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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): March 30, 2026 (March 30, 2026)
Ensysce
Biosciences, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-38306 |
|
82-2755287 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
Number) |
7946
Ivanhoe Avenue, Suite 201
La
Jolla, California |
|
92037 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(858)
263-4196
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 to 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 $0.0001 per share |
|
ENSC |
|
The
Nasdaq Stock Market LLC |
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
March 30, 2026, Ensysce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results
for the fiscal quarter and year ended December 31, 2025. A copy of the press release is included as Exhibit 99.1 to this Current Report
on Form 8-K.
The
information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, nor will they be deemed to be incorporated by reference in any filing
under the Securities Act of 1933, as amended, except as will be expressly set forth by specific reference in such a filing.
Forward-Looking
Statements
This
report contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. These statements may be made directly in this report. Some of the forward-looking
statements can be identified by the use of forward-looking words. Statements that are not historical in nature, including the words “anticipate,”
“expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,”
“targets,” “projects,” “should,” “could,” “would,” “may,” “will,”
“forecast” and other similar expressions are intended to identify forward-looking statements. All forward-looking statements
are based upon management estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company as of
the date of this report, and may include, without limitation, changes in general economic and political conditions, all of which are
accordingly subject to change. Any such estimates, assumptions, expectations, forecasts, views or opinions set forth in this report constitute
the Company’s judgments and should be regarded as indicative, preliminary and for illustrative purposes only. The forward-looking
statements and projections contained in this report are subject to a number of factors, risks and uncertainties, some of which are not
currently known to the Company, that may cause the Company’s actual results, performance or financial condition to be materially
different from the expectations of future results, performance of financial condition. Although such forward-looking statements have
been made in good faith and are based on assumptions that the Company believes to be reasonable, there is no assurance that the expected
results will be achieved. The Company’s actual results may differ materially from the results discussed in forward-looking statements.
Additional information on factors that may cause actual results and the Company’s performance to differ materially is included
in the Company’s filings with the Securities and Exchange Commission (the “SEC”). Copies of such filings with the SEC
are available publicly on the SEC’s website at www.sec.gov or may be obtained by contacting the Company. Readers are cautioned
not to place undue reliance upon any forward-looking statements, which speak only as of the date made. These forward-looking statements
are made only as of the date hereof, and the Company does not undertake any obligations to update or revise the forward-looking statements,
whether as a result of new information, future events or otherwise, except as required by law.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
Number |
|
Description |
| |
|
|
| 99.1 |
|
Press
Release, dated March 30, 2026 |
| |
|
|
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
| Dated:
March 30, 2026 |
Ensysce
Biosciences, Inc. |
| |
|
|
| |
By: |
/s/
Lynn Kirkpatrick |
| |
Name: |
Dr.
Lynn Kirkpatrick |
| |
Title: |
President
and Chief Executive Officer |
| |
|
(Principal
Executive Officer) |
Exhibit
99.1
Ensysce
Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results
~
Fourth Quarter Highlighted by Clinical and Regulatory Milestones Positioning PF614 for Late-Stage Advancement ~
SAN
DIEGO, CA / March 30, 2026 / Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or the “Company”), a
clinical-stage pharmaceutical company developing innovative solutions for novel therapeutics while reducing the potential for abuse and
overdose, today reported financial and operational results for the fourth quarter and full year ended December 31, 2025.
“2025
was a year of meaningful progress for Ensysce, marked by significant clinical advancement, productive regulatory engagement, and continued
strengthening of our intellectual property portfolio,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences.
“We initiated our Phase 3 trial for PF614 and had constructive dialogue with the FDA supporting our manufacturing
pathway.”
Dr.
Kirkpatrick continued, “Enrollment in the PF614-301 Phase 3 study has progressed rapidly, while PF614-MPAR remains on an
accelerated development path under Breakthrough Therapy designation. In parallel, we have advanced commercial manufacturing readiness
for PF614 and have generated additional data supporting overdose-protection labeling for our MPAR platform. Beyond our late-stage
programs, we strengthened the long-term value of our technology platforms through expanded patent protection and pipeline growth,
including the advancement of PF9001 for opioid use disorder (OUD) and leveraging our TAAP™ and MPAR® technologies for additional
indications such as attention deficit hyperactivity disorder (ADHD).”
