BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a
clinical-stage biopharmaceutical company utilizing artificial
intelligence to identify improved therapies in neuroscience and
immuno-oncology, today announced its quarterly results for the
fourth quarter and full year ended December 31, 2019 and provided
an update on key strategic and operational initiatives.
“2019 has been a tremendous year for BTI. We have made
significant growth in our two programs – BXCL501 and BXCL701 –
laying the groundwork to achieve key milestones in the coming
years,” stated Vimal Mehta, Chief Executive Officer of
BTAI. “In neuroscience, we have made momentous advancements in
the clinical development of BXCL501 and look forward to announcing
topline results from our SERENITY program and our Phase 1b/2
TRANQUILITY trial in dementia-related agitation in mid-2020.
Additionally, we have been dedicated to expanding the potential
therapeutic use of BXCL501, announcing a fourth indication last
month as well as examining biomarkers that may have relevance for a
range of hyperarousal disorders. We believe these therapeutic
opportunities, along with our plans to investigate BXCL501 for the
treatment of all types of agitation, are crucial steps to building
out a leading neuroscience franchise.”
Dr. Mehta added, “In addition to our ongoing studies with
BXCL701 in prostate and pancreatic cancers, we are also evaluating
this immuno-oncology candidate, in combination with KEYTRUDA®, in
multiple advanced solid tumors with the goal of improving treatment
responses to this PD-1 inhibitor. We believe this basket trial, led
by researchers at MD Anderson, will help to accelerate the
evaluation of BXCL701 and help to explore its full potential.”
Fourth Quarter 2019 and Recent Highlights
BXCL501-Neuroscience Program BXCL501 is an
investigational sublingual thin film of dexmedetomidine, a
selective alpha-2A adrenergic receptor agonist, designed for the
treatment of acute agitation. The Company believes BXCL501 may
directly target a causal agitation mechanism.
- We initiated pivotal Phase 3 trials for the acute treatment of
agitation in patients with schizophrenia (SERENITY I) and bipolar
disorder (SERENITY II). Enrollment of patients is on track and
topline data readouts from both trials are expected mid-2020;
- In January, the first patient was enrolled in the TRANQUILITY
study, a Phase 1b/2 trial of BXCL501 for the acute treatment of
agitation associated with geriatric dementia, expanding potential
therapeutic use of BXCL501 beyond current neuropsychiatric
disorders. BTI expects to report data in mid-2020;
- We received clearance from the U.S. Food and Drug
Administration for an Investigational New Drug application for the
treatment of opioid withdrawal symptoms, a potential fourth
indication for BXCL501;
- A Phase 2 study designed to measure biomarkers associated with
agitation in patients with schizophrenia and their response to
treatment with BXCL501 was initiated by researchers at Yale
University earlier last month, with data expected in Q2 2020.
BXCL701-Immuno-Oncology
Program-BXCL701 is an orally-delivered small molecule,
innate immunity activator designed to inhibit dipeptidyl peptidase
(DPP) 8/9 and block immune evasion by targeting Fibroblast
Activation Protein (FAP). It has shown single agent activity in
melanoma and safety has been evaluated in more than 700 healthy
subjects and cancer patients.
- We advanced the clinical evaluation of BXCL701 via the
initiation of an open-label Phase 2 basket trial, which is being
conducted at MD Anderson. This study is evaluating the combination
of BXCL701 and Pembrolizumab (KEYTRUDA®) in patients with advanced
solid cancers;
- The Company recently presented additional safety and
tolerability data from the first and second patient cohorts of the
Phase 1b/2 trial of BXCL701 and KEYTRUDA® for tNEPC at the American
Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO
GU). The trial is currently enrolling an expansion cohort to
explore the use of BID dosing. After the successful optimization of
BID dosing, the Company expects to advance to the efficacy stage of
the trial;
- The BXCL701 phase of the triple combination study of BXCL701,
bempegaldesleukin (NKTR-214, Nektar Therapeutics, Inc.) and
BAVENCIO® (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in
pancreatic cancer is expected to be initiated following Nektar and
Pfizer’s safety run-in trial of a double combination of
bempegaldesleukin and avelumab and the outcome of that
trial.
Strengthened Balance Sheet
- In February 2020, the Company raised net proceeds of $60
million in connection with its common stock offering. We believe
that these proceeds, together with current reserves, provide BTI
cash runway to fund key clinical, regulatory and operational
milestones into 2021.
Fourth Quarter and Full Year 2019 Financial
Results
BTI reported a net loss of $8.3 million for the fourth quarter
of 2019, compared to a net loss of $7.1 million for the same period
in 2018. The fourth quarter 2019 results include approximately $0.7
million in non-cash stock based compensation.
Research and development expenses were $6.5 million for the
fourth quarter of 2019, as compared to $6.0 million for the same
period in 2018. The increase was primarily due to an increase in
professional research and related project costs, salary, and
related payroll costs, manufacturing costs offset in part by a
decrease in clinical trial expenses.
