.
- Completed enrollment of
approximately 20 patients with frequent episodes of agitation for
bipolar disorders or schizophrenia in an open-label study.
- Patients self-administered 180 mcg
of IGALMI for repeated agitation episodes over the treatment
period.
- Initiated data cleaning to enable
database lock.
Corporate Updates
IGALMI™ Commercialization
- Net revenue grew 55% in Q1 2024 over
the prior quarter driven largely by volume contracting, new
customer acquisition, increased utilization among existing
customers, and the permanent J-Code for IGALMI that became
effective January 1, 2024.
Patent Portfolio 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.
- Recently granted two new patents for
BXCL501, in Japan and the U.S., with patent protection to 2039 and
2043, respectively.
- Eight currently listed U.S. patents
for IGALMI™ in the United States Food and Drug Administration's
(“FDA”) Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the "Orange Book"), with two
additional recently allowed patents that will be submitted for
listing in the Orange Book once issued by the USPTO.
OnkosXcel Therapeutics
- Announced late-breaking abstract selected for presentation at
2024 ASCO Annual Meeting on preliminary findings from a Phase 2
investigator-sponsored trial of BXCL701 and KEYTRUDA®
(pembrolizumab) in metastatic pancreatic ductal adenocarcinoma
(PDAC).
First Quarter
2024 Financial
Results
Net 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. Research
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.
Selling, 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.
Net 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 March 25, 2024.
Conference Call and
WebcastBioXcel 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.
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 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
INDICATION
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:
- Decreased blood pressure,
low blood pressure upon standing, and slower than normal heart
rate, which may be more likely in patients with low blood volume,
diabetes, chronic high blood pressure,
and older
patients. IGALMI is taken under the supervision of
a healthcare provider who will monitor vital signs (like blood
pressure and heart rate) and alertness after IGALMI is administered
to help prevent falling or fainting. Patients should be adequately
hydrated and sit or lie down after taking IGALMI and instructed to
tell their healthcare provider if they feel dizzy, lightheaded, or
faint.
- Heart rhythm changes (QT interval
prolongation). IGALMI should not be given to patients with
an abnormal heart rhythm, a history of an irregular heartbeat, slow
heart rate, low potassium, low magnesium, or taking other drugs
that could affect heart rhythm. Taking IGALMI with a history of
abnormal heart rhythm can increase the risk of torsades de pointes
and sudden death. Patients should be instructed to tell their
healthcare provider immediately if they feel faint or have heart
palpitations.
- Sleepiness/drowsiness. Patients should not
perform activities requiring mental alertness, such as driving or
operating hazardous machinery, for at least 8 hours after taking
IGALMI.
- Withdrawal reactions,
tolerance, and
decreased response/efficacy.
IGALMI was not studied for longer than 24 hours after the first
dose. Physical dependence, withdrawal symptoms (e.g., nausea,
vomiting, agitation), and decreased response to IGALMI may occur if
IGALMI is used longer than 24 hours.
The 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.
Patients 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 Information at igalmi.com.
About BXCL501In 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.
About BXCL701BXCL701 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
naïve 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.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 StatementsThis
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; its ongoing strategy for IGALMI; the
Company’s current patent applications; expected cash runway; . 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: [the outcome of
the Company’s discussions with Oaktree Capital Management and Qatar
Investment to amend its credit agreement;] 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; 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 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; the significant influence of and dependence on BioXcel
LLC; its exposure to patent infringement lawsuits; its reliance on
third parties; its ability to comply with the extensive regulations
applicable to it; impacts from data breaches or cyber-attacks, if
any; risks associated with the increased scrutiny relating to
environmental, social and governance (ESG) matters; risks
associated with federal, state or foreign health care “fraud and
abuse” laws; and its ability to commercialize its product
candidates, as well as the important factors discussed under the
caption “Risk Factors” in its Annual Report on Form 10-K for the
fiscal year ended December 31, 2023, as such factors may be updated
from time to time in its other filings with the SEC, including
without limitation its Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2024, which are accessible on the
SEC’s website at www.sec.gov. These and other important factors
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management’s
estimates as of the date of this press release. While the Company
may elect to update such forward-looking statements at some point
in the future, except as required by law, it disclaims any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon
as representing the Company’s views as of any date subsequent to
the date of this press release.
Contact Information
CorporateBioXcel Therapeutics Erik Kopp
1.203.494.7062ekopp@bioxceltherapeutics.com
Investor Relations BioXcel Therapeutics Brennan Doyle
1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso PartnersDavid Schull
1.858.717.2310David.schull@russopartnersllc.comScott
Stachowiak1.646.942.5630Scott.stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.
IGALMI™ is a trademark of BioXcel Therapeutics, Inc.BT BIOXCEL
THERAPEUTICS is a registered trademark of BioXcel Therapeutics,
Inc. All other trademarks are the properties of their respective
owners.Copyright © 2024, BioXcel Therapeutics, Inc. All rights
reserved.
BioXcel
Therapeutics, Inc. |
|
|
|
|
|
|
|
|
|
Statements
of Operations |
|
|
|
|
(Unaudited,
in thousands, except per share amounts) |
|
|
|
|
|
|
Three months ended
March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Revenues |
|
|
|
|
Product
revenues |
|
$ |
582 |
|
|
$ |
206 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Cost of
goods sold |
|
|
80 |
|
|
|
9 |
|
Research and
development |
|
|
11,401 |
|
|
|
27,800 |
|
Selling,
general and administrative |
|
|
13,264 |
|
|
|
23,595 |
|
|
|
|
|
|
Total
operating expenses |
|
|
24,745 |
|
|
|
51,404 |
|
Loss from
operations |
|
|
(24,163 |
) |
|
|
(51,198 |
) |
Other
(income) expense |
|
|
|
|
Interest
expense, net |
|
|
3,607 |
|
|
|
3,367 |
|
Interest
income |
|
|
(947 |
) |
|
|
(2,015 |
) |
Other
(income) expense, net |
|
|
(32 |
) |
|
|
246 |
|
Net loss and
comprehensive loss |
|
$ |
(26,791 |
) |
|
$ |
(52,796 |
) |
|
|
|
|
|
Net loss per
share - basic and diluted |
|
$ |
(0.87 |
) |
|
$ |
(1.84 |
) |
Weighted average shares outstanding - basic and diluted |
|
30,868 |
|
|
|
28,616 |
|
|
|
|
|
|
|
|
|
|
|
Condensed
Balance Sheets |
|
|
|
|
(Unaudited,
in thousands) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
74,141 |
|
|
$ |
65,221 |
|
Total
assets |
|
$ |
82,323 |
|
|
$ |
73,702 |
|
Total
liabilities |
|
$ |
154,686 |
|
|
$ |
130,210 |
|
Total
stockholders' equity (deficit) |
|
$ |
(72,363 |
) |
|
$ |
(56,508 |
) |
|
|
|
|
|
BioXcel Therapeutics (NASDAQ:BTAI)
Historical Stock Chart
From Jun 2024 to Jul 2024
BioXcel Therapeutics (NASDAQ:BTAI)
Historical Stock Chart
From Jul 2023 to Jul 2024