Program
Updates
TAAPTM
(Opioid Abuse Deterrent) Program Update
Ensysce’s
lead drug candidate, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone designed to deliver
effective pain relief while incorporating built-in abuse protection. Through proprietary chemical modification of oxycodone, PF614 remains
pharmacologically inactive until swallowed and exposed to trypsin in the small intestine, where it is activated to release oxycodone.
This mechanism is designed to preserve therapeutic efficacy while significantly reducing the potential for tampering and abuse.
In
December 2025, Ensysce announced the enrollment of the first patient in its pivotal Phase 3 clinical trial (PF614-301) evaluating PF614
for the treatment of moderate-to-severe post-surgical pain following abdominoplasty. The multicenter, randomized, double-blind, placebo-controlled
study is designed to assess whether PF614 can deliver potent and consistent analgesia while leveraging its unique chemical design to
mitigate the risk of opioid misuse. Clinical sites currently enrolling patients include CenExel JBR in Salt Lake City, Utah, and CenExcel
Atlanta under experienced principal investigators in anesthesiology and pain medicine. Enrollment in PF614-301 represents a major milestone
in Ensysce’s strategy to introduce a next generation of safer opioid medicines and advance PF614 toward regulatory submission and
potential commercialization.
MPAR®
(Opioid Abuse Deterrent and Overdose Protection) Program Update
PF614-MPAR
combines Ensysce’s TAAP™ chemistry with its proprietary MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology,
designed to actively limit opioid release when multiple pills are consumed beyond prescribed doses. PF614-MPAR incorporates a trypsin
inhibitor that automatically reduces opioid activation in overdose situations, effectively acting as a chemical “off-switch.”
Clinical data from the PF614-MPAR-101 study demonstrated that the MPAR® technology functioned as designed, providing overdose protection
at a 25 mg dose. These results supported the FDA’s Breakthrough Therapy designation granted in January 2024.
In
November 2025, the FDA provided encouraging feedback regarding the development pathway for PF614-MPAR, including support for
pursuing overdose-protection labeling and the potential use of a streamlined 505(b)(2) regulatory pathway, which could accelerate
development and market entry. The FDA and Ensysce are collaborating on a framework to define and communicate the safety benefits of
overdose-protection opioids, including development of a scientific whitepaper on overdose protection. This milestone, backed by
multi-year grants from the National Institute on Drug Abuse (NIDA), marks a significant step toward transforming opioid safety and
redefining pain management.
Opioid
Use Disorder (OUD) Program Update
In
addition to its pain management portfolio, Ensysce is developing treatments for opioid use disorder (OUD) designed to reduce cravings
and relapse risk while maintaining patient safety and quality of life. The Company selected PF9001 as its lead OUD candidate and is evaluating
the compound as a potential next-generation methadone alternative with built-in overdose protection, reduced cardiovascular risk and
an oral delivery profile. This program was supported by a multi-year HEAL (Helping to End Addiction Long-Term) grant and in collaboration
with NIDA.
Intellectual
Property Expansion
In
December 2025, the U.S. Patent and Trademark Office allowed a new patent covering Ensysce’s MPAR® technology, further strengthening
the Company’s intellectual property protection through 2042. The patent, titled “Compositions Comprising Enzyme-Cleavable
Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof,” includes both composition-of-matter and method-of-use
claims.
Ensysce
is also exploring the application of MPAR technology beyond opioids, including potential programs in amphetamines for ADHD and methadone
for OUD. In early January, Ensysce announced that the European patent office Provided Notice of Allowance in December 2025, for the issuance
of a Patent ‘Compositions Comprising Enzyme-Cleavable Amphetamine Prodrugs and Inhibitors Thereof’ for PF8026 protected by
the TAAP and MPAR technologies. These two issuances expand the potential reach of Ensysce’s platforms across multiple therapeutic
areas where abuse and overdose risk remain significant clinical challenges.
