BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq:
BTAI), a clinical-stage biopharmaceutical company utilizing
artificial intelligence approaches to develop transformative
medicines in neuroscience and immuno-oncology, today announced its
quarterly results for the first quarter ended March 31, 2021 and
provided an update on key strategic and operational initiatives.
“This quarter, we have remained committed to
executing on our vision for our neuroscience franchise, as we
continue to advance the development of BXCL501 for treatment of
agitation associated with dementia and prepare for its potential
approval in acute agitation associated with schizophrenia and
bipolar disorders,” stated Vimal Mehta, Chief Executive Officer of
BioXcel. “We are pleased to have recently received Breakthrough
Therapy designation for BXCL501 in agitation associated with
dementia, highlighting the urgent need for new therapy options, as
well as this candidate’s potential to provide a solution across
treatment settings. While we solidify our plans for a pivotal
program in this condition, we are committed to building the
commercial infrastructure needed to successfully launch BXCL501 in
the first two indications, in addition to follow-on indications in
the future.”
Dr. Mehta continued, “Importantly, we are moving
forward with our strategic geographic expansion strategy, with
plans to file a Marketing Authorization Application to the European
Medicines Agency for BXCL501 for the acute treatment of agitation
associated with schizophrenia and bipolar disorders in the second
half of 2021. As we continue to advance our innovative neuroscience
program, we remain committed to delivering transformative medicines
to patients, expanding our regulatory footprint and creating value
for our stockholders.”
First Quarter 2021 and Recent
Highlights
BXCL501-Neuroscience
Program
BXCL501 is an investigational, proprietary,
orally dissolving thin film formulation of dexmedetomidine, a
selective alpha-2 adrenergic receptor agonist, designed for the
treatment of agitation and opioid withdrawal symptoms. The Company
believes BXCL501 may directly target a causal agitation
mechanism.
- Reported positive topline results from the Phase 1b/2
TRANQUILITY trial of BXCL501 for the acute treatment of agitation
associated with dementia.
- Granted Breakthrough Therapy designation by the U.S. Food and
Drug Administration (“FDA”) to BXCL501 for the acute treatment of
agitation associated with dementia.
- End of Phase 2 meeting with the FDA planned in 2Q 2021 to
discuss registrational trial.
- Recruitment in 40 mcg supplemental dose cohort of BXCL501 in
TRANQUILITY expansion study is progressing well.
- Completed its New Drug Application (“NDA”) submission to the
FDA for BXCL501 for the acute treatment of agitation associated
with schizophrenia and the acute treatment of agitation associated
with bipolar disorders I and II.
- Plan to submit Marketing Authorization Application (“MAA”) with
European Medicines Agency (“EMA”) using SERENITY I and II data for
the acute treatment of agitation associated with schizophrenia and
bipolar disorders I and II in 2H 2021.
- Reported results from the Phase 1b/2 study of BXCL501 for the
treatment of opioid withdrawal symptoms. Primary safety endpoints
were met, and numerically improved retention rates, a
secondary endpoint, were demonstrated in multiple BXCL501 dose
cohorts.
- PLACIDITY enrollment was voluntarily paused to assess
challenges posed in opening relevant clinical sites and enrolling
delirium patients in the ICU setting, including as a result of the
burden COVID-19 has placed on ICUs.
- Strengthened BXCL501 IP portfolio with issuance of two Japanese
patents – Patent No. 6868698, directed to methods of treating
agitation, which will expire no earlier than 2037, and Patent No.
1681960, directed to film design, which will expire no earlier than
2041.
Commercial Highlights
- Launched “Boiling Point” educational campaign to raise
awareness about agitation associated with schizophrenia and bipolar
disorder and its impact on patients and clinicians.
- Completed U.S. market assessment initiatives and design of
sales force size and structure.
Medical Affairs Initiatives
- Deployed the Medical Science Liaison and Medical Manage Care
teams and have begun scientific and medical-to-medical exchange
with healthcare professionals and payers, respectively.
