Full Press Release Details
Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update
Key BXCL501 data readouts expected
in mid-2020 - including results from the SERENITY program and the Phase 1b/2 TRANQUILITY trial in geriatric dementia
Strengthened balance sheet
through follow-on offering raising $60 million in net proceeds
NEW HAVEN, Conn., March 9, 2020 -- 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; |
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.
Strengthened Balance Sheet
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
Please note that these numbers do not include our recent financing,
which secured $60 million in net proceeds.
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.
BioXcel Therapeutics, Inc.:
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.
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.
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.
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.
(amounts in thousands, except share and
| 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
| 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 |