Fourth
Quarter and Full Year 2025 Financial Results
Cash
- Cash and cash equivalents were $4.3 million as of December 31, 2025, compared to $3.5 million as of December 31, 2024. Cash used
in operating activities totaled $7.8 million in 2025 compared to $7.5 million in 2024.
Federal
Grants - Funding under federal grants totaled $1.9 million for the fourth quarter of 2025 compared to $1.3 million in the comparable
year ago quarter. For the full year, funding from federal grants totaled $5.1 million in 2025, compared to $5.2 million in 2024. The
differences are due to the timing of research activities eligible for funding under the OUD and MPAR grants, as decreases in funding
under the OUD grant that ended in August 2024 were offset by increases in funding under the MPAR grant which began in September 2024.
Research
& Development Expenses - R&D expenses were $3.6 million for the fourth quarter of 2025 compared to $3.8 million for
the same period in 2024. Research and development expenses were $10.4 million for the year ended December 31, 2025, compared to $7.2
million for the year ended December 31, 2024, respectively, representing an increase of $3.2 million. The increase was primarily the
result of external research and development costs related to increased clinical and pre-clinical programs for PF614 and PF614-MPAR.
General
& Administrative Expenses - G&A expenses were $1.1 million in the fourth quarter of 2025, consistent with $1.1 million for
the fourth quarter of 2024. For 2025, G&A expenses were $4.9 million, representing an increase of $0.2 million compared to $4.7 million
for 2024.
Other
Income (Expense) - Total other income (expense) was income of $13,856 for the fourth quarter of 2025 compared to income of $12,054
in the same period of 2024. For 2025, total other income (expense), net was income of $64,759 compared to expense of $1.3 million for
2024. Other income and expense for the year ended December 31, 2025, consisted primarily of interest income from cash and cash equivalents.
Other income and expense for the year ended December 31, 2024, consisted primarily of interest expense associated with the amortization
of the original issue discount and the debt issuance costs associated with convertible notes issued in 2023.
Net
Income (Loss) - Net loss attributable to common stockholders for the fourth quarter of 2025 was $2.8 million compared to a net loss
of $3.6 million for the fourth quarter of 2024. For 2025, net loss was $10.2 million compared to $8.0 million for 2024. As a clinical
stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected
to result in losses for the foreseeable future.
About
Ensysce Biosciences
Ensysce
Biosciences is a clinical-stage pharmaceutical company dedicated to disrupting the analgesic landscape through the development of a new
class of safer opioid medicines for the treatment of severe pain. Leveraging its proprietary Trypsin-Activated Abuse Protection (TAAP™)
and Multi-Pill Abuse Resistance (MPAR®) platforms, Ensysce is advancing tamper-resistant therapeutic options designed to minimize
the risk of opioid abuse and oral overdose while preserving strong analgesic efficacy. For more information, visit www.ensysce.com.
Definitions
TAAP™:
trypsin activated abuse protection - designed to protect against prescription drug abuse.
MPAR®:
multi-pill abuse resistance - designed to protect against abuse and accidental overdose.
Forward-Looking
Statements
Statements
contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the
safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting
the foregoing, the use of words such as “may,” “intends,” “can,” “might,” “will,”
“expect,” “plan,” “possible,” “believe” and other similar expressions are intended to
identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that
the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays
in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking
statements are based on estimates and assumptions by Ensysce’s management that, although Ensysce believes to be reasonable, are
inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially
from those that Ensysce expected. In addition, Ensysce’s business is subject to additional risks and uncertainties, including among
others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies
and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce’s
product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations,
including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce’s and its partners’
ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of
material risks and uncertainties that are described in Ensysce’s most recent annual report on Form 10-K and current reports on
Form 8-K, which are available, free of charge, at the SEC’s website at www.sec.gov. Any forward-looking statement speaks only as
of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether
as a result of new information, future events or otherwise, except as required under applicable law.