- Presented two posters covering data from the pivotal Phase 3
SERENITY trials in patients with acute agitation associated with
schizophrenia and bipolar disorders I and II at the American
Psychiatric Association (“APA”) Annual Meeting.
BXCL701-Immuno-Oncology
Program
BXCL701 is an orally-delivered small molecule,
immunomodulator designed to inhibit dipeptidyl peptidase ("DPP")
8/9 and block immune evasion by targeting Fibroblast Activation
Protein ("FAP"). It has shown single agent anti-tumor activity in
melanoma and safety has been evaluated in more than 700 healthy
subjects and cancer patients.
- The adenocarcinoma cohort of the ongoing Phase 1b/2 trial of
BXCL701 and pembrolizumab (KEYTRUDA®) in aggressive forms of
prostate cancer has met its efficacy bar to move to stage two. The
trial will now continue to full enrollment and more complete
efficacy data are expected to be presented at a scientific
conference later this year.
- Granted orphan drug designation by the FDA to BXCL701 for the
treatment of soft tissue sarcoma.
Corporate Highlights
- Appointed June Bray to the Company’s Board of Directors. Ms.
Bray brings over forty years of extensive U.S. and global
regulatory experience across all therapeutics areas, including
psychiatry and neurology.
- Appointed Javier Rodriguez as Chief Legal Officer and Corporate
Secretary. Mr. Rodriguez brings over 20 years of extensive
strategic and legal experience within the biopharmaceutical
industry.
First Quarter 2021 Financial
Results
Research and Development
Expenses: Research and development expenses were
$14.7 million during the first quarter of 2021, as compared to
$12.4 million for the same period in 2020. The higher expenses were
primarily attributable to an increase in personnel and related
costs necessary to enlarge our development and medical teams. In
addition, we experienced increased professional fees in conjunction
with higher consulting fees and CMC costs related to BXCL501, as
well as increased costs related to our RELEASE clinical trial.
These increases were offset in part by a decrease in SERENITY I and
II clinical trial costs.
General and Administrative
Expenses: General and administrative expenses were $11.6
million for the first quarter of 2021, as compared to $2.6 million
for the same period in 2020. The increase was primarily due to
higher personnel related costs as well as costs related to our
expansion in preparation of the potential commercial launch of
BXCL501 in the U.S., and increased legal, professional fees, and
insurance costs.
Net Loss: BioXcel reported
a net loss of $26.4 million for the first quarter of 2021, compared
to a net loss of $14.9 million for the same period in 2020.
The first quarter 2021 results include
approximately $5.6 million in non-cash stock-based compensation
costs, compared to non-cash stock-based compensation of $776,000
for the same period in 2020.
As of March 31, 2021, cash and cash equivalents
totaled approximately $194 million.
Conference Call
BioXcel will host a conference call and webcast
today at 8:30 a.m. ET. To access the call, please dial 877-407-2985
(domestic) and 201-378-4915 (international). A live webcast of the
call will be available on the Investors sections of the BioXcel
website and a replay of the call will be available through at least
May 24, 2021. BioXcel Therapeutics website is available at
www.bioxceltherapeutics.com.
BioXcel 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
automatically receive email alerts and other information about the
Company when you enroll your email address by visiting the “Email
Alerts” option under the News / Events menu of the Investors
section of its website at www.bioxceltherapeutics.com.
About BioXcel Therapeutics,
Inc.
