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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 6, 2024
BioXcel
Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-38410 |
|
82-1386754 |
(State
or other jurisdiction of
incorporation) |
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification No.) |
555
Long Wharf Drive
New
Haven, CT
06511
(Address of principal executive offices, including
Zip Code)
(475)
238-6837
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed
since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant
to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common
Stock, par value $0.001 |
|
BTAI |
|
The Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 |
Results of Operations and Financial Condition. |
On August 6, 2024, BioXcel
Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months
ended June 30, 2024 and provided a business update. A copy of the Company’s press release is furnished as Exhibit 99.1
to this Current Report on Form 8-K and incorporated herein by reference.
The information disclosed
under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration
statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Date: August 6, 2024 |
BIOXCEL THERAPEUTICS, INC. |
| |
|
| |
/s/ Richard Steinhart |
| |
By: Richard Steinhart |
| |
Title: Chief Financial Officer |
Exhibit 99.1
BioXcel Therapeutics Reports Second Quarter
2024 Financial Results
Planning initiation of SERENITY At-Home pivotal
Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia
Advancing plans for TRANQUILITY In-Care pivotal
Phase 3 trial with BXCL501 for agitation associated with Alzheimer’s dementia
Reported positive
topline results from IGALMI™ post-marketing requirement (PMR) study
Conference call set for 8:00 a.m. ET today
NEW
HAVEN, Conn., August 6, 2024 — 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 second quarter of 2024.
“We are on track with our business priorities as we focus on
bringing BXCL501 to the greatest number of patients in need,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We are
pleased with the progress with our SERENITY and TRANQUILITY programs and our focused market-access strategy for IGALMI™. Our confidence
in our lead neuroscience asset is underpinned by its broad therapeutic potential across multiple neuropsychiatric conditions and its
growing intellectual property portfolio.”
Late-Stage Clinical Programs
| · | SERENITY
At-Home* Pivotal Phase 3 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. |
| o | Recently received feedback on
protocol from U.S. Food and Drug Administration (FDA). |
| · | TRANQUILITY
In-Care Pivotal Phase 3 Trial: designed to evaluate the efficacy and safety of
a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia (AAD). |
| o | Protocol being finalized for
planned submission to FDA. |
IGALMI™ (dexmedetomidine) Sublingual film
Post-marketing Requirement (PMR) Study
| · | Reported positive topline results from PMR study evaluating PRN (as-needed) treatment of IGALMI™ for agitation
associated with bipolar disorders or schizophrenia. |
| o | Study
achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal
with 180 mcg dose (highest approved dose). |
| o | Although
this PMR study was not statistically powered to evaluate repeat dose efficacy, a reduction
in agitation was observed for each episode occurring during the seven-day study period, and
no serious adverse events were reported following treatment. |
Commercialization
| · | IGALMI™
net revenue grew 90% in Q2 2024 over Q1 2024 driven by focused market-access strategy and
increased contracting with psychiatric care clinics and behavioral health facilities using
a small commercial team. |
Patent Portfolio
The Company continues to strengthen its intellectual
property portfolio for IGALMI™.
| · | Recently
received a U.S. Patent and Trademark Office (USPTO) Notice of Allowance for U.S. Patent Application
No. 18/526,686 for IGALMI™. Once issued by the USPTO, the patent is expected to
have an expiration date of January 12, 2043, and will be submitted for listing in the
FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known
as the "Orange Book"). |
| · | This
is expected to be the 11th listed U.S. patent for IGALMI™ in the Orange
Book. |
OnkosXcel Therapeutics
| · | Late-breaking
abstract on preliminary findings from a Phase 2 investigator-sponsored trial of BXCL701 and
KEYTRUDA® (pembrolizumab) in metastatic pancreatic ductal adenocarcinoma (PDAC)
presented at 2024 ASCO Annual Meeting by Dr. Benjamin Weinberg, Principal Investigator,
Georgetown University Lombardi Comprehensive Cancer Center. |
Second Quarter 2024 Financial Results
Net
Revenue: Net revenue from IGALMI was $1.1 million for the second quarter of 2024, compared to $457 thousand for the same period
in 2023, representing a 141% increase. Sequential
quarterly revenue increased 90% in Q2 2024 from Q1 2024. The increased revenue for both periods was primarily driven
by an increase in contracting with psychiatric care clinics and behavioral health facilities.
Research
and Development (R&D) Expenses: R&D expenses were $8.0 million
for the second quarter of 2024, compared to $27.0 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 $9.5 million for the second quarter of 2024, compared
to $25.9 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 second quarter of 2023, driven by the
Company’s strategic reprioritization announced in August 2023.
Net
Loss: BioXcel Therapeutics had a net loss of $8.3 million for the second quarter of 2024**, compared to a net loss of $53.5
million for the same period in 2023. The Company used $23.2 million in operating cash during the second quarter of 2024.