Ensysce
Biosciences Company Contact:
Lynn
Kirkpatrick, Ph.D.
Chief
Executive Officer
(858)
263-4196
Ensysce
Biosciences Investor Relations Contact:
Shannon
Devine
MZ
North America
Main:
203-741-8811
ENSC@mzgroup.us
Ensysce
Biosciences, Inc.
Condensed
Consolidated Statements of Operations
| | |
Three Months Ended
December 31, | | |
Year
Ended
December 31, | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| Federal grants | |
$ | 1,882,336 | | |
$ | 1,303,659 | | |
$ | 5,066,650 | | |
$ | 5,210,031 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 3,613,029 | | |
| 3,802,630 | | |
| 10,376,895 | | |
| 7,219,437 | |
| General and administrative | |
| 1,051,132 | | |
| 1,077,505 | | |
| 4,930,701 | | |
| 4,720,728 | |
| Total operating expenses | |
| 4,664,161 | | |
| 4,880,135 | | |
| 15,307,596 | | |
| 11,940,165 | |
| Loss from operations | |
| (2,781,825 | ) | |
| (3,576,476 | ) | |
| (10,240,946 | ) | |
| (6,730,134 | ) |
| Total other income (expense), net | |
| 13,856 | | |
| 12,054 | | |
| 64,759 | | |
| (1,256,875 | ) |
| Net loss | |
$ | (2,767,969 | ) | |
$ | (3,564,422 | ) | |
$ | (10,176,187 | ) | |
$ | (7,987,009 | ) |
| Adjustments to net loss | |
| 321 | | |
| — | | |
| 487 | | |
| (216 | ) |
| Net loss attributable to common stockholders | |
$ | (2,767,648 | ) | |
$ | (3,564,422 | ) | |
$ | (10,175,700 | ) | |
$ | (7,987,225 | ) |
| Net
loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.75 |
) |
|
$ |
(2.90 |
) |
|
$ |
(3.98 |
) |
|
$ |
(11.45 |
) |
Ensysce
Biosciences, Inc.
Condensed
Consolidated Statements of Cash Flows
| | |
Year Ended December 31, | |
| | |
2025 | | |
2024 | |
| Net cash used in operating activities | |
$ | (7,806,292 | ) | |
$ | (7,502,700 | ) |
| Net cash used in investing activities | |
| (123,643 | ) | |
| — | |
| Net cash provided by financing activities | |
| 8,738,212 | | |
| 9,881,173 | |
| Change in cash and cash equivalents | |
| 808,277 | | |
| 2,378,473 | |
| Cash and cash equivalents at beginning of period | |
| 3,502,077 | | |
| 1,123,604 | |
| Cash and cash equivalents at end of period | |
$ | 4,310,354 | | |
$ | 3,502,077 | |
Ensysce
Biosciences, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
| | |
December 31, | | |
December 31, | |
| | |
2025 | | |
2024 | |
| Assets | |
| | |
| |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 4,310,354 | | |
$ | 3,502,077 | |
| Prepaid expenses and other current assets | |
| 2,932,114 | | |
| 1,842,605 | |
| Total current assets | |
| 7,242,468 | | |
| 5,344,682 | |
| Property and equipment, net and other assets | |
| 210,011 | | |
| 252,550 | |
| Total assets | |
$ | 7,452,479 | | |
$ | 5,597,232 | |
| | |
| | | |
| | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 3,267,610 | | |
$ | 1,357,079 | |
| Accrued expenses and other liabilities | |
| 993,411 | | |
| 548,458 | |
| Notes payable and accrued interest | |
| 306,708 | | |
| 301,660 | |
| Total current liabilities | |
| 4,567,729 | | |
| 2,207,197 | |
| Long-term liabilities | |
| — | | |
| 10,096 | |
| Total liabilities | |
| 4,567,729 | | |
| 2,217,293 | |
| Stockholders’ equity | |
| 2,884,750 | | |
| 3,379,939 | |
| Total liabilities and stockholders’ equity | |
$ | 7,452,479 | | |
$ | 5,597,232 | |