BioXcel Therapeutics, Inc. is a clinical-stage
biopharmaceutical company utilizing artificial intelligence
approaches to develop transformative medicines in neuroscience and
immuno-oncology. BioXcel’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 indices. BioXcel’s two most
advanced clinical development programs are BXCL501, an
investigational, proprietary, orally dissolving thin film
formulation of dexmedetomidine for the treatment of agitation and
opioid withdrawal symptoms, and BXCL701, an investigational, orally
administered, systemic innate immunity activator in development for
the treatment of aggressive forms of prostate cancer and advanced
solid tumors that are refractory or treatment naïve to checkpoint
inhibitors. For more information, please visit
www.bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements in this press
release include but are not limited to the timing and data from
clinical trials for BXCL501 and BXCL701, the Company’s planned
commercial structure, the potential value of BXCL501 and BXCL701 as
treatment options, the Company’s geographic expansion program for
BXCL501, delivering transformative medicines to patients, expanding
the Company’s regulatory footprint and creating value for
stockholders. When used herein, words including “anticipate,”
“being,” “will,” “plan,” “may,” “continue,” and similar expressions
are intended to identify forward-looking statements. 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 BioXcel's current expectations and
various assumptions. BioXcel believes there is a reasonable basis
for its expectations and beliefs, but they are inherently
uncertain.
BioXcel 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; its limited experience in
drug discovery and drug development; its dependence on the success
and commercialization of BXCL501 and BXCL701 and other product
candidates; 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 BioXcel’s product candidates;
its approach to the discovery and development of product candidates
based on EvolverAI is novel and unproven; its exposure to patent
infringement lawsuits; its ability to comply with the extensive
regulations applicable to it; impacts from the COVID-19 pandemic;
its ability to commercialize its product candidates; and the other
important factors discussed under the caption “Risk Factors” in
Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2021, as such factors may further be updated from time to time
in its other filings with the SEC, accessible on the SEC’s website
at www.sec.gov and the Investors section of BioXcel’s website at
www.bioxceltherapeutics.com.
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 BioXcel 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 BioXcel’s
views as of any date subsequent to the date of this press
release.
BioXcel Therapeutics, Inc.
(BTAI)
Statement of Operations
(Unaudited, in thousands, except per
share amounts)
|
Three Months EndedMonth 31, |
|
|
2021 |
|
|
|
2020 |
|
Revenues |
$ |
– |
|
|
$ |
– |
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
Research and Development |
|
14,741 |
|
|
|
12,371 |
|
General and administrative |
|
11,638 |
|
|
|
2,625 |
|
Total operating expenses |
|
26,379 |
|
|
|
14,996 |
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
(26,379 |
) |
|
|
(14,996 |
) |
|
|
|
|
|
|
|
|
Other Income (expense) |
|
|
|
|
|
|
|
Interest income |
|
10 |
|
|
|
91 |
|
Interest expense |
|
(7 |
) |
|
|
(6 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(26,376 |
) |
|
$ |
(14,911 |
) |
|
|
|
|
|
|
|
|
Net loss per – basic and
diluted |
$ |
(1.08 |
) |
|
$ |
(0.79 |
) |
Weighted average shares
outstanding – basic and diluted |
|
24,524 |
|
|
|
18,968 |
|
|
|
|
|
|
|
|
|
BioXcel Therapeutics, Inc.
Condensed Balance Sheet
(Unaudited, in thousands)
|
March 31, |
|
December 31, |
|
2021 |
|
2020 |
|
|
|
|
Cash and cash equivalents |
|
194,015 |
|
|
|
213,119 |
|
Working capital |
184,459 |
|
|
205,223 |
|
Total assets |
200,389 |
|
|
219,936 |
|
Long-term liabilities |
1,328 |
|
|
1,398 |
|
Total liabilities |
13,652 |
|
|
13,240 |
|
Total stockholders’
equity |
186,737 |
|
|
206,696 |
|
|
|
|
|
Contact Information:
BioXcel Therapeutics,
Inc.www.bioxceltherapeutics.com
Investor Relations:
Mary ColemanBioXcel Therapeutics, VP of
Investment
RelationsMColeman@bioxceltherapeutics.com1.475.238.6837
John GrazianoSolebury
Troutjgraziano@soleburytrout.com1.646.378.2942
Media:
Julia DeutschSolebury
Troutjdeutsch@soleburytrout.com1.646.378.2967
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