Cash and cash equivalents totaled $56.3 million as of June 30,
2024.
*SERENITY At-Home represents the redesigned SERENITY III trial.
**In the second quarter of 2024, the loss from operations of $17.3
million was offset by unrealized gains related to derivative liabilities.
Conference Call and Webcast
BioXcel
Therapeutics will host a conference call and webcast today, August 6, 2024, at 8:00 a.m. ET to discuss its second quarter 2024
financial results. To access the call, please dial 877-407-5795 or +1 201-689-8722. A live webcast will be available on the Investors
section of the corporate website, bioxceltherapeutics.com and a replay will be available for 90 days.
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 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.
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.
About BXCL501
Outside of its approved indication by the
U.S. Food and Drug Administration as IGALMI™ (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally
dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel
Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia 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 BXCL701
BXCL701 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 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 FDA in four
indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. The 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 Statements
This 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 commercial strategy for IGALMI; the Company’s current patent applications and
potential Orange Book submissions. 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: 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; the number of episodes of
agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain
may be based on a narrower definition of the patient population; 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 Quarterly Report on Form 10-Q for
the quarterly period ended June 30, 2024, 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 the Investors section of the Company’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 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
Corporate
BioXcel Therapeutics
Erik Kopp
1.203.494.7062
ekopp@bioxceltherapeutics.com
Investors
Russo Partners
Nic Johnson
1.303.482.6405
Nic.Johnson@russopartnersllc.com
Media
Russo Partners
David Schull
1.858.717.2310
David.schull@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
June 30, | |
|
Six months ended
June, | |
| | |
2024 | |
|
2023 | |
|
2024 | |
|
2023 | |
| Revenues | |
| | |
|
| | |
|
| | |
|
| | |
| Product revenues | |
$ | 1,104 | |
|
$ | 457 | |
|
$ | 1,686 | |
|
$ | 663 | |
| | |
| | |
|
| | |
|
| | |
|
| | |
| Operating expenses | |
| | |
|
| | |
|
| | |
|
| | |
| Cost of goods sold | |
| 62 | |
|
| 26 | |
|
| 141 | |
|
| 34 | |
| Research and development | |
| 8,032 | |
|
| 26,973 | |
|
| 19,433 | |
|
| 54,773 | |
| Selling, general and administrative | |
| 9,450 | |
|
| 25,872 | |
|
| 22,715 | |
|
| 49,467 | |
| Restructuring costs | |
| 856 | |
|
| - | |
|
| 856 | |
|
| - | |
| Total operating expenses | |
| 18,400 | |
|
| 52,871 | |
|
| 43,145 | |
|
| 104,274 | |
| Loss from operations | |
| (17,296 | ) |
|
| (52,414 | ) |
|
| (41,459 | ) |
|
| (103,611 | ) |
| Other (income) expense | |
| | |
|
| | |
|
| | |
|
| | |
| Interest expense, net | |
| 3,700 | |
|
| 3,259 | |
|
| 7,307 | |
|
| 6,627 | |
| Interest income | |
| (671 | ) |
|
| (1,621 | ) |
|
| (1,618 | ) |
|
| (3,636 | ) |
| Other (income) expense, net | |
| (12,026 | ) |
|
| (537 | ) |
|
| (12,058 | ) |
|
| (291 | ) |
| Net loss and comprehensive loss | |
$ | (8,299 | ) |
|
$ | (53,515 | ) |
|
$ | (35,090 | ) |
|
$ | (106,311 | ) |
| | |
| | |
|
| | |
|
| | |
|
| | |
| Net loss per share - basic and
diluted | |
$ | (0.21 | ) |
|
$ | (1.83 | ) |
|
$ | (0.99 | ) |
|
$ | (3.68 | ) |
| Weighted average shares outstanding - basic and
diluted | |
| 40,253 | |
|
| 29,187 | |
|
| 35,560 | |
|
| 28,903 | |
Condensed Balance Sheets
(Unaudited, in thousands)
| | |
June 30, | |
|
December 31, | |
|
|
|
|
|
|
|
|
| | |
2024 | |
|
2023 | |
|
|
|
|
|
|
|
|
| Cash
and cash equivalents | |
$ | 56,271 | |
|
$ | 65,221 | |
|
|
|
|
|
|
|
|
| Total assets | |
$ | 65,435 | |
|
$ | 73,702 | |
|
|
|
|
|
|
|
|
| Total liabilities | |
$ | 139,736 | |
|
$ | 130,210 | |
|
|
|
|
|
|
|
|
| Total stockholders'
equity (deficit) | |
$ | (74,301 | ) |
|
$ | (56,508 | ) |
|
|
|
|
|
|
|
|
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