General and administrative expenses were $1.9 million for the
fourth quarter of 2019, as compared to $1.3 million for the same
period in 2018. The increase was primarily due to increases in
salary, and related payroll costs and professional fees.
BTI reported a net loss of $33.0 million for the full year 2019,
compared to a net loss of $19.3 million for the same period in
2018.
Research and development expenses were $25.8 million for full
year 2019, as compared to $14.6 million for the same period in
2018. The increase was primarily due to clinical trial costs,
salary and related payroll costs, professional research and project
costs and manufacturing costs.
General and administrative expenses were $7.8 million for full
year 2019, as compared to $5.4 million for the same period in 2018.
The increase was primarily due to salary and related payroll costs
and professional fees.
As of December 31, 2019, cash and cash equivalents totaled
approximately $32.4 million.
Please note that these numbers do not include our recent
financing, which secured $60 million in net proceeds.
Conference Call:BTI 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 BTI website at www.bioxceltherapeutics.com. The replay will be
available through March 23, 2020.
About BioXcel Therapeutics,
Inc.:
BioXcel Therapeutics, Inc. is a clinical stage
biopharmaceutical company focused on drug development that utilizes
artificial intelligence to identify improved therapies in
neuroscience and immuno-oncology. BTI's drug re-innovation approach
leverages existing approved drugs and/or clinically evaluated
product candidates together with big data and proprietary machine
learning algorithms to identify new therapeutic indices. BTI's two
most advanced clinical development programs are BXCL501, an
investigational sublingual thin film formulation in development for
acute treatment of agitation resulting from neuropsychiatric
disorders, and BXCL701, an investigational orally administered
systemic innate immunity activator in development for treatment of
a rare form of prostate cancer and for treatment of pancreatic
cancer in combination with other immuno-oncology agents. 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 development initiatives and trials for BXCL501 and
BXCL701, the Company’s cash runway and the Company’s future growth
and position to execute on key milestones. 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
BTI's current expectations and various assumptions. BTI believes
there is a reasonable basis for its expectations and beliefs, but
they are inherently uncertain.
BTI 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 BTI’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; its ability to commercialize its
product candidates; and the other important factors discussed under
the caption “Risk Factors” in its Annual Report on Form 10-K for
the fiscal year ended December 31, 2019 as such factors may be
updated from time to time in its other filings with the SEC, 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 BTI 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 BTI’s views as
of any date subsequent to the date of this press release.
BIOXCEL THERAPEUTICS, INC.
BALANCE SHEETS
(amounts in thousands, except share and
per share data)
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
2019 |
|
2018 |
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
32,426 |
|
|
$ |
42,565 |
|
Prepaid expenses and other current assets |
|
1,681 |
|
|
|
491 |
|
Due from Parent |
|
— |
|
|
|
115 |
|
Total current assets |
|
34,107 |
|
|
|
43,171 |
|
Property and equipment,
net |
|
1,041 |
|
|
|
327 |
|
Operating lease right-of-use
asset |
|
1,193 |
|
|
|
— |
|
Other assets |
|
51 |
|
|
|
51 |
|
Total assets |
$ |
36,392 |
|
|
$ |
43,549 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
4,953 |
|
|
$ |
1,604 |
|
Accrued expenses |
|
3,120 |
|
|
|
3,056 |
|
Due to Parent |
|
64 |
|
|
|
— |
|
Other current liabilities |
|
331 |
|
|
|
— |
|
Total current liabilities |
|
8,468 |
|
|
|
4,660 |
|
|
|
|
|
|
|
Operating lease liability |
|
1,029 |
|
|
|
— |
|
|
|
|
|
|
|
Total
liabilities |
|
9,497 |
|
|
|
4,660 |
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
Preferred stock, $0.001 par
value, 10,000,000 shares authorized; no shares issued or
outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value, 50,000,000 shares authorized; 18,087,382 and 15,663,221
shares issued and outstanding as of December 31, 2019 and
December 31, 2018, respectively |
|
18 |
|
|
|
16 |
|
Additional
paid-in-capital |
|
83,565 |
|
|
|
62,593 |
|
Accumulated deficit |
|
(56,688 |
) |
|
|
(23,720 |
) |
Total stockholders'
equity |
|
26,895 |
