Full Press Release Details
BioXcel Therapeutics Reports First Quarter 2021
Financial Results and Provides
Granted FDA Breakthrough Therapy designation
for BXCL501 for the acute treatment of agitation
associated with dementia; registrational program expected to begin in 2H 2021
Submitted NDA to FDA for BXCL501 for the acute
treatment of agitation associated with schizophrenia
and bipolar disorders
Strategic geographic market extension plans
for BXCL501 underway; expects to submit MAA to EMA
for the acute treatment of agitation associated with schizophrenia and bipolar disorders
Commercial readiness preparations ramping-up
for potential approval of BXCL501 in first two
Company to host conference call today at 8:30
NEW HAVEN, Conn., May 10, 2021 -- 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.
| 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. |
Commercial Highlights
Medical Affairs Initiatives
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
Corporate Highlights
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.
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
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.
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
na ve 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;