|
|
|
38,889 |
|
Total liabilities and
stockholders' equity |
$ |
36,392 |
|
|
$ |
43,549 |
|
BIOXCEL THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
(amounts in thousands, except share and
per share data)
|
|
|
|
|
|
|
2019 |
|
2018 |
Revenues |
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
Operating costs and
expenses |
|
|
|
|
|
Research and development |
|
25,797 |
|
|
|
14,558 |
|
General and administrative |
|
7,804 |
|
|
|
5,404 |
|
Total operating expenses |
|
33,601 |
|
|
|
19,962 |
|
Loss from operations |
|
(33,601 |
) |
|
|
(19,962 |
) |
Other income |
|
|
|
|
|
Dividend and interest income, net |
|
633 |
|
|
|
692 |
|
Net loss |
$ |
(32,968 |
) |
|
$ |
(19,270 |
) |
|
|
|
|
|
|
Net loss per share
attributable to common stockholders/ Parent basic and diluted |
$ |
(2.02 |
) |
|
$ |
(1.32 |
) |
|
|
|
|
|
|
Weighted average shares
outstanding - basic and diluted |
|
16,289,175 |
|
|
|
14,571,553 |
|
BIOXCEL THERAPEUTICS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY (DEFICIT)
(amounts in thousands, except share and
per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
Common Stock |
|
Paid in |
|
Accumulated |
|
|
|
|
|
Shares |
|
Amount |
|
Capital |
|
Deficit |
|
Total |
Balance as of January 1, 2018 |
|
9,907,548 |
|
$ |
10 |
|
$ |
3,458 |
|
$ |
(4,450 |
) |
|
$ |
(982 |
) |
Issuance of common stock |
|
283,452 |
|
|
1 |
|
|
1,949 |
|
|
— |
|
|
|
1,950 |
|
Issuance of common stock, upon completion of Initial Public
Offering, net of issuance costs of $5,898 |
|
5,454,545 |
|
|
5 |
|
|
54,097 |
|
|
— |
|
|
|
54,102 |
|
Stock-based compensation |
|
— |
|
|
— |
|
|
3,082 |
|
|
— |
|
|
|
3,082 |
|
Exercise of stock options |
|
17,676 |
|
|
— |
|
|
7 |
|
|
— |
|
|
|
7 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(19,270 |
) |
|
|
(19,270 |
) |
Balance as of December 31,
2018 |
|
15,663,221 |
|
$ |
16 |
|
$ |
62,593 |
|
$ |
(23,720 |
) |
|
$ |
38,889 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net of issuance costs of $1,991 |
|
2,369,223 |
|
$ |
2 |
|
$ |
17,808 |
|
$ |
— |
|
|
$ |
17,810 |
|
Stock-based compensation |
|
|
|
|
— |
|
|
3,142 |
|
|
— |
|
|
|
3,142 |
|
Exercise of stock options |
|
54,938 |
|
|
— |
|
|
22 |
|
|
— |
|
|
|
22 |
|
Net loss |
|
|
|
|
— |
|
|
— |
|
|
(32,968 |
) |
|
|
(32,968 |
) |
Balance as of December 31,
2019 |
|
18,087,382 |
|
$ |
18 |
|
$ |
83,565 |
|
$ |
(56,688 |
) |
|
$ |
26,895 |
|
BIOXCEL THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(amounts in thousands, except share and
per share data)
|
|
|
|
|
|
|
Year ended December 31, |
|
2019 |
|
2018 |
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
|
Net loss |
$ |
(32,968 |
) |
|
$ |
(19,270 |
) |
Reconciliation of net loss to
net cash used in operating activities |
|
|
|
|
|
Depreciation and amortization |
|
156 |
|
|
|
17 |
|
Stock-based compensation expense |
|
3,142 |
|
|
|
3,082 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Prepaid expenses and other assets |
|
(1,190 |
) |
|
|
(539 |
) |
Accounts payable, accrued expenses and other liabilities |
|
3,580 |
|
|
|
3,201 |
|
Net cash used in operating
activities |
|
(27,280 |
) |
|
|
(13,509 |
) |
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
|
Purchase of equipment |
|
(870 |
) |
|
|
(340 |
) |
Net cash used in investing
activities |
|
(870 |
) |
|
|
(340 |
) |
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
Proceeds from issuance of
common stock, net |
|
17,810 |
|
|
|
56,513 |
|
Exercise of options |
|
22 |
|
|
|
7 |
|
Payable to Parent for
services |
|
— |
|
|
|
(67 |
) |
Due to Parent |
|
179 |
|
|
|
(555 |
) |
Note Payable — Parent |
|
— |
|
|
|
(371 |
) |
Net cash provided by financing
activities |
|
18,011 |
|
|
|
55,527 |
|
|
|
|
|
|
|
Net (decrease) increase in
cash and cash equivalents |
|
(10,139 |
) |
|
|
41,678 |
|
|
|
|
|
|
|
Cash and cash equivalents,
beginning of the period |
|
42,565 |
|
|
|
887 |
|
Cash and cash equivalents, end
of the period |
$ |
32,426 |
|
|
$ |
42,565 |
|
|
|
|
|
|
|
Supplemental cash flow
information: |
|
|
|
|
|
Interest paid |
$ |
62 |
|
|
$ |
1 |
|
|
|
|
|
|
|
Supplemental disclosure of
non-cash Operating, Investing and Financing Activities: |
|
|
|
|
|
Deferred issuance costs reclassified to additional paid-in-capital
upon completion of initial public offering |
$ |
— |
|
|
$ |
461 |
|
Right-of-use asset obtained in exchange for new operating lease
liability |
$ |
1,308 |
|
|
|
— |
|
Contact Information:
BioXcel Therapeutics,
Inc.www.bioxceltherapeutics.com
Investor Relations: John Graziano jgraziano@troutgroup.com
1.646.378.2942
Media: Julia Deutsch jdeutsch@troutgroup.com
1.646.378.2967
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